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Procedure : 2008/0240(COD)
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Texts tabled :

A7-0196/2010

Debates :

PV 22/11/2010 - 18
CRE 22/11/2010 - 18

Votes :

PV 24/11/2010 - 8.5
Explanations of votes
Explanations of votes

Texts adopted :

P7_TA(2010)0431

Debates
Wednesday, 24 November 2010 - Strasbourg OJ edition

9. Explanations of vote
Video of the speeches
PV
  

Oral explanations of vote

 
  
  

Report: Christofer Fjellner (A7-0290/2010)

 
  
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  Jarosław Kalinowski (PPE).(PL) Mr President, to protect public health effectively, it is essential to ensure patients have extensive access to high quality information about medicines. Harmonisation of the law in this field will allow us to ensure a high level of awareness among European patients and will help to even out differences in the health situation in all Member States. In addition, making legislation more detailed, and in particular the obligation to ensure that patients have access to information, will allow us to prevent pharmaceutical companies from unfairly promoting their own products. Currently, this procedure is not adequately supervised. It is also necessary to introduce particular legislation concerning pharmaceutical agents and to enforce its implementation effectively in all Member States. I endorsed the report.

 
  
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  Jens Rohde (ALDE).(DA) Mr President, first of all, I would like to congratulate Mr Fjellner on a splendid result. The Danish Liberals have chosen to vote in favour of the directive concerning information on medicinal products subject to medical prescription. It is important for the EU’s citizens to have access to sound information on these medicinal products, and we therefore think that this is a good report that puts the patient first.

That being said, we felt obliged not to vote on the regulation itself. That is not because we are not in favour of EU citizens having access to sound information on these medicinal products subject to medical prescription, but because parts of the proposal contravene a number of national constitutions. Even before the medicinal products package was presented, several countries had already made the Commission aware of the fact that there is a legal problem in relation to their national constitutions. Prior checking by the authorities of information that is disseminated to the general public contravenes the definition of freedom of expression in several countries. Therefore, we cannot vote in favour of the European Medicines Agency checking certain kinds of information before it is disseminated to the general public. However, we expect both the Council and the Commission to seek ways to solve this problem before the second reading, and therefore we hope that we will then be able to vote in favour of the regulation itself.

 
  
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  Licia Ronzulli (PPE).(IT) Mr President, ladies and gentlemen, the legislative proposal voted on today, which I supported, outlines the importance of pharmaceutical industries in their delicate role as sources of non-promotional information on their products.

Making patients better informed must give the pharmaceutical industry a sense of responsibility, and it must carry out this task clearly and rigorously, contributing to avoiding the excessive consumption of medicinal products caused by commercial motives. Indeed, this vote emphasises the importance of how information on medicinal products must also be available on the Internet or in hard copy, following specific rules which are the same in all Member States.

However, this does not relieve healthcare professionals of their fundamental role as the primary and irreplaceable source of information for citizens on health and treatment. The agency-style relationship between doctor and patient remains unique and irreplaceable, and verbal communication is affirmed as the basis of any medical treatment. Furthermore, it allows patients to be better informed about the medicinal products they are taking, and it involves them in the treatments they have to undergo, making them active participants in their own recovery.

 
  
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  Paolo Bartolozzi (PPE).(IT) Mr President, ladies and gentlemen, the reports by Mr Fjellner aim to integrate and complete the existing European Union regulations on the subject, bringing them up to date and making them capable of tackling the challenges that technological development has created and poses for public health.

In our opinion, at its centre is the patient and his or her right to be informed and have access to scientific information, which has now become both qualitatively and quantitatively better and must be monitored, starting with a more precise and accurate distinction between scientific information and advertising.

Indeed, the reports use precise and standardised criteria to establish the types of information to be provided, which data are optional or not, as well as the channels through which they may be made available, thereby setting out the obligations of pharmaceutical companies and Member States.

Based on this understanding, we express our support for this report, recognising its merits not only in terms of health but also in social terms.

 
  
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  Miroslav Mikolášik (PPE). (SK) Mr President, I naturally voted in favour of Mr Fjellner’s report, which, in addition to talking about information for patients on product leaflets and the individual packaging of medicines, mainly focuses on the behaviour of pharmaceutical companies. Until recently many of them combined information on the medicine with their own advertising. In my opinion, they were influencing patients in a non-objective way to take note of a particular product.

I am in favour of patients having the best, and most up-to-date information, which is approved at the same time as a new medicine is approved, for example, and I believe we have made a major contribution to this. High quality information must also be provided, of course, in the mother-tongue on the Internet, which is the modern medium of communication. I am pleased that, by adopting this report, we have actually reduced the disparity between EU countries that are less developed in this area, and I am pleased that doctor-patient relationships have not been impaired in any way. That is the main source of information.

 
  
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  Hannu Takkula (ALDE). (FI) Mr President, firstly, I wish to thank Mr Fjellner for an excellent report. It has to be said that it really is important to amend the existing legislation and bring it up to date. If we are talking specifically about medicines and researched data on what the drugs contain, it is also very important for patient safety.

Now that advertising has assumed an even greater role, it is essential that we determine the criteria that enable consumers and patients to be fully aware of, and certain about, what sort of effects these medicines have. This information must be based on researched data, and not on fantasy or the ways and means of advertising. Such legislation, which is up­to­date and good for patient safety, is needed more generally in the European Union.

 
  
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  Sonia Alfano (ALDE).(IT) Mr President, ladies and gentlemen, the issue of information about prescription-only medicinal products is a sensitive subject because it has an important effect on the protection of the right to health and welfare of all citizens.

The European Commission sent us a proposal on the revision of the directive that risked opening a loophole in the legislation, which would have allowed pharmaceutical companies to exploit an unclear distinction between the definitions of information and advertising to promote their prescription-only medicinal products, to the detriment of the people.

Of course, there is still much to do with regard to a suitable strategy for information on medicinal products, but fortunately this time the European Parliament has reacted as it always should. Parliament has taken a stand to protect citizens and defend a patient’s right to better information, and it has not given in to pressure from pharmaceutical companies.

 
  
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  Daniel Hannan (ECR). – Mr President, the restriction and, in some case the prescribing of alternative medicines, herbal remedies, higher-dose vitamin and mineral supplements has been one of great scandals of European regulation.

I have no idea what the efficacy of these cures is. My wife swears by them, I am a little bit more sceptical but, as King Solomon wisely says, it is better to have a dish of bitter herbs in a house where there is love than a stalled ox and hatred therewith. Rarely could the proverb about the bitter herbs have applied quite so aptly as in this case.

But whether they are useless or whether they are helpful, they are certainly not deleterious to health. So why did the European Union criminalise an activity harmlessly pursued by some 20 million Europeans? Answer: lobbying by some large pharmaceutical corporations, which saw the opportunity to put small herbalists out of business – something that has now happened all over my constituency. They could never have got these rules through the national parliaments. Once again, we see the way in which the Brussels machinery has become a racket open to the big corporations.

 
  
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  Philip Claeys (NI).(NL) Mr President, I should like to take this opportunity to object to your decision to deny Mr Bloom access to the Chamber. It is true that he used unparliamentary language. This time it was Mr Schulz himself who was on the receiving end of this kind of term. He very often uses the word ‘fascist’ himself ...

(The President cut off the speaker)

 
  
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  President. – Mr Claeys, this is not a point of order on the Fjellner report and I am not going to allow you to carry on. I have said to Mr Gollnisch that he can make his point of order when the President is next in the chair, and that is what will happen.

 
  
  

Report: Christofer Fjellner (A7-0289/2010)

 
  
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  Anna Rosbach (EFD).(DA) Mr President, I would actually like to talk about Mr Fjellner’s report (A7-0289/2010) on establishing a European Medicines Agency, which contains a number of good and important initiatives. That is why I voted in favour of it. I actually found that quite difficult to do, because I am in fact opposed to the setting up of yet more EU agencies. However, one overall agency for the evaluation of medicinal products and for providing information to the general public concerning medicinal products subject to medical prescription for both humans and animals makes perfect sense to me, particularly as medicines these days are increasingly produced both within and outside the EU’s borders.

 
  
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  Daniel Hannan (ECR). – Mr President, last year, when some of us held up placards saying ‘referendums’, Mr Watson said that our behaviour reminded him of National Socialists in the German Reichstag. Mr Schulz himself said that our behaviour put him in mind of Adolf Hitler. I see you are in a difficult…

(The President cut off the speaker)

 
  
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  President. – Mr Hannan, I can see where you are going with this. I have said that on these questions Mr Gollnisch has asked for a point of order. He will make that point of order when the President is present. That I think is the appropriate way of dealing with this. If you have nothing to say on the Fjellner report I will move on to Mr Březina.

I heard what you said. You said Mr Gollnisch does not speak for you. I shall report that to the House. Mr Gollnisch is a Member of the Non-Attached Group. The Non-Attached Group is not a group, but he does speak for a significant component of it. I accept that, and that is why I have suggested that Mr Gollnisch makes his point of order when the President is present.

I do not propose to allow you to speak, Mr Hannan, because if I allow you then everybody will want to have a say on this sensitive and important question, so I am sorry. We shall now move on to the explanations of vote on the Evans report.

 
  
  

Report: Jill Evans (A7-0196/2010)

 
  
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  Jan Březina (PPE). (CS) Mr President, this directive undoubtedly represents a step forwards on the path to preventing the creation of waste, and limiting the use of hazardous materials. However, I consider it somewhat contentious to include PVC within the scope of the directive among the materials designated for a priority review. Neither PVC, in other words polyvinyl chloride, nor waste from PVC are classified as hazardous under EU law. Even if we accepted the objection that the legislation on hazardous materials and the studies are now 10 years old, and may therefore be outdated in some aspects, it is clear from the earlier research that PVC can be recycled and that there might be a negative impact on the environment if it was replaced with alternative materials. It is therefore impossible to agree with the frequently-heard argument that discouraging the use of PVC in electrical and electronic equipment is justified because of dioxin emissions when it is burned outdoors. This argument totally ignores the fact that the burning of any kind of waste is undesirable.

 
  
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  Radvilė Morkūnaitė-Mikulėnienė (PPE). (LT) Mr President, sooner or later, electronic equipment becomes waste which, unfortunately, still consists of certain hazardous substances. The Member States sometimes have difficulty dealing with such waste electronic equipment, so it is essential to gradually move towards the so-called principle that ‘prevention is better than cure’. By unifying chemicals through the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation with the Restriction of Hazardous Substances (RoHS) Directive at least we are going some way towards unifying other hazardous substances in electrical and electronic equipment. Clearly this does not harmonise all systems entirely and leaves the Member States some room for interpretation, but this harmonisation at least stops the significant differences that currently exist among the Member States. The restriction of the use of certain hazardous substances in electronic equipment and the measures adopted today must not exceed two limits. Firstly, they must not cause disproportionate difficulties for small business. Secondly, the list of forbidden substances must not halt the development of technologies. We must not be prejudiced against substances that are currently only being tested, and which may in future bring breakthroughs in the world of technology and electronics.

 
  
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  Sonia Alfano (ALDE).(IT) Mr President, ladies and gentlemen, I voted in favour of the report by Mrs Evans on the recast of the directive because I really regret the fact that in the compromise text, which was adopted due to strong pressure from industrial lobbies, all references to PVC and halogenated fire retardants have disappeared, even though all the studies carried out by the Commission have demonstrated since as far back as 2000 that the disposal of these substances poses serious risks for human health and the environment.

Transferring the costs of industry to the environment and to citizens is an approach that we absolutely cannot support because, in addition to distorting the free market, it represents an unacceptable trade-off between peoples’ quality of life and the profits of business.

I hope the next time the directive is updated, in three years’ time, that citizens' right to health and environmental protection will be placed right at the forefront.

 
  
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  Daniel Hannan (ECR). – Mr President, perhaps you would allow me to make the general point that in an open society, the right to free speech trumps the right not to be offended and in a democracy, the only people who should determine whether or not we sit and legislate in a chamber are our constituents.

The removal of a Member can materially affect the outcome.

Now, if we are going to be disinterested in our application of the rules, then we ought to censure obnoxious allusions whichever side they come from, but I think there is something arbitrary and unfair about allowing Eurosceptics to be called Nazis ...

(The President cut off the speaker)

 
  
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  President. – No, Mr Hannan, you strayed from the general to the particular. Mr Kamall, on the Evans report or else I will cut you off.

 
  
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  Syed Kamall (ECR). – Mr President, I have no doubt that you will try to cut me off, as usual when it comes to freedom of speech, but I really want to talk about the hazardous substances and toxicity. I think we all agree and, as a former electronic engineer, I know about the level of hazardous and toxic substances within this equipment. It is absolutely right that we are trying to tackle this issue. But I would also like to talk about the toxicity that has permeated the debate and democracy here in the European Parliament today. Surely when a German national, a socialist talks ...

(The President cut off the speaker)

 
  
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  Zuzana Roithová (PPE). (CS) Mr President, I was happy to vote for the compromise version of the Directive on Hazardous Substances in Electrical and Electronic Equipment. We are all committed to the protection of nature and public health, but it is also necessary to maintain some sense of balance. Today, in the middle of an economic crisis, it is not wise to increase the financial burden on small firms and consumers through very stringent provisions. I therefore appreciated the fact that the inter-institutional team charged the Commission with reviewing the original list of hazardous substances rather than immediately banning them, which would have a negative impact on SMEs and on the social and economic situation of the EU.

 
  
  

Motion for a resolution B7-0617/2010 (Anti-Counterfeiting Trade Agreement)

 
  
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  Clemente Mastella (PPE).(IT) Mr President, ladies and gentlemen, I voted in favour of this motion for a resolution because it represents the outcome of extremely difficult negotiations between the European Commission and several third countries, including Canada, Japan, the United States, Australia and Mexico.

The fight against counterfeiting must be one of our priorities and an objective of all national and international policies. Consequently, cooperation between Member States is essential in order to achieve effective results.

The agreement reached will definitely not be able to resolve the complex situation on international markets, but it represents a step in the right direction. Our task now is to continue working for the civil and customs protection of our geographical indications, which are damaged by competition which is at the very least unfair, due to the constant use of names and acronyms that reference the best-known European brands. The most obvious damages are destined to build up for our industries and producers in the agro-food, design, fashion and luxury products sectors.

I believe that the Commission has made an effort to keep the European Parliament fully informed during all the phases of the negotiations on the international agreements. I should like to reiterate here our request to give the public and the European Parliament access to the texts. In conclusion, I urge the European Commission to continue to keep Parliament fully and punctually informed regarding all the future initiatives it intends to adopt on this matter.

 
  
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  Miroslav Mikolášik (PPE). (SK) Mr President, in the area of intellectual property rights protection, I believe that special attention should be paid to ensuring the right to health, which is closely connected to the actual right to life.

I find totally unacceptable a situation where, under the pretext of robust protection for intellectual property rights - which in some cases appears almost exaggerated - access to basic medicines is denied to whole swathes of the population, particularly in developing countries. I therefore call on the Commission to promote the fundamental principles of public health protection and access to medicines when negotiating the technical particulars of the anti-counterfeiting trade agreement.

 
  
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  Peter Jahr (PPE).(DE) Mr President, anti-counterfeiting is an extremely important issue. Twenty years ago we could still laugh if someone bought a ‘Rolex watch’ for USD 10. The market in this premium price bracket was not put at risk by this. Today the situation is completely different. In particular, products in the lower and middle price brackets are also counterfeited. T-shirts, toys and protective clothing are counterfeited, as well as intellectual property. In this case, it is not only a question of financial interests, but also of safety at work, environmental protection and protection of health, as well as social standards. Anyone who wants a fair world must fight hard to combat counterfeiting.

 
  
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  Jarosław Kalinowski (PPE).(PL) Mr President, the situation in which unfair competition is flooding the European market with counterfeit goods from around the world is unfair and obviously unacceptable. I would also like to draw attention to the insufficiently clear wording concerning the imposition of an obligation to monitor Internet service providers. This contravenes the right to privacy and looks like an attempt at censorship. It also works against e-commerce, which is a part of the economy which on the one hand we want to develop very dynamically by the use of increasingly innovative methods, while on the other hand we continue to impose restrictions in this area. The decisions made on this matter, today, slightly improve the situation.

 
  
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  Zuzana Roithová (PPE). (CS) Mr President, I supported the joint resolution on ACTA, even though I voted differently to my political group, because I too believe that we must encourage the Commission to draw up studies which will remove the final question marks over the impact of ACTA on European citizens, and confront the information gap from the past caused by an unwillingness to provide the negotiated texts. This mainly involves the opinion of the European Data Protection Supervisor, the impact studies on existing European legislation and assurances that exemptions for providers of Internet connections will not be affected. However, I find it quite outrageous that the agreement retains the option of examining the computers and other personal items of individual travellers at borders.

I was also pleased to support the PPE resolution, which offered a version that was balanced and of a very high standard, of course without the important pressure on the Commission before the important negotiations on the final form of the agreement.

 
  
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  Syed Kamall (ECR). – Mr President, I assume that your finger will be hovering over the button. Many people ask me what ACTA stands for, and I was one of the shadow rapporteurs on the Anti-Counterfeit Trading Agreement.

I know after today some will wonder about our level of transparency, democracy and freedom of speech, but I want to focus on the five reasons why we disagreed with the resolution. I was very grateful to get the joint PPE/ECR resolution. Firstly, it goes no further than the acquis communautaire. Secondly, the Commission has been transparent. Thirdly, this is not negotiated at WTO level, because China and India were against the agreement in the first place. Fourthly, this does not affect generic medicines in transit across the EU, and finally, developing countries are free to join the ACTA agreement if they want to. They just have not chosen to do so. It is an open mechanism that countries can join if they want to. It is only a shame that we do not keep to the same principles of freedom of speech when it comes to this Chamber.

 
  
  

Written explanations of vote

 
  
  

Report: László Surján (A7-0327/2010)

 
  
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  Sophie Auconie (PPE), in writing. (FR) Following the 2002 floods, which caused great human and material damage in Germany, Austria, the Czech Republic and France, the Council of the European Union created an instrument to allow funds to be released rapidly to assist regions affected by natural disasters. Today it is Ireland, itself affected by floods, that will benefit from these funds. I voted in favour of this amendment to the EU budget, as it allows this aid to be paid to our Irish friends. This vote symbolises European solidarity in the face of natural disasters. This solidarity is being shown today in Ireland and tomorrow in France. Indeed, our country will soon receive substantial financial aid to deal with the consequences of storm Xynthia in February 2010.

 
  
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  Diogo Feio (PPE), in writing. (PT) The floods that took place in November 2009 seriously affected Ireland and caused severe damage estimated at more than EUR 520 million. The amending budget provides for the mobilisation of the Solidarity Fund to cover the losses suffered, to a total of EUR 13 022 500 in commitment and payment appropriations. As I had the opportunity to say yesterday, I feel that the mobilisation of the fund is fully justified as it helps those who have suffered the most due to this natural disaster, and thus the amendment is in line with the EU budget.

 
  
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  José Manuel Fernandes (PPE), in writing. (PT) On 24 September 2010, the European Commission put forward a proposal on a decision by the European Parliament and the Council relating to the mobilisation of the Solidarity Fund, on the basis of the provisions of item 26 of the interinstitutional agreement (IIA) of 17 May 2006. This was the first proposal for mobilisation of the Solidarity Fund within the 2010 financial period. The IIA allows for mobilisation of the Solidarity Fund up to a maximum annual limit of EUR 1 billion. It is important to note that the purpose of the Fund is not to provide compensation for private losses, but to repair infrastructure, and the Fund is a re-financing instrument.

The Irish authorities estimate total losses caused directly by the disaster to be EUR 520.9 million. The Commission proposes the mobilisation of EUR 13 022 500 of the maximum limit of EUR 1 billion in commitment and payment appropriations relating to the effects of the flooding in Ireland. The legal requirements having been fulfilled, I agree with this amending budget.

 
  
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  João Ferreira (GUE/NGL), in writing. (PT) We voted in favour of the mobilisation of the EU Solidarity Fund for Ireland, following the floods that hit that country last November. Once again, however, we would like to criticise the delays in mobilising the fund. Many long months elapse between the time of the disaster and the point at which the Member State actually receives the aid: in this case it has been more than a year. This fund, and potentially others, depending on the circumstances of each case, need to be mobilised more rapidly in order to hasten an effective and swift response to emergency situations. There should be a cohesion dimension to the ability to deal with the consequences of disasters, reducing disparities between the EU’s different regions and Member States. Once again, we would stress that it is also important to strengthen disaster prevention, putting into practice the recommendations recently adopted by Parliament.

 
  
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  Giovanni La Via (PPE), in writing. (IT) I voted to approve draft amending budget No 8/2010 because it is essential if we are to allocate EUR 13 022 500 for the mobilisation of the Solidarity Fund in favour of Ireland, with reference to the heavy rainfall that caused serious flooding in November 2009.

I believe that the Solidarity Fund is a valuable tool for enabling the EU to show solidarity with the populations of regions affected by natural disasters, by providing financial support to help ensure a swift return to living conditions that are as normal as possible. The overall annual budget available for the Solidarity Fund is EUR 1 billion. No amount has yet been allocated in 2010 for previous applications, and so the entire sum of EUR 1 billion is still available.

 
  
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  David Martin (S&D), in writing. – I voted for this proposal to transfer EUR 13 022 500 from the ESF to a budget line to give support to Ireland following the severe flooding it suffered in November 2009.

 
  
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  Nuno Melo (PPE), in writing. (PT) This draft amending budget makes complete sense, given the purpose of the funds mobilised through the Solidarity Fund. The floods in Ireland during November 2009 caused severe damage, particularly to the agricultural sector, homes and businesses, the road network and other infrastructure. However, I would like to point to the delay in the mobilisation of this type of support. The process needs to be made less bureaucratic and quicker in order to respond to future disaster situations in a timely manner.

 
  
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  Alexander Mirsky (S&D), in writing. (LV) I voted in favour, as I consider that every EU nation must feel itself to be part of the system of a united European Union. Nevertheless, it would be desirable if, next time, the rapporteur were not only to publicise the allocation of resources but also to make it crystal clear on which specific works and measures such vast financial resources (EUR 13 022 500) were being spent. Otherwise the misuse of resources and other offences are inevitable. The amount must be made specific and justifiable.

 
  
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  Andreas Mölzer (NI), in writing. (DE) EUR 1 billion per year is available to the European Solidarity Fund. In the current calendar year, there has as yet been no request for the mobilisation of this Fund. The rules for the mobilisation of this Fund, which under no circumstances serves to provide compensation for private losses, but rather to restore infrastructures, are laid down precisely. Ireland has now requested aid that is intended to be used to repair damage caused by floods. I am voting in favour of the report, as there has not yet been a mobilisation of the Fund this year and the budget really ought to be used in a beneficial way. Furthermore, Ireland fulfils all of the criteria.

 
  
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  Alfredo Pallone (PPE), in writing. (IT) I voted in favour of this report. As I already stated yesterday during the vote in favour of Mr Böge’s report, I believe it is the European Union’s duty to provide help and support to certain regions affected by natural disasters and catastrophes. I believe that the concept of solidarity is connected to the idea and values underpinning the European Union. It is one of the core values that brought the Union into being and ensured that it prospered and enlarged over time. This is the reason why this allocation is not only justified and well founded but practically a duty. I therefore hope that such assistance will also be provided to the Italian regions severely affected by the recent floods, which brought local economies to their knees.

 
  
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  Maria do Céu Patrão Neves (PPE), in writing. (PT) Given that draft amending budget No 8/2010 to the general budget for 2010 covers mobilisation of the EU Solidarity Fund in the sum of EUR 13 022 500 in commitment and payment appropriations, following the floods that wreaked havoc in Ireland, and the corresponding reduction in payment appropriations of EUR 13 022 500 from line 04 02 01 – Completion of European Social Fund (ESF) – Objective No 1 (2000-2006), I voted in favour of agreeing with the Council’s position on draft amending budget No 8/2010.

 
  
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  Aldo Patriciello (PPE), in writing. (IT) I would like to thank Mr Surján for his excellent work. I voted in favour and agree with the approval of draft amending budget No 8/2010, which grants aid amounts to the Solidarity Fund and the European Union Solidarity Fund – Member States, and redeploys EUR 13 022 500 in payment appropriations from policy area 4 ‘Employment and Social Affairs’.

 
  
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  Paulo Rangel (PPE), in writing. (PT) I welcome this draft amending budget, which provides for the mobilisation of the European Solidarity Fund (ESF) in the sum of EUR 13 022 500 in commitment and payment appropriations, in order to assist Ireland following the floods that occurred during November 2009, which caused substantial losses to the agricultural and business sectors and to infrastructure, particularly the road and water supply networks, as well as in residential areas, amounting to a total of over EUR 520 million.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – According to Article 37(1) of the Financial Regulation, the Commission may present draft amending budgets if there are ‘unavoidable, exceptional or unforeseen circumstances’. Concerning the different points of draft amending budget No 8/2010, the report that we adopted refers to the mobilisation of the EU Solidarity Fund. The European Commission proposed on 24 September 2010 a decision of the European Parliament and of the Council on the mobilisation of the Solidarity Fund, which is based on the provisions of point 26 of the interinstitutional agreement of 17 May 2006. The conditions of the eligibility to the Fund are detailed here and as well as in Council Regulation No 2012/2002 establishing the EUSF. It is important to note that the objective of the Fund is not the compensation for private damage but to repair infrastructure and it is a tool of refinancing.

 
  
  

Recommendation: Graham Watson (A7-0300/2010)

 
  
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  Zigmantas Balčytis (S&D), in writing. (LT) The European Commission is initiating discussions on a review of the European Neighbourhood Policy in order to define the future relations of the EU and its southern and eastern neighbours. The objective of the EU Eastern Partnership initiative being pursued should be the promotion of common European values, with an emphasis on the functioning of democratic institutions and respect for human rights and freedoms. I supported this report which lays down the general principles for the participation of the Republic of Moldova in Community programmes and agencies. I feel that the conclusion of the Protocol would permit the gradual opening of or reinforced participation in certain Community programmes for Moldova, offering an opportunity to promote further cultural, educational, environmental, technical and scientific links and to reinforce political relations. It is essential for Moldova to proceed with the implementation of the ENP Action Plan and reforms in order to achieve the objectives of political stability and democratic development.

 
  
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  Elena Băsescu (PPE), in writing. (RO) I voted for Mr Watson’s recommendation because concluding a protocol provides the Republic of Moldova with new opportunities for getting involved in the Community programmes it is interested in. The gradual opening up of the EU’s programmes and agencies to the countries belonging to the European Neighbourhood Policy will encourage these countries in their efforts to carry out reform and modernisation. This will help promote cooperation with the EU in important areas such as customs, transport or competitiveness. I think that the Republic of Moldova’s involvement in the relevant initiatives will help establish a link between its domestic and European policies. At the same time, it will give some impetus to the negotiation process for signing the new Association Agreement. Satisfactory progress has already been made towards this. I also welcome the Council’s intention to continue to grant macro-financial assistance to the Republic of Moldova and to provide expert advice to the government in Chişinău.

As the progress report compiled by the European Commission has also highlighted, the Republic of Moldova has made significant efforts to implement efficiently the structural reforms, in line with EU recommendations. Furthermore, the European integration platform of the current administration has contributed to unprecedented dynamic development in relations with the EU. Therefore, increasing the Republic of Moldova’s involvement in Community programmes and agencies is a natural step in the process of alignment with European standards.

 
  
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  Corina Creţu (S&D), in writing. (RO) I voted in favour of concluding the protocol which will enable the Republic of Moldova to have greater involvement in certain Community programmes, offering the opportunity to promote cooperation in the fields of culture, education, media, science and technology, as well as consolidate political relations through the Eastern Partnership and speed up negotiations on the new Association Agreement. Political stability and democratic development are essential to the comprehensive implementation of the protocol and to facilitating the conclusion of all the necessary MoUs. The current constitutional stalemate in the Republic of Moldova is therefore a concern that must be addressed promptly and efficiently. It is crucial for the Republic of Moldova to continue with the implementation of the ENP Action Plan and the reforms it has set out in the document ‘Rethink Moldova’. The holding of elections, as required by the constitution, is vital to the Republic of Moldova’s future stability and prosperity and to the development of its relations with the EU.

 
  
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  Vasilica Viorica Dăncilă (S&D), in writing. (RO) The Republic of Moldova’s aspirations for pursuing a path towards Europe as part of the Union and its preparation for this are made possible through the Partnership and Cooperation Agreement between the EU and the Republic of Moldova, included in the European Neighbourhood Policy. I welcome the Republic of Moldova’s involvement in certain Community programmes, helping to promote cooperation in the fields of culture, education, media, science and technology, as well as consolidate political relations through the Eastern Partnership and speed up negotiations on the new Association Agreement.

 
  
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  Diogo Feio (PPE), in writing. (PT) The low turnout for the recent referendum on how to elect the President of the Republic of Moldova and the fact that the country is being led by an interim president demonstrate the difficulties in the country’s governance and the disillusionment among the public. The Transdniestria situation is getting worse, putting particular strain on the authorities and the Moldovan public. This country still has a long way to go towards institutional stabilisation and the establishment of the full rule of law. It is therefore worthy of particular support and attention by the European Union. Moldovan involvement in EU programmes is an important step along that path.

 
  
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  José Manuel Fernandes (PPE), in writing. (PT) The Partnership and Cooperation Agreement between the Republic of Moldova and the European Communities was signed on 28 November 1994, and since 2004 Moldova has been covered by the European Neighbourhood Policy (ENP). The subject of the draft recommendation is the participation of the Republic of Moldova in Union programmes. On 18 June 2007, the Council issued guidelines to the Commission on negotiating framework agreements relating to the general principles of participation in Union programmes with thirteen neighbouring countries. Negotiations with the Republic of Moldova began in March 2008.

The Republic of Moldova will contribute financially to the specific programmes in which it participates. This financial contribution varies from programme to programme, and is set out within the Memorandum of Understanding. The signing of the Protocol will enable Moldova to open up gradually or to increase its participation in certain Union programmes, to the extent that it will provide an opportunity to promote greater cultural, educational, environmental, technical and scientific links, as well as strengthening political relations through the Eastern Partnership and supporting negotiations for a new association agreement. Political stability and democracy are essential for the full application of the Protocol.

 
  
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  Ilda Figueiredo (GUE/NGL), in writing. (PT) The EC-Moldova Partnership and Cooperation Agreement was signed on 28 November 1994, and since 2004 Moldova has been covered by the European Neighbourhood Policy.

On 18 June 2007, the Council issued guidelines to the Commission on negotiating framework agreements on the general principles of participation in EU programmes with 13 neighbouring countries, and, in March 2008, negotiations began with the Republic of Moldova.

The protocol includes a framework agreement on the general principles governing the Republic of Moldova’s participation in EU programmes and agencies. The Republic of Moldova has contributed financially to the specific programmes in which it participates. This varies from programme to programme, and is set out in the Memorandum of Understanding.

However, the issue that arises is the demand that the EU makes in the name of ‘political stability and democracy’, seeking to interfere in a country’s internal affairs, openly siding with forces in Moldova that are championing the interests of the EU’s economic groups, and attacking the country’s independence and sovereignty, as well as the wishes of its people. That is why we disagree with the adopted resolution.

 
  
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  Ian Hudghton (Verts/ALE), in writing. – I supported Mr Watson’s recommendation and welcome the continuing cooperation between the EU and Moldova.

 
  
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  Cătălin Sorin Ivan (S&D), in writing. – I have always sustained and encouraged the European goals of the Republic of Moldova. I believe in strong cooperation with a country that proved recently that is ready to follow a European path. Participation in certain Community programmes for Moldova will encourage this neighbour country to implement its reforms, offering an opportunity to promote further cultural, educational, environmental, technical and scientific links, in addition to the reinforcing of political relations through the Eastern Partnership and the negotiation of the new Association Agreement. I endorse the recommendation of Graham Watson, because it promotes Moldova’s participation in several European Community programmes and agencies, to support the neighbouring country’s efforts to reform and modernise.

 
  
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  Jarosław Kalinowski (PPE), in writing.(PL) The Republic of Moldova is one of the poorest countries of Europe. Research has shown that the decided majority of the country’s population lives in extreme poverty. Internal reforms which could help the economy are usually blocked by political or ethnic conflicts. Therefore, the European Union should help Moldova and bring about an improvement in the country’s situation in terms of stability, security and prosperity.

A European policy could solve the constitutional problem being faced by the Republic of Moldova, and this could, in turn, result in further beneficial changes. The Republic of Moldova is expressing a desire to participate in the programmes of the European Neighbourhood Policy, and its financial contributions are proof of this. The European Union should support such countries with even greater commitment, and so a strengthening of cooperation with the Republic of Moldova is most definitely justified.

 
  
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  Alan Kelly (S&D), in writing. – The conclusion of this Protocol would permit reinforced cooperation on certain programmes with Moldova. It will lead to closer integration between Moldova and the EU. Considering the amount of Moldovans who live and work in Ireland and contribute to Ireland’s society, this is a welcome step for the future of Europe.

 
  
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  Petru Constantin Luhan (PPE), in writing. (RO) The main measure for promoting reforms, modernising and facilitating transition in the countries immediately neighbouring the European Union, including the Republic of Moldova, is to open up gradually certain Community programmes, institutions and agencies to participation from European Neighbourhood Policy partner countries. I voted for this report as I think that the European Union must support the Republic of Moldova and facilitate its access to certain Community programmes. This will help promote good cooperation between the Union and the Republic of Moldova in different areas such as the economy, science, culture and education.

 
  
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  David Martin (S&D), in writing. – I voted for this report on the Protocol to the Partnership and Cooperation Agreement between the EC and Moldova. Although I have serious concerns about human rights in Moldova, I was encouraged by recent Amnesty International comments, in particular with regard to Moldova’s October ratification of the Rome Statute of the International Criminal Court, which is a very positive step.

 
  
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  Jiří Maštálka (GUE/NGL), in writing. (CS) As a member of the delegation to the EU-Moldova Parliamentary Cooperation Committee, I welcome every step that leads or may lead to a consolidation of the political situation in Moldova and to a better standard of living for its inhabitants. The recommendations which we are voting on today and the implementation of which might be a strengthening of an appropriately integrational European Neighbourhood Policy could be regarded as just such a step. I agree with the opinion of the rapporteur that the current crisis in Moldova is a problem that must be resolved rapidly and above all by lawful means. The completely opaque and misleading expression ‘a European solution’ must be taken out. The rapporteur clearly has in mind a solution corresponding to the agreements and document of the Council of Europe and generally accepted democratic rules. In any case, we must jointly and emphatically reject any form of deliberate external meddling in the internal affairs of the Moldovan Republic. Any other approach will simply lead to an escalation of tension in Moldova, and not to a positive solution of problems that were partly caused by the EU through its uneven approach in the past.

 
  
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  Jean-Luc Mélenchon (GUE/NGL), in writing. (FR) Moldova’s human development index is one of the lowest in the region. The fast-track liberalisation policies designed to benefit the financial elites of the European Union are to a large extent responsible for this. The stranglehold by the European Commission and the International Monetary Fund, promised by the macro-financial assistance to come, will only make the situation worse.

In conditions such as these, to allow the Moldovan Government to force its population to finance such uncertain European programmes and agencies as the Competitiveness and Innovation Framework Programme or the Single European Sky ATM Research Programme (SESAR), when Moldova is not even a Member of the European Union, smacks of cynicism. I am voting against this report.

 
  
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  Nuno Melo (PPE), in writing. (PT) Moldova has been making efforts in recent years to move ever closer towards European standards of freedom, democracy and good governance. The efforts described have been consistent with and have demonstrated Moldova’s concern with continuing on the route towards possible enlargement.

The recent elections did not pass off in the best way possible, and the fact that the country currently has an interim president is not the best sign that the degree of consolidation of its democratic culture is on the right path. To this must be added the question of Transnistria, which could cause some kind of instability. The EU should continue making every effort so that the reforms that need to be implemented in Moldova continue along the right path, which is the direction of this partnership and cooperation protocol.

 
  
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  Louis Michel (ALDE), in writing. (FR) Increasing Moldova’s involvement in Community programmes will offer an opportunity to promote further cultural, educational, environmental, technical and scientific links and, in addition, to reinforce political relations through the Eastern Partnership and the negotiations on the new association agreement. Political stability and democratic development in Moldova are, however, essential for the implementation of the protocol. The failure of the constitutional referendum of 5 September 2010 is regrettable. It is essential for Moldova to proceed with the implementation of the European Neighbourhood Policy (ENP) Action Plan and of the reforms it has set out in the document ‘Rethink Moldova’. The organisation of legislative elections on 28 November is essential for the future stability and prosperity of Moldova and the development of its relations with the European Union. These elections must help the country to make progress along these lines and must comply fully with international standards on the holding of free and fair elections.

 
  
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  Alexander Mirsky (S&D), in writing. (LV) Unfortunately, Moldova finds itself today in a wholly unstable zone of economic and political change. The protocol to the European Union-Moldova Partnership and Cooperation Agreement on the participation of the Republic of Moldova in EU programmes gives the people of Moldova the hope of positive change. The conclusion of the Protocol encourages the strengthening of cooperation in the cultural, educational and other fields. I voted in favour, since I hope that the partnership will assist Moldova’s integration with the European Union.

 
  
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  Rareş-Lucian Niculescu (PPE), in writing. (RO) I voted, like the majority in Parliament, in favour of the recommendation, which I welcome, as it gives a strong indication of support and encouragement for the Republic of Moldova’s pro-European tendency. This state, at the European Union’s border, will not be able to get through the current deadlock without such messages which inspire the belief in Moldova’s citizens that Europe is the right option. It could not be a more appropriate time either at the moment, just a few days before the early parliamentary elections take place in this country.

 
  
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  Justas Vincas Paleckis (S&D), in writing. (LT) I support the Protocol which lays down the general principles for the participation of the Republic of Moldova in Community programmes and agencies. It offers Moldova new opportunities to promote further cultural, educational, environmental, technical and scientific links with EU Member States. I am convinced that political relations between the EU and Moldova will be reinforced through the Eastern Partnership and the negotiations of the new Association Agreement. Political stability and democratic development in Moldova are essential for full participation in Community programmes, therefore it is very important for the prolonged period of unrest and instability to end following the parliamentary elections.

 
  
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  Maria do Céu Patrão Neves (PPE), in writing. (PT) There has been a preferential channel for relations with Moldova since 1994, the date of the signing of the EC-Moldova Partnership and Cooperation Agreement. In 2004, Moldova was included within the European Neighbourhood Policy. Institutional cooperation between the EU and neighbouring countries may or may not lead to a procedure for the accession of a country to the EU. Irrespective of this outcome, the EU, as a supra-national entity, is governed by a collection of values based on peace, freedom and democracy, which it considers fundamental to the prosperity of the European continent.

It is essential that cooperation with neighbouring countries is accompanied by special attention on the part of the Union being paid to the stability of these countries, without interference, supporting institutions on the path towards the effective implementation of the rule of law and complete respect for human rights. The ratification by Moldova in October of this year of the Rome Statute establishing the International Criminal Court is a very positive step in this direction.

Within this context, I voted in favour of this legislative resolution relating to the signing of an additional protocol to the EU-Moldova Partnership and Cooperation Agreement, and an EU-Moldova Framework Agreement on the general principles governing the participation of Moldova in Union programmes.

 
  
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  Aldo Patriciello (PPE), in writing. (IT) I would like to thank Mr Watson for his excellent work. I voted in favour because I agree it is essential for Moldova to proceed with the implementation of the ENP Action Plan and of the reforms it has set out in the document ‘Rethink Moldova’.

Holding of elections, as required by the constitution, is essential for the future stability and prosperity of Moldova and the development of its relations with the EU. All parties should unite to find a solution and reflect the confidence of the Moldovan people for a European solution. The EU and Council of Europe have provided significant assistance and should continue to do so to overcome this impasse in a timely manner.

 
  
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  Mario Pirillo (S&D), in writing. (IT) The adoption of the protocol on the general principles for the participation of the Republic of Moldova in European Union programmes is fundamentally important for continuing down the road of a more structured collaboration, which should reasonably conclude in future with an association agreement.

The current constitutional impasse in Moldova could affect the comprehensive implementation of the protocol and the related memoranda of understanding After the failure of last September’s referendum, it is very important that all political forces act responsibly ahead of the forthcoming elections of 28 November 2010. Political stability is a conditio sine qua non for greater involvement in EU programmes. Equally, a decisively pro-European choice could contribute to smoothing the path of both economic and democratic development in Moldova.

That, Mr President, is why I voted in favour of this resolution of the European Parliament today, in the hope that all the processes activated in Moldova are accompanied by technical and scientific support from Europe.

 
  
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  Rovana Plumb (S&D), in writing. (RO) As part of the European Neighbourhood Policy, the initiative of gradually opening up certain EU programmes and agencies to participation from ENP partner countries is one of the numerous measures intended to promote reform, modernisation and transition in the countries neighbouring the European Union. The decision was taken in March 2008 to initiate negotiations with the Republic of Moldova, which have now been completed. This draft protocol contains a Framework Agreement on the general principles for the Republic of Moldova’s participation in a number of Community programmes and agencies in areas such as transport, food security, customs, air safety and others. I voted for this report as this initiative supports the efforts being made by the Republic of Moldova, a state neighbouring the EU, to carry out reform and modernisation.

 
  
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  Paulo Rangel (PPE), in writing. (PT) I voted in favour of the signing of this Protocol to the Partnership and Cooperation Agreement between the EU and Moldova because I understand that the assistance that the EU has provided to Moldova is essential for that country to be able to implement necessary reforms and to achieve the desired political stability, with complete respect for the principles of the democratic rule of law.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – This report refers to the draft Council decision on the conclusion of a Protocol to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Republic of Moldova, of the other part, on a Framework Agreement between the European Union and the Republic of Moldova on the general principles for the participation of the Republic of Moldova in Union programmes. By voting in favour, the EP consents to the conclusion of the Protocol.

 
  
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  Traian Ungureanu (PPE), in writing. – In my capacity as EPP shadow rapporteur on the EU-Republic of Moldova Agreements, I warmly welcome the vote with an overwhelming majority in favour of the conclusion of the Protocol to the EU-Republic of Moldova Partnership and Cooperation Agreement on the participation of the Republic of Moldova in the Union’s programmes. Even before the conclusion of an Association Agreement with the Republic of Moldova, the country is already being offered the legal opportunity to participate in EU internal programmes and agencies and thus continue its approximation to EU standards, particularly in such fields as transport, food safety, customs and aviation safety. On the eve of the parliamentary elections in the Republic of Moldova, the European Parliament is sending a strong signal of support for the pro-European reforms in this neighbouring country and for the need to firmly pursue them. I am glad to conclude that the European Parliament expressed cross-party unanimity at every stage of the examination of the issue in this House, thus shaping a single position on the need to conclude this Protocol as soon as possible and hence offer the Republic of Moldova all possible opportunities to benefit from the advantages of its relations with the EU.

 
  
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  Viktor Uspaskich (ALDE), in writing. (LT) The European Union, including the new Member States like Lithuania, is responsible for observing the interests of our eastern neighbours. The strengthening of cooperation between the EU and Moldova and the inclusion of Moldova in Community programmes will help bring this country closer to EU standards and norms. The Partnership and Cooperation Agreement would enable the promotion of new close links between the EU and Moldova in the fields of culture, education and technology. It is particularly important for the EU to demonstrate to Moldova’s young people the benefits of future EU membership. Last year, Moldovan emigrants working in other European countries, sometimes illegally, were responsible for 19% of Moldova’s GDP. Poverty, corruption and human trafficking are problems that we must solve together. As it prepares for EU accession, Moldova faces numerous serious structural reforms.

The EU must continue to support the efforts Moldova has made. It is particularly important to strengthen democracy and the rule of law. The Transnistria conflict is a problem for Europe, but it is also an opportunity for the EU to cooperate more closely with Moldova, Russia and Ukraine. We must not ignore that. I hope that the parliamentary elections on 28 November will enable Moldova to move forward.

 
  
  

Report: Christofer Fjellner (A7-0290/2010)

 
  
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  Damien Abad (PPE) , in writing. (FR) Parliament today adopted two legislative reports at first reading: a regulation relating to aspects specific to the European Union and a directive on the rules to be applied by Member States at national level. Member States will be responsible for national legislation to ensure that objective and impartial information is available to the general public. This includes information on packaging, a product assessment report, and information on disease prevention. Patients should have better access to good quality information on prescription-only medicines. This involves information on the characteristics of the medicine and the diseases it treats. We have a duty to protect consumers and to keep them informed in a transparent manner. Our work as MEPs is also to make a Europe that protects and informs, and that is why I voted in favour of these two texts.

 
  
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  Sophie Auconie (PPE), in writing. (FR) Directive 2001/83/EC establishes a Community code relating to medicinal products for human use. It lays down rules on the information to be annexed to medicinal products concerning their characteristics and use. Nonetheless, it does not provide a harmonised framework on the contents and the quality of non-promotional information for patients. Furthermore, experience has shown that different interpretations of the texts could lead to situations where the general public is exposed to disguised advertising, especially on the Internet. The Commission has proposed a directive which amends the current legislation in order to improve the way in which information relating to prescription-only medicines is disseminated to the general public. It aims to establish a legal framework governing the dissemination of specific information on medicinal products from marketing authorisation holders to the general public. The European Parliament has drafted a legislative resolution which is more ambitious than the Commission’s proposal. I voted for this text as it improves the information made available to patients and makes it a little safer still.

 
  
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  Zigmantas Balčytis (S&D), in writing. (LT) I voted for this important resolution which aims to enable patients to be better informed on the medicines they are prescribed. There are considerable problems with the current legal framework and the situation within Europe when it comes to patients’ access to information on prescription-only medicine. The differences in interpretations of the directive by the Member States give patients in different parts of Europe different access to high quality and comprehensive information on pharmaceuticals. In some Member States, patients lack easy access to even the most basic information about the pharmaceuticals they are prescribed. Given the different interpretation of the directive in the Member States, I feel there needs to be increased clarity in the provisions so that all EU citizens are able to receive the information they require in connection with pharmaceuticals. The amendments adopted by the European Parliament also ensure that information on prescribed medicine is only given to the public through specific communication channels, including specialised and certified websites safeguarding patients’ interests and aiming to limit advertisement opportunities for the pharmaceutical companies.

 
  
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  Sebastian Valentin Bodu (PPE), in writing. (RO) Providing patients with better access to quality information about the treatment being administered to them increases the chances of them understanding the decision directly affecting them. There is therefore a very good intention behind this; however, it must be part of a more comprehensive health education strategy, which focuses on the patient and not on the pharmaceutical company. There are many problems with the current legal framework and the situation within Europe when it comes to patients’ access to information about prescription-only medicines. The differences in interpretations of the directive by Member States give patients in different parts of Europe different access to high quality information on the relevant drugs. In some Member States it is difficult to access even the most basic information about the drugs which are prescribed. This creates health inequalities. Patients have unlimited access via the Internet to uncontrolled and frequently incorrect information about prescription-only medicines in a few seconds. However, they need to have access to controlled, safe information so as not to complicate matters even more. Therefore, the provisions regarding information about prescribed drugs need to be updated.

 
  
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  Vito Bonsignore (PPE), in writing. (IT) I should like to congratulate the rapporteur, my colleague Mr Fjellner, on his work on this report. I voted in favour as I believe it is essential to guarantee patients access to information on prescription-only medicinal products.

Both the European Parliament and patients’ organisations have for some time been asking for an adjustment to the current regulations which, as they stand, do not guarantee the necessary information. Indeed, technical development and the easy availability on the Internet of information on the use of medicinal products are too often shown to be illusory and untrue.

I agree with the underlying spirit of this report, which aims to put the ‘patient’s right to know’ into the centre of the legislation and, consequently, recommends that pharmaceutical companies give patients some basic information.

I therefore hope for greater certainty in the law, which often falls short, partly due to the different degrees to which the Member States have implemented the previous directive. The provisions relating to information on prescription-only medicinal products therefore need to be updated and new rules need to be adopted, promoting greater health literacy and involving the health industry to a greater extent in carrying out a fundamental role to improve public health.

 
  
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  Alain Cadec (PPE), in writing. (FR) In the area of health, access to comprehensive, good quality information guarantees better results, insofar as patients are more likely to follow a treatment that they are able to understand. I join with the rapporteur in emphasising the difficulty in accessing this kind of information in some European countries, due to different interpretations by the Member States of the directive on information relating to medicinal products, as well as the unreliable and unclear nature of that information. We need to make it more accessible, in accordance with patients’ right to information. Nonetheless, in order to avoid creating any imbalance between Member States, it is vital to identify the means by which to disseminate this information, and not favour one at the expense of the others. Finally, it is essential to clearly distinguish between information and advertising and to prevent pharmaceutical companies from exploiting these information campaigns in order to promote their products.

 
  
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  Maria Da Graça Carvalho (PPE) , in writing. (PT) The amendments that the European Parliament put forward to a proposal by the Commission relating to information on medicines warranted my vote in favour, as I believe it to be essential for the general public to have easy access to knowledge concerning medicines, in particular through information being made available on the Internet in all European languages.

 
  
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  Françoise Castex (S&D), in writing. (FR) I voted against this text, as we cannot allow pharmaceutical companies and the Commission to turn health into a commodity like any other. The link between the pharmaceutical industry in Europe and pharmacovigilance is yet again at the heart of the debate. We cannot let pharmaceutical firms inform the public as they please nor authorise direct advertising to the general public for prescription-only drugs. Indeed, the commercial concerns of these firms are incompatible with the objectives of general interest pursued by our health policies, and it would be dangerous to turn a blind eye.

 
  
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  Nikolaos Chountis (GUE/NGL), in writing. (EL) The European Commission’s initial proposal for a directive on information to the general public on medicinal products subject to medical prescription has thrown the doors open for pharmaceutical companies to advertise their drugs. Today plenary amended the Commission’s initial proposal, which was tailored to the pharmaceutical industry. I voted in favour of all the amendments which significantly improved the original text, by shifting the focus of the legislation away from the right of the pharmaceutical industry to advertise their products to the right of patients to have reliable, objective and independent information. I also voted in favour of the amendments which prohibit the provision of information on drugs both on television and radio and in the press. However, despite the improvements which we made, the dividing line between information and advertising is still blurred and the text still has a number of weaknesses and loopholes. I abstained in the final vote, because I consider that the best solution would be for the Commission to review its proposal for a directive on the basis of the guidelines which we have given it today. Nor is it a coincidence that the Member States took an almost unanimously dismissive stand on this dossier in the Council.

 
  
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  Vasilica Viorica Dăncilă (S&D), in writing. (RO) I think that patients must have access to better information about medicinal products subject to medical prescription. This entails providing objective information about the medicines’ characteristics and the diseases for which they are recommended, as well as preventing the provision of unsolicited information or disguised advertising.

 
  
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  Christine De Veyrac (PPE), in writing. (FR) Making a distinction between information and advertising concerning medicines is essential for the protection of the public. That is why I voted in favour of Mr Fjellner’s report, which requires that an objective description for patients’ use be included on the packaging of medicines. Furthermore, access to clear and reliable information will be strengthened, by making it available in all the languages of the European Union on approved websites and in official brochures. I welcome the adoption of this proposal, which marks real progress towards greater transparency in health matters.

 
  
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  Anne Delvaux (PPE), in writing. (FR) I voted against this report, to which I have always expressed my strong opposition. While I approve of the idea of providing better information to patients, I disapprove of the means used to do so. The pharmaceutical industry’s goal will never be one of philanthropy. Moreover, there is a very fine line between information and advertising. It is true that the text, which was adopted almost unanimously, has nothing to do with the Commission’s initial idea. The latter would have simply opened the door to advertising disguised under the label ‘Information’. That proposal corresponded, moreover, to the pharmaceutical sector’s clear expectation of being able to get out of the legal ban on advertising of medicines. The report, as adopted today, includes many more guarantees: that the information provided by pharmaceutical companies for dissemination will, in particular, be checked beforehand, and will not be disseminated by the media. Nevertheless, the authorisation to publish package leaflet summaries means that there will be items that must be highlighted and others, such as adverse reactions, which may well be regularly excluded from the summaries, as they do not ‘sell’ well. Is that not already a promotional move? Was that really the aim? Was the game really worth the candle?

 
  
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  Edite Estrela (S&D), in writing. (PT) I voted in favour of the report on the proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC. This directive sets out a Community code relating to medicinal products for human use and helps ensure the right of patients to reliable, accessible and independent information, validated by the competent authorities, on the medicinal products available.

 
  
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  José Manuel Fernandes (PPE), in writing. (ES) Directive 2001/83/EC, which sets out a Community code relating to medicinal products for human use, provides for a harmonised framework for the advertising of medicines at a Community level, the application of which continues to be a responsibility of the Member States. This legislation prohibits advertising to the general public of medicines subject to medical prescription.

However, provisions relating to information on medicines are not regulated, since it only stipulates that information relating to certain supply activities is exempt from the advertising provisions. Therefore, Union legislation does not prevent Member States from establishing their own approaches to the provision of information on medicines, provided that the above-mentioned rules on advertising are complied with. I agree with the rapporteur’s proposal to rule out the possibility of making information from pharmaceutical companies available in newspapers, magazines and similar publications, or on the television or radio.

 
  
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  João Ferreira (GUE/NGL), in writing. (PT) This proposal for a directive amends the earlier directive as regards information to the general public on medicinal products subject to medical prescription. In general terms it concentrates, firstly, on the responsibility of the pharmaceutical companies to inform the public, ensuring that this information is not of an advertising nature. Secondly, the Commission is given the role of monitoring and decision making through delegated acts on the definition of what constitutes information and what constitutes advertising. We believe that this approach means that too many roles for providing information are concentrated in the hands of pharmaceutical companies and within the Commission, and that these roles should be carried out on a sovereign basis, coordinated and approved by specific national authorities in order to improve the information given to patients and the public, and to safeguard their rights.

 
  
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  Elisabetta Gardini (PPE), in writing. (IT) Approval of the new legislation on information on medicinal products represents a further step toward guaranteeing patients clearer and more effective information on the drugs they take and are prescribed.

We need a harmonised legal framework at European level that not only maintains the ban on advertising medicinal products subject to medical prescription but also takes into account the patient’s right to information. This is no small matter, because the sometimes blurred boundary between ‘product promotion’ and ‘product information’ is liable to confuse patients.

We must remember that patients are playing a more and more active role in the health sector throughout the European Union. Better access to non-promotional information may therefore help the public to gain a better understanding of the treatments prescribed to them and help their recovery, all naturally in the interests of their health.

To conclude, I would like to underscore the importance of defining in a transparent way the types of information on drugs and the channels through which such information may be disseminated. We must reduce the risk of disguised advertising and, where necessary, the risk of a surfeit of uncontrolled and misleading information.

 
  
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  Giovanni La Via (PPE), in writing. (IT) I voted in favour of the proposal for a directive as regards information to the general public on medicinal products for human use subject to medical prescription because I believe that harmonising the laws in this sector is a fundamental means of safeguarding the knowledge of European patients. This is actually a very sensitive issue because it relates to health protection, which is a fundamental human right. I fully support this House’s call for a clear distinction to be made between therapeutic information and advertising. Pharmaceutical companies, in fact, must not use patients’ right to information as a vehicle for disguising their promotional aims but instead must use it to guarantee European consumers a real understanding of products, through the scientific indication of their characteristics, labelling and assessment reports. It should also be noted that greater access to information both in electronic form, available over the Internet, and in printed form can also contribute to the achievement of better medical results, because a patient who is informed about prescribed medicines is one who can play an active and more knowledgeable role in the therapeutic recovery process.

 
  
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  David Martin (S&D), in writing. – I voted for this report, which is part of a package which will amend the current 2001 directive on medicinal products for human use. It specifically focuses on the provision of information to the public on prescription-only medicines. The stated aims of the directive are to allow for better access to information for patients and to clarify the rules, which are currently interpreted differently across the EU, leading to health inequalities. It also deals with information on the Internet, which is not covered at present and is a particularly difficult topic, as it is so hard to regulate.

 
  
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  Marisa Matias (GUE/NGL), in writing. (PT) This proposal, adopted today by a large majority in Parliament, is a great improvement on the initial proposal presented by the Commission, as it better advocates patients’ rights to information. However, despite the clear improvements in Parliament’s report, I abstained because some of the guarantees that would be necessary in order for people to have access to clear and independent information on medicinal products are still weak.

 
  
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  Jean-Luc Mélenchon (GUE/NGL), in writing. (FR) Not all the amendments made by this House to the proposal by the Commission and the Council are along the right lines. They adhere strictly to the principle of a single market in medicinal products and still view products available over the counter as goods like any others; the authors even end up talking of ‘consumers’ rather than patients. The amendments do not propose preventing pharmaceutical companies from producing information about their medicines for the general public.

They do, however, have the virtue of seeking to enable the Member States to regulate as far as possible the dissemination of information published by those companies. In particular, they grant them the right to publicly condemn companies that publish information which is not in line with official State data or that disseminate it in a misleading fashion. That is better than nothing. I cannot, however, vote for such a weak text. I will therefore abstain.

 
  
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  Nuno Melo (PPE) , in writing. (PT) Access to quality information relating to medicinal products that are subject to medical prescription will contribute to achieving better results in terms of patient health, in that the better informed they are, the more likely they will be to better understand decisions related to their treatment. Therefore, the objective of this proposal cannot be limited to harmonising European legislation, but should also promote health, through the improvement of knowledge in the area of health. The pharmaceutical industry has an important role to play in the promotion of literacy in the area of health, but this role should be clearly defined, and participation by the sector strictly regulated, in order to prevent commercial considerations from leading to an excessive consumption of medicines.

 
  
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  Andreas Mölzer (NI), in writing. (DE) Elderly people and the chronically ill in particular have a multitude of medicines prescribed to them, which could adversely affect each other – because, of course, one doctor does not know what his colleague has prescribed. Meanwhile ever more products, from aspirin to cold remedies right through to sleeping remedies are sold without a prescription. Does anyone actually consider the possibility that even natural plant-based products could interact with various medicinal products? Patients also contribute to the confusion: nothing is said about prescribed medicinal products that we have taken at the wrong time, or medication that we have taken it upon ourselves to stop taking or to change, and so on. The economic damages arising as a result of insufficient compliance with treatment instructions run into billions. Therefore, the clear distinction between advertising and information called for by the rapporteur is important. This will hopefully result in better clarification of the fact that non-prescription medicines can also interact with prescription medicines. The prescribing doctor must remain the primary source of information, as only he selects a medicine that is tailored to the patient’s age, gender, weight, known intolerances and so on. In view of these considerations, I abstained from the vote.

 
  
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  Alfredo Pallone (PPE), in writing. (IT) I voted in favour of Mr Fjellner’s report, inasmuch as I believe that the message and guidelines provided are extremely important. European consumers are often lost when faced with medicinal product package leaflets because they find them complicated and they contain information that is often confusing.

The very aim of the proposal for a directive as regards information to the general public on medicinal products subject to medical prescription is to provide simple information that is easy to understand and use, but that avoids forms of advertising. It is also important for information to be accessible via other channels, in addition to package leaflets, and I therefore welcome publication on the Internet.

 
  
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  Maria do Céu Patrão Neves (PPE) , in writing. (PT) I believe the establishment of the distinction between information and advertising that is made with regard to medicines to be fundamental for the protection of citizens. My vote in favour of the Fjellner Report was a result of the clear improvements that were introduced into Directive 2001/83/EC. The large majority that approved this document were convinced about the defence of the patient’s right to information. The work carried out by the Committee on the Environment, Public Health and Food Safety in improving the proposal initially presented by the European Commission deserves to be emphasised.

 
  
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  Aldo Patriciello (PPE), in writing. (IT) I would like to thank Mr Fjellner for his excellent work. I voted in favour because I agree that non-promotional information on medicinal products must be made available to patients and the general public by marketing authorisation holders according to the ‘pull principle’ whereby patients/the public have access to information if they need it, contrary to the ‘push principle’ whereby the marketing authorisation holders disseminate information among patients and the general public.

 
  
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  Rovana Plumb (S&D), in writing. (RO) The information supplied to patients should fulfil the following main characteristics:

- Reliability: information to patients should be based on the latest scientific knowledge with clear references made to the sources this knowledge comes from;

- Independence: it has to be clear who provides and who finances the information so that consumers can identify potential conflicts of interest;

- Information should be easily accessible to consumers and patient-oriented: it should be comprehensible and easily available, taking into account the particular needs of consumers such as age, cultural differences and availability in all European languages. Information supplied to patients about prescription-only medicines should be part of a wider ‘information to patients’ strategy and a broader health education strategy.

Patients and anyone interested should be able to find accurate, unbiased information about having a healthy lifestyle, the prevention of illness and specific diseases and on the various treatment options. This is why I think that this proposal must be supplemented with a code of conduct concerning the information supplied to patients and drafted in cooperation with patients’ organisations. This will allow the ‘patients’ voice’ to be heard.

 
  
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  Paulo Rangel (PPE) , in writing. (PT) I voted in favour of this report since I welcome the fact that the compromise changes introduced into the proposal initially presented by the Commission will have contributed decisively to guaranteeing patient access to reliable and independent information on prescription-only medicines that are available on the market.

 
  
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  Frédérique Ries (ALDE), in writing. (FR) Advertising of prescription-only medicines is banned within the European Union, and remains so. Pharmaceutical companies must comply with clear rules on objectivity in the non-promotional information that they disseminate. These are the two important messages sent this lunchtime with the adoption of the legislative package on information for patients. A consensual vote by Parliament (558 votes to 48) that merely confirms the unanimous vote, less one vote from the Committee on the Environment, Public Health and Food Safety. Numerous safeguards have been put in place. The European Commission proposed a ban on information about prescription-only medicines broadcast on television or radio, and the European Parliament has decided to extend this to the written press. Manufacturers are subject to numerous obligations: descriptions of product characteristics, strengthened labelling, and prior authorisation by health authorities. I do not understand all the ‘commotion’ that the issue has caused, especially in French-speaking Belgium, amongst consumers’ associations and mutual societies, supported by certain MEPs who, even before the discussions had started, had already condemned these two laws. This is facile political posturing that I find regrettable, given the high expectations of patients when faced with illness and given that, without these laws, the public would be at the mercy of the cowboys on the Internet.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – We decided we would vote in favour or abstain depending on the result of the third part of Amendment 31, which ensures that pharmaceutical companies can only provide information material to health professionals for their own use, not for patients via healthcare professionals. This was key for the Greens/EFA. As it was finally adopted, we decided to support the report in the final vote.

 
  
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  Sergio Paolo Francesco Silvestris (PPE), in writing. (IT) Our vote in favour of this measure is a consequence of the formal distinction that has been made between information on medicinal products and advertising.

We support the greater dissemination of information on medicinal products, if this improves patients’ awareness. We do not, and shall never, agree with any measure that clearly or surreptitiously attempts to introduce forms of advertising, turning an ethical medicinal product into a commercial product. The fact that the information on drugs will not be allowed to be published in newspapers or magazines, nor much less broadcast on the radio or television, is therefore appreciated.

It is also a good thing that this proposal for a directive clarifies which and how much information can and must be divulged, including scientific information and clearly excluding advertising material.

The amendment that introduces certification and monitoring of Internet sites that publish said information further assures us that the information will not constitute advertising. The pharmacy is and must remain a basic healthcare facility, and as such a protected area with regard to the rules of trade and competition. We believe that this rule helps pharmacies carry out their difficult role in pharmacovigilance and education on the correct use of medicinal products.

 
  
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  Bart Staes (Verts/ALE), in writing. (NL) In an age when people search for information themselves, patients must be informed clearly, objectively, reliably and well about the effects of medicinal products. Although advertising of medicinal products is banned in the Union, the Commission has created an opening. Its proposal – which I did not endorse – lacked such a strategy, and the distinction from advertising was too vague. In addition, the Commission gave too many rights and too much responsibility to the pharmaceutical industry. Now that Parliament has made major changes, however, I can support the proposal. Companies’ use of official documents (summarised product information, evaluation reports) and the channels through which they make the information available are restricted: health newspapers and magazines, websites and letters to patients are no longer permitted. All guidance on the medicinal products must be screened and approved in advance by the competent authorities. This precludes self-regulation, which the original proposal did not do. I still have my doubts about the feasibility of this proposal, as a mandatory government information strategy would still be stronger than the government monitoring companies’ policies. I nevertheless voted in favour of the legislative proposal as, at the end of the day, it does ensure better information for patients.

 
  
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  Marc Tarabella (S&D), in writing. (FR) The Fjellner report on information on medicinal products raises legitimate concerns regarding the possibilities for pharmaceutical companies to advertise to patients. My colleagues in the Committee on the Environment, Public Health and Food Safety have certainly improved the text by refusing to support several kinds of disguised advertising and by proposing that Member States’ health authorities check communications from pharmaceutical companies to the general public on their prescription-only medicines. Nevertheless, I remain very cautious about the extremely fuzzy line between information and advertising.

I am fiercely opposed, for example, to the idea of authorising companies to advertise their medicines to patients via medical personnel. I do not want doctors to be put under pressure and to become salesmen and -women for the pharmaceutical industry. That is why, despite the strict supervision laid down by my colleagues, I abstained on a text which I found truly problematic.

 
  
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  Thomas Ulmer (PPE), in writing. (DE) I voted in favour of the report because it provides a clear and sustainable improvement to patient information on medicinal products. The advertising of medicinal products continues to be prohibited. The doctor-patient relationship will not be adversely affected by the directive and the authority of the service provider to prescribe medicinal products remains clear. Overall, we have a very successful proposal for a directive from the pharmaceutical package for second reading.

 
  
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  Angelika Werthmann (NI), in writing. (DE) This directive will introduce for the first time uniform regulations on the provision of certain information to the general public on medicinal products subject to medical prescription. The necessary information is to explain to patients the benefits and risks associated with prescription-only medicinal products to enable them to make informed decisions. Following consultation with patient organisations and healthcare professionals, among others, the Commission will adopt quality criteria for information. These criteria will ensure the reliability of the data provided – including on websites and on Internet portals – and will hold the pharmaceutical industry accountable for the information it provides.

Mr Fjellner’s amendments also recommend information campaigns to raise awareness among the general public of the risks of falsified medicines, which have already had fatal consequences in Member States such as the United Kingdom. For years, the EU customs authorities have been noticing a rapid increase in the import of falsified medicines, in particular antibiotics, painkillers and even cancer medicines. Contrary to some reports in the media, the directive relates only to medicinal products subject to medical prescription. No one need fear for their herbal tea.

 
  
  

Report: Christofer Fjellner (A7-0289/2010)

 
  
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  Sophie Auconie (PPE), in writing.(FR) Regulation (EC) No 726/2004 lays down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishes a European Medicines Agency. The amendment to Directive 2001/83/EC emphasises better information for patients, especially in relation to the distinction between information and advertising. Following this amendment, the regulation, for its part, should be amended so that certain items of information on the products it covers can also be subjected to prior monitoring by the European Medicines Agency. With this aim in mind, the European Commission has tabled a proposal to amend the regulation, concerning the dissemination to the general public of information on prescription-only medicinal products for human use. The European Parliament, called on to express an opinion on the proposal, has tabled a number of amendments to the European Commission’s text. These are the reasons that have led me to vote in favour of the resolution amending Directive 2001/83/EC. These two sets of legislation work hand in hand to improve information to patients on the medicines that are issued to them.

 
  
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  Charalampos Angourakis (GUE/NGL), in writing. (EL) The Greek Communist Party voted against both proposals for a regulation and the corresponding European Parliament reports, because they shift the responsibility for responsible, reliable and accurate information for patients from government departments to the multinational pharmaceutical companies. Information for patients is a government, not an individual responsibility. The profits made by monopoly pharmaceutical groups and protection for public heath are mutually exclusive. The recent vaccination scam in connection with the supposed ‘new flu’ pandemic is a typical example of how targeted information translates into profits of billions for the international drug companies. We maintain that the responsibility for informing citizens about drugs in general, not just drugs available on prescription as provided for in the regulation, should rest solely with the State. That is the very least that is required in order to protect patients and workers. Drugs, drug research and the means for disseminating knowledge and information are in the hands of the multinationals, whose only criterion is profit. Workers and health professionals cannot be certain of the quality and efficacy of drugs and of the knowledge and information which they receive. This policy needs to be combated, in order to eliminate business from health and drugs. We need government drug agencies and free national health services.

 
  
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  Zigmantas Balčytis (S&D), in writing. (LT) I voted in favour of this report which strives to ensure the key EU objective of ensuring the proper functioning of the internal market for medicinal products for human use and of better protecting the health of EU citizens. The document adopted today will create the conditions to plan a clear framework for information on prescription-only medicines to consumers with a view to promoting more informed consumer choices and will ensure that the direct advertising of prescribed medicines to consumers continues to be prohibited. According to the European Parliament’s proposal, a publicly accessible pharmaceutical database must be established in the EU in all the official languages of the Union with assurances that it will be updated and administered independently of the business interests of pharmaceutical companies. The establishment of the database will simplify information searches and will allow information to be understood by the non-expert public.

 
  
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  Anne Delvaux (PPE), in writing. (FR) I voted against this report, to which I have always expressed my strong opposition. While I approve of the idea of providing better information to patients, I disapprove of the means used to do so. The pharmaceutical industry’s goal will never be one of philanthropy. Moreover, there is a very fine line between information and advertising. It is true that the text, which was adopted almost unanimously, has nothing to do with the Commission’s initial idea. The latter would have simply opened the door to advertising disguised under the label ‘Information’. That proposal corresponded, moreover, to the pharmaceutical sector’s clear expectation of being able to get out of the legal ban on advertising of medicines. The report, as adopted today, includes many more guarantees: that the information provided by pharmaceutical companies for dissemination will, in particular, be checked beforehand, and will not be disseminated by the media. Nevertheless, the authorisation to publish package leaflet summaries means that there will be items that must be highlighted and others, such as adverse reactions, which may well be regularly excluded from the summaries, as they do not ‘sell’ well. Is that not already a promotional move? Was that really the aim? Was the game really worth the candle?

 
  
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  Edite Estrela (S&D), in writing. (PT) I voted in favour of the report on the proposal for a regulation of the European Parliament and of the Council on amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004. This regulation sets out Community procedures for the authorisation and supervision of medicinal products for human and veterinary use, establishes a European Medicines Agency and helps to ensure the right of patients to reliable, accessible and independent information, validated by the competent authorities, on the medicinal products available.

 
  
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  Diogo Feio (PPE), in writing. (PT) Given how important patient compliance and the correct administration of medicinal products are for successful treatment, it is vital that the public, that is, the patients, have access to good quality, non-advertising information that is true, current and not misleading, in line with the Summary of Product Characteristics. The best-placed body to provide current and accurate information for each medicinal product is its marketing authorisation holder. Parliament has rightly decided to focus on and protect the interests of patients. I could not agree more with this approach, although I do not believe that there is any need to limit the possibilities afforded by the Commission’s proposal on disclosure of information by the pharmaceutical industry, under the ‘push principle’. This was a balanced proposal that took the interests of all parties into account, involving health professionals and protecting the public from advertising about medicinal products subject to medical prescription, which quite rightly remains banned. I do not believe the text that has just been adopted will actually change the reality of patient’s access to information much, which I think is a missed opportunity.

 
  
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  Ian Hudghton (Verts/ALE), in writing. – It is important for patients to be better informed about any medications they are taking. It is important too that any information they receive is objective and that the pharmaceutical industry does not blur the line between information and advertising. The Committee on Economic and Monetary Affairs (ECON) has done a good job in amending this proposal and I was able to support this report.

 
  
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  Alan Kelly (S&D), in writing. – I do not agree with direct-to-consumer advertising in relation to pharmaceutical products. It is important for patients to have access to information on the medicine that they are taking but I feel that this type of advertising would undermine the doctor’s role as gatekeeper and may damage their responsibility to patients.

 
  
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  Giovanni La Via (PPE), in writing. (IT) I congratulate Mr Fjellner on his important work as regards information to the general public on medicinal products for human use subject to medical prescription and more particularly on EU procedures for medicinal product authorisation and monitoring.

The current EU legal framework on the scientific information provided to European consumers presents many problems, particularly as regards the different interpretations of the directive by individual Member States.

The report approved today aims to improve the level of harmonisation of the regulations in the sector in an attempt to close the gaps and eliminate the disparities that exist today with regard to safeguarding the right to health. This is all situated within a broader strategy of health literacy, aimed at ensuring that the European public can, in fact, easily access scientific information on prescription-only medicines.

 
  
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  Petru Constantin Luhan (PPE), in writing. (RO) I voted in favour of this report as I am particularly interested in health-related topics, especially concerning equal access for patients to medical care and information. At the moment, the level of information about the medicines available on the market varies hugely in Europe, which I could say is even unfair to patients. Patients must have the right to obtain complete, correct information about medicines. The proposals from my colleague Christofer Fjellner have gone precisely in this direction, thereby giving priority to the patient. The amendments made by the European Parliament to the European Commission’s legislative proposal highlight that manufacturers of medicinal products must provide basic information such as product characteristics, a label, patient information leaflet and a publicly available version of the assessment report. However, so that we can ensure that the information is reliable, I think that national authorities must monitor stringently the specialist sites which supply such details.

 
  
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  Jean-Luc Mélenchon (GUE/NGL), in writing. (FR) This report consists of a reminder of what the European Medicines Agency should be. One cannot oppose a draft that states obvious facts such as the need to ‘place emphasis on the rights and interests of patients’, the need to oblige companies to publicly list the adverse reactions of their medicines and the need to publish information in all the official languages of the European Union.

One can, however, be taken aback by the fact that such commonplaces have to be pointed out 15 years after that Agency was created. Parliament should denounce the Agency’s lack of transparency and say loud and clear that it should be reformed in everyone’s interests.

 
  
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  Nuno Melo (PPE) , in writing. (PT) Access to quality information relating to medicinal products that are subject to medical prescription will contribute to achieving better results in terms of patient health, because the better informed they are, the more likely they will be to better understand decisions related to their treatment. Therefore, the objective of this proposal cannot be limited to harmonising European legislation, but should also promote health, through the improvement of knowledge in the area of health.

The pharmaceutical industry has an important role to play in the promotion of literacy in the area of health, but this role should be clearly defined, and participation by the sector strictly regulated, in order to prevent commercial considerations from leading to an excessive consumption of medicines. It is also necessary to avoid misleading advertising and to try to provide better information to the consumer (patient), who has access to a variety of uncontrolled information through the Internet, which is not the case with regard to the reliable information provided by pharmaceutical laboratories.

 
  
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  Louis Michel (ALDE), in writing. (FR) In order to safeguard the rights and interests of patients, the latter should be able to avail themselves of good quality, objective, reliable and non-promotional information on medicines. If we wish to protect health, pharmaceutical leaflets must be as clear and comprehensive as possible, and must satisfy basic quality criteria. With this same concern to protect patients and provide information to the general public, we must promote the easiest possible access to information, in particular by summarising the characteristics of the product and providing a leaflet for these in both electronic and printed form. That is why we will have to ensure the availability of certified and registered websites offering considerable amounts of independent, objective and non-promotional information.

 
  
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  Alexander Mirsky (S&D), in writing. (LV) Mr Fjellner’s report is very timely. The veiled advertising of medicines is unacceptable. Doctors must be able to give their patients recommendations on medicines. Doctors must regulate and prescribe medicines to patients, in order to avoid speculation and competition between drug manufacturers. Pharmaceutical companies should be limited to providing support in the form of information, but in no event must they be allowed to try and foist their products on patients. Doctors are responsible for treatment; they must also decide which medicines should be administered to the patient in the course of that treatment.

 
  
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  Andreas Mölzer (NI), in writing. – (DE) In view of the fact that, in Germany alone, around 25 000 people die each year as a result of adverse reactions and interactions and 3% of accidents can be attributed to prescription-only medicines, it is clear that we must provide patients with better information. For instance, we could take France as an example, where any functional impairment is clearly indicated on the packet. We need to provide patients with information, but we also need to help them through the medicinal product jungle, for example by agreeing on the daily routine, package designs or special labelling. This will save the public purse billions and spare the patients the adverse reactions and interactions. This proposal contains a couple of initiatives intended to enable patients to be better informed about the medicines they have been prescribed and the use of these medicines. Whether patients will actually make use of this improved access to high quality information is questionable given the behaviour of many patients. Nevertheless, it is of course important for the information to be made available throughout the EU. For this reason, I voted in favour of the report.

 
  
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  Alfredo Pallone (PPE), in writing. (IT) Since it focuses on the patient’s right to information, I fully support the report, which includes some important innovations.

The first concerns the Internet: Parliament intends to make consumers aware of the risks of buying drugs online while also pushing for the proposal of ad hoc legislation on this selling method.

The second concerns the ban on advertising prescription-only drugs, because it is important to draw a distinction between generic and non-generic drugs, not only from the viewpoint of information to be given to patients but above all with regard to compliance with good practice in the manufacturing of active substances, particularly outside Europe.

 
  
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  Maria do Céu Patrão Neves (PPE) , in writing. (PT) The report on the proposed regulation of the European Parliament and of the Council amending Regulation (EC) No 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription, introduces new rules with regard to the transparency and effectiveness of the information, placing the emphasis on the interests of patients, protecting them, a fact on which I based my vote in favour. Important points are the establishment of a European Medicines Agency, and clear contributions towards guaranteeing the right of patients to reliable, accessible and independent information, validated by the relevant authorities for the available medicines.

 
  
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  Rovana Plumb (S&D), in writing. (RO) There are many sources of independent and evidence-based information on treatment options available within the European Union. These resources take into account cultural specificities and contexts for the population, including health determinants. Increased access to quality information will help achieve better health outcomes for patients as better informed patients are much more likely to continue necessary treatments and have far more chance of understanding the decisions related to their treatment. Consequently, if properly phrased and implemented, the proposal will generate added value.

The regulation being discussed fails to take into account technical developments, as well as the opportunities and challenges created by the Internet. Patients in Europe already have unlimited access via the Internet to uncontrolled and frequently incorrect information about prescription-only medicines in a few seconds. However, access via the Internet to controlled and safe drug information is very limited for most patients. This is especially a problem for those who need information in their own language. Therefore, the objective of the proposal can not only be to harmonise European legislation but also to improve health through improved health-related knowledge.

 
  
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  Paulo Rangel (PPE) , in writing. (PT) I voted in favour of the report on the proposed regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. I believe that it is essential to guarantee patient access to reliable and independent information on medicines subject to medical prescription that are available on the market.

 
  
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  Crescenzio Rivellini (PPE), in writing. (IT) In today’s sitting, we voted at first reading on the proposal for a regulation of the European Parliament and the Council as regards information on medicinal products (EU procedures for the authorisation and supervision of medicinal products). Parliament and patient organisations have been asking for such a proposal for a long time, in order to enable patients to better informed on the medicines they are prescribed and taking.

The current regulation is not in line with technical development or the possibilities and challenges created by Internet. Patients in Europe already have infinite access to uncontrolled and often incorrect information about prescription-only pharmaceutical products in a few seconds.

The rapporteur proposed to shift the focus of the proposal and to mandate pharmaceutical companies to provide certain information to the patients and thus, to put the ‘patients’ right to know’ at the centre of the legislation. Increased access to quality information will contribute to achieving better health outcomes for patients as better informed patients are more likely to continue necessary treatments and better understand decisions related to their treatment. The proposal will therefore bring an added value.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – This report welcomes the proposal by the Commission on information to patients on prescription-only medicines (COM(2008)0662-0663). Parliament and patient organizations have been asking for such a proposal for a long time, in order to enable patients to better informed on the medicines they are prescribed and taking. Increased access to quality information will contribute to achieving better health outcome for patients as better informed patients are more likely to continue necessary treatments and better understand decisions related to their treatment; so the proposal, if properly phrased and implemented, will bring an added value. Therefore the objective of the proposal can not only be harmonisation of European legislation but also to improve health through improved health literacy. The pharmaceutical industry has an important role to play in promoting health literacy and good health, but their role must be clearly defined and their involvement strictly regulated, in order to avoid commercially driven overconsumption of pharmaceuticals.

 
  
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  Christel Schaldemose (S&D), in writing. (DA) We, the Danish Social Democrats in the European Parliament (Dan Jørgensen, Christel Schaldemose, Britta Thomsen and Ole Christensen), have abstained from voting on the report on the proposal for a regulation of the European Parliament and of the Council on amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Even though the report contains a number of good proposals, we do not believe that we can vote for a proposal that runs counter to the Danish constitution.

 
  
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  Silvia-Adriana Ţicău (S&D), in writing. (RO) I voted in favour of the proposal for a regulation of the European Parliament and of the Council on amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency so that it will guarantee in future a legal EU framework enabling European citizens to have equal access to correct and clear information about medicinal products.

The report presented by the Commission on 20 December 2007 concerning ‘current practices with regard to the provision of information to patients on medicinal products’ indicates that Member States have adopted divergent rules and practices with regard to the provision of information on medicinal products, resulting in a situation where patients and the general public have unequal access to this information. Europe’s citizens are entitled to have access to correct and clear information about medicinal products. I think that it is important that the regulation safeguards the interests of patients and ensures that the latest communication media are used to provide the general public with information that is correct, accessible and easy to understand, in a transparent way, independently of the commercial interests of the pharmaceutical companies.

 
  
  

Report: Christofer Fjellner (A7-0290/2010), (A7-0289/2010)

 
  
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  Göran Färm (S&D), in writing. (SV) In view of the fact that, in a former job, I acted as a consultant for one of the interested parties in this matter, I have today abstained from voting on these reports, in other words, A7-0289/2010 and A7-0290/2010.

 
  
  

Report: Jill Evans (A7-0196/2010)

 
  
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  Sophie Auconie (PPE), in writing.(FR) Every year, in Europe, there is an estimated 9.3 million tonnes of electronic equipment waste. The fact is that this equipment often contains a substantial amount of highly polluting materials. This waste presents a considerable environmental challenge. Reprocessing aside, it would appear vital to restrict, from the outset, the use of these hazardous substances. Large industrial groups have already started to restrict their use. Nonetheless, we need clear rules in order to provide a common framework for this essential task. I therefore voted for the European Parliament legislative resolution on the adoption of a directive restricting the use of these substances. However, this has not been an easy vote. Indeed, the proposal contains a number of derogations, particularly as concerns photovoltaic panels. As they allow for a reduction in greenhouse gas emissions, we saw fit to tolerate the substances that they contain. However, this became an issue for debate, naturally, on the priorities of the Union’s environmental policy, which unfortunately faces mutually contradictory issues.

 
  
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  Zigmantas Balčytis (S&D), in writing. (LT) I supported this report. Every year, in the EU alone, an estimated 9.3 million tonnes of electrical and electronic equipment (EEE) are sold annually, the biggest share of which are large household appliances and IT and telecommunication equipment. As the market continues to grow and innovation cycles become even shorter, the replacement of equipment accelerates, making waste electrical and electronic equipment (WEEE) the fastest growing waste stream. WEEE arisings are estimated to grow to 12.3 million tonnes by 2020. WEEE includes several hazardous substances, which can be released into the environment and damage human health and the environment, especially if not treated appropriately. These problems have not been solved with RoHS 1.0.

I support the document's proposals that the European Commission should strengthen the prevention of the use of harmful substances and periodically examine the prohibition of other hazardous substances and their replacement with more environmentally friendly alternative substances or technologies which would ensure an appropriate level of protection of human health and the environment.

 
  
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  Jean-Luc Bennahmias (ALDE), in writing.(FR) The European Parliament has ratified the agreement with the Council under the ordinary legislative procedure by adopting, at first reading, the recast of the directive restricting the use of certain hazardous substances in electrical and electronic equipment. This is good news for European consumers: electrical and electronic equipment sold in the European Union make up a substantial proportion of consumer goods sold, The quantity of electrical and electronic equipment sold each year in the European Union alone is estimated at 9.3 million tonnes. The increasingly frequent replacement of these various items of equipment presents the issue of waste and of the hazardous substances present in that waste. It is necessary, for safety and public health reasons, to restrict their use. The idea behind the recast of the current directive, which dates back to 2003, is to progress even further in restricting the use of hazardous substances. The Commission is also due to revise its legislation in three years’ time, in order to adapt the legislation still further to future innovations.

 
  
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  Vito Bonsignore (PPE), in writing. (IT) I should like to congratulate the rapporteur, Mrs Evans, on her work and the good compromise that she managed to reach amongst our political groups.

The text adopted, a recast of the directive currently in force, aims to set more ambitious parameters for the use of electrical and electronic equipment (EEE). It should be noted that in recent years the European institutions have, with great effort, made notable progress in making the disposal and production of electronic equipment more respectful of the environment and human health.

I voted in favour of this measure, which fits into this context and certainly represents both a burden and an opportunity for companies and small and medium-sized enterprises. In fact, the ability to offer consumers less polluting products is a good chance for enterprises to improve their business processes and their global competitiveness. Finally, the new parameters examined in this report will guarantee both greater protection for European consumers and greater respect for the environment.

 
  
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  Edite Estrela (S&D), in writing. (PT) I voted in favour of the report on the proposal for a directive of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast), as I believe that the agreement reached with the Council meets the objective of contributing to the protection of human health and the environment, simplifying and giving greater coherence to existing legislation.

 
  
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  Diogo Feio (PPE), in writing. (PT) According to the Commission, 9.3 million tonnes of electrical and electronic equipment (EEE) are sold every year in the EU alone, most of which comprises large household appliances and IT and telecommunications equipment. As the market continues to grow and innovation cycles become shorter, waste electrical and electronic equipment (WEEE) is seen as the fastest growing waste stream. It is estimated that WEEE will increase to 12.3 million tonnes by 2020. The recasting of the directive on the restriction on the use of certain hazardous substances is aimed at broadening the scope of the directive and strengthening its preventative part, so that environmental damage can be corrected at the source as a priority, in line with Article 174.2 of the treaty. However, this directive essentially focuses on large distributors, neglecting the budgetary impact that it may have on small and medium-sized enterprises (SMEs) producing EEE, and it does not offer solutions in the wake of the COM(2008)0809 proposal and the report on BioIntelligence, which stated that under this new scheme, SMEs that produce medical supervision and monitoring equipment are likely to face problems.

 
  
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  José Manuel Fernandes (PPE) , in writing. – (PT) This recast relating to the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) is necessary, according to the Commission, because of uncertainty with regard to scope, a lack of clarity with regard to legal provisions, and disparities among Member States with regard to the conformity of the products in question.

Prior to the vote, I received several calls to reject the inclusion of PVC on the list of substances identified for priority review within Annex III of the RoHS Directive. I would like to state that I disagree with this inclusion, as the listing of a series of suspect products, including PVC, not based on any criteria, does not make sense. Considering a product to be susceptible a priori of being banned in the future without any scientific basis gives rise to an unacceptable situation of a lack of legislative definition. In the case of PVC, an initial assessment carried out under the terms of the REACH Regulation concluded that it is not very hazardous, and is not a priority substance for inclusion in Annex III. I voted in favour of this report because, during the negotiations that preceded the plenary vote, this list was withdrawn. The Commission should now carry out a reassessment, three years after this legislation came into force.

 
  
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  João Ferreira (GUE/NGL), in writing. (PT) The amount of sales of electrical and electronic equipment in the EU and the inevitable increase in waste from this equipment means that there is a need to replace certain hazardous substances in them, so as to minimise their impact on the environment and ensure the protection of consumers and public health. We realise that this is necessary, and see the search for solutions that could provide an answer as valuable. We therefore voted for this report. Over the course of the discussion process that has taken place over recent months, the Council has reached agreement with Parliament, following negotiations on certain more controversial and troubling issues. We regard the fact that the proposed final text excluded polyvinylchloride from the scope of the directive, which allows production in certain industrial sectors to be maintained, as a positive factor, as these sectors could have been seriously hit had this been included, as was proposed.

 
  
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  Robert Goebbels (S&D), in writing. (FR) I abstained on the Evans report on the restriction of the use of certain hazardous substances in electrical and electronic equipment because I find Parliament’s approach strange. On the one hand, the report relentlessly opposes, without any scientific proof, nanoparticles, which, because they are small, must necessarily be hazardous. On the other hand, the proposal for a directive, by claiming to want to encourage the development of renewable energy technologies, excludes wastes from solar panels. Either electrical substances are hazardous, or they are not. If the aim is to impose the ‘precautionary principle’, then it should be applied to solar technology, too.

 
  
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  Matthias Groote (S&D), in writing. (DE) I voted in favour of the report on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS), because the extension of the area of application to cover all electronic equipment represents a definite improvement. However, I find the fact that there are so many exceptions problematic. In particular in the area of renewable energies, photovoltaic modules, which consist in part of cadmium telluride compounds, are not covered by this directive. This substance is not only harmful to health, it is also hazardous and therefore really ought to be placed within the scope of the RoHS Directive. The danger that, as a result, photovoltaic installations would have to completely disappear from roofs would not arise. Rather, there are numerous cadmium telluride-free alternatives on the market. I therefore disagree in this regard with the decision of the majority in Parliament and the Council.

 
  
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  Françoise Grossetête (PPE), in writing. (FR) Waste electrical and electronic equipment is increasing all the time, and it brings together several hazardous substances. These substances may be discharged into the environment and harm human health if they are not treated properly.

This directive will enable numerous companies to make even more progress in designing new and safer electrical and electronic equipment by encouraging technological innovation. The reduction in hazardous substances, upstream, will also lead to a reduction in recycling costs. Finally, and critically, we have obtained an exemption for solar panels in order to encourage the development of renewable energy technologies within Europe.

 
  
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  Małgorzata Handzlik (PPE), in writing.(PL) Poland is one of the largest producers of television, radio and domestic electrical appliances in Europe. It is also a country in which sales of this type of appliance are rising year by year. The development of technology and the growth in demand for goods of this type are also causing an increase in the quantities of what is known as e-waste, and there is a problem with processing this waste and with the effect of this process on environmental pollution. Therefore, the new provisions of the Restriction of Hazardous Substances Directive are extremely important for the producers of this type of appliance. They are required to eliminate harmful substances and to raise safety standards for appliances which are intended for everyday use. This is also good news for consumers, because the new rules introduce the obligation to use substances which are safe for health and the environment, and this applies to all producers of electrical appliances throughout the European Union.

 
  
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  Jutta Haug (S&D), in writing. – Though not very ambitious, the first reading compromise improves the current legislation – I therefore voted in favour. Besides the new methodology for substance restrictions, one key improvement is the open scope: all electric and electronic equipment, including equipment for the generation of electric currents, will in the medium term fall under the RoHS legislation. A major drawback, however, is the long list of exclusions, including photovoltaic panels. Excluding this decisive ‘clean’ technology from environmental legislation will send the wrong signal, EU-wide and globally. This is about setting the right regulatory framework for coherent sustainable investments! Even if the production of photovoltaic panels with hazardous substances like cadmium telluride might be more cost-efficient, less problematic alternatives have existed for a long time and have proved to function excellently. I do not see any need, therefore, to cover our roofs and fields with potentially hazardous waste, shifting the disposal challenge to future generations. On this point, I strongly disagree with the position and decision of the EP’s and Council’s majority.

 
  
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  Ian Hudghton (Verts/ALE), in writing. – The compromise negotiated by my colleague Jill Evans marks progress in this area of law. The legal certainty it provides will lead to improvements in environmental protection and I accordingly voted in favour of the report.

 
  
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  Jarosław Kalinowski (PPE), in writing.(PL) The constantly rising production of television, radio and domestic electrical appliances is the result of the development of modern technologies and the increase in demand for this type of product. As consumers, we expect functionality and ergonomics from these appliances, but above all we should require that different types of product comply with appropriate norms which regulate safety standards both for the user and the environment. We exchange used appliances for new ones, producing alarming amounts of waste, and the dangerous substances used in their production are causing irreversible damage to the ecosystem.

Therefore, it is indispensable to introduce legislative regulations which will limit the use of harmful substances in the production of appliances which come into our homes, and which at the same time will support producers in the introduction of innovative, ecological measures.

 
  
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  Alan Kelly (S&D), in writing. – The current RoHS restricts the use of six hazardous materials that were once contained in certain electrical and electronic equipment. It is being recast in order to simplify it and to make it easier for producers to tell which substances are banned, so as to avoid any unnecessary mix-ups that could be dangerous to the consumer and waste companies’ resources.

 
  
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  Giovanni La Via (PPE), in writing. (IT) The European Union needed a detailed set of rules on the use of certain substances considered hazardous in electrical and electronic equipment. This requirement is made clear from Commission data, which shows that, every year, in the EU alone, an estimated 9.3 million tonnes of electrical and electronic equipment (EEE) are sold.

As the market continues to grow and innovation cycles become even shorter, the replacement of equipment accelerates, making waste electrical and electronic equipment the fastest growing waste stream. After a short transitional phase to allow companies to adjust to the new legislation, the use of hazardous substances will be banned from all electrical and electronic equipment, albeit with some exceptions such as photovoltaic panels. The measure will also require competing third-country industries to observe the same obligations imposed on our own businesses, with the express requirement that imported products must comply with the same safety standards guaranteed by EU rules.

I therefore ultimately believe it is a priority to safeguard certain primary assets such as public health and the environment, albeit in the knowledge that we are operating in conditions that are very much defined by the severe economic crisis that has affected Europe and the world.

 
  
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  David Martin (S&D), in writing. – I voted for this report on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The current Restriction of Hazardous Substances Directive restricts the use of six hazardous materials in the manufacturing of certain electronic and electrical equipment. It is intended to avoid toxic waste once this equipment is thrown away, to ensure that Europe’s unwanted mobile phones, computers and fridges do not damage the environment or human health by the seepage of chemicals in landfills or by giving off toxic fumes at incineration. The directive is being simplified.

 
  
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  Marisa Matias (GUE/NGL), in writing. (PT) The use of hazardous substances in electrical and electronic equipment is a major problem for public health, for the environment and for waste management. These risks are even greater in recycling and recovery operations under poor conditions in developing countries, especially in the case of illegal exporting for disposal in dumps in poorer countries. With this draft legislation, all the material in question will be included under this directive. In future, therefore, all materials will have to comply with the provisions of the directive if this is deemed necessary in an environmental assessment.

This directive contributes to the setting out of clear rules in the Member States as regards placing these substances on the market, and subsequently reusing them. This directive will lead to a significant improvement to the present situation, which is why I voted in favour. However, I believe that some hazardous substances that were left out of the directive should be included within the next three years, following a review and assessment of their impact.

 
  
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  Nuno Melo (PPE) , in writing. (PT) The increased use of electrical and electronic equipment, combined with their considerable technological development, has led to an ever shortening life cycle. This, in turn, has led to serious problems with regard to the use of dangerous substances in this equipment, as well as difficulties in the management of the ever larger quantity of waste. Therefore, this directive relating to the restriction of the use of certain hazardous substances (RoHS) is aimed at broadening its scope and strengthening its preventative part, so that environmental damage may be corrected at source as a priority, in line with Article 174(2) of the treaty. This recast is essential for there to be a successful reduction of hazardous substances in this type of equipment.

 
  
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  Alexander Mirsky (S&D), in writing. (LV) I fully support Mrs Evans’s report. However, I should like to add that this issue should be paid more attention. The use of lead, magnesium, mercury and rare-earth metals in electronics and industrial technology is unavoidable. Our task is to compel manufacturers to move over to less harmful materials. Where that is not possible, it is essential that the public be informed of the potentially deleterious effect on consumers of all the harmful substances that have been used.

 
  
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  Andreas Mölzer (NI), in writing. (DE) The directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) governs the use of hazardous substances in devices and components. It is also an important instrument for setting a European, as well as global, standard for manufacturers. The extension of the scope of the directive is intended to also take account of the waste treatment of hazardous substances. I abstained from voting, as the report does not yet completely resolve all of the problems associated with the handling of hazardous substances.

 
  
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  Franz Obermayr (NI), in writing. (DE) There has certainly been a rapid growth in the market for electrical equipment, in particular in the areas of IT and telecommunications. This and the ever shorter innovation cycles are also resulting in ever increasing amounts of electrical waste. The recast of the RoHS Directive is aimed at preventing the use of hazardous substances that could harm the environment or human health. Some of the proposals are controversial: on the one hand, large computer manufacturers like HP, ACER or Sony Ericsson have pronounced themselves in favour of a ban on all brominated flame retardants in electrical and electronic equipment. On the other hand, the results of the Commission’s studies are clearly not very conclusive, at least as regards the potential damage to the environment. In addition, there are concerns being expressed by the industry with regard to the ban on PVC, particularly in the area of the cables industry. The negative properties of PVC are disputed and there is a fear that costs will increase if there is a ban on PVC-covered cables. These arguments need to be weighed up before specific bans are laid down. I have therefore abstained from voting.

 
  
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  Alfredo Pallone (PPE), in writing. (IT) I voted in favour of the report for a variety of reasons. I agree that fixed installations and photovoltaic panels should be excluded from the scope of the directive. I was also pleased at the adoption of a methodology for reviewing the hazardous substances contained in Annex IV, as it means that the list of substances to be examined by the Commission (Annex III) can be removed. I also believe that the not overly broad definition of ‘dependency’ to mean needing electricity for equipment operation is correct. I also believe it premature for the legislation to cover the evaluation of nanomaterials, which are currently being examined by the Commission. Lastly, I applaud the fact that the scope is ‘open’ to include all electrical and electronic equipment.

 
  
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  Maria do Céu Patrão Neves (PPE) , in writing. (PT) My vote in favour of the report on the proposal for a directive of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) was due to the improvements introduced by mutual agreement with the Council, which should contribute to major improvements in the protection of public health and the environment, and waste management. I would highlight the simplification and increased consistency of the new legislation. The reorganisation and restriction of the use of hazardous materials was imperative in view of the substantial increase in sales of electrical and electronic equipment within the EU.

With this legislation, we are contributing to preventing the waste that we produce with electrical and electronic equipment, such as mobile phones, computers and refrigerators, from harming the environment and human health through the introduction of chemical products into the environment, either from landfill or through the release of toxic gases from incineration.

 
  
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  Aldo Patriciello (PPE), in writing. (IT) I would like to thank Mrs Evans for her excellent work. I voted in favour because I agree that the RoHS recast needs to be put into the context of the EU’s international obligations to reduce total releases of dioxins and furans, with the goal of their continuing minimisation and, where feasible, ultimate elimination.

The final destiny of large quantities of waste electrical and electronic equipment (WEEE) remains unclear. High-temperature incineration remains the exception. Sub-standard treatment of WEEE – in the EU or in third countries – risks remaining a reality for significant amounts. Emissions of dioxins and furans can only be addressed via material choices at design stage.

 
  
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  Rovana Plumb (S&D), in writing. (RO) In the EU alone, an estimated 9.3 million tonnes of electrical and electronic equipment (EEE) are sold annually, the biggest share of which are large household appliances and IT and telecommunication equipment. As the market continues to grow and innovation cycles become increasingly shorter, the replacement of equipment accelerates, making waste electrical and electronic equipment (WEEE) the fastest growing waste stream. The volume of WEEE items is estimated to grow to 12.3 million tonnes by 2020.

The key aspects of this recast of the directive are as follows:

- open scope

- differentiation between RoHS and REACH

- modification of the exemption criteria

- criteria for deciding on the duration of exemption/grace periods

- codecision for future restrictions instead of comitology

- specific provisions on nanomaterials.

I welcome that agreement was reached on first reading. I voted for this report as the new proposal for a directive is simpler and will offer manufacturers an easier instrument to use for classifying their products in the categories envisaged by the directive. It also takes into account the socio-economic impact linked to the protection of health and the environment when amending the exception criteria.

 
  
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  Paulo Rangel (PPE), in writing. (PT) According to the Commission, it is advisable to reformulate the current directive relating to the restriction of the use of certain hazardous substances in electrical and electronic equipment, adopted in 2003, on the grounds of clarity and legal certainty. This recast naturally requires the expansion of the directive’s scope, so as to contribute to the protection of human health and the ecologically correct recycling and disposal of waste from electrical and electronic equipment. With regard to this question, it is now crucial to take into consideration the potential impact of the recommended solutions on small and medium-sized enterprises.

 
  
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  Frédérique Ries (ALDE), in writing. (FR) Nearly eight years ago, the European Parliament adopted a directive on the restriction of hazardous substances (the RoHS Directive), and thereby responded to a strong demand by consumers for safe and non-harmful everyday consumer products. This safety approach was implemented mainly through a ban on the use of lead, mercury and cadmium in products as diverse as domestic appliances, radio and television sets, electric trains and video games. I welcome the revision adopted today, which extends the scope of the directive to other products, but without prejudging substances as important as PVC. Similarly, it was important to reconsider the restrictive position on nanomaterials adopted by the Committee on the Environment in June. This revolution in the infinitely small deserves better than a simplistic position: for or against, as in the case of Genetically Modified Organisms (GMOs). It is also essential for the RoHS Directive to be workable and, in this respect, I welcome the account that has been taken of the potential effects of these substances on health and the environment, the establishment of a methodology and the guaranteed complementarity with the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) Regulation.

 
  
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  Crescenzio Rivellini (PPE), in writing. (IT) At today’s sitting, I voted in favour of the revision of the directive on the use of hazardous substances in electric or electronic equipment.

Partly as a result of new scientific knowledge on the subject, the text – a recast of the 2003 directive – seeks to introduce restrictions on the use of materials such as cadmium, chlorine, mercury and polyvinyl chloride (PVC), which have been shown to endanger human health.

Despite being aware of the strong opposition from the manufacturers of the sector, in particular against the limitations on the use of PVC, I believe it is a primary duty of politics, and consequently of democratically elected politicians, to try to control the use of substances that, even if only potentially, can damage human health. At the same time, we need to encourage the use of alternative and replacement substances within the limits of the available technology.

I believe that the final outcome for electric and electronic equipment waste is of particular importance, particularly in cases in which these contain materials later recognised as dangerous. In such cases, in fact, disposal must be even more rigorous and careful.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – According to the Commission, every year, in the EU alone, an estimated 9.3 million tonnes of electrical and electronic equipment (EEE) are sold annually, the biggest share of which are large household appliances and IT and telecommunication equipment. As the market continues to grow and innovation cycles become even shorter, the replacement of equipment accelerates, making waste electrical and electronic equipment (WEEE) the fastest growing waste stream. WEEE arisings are estimated to grow to 12.3 million tonnes by 2020. WEEE is a complex waste stream, including several hazardous substances. These substances, or their transformation products, can be released into the environment and damage human health, especially if not treated appropriately. Risks for human health and the environment are further increased by sub-standard recycling/recovery operations in developing countries. According to Article 174(2) of the treaty, environmental damage should as a priority be rectified at source. The waste hierarchy in the waste framework directive gives first priority to prevention, which is defined inter alia as setting out waste prevention measures that reduce the content of harmful substances in materials and products. I really hope this report will help to solve those problems.

 
  
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  Daciana Octavia Sârbu (S&D), in writing. – Electronic equipment produces the fastest growing waste stream in Europe, and reducing the carcinogenic and toxic substances from this waste stream must be a top priority. The open scope of the legislation, as recommended by the Environment Committee, is a much better approach than that proposed by the Commission. A definitive list of specific products could exclude new products from the regulation, and we need to ensure that the legislation not only facilitates – but also keeps up with – innovation by industry. It is encouraging to see that several companies are now phasing out the use of some of these potentially harmful substances from their products. But we still need to adopt ambitious legislation which will encourage the rest of industry to follow the lead of others and to innovate in order to ensure better environmental protection.

 
  
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  Bart Staes (Verts/ALE), in writing. (NL) I have endorsed the report on the restriction of the use of certain hazardous substances in electrical and electronic equipment. This report is a step in the right direction. It extends the category of equipment to, inter alia, medical apparatus. In addition to heavy metals such as mercury and lead, a number of brominated flame retardants are banned. Moreover, the report provides an open scope, enabling all electronic equipment, with a number of specifically defined exceptions, and also other hazardous substances to be covered by this directive in the future. Clear criteria are laid down for this. However, I regret that a ban on PVC has not been included in this directive as the Group of the Greens/European Free Alliance had proposed. It is very important to achieve a reduction in hazardous substances in electronic waste. Even though European legislation prohibits the export of hazardous waste for recycling, studies have shown that more than two thirds of European electronic waste is exported. Often, this e-waste is dumped illegally in places such as West Africa, where waste treatment is very substandard and causes tremendous health problems and environmental pollution. There is much money to be made from this fast-growing market in waste, and so sound supervision and monitoring are necessary to curb the illegal export of electronic waste.

 
  
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  Marianne Thyssen (PPE), in writing. (NL) It has become impossible to imagine our daily life without electrical and electronic equipment. The European Restriction of Hazardous Substances (RoHS) system that regulates the use of hazardous substances in this electronic equipment has in fact become a universal system that is used in no less than 28 non-EU countries. To date, restrictions have already been imposed on mercury, lead, cadmium and a number of flame retardants on the basis of the current RoHS Directive. Rapid technological progress and better scientific knowledge have compelled us to recast this legislation. The recast of the directive is also necessary in order to make RoHS an efficient, flexible instrument. Indeed, from now on, it will be possible to exclude hazardous substances more quickly, which will benefit humans and the environment. The relationship between the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the RoHS Directive is also laid down, and thus double regulation avoided. For these reasons, I have endorsed with conviction today the agreement that Parliament was able to conclude with the Council. I hope that an agreement can also be reached quickly regarding the Directive on Waste Electrical and Electronic Equipment (WEEE). After all, the two legislative instruments are inextricably interlinked.

 
  
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  Thomas Ulmer (PPE), in writing. (DE) This is a good report, which takes most of the concerns of the industry and environmental protection concerns into account in a balanced manner. Although it will surely not be possible to achieve complete satisfaction in relation to such a complex matter, this provides a very close approximation.

 
  
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  Kathleen Van Brempt (S&D), in writing. (NL) I have voted in favour of the Evans report because the overall balance of the agreement reached with the Council is positive. Nevertheless, as shadow rapporteur, I would like to express my displeasure at the fact that solar panels have been excluded from the scope of the directive after intense lobbying from the sector. As a result, cadmium will be allowed to remain in solar panels placed on the European market for (at least) another ten years, whereas that will not be allowed for any other electrical or electronic equipment. I expressly disapprove of a situation where a sector which ought to be a driving force in our evolution towards a green economy has been anxious to evade this important environmental legislation and where a majority in Parliament and the Council have given in to the interests of one type of technology in particular (the use of cadmium telluride thin-film solar panels).

 
  
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  Artur Zasada (PPE), in writing.(PL) In today’s vote, I endorsed the report on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Recently, we have been able to see the significance of the problem addressed by the legislation we have adopted, as several million households around the European Union have exchanged their CRT television sets for modern LCD screens. Today, those same households are thinking about changing their LCD televisions for LCD-LED ones.

The experts say that used electrical and electronic equipment is becoming the fastest growing source of waste. In addition, analyses carried out by the research institute Öko-Institut have demonstrated the adverse effect of PVC and halogenated flame retardants on the environment and human health. I am sure the document adopted today will contribute to a reduction in the amounts of hazardous substances of this kind.

 
  
  

Motion for a resolution B7-0617/2010 (Anti-Counterfeiting Trade Agreement)

 
  
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  Damien Abad (PPE) , in writing. – (FR) Parliament today adopted the motion for a resolution on the international Anti-Counterfeiting Trade Agreement (ACTA), to ensure better international application of anti-counterfeiting measures. ACTA is a tool for making the existing regulations more effective and for providing better protection against violations of copyright, trademarks, patents, designs and geographical indications. I voted in favour of this resolution, tabled by my political group, the Group of the European People’s Party (Christian Democrats), as I believe that ACTA provides a protective shield for European industry. Hence, we will be able to ensure the protection of copyright, as well as creativity and innovation in cultural and scientific matters. Indeed, we should stop and reflect today on how better to combat piracy, and this international agreement is a step in the direction of the more effective application of anti-counterfeiting measures.

 
  
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  Sophie Auconie (PPE), in writing.(FR) I voted in favour of the joint motion for a resolution tabled by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists on the Anti-Counterfeiting Trade Agreement, known as ‘ACTA’. This agreement aims to combat the proliferation of counterfeiting and the increased piracy of ‘copyrighted’ products by establishing a new international governance structure. I think it is crucial to protect creativity from theft, for that is what piracy and counterfeiting really is. The Union, which aims to become the world’s most competitive knowledge-based economy, cannot remain indifferent to this major problem. That is why I welcome the adoption of this resolution. It is a strong text which should have united all MEPs. Unfortunately, it was only adopted by a slim majority. While the European Commission was offering strong guarantees as regards respect for fundamental rights, the left in Parliament preferred to cling onto groundless protest slogans. In my view, the European Union must spearhead this fight against negligence and lack of commitment of which China and Russia are frequently guilty in this area. Our competitiveness in the globalised economy is at stake.

 
  
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  Zigmantas Balčytis (S&D), in writing. (LT) Combating counterfeiting is an essential element of EU political strategy, aimed at ensuring fairness, uniform conditions for our manufacturers, employment for our citizens and respect for the principles of the rule of law. With the emergence of digital technologies, counterfeiting took on an uncontrollable international dimension, and so international cooperation is the main tool for combating this problem. I supported this motion for a resolution which sets out the European Parliament’s objectives and priorities in the multilateral negotiations on the Anti-Counterfeiting Trade Agreement, which aims, for the first time, to establish a comprehensive international framework to combat infringements of intellectual property rights more effectively. I feel that it is important to ensure that IPR enforcement measures are not an obstacle to innovations and competition and that there is no damage to IPR restrictions and the protection of personal data, or that the free flow of information is restricted or legitimate trade unjustifiably impeded.

 
  
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  Françoise Castex (S&D), in writing.(FR) I voted against this text: the European right has given in to the demands of certain governments and to the pressure of the cultural industries, at the expense of the fundamental rights of European citizens. All the safeguards which we asked of the Commission have been dismissed out of hand by the Group of the European People’s Party (Christian Democrats). That sends a bad signal to the Commission ahead of the Sydney negotiations next week. Furthermore, the vague definition of the term ‘commercial scale’, relating to the increase in criminal sanctions in the area of on-line copyright infringements, could encourage States to adopt legislation leading to the criminalisation of private users and technical intermediaries. ACTA must not have the effect of enabling the European Union to carry out investigations into individuals or to introduce flexible response systems or the like. Finally, the Commission must carry out an impact assessment quickly – before rather than after ACTA has been implemented – regarding its application and its consequences for fundamental rights, data protection and the E-Commerce Directive.

 
  
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  Carlos Coelho (PPE), in writing. (PT) This will allow the strengthening of international cooperation in combating counterfeiting, creating a tool to protect intellectual property rights (IPRs) effectively. It is not intended to create new rights, but to ensure respect for existing rights through repressive measures and the creation of a comprehensive international framework of assistance to the parties. This is a difficult agreement, with conflicting interests that leave room for controversial interpretations as to its effects. Protecting IPRs is essential, but, on the other hand, it is vital to ensure a balance so that freedom of expression and innovation are not threatened, and so that the ability of individual to exercise his or her civil and fundamental freedoms is not constrained. Counterfeiting is a very serious problem that carries enormous risks for European industry, the economy and innovation.

I hope that this agreement will be a step in the right direction, and that in forthcoming negotiations it will be possible to resolve the ambiguities and omissions that still plague the text, such as in the reference to false geographical locations. I could like to congratulate the Commission for its efforts in increasing the transparency of the negotiations, and I hope that it will maintain this stance, keeping Parliament fully informed of the progress of negotiations.

 
  
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  George Sabin Cutaş (S&D), in writing. (RO) I voted for the joint motion for a resolution on the ‘Anti-Counterfeiting Trade Agreement’ proposed by the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, along with another three political groups from the European legislative. The intention behind this resolution was both to respect fundamental freedoms and individual rights and keep free access to the Internet. The resolution also endeavoured to guarantee access to medicines in developing countries. It is deplorable that this resolution failed to win the vote of the House as the socialist position supported the interests of European citizens.

 
  
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  Mário David (PPE) , in writing. (PT) I agree on the whole with this motion for a resolution, which concerns the Anti-Counterfeiting Trade Agreement (ACTA), approved after long months of debate and efforts to find a compromise solution between the various political groups, which was unfortunately not achieved. For the sake of the healthy functioning of the markets, the protection of the single market, the competitiveness of European companies within a global economy, and the creation and maintenance of jobs within the EU, it is important that the Union makes action against counterfeiting in its various forms a priority of its internal and international policy. Aware that ACTA does not recommend a solution to a complex and multi-dimensional problem such as counterfeiting, as expressed in paragraph 3, I still believe that ACTA constitutes a valid tool for making existing standards more effective, thus benefiting exports from the EU and protecting rights-holders when they operate within the global market, where various holders of industrial and intellectual property rights are currently the victims of systematic and widespread violation of copyright, trademarks, patents, designs and geographical indications.

 
  
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  Proinsias De Rossa (S&D), in writing. – I voted against this resolution, which states the position of the European Parliament ahead of the initialling of the Anti-Counterfeiting Trade Agreement (ACTA), because the conservative majority in this House refused to raise the need for basic safeguards for our citizens vis-à-vis this global copyright agreement. Parliament has yet to see evidence that the legal basis for this negotiation is consistent with the Treaty of Lisbon prior to the initialling of the agreement. The Commission must also demonstrate to us that cooperation between service providers and copyright holders will not impinge on citizens’ fundamental rights, especially the right to privacy, the right to freedom of expression and the right to due process. This requires an assessment of the impact of ACTA on data protection and fundamental rights. We need a guarantee by the Council and the Commission that ACTA will not necessitate any changes to EU law as far as criminal measures relating to the enforcement of intellectual property rights are concerned. Civil enforcement provisions on patents could also negatively impact access to generic medicines, and the Commission should address this concern. We should withhold our consent to ACTA until we receive written guarantees on these critical issues.

 
  
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  Marielle De Sarnez (ALDE), in writing.(FR) A question remains over the content of the Anti-Counterfeiting Trade Agreement (ACTA). The main aim of this agreement, which has been negotiated for years in the utmost secrecy between 10 or so countries, is to combat counterfeiting and to protect intellectual property rights. Nonetheless, it should be noted that neither China nor Brazil nor India has participated in these negotiations. Furthermore, while counterfeiting must be combated, the well-known provisions in the treaty in question imply the establishment of measures that might be considered to be attacks on individual freedoms: supervision of Internet access providers, strengthening of border controls, and greater difficulties in transporting low cost generic medicines to developing countries. These are all concerns that have been relayed by many MEPs, who do not wish to place ‘blind’ confidence in the negotiations conducted by the European Commission. The resolution, which was adopted by a slim majority – and only just – cannot actually be regarded as support, as doubts remain over whether the text complies with the acquis communautaire and whether it is compatible with respect for fundamental rights.

 
  
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  Edite Estrela (S&D), in writing. (PT) I abstained from voting on the resolution on the Anti-Counterfeiting Trade Agreement (ACTA) because I believe that, although the text has some important points, it is excessively critical of the agreement under consideration. Overall, I believe that the ACTA is favourable to the economic interests of the EU, and that it strikes a balance between protecting intellectual property rights and ensuring fundamental rights.

 
  
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  Diogo Feio (PPE), in writing. (PT) After much insistence by Parliament, there has been a substantial increase in the degree of transparency in the Anti-Counterfeiting Trade Agreement (ACTA) negotiations, and since the round of negotiations in New Zealand Parliament has been kept fully informed. The negotiated text reflects the main concerns expressed by Parliament, especially on issues such as respect for fundamental rights, privacy and data protection, respect for the importance of a free Internet, the usefulness of safeguarding the role of service providers and the need to safeguard access to medicines. The fight against counterfeiting is a priority, and international cooperation is fundamental to achieving this objective. With the possibility of new emerging and developing countries acceding to the agreement, thus promoting widespread protection of intellectual property rights, the ACTA will be able to achieve the required multilateralism.

 
  
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  José Manuel Fernandes (PPE) , in writing. – (PT) The agreement negotiated is an important step in the fight against counterfeiting, and is a key element in the EU’s political strategy for ensuring justice, a level playing-field for European producers, the preservation of jobs for citizens, and respect for the rule of law. The fight against counterfeiting should be one of the priorities of internal and international political strategy, and international cooperation is fundamental to the achievement of this objective.

ACTA is a tool that makes existing standards more effective, thus benefiting exports from the EU and protecting rights-holders when they operate within the global market. I would stress the importance for European companies and jobs within the EU of protecting geographical indications, and I welcome the efforts made by the Commission to include the protection of geographical indications within the scope of ACTA. Finally, I would emphasise the importance of the Commission confirming that the application of ACTA will not have any impact on fundamental rights and data protection, or on the efforts that the EU is currently making to harmonise implementation measures for intellectual property rights.

 
  
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  Bruno Gollnisch (NI), in writing. (FR) Had I not decided to boycott the sitting after the lamentable episode of Social-Eurocratic totalitarianism that we have just experienced, I would have voted in favour of the joint motion for a resolution of the left-wing groups on the counterfeiting agreement. I would have done so not because I have changed political persuasion, but because I believe that this agreement is insufficient to protect our industries from counterfeiting, that it fails to guarantee respect for geographical indications, that it serves little purpose if it does not involve China, the biggest counterfeiter in the world, and that it endangers the rights and freedoms of citizens as it concerns ‘intangible’ property rights. I am also in favour of all the requests for prior information, impact assessments and so on set out in this resolution. In short, this agreement is, as it stands, pointless and potentially harmful. It should not even be under negotiation, and even less so, given the issues it covers, by the European Commission alone.

 
  
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  Sylvie Guillaume (S&D), in writing.(FR) I voted against the motion for a resolution on the Anti-Counterfeiting Trade Agreement tabled by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists because that text is by no means sufficient to protect individual freedoms. MEPs have regularly expressed their many concerns about the negotiation of this international agreement and before the agreement was definitively ratified by the Member States and the European Union, it was important to raise a number of problems, particularly those relating to access to medicines, the responsibility of Internet access providers, and searches of travellers’ personal luggage at borders. Unfortunately, the joint motion for a resolution tabled by the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, the Group of the Greens/European Free Alliance, the Group of the Alliance of Liberals and Democrats for Europe and the Confederal Group of the European United Left – Nordic Green Left, for which I voted, and which expressed these concerns, could not be adopted, as it was just short of the number of votes required.

 
  
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  Ian Hudghton (Verts/ALE), in writing. – I am disappointed that the resolution supported by my own group today was not adopted. The Anti-Counterfeiting Trade Agreement (ACTA) has the potential to have an extremely negative effect on civil liberties and today’s vote does nothing to diminish those fears.

 
  
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  Elisabeth Köstinger (PPE), in writing. (DE) I voted in favour of the motion for a resolution tabled by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists on the Anti-Counterfeiting Trade Agreement (ACTA). The resolution expresses the same concerns as those expressed by EU citizens with regard to data protection. It expressly rejects a ‘three-strikes’ regulation, which has been discussed as a measure to be used in the event of copyright infringements. The resolution also points out that the agreement must be in line with the acquis communautaire, in other words the common body of EU law. Counterfeit products and international copyright infringements damage the European economy, thereby putting European jobs at risk too. Decisive measures must be taken to counter this.

 
  
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  Edvard Kožušník (ECR), in writing. (CS) I applaud the fact that the most controversial provisions have been removed from the final form of this international agreement, such as the responsibility of third parties, mandatory checks on computer memories when crossing borders and the mandatory application of the ‘digital guillotine’. Although I welcome the effort made here to provide greater protection for intellectual property rights, I am not convinced that the form of the agreement presented to us here is entirely optimal. I am very concerned that countries such as China and Russia are not signatories. The fact that the agreement places greater emphasis on protecting the holders of rights, and not the actual authors, makes me concerned as to whether the agreement will really serve to protect general intellectual property rights, and not just to protect the rights of a narrow group of entities based mainly in the US.

Moreover, the fact that it was not possible to include geographical indications in the agreement only confirms my fears. It is perhaps not necessary to comment again on the method of negotiating the agreement, but I do believe that a similarly non-transparent form of negotiation to that chosen for ACTA will not be repeated and Parliament will in future be informed in good time over the negotiation procedure for similar agreements and the content of the agreements.

 
  
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  Giovanni La Via (PPE), in writing. (IT) The Anti-Counterfeiting Trade Agreement (ACTA) has increased and continues to increase the effectiveness of the rules that promote European Union exports and protect those people who are increasingly subject to widespread infringements of their intellectual property rights when they operate on the global market.

As is emphasised effectively in the joint motion for a resolution, the fight against counterfeiting at global level represents a key aspect of European Union political strategy, with the aim of being able to offer standard conditions of competition for all European producers. I believe that in this sector, as in others, the essential nature of cooperation between States has now been clearly accepted. The protection of copyright, trademarks, patents, designs and geographical indications is certainly a sensitive issue because it is concerned with fundamental human rights, but today’s motion constitutes a serious appeal to continue in the right direction. The Commission must, in fact, commit itself to guaranteeing the inclusion of effective methods for actually enforcing the protection of geographical indications, because this is essential for companies and the employment of European citizens.

 
  
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  Constance Le Grip (PPE) , in writing.(FR) I voted in favour of the motion for a resolution on the Anti-Counterfeiting Trade Agreement tabled by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists. This PPE/ECR resolution points out that the fight against counterfeiting is a priority within the Union’s internal and international political strategy and that international cooperation is a key element in the global pursuit of this goal. In taking up the concerns of the European Parliament and of our fellow citizens, such as respect for fundamental rights, the protection of privacy and personal data, the recognition of the vital role of unrestricted Internet access, the importance of protecting the role of service providers, and the need to safeguard access to medicines, the act makes the current rules more effective. It aims to provide better protection against all violations of intellectual property rights, trademarks, designs and patents in the interests of Community exports and the holders of these rights. Contrary to what has been said by its detractors, the agreement is fully compatible with the acquis communautaire. It does not introduce, for example, the so-called ‘three-strikes’ procedure.

 
  
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  Petru Constantin Luhan (PPE), in writing. (RO) I voted for the motion for a resolution on the Anti-Counterfeiting Trade Agreement (ACTA) as it: 1. is fully in keeping with the acquis communautaire; 2. will result in a positive impact on the measures for protecting intellectual property rights globally and for protection against other territories such as Asia, Australia, the Pacific region and so on; 3. will protect competition at EU level and cultural diversity, as well as contribute to job creation.

 
  
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  David Martin (S&D), in writing. – I voted for this resolution on the Anti-Counterfeiting Trade Agreement (ACTA). ACTA is concerned with the enforcement of IP law at international level and concerns commercial copyright violations. This is a very delicate subject where we need to give rights holders adequate protection and a reasonable return on their investments without, on the other hand, infringing civil liberties, restricting access to medicine or criminalising individuals for trivial breaches of copyright. The right place to carry out this assessment is in the Trade Committee when it considers whether or not to give Parliamentary assent to ACTA.

 
  
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  Jiří Maštálka (GUE/NGL), in writing. (CS) Protection against counterfeiting and the protection of intellectual property are undoubtedly an important element on an international scale. However, no clear significance emerges from the proposed ACTA agreement in terms of high quality and especially balanced protection of the interests of all EU Member State citizens. This agreement, which has taken a long time to draw up, has lacked transparency at various levels in the preparatory stages, and is geared in its context more to the interests of one group. Although the agreement also declares, among other things, a strengthening of the monitoring by relevant bodies of goods in transit and the export regime or ex officio negotiations, a question arises here as to scope and other possibilities for enforcing the agreement, as its effect seems debatable without the agreed ratification by a large number of important countries worldwide.

In relation to actually ensuring the protection of intellectual property, it can be said that on a global scale there is now a whole range of recognised, functioning and sufficiently proven instruments, institutions and contractual arrangements which currently ensure protection against counterfeits. At the same time, the assurance that it is not necessary to change the acquis communautaire would, for a document of such importance and such a character, merit the submission of a more thorough legal analysis.

 
  
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  Marisa Matias (GUE/NGL), in writing. – (PT) I voted in favour of this motion for a resolution as it represents an important step in combating counterfeiting without calling into question issues such as the transportation of generic medicines, and it ensures fundamental rights such as the right to privacy and data protection.

 
  
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  Jean-Luc Mélenchon (GUE/NGL), in writing. (FR) The Anti-Counterfeiting Trade Agreement (ACTA) was negotiated behind the backs of our citizens and in opposition to UNO and its World Intellectual Property Organisation, the sole body that can legitimately establish such an agreement. In the case of ACTA, a handful of countries have negotiated among themselves the rules that are to prevail in the area of intellectual property rights. This misappropriation of international law to the benefit of the richest countries and their closest allies is wholly intolerable.

What is more, given that there is uncertainty over a possible patenting of living beings and potential obstacles to the circulation of generic medicines, what is imperative is not to be concerned about this point or regret that point, while accepting that we have been faced with a fait accompli. I am voting against this text.

 
  
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  Nuno Melo (PPE) , in writing. (PT) The introduction of the draft Anti-Counterfeiting Trade Agreement on 2 October 2010, following the Tokyo round of negotiations, is very important. There is also a need for the Commission to make available to Parliament and the public the definitive text of the ACTA agreement following the meeting to negotiate technical aspects that took place in Sydney between 30 November and 3 December 2010.

Combating counterfeiting is one of the main priorities of internal and international political strategy, and international cooperation is fundamental to the achievement of this objective. We are perfectly well aware that the agreement negotiated will not solve the complex and multi-dimensional problem of counterfeiting, but it is a step in the right direction towards putting an end to this serious problem, which is responsible for severe losses to the EU economy and the gross domestic product of Member States.

 
  
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  Alexander Mirsky (S&D), in writing. (LV) It is essential that this agreement come into effect as soon as possible. Any delay will open the gates to the plain theft of intellectual property. Manufacturers’ costs exceed all imaginable amounts. Piracy on the Internet is an extremely topical issue these days. Many Internet service providers and European Union citizens are involved in unethical activities. In this context, we must regulate all operations associated with the downloading and so-called exchange of information. Inaction as regards the prevention of counterfeiting promotes impunity and appears cynical. I fully support this motion for a resolution.

 
  
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  Vital Moreira (S&D), in writing. (PT) I abstained from voting on the joint motion for a resolution tabled by the Group of the Progressive Alliance of Socialists and Democrats in the European Parliament, the Group of the Alliance of Liberals and Democrats for Europe, the Group of the Greens/European Free Alliance, and the Confederal Group of the European United Left – Nordic Green Left on the Anti-Counterfeiting Trade Agreement as I believe that the text in question is overly critical and that it should be more balanced. In the tabled version there is a clear indication that our final position will be opposed to the adoption of the agreement. I believe that the agreement is generally favourable to the economic interests of the European Union, especially given the fact that we want our economy to be based on innovation, research and development, or ‘smart growth’.

I therefore believe that enhanced protection of industrial property rights, including patents, is essential for European competitiveness. On the other hand, I believe that initial concerns about generic medicines, protection of the right to Internet access and the protection of geographical indications, or designations of origin, were satisfactorily overcome in the final negotiations. We cannot ignore the progress that has been made. Obviously, not everything is satisfactory, but an international agreement must be judged in overall terms.

 
  
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  Rareş-Lucian Niculescu (PPE), in writing. (RO) I voted in favour of the motion for a resolution from the Group of the European People’s Party (Christian Democrats)/European Conservatives and Reformists and against the others because the international ACTA makes it possible to combat counterfeiting more effectively, which will lead to better copyright protection and, by extension, help protect European industry. Furthermore, the ACTA will help protect consumers against counterfeit products, which are becoming increasingly prevalent on European markets.

 
  
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  Alfredo Pallone (PPE), in writing. (IT) I voted in favour of the motion for a resolution of the Group of the European People’s Party (Christian Democrats) on ACTA, inasmuch as I believe that it is essential for the agreement to be implemented. This must be done quickly without any more delays or time-wasting, otherwise we risk an impasse in negotiations to the detriment of both manufacturers and European consumers alike.

Europe has an obligation to continue concentrating its efforts on two issues. The first issue is that it must be compulsory for European geographical indications to be protected in both civil and customs terms, as these are today suffering damage that affects not only the agri-food industry, the counterfeited products of which suffer unfair competition typically involving the use of names that copy and evoke familiar European brands, but also industries operating in the design and fashion sectors. The second issue is the obligatory need for common rules to control online sales. This sector has seen an increase in the sale of books, films, music and millions of counterfeit goods, which harms not only consumers but also European manufacturers.

 
  
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  Georgios Papanikolaou (PPE), in writing. (EL) I voted in favour of the motion for a resolution tabled by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists on the Anti-Counterfeiting Trade Agreement (ACTA), as this is an agreement designed to safeguard justice and healthy competition. The agreement introduces a full international framework to strengthen the fight against infringements of intellectual property rights. It promotes the accession of other developing countries to the agreement, as participation in ACTA is not restricted.

Negotiations on the agreement now take account of the EU’s main concerns, including: respect for fundamental rights and privacy; data protection; respect for the role of the free Internet; defence of the role of service providers and the need to safeguard access to drugs and protect public health.

 
  
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  Maria do Céu Patrão Neves (PPE) , in writing. (PT) I am convinced that this motion for a resolution represents an important step in combating counterfeiting, while maintaining the necessary balance between conflicting values. It does not call into question freedom of expression and innovation, and guarantees fundamental rights, such as the right to privacy and data protection.

There are opposing interests that make consensus difficult, but what has been achieved here with some success is an agreement that is essentially a meeting of common desires. The transparency adopted by the Commission during these negotiations in keeping the EP informed is to be applauded, and I hope that it will be possible during forthcoming negotiations to resolve the ambiguities and omissions that are still pointed to by all parties. I believe that the agreement reached will strengthen international cooperation in the fight against counterfeiting, creating a tool for the effective protection of Intellectual Property Rights and the guaranteeing of fundamental rights. It is also essential to ensure respect for existing rights through repressive measures and the creation of a comprehensive international framework of assistance to the parties involved.

 
  
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  Miguel Portas (GUE/NGL), in writing. (PT) I voted in favour of this motion for a resolution as it represents an important step in combating counterfeiting without calling into question issues such as the transport of generic medicines, and it ensures fundamental rights such as the right to privacy and data protection.

 
  
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  Paulo Rangel (PPE) , in writing. (PT) The fight against counterfeiting, which is a global phenomenon, requires a multilateral approach, based on the strengthening of cooperation between the major parties involved globally. Consequently, although I am aware that the agreement negotiated will not solve the complex problem of counterfeiting, I am convinced that it constitutes a step in the right direction.

 
  
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  Crescenzio Rivellini (PPE), in writing. (IT) Today, I voted for the recently finalised international Anti-Counterfeiting Trade Agreement (ACTA).

The aim of the new multilateral ACTA between the European Union, the United States, Australia, Canada, Japan, Mexico, Morocco, New Zealand, Singapore, South Korea and Switzerland is to strengthen the protection of intellectual property and contribute to the fight against counterfeiting and piracy of products such as big-name clothing brands, music and films.

I am aware that the agreement negotiated will not resolve the complex and multidimensional problem of counterfeiting, but I believe it constitutes a step in the right direction. In any case, I call on the European Commission to confirm that the text does not have any repercussions on fundamental freedoms and European Union legislation. I would also note that Parliament has the right to veto international agreements.

 
  
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  Raül Romeva i Rueda (Verts/ALE), in writing. – The European Parliament just narrowly failed to adopt a resolution demanding that the Commission clarify and assess the consequences of the Anti-Counterfeiting Trade Agreement ACTA. The numbers were 306 in favour, 322 against, with 26 abstentions. The resolution had been put forward by the Green Group (including the Pirate Party), the Social Democrats, the Liberals and the left. Instead, an alternative resolution by the Christian Democrat group EPP and the Conservative group was carried. This resolution basically welcomes what the negotiators have been doing so far, without placing any specific demands on the Commission for further clarifications or assessments. This was a defeat, but it is far from the final word on the issue. The resolution has no formal effect at all, but is merely an expression of how Parliament feels. The deciding vote will (probably) be some time early next year, when Parliament will be asked to give its consent to the agreement. If we get a No vote then, the agreement will be scrapped. The vote today was a reminder that we will have to continue working hard to get more information on the effects of ACTA so that the European Parliament can make an informed decision in the final consent vote.

 
  
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  Marie-Thérèse Sanchez-Schmid (PPE), in writing. (FR) The Anti-Counterfeiting Trade Agreement (ACTA) is an agreement that protects our citizens, our creators, our artists and our businesses, and that is why I support it. Indeed, it helps clarify the means of redress available in the event of flagrant breaches of intellectual property rights in one of the countries party to the agreement. The Commission has been transparent, ACTA cannot go beyond the acquis communautaire, cannot exceed any of the measures taken within the framework of the European directives, and cannot under any circumstances violate fundamental rights. It has been negotiated outside the traditional international institutions (the World Trade Organisation and so on) because China and India opposed any agreement. Finally, ACTA is an open agreement, and all those States that wish to participate freely in it can join with us, so that together we can provide legal, and also physical, protection to our fellow citizens against the damage caused by counterfeiting. I therefore voted for this motion for a resolution.

 
  
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  Olle Schmidt (ALDE), in writing. (SV) The European Parliament has expressed its opinion on the ACTA agreement on numerous occasions. For example, I voted in favour of Parliament’s motion for a resolution in March 2010 with regard to the lack of public scrutiny and transparency in the negotiations and I have signed Parliament’s written declaration concerning ACTA. At that time, the Commission deserved criticism, as it does now, for the lack of transparency in the negotiations for both Members of this Parliament and for the citizens of Europe. I think that, as things currently stand, Parliament’s previous opinions are adequate, and I voted against all of the proposals in the resolution. It is important that Parliament takes its responsibility for international agreements very seriously. The Commission negotiates and signs the agreements. Parliament has the right to be fully and immediately informed during the process and, after the Commission has signed the agreement, it has the right to approve or reject it. It is reasonable for Parliament to make its position clear, which we have done in many ways, to ensure that the Commission does not negotiate agreements that lack Parliament’s support. The joint motion for a resolution required the Commission to present a number of time-consuming analyses before it was to sign the agreement, which would run the risk of creating a situation in which other parties would start to doubt whether Europe really is a serious party with which to conclude international trade agreements. This would damage Europe’s chance of participating in negotiations on international free trade agreements in the future.

 
  
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  Bogusław Sonik (PPE), in writing.(PL) I endorsed the European Parliament motion for a resolution on the Anti-Counterfeiting Trade Agreement (ACTA), because I think that as part of the fight against piracy it is necessary to establish common principles for the enforcement of intellectual property rights. The problem of the counterfeiting of goods and the unauthorised use of other people’s intellectual property is still widespread. It is particularly difficult in the case of intangible property, such as the copyright to musical and literary works and patents. ACTA will be a good tool for establishing a common legal platform whose objective will be to fight counterfeiting and piracy.

 
  
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  Thomas Ulmer (PPE), in writing. (DE) I am very pleased that the report by the Group of the European People’s Party (Christian Democrats) and the European Conservatives and Reformists has been adopted. As a result, the poisoned, demagogic work of the opposition did not have a chance. Congratulations to the authors, our coordinator, Mr Caspary, and the whole group for showing unity here on this important matter.

 
  
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  Dominique Vlasto (PPE), in writing.(FR) I voted in favour of my group’s motion for a resolution because the fight against counterfeiting is crucial and must be worldwide to be effective. Counterfeiting is a growing parallel economy and one that allows for large-scale money laundering. Furthermore, our industries, already penalised in export terms by the undervaluation of the yuan and the weakness of the dollar, cannot in addition tolerate seeing counterfeits produced outside the EU unfairly compete with their products on the internal market. This globally organised theft has a serious effect on creativity and innovation and disastrous consequences for our jobs and for the safety of misled consumers. Our development model, focused as it is on the knowledge economy, requires the protection, at international level, of the fundamental right that is intellectual property. This vote henceforth opens the way to the ratification of the Anti-Counterfeiting Trade Agreement, which will make it easier to bring legal appeals where intellectual property rights have been infringed in one of the signatory countries. In this way, we are laying the foundations of a multilateral strategy which will protect that which makes our economic development dynamic: our inventions, our brands and our artistic works.

 
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