Verbatim report of proceedings

Wednesday, 22 October 2008 - Strasbourg

2. Variations to the terms of marketing authorisations for medicinal products - Counterfeiting of medicinal products (debate)

  President. − The next item on the agenda is the joint debate on:

- the report of Françoise Grossetête on behalf of the Committee on the Environment, Public Health and Food Safety on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products (COM(2008)0123 - C6-0137/2008 - 2008/0045(COD)) (A6-0346/2008)

- the Commission report on the counterfeiting of medicinal products.

  Françoise Grossetête, rapporteur. − (FR) Mr President, Commissioner, ladies and gentlemen, allow me first of all to warmly congratulate the Council, the Commission and the shadow rapporteurs for their cooperation on this dossier of amendments regarding marketing authorisations for medicinal products.

It must be made possible for medicinal products, whatever procedure is applied in authorising their marketing, to be subject to the same evaluation, approval and administrative processing criteria in the event of changes being made to them. These changes, known as ‘variations’, relate, for example, to the manufacturing process, the introduction of a new therapeutic indication, updating of information leaflets, or administrative changes. These variations must be reported to the competent authorities by the holders of authorisations to market medicinal products.

However, the current way of managing variations is proving increasingly inefficient and is no longer satisfactory either for the authorities or for the pharmaceutical industry as a whole. There is too much red tape, adversely affecting patients, whose access to the best medicinal products is delayed.

The pharmaceutical industry devotes a growing part of its regulatory work to managing these variations. By way of example, in the case of a medium-sized company producing generic medicines and carrying a list of 400 products, the total number of variations submitted would exceed 4 000 per year. In the case of a large company, the number can reach 19 000. Changes to purely national marketing authorisations take place in accordance with provisions specific to each Member State, which are different from the European regulatory requirements.

Given that 80% of all human and veterinary medicinal products are authorised via national procedures, this revision will have a considerable impact on the pharmaceuticals market in the European Union. Any one change to products authorised under national procedures in different Member States is therefore treated in a number of different ways in terms of the dossier to be submitted and the evaluation procedure.

This situation has some undesirable repercussions: namely, it entails an unjustified additional administrative burden for the competent authorities and pharmaceutical businesses; logistical issues for the actual implementation of changes; and widely differing deadlines for introducing changes to the summary of characteristics of the product and the information leaflet for health care personnel and patients, with a knock-on effect on the overall working of the single market in pharmaceutical products. Lastly, it adversely affects patients, since the introduction of some changes that improve the effectiveness of a medicine may be delayed or, worse, never happen at all.

My report therefore has as its main objective the simplification and harmonisation of the rules relating to these variations of marketing authorisations for medicinal products. With this directive, the situation will be more straightforward, clearer and more flexible for all concerned. The rules relating to variations will be the same everywhere, whatever the type of authorisation, whether it is a national authorisation, mutual recognition procedure or centralised procedure for a medicinal product.

Simplifying these variations will mean they are subject to the same criteria with regard to the authorisation, administrative management and supervision of the changes made, whatever the legal procedure may have been whereby the medicinal products were licensed.

Moreover, I have proposed an additional amendment to the system where a change concerns a number of marketing authorisations. In this event, it must be made possible to submit a single application covering all these marketing authorisations.

I am aware, Mr President, that Mr Verheugen is to speak after me about the counterfeiting of medicinal products. We expect a great deal from his statement since it is important for this package, which includes the counterfeiting of medicinal products, to be presented to us. We have been looking forward to it for a long time. Counterfeiting is a crime which concerns public health. It is important for Mr Verheugen to tell us what stage he is at, as we are anxious to see this text. In any case, we offer him our full support.

  Günter Verheugen, Vice-President of the Commission. – (DE) Mr President, honourable Members, today’s debate takes place in the context of a development in the health sector that changes a great deal.

The development concerned is the ever increasing number of senior citizens in our societies, whose supreme concern will be the issue of health. This must be understood. The more senior citizens in society – and this group will keep on growing – the more important the issue of health, of how to deal with care for these people and with therapies and medicinal products; and, incidentally, the more important the issue of how to ensure that these people obtain the information they need in order to not only stay abreast of their state of health but also to do what is necessary to remain in good health. Such is the background to today’s debate.

The issue we are dealing with directly today is the Variations Regulation. I am very pleased that a compromise has been reached on this. The Regulation governs any variations required – be it on public-health or economic grounds – after a medicinal product has already been authorised. We cannot just stand by and watch as variations – of any kind – are made to a medicinal product after its authorisation. It goes without saying that regulation and scrutiny are required. Your decision today, honourable Members, will contribute significantly to ensuring that medicinal products continue to be safe and effective in future.

The existing legislation has brought a number of problems, which we have analysed. For example, the current legislation entails considerable financial and administrative burdens on all parties concerned. This can result in certain variations not being implemented – and we have examples of this – even though, in themselves, they are necessary in the interests of patients.

For example, there have been cases where medicinal products have required further development at a certain point but this has not happened because the costs associated with putting variations through the authorisation procedure are too high. For this reason, it is very important that the proposal to be adopted here today improves the existing legislation in terms of simplicity, precision and flexibility. This will also mean that this solution is in keeping with our better law-making agenda.

I should like to express my sincere thanks to Mrs Grossetête and all those who have contributed to her report for their work on this difficult dossier. I should also like to thank the House for the massive support the European Parliament has already given me on many occasions with regard to the fight against counterfeit medicines. I understand Mrs Grossetête’s impatience to see this proposal adopted, which I share, but in this case, too, of course, quality is more important than speed. In a moment I shall be saying a few things about the timetable. The pressure Parliament is exerting in the matter of the fight against counterfeit medicines is helpful and important. Please do not think that this bothers me; quite the reverse, I feel strengthened by it.

How do things stand? We are currently having to contend with an alarming increase in counterfeit medicines discovered in the European Union itself. Previously, we had always assumed that Europe was a transit area for illegal products destined for third countries. I remember that when we discussed the matter here for the first time that I took the view that this was not, in fact, a problem for Europe, but one for Africa and other less developed parts of the world in particular.

This situation has changed: it has now become a problem for us, too. The European market itself is increasingly becoming a destination for counterfeit medicines. This represents a very serious threat to public health. It can cost many lives, and so the Commission is determined to act.

Parliament’s very important resolution of 12 July 2007 contained a very significant statement on which I, too, base my deliberations, namely ‘that counterfeiting of medicines is not a patent issue as such’. This is a very important point to note. Under discussion here are not intellectual property rights, nor patent rights, but criminal offences. Counterfeiting of medicines constitutes criminal wrongdoing whether or not the medicine concerned is still under patent; that aspect is completely irrelevant in this regard. Counterfeiting is counterfeiting and, in the case of medicines, should always be classed as criminal behaviour.

Parliament then continued: ‘measures to tackle counterfeiting need to be taken in the area of criminal enforcement […] and drug regulation by strengthening the regulatory capacity of the national authorities and not by increasing levels of intellectual property protection’. In its work on its proposal on the fight against counterfeit medicines, the Commission has been guided precisely by the deliberations presented by you, honourable Members.

Over the next few weeks, the Commission will present legislation to strengthen the existing legal framework. This is intended to ensure, with a probability verging on certainty, that is, where humanly possible, that no more counterfeit medicines can be smuggled into the legal supply and distribution chain. As you know, the Commission has not yet dealt with the proposal. I have not even presented it to the Commission as yet, as a large number of very difficult issues has still to be clarified, and I should also like to include the outcome of today’s debate in my final decision on the proposal. What I can describe to you already, however, are the most important elements, the foundations.

As has already been mentioned, the distribution chain must be strengthened in the first instance. Therefore, we must ensure that it is possible to verify the authenticity of every single pack at all times on its way from the manufacturer to the consumer – that is, the patient. This requires the origin of the pack and of the medicine to be traceable at all times throughout their journey from the manufacturer to the patient. You can guess what that means. It is a very ambitious demand that will make tough technical demands on all links in the distribution chain, from the manufacturer to the chemist’s shop, and will require large-scale investment. I am happy to say, however, that all parties concerned consider it right and necessary, and that the technical solutions concerning the traceability of medicines do exist.

Secondly, the rules for products passing through the hands of importers must be absolutely clear, and all parties concerned must be subject to stricter supervision. In this regard, it must be made quite clear that, naturally, the risk at our borders may be even greater than the risk within the European Union; i.e., that there is the risk of counterfeit medicines being brought into the EU from outside. This is a problem best combated directly at the external borders. The proposal will also therefore contain the relevant improvements.

Finally, a further important point consists in ensuring that the active ingredients, that is, the most important components of the medicine, be produced according to legislation with safety standards corresponding to those within the EU. Honourable Members, why should that be a problem? Incidentally, I was surprised when I saw this: it is a fact that the active ingredients, the most important components of the medicine, very often, indeed even usually, originate from non-European countries, third countries. In this regard, we must ensure that the active ingredients, wherever they may be produced, are manufactured to the same standards as our own. This, in turn, will be a very ambitious, difficult task.

However, I believe that, in our globalised world, Europe needs a dynamic, competitive pharmaceutical industry in order to take advantage of the opportunities presented by globalisation. Yet we must also take up the associated public-health challenges.

The forthcoming Commission proposal will be moderate, sound and balanced, but also determined and clear wherever determination is called for. Our society is entitled to the most effective protection possible against counterfeit medicines. When, very shortly, in just a few weeks’ time, we are in a position to discuss the Commission proposal, I would ask that you judge it precisely on the basis of the following principle: are we doing our best here to protect Europeans effectively against counterfeit products?

  Petya Stavreva, draftsman of the opinion of the Committee on Agriculture and Rural Development. − (BG) Mr President, Commissioner, ladies and gentlemen, the report we are discussing today relates to some very important issues of harmonising the terms of marketing authorisations for medicinal products. As draftsman of the opinion of the European Parliament’s Committee on Agriculture, I would like to express my support for the Commission’s proposal. To date, only a small proportion of medicinal products falls within the remit of European legislation. Products that have received only national marketing authorisation are not subject to current European legislation on variations, and are therefore subject to various specific national laws. On the one hand, this is inefficient and costly to the economy while, on the other, it prevents the internal market from functioning smoothly.

Implementing the present directive would provide a legal basis for harmonisation and would bring great benefits to consumers and to the sector. It would also enable faster access to the latest medicinal products in all Member States. The lack of harmonised regulations means that each country applies its own specific national rules. This situation gives rise to red tape, barriers and difficulties in the operation of the internal market while resulting in differing safety criteria. Special attention should be paid to the cost to the Member States of implementing the new legislation. I do not believe that the countries of Europe will be able to amend their internal legislation within the short timescales provided to accommodate the additional changes, and which will entail high costs.

My congratulations to the rapporteur and I ask you to vote in favour of Mrs Grossetête’s report.

  Cristina Gutiérrez-Cortines, on behalf of the PPE-DE Group. – (ES) Mr President, on this subject I want to do two things: firstly, congratulate the Commission and Mrs Grossetête, and, secondly, talk about subsidiarity.

I have frequently criticised the European Union in this respect, as, for example, with the Services Directive and also the current attack on pharmacies in the name of liberalisation. In these examples, the European Commission has entered into areas which properly come under subsidiarity and which have been developed for each individual society and with which this society is content. In other words, the European Union’s meddling could damage what is working effectively, as in the case of pharmacies.

However, in the present case, I feel that this report must be clearly welcomed, bearing in mind that it represents the only way of controlling quality and guaranteeing good health. Why? The reason is that, without a single point of control for all medicinal products, there are too many avenues left open and the system is much more vulnerable to infiltration by harmful or unauthorised products. This is also true in the case of active ingredients on which there was a resolution last year, tabled by Mrs Sartori and myself, which I see has been taken up by the Commission.

I therefore feel that this is a good proposal which will cut through a lot of red tape and offer safeguards to society. I also welcome the emphasis placed on information because it is clear that, in a society with patient mobility as it is, where patients can easily travel for treatment and where many elderly people live in countries other than their countries of origin, it is very important that doctors and all health care staff can have access to the same information and criteria in their work.

  Dagmar Roth-Behrendt, on behalf of the PSE Group. – (DE) Mr President, ladies and gentlemen, I wish to express my sincere thanks to Mrs Grossetête for her work on this report. It has been a pleasure to work with her, and she has undoubtedly achieved two things with the compromise she has reached. Firstly, she has made a procedure simpler and less bureaucratic and, secondly, she has met the needs and requirements of small enterprises in individual Member States with purely national systems and authorisations in a flexible manner, and done them a great favour.

The report by Mrs Grossetête is also connected with patient safety, and this is another issue we are discussing today. We are speaking broadly about the safety of individuals, patient safety. Commissioner Verheugen rightly pointed out that, with the ageing of society, people’s health needs and fear of illness have grown ever larger. Fear is something that has already been growing in society for a long time, and it is up to us, where we have competence and where we are able, to keep this fear to a minimum or to tackle or resolve it as far as possible.

A great many of the measures necessary to this end are ones on which we have competence and are able to give advice. One among very many issues is undoubtedly patient information and the safety of medicinal products. Patients are entitled to be fully informed about their illness; and, if they are fully informed and able to act on a par with medical practitioners, they must be entitled to safe medicinal products and safe treatment methods.

This is not the case in the European Union at present, and we are conscious of a growing danger. I am really not one to dramatise; I may sometimes be rather emotional, but I do not dramatise. I am also the last person who would arouse fear. Yet I would caution against overlooking, or closing our eyes to, a problem that exists. The banking crisis is a good current example of what happens if we omit to solve small problems we are capable of solving, if we wait too long: we find ourselves overcome by a giant wave of almost tsunami proportions.

That is why I thank Commissioner Verheugen for his words here today, and also urge him to be true to them and combat counterfeit medicines. There are no simple solutions to this problem, and those who believe that patient safety and the safety of medicinal products are an issue only with regard to parallel trade – I glance up at the gallery, but it is probably a little too early for the representatives of parallel trade – take too narrow a view and insult my intelligence and that of my fellow Members.

What we must endeavour to do here is to protect patients. This can be done by means of various measures, for example, by checking whether the packaging of the medicinal product is intact. What would you say if you were to buy a product in your home country whose packaging was in a language you did not understand, with only a small sticker on it, and small, chopped-up blister packs inside? Would you have confidence in the product? I ended up with a pack such as this, containing an urgently needed medicine, and I can tell you that I did not have confidence in it. This is something we must prohibit, and I am sure that parallel traders – for it is they who evidently believe we wish to threaten their livelihoods, which is not the case – will have enough intelligence to find an alternative. They will come up with new packaging, or will at least stop cutting up blister packs.

As Commissioner Verheugen pointed out, there are technical solutions. The medicinal products industry is prepared for a complete traceability system, with a bar code enabling the tracing of each medicinal product. In addition, there is a pilot project. Switzerland and Belgium have demonstrated that it is possible. It is our task to give patients this security.

I should like to say a final word about ingredients, where the issue is not only with counterfeit medicines. As you know, there was a major scandal involving heparin – a blood-thinner. When people use a counterfeit medicine, they can die; it is extremely dangerous. We obtained these counterfeit preparations from China. It is also our task to ensure that no counterfeit preparations or active ingredients are produced in our third-country trading partners and that our markets are properly protected.

Two things are needed to this end: we must properly protect our borders, we need traceability systems and we must ensure safety in these countries.

  President. – Mr Donato Tommaso Veraldi has the floor on behalf of the Alliance of Liberals, but I am informed that he is not in the hall, and I therefore call upon ... there you are. You were hiding somewhere else.

  Marios Matsakis (ALDE). – Mr President, I am not Mr Veraldi; I am Mr Matsakis. I will be speaking later on behalf of the ALDE Group, and I was wondering if, in the absence of my colleague Mr Veraldi, I could take his slot.

  President. − No, I am sorry: we have to keep to the order of speakers. When your time comes, I will ask you to take the floor.

  Alessandro Foglietta, on behalf of the UEN Group. – (IT) Mr President, ladies and gentlemen, I would like to express my support for this report, which is perfectly in line with the commitment to better regulation that Europe has stood for for many years. The new system of marketing authorisations for medicinal products will considerably simplify the procedure in the case of minor changes or new scientific discoveries and will signify a substantial easing of the technical and administrative burden on businesses.

All of this is fully in keeping with the goals set out in the Lisbon strategy launched by the European institutions at the dawn of the new millennium. It identifies better regulation as one of the pillars underpinning the growth of the economy and jobs in Europe. It cannot be denied that the competitiveness of our businesses is suffering under the excessive legislative and bureaucratic conditions on manufacturing that have accumulated in recent decades, and that the impact of this is becoming ever more burdensome and unsustainable in the case of small and medium-sized enterprises that form the backbone of the national production system in many Member States.

More to the point, at this precise moment in time, when the international crisis is threatening to suffocate our economy, we cannot allow ourselves to put our businesses at a further disadvantage with wasted costs and administrative delays. The will to streamline the legislative framework must be perceived as a duty and an unbreakable commitment. I am pleased that the Council, too, has accepted the European Parliament’s request to protect small and medium-sized enterprises by excluding from the scope authorisations for pharmaceuticals issued by Member States up to 1998. This has prevented small and medium-sized enterprises from having to make further efforts in order to comply with current legislation.

  Jiří Maštálka, on behalf of the GUE/NGL Group. – (CS) I would first of all like to express my thanks to the rapporteur for producing such an extensive piece of work in this report, and especially for the successful efforts, or should that be the potentially successful efforts, in negotiating a compromise with the Council and with the Commission. I would also like to thank the Commission for directing its efforts towards unifying the administration in the area of certifying drugs and also to thank it for the fact that these efforts should result in higher levels of safety for patients.

It is clearly essential to harmonise legislation at a European level in the area of registering drugs. We need a unified set of administrative rules for all drugs on the internal market, in order that we can prevent negative impacts on human health. I therefore warmly welcome the aim of this proposal to ensure that all drugs on the market are subject to the same criteria, including those drugs that have been approved purely at a national level. I would like to consider the question of purely national registration in more detail. Even though I was a supporter of unified criteria with no exceptions, I believe that the text of proposed amendment number 36, allowing national regulations to continue in use for drugs that have been registered at a purely national level and approved prior to 1 January 1998, should not be an obstacle to harmonisation at a European level as it is so well thought-out and provides sufficient guarantees, such as the requirement to inform the Commission of decisions to continue with the application of national regulations or the requirement for transfer to European regulations where a drug has already been registered in another Member State.

Regarding the implementation of a single application covering one or more identical changes, I feel that it would bring a certain measure of relief to the large pharmaceutical companies, which is surely a good thing. I am not quite so sure, however, that the positive effect will be to reduce the administrative burden in the individual Member States. That is a negative effect which we may be able to eliminate in the future. Despite the minor reservations that I have expressed here, I consider the text which has emerged from the debate to be a positive step in the area of registering drugs and, bearing in mind how difficult it was to achieve this compromise, I recommend it as shadow rapporteur to colleagues from my political group for approval. Apart from anything else, there is also the practical reason that if this directive is not passed at the first reading this year, it will be up to the Czech presidency to find a solution to these very difficult questions. Therefore, we have an opportunity now.

  President. − I would like to point out that it is not the President who has been kind and given more time to speak, but the group. Perhaps it was because of the coming holidays.

  Kathy Sinnott, on behalf of the IND/DEM Group. – Mr President, there are many things people want to know about medicines before they take them or give them to their animals: that they are safe and effective, and come from ethical sources, and how they will interact with other medicines. This should be the focus of our authorisation process. In terms of business, companies want to know that their investment is safe. Simplification will not mean being lax, but sticking to the essentials.

While I am on the topic of authorisation, I would like to alert the Commission to the fact that hexafluorosilicic acid is put in Irish drinking water and yet it has no authorisation at all; nor has there been any attempt by successive Irish governments to obtain any authorisation at all, and yet it is the most widespread medicine in Ireland. If we are going to be serious about authorisation and correcting the authorisation process to make it more effective and safer, we must tackle this flagrant abuse of the process.

  Irena Belohorská (NI). – (SK) In most Member States, there has been no harmonisation with community law in the area of marketing authorisations for medicinal products, and therefore varying practices have emerged in these states. The aim of the proposal is that all medicinal products, regardless of the procedure under which they were authorised for release onto the market, should be subject to the same assessment criteria in respect of the administrative process for approving changes.

I welcome initiatives of this kind, aimed at simplifying the framework, without abandoning the criteria necessary for protecting the health of humans and animals. Harmonisation is necessary mainly because of the risk to public health which arises through Member States applying varying sets of scientific criteria when evaluating changes to medicinal products. Without this legal amendment, such a state of affairs constitutes a barrier to the free movement of medicinal products, which is to the detriment of patients.

The consultations relating to the drafting of the amendment to the directive themselves showed that many Member States support harmonisation in this area. The administrative burden and logistical complications are, however, a shared issue which we must resolve. We must therefore emphasise that the improvements to the system will, apart from anything else, be beneficial for patients in the long term, since better use will be made of drugs and better use will also be made of the resources employed by the relevant authorities for protecting public health.

Despite this, I recommend caution in view of the hidden costs which will arise for the Member States. Care must also be taken to ensure a reasonable timetable for practical implementation. Member States cannot be called on to change their internal laws in order to fulfil this provision, but must rather be assisted in order to ensure that excessively short implementation periods do not impose a major expense on them.

  Eija-Riitta Korhola (PPE-DE). – (FI) Mr President, I wish to thank my colleague, Mrs Grossetête, for her excellent report. It is important to reform the laws on marketing authorisations because it will reduce the administrative burden that goes with processing them. At the same time, too, it will allow the use of resources to be steered towards issues that are essential for drug safety and public health, which is also in the interests of patients needing medication. After all, the main criterion is ultimately the interests of the patient.

I am in favour of a system where the same rules would apply both nationally and for authorisations granted in the context of EU processes. At present, the rules on the issue of market authorisations are harmonised regardless of the issuing process that is applied to them, but that has not been the case with the changes to the marketing authorisation. Accordingly, different Member States have been expecting partially different rules for such matters as the classification of the applications for amendments and in connection with the process for evaluating them. It is important for the pharmaceutical industry that it will still be able, in future, to submit a complete, new application for a market authorisation for a drug that already has one, but which has another commercial name and a different summary of product characteristics. This is necessary in situations where a marketing authorisation is being applied for in respect of medicinal products for a new purpose, and permitting a new name to be used is also clearer for the patient than using the same name when the drug is being used for very different purposes. I therefore support Amendments 4 and 18, which deal with this.

As pharmaceutical companies often supply the entire EU with medicinal products, it is important that the administrative processes in different countries are harmonised. Any other approach would mean not just a huge administrative burden for the industry, but often also logistical problems. I hope that Parliament will support Mrs Grossetête's report in tomorrow’s vote and that the Member States later on this year will also support Parliament’s views, so that the reform of the laws on marketing authorisations can be brought to a conclusion by the end of this year.

  Daciana Octavia Sârbu (PSE). – (RO) Creating harmonised criteria for the approval and administrative management of any kind of variations to marketing authorisations for medicinal products will benefit patients as they will have access to better and safer products in the long term.

Bearing in mind that only 20% of medicines for human and veterinary use are authorised via Community procedures, this revision of the directive will have a considerable impact on the pharmaceuticals market in the European Union. Any variations in the production process, changes to the packaging, or the manufacturer’s address, must be reviewed and simplified to ensure the best protection for public health. We need to create a simple, flexible legislative framework so that all medicinal products, whatever the procedure applied in authorising their marketing, are subject to the same evaluation and approval criteria.

This measure will ensure the free circulation of medicines in the European Union by abandoning the controls required to guarantee the quality of imported medicines and will help establish and make the internal market operate efficiently. This will speed up access to the latest medicines for consumers and the pharmaceutical industry, while also eliminating the discrepancies between national provisions and creating a harmonised system.

  Marios Matsakis (ALDE). – Mr President, I hope it does not have to do with counterfeiting medicines. Will I get a little extra time along with this allocation?

  President. − In view of the lack of other representatives from your group, I think you can speak for a very long time! I do not know about the others who are on the list, but for sure you are on the list.

  Marios Matsakis (ALDE). – Mr President, I shall not speak for a very long time, but I might speak for longer than my allocated time.

I would like to say to the Commissioner that it is undoubtedly a fact that the current system of dealing with variations in the terms of marketing authorisations for medicinal products is unsatisfactory and, in many cases, works against the interests both of the pharmaceutical industry, but also – most importantly – of the patients themselves. It is therefore essential that the revision should be conducted.

In this respect, the Commission’s proposal, and indeed Mrs Grossetête’s report, are, overall, sound and fair and should meet with our agreement. I would, however, like to register my reservations in relation to the following point which concerns the extension of marketing authorisations.

The Commission and the rapporteur both seem, in my understanding, to agree that it should be possible for an authorised drug to have its name completely changed if it is found that it has a new pathology application. For example, the drug aspirin, whose active ingredient is salicylic acid, could, if the Commission’s proposal is adopted, be marketed with a number of different names, even though the chemical component is exactly the same – i.e. salicylic acid. Hence, a patient could end up taking three different tablets, all looking different and having a different name, for three different pathologies, whereas in reality, all three tablets would be exactly the same as far as their chemical composition is concerned – i.e. he would, in effect, be taking three tablets of aspirin.

This is, in my view, misleading and confusing to the patient and to the doctor, and increases the risk of overdosing and of causing dangerous side effects. I therefore call on both the Commission and the rapporteur to have second thoughts on this point.

Since I have a few more seconds, I would like to say that, on the question of counterfeiting medicines, I agree entirely with the Commissioner that this is a criminal offence and it puts at risk the lives of patients. But I fail to see why there is a delay. This is a straightforward case as far as I understand. These medicines, which are produced by registered pharmaceutical companies, are sold under prescription by registered pharmacists. If we cannot get to the bottom of this and discover whether some of these are criminally manufactured, then I do not know what we in the EU can do. I would have thought that this is more a police case than a change-in-legislation case. Commissioner, we should get to the bottom of this as fast as possible.

  Hanne Dahl (IND/DEM). – (DA) Mr President, I would like to take the liberty of giving a general, overall perspective since, up to now, EU harmonisation of medicinal product legislation has only involved relaxing the rules in Denmark. and the sale of medicines has increased. The new proposal with regard to marketing authorisations for medicines extends a helping hand to the pharmaceuticals industry. It will, in general, be easier to make small changes to medicines and release them under the same name, as mentioned by the previous speaker and, at the same time, it will be easier to change the name of a product if it is to be sold to treat a different pathology. There is a fear that these changes could make it more difficult for consumers to see the wood for the trees and make life easier for the pharmaceuticals industry. We also need to give consideration to the fact that the relationship between easier access to the authorisation of medicines and an increased risk for consumers is often, unfortunately, directly proportional. I am not saying that we should put unnecessary administrative obstacles in the way of the industry, but neither should we accept a slackening of the reins to make it easier for the pharmaceuticals industry to make a profit when it is people’s health and the health of animals that are at stake. In doing this, we will purely and simply be barking up the wrong tree. If we view it in a wider context, this directive is part of the industry’s efforts to improve profits in relation to the US. Let us not be naïve. We must not allow ourselves to be misled by fine-sounding, but empty statements relating to patients and consumers.

  Zuzana Roithová (PPE-DE). – (CS) The proposed directive, which will greatly simplify the introduction of pharmaceutical products onto the European market for both human and veterinary use, is very good news for patients and also for the European pharmaceutical industry. Technological progress makes possible the almost continuous improvement of drugs that have been registered already. Every change, however, must go through an approval process, as health and safety is involved. While registration at a purely intra-state level is subject to the same regulatory requirements as registration within the framework of European processes, the regulatory requirements for changes to registration have not, however, been unified. This situation represents an unnecessary administrative burden and brings no added value. Just one declaration will now be enough for the entire internal market.

I therefore warmly welcome the Commission’s proposal and I congratulate the rapporteur for her report, which has improved the proposal and made it more precise. By means of the proposed changes, the administrative burden connected with the process for introducing new products of this kind onto the market will be lightened. Pharmaceutical companies operating at a supra-national level will be better able to cooperate and the result will be faster access to the latest drugs for everyone, especially those most in need.

Europe is, however, facing a very dangerous development in the spread of counterfeit drugs. This is no longer a problem just for Africa or Asia. In Europe, too, people are often purchasing drugs over the internet or from places other than pharmacies. That is why it is so important to ensure high standards for the introduction of drugs onto the market, which will simultaneously make it possible to trace packages back to the producer and to check whether they have actually been registered. It will be necessary for all drugs to be bar-coded and packaged in such a way that even the man in the street will see from the packaging whether they are safe drugs or counterfeits, in case the drugs have been purchased from somewhere other than a pharmacy. In my view, Member States have enough time in these two years to prepare for the introduction of the directive.

  Giovanna Corda (PSE). – (FR) Mr President, Commissioner, ladies and gentlemen, I would firstly like to pay tribute to the work of Mrs Grossetête and that of my fellow Members who worked on this report. This is a very important subject since it concerns our health. This report is a big step forward in harmonisation of the internal market, but also in consumer protection, especially for the elderly.

As Mr Verheugen stated, our population is living longer, which, of course, we are delighted about, but this is an issue set to grow in importance. When this directive is implemented, the indications appearing on a medicine will be identical in all Member States, providing clarity and transparency for European users, whether they are patients, veterinarians or farmers.

Likewise, with the implementation of a single procedure to apply for authorisations, this report will greatly contribute to simplifying current procedures on an administrative and technical level.

Indeed, it will no longer be necessary to submit 27 applications within the Member States. A single application to the European Medicines Agency will suffice. This report marks a further step towards European integration.

  Thomas Ulmer (PPE-DE). – (DE) Mr President, Commissioner, ladies and gentlemen, I should like to congratulate Mrs Grossetête on her draft report on variations to the terms of marketing authorisations for medicinal products.

I must make two brief comments on what previous speakers have said. As I see it, new medicinal products represent an opportunity to treat and cure health conditions, and the risk is proportionate. In addition, in the Federal Republic of Germany, for example, active ingredients already exist in many pharmaceutical forms and under many names without any increase in risk. The main focus of this Regulation, however, is the simplification of variations; that is, of the partial extension or variation of the pharmaceutical form of a medicinal product. Current practice is extremely cumbersome and entails a great deal of bureaucracy for companies, and the competent authorities are occupied with relatively inefficient measures. Therefore, the amendment creates a rare win-win situation.

The report significantly improves safety and reliability in the internal market. In addition, thanks to the work in committee, numerous other interests have been taken into account that further expedite or simplify the procedure. For example, sufficient account has been taken of the issue of national authorisations, thus avoiding a duplication of effort.

Due account has also been taken of the interests of Germany and German pharmaceutical companies. The draft has been aligned with omnibus proposal EU/2008/0032. The extension of marketing authorisations under other names has been expressly simplified. It has been made easier to supplement or extend product characteristics.

I am as satisfied and positive today about the report by Mrs Grossetête as I was critical about the Jørgensen report yesterday evening. The Grossetête report goes in the right direction: towards the Lisbon process objective of becoming the most efficient knowledge-based area in the world. I support this report.

  President. − A word of apology: there is some confusion involving the Secretariat, because my list is different to the one displayed. As long as I am chairing the sitting, I shall follow my list. If the Secretariat takes my place, they will follow their list.

So, Mr Buşoi will take the floor after Ms Grabowska.

  Genowefa Grabowska (PSE). – (PL) Mr President, I would like to start by congratulating the rapporteur since, from the technical point of view, this report will provide greater safety for patients and greater safety for European Union citizens who need to take medicines. It is good that we are eliminating the difference between issuing marketing authorisation for a medicine, and the procedure for amending that decision.

I would also like to refer to the words of Commissioner Verheugen and express my pleasure at the news that we will have new common regulations to combat counterfeiting and the illegal marketing of medicines. You made statements to the effect that you are doing everything to prevent counterfeit medicines from getting into the legal distribution network. My question is, what will happen outside the legal distribution network? Do the new regulations also cover this, or will the pharmaceutical industry just get a rap over the knuckles? My last question is as follows: do you plan to include a solution for greater pharmaceutical information for citizens in the new regulations?

  Cristian Silviu Buşoi (ALDE). – (RO) It is my firm belief that this draft directive marks significant progress in terms of speeding up access to medicines. I would also like to congratulate the Commission, Commissioner Verheugen and the rapporteur for this initiative. Given that the free circulation of goods is one of the basic principles of the internal market, it seems completely natural to me that this principle should apply to medicinal products as well.

At the moment, due to the complexity and diversity of the administrative procedures for authorising variations made to medicines already on sale, the actual operation of the internal market is distorted. Of course, this situation affects the pharmaceutical industry and authorities, but it is patients who are primarily affected because these complex procedures delay them receiving the benefits of improved medicines. I therefore totally agree with the Commission’s proposal to harmonise the procedures for authorising variations made to medicines, regardless of the initial authorisation procedure, as this simplification will streamline the entire system and, above all, guarantee a higher level of public health protection.

I also support the idea put forward by the rapporteur, Mrs Grossetête, concerning the need for a single procedure for authorising variations which will provide greater authority. With regard to the final remark concerning the Commission’s proposal to retain the medicine’s initial name in the event of extending authorisation, I support keeping the initial name, since frequently changing the names of medicines may confuse patients who need, in any case, to see a doctor before receiving any treatment, and the doctor will be up to date with the medicine’s new therapeutic indications.

  Amalia Sartori, (PPE-DE). – (IT) Mr President, ladies and gentlemen, I am very pleased with this directive. It will ensure that the rules on variations are made clearer, simpler, more flexible and truly harmonised. Congratulations, Mrs Grossetête.

I am also pleased to hear from the Commission that, partly in response to several resolutions of this Parliament, including one tabled by myself, Mrs Grossetête, Mrs Gutiérrez-Cortines and Mr Ulmer, there is to be a directive aimed at combating counterfeiting. It will require manufacturers and importers of active substances to obtain a certificate of good manufacturing practice, issued by the European authorities following mandatory inspections of manufacturing sites. By introducing product traceability in terms of country, company and manufacturing site, this measure will discourage the relabelling and repackaging of extra-Community products.

  Miroslav Mikolášik (PPE-DE). – (SK) I welcome the report of Françoise Grossetête, which has the aim of simplifying and improving the system of regulatory conditions applying to changes to marketing authorisations for medicinal products. The original system for administering changes appears ineffective and unsatisfactory in view of new scientific knowledge and technological progress. The process for granting authorisation varies enormously at an intra-state level across the Member States of the European Union. There are variations in the procedures for reviewing medicinal products, in the time it takes to implement changes, and also in the requirements relating to the submission of documents.

I firmly believe that the harmonisation of these aspects will make a big contribution to the protection of public health. A more effective system will also have a positive impact on the pharmaceutical industry as a whole. I support the rapporteur in the improvements she has proposed. I agree with the view that all drugs, regardless of the procedure under which they were authorised for release onto the market, should be subject to the same assessment and approval criteria. A new improved regulatory system will deliver benefits for all patients, for the approval bodies and also for the pharmaceutical companies.

  Dagmar Roth-Behrendt (PSE). – (DE) Mr President, I have a further two questions for Commissioner Verheugen. Commissioner, do you agree that the intactness of packs and bar codes on packs are no obstacle to additional forms of trade and that, on the contrary, with a modicum of intelligence, a bar code can be applied to another product or a patient information leaflet inserted in further repackaging? Do you agree that a modicum of intelligence, and the flexibility that is expected of all Europeans, is also to be expected of all those involved in the trade and distribution of medicinal products here in the European Union?

I have one final question. We shall increasingly be seeing problems involving active ingredients entering the European Union from third countries. Do you envisage any prospect of our creating incentives to ensure that more active ingredients are produced in the European Union again and that manufacturers of medicinal products obtain these substances from within the EU rather than from countries in which we cannot guarantee their safety?

  Jorgo Chatzimarkakis (ALDE). – (DE) Mr President, I should like to start by congratulating Mrs Grossetête. I also wish to thank the Commissioner for his speech, particularly the aspect of piracy and counterfeiting.

A 300% increase over the last year is no small amount, and this also endangers the health of European citizens. Yet we must also think about where piracy originates, its sources. In this regard, we note that 80% of counterfeit products originate from Internet trade and only 20% from actual smuggling. This must be our starting point.

In the case of the smuggled goods, we must mobilise our customs authorities, we must use new technologies, and we must look much more closely and thoroughly at how we can ensure safety in the case of blister packing, too. We must, of course, also ensure that there are safe Internet chemists and that citizens know which chemists are safe.

I should also like to draw attention to new principles. We need a coherent approach based on the principle: ‘Know your supplier, know your client.’

  Dumitru Oprea (PPE-DE). – (RO) In many European countries, the procedure for authorising medicines is clear and even well regulated from an official point of view. However, I would like to draw your attention to some authorisation procedures that are too rapid, which then lead to many deaths caused by medicine overdoses, medicines taken on an ad hoc basis, or by medicines which can cause side-effects that have not been investigated sufficiently before.

I think that new medicines and improved medicines with miraculous properties are released too easily on the market, but are then withdrawn within a very short time. Who is responsible for their quality and the side-effects they cause? We welcome this initiative for introducing on the market a harmonisation procedure which is unanimously accepted in Europe. However, new medicines should be included as part of an analysis carried out by an international committee of experts.

  Donato Tommaso Veraldi (ALDE). – (IT) Mr President, ladies and gentlemen, thank you for the opportunity given to me to discuss the excellent work carried out by the rapporteur, Mrs Grossetête, and this proposal for a directive aimed at providing Community regulation applicable to all types of marketing authorisations for medicinal products.

This is a positive directive, welcomed for its objectives of protecting public health and cutting red tape. The proposal for a directive is of a legal nature, introducing simple amendments to the legal basis behind the rules on variations, such as the introduction of a new therapeutic indication or a new method of administration, made to medicinal products for human or veterinary use after they are first placed on the market.

Harmonisation in this area has become necessary, if not crucial, because without a single Community legal framework, variations concerning national authorisations will continue to be subject to national laws that differ from one Member State to another, as is the case at present.

  Emmanouil Angelakas (PPE-DE). – (EL) Mr President, I too should like to congratulate the rapporteur and to make two comments in reply to the Commissioner. Firstly, as far as the trade in counterfeit medicinal products is concerned, we were surprised to learn that some of them are being produced in two countries of the European Union and then marketed through a third European country, namely Switzerland. This is something you need to look into, Commissioner.

My second comment concerns the industry which produces raw materials for medicinal products, which may have been flourishing 20 years ago, but which is now slowly dying. The reasons are, firstly, the high costs and, secondly, the protection of innovation, about which we are all agreed, but which has resulted in European companies being unable to manufacture raw materials for medicinal products which come under the rules protecting innovation. As a result, research centres have moved to China and India. There are certain policies which you can apply so that they return to the European Union.

  Günter Verheugen, Vice-President of the Commission. – (DE) Mr President, honourable Members, indeed, the debate has confirmed the broad consensus on the Variations Regulation, and so I shall not discuss it further. We should now bring this into force as it stands and make sure that we do so as effectively as possible. I think that, beyond this, what are more important overall are the other issues that have been raised here.

Allow me to make a couple of very fundamental points. It is not my job, of course, to explain technical rules to you, but to tell you why we do certain things and why we do not do certain things.

There is a conflict in our societies between the requirements of the health care bureaucracy, on the one hand, and those of patients on the other. This is absolutely clear. The proposals that will be occupying our attention in future lie at the centre of this conflict area. The health bureaucracies in the Member States are not interested in informed patients. Informed patients mean more work, more effort. Those who should be there for them are forced to give them information, answering questions such as: why am I being given this medicine, why am I not being given that medicine? Why should I be given this treatment and why am I not being given that treatment? They are entitled to know this as human beings.

An unwavering principle for me is the following. In a democratic society, it should not be the case that those wishing to provide information must justify themselves, but that those not wishing to provide information do not have to. It is the health care bureaucrats in the Member States who must explain why they do not want to see informed patients. I do not have to explain why I do want to see informed patients.

To be perfectly clear, there will be a heated, lively, controversial debate here, and it is my hope and wish that the European Parliament will support the Commission and me in this debate. After all, this issue is quite fundamental, and concerns not only public health but also social policy. It is a question of what the freedom of citizens in health care, too, means to us.

On the second issue, with regard to counterfeiting, I agree with all those who have said that this is a criminal matter. Counterfeiting in the illegal distribution chain is a matter for the police. Illegal is illegal – we cannot do much more than that. I do think, however, that the proposals we can make will ultimately make it virtually impossible to introduce counterfeit medicines into the legal distribution chain. That is what we can do.

Mrs Roth-Behrendt is absolutely right. In my opinion, it really is an impertinence to suppose that, in reality, this is about placing obstacles in the way of any forms of distribution of pharmaceutical products for competitive reasons. I could not care less about that. Parallel trade is a legal activity within the European Union. This has been confirmed unequivocally by the European Court of Justice. I am absolutely not thinking of getting my hands on parallel trade, but one thing I would say is that all parties involved in the distribution of medicinal products must be subject to the same strict safety requirements. I fail to see why someone should be exempted from safety requirements just because they buy cheaply in one Member State a medicinal product that is sold for a higher price in another Member State, bring it back into the more expensive country, and resell it for a high price there. I do not understand this.

Those of you with some knowledge of food law will have already been asking themselves, as I did, why it is most strictly forbidden in Europe to open a pack of spaghetti on the way from the manufacturer to the consumer – this is indeed most strictly forbidden – yet it is permitted to open on the way from the manufacturer to the consumer medicinal products which, when taken wrongly, can result in death.

It is worth reflecting on why this astounding disparity exists, why it is forbidden in the case of spaghetti, for example, but permitted in the case of vital medicinal products. I find this difficult to understand.

We shall find solutions that make it possible for all parties to continue their business, precisely in the spirit of what Mrs Roth-Behrendt said: we must apply a little creativity, use our brains and give it some thought, but the safety requirements apply in full to all: there can be no exceptions!

I believe I have answered your questions and also given you a foretaste of the coming lively debate. The proposals will be presented in a few weeks’ time, and all I can say in this regard is that we shall meet again in this Chamber and we shall have to discuss this matter further.

  Françoise Grossetête, rapporteur. − (FR) Mr President, firstly I would like to thank my fellow Members who have spoken in support of the report that I presented. I would remind those who, unfortunately, are no longer here but who expressed some concerns, that this really does constitute an improvement, harmonisation and simplification of procedures. However, the simplification of procedures does not mean lowering quality or having fewer controls. It represents lower costs for industry and, above all, for SMEs, which is essential. Lower costs and saving time: in other words, European patients will finally have quicker access to medicines. I sincerely hope, moreover, that we will conclude at first reading. We have done everything possible so that an agreement can be reached, and naturally I would like once more to thank the Commission for its help, as well as the Council.

With regard to counterfeiting, we were delighted, Mr Verheugen, to hear the information you gave concerning the text which you will present to us, as soon as possible I hope, since you are aware that we are anxious to see it. Counterfeiting, as my fellow Members said, is a crime and we cannot wait when it comes to crime. We know that the vast majority of sales of medicines on the Internet concern counterfeit medicines which are therefore dangerous for citizens’ health.

Well, you spoke of active ingredients and the controls which we must apply to active ingredients, including when they are manufactured, when they are produced in third countries, and not in the European Union. Yes, this is essential. We will be there to help you because we are going to have to work on traceability, penalties for offenders and safety of the distribution chain. It is important for patients to have 100% confidence in the medicines they are prescribed: it must not be possible to open or repackage these medicines.

This is what I wanted to say on behalf of all of my fellow Members. Mr Verheugen, I would like you to know that when leaving here today, you will have Parliament’s full support, and it is essential to convince the College of Commissioners that we must not waste any more time but at last take action against the counterfeiting of medicines.

  President. − The debate is closed.

The vote will take place today, 22 October 2008

Written statements (Rule 142)

  Rareş-Lucian Niculescu (PPE-DE), in writing. – (RO) The European Union needs clear and stringent regulations with regard to the conditions for launching medicines on the market, and for all medicinal products in general too. I would like to illustrate the need for this by referring to a recent case which occurred in Romania. In September, a woman died following an operation during which unsterilised surgical thread imported from China was used. Other patients suffered complications which put their lives in danger.

The Romanian Health Ministry’s inquiry committee acknowledged without a doubt that the surgical thread in question did not carry the CE quality mark. The law on assessing the products’ compliance clearly shows that the guilt lies mainly at the door of the relevant ministry, but clearer rules and greater transparency could have prevented this situation.

  Marian Zlotea (PPE-DE), in writing. – (RO) Although medicinal products from the European Community are constantly faced with regulations drawn up by national governments and the Community throughout their entire existence, discrepancies between the Commission’s regulations and the Member States’ provisions have negative repercussions from a public health and administrative perspective, as well as in terms of the general operation of the internal pharmaceuticals market.

The purpose of this report is to make sure that all medicinal products marketed in the Community, including those authorised at national level, are subject to the same administrative approval and amendment criteria, no matter which procedure was used to authorise these medicines. This proposal simplifies the administrative procedures for Member States and facilitates the harmonisation of evaluation and supervision requirements for all medicinal products.

Adopting this report will protect far more consumers who will benefit directly from improved efficiency, consolidated organisation, as well as clarity and transparency. This is the result of implementing a simplified, standardised regulation system supporting marketing authorisations for medicinal products in Europe.