Verbatim report of proceedings

Monday, 10 September 2012 - Strasbourg

29. Pharmacovigilance (amendment of Directive 2001/83/EC) - Pharmacovigilance (amendment of Regulation (EC) No 726/2004) (debate)

  President. – The next item is the joint debate on the following reports:

- A7-0165/2012 by Linda McAvan, on behalf of the Committee on the Environment, Public Health and Food Safety, on pharmacovigilance (amendment of Directive 2001/83/EC) (COM(2012)0052 - C7-0033/2012 - 2012/0025(COD)); and

- A7-0164/2012 by Linda McAvan, on behalf of the Committee on the Environment, Public Health and Food Safety, on pharmacovigilance (amendment of Regulation (EC) No 726/2004 (COM(2012)0051 - C7-0034/2012 - 2012/0023(COD)).

  Linda McAvan, rapporteur. – Madam President, pharmacovigilance is, of course, about the safety of medicines and monitoring medicines on the market for potential side effects. Two years ago, Parliament and the Council signed off a major reform of the European system. We had not expected to be back here tonight updating that legislation before it took effect, but that was before the Mediator case in France, which highlighted potential weaknesses in what we had already agreed.

My big priority in the course of negotiations over the last few weeks has been to strengthen the hand of regulators in the pharmaceutical system and, by doing so, to improve patient safety. Two things struck me when I looked at the Mediator case. Firstly, safety issues had been discussed at the European Medicines Agency on a number of occasions among regulators, but no formal referral had ever been made, and the issue was dropped. The company withdrew the medicine from markets in some countries for commercial reasons. The second issue which struck me was that the French and Italian authorities had requested a safety study from Servier back in 2000 because of these concerns, but that study was not finished until almost a decade later. By that time, the medicine had been withdrawn because of the vigilance of a regional pharmacovigilance expert in France.

So, when we looked at the revision, we made several key changes. The first is that, in future, companies will be under much more scrutiny when they voluntarily withdraw a medicine from the market anywhere in the world: this must be reported to the EMA and questions can be asked. Secondly, whenever there is any concern about safety, there will now be an automatic trigger which will lead to an investigation at European level. There will not be national discretion over that decision. Thirdly, when a post-authorisation safety study is requested, that study will have to be carried out. Drugs which are subject to a study will now be labelled with a black triangle so that health professionals and the public know that drug is subject to a post-authorisation safety study. What struck me about the French case was that the French regulator said that it did not have the powers to actually make a post-authorisation safety study happen. This cannot be allowed to happen again.

Commissioner, two outstanding issues came up during the course of negotiations which MEPs hope you will comment on tonight. The first was the issue of fee regulation for the EMA. We need enough money to be able to carry out our pharmacovigilance work properly. The second is the issue of the black box of essential information on the patient information leaflet. You have sent me a letter about these matters and I know that you say that the Commission will look very carefully at both these issues. I hope you will make a comment on this.

Finally, I should like to thank all the shadow rapporteurs who are here this evening for the all the hard work they have put in on this dossier. I thank the Danish Presidency, the Commission and the Council Presidency. The Council Presidency helped us expedite the work quickly so that we could reach an agreement before the summer so that it takes effect at the same time as the other changes to the pharmacovigilance legislation.

  John Dalli, Member of the Commission. – Madam President, honourable Members, I am glad to be here for the formal endorsement of a first reading agreement on the important proposals on post-market control of medicines, the so-called pharmacovigilance. Pharmacovigilance makes a crucial contribution to public health and is key to the safety of patients.

May I take this opportunity to thank all those who worked very hard to make this agreement possible – in particular Ms McAvan, rapporteur for the lead committee, who has successfully facilitated the early conclusion of this dossier.

The stress test following the Mediator case identified certain gaps in our legislation. The proposal under consideration today will strengthen the transparency and reporting requirements of the 2010 package on pharmacovigilance. In particular, more categories of products will be subject to increased monitoring with a view to improving the reporting of adverse reactions to such medicines.

In addition, there will be greater transparency of the reasons for the withdrawal, interruption or non-renewal of the marketing of a product, as companies will have to declare the reasons for these. This will help to minimise the risk that a product falls through the net and thus escapes scrutiny when safety concerns are identified.

The confidence of patients in medicinal products is essential for therapeutic compliance; such confidence can only be achieved and maintained if patients trust our system. I am pleased that the proposal on which Parliament will vote tomorrow addresses the gaps identified in the existing pharmacovigilance legislation.

The Commission stands fully behind this agreement and is very pleased that it was concluded between the institutions before the summer break. As part of the agreement, with respect to the legislation on fees related to pharmacovigilance activities, the Commission makes the following statement:

On 18 June 2012, the Commission launched a public consultation on a concept paper concerning the introduction of fees for pharmacovigilance, as set out in Regulation (EU) No 1235/2010 and Directive 2010/84/EU, which is open for comments until 15 September 2012.

After examination of the comments received, the Commission will prepare an impact assessment which is one of the necessary steps in the legislative process before the Commission puts forward a legislative proposal. The Commission will continue to work on this file as a priority with the intention of presenting a legislative proposal as soon as possible to the European Parliament and the Council.

  Pilar Ayuso, on behalf of the PPE Group. – (ES) Madam President, Commissioner, first of all, I would like to draw attention to the excellent work done by Ms McAvan, the rapporteur, and also the other shadow rapporteurs, in order to reach this agreement at first reading. This was very important because the regulation we adopted in 2010 was coming into force and it needed to be amended. It was not amended because it was a flawed piece of legislation – quite the contrary. Rather, it was amended because, as has been said, recent events took place, of which we are all aware, showing that there was a loophole that needed to be closed in order for it not to occur again. It was also necessary to strengthen certain specific points concerning pharmacovigilance and the safety of medicines once placed on the market.

As we have already heard, from now on, marketing authorisation holders who do not renew a marketing authorisation or who withdraw or request the withdrawal or suspension of an authorisation will be obliged to inform the competent authorities of the real reasons and motives for withdrawing or suspending it.

This is a major success for transparency and it will prevent the market authorisation holder from trying to conceal the real reasons behind its decision. Moreover, in the event that any of these actions is carried out in a third country, all the Member States in which that medicine is marketed must be informed.

All this will improve transparency and safety, without the European Medicines Agency and national agencies being overly burdened as a result.

The second important amendment we have achieved is that all authorised products that are subject to some kind of post-authorisation safety study (PASS) will be systematically included on the list of products subject to such monitoring.

Lastly, we cannot forget that pharmacovigilance plays a fundamental role, and Parliament should therefore adopt this proposal.

  Karin Kadenbach, on behalf of the S&D Group. – (DE) Madam President, I, too, would like to thank Ms McAvan and the shadow rapporteurs once again. I believe that the European Union has acted very quickly here. Something that was regarded as modern and effective as recently as 2010 has proven to be inadequate in such a short space of time, and we must now act together as quickly as possible to put it in order. These loopholes need to be closed. The document before us shows very clearly where work needs to be done.

We need transparency and we need speed, as we need patients and consumers to have confidence in their drugs. Above all, we need confidence in the system. We need close collaboration in order for it still to be possible to later monitor medicinal products that have already been authorised in Europe, in order to be able to ensure that adverse reactions and, above all, harmful side effects are detected as quickly as possible and that the entire European market is informed in the shortest possible time. In other words, medicines cannot simply quietly and secretly disappear from the market when producers have noticed that there may be some harmful side effects. Instead, such occurrences must be explained. We need this transparency, we need the urgency and we also need the longer monitoring periods.

What we very particularly need is the close cooperation with the patient, but also with the staff working in health care, as I believe that the pharmacovigilance package can ultimately only work if everyone knows about it, in other words, if this information also coalesces. Legislation of this kind can only really work if patients are able to make sense of the package insert and if, on the other side of the coin – as Ms McAvan mentioned – the European Medicines Agency also has the necessary financial means to be able to meet all the responsibilities handed over to it in future.

  Antonyia Parvanova, on behalf of the ALDE Group. – Madam President, let me start by congratulating Linda McAvan on a successful leadership on this dossier and by praising the work accomplished by the Danish Presidency, the Commission and all political groups in making possible a prompt and necessary agreement on such a crucial issue. Less than two years after the case in France, we shall review the remaining gaps and loopholes in our European pharmacovigilance framework. All the European institutions and stakeholders are demonstrating today that when patient safety is at stake, actions can be taken swiftly and effectively.

The ALDE Group welcomes the agreement, which will be put to the vote tomorrow, upgrading our new framework adopted in 2010 with a clear focus on transparency, efficiency, follow-up mechanisms and the reinforcement of the monitoring of drugs placed on the market but subject to post-authorisation studies.

I particularly welcome two key elements of the future provisions to be implemented: the obligation for companies to communicate the reasons for withdrawing a product from the market and the automatic trigger of the emergency procedure when this decision is taken due to safety concerns. We must indeed keep in mind that, in addition to guaranteeing the highest level of patient safety, the good functioning of our pharmacovigilance system is also a tool to reinforce European citizens’ confidence and understanding of the medicines they are taking. As decision makers, we have a public health responsibility, which we are taking today in ensuring the efficiency of our system and adapting it when necessary.

To conclude, I would like to mention the need to provide sufficient resources for the European Medicines Agency to assume effectively its new missions. I understood that the Commission is already working on this issue and I hope it will come up with the relevant proposal without undue delay.

  Marina Yannakoudakis, on behalf of the ECR Group. – Madam President, patient safety should always be our first priority. Recent misleading information about the drug Mediator led to hundreds, maybe even thousands, of deaths. This reinforces the importance of this report. We need rules to protect patients from dangerous side effects of drugs.

It is hoped that this report will close the existing loophole, thus forcing companies to declare the withdrawal of drugs on safety grounds. This being the case, an emergency evaluation will automatically be triggered. I am pleased to say the Members working on this report acted swiftly and reasonably.

Could there have been other changes? Yes, but now was not the right time. I am pleased that Parliament put patient safety first by reacting rapidly, rather than seeking a long drawn-out revision of this legislation. I congratulate the rapporteur on her work.

  Oreste Rossi, on behalf of the EFD Group. – (IT) Madam President, ladies and gentlemen, first of all, I would like to thank Ms McAvan for the work she has done, which I endorse.

The entry into force of the new provisions has significantly strengthened the legal framework for the surveillance of medicinal products. The overall strategic objectives of the new regulation and the new directive are in line with the overall objectives of EU legislation in the pharmaceutical field and their aim is, above all, to provide better health protection for citizens and ensure the proper functioning of the internal market as regards medicinal products for human use.

I support the proposal since I consider it vital, in order to protect patients, to strengthen pharmacovigilance systems so as to guarantee greater transparency in procedures, thereby improving the effectiveness of products.

Recent cases have shown the need for a further improvement of the system. It is appropriate to continually define a medicinal product’s tolerability profile under actual conditions of use and to promote balance in the use of medicinal products among the population.

  Jiří Maštálka, on behalf of the GUE/NGL Group. – (CS) Madam President, I, too, would like to thank the rapporteur, Linda McAvan, for the fine work she has done on this legislative proposal.

I am delighted that, following a successful trialogue, it will be possible to reach agreement in the first reading. I am sure that the amendments to the recently adopted legislation that we agreed on will lead to safer medicines, better protection for patients in Europe, and greater coordination and cooperation.

The amendments were necessary in order to prevent a repetition of scandals such as the one surrounding the Mediator drug.

I would like to emphasise, however, that even perfect legislation will be worthless if not properly implemented, and if compliance is not properly enforced.

The economic crisis and related cuts are also affecting the health sector, including the budgets of national and European medicines agencies.

It is therefore important to ensure that the competent bodies at both national and European levels receive adequate support and trained staff to fulfil all of the important tasks that we have given them under this new legislation.

  Franz Obermayr (NI). – (DE) Madam President, it is absolutely necessary that we should continue to monitor medicines after their marketing authorisation, the more so given that they are only trialled on a relatively small number of patients. New knowledge often only comes to light once the medicine in question is already on the market.

Medicinal products that require additional monitoring or are subject to a post-authorisation safety study (PASS) should be labelled to that effect using a black symbol. In addition, doctors, patients and the authorities must be told in good time – meaning as soon as possible – when and why a medicinal product that had, up to then, been regarded as safe is withdrawn from the market. Clearly, we cannot allow a situation where investors in pharmaceutical companies are informed before doctors and pharmacists. Ultimately, the monitoring of medicinal products, as good as it is, only serves patients if it warns them in good time of a dangerous medicine.

  Peter Liese (PPE). – (DE) Madam President, Commissioner, ladies and gentlemen, what happened in the Mediator case really was a major scandal. We do not know exactly how many people lost their lives – reports vary from 500 to 2 000 – but every death is one too many. This was a case of irresponsible behaviour on the part of the company but, unfortunately, there were also gaps in the law. These gaps in the law urgently need to be closed. I would therefore like to offer my heartfelt thanks to Ms McAvan, to the shadow rapporteurs and, in particular, to Ms Ayuso in my group, and to Commissioner Dalli, who produced this proposal efficiently and guided the whole process very constructively.

It is important that, in future, precise reasons will have to be given when a medicine is no longer marketed – no one can be in any doubt in this regard – and it is also important that the information is then shared between the Member States competently and accurately so that cases like this do not happen again.

Ms Weisgerber and I have tabled an amendment on a drug facts box going beyond what the Commission has already proposed. I want to emphasise that, when using the English terms, we should talk not of a ‘black box’, but of a ‘drug facts box’. We might well not be dealing with a box that is black, you see. That was, after all, possibly one of the reasons why this proposal, which was tabled by the Commission once before, was rejected in the past. A black box is possibly not the right way to indicate this kind of information. However, we do need to improve the package insert.

A system of drug facts boxes has proven itself in the United States. We still have the problem that our package inserts are too complicated. To put it in a somewhat simplified and exaggerated way: there are two kinds of patients. One group do not read the package inserts at all, as they do not understand anything on them anyway, and throw them away. The other group read the package insert quite carefully, are scared by the many potential side effects and consequently do not take the drug. As a doctor, I have experience of both groups, and it goes without saying that both approaches are wrong. We need collaboration between doctors and patients. When important side effects occur, people need to get in touch with a doctor quickly. However, the drug must be taken as prescribed. With antibiotics in particular, it is important that patients must not stop taking a drug when they feel a little better, as that is how resistance develops.

All this kind of information could be much better presented in a drug facts box than it is on current package inserts and, as I mentioned, this approach has proven itself in the United States. I am therefore very grateful that the Commissioner has promised to include this in further investigations, and I hope that we will soon have a proposal on this that is as precise as possible.

  Monika Flašíková Beňová (S&D). – (SK) Madam President, the stress testing of legislation in the area of pharmacovigilance has exposed serious shortcomings in the EU system, which we must resolve, as no shortcomings can be allowed in the safety area of our drugs policy.

The Mediator drug mentioned earlier was registered in many European countries through national procedures, and despite the fact that the first reports of undesirable effects in its main active ingredient – mentioning fears of potential heart valve failure – appeared as early as 1999, the drug was prescribed very widely in Europe up to 2009, when it was taken off the market, with prescriptions handed out to 5 million people. The number of deaths related to this medicine is estimated to be as high as 2 000, up to 2 000 people.

Despite the fact that concerns over this drug were discussed by regulatory bodies at various meetings at European level, and despite all of the properly documented concerns, no decision was taken for this drug to undergo scientific assessment at EU level. The regulatory bodies took no further measures.

These facts show very clearly that safety in respect of drugs policy and drugs must be reinforced at EU level. I therefore support the aim of revising the legislation from 2010 and, at the same time, I would like to emphasise the need to achieve this amendment as quickly as possible, in the interests of public health. I would also like to thank the rapporteur very much for the finely drafted opinion.

  Frédérique Ries (ALDE). – (FR) Madam President, ladies and gentlemen, we will probably never know the number of deaths attributable to Mediator, which was placed on the market for the treatment of diabetes and was often prescribed, in reality, as an appetite suppressant. In any event, there have been too many victims of this system failure, in France anyway, where, as has already been mentioned, the drug was not withdrawn from the market until 2009, six years after the same decision was taken in Italy and Spain.

This scandal has quite clearly been the catalyst for the revisions we are debating this evening. These revisions are essential given the widespread but risky practice of marketing non-prescription medicines.

The shortcomings in the legislation we adopted in this very Chamber just two years ago are clearly highlighted. The legislative framework is reinforced where necessary. Yes, it is essential to compel manufacturers to give their reasons for withdrawing a drug from the market or for not applying to renew a marketing licence. Yes, this alarm, this triggering of the emergency procedure when practitioners stress that taking this medicine results in adverse patient reactions, must be made systematic.

Now we must remain realistic, so that this pharmacovigilance system can function effectively. It is for the national authorities and the London-based European Medicines Evaluation Agency (EMEA) to exercise greater control over the sector’s commercial players and to demonstrate greater independence from them.

  Tadeusz Cymański (EFD). – (PL) Madam President, I would like to express my esteem for the rapporteur and the shadow rapporteurs, who drafted two reports in a very short time, considering the urgent implementation of new legislation planned before the end of this year. I welcome the idea that the Commission and the European Medicines Agency bear more responsibility for the safety of pharmaceuticals. The agency’s broad mandate, which includes granting commercial licences to manufacturers, valid across the European Union, have been linked with the obligation to warn of dangers that have been detected but have not been the subject of state-level intervention. In the widely publicised case of a lethal drug in France, European institutions were, for many years, unable to have the drug prohibited in its country of origin while successive Member States withdrew it from the market. We know that there was a conflict of interest between the supervisory authority and the manufacturers of the medicine who financed it. We realise that the pharmaceutical companies are in too powerful a position. The battle is a difficult one, but victory remains possible and efforts should be continued.

  Marisa Matias (GUE/NGL). – (PT) Madam President, I would also like to add my voice to the comments made by my fellow Members with regard to the report by Ms McAvan, which was an excellent piece of work. Today, we can say that European patients are much safer with this new amendment to the legislation and the regulation, and that patient protection is indeed one of our priorities. In view of all this, as I do not want to repeat what has already been said, and because I support the comments in their entirety, I would just like to mention a couple of things that occurred to me during this discussion.

The first relates to the fact that the economic crisis is causing setbacks in the areas of health care and public health. Therefore, in order to make the most of your presence here, Commissioner, I would also like to draw attention to the fact that we cannot allow the economic crisis to prevent the package comprising the three pieces of legislation relating to medicines, including pharmacovigilance, counterfeit medicines and information given to patients, from being put on the waiting list, using the crisis as an excuse for failing to grant patients access to all the care, information and medicines to which they should be entitled. Neither can we in any way accept that this should be the case!

A second point occurred to me during this discussion: in 2010, we voted at the first reading of the directive, but here we are in 2012 and I see that we have actually gone backwards, as now we are talking about the quality of the medicines. Today, in 2012, what might have been a rare case in 2010 has become an epidemic, and people are dying in Portugal and Greece due to lack of access to medicines. This problem is not caused by the pharmaceutical laboratories, but by this laboratory here. I sincerely hope that we succeed in addressing these problems, as medicines represent advances in public health and health care, and we cannot ignore these problems, which touch upon a vital part of people’s lives.

  Françoise Grossetête (PPE). – (FR) Madam President, Commissioner, ladies and gentlemen, I should like to congratulate the rapporteur, but also Commissioner Dalli on his responsiveness with regard to the Mediator case. His ability to respond swiftly enabled stress tests to be carried out on the legislation we have just adopted concerning pharmacovigilance in order to identify additional lessons which needed to be learned in the light of the Mediator case.

However, experience has shown that there were weaknesses in our legislation. Today, we are providing solutions to the various weaknesses we have identified. In so doing, we are increasing transparency and strengthening communication with regard to the safety of medicines.

Nevertheless, I think that one weakness remains. Regrettably, this new legislation does not address the central issue of off-label prescriptions, which, in fact, represent 15% to 20% of all prescriptions, or indeed more in certain areas (including paediatrics, psychiatry and cancer research). Indeed, doctors may prescribe off-label medicines when other solutions for the treatment of a given disease are limited or non-existent.

Prescribing such medicines may be useful but it is not without danger, as it is carried out without any form of validation by the health authorities. Most importantly, in terms of pharmacovigilance, it gives rise to very little feedback on adverse reactions by health care professionals, who were afraid that such information would establish their liability.

It is a shame that my proposal, drafted with my colleague, Ms Ries, to mandate the European Medicines Agency (EMA), in partnership with the relevant national authorities, to develop guidelines on this point was not adopted in the final compromise. Stricter control of this type of prescription would enable a balance to be maintained between the need to prevent the unauthorised use of medicines and the need to fill gaps in treatment to meet special medical needs.

I will end by saying that Mediator was often used, in one out of five cases, off-label. I think that it is essential to demonstrate vigilance in this regard and I await Commissioner Dalli’s response.

  Anja Weisgerber (PPE). – (DE) Madam President, I would like to start by congratulating the rapporteur, Ms McAvan, warmly for her excellent work once again. Good pharmacovigilance protects the citizens of Europe. At the same time, we are also bolstering informed patients. It was therefore very important to close the safety loopholes exposed and actually opened up by the Mediator case as soon as possible.

From now on, a company that removes a medicinal product from the market must state the reasons why it is doing so. The other Member States will also be informed via the European Medicines Agency – something that is irremissible for the protection of patients in Europe’s internal market, too.

There is one point that is particularly close to my heart, which is the better readability of package inserts. Many patients really do complain about the complexity of package inserts. They say they are too difficult, too hard to understand, too unreadable, too confusing. This is a subject that the older elements of the population in particular bring up, although it is not only them. Some patients are even so scared by the side effects when trying to find important information that, in the end, they do not even take the medicine. Together with Mr Liese, I therefore advocated the idea that the package insert should be made more readable for patients and that a drug facts box containing the most important information, including the side effects, should be included on the package insert, written in plain language and given graphic emphasis.

I am very pleased about the result obtained from the negotiations, and about the fact that the Commission, Commissioner Dalli, has also promised to produce a report on better readability. I hope that the Commission will keep its promise and also that it does so as soon as possible. I would be interested to hear – and I am happy to take the opportunity presented by the presence of Commissioner Dalli with us here today – whether there are already specific ideas in this regard at this point. I would be really interested to hear the answer to that question. I would like to offer my thanks to the Commission for having tackled this issue, as it really does represent a major step towards patient friendliness if we can improve the package insert and make it more readable.

  Erik Bánki (PPE). – (HU) Madam President, I would first of all like to thank Ms McAvan for her quick, precise and accurate work on the subject. I believe that this is a matter of special importance, and stands as proof that this is an issue in which the Commission and Parliament are capable of cooperation. I hope that this cooperation will soon result in the agreement that is essential for the settlement of the issue. There are some very important matters that this case revealed. Firstly, deficiencies still remain in respect of safety risk warnings. I cannot stress enough that this is once again a case where it is the poorest and least educated who are the most vulnerable.

After all, as my fellow Members, including Mr Liese, pointed out, the descriptions of the side effects of drugs are long and complicated. Most people do not even read these, or are unable to understand their contents. This is one of the reasons why it is important to regain the trust of patients by responding rapidly and accurately to cases of abuse, which can, unfortunately, occur in this field as well. We need only think back to the situation of four or five years ago, where the distribution of H1N1 vaccines caused considerable internal political tensions in Hungary, for example. However, this did not just happen in Hungary but in several other European countries as well.

I still remember the stand made by a Polish minister who herself encouraged the Polish people to not take this vaccine, arguing that the side effects were uncertain, and that children and pregnant women should not be exposed to risks that have not yet been investigated due to insufficient time. I therefore believe that rapid response is a responsibility of the EU, and this procedure, too, proves that it is capable of such a response. In important cases where the health and lives of our citizens are at stake, we are capable of setting aside our political disputes to follow a common path to achieve significant results together. I believe that this report exemplifies that it is worth encouraging cooperation in this matter. I very much hope that this, too, will produce quick results.

  Róża Gräfin von Thun und Hohenstein (PPE). – (PL) Madam President, it is really positive that the Commission has proposed to review the Pharmacovigilance Directive. The safety of pharmaceuticals available in the single market is, indeed, of paramount importance to citizens. The European Parliament, as well as other European institutions, must continue their systematic efforts, doing their utmost, in these changing times and retail conditions, to ensure that citizens can be certain about products that are available not only in shops and pharmacies but also online. The case of the medicine named Mediator, which we are discussing here, triggered the revision of this directive and the pharmacovigilance regulation. This is certainly a step in the right direction. We must improve supervision of products being sold in the single market. There are many counterfeit products and many extremely dangerous substances, and there are no warnings or campaigns which inform citizens and consumers which sources are dangerous, how a medicine can be verified, and where not to buy them. Any counterfeit products may be very dangerous, but here we really are talking about a direct threat to human health and life.

The citizens are not being adequately informed about the consequences of taking a particular substance. I fully agree with Peter Liese, who states that information is often overly complicated and sometimes incomplete. This is why I extend my special congratulations to Peter Liese and Anja Weisgerber in connection with the drug facts box initiative. Indeed, it is likely to benefit the consumers of medications and may lead to a regime which would require clarity of information regarding the content and effects of particular substances.

And a brief question to Commissioner Dalli. You referred to consultations. I have been present at some of these consultations, and I ask once again: in how many languages are they conducted? Are they accessible by people and institutions that do not use English?

Catch-the-eye procedure

  Miroslav Mikolášik (PPE). – (SK) Madam President, I wanted to say one important thing. If we have decided in this Parliament that information for consumers on food products must be enhanced, clear and legible, there must be an even greater need for information for patients on package leaflets that is clear, legible and true. However, I will return to the substance of the matter. I would like to congratulate Linda McAvan, who has made great progress by bringing to bear all of Parliament’s strength on revising this document, which will make it more likely that patients are not treated with the wrong drugs.

How is it possible that Mediator was prescribed for many years, when it had such side effects that it is estimated that up to 2 000 people may have died from the drug? In addition to this, it was even prescribed in a completely different way, not for type 2 diabetes, but for anorexia. This should not be repeated now. I would only like to say that I welcome this report.

  Elena Băsescu (PPE). – (RO) Madam President, the revision of the rules regulating pharmacovigilance at EU level is a necessary and welcome step. The current system needs to be tightened to ensure greater safety and close existing loopholes. It is of paramount importance that the information provided on medicine labels is clear and helpful and worded in a way that everyone can understand. This will enable both patients and health care professionals to act accordingly. At the same time, the side effects of medicinal products must be monitored much more closely. This will put an end to cases like the one involving Mediator, the medicine from France which nearly all my colleagues have mentioned.

Transparency with regard to the safety of medicines is crucial to protecting public health. I should point out that the benefits gained by patients from a medicine should always outweigh any possible harm caused by the occurrence of side effects.

  Zuzana Roithová (PPE). - (CS) Madam President, Commissioner, I would, of course, like to join everyone in welcoming the Commission’s response to the tragic case of the Mediator drug, proposing greater informational obligations for Member States when withdrawing drugs from the market, and strengthening the coordinating role of the European Medicines Agency.

There is some doubt, of course, as to whether this informational obligation also applies to third countries outside the EU. I also support publication of the reasons for a refusal to authorise the placing of medicines on the market. This is all well and good. I would also, of course, like to call on the Commission to analyse the impact of European legislation on other areas when it discovers problems in Member States, and to propose amendments in a prompt and timely manner.

I would like to mention as an example fraudulent mail order businesses, in relation to which the Commission is still unable to rectify matters, despite petitions from European citizens, and interventions and resolutions of the European Parliament.

Another example might be the issue that has dragged on for over three years in relation to the Canadian visa requirement for Czech citizens.

End of the catch-the-eye procedure

  John Dalli, Member of the Commission. – Madam President, the Commission is grateful for Parliament’s support for the first reading agreement on the pharmacovigilance proposals.

With regard to the black box referred to by Ms McAvan, there is an ongoing project to analyse the feasibility and value added of certain information that will be summarised in what is now being called the drug fact box. The studies will involve collaboration with the European Medicines Agency and national competent authorities, as well as consultations with organisations at EU level representing patients, consumers, doctors and pharmacists, social health insurers and industry. The report on the readability of the package information requested by Parliament in 2010 and the outcome of the study on the drug fact box is expected to be ready by mid-2013.

I agree with Ms Matias that we cannot allow the financial crisis to punch holes in our health care system. Health is, in my view, a fundamental right of all our citizens. Apart from this, health is a major motor of economic growth, and cutting health is based on a major fallacy. We look forward to the adoption of the new legislation and its application, which will benefit EU citizens by strengthening both safety and transparency, and, in particular, to a greater number of medicinal products that will be subject to increased monitoring.

  Linda McAvan, rapporteur. – Madam President, just to respond to Ms Grossetête, I agree that the issue of off-label use is extremely important, but I felt we needed a more in-depth discussion on the many aspects of it and I hope we will find some time in our committee to look again at this issue.

On the drug fact box, I think Mr Liese is correct. The problem people have is information overload. When you read it, it is more like a lawyer’s list to get companies off the hook if anything goes wrong, which is a list of anything that could go wrong. So people do not believe the patient information leaflets, they are not useful to patients, and we do urgently need to look at this problem again.

But, finally, one special thank you I want to make is to my researcher, Ms Hanks, who has put in a tremendous amount of work over the last two-and-half years on this whole dossier of pharmacovigilance and she, like all our assistants, works extremely hard on our behalf and on behalf of the people of Europe, and often they are not so recognised in the work that we do.

  President. – The joint debate is closed.

The vote will take place on Tuesday, 11 September, at 12.00.

Written statements (Rule 149)

  Daciana Octavia Sârbu (S&D), in writing. – (RO) The delay which occurred in withdrawing the medicine Mediator from the French market, in spite of the problems reported for almost 10 years, has highlighted irresponsible marketing practices and repeated mistakes which have had tragic repercussions. It is deplorable that such a tragedy had to occur, which has affected the lives of thousands of people, to make those involved withdraw the medicine from the market and initiate the legal reforms required to guarantee the system’s safety. I would like to thank the rapporteur and the other political groups who responded quickly and readily to dialogue in order to plug the gaps in the previous legislation. The credit for the Council accepting Parliament’s position goes to our negotiating team. Our monitoring system will be tighter and more transparent, and will provide a more effective way of protecting European citizens’ health.

  Bernadette Vergnaud (S&D), in writing. – (FR) The amendments to pharmacovigilance legislation finally introduce the principle of the automatic evaluation of a medicinal product at EU level if the product is withdrawn in a Member State. They also extend the list of drugs subject to additional monitoring. However, the Commission did the very bare minimum after the Mediator scandal. We should remember that its initial proposals on the texts adopted in 2010 were quite simply unacceptable. We had to fight to get rid of measures that were very favourable to the laboratories, making it easier for them to put on the market drugs that had been insufficiently tested with no therapeutic justification in terms of risk and benefit. Unfortunately, these minor changes do not integrate the fundamental measures we had asked for: the financial, hierarchical and intellectual independence of pharmacovigilance activities relating to the industry and medicines agencies, and the implementation of the requirement to demonstrate therapeutic progress in order to obtain a marketing licence. Nonetheless, Ms McAvan’s reports still represent progress in the expectation that a truly ambitious text will be proposed at the earliest possible opportunity.