Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate) 
President
The next item is the joint debate on the following reports:
the report by Mrs McAvan, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - C6-0515/2008-; and
the report by Mrs McAvan, 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, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use - C6-0514/2008-.
Linda McAvan
rapporteur. - Mr President, I am sure everybody in this room has taken pharmaceutical products at some time or other. The safety of those products is of paramount importance for public health.
Last week, at a meeting of experts to talk about this new legislation, we were reminded that 2010 marks the 50th anniversary of thalidomide. Anybody my age will certainly remember what thalidomide meant: the images of children born with no limbs. Lessons were learned from that experience, and, over the years, governments developed pharmacovigilance systems to monitor the safety of medicines, because it became clear that clinical trials alone would never be enough to ensure that, when we put medicines out into the public domain, we would know all the side effects in advance.
Improvements have been made. Last week, experts told us that, with the improvements we have already made, it would have taken only a handful of cases of thalidomide to actually identify the problem. In the 1960s, it took 2 000 cases before the problem was picked up.
In recent years in Europe, we have been working at European level to develop a coherent system between Member States and the European Medicines Agency in London on pharmacovigilance. It is very clear that we need to work together. With a pool of 500 million people, it is much easier and quicker to pick up an adverse reaction than working separately at national level.
The creation of the Medicines Agency, a network of agencies in each country, underpinned by EU law, has helped us to make such progress. The practical tools we have created - like the EudraVigilance database, the biggest in the world - help us to reduce the amount of time we need to identify adverse reactions.
But we need further improvements. Since thalidomide in the 1960s, we have seen problems with drugs like Vioxx and, very recently, with the diabetes drug Avandia. I believe that the package of laws that MEPs and the Council have agreed on, negotiated at first reading, and to be put to this House tomorrow, is a very good package and one which will further improve pharmacovigilance in the European Union.
What are the key changes? First, there is the creation of the Pharmacovigilance Risk Assessment Committee, which is a beefed-up safety committee that separates medicine safety from the approval of medical products. It will include experts, not just from national governments, but also from among patients and healthcare professionals. We are improving information to patients, direct patient reporting to national authorities, and a notice on patient information leaflets encouraging people to report any adverse reactions.
There will be a black symbol on new products. At the moment, healthcare professionals know when they give you, as a patient, a new product. They know they should be looking out especially for adverse reactions but you, as a patient, do not know this.
There will be better public information: a one-stop-shop web portal on medicines, bringing together all the different information about medicine safety, the patient information leaflet - the kind of information that, at the moment, you have got to spend hours putting together. There will be gains for companies in terms of streamlining procedures, cutting out duplication in reporting and freeing up resources for more important research work. These are changes which I believe will vastly improve the whole system of pharmacovigilance in Europe.
Finally, I would like to thank the people who have helped us get where we are today, as well as my shadow rapporteurs. It is a very complex dossier and we were very lucky to have such expert colleagues amongst us. Dolores Montero, from the Spanish Council Presidency, is here with us today. She and her team did an excellent job, as did the Parliament's secretariat, Jo Wood from the Socialist Group and my own researcher, Kiri Hanks, who made a major contribution to getting the issues clarified, on the table, and helping us.
I should also like to thank the Commission and Council secretariats, and the many organisations who sent in information and who helped us to understand the issues from their point of view - patients' organisations, pharmacists' groups, doctors, companies and the national regulators.
This has been a great team effort and we now have to work together to implement the legislation properly.
Antonio Tajani
Mr President, ladies and gentlemen, Commissioner Dalli is unable to attend this evening in order to address this issue in person and offers his apologies.
However, I have the pleasure of replacing him for the formal adoption of an agreement at first reading on the important subject of pharmacovigilance. May I take this opportunity to thank everyone who worked tirelessly in order to achieve this agreement, especially the rapporteurs, co-rapporteurs and shadow rapporteurs, especially Mrs McAvan, the rapporteur for the committee responsible. Thanks to the proposal which will be put to the vote in Parliament tomorrow, patients will be better protected against the adverse reactions of medicinal products.
In fact, the system of pharmacovigilance of medicinal products for human use in the European Union is to be strengthened and modernised. Not only will it offer better protection for public health; this system will also allow the internal market to function properly and current regulations and procedures to be rationalised. In addition, legislation will increase transparency and patient participation in the field of pharmacovigilance.
Finally, with the new scientific committee for pharmacovigilance created within the European Medicines Agency, the EMA will provide access to the most specialised scientific and medical expertise available for assessing the safety of medicinal products and recommending risk reduction measures.
The Commission is delighted that the institutions were able to arrive at a pre-negotiated common position before the summer recess and fully endorses the substance of the agreement reached. Within the framework of this agreement, the proposed amendment to restore the grade of director of the EMA has been deleted and the Commission is to publish the following statement:
'Following the request made by the European Parliament and the Council on the grading of the head of the European Medicines Agency, the Commission, in order not to delay the adoption of this important proposal, undertakes to re-publish the vacancy notice for the next head of the European Medicines Agency with the grade AD15 instead of AD14.
The Commission considers that the right place to deal with the issue is the ongoing horizontal discussion on the role of EU agencies within the interinstitutional working group on agencies. The discussion on this aspect is open in the interinstitutional working group, and if this discussion leads to different conclusions at the appropriate publication level, then this grading could be reconsidered for future publications.'
Michèle Rivasi
Mr President, I am going to take one minute and I shall speak for a further minute afterwards. I should like to speak first as rapporteur for the opinion of the Committee on Industry, Research and Energy and to thank the rapporteur, Mrs McAvan, for this report.
I should like to say that it is very important in this sector to provide patients with better protection and better information, but also to fight against the stranglehold exerted by the pharmaceutical industry, which wanted to collect reports of side effects and to analyse and interpret the results.
At the level of the Committee on Industry, Research and Energy - and, moreover, at the level of the Committee on the Environment, Public Health and Food Safety - we therefore succeeding in ensuring that, when it comes to the collection of reports, doctors and patients will be the ones able to report side effects for transmission to the national authorities.
As far as analysis and interpretation are concerned, the Member States are responsible for detecting and monitoring the adverse reactions of medicinal products. It transpired, in connection with the outbreak of H1N1 influenza, that it was the Swedish national authorities which referred to narcolepsy even though, until now, the H1N1 vaccine had not been associated with such side effects. This is very important. On the other hand, I am very disappointed that we have not achieved financial independence from the national authorities.
Finally, as far as controls are concerned, there has been real progress in relation to this Pharmacovigilance Committee, which is separate from the Committee for Medicinal Products for Human Use, and I hope that there will also be more information available for patients, either on package leaflets or in terms of ultra-vigilance.
Claude Turmes
Mr President, medicinal products are, of course, a business worth several billions, and this was therefore a dossier which was subject to a great deal of lobbying. One very positive point in the Committee on the Internal Market and Consumer Protection is that we succeeded in keeping the internal market open. We worked on all aspects of the surveillance of adverse reactions explained by my colleagues and, above all, we managed, the pharmaceutical lobby notwithstanding, to ensure that controls during the placing on the market are not watered down and that patient information is guaranteed. In fact, one of the ideas being put around was to issue prospectuses or summaries, which would have been a very bad idea.
I am sorry that one idea which I put forward in my report, the idea of also testing the therapeutic added value of new medicinal products, was not adopted. Today, we face a strategy by the major companies which, whenever a patent expires, change a few molecules and launch a massive marketing campaign. Today, many companies spend more on marketing than on research and, as a result, we have new medicinal products which cost a lot of money and have almost no added value compared with existing cheaper medicinal products.
We really must examine this in detail at the next review. Our national health systems are collapsing under the cost, and every measure which can offer them relief must be taken. The fact that there is no obligation to test for therapeutic added value is a real loophole in our legislation.
Pilar Ayuso
Mr President, Commissioner, I would first of all like to highlight the work that has been done by the rapporteur, Mrs McAvan, not only on the content of the report, but also in terms of her methods, because she has worked alongside all the shadow rapporteurs. I would also like to thank the experts from the Spanish Government for their contribution to this agreement.
The purpose of this system of pharmacovigilance in the European Union is to strengthen vigilance, transparency and communication in relation to the safety of drugs once they have been put on the market, especially with regard to their risk profiles and the adverse reactions that they can cause.
It is important to highlight the creation of the European Pharmacovigilance Committee, which will evaluate and issue recommendations to the European Medicines Agency on the safety issues that can arise in connection with medicines sold in the European Union. The solution that has been reached for both Member States and those responsible for marketing medicines to notify the EudraVigilance database of suspected adverse reactions is very important.
EudraVigilance will be the only source of information, but the competent authority in the Member State where it is suspected that an adverse reaction has occurred will be informed at the same time, which is very important.
It is also important to highlight the possibility that is being opened up of consumers being able to communicate any adverse reactions, and in this respect, the creation and management by the agency of a European medicines safety web-portal which, in turn, is linked to the portals in each of the Member States, is going to help to improve the public's knowledge regarding the safety of the medicines that they take.
Finally, we cannot forget that given that pharmacovigilance plays a fundamental role in protecting public health, the adoption of this directive and this regulation is going to make a significant contribution to that protection by improving not only the current procedures but also the coordination of actions between the different Member States.
António Fernando Correia De Campos
Mr President, the fact that there is a growing trend for the safety profile of new medicines to only become fully known after they have been put on the market means that we need a more effective pharmacovigilance system than has existed hitherto.
We are facing a typical risk management problem, but we have now made it more accessible to people at a macro and supranational level.
Over recent decades, new medicines have played a vital role in public health and in advances in healthcare. Adverse drug reactions, however, remain the fifth most common cause of hospital deaths.
The proposals tabled reinforce the contribution of medicines to modern public health through an EU-wide pharmacovigilance system, thus improving coordination and transparency. Their aims are the monitoring, early detection, reporting and evaluation of adverse reactions.
New medicines will bear a symbol saying that they are still under scrutiny. Users will be encouraged to take part in monitoring them; efficacy studies will be promoted at national level; there will be a new awareness of environmental effects; and the Union's monitoring bodies will be enhanced in the form of the Pharmacovigilance Risk Assessment Committee (PRAC).
I therefore welcome the proposals, Mr President. I congratulate the rapporteur and also the Commission on their spirit of cooperation, as well as the Spanish Presidency. I therefore welcome the proposals put forward in this legislative package and am pleased to endorse the final document to be put to the House tomorrow.
Antonyia Parvanova
on behalf of the ALDE Group. - Mr President, let me first thank Linda McAvan for the incredible intelligence with which she has tackled this very technical dossier, as well as the shadow rapporteurs, the Commission and the Council for the fruitful cooperation which has been crucial in reaching this first reading agreement, paving the way towards a safer, more efficient and more transparent pharmacovigilance system in Europe. As shadow rapporteur for the ALDE Group, I very much welcome this agreement concluded under the Spanish Presidency, and the fact that Parliament's position remains firmly included in the final text.
One may say that we are dealing today with a less exciting dossier within the pharma package, but pharmacovigilance is actually crucial in ensuring observance of some of the key principles which have guided the ALDE position towards patients' trust in pharmaceutical treatments. The development and smooth functioning of EudraVigilance, collecting Adverse Drug Reactions at the larger European scale, as well as the better coordination with national authorities and pharmaceutical companies, are major steps towards making sure risks relating to the use of medicinal products are duly assessed in a timely manner.
Patient safety will also be reinforced, with the possibility for authorities to request efficacy studies after a product has been authorised on the market. For the first time here, we will be able to use health technology assessment in order to avoid putting patients' lives at risk.
Transparency has been one of Parliament's guiding principles during the negotiations. While avoiding any misuse of the information available, more transparent communication about pharmacovigilance activities will enhance patients' trust in their treatment, as well in the authorities that guarantee their safety.
To conclude, the changes made to the pharmacovigilance system in Europe should be a tool to reinforce European citizens' confidence and understanding of the medicines they are taking. In this regard, I very much welcome the call for a broader and complete review of the Patient Information Leaflet. We have a public health responsibility to guarantee the highest level of safety, efficiency and transparency in the future European pharmacovigilance system to be implemented.
Michail Tremopoulos
Mr President, I, too, should like to thank the rapporteur, Mrs McAvan, for her well-drafted report and my fellow Member in the Group of the Greens/European Free Alliance, Mrs Rivasi, for her detailed work.
Our initial concern was that this draft underpins a tendency for medicinal products to be hastily placed on the market, without detailed clinical trials, under a fast-track authorisation procedure, the thinking behind this being that there will be an enhanced system of pharmacovigilance and risk analysis and for reporting the undesirable effects of medicinal products.
We were initially opposed to this and, in keeping with demands by civil society, we called for strict authorisation procedures before a medicinal product is placed on the market, during which a report would be submitted on the results of comparative clinical trials, together with proof of its added therapeutic value.
I believe that this compromise attempts to get round this issue by strengthening the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency and by strengthening the procedure for civilian reports.
The second point I wanted to raise has to do with the environmental impact and risk of medicinal products, on which we were ultimately unable to reach a compromise. The Commission should introduce a standard obligation, via the pharmacovigilance system, for the environmental impact to be monitored and reported and for these data to be compared with the results of trials presented by companies during the approval and authorisation procedure for new medicinal products.
Unfortunately, all we managed to include in the compromise text was a call for the Member States to consider the next stage for monitoring the environmental impact and for the Commission to present a report analysing the extent of the problem and whether or not the current legislation needs to be amended.
Milan Cabrnoch
Mr President, ladies and gentlemen, I, too, would like to thank the rapporteur for the work she has done in drafting this report, as well as all of you for the attention you have given to this work.
The directive on pharmacovigilance has not been significantly amended for almost 10 years, and I would therefore like to point out that a comprehensive revision of this directive is well overdue. I am all in favour of patients always being better informed and for them to be fully-fledged partners of doctors. Availability of information undoubtedly plays a fundamental role in this change, and the information in question also includes data on medicines, their effects and their side effects.
The unification of data on the effects of medicines in one place, in the same way as the proper, smoothly functioning sharing of information between national computer systems in this area, will lead to greater awareness and greater confidence in medicines on the part of citizens, and may also help to prevent fatal consequences, for example, through the rapid withdrawal from sale of unsafe medicines. These measures will therefore help to improve health and the quality and safety of healthcare.
Jiří Maštálka
Ladies and gentlemen, we are debating a serious topic, which involves medicines. Medicines preserve life, but they can also harm it in a dramatic way. As already mentioned here, the adverse effects of medicines have been shown to be the fifth most frequent cause of death among hospital patients. A strong, transparent and proactive system of pharmacovigilance is therefore essential for ensuring patient safety.
I firmly believe that we have jointly achieved a major improvement in the text and better patient protection during negotiations over these legislative proposals.
I very much welcome the system of direct notification, by means of which patients all over Europe can directly submit reports on adverse effects. This system will make it possible for adverse effects to be picked up earlier, and patients will be able to submit reports on effects which they might find it difficult to talk about with their doctor, for example, because they involve psychological or sexual factors. Patients will also be able to submit information both via the Internet and by using other methods, which is good for people who do not have a computer.
We have strengthened patients' right to information by improving access to information through the creation of a European web portal and the establishment of a European database on pharmacovigilance. Special attention was given to the protection of personal data in this area. We have achieved good results, but many things need improving: greater transparency in the decision making of competent authorities, the securing of essential resources for these authorities to do their work, ensuring that they are independent and that they have sustainable budgets, and, last but not least, adopting strict requirements over conflicts of interest in order to guarantee that decisions taken in the area of patient safety are not influenced by commercial interests. In conclusion, I, too, would like to thank the rapporteur for her excellent cooperation.
Peter Liese
(DE) Mr President, Mr Tajani, ladies and gentlemen, I would like to join in the thanks to the rapporteur Mrs McAvan and I would also like to thank Mrs Ayuso, the shadow rapporteur for the Group of the European People's Party (Christian Democrats) and acknowledge her hard work. Mrs McAvan and the shadow rapporteurs have produced good results, which we will be voting on tomorrow. The safety of patients will be improved significantly and, in my opinion, the most important progress that we have made is to provide considerably better information for patients, largely without any major controversies.
The database and the web portal, which will be introduced in all the Member States in every language, will improve the information available to patients and will, in particular, be of assistance to patients who are on the move. Anyone travelling in Europe today who receives a patient information leaflet in a foreign language is at an even greater disadvantage than the average patient who also cannot understand the leaflet. If it is possible to obtain the information in every language via this web portal, that will definitely be a great help.
This proposal, which has been accepted almost without comment, will improve the information considerably more than the proposal submitted by Mr Verheugen under the title of 'Patient information'. This is what we are working on and I have had a very positive discussion with the rapporteur, Mr Fjellner. We will, of course, have to add to what has come out of the work on pharmacovigilance, but nevertheless, Mrs McAvan and the shadow rapporteurs have made a huge amount of progress.
Finally, I also welcome the fact that we will be revising the patient information leaflets. I believe that the Commission should also make an effort in this area and take rapid action. I feel rather sad that we were unable to come to a conclusion on the summary of the patient information leaflet. The Commission made the mistake of proposing a black box, but people found the black box intimidating. Perhaps we should consider once again whether it is possible to produce a summary of the most important points in a suitable form. That is also a topic for the future. I would like once more to thank everyone who contributed to producing these positive results.
Karin Kadenbach
(DE) Mr President, Mr Tajani, I would also like to thank Mrs McAvan very much, together with the shadow rapporteurs who have contributed to the report.
Firstly, I would like to make an appeal to patients and to the European healthcare system. We must take the time to explain to patients about the medicines that are being prescribed for them so that they really know what they are taking and understand the possible undesirable side effects of the drugs. On the other hand, we must also encourage patients to be completely honest with their doctor or with the pharmacist who is dispensing the medicines. This is the only way that what we are calling for will work in reality, in other words, ensuring that medicines are as safe as possible.
I welcome this report very much because it is a further step towards recording side effects throughout Europe in such a way that both healthcare staff and the pharmaceutical industry can investigate and respond to these side effects as quickly as possible. Some of the Member States already have very good systems for doing this. The next step is to standardise and combine these systems. The old saying that the whole is more than the sum of its parts also applies in this case. I would be very pleased if this directive were to be adopted in plenary with an absolute majority.
Corinne Lepage
(FR) Mr President, I should like, in turn, to congratulate our rapporteur, Mrs McAvan, on her work. Agreements at first reading are no longer very popular in this House because, if truth be told, they often reduce Parliament's powers, but this is, without doubt, a very good agreement at first reading. I must also say that our shadow rapporteur, Mrs Parvanova, did an excellent job.
Considerable progress has been made, especially on an aspect which I hold dear: transparency. For me, transparency should be the rule and restricted access the exception. It is absolutely vital if we want to move towards the counter-expertise which is developing. It should not be possible to exercise the right to keep information on property rights secret at the expense of information on health and the environment. That is why I tabled several amendments to guarantee a high level of transparency. I would have preferred us to have gone further, but the result we have is satisfactory.
On the text itself, one provision - which may appear anecdotal but which probably is not - is important: I refer to the request made to the Commission to address the question of water and soil pollution by pharmaceutical residues and, if necessary, to evaluate the impact of this legislation.
Martin Callanan
Mr President, Marina Yannakoudakis, our shadow rapporteur, sends her apologies; she is unable to be in Strasbourg this week but she has asked me to pay particular credit to Linda McAvan for the very fruitful and cooperative way that she has worked with the other groups in drafting this legislation.
The aim of it is to strengthen the Community pharmacovigilance system of medicinal products for human use and we certainly believe that we have reached an agreement which will ensure, firstly, a more robust system of risk assessment, secondly, an improved system for marketing authorisations and post-authorisation safety and efficacy studies, thirdly, a better and more efficient means of reporting of any adverse drug reactions and fourthly, of course, greater transparency and medicinal safety.
Patients will also have better access, through web portals, to information regarding potential side effects of medicines, and these measures, we believe, will be of benefit, first and foremost, to European patients and citizens, but will also clarify and simplify the roles of the Commission, Member States, and risk assessment committees and pharmaceutical companies in ensuring the highest possible levels of patient safety throughout the EU.
Marisa Matias
(PT) Mr President, first of all, I would like to start by thanking and congratulating the rapporteur, together with all the Members who have been involved in this process.
As we know, adverse drug reactions are the fifth most common cause of hospital deaths - it cannot be said too often - and a strong, transparent pharmacovigilance system is essential. We now have the opportunity to enhance the safety of those medicines that are already available by going beyond laboratory tests, which do not always catch problems before they arise.
If concrete examples were necessary to justify the importance of a new system, one need only look at what happened with the H1N1 influenza vaccine: the vaccine was rushed onto the market, but the side effects that were detected were not investigated with due care and are still delaying a full inquiry.
That is why we need to continue to improve these measures. This directive ensures that both healthcare professionals and patients will be more actively involved in identifying difficulties. Cooperation between countries and the Union may, in fact, be a plus-sum game.
Françoise Grossetête
(FR) Mr President, Commissioner, we are debating pharmacovigilance. This is an important pillar of the pharmaceutical package on which we have been working for some time, and this agreement at first reading will give patients better protection from the risks associated with the use of medicinal products. This agreement is therefore a big step forward for patient safety, because rare patterns can be picked up more quickly and unsafe medicines can be withdrawn from the market when required.
We are not, in fact, reinventing pharmacovigilance; we are simply improving the situation on the basis of improved knowledge of the risks linked to medicinal products, thanks to greater cooperation between the competent authorities. The point of this regulation is to improve our knowledge of adverse reactions, thanks to the development within the European Medicines Agency of the EudraVigilance database, which will become the single point of receipt and consultation of all medicine-related information. This will help improve communication between the competent authorities.
The national authorities will also be better able to re-evaluate the risk/benefit balance by reactively entering and integrating all signals or new data, and adapting information for health professionals and patients accordingly. However, we must also take care not to frighten patients with excessive warnings; providing too much information could ultimately prove harmful.
Medicines are complex products. We need to explain them, to provide proper information, but, above all, we must not be over-alarming. It is clear, today, that package leaflets are no longer as relevant. They are sometimes hard to read. It is now necessary to address how they should evolve, with all the partners, so as to improve patients' understanding and, above all, give them confidence in medicinal products.
Bernadette Vergnaud
(FR) Mr President, Commissioner, ladies and gentlemen, pharmacovigilance, which involves analysing the side effects of medicinal products and calling for their withdrawal from the market in the event of an alert, incited little interest in the midst of the pharmaceutical package. It is, however, essential to the safety and quality of our health systems and, even though I am delighted to see you, Commissioner, I must deplore Mr Dalli's absence.
I was dismayed by the Commission's proposals, which jeopardised the pharmacovigilance systems for the benefit of the pharmaceutical companies. Fortunately, thanks to the work of Parliament and the Council, the situation has been improved somewhat. Thus, it will not be possible to generalise advance marketing authorisations for new medicinal products. We can also be pleased with the progress made in terms of transparency.
However, I think that this agreement represents a missed opportunity to improve pharmacovigilance and I am concerned, above all, at the lack of guarantees regarding the independence of the system. Thus, even though the role of the Pharmacovigilance Risk Assessment Committee has been strengthened, it is not totally independent of the European committee which grants the marketing authorisation. We know from experience that this committee is loath to go back on its decisions. As for national structures, there is absolutely no provision on the matter. Also, I am sorry that the Member States do not have to report possible conflicts of interest of experts on the European committee.
Finally, and this is the most serious point, this agreement endorses the end of the best guarantee of independence: public funding for pharmacovigilance activities, most of which will be funded in future by private fees.
I congratulate Mrs McAvan on having improved the Commission's initial proposal but, as there are a number of problematic issues, I question the point of closing this dossier in a single reading. If we had taken our time, we could have increased patients' confidence in safe, high quality pharmaceutical products.
Frédérique Ries
(FR) Mr President, pharmacovigilance should be to medicinal products what haemovigilance is to blood and organ vigilance is to organs: a comprehensive insurance policy. Having said which, I should, in fact, say a quasi-comprehensive insurance policy, because we know - as has been said - that taking medicinal products, even strictly in keeping with the package leaflet, is not without adverse reactions.
Sometimes, it is even fatal; 197 000 deaths a year, as our rapporteur, Mrs McAvan, pointed out in her explanatory statement, just as she also pointed out this afternoon the tragic episodes which have marked the history of this sector.
This statistic is unacceptable. It needs to be significantly reduced through more efficient collaboration between all links in the chain. That is why I support all the proposals made in this direction: better coordination through the EudraVigilance database, improved patient information and, as has been said, better information in both senses - Mrs Rivasi and Mr Turmes explained this - as well as real transparency in the work of the new European Pharmacovigilance Risk Committee.
To conclude, independent expertise - and I shall come back to this time and again - is the alpha and omega of all our policies. It is vital here in order to strengthen patients' confidence.
Elżbieta Katarzyna Łukacijewska
(PL) I would like to begin by congratulating Mrs McAvan and everyone who worked on the directive and the regulation on pharmacovigilance. The issues dealt with in these documents are very important for the health system but, above all, they are important for the safety of patients. Statistics show that nearly 200 000 people die every year from the side effects of medicines they have taken, around 50% of patients do not take medicines in accordance with medical recommendations and over 70% of patients would like to be able to obtain reliable information on medicines and procedures on the Internet. Therefore, it is evident that, together with the change to the principles for registering pharmaceutical products, it has become essential to introduce a system which - using the Internet - will supply reliable information about medicines.
However, without correct reporting of all side effects of medicines by medical personnel, patients and drug companies, there will not be good monitoring of the safety of pharmacotherapy. For it is first necessary to notice certain signals which are indicative of potential problems and to take action on this basis. This is a new step towards complete openness and transparency of information in the field of pharmacology.
An important element of pharmacovigilance is the posting of information about medicines on the Internet in all the official languages of the European Union in a form which will enable its content to be understood by all patients. However, attention should be drawn to the fact that the Internet, besides being a very good source of information, may also contain false information. Therefore, it is essential to conduct continuous monitoring and updating of the system, because it is paramount that the system be effective.
Also important are the proposals concerning increasing the transparency of the Union system of monitoring by using public hearings for gathering information on side effects. This is a useful tool for carrying out monitoring, especially if the whole of society and not just a small group of specialists is going to be able to participate in it, and it will certainly increase patient confidence in medicines.
Nessa Childers
Mr President, I congratulate my colleague, Linda McAvan, on her report. With almost 200 000 deaths per year in the EU caused by adverse reactions to prescribed drugs, I welcome the new EU-wide system to monitor the safety of medicines which have already been approved for use by doctors. Adverse reactions are the fifth most common cause of hospital death in Europe.
This legislation will set out rules and procedures for monitoring the safety profile of medicinal products once they have been authorised and placed on the market. The new powers will also equip national and EU authorities to target the growing problem of forged or falsified medicines, which pose an enormous threat to public health. The more up-to-date information available to the healthcare sector and to individual patients on the safety of medicines in common use, the better it is for the health and safety of all European citizens.
I therefore welcome the European medicines web portal, which will be created and linked to national medicines web portals in each Member State, and where patients will be able to find information about the safety of the medicine they are taking.
Paolo Bartolozzi
(IT) Mr President, Commissioner, ladies and gentlemen, this measure sets out to reinforce and rationalise the system of pharmacovigilance in the European Union: these are the ambitious goals set by the McAvan reports, which aim to amend Regulation (EC) No 726/2004 and Directive 2001/83/EC respectively.
Thanks to a close and effective working relationship between the European Council and Parliament, and between the parliamentary committees responsible for this area, we have reached the point where we are able today to discuss a proposal that aims to improve the EU pharmacovigilance system, and to conclude the consistent work that the European Union has carried out in this field over more than a decade.
Simplification, transparency and rationalisation may be considered the key points of these two reports, which propose measures aiming to guarantee the best possible protection of public health on the basis of standards that are harmonised throughout Europe.
Reference is made to an extensive series of actions, ranging from better definition of the roles and responsibilities of the main national and international stakeholders seeking to ensure a new, more informed and active involvement of patients, who are given a fundamental role in the system, to the increased transparency of information concerning the safety of medicinal products and the simplification of activities involved in communicating, recording and evaluating suspected adverse reactions.
The current pharmacovigilance system must also be improved through closer cooperation at European, national and regional levels. Effective participation at all three of these levels will, in fact, ensure a profitable exchange of information on the side effects of medicinal products.
When reorganised as a network, with Internet support, the new pharmacovigilance system will be able to ensure a high level of information sharing and security to benefit patients, national authorities and healthcare professionals.
Marian-Jean Marinescu
(RO) The pharmaceutical industry is a key sector for the European Union because of both its direct links with the health of every one of us and its economic potential. I believe that the directive and regulation being debated will help improve the system for the supervision of medicinal products. This will facilitate an exchange of information between national and European authorities, which will be in constant contact with patient organisations and representatives from the pharmaceutical industry. Data on adverse drug reactions must not only be accessible to the authorities and healthcare professionals, but to patients as well. Patients must be informed about all the features of the drugs which they are taking and this information must be specified clearly in the patient information leaflet.
Patients must be able to identify easily new drugs which have been authorised at a time when all the adverse effects are not yet known and which contain new active substances. Regular monitoring must be carried out and a regular report must be drafted, at least every five years, on the safety of the relevant drugs. Drastic adverse effects can be discovered even 30 years after a drug has been granted market authorisation. Last but not least, I wish to emphasise the interdependence between investment in pharmaceutical research and innovative medical technologies and patient safety and the growth of the pharmaceutical industry.
Licia Ronzulli
(IT) Mr President, Commissioner Tajani, ladies and gentlemen, the main aim of this proposal for a regulation is to verify the safety of medicinal products once they have been authorised for public use.
There can never be too many checks and evaluations of positive or negative reactions. An estimated 197 000 deaths per year are caused by adverse drug reactions (ADRs) within the European Union. Clinical trials can often miss side effects from drugs if they are rare, only appear after long-term use, or involve interaction with other drugs.
Tracking drug use and reporting on ADRs is, and must remain, a priority of European public health policy. A good pharmacovigilance system must make it possible for healthcare professionals, companies and patients themselves to report ADRs and also allow for signals pointing to potential problems to be detected.
These signals must then be followed up with action, which can include changes to the way a medicine is prescribed, better information on how it is used or, where the nature of the ADR is severe, the withdrawal of the medicine altogether.
The proposal to strengthen cooperation in pharmacovigilance may offer numerous advantages insofar as the pool of reported ADRs is larger, meaning that rarer patterns can also be picked up more quickly.
Therefore, unsafe medicines can be withdrawn more quickly from the market if necessary. All the Members States must remain key players in the EU pharmacovigilance system.
I shall conclude, Mr President, by emphasising the importance of allowing direct patient reporting of ADRs. Unfortunately, at present, only a few Member States accept direct reporting, and I am happy to point out that, where it exists, this system has not overburdened the competent authority.
RadvilMorkūnaitė-Mikulėnien
(LT) In my opinion, the two most important elements of this whole document are the inclusion of the patient in the information system and the fact that all information, reliable information, will be accessible in one place. These figures are truly appalling - approximately 200 000 deaths a year from the side effects of drugs.
Another issue is the fact that the recording of cases of side effects is very uneven throughout the Member States. Let us say that in my country, there are around 170 cases, but in other countries, there are at least several times that amount. The reason for this is that the patients were not directly involved in providing information. Doctors are often afraid to report relevant information, perhaps fearing that they may be accused of improper conduct.
I am especially pleased that patients concerned about their health will be able to inform national institutions of the negative side effects of medicines.
Another thing is to urge institutions in the European Union Member States to be more active in their response to relevant reports. The situation at present is such that around half of the Member States are slow to provide information about side effects. It is excellent that henceforth, manufacturers, consumers and control institutions will all be included in the medicine safety control system. A common position is required, based on responsibility, not fear.
Miroslav Mikolášik
(SK) The aim of pharmacovigilance is to ensure that patients and hence, the relevant authorities, report everything, and not just serious adverse effects, to the EudraVigilance database. All information on the adverse effects of medicines will thus be concentrated for the first time in one place, representing a valuable research instrument. Measures can then be adopted on the basis of this, such as changes to methods of prescribing, better provision of information on the use of medicines and even withdrawals of medicines from the market.
I support proposals aimed at motivating informed patients, who will have available all the relevant information on a medicine in the accompanying leaflet. The system should not only inform patients but also motivate them to report any adverse effects. Manufacturers must not conceal any adverse side effects of a product, as happened in the case of hormonal contraceptives, for example. Both of Mrs McAvan's reports represent progress and will be of benefit to all patients by providing access to safer medicines in the EU and a legal framework for the competent authorities.
Anja Weisgerber
(DE) Mr President, firstly, I would like to thank the rapporteur and the shadow rapporteurs very much for their excellent work. Effective supervision of medical products provides protection for the citizens of Europe and, at the same time, gives more power to responsible patients.
Two points in particular are very important to me: the safety web portal for medicines and the patient information leaflet (PIL). The positive news is that tomorrow's resolution will introduce safety web portals for medicines into all the Member States, where the approved patient information leaflet and other information must be published. This will put an end to an untenable situation. In many Member States, it is not possible to publish the PIL on the web. However, this is not in line with the real lives of many citizens who make use of the right of free movement within the European Union. Now they will be able to download PILs from the web in their own language anywhere in Europe. This will also be useful for patients who have lost their PIL.
At the same time, I want the PIL to be improved and I am very pleased about the resolution calling on the Commission to submit draft legislation on this subject.
Michèle Rivasi
(FR) Mr President, I would like to come back to the environmental impact of medicinal products.
Since 1965, Europe has established criteria for obtaining marketing authorisations. There are three criteria, namely efficacy, safety and the pharmaceutical quality of the medicinal product, but there is nothing about the environmental impact of medicinal products. As you know, the oestrogen found in river waters is changing the sex of fish. As you also know, there are high levels of residues of medicinal products in purification plants and in waste water from hospitals.
There has been a fair amount of discussion on this matter; a debate has been held and, in the Pharmacovigilance Directive, it has finally been taken into account in the form of a recital calling on the Commission to publish a report, on the basis of data provided by the European Medicines Agency, the Environment Agency and the Member States, on the scale of the problem and an assessment of whether or not it would be appropriate or useful to amend EU legislation on medicinal products or in other areas.
What I want of the Commission is a proper report based on these data, because this indirectly affects human health in that, in numerous cases, it is the consumption of water that caused the side effects identified.
Herbert Dorfmann
(DE) Mr President, Mr Tajani, ladies and gentlemen, I think it is important that we are discussing this subject here today and I would like to draw attention to one area in particular, which is the availability of information and, above all, the patient information leaflet (PIL) in multiple languages. I am a member of a linguistic minority and I live in one of the most popular tourist regions of the European Union. In every state, a PIL in the official language is supplied with medicines. In my region, for example, the result is that a significant proportion of people simply do not understand the PIL. This is not just irritating, but also dangerous.
This directive must now make it possible for patients to access information on PILs at home on the web and for the same information to be available in pharmacies. If we can also present this information in a brief, summarised form, it can be printed on the PIL itself in several languages without us having to include whole brochures with every medicine.
Oreste Rossi
(IT) Mr President, ladies and gentlemen, we are in favour of the rapporteur's approach because she stresses the importance of verifying the safety of medicinal products and improving the transparency of pharmacovigilance activities.
The Northern League has focused on certain aspects: allowing patients direct access to the EU database of suspected adverse reaction reports; permitting the introduction of fees, at the discretion of Member States, to be paid for pharmacovigilance assessments; and defining the composition and powers of risk assessment committees with the aim of allowing Member States, healthcare professionals and patients to play their part.
Unfortunately, in a Europe that is ever more mindful of and attentive to life expectancy and quality of life, it is easy to abuse drugs. Adverse interactions may occur between medical and plant health products used for medicinal purposes, and in sensitive individuals, these may range from the simplest allergic reactions to genuinely debilitating conditions.
One such condition that is not yet fully understood and, unfortunately, not easy to cure, is Multiple Chemical Sensitivity: those who are affected by it cannot lead a normal life because they can no longer stand contact with any kind of chemical product.
It is therefore important for the European Union to take action to instruct and train the public in informed drug use.
Horst Schnellhardt
(DE) Mr President, ladies and gentlemen, if we look back at how we began discussing this problem last year in the last parliamentary term, we can only be full of admiration for the achievements of the rapporteurs. What they have achieved by bringing the process to a conclusion after the first reading is excellent. Well done! This is an important instrument, as many people have already said today. I was most surprised by the fact that the Member States agreed without objection to establishing a database with links across Europe.
I would like to make one additional point. We should make better use of the opportunities provided by the European Medicines Agency and the EudraVigilance database, and I am calling on the Commission to do this, in order to improve and promote the quality of healthcare and the quality of products in Europe. This is an important step in the right direction.
However, I do not want to see too much attention being paid to reports from individual citizens about side effects. We should ensure that this does not happen. The reports should only be included in the database when they have been submitted for an expert investigation. Just because someone criticises a product, this does not necessarily give them the right to have their criticism documented in the database.
Dominique Riquet
(FR) Mr President, Commissioner, I should like to take the floor briefly, first of all, to congratulate everyone who worked on this subject, and then to express my surprise, nonetheless, that one point has been overlooked, namely cross-pharmacovigilance.
In fact, vertically, from the point of view of a single product, the report is extremely exhaustive, and the work that has been done is remarkable. Nevertheless, most problems are caused by the cumulative effect of medicinal products, as, in 92% of cases, patients receive multiple treatments. A medicinal product which, vertically, has no particular side effects, could have highly toxic side effects if crossed with another medicinal product.
It is vital that we have access to a database on the cross effects of medicinal products, and it should, moreover, be made available to professionals and patients alike. This is all the more necessary given that many patients take prescription medicines and then self-medicate also, without having any information, in general, on the potential for highly toxic cross effects.
I think that this issue has been touched on, but not dealt with, which is a great pity.
Olivier Chastel
Mr President, ladies and gentlemen, I should like first of all to congratulate Mrs McAvan and the various rapporteurs, as well as the Spanish Presidency and the Commission, on the work done in order to reach this balanced agreement, which is so vital to all European patients.
This dossier is, in fact, a specific example of European added value in the lives of our fellow citizens, and the application of these provisions will, no doubt, allow us to revise downwards the number of medical cases caused by adverse drug reactions, a factor which, even today, as we have been reminded here, is one of the main causes of death, especially in hospitals. We have every reason to welcome this vote, at first reading, of these clear and effective new pharmacovigilance rules.
I also hope that, by the end of the Belgian Presidency, we shall be able to welcome an agreement on the other dossiers in the pharmaceutical package. The Presidency has, in fact, taken action in collaboration with Parliament and the Commission to advance what are vital dossiers both for our fellow citizens, and European patients in particular, and for the pharmaceutical sector.
Antonio Tajani
Mr President, ladies and gentlemen, I believe that the debate we have held today with the participation of so many MEPs demonstrates the importance of the agreement that has been reached between the EU institutions.
The Commission, the Council and Parliament are sending out a strong signal to the citizens of our European Union, and this will also be reinforced by the fact files that will be approved - quickly, I hope - on counterfeit medicines and information to be given to patients. I also share the concerns expressed during the debate on the deaths caused by medicines that do not comply with the rules, as Mrs Ronzulli discussed. I also congratulate her for coming to the Chamber today with her baby daughter. This is a good sign: it means that young Europeans are growing up with a pro-European attitude.
I also agree with the words of Mr Dorfmann, and I believe it is only right for each one of us to be able to express ourselves in our own mother tongues and be able to understand what the standards guaranteeing our safety mean in our own languages, including in the world of medicines. I am a great supporter of multilingualism in all sectors, including the ones I am normally concerned with.
I would also like to reassure Mrs Vergnaud with regard to her concerns. I thank her on behalf of the entire European Commission, even though Commissioner Dalli was unfortunately unable to join us today; he will certainly be brought up to speed on this debate, and I will inform him of all the observations made by all the MEPs who took part in today's meeting.
The Commission is sincerely grateful to you because, together, we have been able to send out a strong message to our fellow EU citizens.
(FR) As regards the issue raised by Mrs Rivasi on stronger rules on the environmental risks of medicinal products, we also consider that it is important to take account of the environmental protection aspect, and we accept Parliament's suggestion that the Commission should present a report, where applicable, together with a legislative proposal on the environmental risks of medicinal products.
I should like to take this opportunity to remind the honourable Members that environmental aspects have already been included as an action point in the Commission communication on the future of the pharmaceutical sector, adopted prior to the present legislative proposal, within the framework of the pharmaceutical package presented in December 2008.
Annex - Position of the Commission
Proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use - C6-0514/2008 -
Amendments:
Directly acceptable: Amendment 74 (text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators.
Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - C6-0515/2008 -
Amendments:
Directly acceptable: Amendment 41 (text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators.
Linda McAvan
rapporteur. - Mr President, I would first like to respond to some of the points raised.
Colleagues talked about transparency: I think that what we have achieved is a big breakthrough in transparency. The amount of information that will be made public through the web portals is a huge increase on what we have already.
On the independence of the work on pharmacovigilance: it was the amendment from this Parliament which has now separated authorisation from pharmacovigilance and makes sure it is the Pharmacovigilance Committee that will make the recommendation, which can only be overturned if there is a very strong reason. So we have done a big job in establishing this independence and improving it.
The Commission: there is a lot of work for the Commission to do after this legislation is approved tomorrow. I think we will achieve a big majority in the House. There is a lot of work to do on the patient information leaflet, with a lot of dissatisfaction from patients' organisations and from individual patients about it. You tried to find a solution in the Commission. It was not one which found acceptance. But we want to work with you to have a good patient information leaflet.
The leaflet cannot be a repository for every possible thing that can happen to a patient, because that makes the leaflet useless in the eyes of the average patient. It has got to make sense. It has to prioritise information. We need to work with you on that.
You are going to do the study on the environmental impacts of medicine. That is very important, and we want to see the black symbol. We want that symbol developed; we do not want to see it go away, like it did on the medicines for children, the paediatric medicines. We want to see that symbol soon.
For the Member States, an awful lot of work on the web portals has to be done. We want to see these up and running and a timetable for when they are being established. It is vital, as the Commission has said, that people get information in their own language, and the Member States also have to set up their direct reporting systems. It is a lot of work for national agencies.
For the EMA, there will be an increase in work, and we have to resource it properly. We discussed this at length in the negotiations and want to see that happen.
Thank you once again to everybody concerned. I hope we will get a big majority tomorrow and then the real work can start to make a difference, on the ground, to people's lives.
President
The debate is closed.
The vote will take place tomorrow at 12:00.
Written statements (Rule 149)
Sergio Berlato  
Medicinal products make an essential contribution to the health of European Union citizens. They may, however, sometimes lead to severe side effects which, according to the Commission, are the cause of approximately 5% of hospital admissions and deaths. Over recent years, cases have been recorded of medicinal products that have given rise to far from negligible secondary effects on patients despite having been marketed following the required control procedure. This situation emphasises the need for the Union to avail itself of an effective pharmacovigilance policy with the aim of protecting the health of European citizens. I believe that an efficient pharmacovigilance system must allow the timely indication of medicinal product side effects to the competent authorities and, above all, when necessary, the swift withdrawal of hazardous drugs from the market. I also support the proposals contained in the report under discussion that aim to improve cooperation between Member States over pharmacovigilance and strengthen the criteria for granting marketing authorisations to new medicinal products. Lastly, I call on the Commission to consider revising the composition of medicinal product package leaflets with the aim of also improving information on the use of a drug.
Elisabetta Gardini  
Many conditions may be tackled nowadays without having to resort to hospitalisation and even cancer patients may be treated with drugs that make home treatment feasible. Control of the drug chain therefore requires rational and clear procedures that improve the circulation of information and transparency of content, accurately defining the roles and responsibilities of the main parties involved. I fully support the setting up of a central data collection and evaluation system that is able to integrate national pharmacovigilance networks, maintaining the consistency of information. It would not indeed have been possible to exclude the filter of national networks, which are the only instrument able to guarantee the objectivity of validation, the quality of data coding, the relationship of causality and relations with those responsible for reporting. This is even more necessary when we come to open up a further channel of direct information with the patient and health professionals who will now be able to send valuable feedback quickly to the pharmacovigilance system. To this end, I must highlight the opportunity of training measures for health operators and an information campaign aimed at patients for more effective use of this instrument.
Louis Grech  
in writing. - Improvements to the current system of pharmacovigilance are necessary to have a system which operates quickly and efficiently in order to better protect consumers. The monitoring of the safety of medicines can be crucial to save lives and prevent public health crises. Further integration of pharmacovigilance at the European level is necessary because it increases the number of consumers reporting incidents of adverse drug reactions (ADRs). By increasing the pool of reported ADRs patterns, they can be assessed more quickly, thus allowing for drugs with adverse side effects to be withdrawn from the market or warnings added to the medicines. I support the amendments that seek to further protect consumers by allowing public and healthcare professionals full access to the central European EudraVigilance database. This allows all Member States to have access to the same information regarding ADRs. I agree to exclude pharmaceutical companies from the process of pharmacovigilance. In view of the facts, taking the pharmaceutical companies out of the process allows for more honest reporting of ADRs by removing the conflict of interest inherent in the process of self regulation.
Anneli Jäätteenmäki  
The World Health Organisation has estimated that counterfeit medicines account for as much as 10% of the world's pharmaceutical market. Counterfeit medicines are a matter of people's health and welfare, and so the issue is a worrying one. It is a welcome move that improvements are now being made to patients' access to information about medicines and their adverse reactions. In future, the information will be more easily accessible, for example, on new national and European websites dedicated to drug safety. Finally, I want to state my support for the rapporteur's proposal that the Commission should be requested to produce a report on the environmental impact of medicines and assess whether there is a need to make further amendments to EU legislation on drugs in the near future. Thank you.
Siiri Oviir  
Pharmacovigilance has a very important position in public health. The side effects of medicines often have damaging effects on the health and lives of patients. Many legal cases have shown that pharmaceutical companies aim, for commercial reasons, to conceal the undesirable side effects of medicines for quite a long time. It is to be welcomed that, through adopting the proposed legislative acts, we will toughen up the criteria for ensuring the greater reliability of marketing authorisations or support the widespread use of the so-called emergency procedure. I support the measures for ensuring the quality of data in the pharmacovigilance system, and we should guarantee resources for efficient national pharmacovigilance. The whole system must be transparent for patients.
Daciana Octavia Sârbu  
in writing. - This report is an important step on the way to a more coordinated and effective monitoring system for pharmaceutical products. Increasing the number of patients who are monitored will provide more information about new drugs, allowing the authorities and manufacturers to identify potential problems more quickly. There are many aspects of this report which will bring benefits, but I especially welcome the call for further research into the environmental impacts of pharmaceutical products, and the effects they can have on ground water, for example. Whenever we discuss health issues, I think it is always important to stress the value of preventative medicine and the importance of the principle that prevention is better than cure. Simple, health conscious decisions about lifestyle, including exercise and diet, can prevent the suffering and costs associated with serious - but preventable - diseases. We should always keep this in mind when discussing any aspect of health policy.
Richard Seeber  
For patients, easy access to factual and independent background information on medicinal products is essential and also plays an important role in the research into adverse reactions and in the market safety of prescription medicines. The new directive and regulation on pharmacovigilance will substantially improve transparency and access to such information. The basis of, and explanations for, any adverse reactions will now be collected from the whole of Europe by the European Medicines Agency. The storage and processing of this data and the establishment of web portals to facilitate access to it will substantially improve the opportunities for patients to find out about medicines and their adverse effects. Particularly when European citizens are travelling, they will not be reliant on any particular websites but, where necessary, will be able to obtain objective information in their own language. In order to guarantee independence and objectivity, however, the information will have to be approved by relevant approval authorities. On the other hand, this will also guarantee the freedom of advertising in respect of this information. The new drug facts box will identify active substances that have been approved for the first time. All these measures will increase transparency and make it easier for patients to find pharmaceutical information in a clear and uncomplicated manner.
Olga Sehnalová  
Pharmacovigilance is an important part of the system protecting patient health, reducing the risks and increasing the benefits of medicines. It is particularly important to assess and monitor the safety of medicines in the first years after they are brought into use. Within the framework of the licensing process, before medicines are actually put on the market, the information from preclinical and clinical studies is assessed first and foremost. However, many possible side effects cannot be discovered until after a medicine has been brought into use. In this context, it is patients who play an important role along with health workers in identifying adverse effects or the suspicion of such effects. However, it is equally important to have an expert assessment of this information, particularly in view of the frequently causal relationship between an adverse effect and the administration of a medicine. I therefore support the new element strengthening the position of patients by enabling them to get actively involved in the process of reporting adverse effects and a high quality evaluation system. In the Czech Republic, patients already have this option on the web portal of the State Institute for Drug Control, which I consider to be an example of good practice for those Member States where such an option does not yet exist.
Bogusław Sonik  
The statistics show that as many as half of patients do not take medicines in accordance with medical advice, and around three quarters of patients would like to have easy access to reliable information on the action of medicines and possible side effects. The proposal for supervision of the safety of medicines strengthens the safety of patients and guarantees them the right to better information about the uses and action of a particular medicine. An important step towards transparency of information about medicines is the project to open an Internet-based information service, both at European and national levels. The national websites will be connected with the European one and will have to contain a description of the characteristics of each product, an information leaflet and an evaluation of the product's effect on human health. The European Medicines Agency, in cooperation with the Member States and the Commission, will supervise this database, where it will assemble and compare information as part of its work in pharmacological supervision. I think this is an important step towards ensuring patients the right to better, reliable and objective information about pharmaceutical products.
