Information on medicinal products (Community code relating to medicinal products) - Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) (debate) 
President
The next item is the joint debate on
the report by Christofer Fjellner, 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 information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use - C6-0516/2008 -, and
the report by Christofer Fjellner, 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 information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency - C6-0517/2008 -.
Christofer Fjellner
Mr President, Commissioner, ladies and gentlemen, at last, we have come to the plenary debate on the new legislation on information on medicinal products. What we are about to debate is the last part of what certain people are calling the most controversial issue in the medicinal products package, namely, information on medicinal products. I will admit that as recently as a year ago, I probably would never have believed that we would come to plenary together in as much agreement as we have nevertheless achieved here in Parliament. The fact that this is the case is largely down to my shadow rapporteurs. It is their constructive proposals and their willingness to compromise that has helped us to reach agreement and hopefully adopt this report with considerable support in plenary.
It is not only a question of willingness to compromise. I think that perhaps it is even more important that we have realised that we want, and are working for, the same things here in Parliament. The first is that we all, first and foremost, want Europe's patients to have better and more accessible information on medicinal products. The second is that none of us wants advertising for prescription-only medicinal products, and the third is that the information that reaches patients and is disseminated by companies must be checked and approved by the relevant authorities. These are principles that everyone shares and that have made it easier for us to reach agreement. However, it is also why we felt somewhat compelled to re-draft the Commission's proposal.
I would like to highlight five things that we focused on when re-drafting the Commission's original legislative proposal. The first is that we tried to change the perspective of the legislation - from a focus on the right of pharmaceutical companies to disseminate information to now focusing on the right of patients to have access to information and, with that, the companies' obligation to publish and make available this information. Secondly, we tried to tighten up all of the exceptions that existed to avoid possible loopholes for advertising - something none of us wants. Thirdly, we ensured that the information on medicinal products coming from companies is checked and is reliable in that it must have passed through a pharmaceuticals authority somewhere. The fourth thing we did was to say that any information that could come from pharmaceutical companies should not be received by patients or the general public without them asking for it first. No one should ever receive unsolicited information on medicinal products. We have therefore rejected any so-called 'push channels', such as advertisements on the radio, television or in newspapers. The last point I would like to highlight is that companies are only one link in the information chain. Healthcare and society in many countries throughout Europe must take a much greater share of the responsibility than they currently do.
There are points on which we do not agree. In this regard, I would simply like to ask a question and call on my fellow Members to in fact accept the exception relating to information that doctors give to patients they are treating, in other words, that such information need not go through the same process of checks as other information. I have a specific example that could pose a problem if such an exception is not accepted, namely that a doctor in Sweden, for example, would not be able to give an English package leaflet to a patient who does not understand Swedish on account of the fact that it could never be approved in Sweden, as English is not an official language there.
I will conclude by addressing the Council, which, unfortunately, is not here - something that has been quite telling in this matter. I regret the absence of the Council. I really wanted to take account of the Council's opinions and arguments in order to facilitate the debate, but as yet I have been met almost entirely by a flat refusal. It has been difficult to listen to someone who does not provide any information.
We have succeeded in reaching agreement on this matter. I am certain that the Council, too, if it begins to discuss this matter in detail, will actually encounter more or less the same conditions for agreement as we have created here. However, the Council must not try to ration information in order to save money. That is not something that we want to encounter. We do not believe that more poorly informed patients are in any way easier to deal with or that it is cheaper to withhold information. I call on the Council to take the baton so that, together, we can ensure that Europe has better information on medicinal products for the sake of the patients.
John Dalli
Member of the Commission. - Mr President, during my hearing as Commissioner-designate, I made it clear that information to patients is a very important topic for me. Patients are highly interested in their own health and wellbeing. But today, the availability of information on medicines in Europe is very diverse: you could even say very unfair.
Whether patients obtain the relevant information depends on languages, IT skills and often even social class and networks. For a Europe that strives to overcome today's health and inequalities, this is not sustainable. The key ambition of the Commission's initial proposal therefore remains justified, and I applaud Parliament and, in particular, your rapporteur, Mr Fjellner, on taking this important proposal forward.
However, I strongly believe - as I also stressed during my hearing - that we have to address this file from a patient's angle. We have to ask what information patients need, not what information industry may wish to provide. We have to ensure that we do not drift into direct-to-consumer advertising, which patients clearly do not want.
Again, I applaud Parliament for taking exactly this stance. This will allow the Commission to accept many of your key amendments when we present our modified proposals. This concerns, in particular, the obligation to publish information, the question of what information is covered, the information distribution channels and the control mechanisms.
Firstly, I support the amendment stating that industry must have the obligation and not just the right to make certain information on medicinal products available. This is a very important change.
Secondly, as regards what information is published, I generally agree that information should not cover comparisons between medicinal products, as this could be seen as promotional. Of course, this information is highly relevant for patients and healthcare professionals but, due to its potential abuse for promotion, it needs a strict framework. We are cooperating with Member States on such a framework in the area of health technology assessments.
I also share the view that the proposals should concern the information made available by industry and not by third parties such as journalists and scientists. However, we know that there is a grey zone which leaves room for abuse. I therefore believe that such parties should be obliged to declare whether they have received financial or other benefits from industry.
Thirdly, as regards the information channels, I partially agree with your amendments. However, not everybody uses the Internet; we must avoid corroborating inequalities by excluding those who do not use digital communication tools from access to medical information. I consider, therefore, that it should be possible for industry to draft printed material on its own initiative and not only by request. This draft information could be used on request by the public or via healthcare professionals.
Fourthly, on the control of information, I agree that information which has not already been approved during the marketing authorisation process must be pre-approved by competent authorities as a matter of principle. However, I believe that Europe should play close attention to the constitutional concerns that some Member States raise as regards the compatibility of pre-vetting with freedom of expression. It should be possible for these Member States to provide for exposed control, irrespective of whether they already have such exposed control in place.
Several of Parliament's amendments concern information from sources other than industry sources. In this context, let me stress that I fully agree with the political ambition to place the proposals on industry-generated information on medicines, which we are discussing today, in a broader and more comprehensive agenda on patient information. Yes, there are other very important sources which have to be exploited as fully as possible, but the proposals are not the right place to address them.
The Commission is already obliged to draft a report on the readability of the package leaflet. Therefore, any changes regarding this issue would be premature. Nor is it feasible to introduce, for each clinical study mentioned in the summary of the European Public Assessment Report, a link to the Eurydice Database on clinical trials. A general link between databases would suffice.
The public summary of the assessment report should not be annexed to the European marketing authorisation, as it is already publicly available through the EMA website. I recognise that, in addition to information provided by industry, there are already a number of European and national databases and portals providing information on medicinal products. What we lack is interlinkage between them. I propose that the future European medicinal web portal recently created by the Pharmacovigilance Directive be used as a central point to access information.
In this context, I fully recognise the need for broader information about diseases and their prevention. Patients are interested in all different treatment options, not just learning about medicines. However, this cannot be addressed through the present proposals, which focus on medicines. Nevertheless, the Commission is well placed to serve as a European information switchboard. I see our role as connecting other reliable information providers such as Member States or patient organisations. European action can add value, and many information tools such as the EU health portal are already in place.
Honourable Members, you will not be surprised that there are some amendments that the Commission, after careful reflection, cannot support. The right of citizens to lodge complaints, for example, is a fundamental EU principle. It is neither appropriate nor necessary to restate this. The level of penalties should be determined at national level and not at European legislative level. A list of the Commission's positions on all the proposed amendments has been made available to Parliament.
Let me conclude by again thanking Parliament and Mr Fjellner and the shadow rapporteurs for your important contribution. I hope this week's vote will help strengthen patients' access to information and convince the Council of the need to start in-depth discussions of the proposals.
António Fernando Correia De Campos
Mr President, ladies and gentlemen, Commissioner Dalli, patients should have the right to know as much as possible about their illness and the medication available to treat it. Yet how can we distinguish information from advertising? Where and how is it possible to obtain objective and unbiased information? There are various interpretations of the texts currently in force, with the result that they need to be harmonised, strengthening the sovereignty of the individual. Information needs to be reliable, validated by the authorities, independent, accessible and targeted to an average, non-expert audience. The intention is to ensure more informed and responsible citizenship on the part of the end user. The deadline for the tacit approval of the European Medicines Agency (EMA) should be extended from 60 to 120 days. The requirement to state the reasons for a refusal lends weight to such rejections and gives balance to the final outcome. The EMA has a vital role as the preferred source of objective information. I would like to conclude by congratulating the rapporteur, Mr Fjellner, on his work, and by saying that I am delighted that he accepted almost all the proposals that I tabled as rapporteur for the opinion of the Committee on the Internal Market and Consumer Protection.
Cristian Silviu Buşoi
rapporteur for the opinion of the Committee on the Internal Market and Consumer Protection. - Mr President, I would like to congratulate the rapporteur and the other colleagues who have contributed to this dossier. I would also like to congratulate Commissioner Dalli. I think we have reached a good outcome, and now the report is much more patient-oriented than the initial proposal.
Nowadays, patients increasingly tend to seek health-related information so that they can be actively involved in the decisions concerning their health. Patients also tend to seek information online. This information is not easy to control on the Internet, but sooner or later we have to deal with that problem, which will not disappear if we simply do not do anything because it is too complicated.
I therefore support imposing strict rules for the registration and monitoring of websites, as well as making available a list of registered websites so that patients can be sure of the reliability of their source. Safeguards are also needed, and the report provides them, namely by limiting the information that can be made available to information that is approved by the competent authorities.
To this end, we in the Committee on the Internal Market and Consumer Protection have adopted a number of amendments covering advertising, concentrating on changing the wording from 'disseminate' to 'make available' in the context of non-promotional information according to the 'pull principle', whereby patients have access to information if they need it.
Horst Schnellhardt
Mr President, Commissioner, ladies and gentlemen, when you consider how we debated this proposal from the Commission during the last parliament - going from outright rejection to celebrating all the good things coming our way - then I must say that I am very enthusiastic about what has been tabled here. For this, we owe the rapporteur and his co-rapporteurs a great deal of thanks for having brought together this broad spectrum of opinions into a coherent position. I feel that the key words here are 'patient oriented'. In other words, we have not been distracted by peripherals but instead have asked what it is that the patient needs. I believe it is right that we have established that patients are able to obtain information from a number of channels, not just one. I should like to reiterate, however, that the doctor must continue to be the trusted point of contact for the patient and must undoubtedly have an influence over decisions. The way we are guaranteeing that is by banning advertising and ensuring that the information patients receive has been checked and approved by an authority. This means that the information is based on scientific fact to start with, so patients can rely on it.
Of course, it is true that not everyone is able to find these things out via the Internet. That is why we have various channels, however, and I think it is so widespread that we do not need to worry about that. I only hope that the Council will now at last have the courage to deal with this matter. It is very important; action needs to be taken quickly. Our patients expect it. Then we will have done a good job.
Gilles Pargneaux
Mr President, Commissioner, ladies and gentlemen, as the 21st century dawns, patients particularly need appropriate information so that they can be fully involved in the treatment pathway, know where to find treatment, decide on the best treatment with healthcare professionals and follow the planned treatment to the letter.
Nowadays, patients demand independent, comparative information that is tailored to individual needs. Unfortunately, the proposals for the revision of the directive submitted by the European Commission failed to properly meet the needs expressed by European citizens. These proposals opened the door to direct promotion by pharmaceutical companies, which we believe is a nonsense in terms of responding to patients' real needs.
Neither the public nor the Member States stand to gain from this move. On the contrary, it means more red tape, increased costs and risks to patients.
It is for these reasons that we initially submitted a proposal to reject these texts, thereby requiring the Commission to revise its proposals. This approach, which was also adopted by my fellow Member, Mr Schlyter, of the Group of the Greens/European Free Alliance, enabled our rapporteur, Mr Fjellner - to whom I pay tribute - to undertake a major review of the Commission's proposals.
At the same time, we tabled some 60 amendments with the aim of better protecting the health of our citizens and of facilitating patient access to independent, comparative information tailored to individual needs. The adoption of these amendments by the Committee on the Environment meant that we could place more emphasis on patients' rights to information, rather than make it an option for the pharmaceutical industries to provide that information.
In light of the compromise amendments reached, and given the positive changes made to the substance of the text over recent months, we have decided to withdraw our proposal to reject the texts. The draft report, as amended, has succeeded in counterbalancing the European Commission's initial proposals.
Nevertheless, we shall continue to speak out against health professionals being used to distribute to their patients brochures and information that have been supplied by pharmaceutical companies without any checks by health authorities. Similarly, we will oppose the authorisation of industrial campaigns, especially information campaigns, in relation to vaccines.
Information must not be freely distributed by pharmaceutical companies. Experience shows that we must be very vigilant - and what happened with the Mediator medicinal products shows, in fact, just how vigilant we must be - and make sure that we strike a balance, as we have sought to do with this draft report.
Antonyia Parvanova
on behalf of the ALDE Group. - Mr President, on behalf of my group's shadow rapporteur, I would like to congratulate Mr Fjellner for the great work accomplished.
The ALDE Group welcomes this report, which finally sets a clear framework for the provision of information to patients on medicinal products. Patients need to be informed objectively and there needs to be a clear barrier between information and advertising. Therefore, information about prescription medicines should be regulated strictly.
Special attention has also been given to new media - mainly Internet websites - defining clear safeguards, developing mechanisms for the monitoring of contents and ensuring specific provision for proper enforcement.
I would also like to make a personal point with regard to the materials provided to healthcare professionals for distribution to patients. There is no objective reason to exclude such materials from the provision covering other contents, especially when we know that doctors are the most trusted sources of information to patients.
I will therefore personally vote against Amendment 88 and I hope coherence will guide our voting position in order to maintain the major improvement that this report would bring to the Commission proposal.
Miroslav Ouzký
on behalf of the ECR Group. - (CS) Mr President, I would like to begin by emphasising that this is one the reports that I fully support. I have been campaigning throughout my career for every citizen to be put in charge of his or her own health, but this can happen only if people are properly informed
As Horst Schnellhardt has already mentioned here, we have been campaigning since the last legislative session for progress to be made over this standard. These eternal debates over the fact that we are unable to distinguish between advertising and information now seem ridiculous to me, if you will pardon the expression. We can all distinguish between requested information and information that is forced on us. We should open the door fully to all information that is requested. Let us not forget that we are living in a globalised world, and let us not oblige European citizens to seek out information on US websites.
Jiří Maštálka
Madam President, just like Mr Ouzký, I, too, have devoted my professional career as a doctor to the question of how better to inform my patients. However, it is customary to begin by applauding the good work of the rapporteur, and I would like to do this, although with a minor criticism which I will return to later.
When we began negotiating this proposal, we faced two problems following the election of the new Commission. First, the issue had transferred to a new Commissioner, and second, we faced a problem over whether to continue the work started, or to throw away the existing document and start afresh.
Just like most of you and Commissioner Dalli, I agreed that the original Commission proposal was not a good one, as it did not address the needs of patients and consumers. We therefore did not want to lose time working together on the old document. We agreed to reject the commercial campaign mounted by the pharmaceutical companies. We ruled out print media as a communications channel, and we agreed that patients had a right to know who was providing information, and that companies were responsible for all the information they disseminated.
I am rather surprised that Mr Fjellner is again submitting to the plenary an amendment proposal which we rejected in the committee and which would be a retrograde step, contrary to the amended wording of the proposal. If such a proposal were to be adopted, I would find it difficult to vote for what is generally a decent document.
Anna Rosbach
Madam President, Commissioner, I agree with the rapporteur that the focus should be on patient safety and providing patients with information. Patients, nurses and doctors should all have access to the best possible information on a given medicinal product. Doctors I speak to want greater accessibility of impartial information on medicinal products, both for themselves and for patients and other professionals. They also want the descriptions of the preparations to be standardised, as they use the Internet predominantly to find information on the effects of medicinal products. Here they compare the active ingredients of the same medicine from different companies at home and abroad. It is therefore extremely important for pharmaceutical companies to understand their responsibility and the importance of their information being factually and technically correct and of it not being construed as advertising. Pharmaceutical companies must sell their products, we know that, but accountability actually increases consumers' confidence in a preparation.
Franz Obermayr
(DE) Madam President, the wellbeing of patients is key here. In order to cover themselves, pharmaceutical companies often include every minor side effect in package leaflets, which, of course, complicates matters greatly. Confused patients tend to change the dose on their own initiative or to discontinue the medication.
Moreover, the flood of information via the Internet, some of which is reliable and some not, adds greatly to the confusion and uncertainty. Certified websites are a step in the right direction, but are not yet enough. A further priority is to make the information comprehensible even to those without medical or pharmaceutical qualifications. The package leaflet must be unmistakable and legible. The font size should be increased, particularly for older people.
I regret to say that there are third countries that are profiting from the high level of protection in the European pharmaceutical sector. Both original and fake medicines are thus freely available in large quantities in Turkish bazaars. We therefore also need to impose obligations on these third countries in order to put an end to this black market entirely.
Salvatore Tatarella
(IT) Madam President, ladies and gentlemen, the directive that we are discussing is intended to harmonise the content and quality of pharmaceutical information which is accessible to all citizens of the Union. Whilst it stresses the right to advertise, it ultimately asserts the patient's right to information. We must give all European citizens the same opportunity to access information on medicinal products.
The main objective of this directive is to make European patients more informed so that they can take a more knowledgeable approach to medicine. Every one of us, and especially the pharmaceutical industry, must have the same objective, which is to provide information that is accurate and useful and, at the same time, available to all citizens without distinction.
I believe that there are two particularly important points in the directive. Firstly, citizens must be given the opportunity, by means of accurate information, to use medicines correctly, so that they have a more beneficial effect on their health, whilst the risks associated with their misuse are minimised. Secondly, accurate and effective information can increase citizens' awareness of the burden of pharmaceutical costs on public spending.
In any case, we must be very attentive and rigorous on certain points. I refer, above all, to the danger of medicinal information turning into disguised advertising. We must avoid the risk of supposedly scientific information disguising a much less noble intention, which is to influence patients and steer them towards buying a particular medicine. It is therefore crucial to have effective tools to control information, especially that which patients may obtain from the Internet.
In conclusion, I therefore hope that the Committee will provide ways to control information in such a way as to guarantee its accuracy. These controls should be entrusted to dedicated independent organisations so as to offer greater guarantees of impartiality.
Karin Kadenbach
(DE) Madam President, Commissioner, ladies and gentlemen, in his address, Commissioner Dalli himself said that we must focus on the patient. Although the original proposal from the Commission tended rather to put the market at the centre, we have now succeeded - through a wide range of amendments that were adopted with a large majority - in putting people at the centre instead, thereby taking into account what Commissioner Dalli said.
The right of the patient to high quality non-promotional information on the benefits and risks of prescription-only medicines was urgently needed. We need this regulation. I myself come from the world of advertising - my professional background is in advertising and PR - and I know that advertising has one aim, and that is to sell. Our task, however, is to provide information. I believe that the present report and the corresponding amendments give due consideration to our responsibility to provide information.
Commissioner, since the costs of medicines make up a large proportion of healthcare spending, I urge you to work to ensure that patients are well informed and continue to pursue and focus on your initiatives, prevention and health promotion. Together, we will then be successful.
Marina Yannakoudakis
Madam President, how often do we wonder about the side-effects of medicines we are taking? How often do we wish for more information on products and illnesses? This report deals with these questions and the need the public has for information.
The change of focus from the original Council proposals was important, as was the emphasis on the patient's right to access information as opposed to the possibility of pharmaceutical companies providing information. This was achieved by a ban on direct consumer advertising for prescription-only medicines.
In addition, an important issue was the recognition of the national competent authority and healthcare professionals as the main source of information. Again, this was achieved.
The Information to Patients Directive sends a strong message on the rights of patients.
I congratulate the rapporteur on tackling a difficult dossier and producing a comprehensive directive which, I hope, we will all support unitedly.
RadvilMorkūnaitė-Mikulėnien
(LT) Madam President, in the European Union, we stand for the principle of consumer, in this case, patient, awareness and are aiming for citizens to partly take responsibility for their own health. However, our duty as politicians is to protect patients from incorrect and misleading information. That is what we are doing today.
As far as public access to information about pharmaceuticals is concerned, it would seem that the situation varies across the European Union. The distinction between information and advertising is becoming less clear. I therefore support Parliament's position which aims for a clearer definition of information and advertising. It is important for patients to obtain reliable objective information in their mother tongue, for it to be designed for the non-expert public, and for it to be easy to understand and access, bearing in mind the particular needs of consumers. As well as patients, we must protect doctors from hidden advertising as their relationship in the treatment process is particularly important.
We are living in an age when borders are disappearing and information can move freely, just as we can ourselves. Therefore, we must apply certain safeguards to ensure the wellbeing of European patients. I therefore congratulate the rapporteur for his excellent work and hope that we will all be healthier and will have easier access to information.
Milan Cabrnoch
(CS) Madam President, the directive on medicinal products has not been significantly amended for almost 10 years, and a revision of this directive is therefore long overdue. I fully support patients being fully informed and being made equal partners with doctors, sharing in decisions and also taking their share of responsibility for such decisions.
Accessibility of information will undoubtedly play a fundamental role in this change. Such information clearly includes information on medicinal products, including those that are subject to medical prescription. Patients should have access to information on a product, and not only in printed form, but also in electronic form. They should have access to information that is independent, objective, comprehensive, true and accessible in an intelligible form and intelligible language. I would like to thank the rapporteur for his good work. I support his proposal.
Anja Weisgerber
(DE) Madam President, I would like to thank the rapporteur, Christofer Fjellner, and his shadow rapporteurs. Under difficult conditions, and despite battling against a severe headwind, a very good result has genuinely been achieved with this report. The Commission proposal has been improved considerably. A strict ban on advertising remains: there will be no information on the radio, television or in magazines; instead, patients must actively seek out the information. I base my position on the idea that patients are responsible people. They want to be informed, and I would very much like to help them achieve that. I therefore also want the patient to be at the centre of the information. I would like to focus on two key points. I myself have said in no uncertain terms - including in the Committee on the Internal Market and Consumer Protection and in the Committee on the Environment, Public Health and Food Safety - that I would like to see health portals on the Internet and similar information in printed media. Our citizens often look things up on the Internet, where they often come across poor and uncontrolled information. We must therefore counter this with an alternative: controlled information. Pharmacovigilance was a first success, with the adoption of drug safety portals that included the package leaflets and information on the medicines. However, I would like to go beyond this, Commissioner, and would have liked to have seen comprehensive Internet portals that also provide information on illnesses and prevention. If I have understood you correctly, you support this in principle, but perhaps have not said so in this dossier. I would like the Commissioner to make a clear statement as to whether he also supports this. I consider this to be a very, very important matter.
Françoise Grossetête
(FR) Madam President, I would like to congratulate our rapporteur, Mr Fjellner, on the excellent work he has been doing for several months on these two reports. I say this especially because we have been waiting years for this text. The oldest MEPs among us will remember that, back when the pharmaceutical legislation was being revised, we wanted to talk about teaching patients about medicinal products and treatments, but that, unfortunately, there was some confusion between information and advertising.
Nowadays, information must not be allowed to be disguised advertising and, in fact, the emphasis in these reports is no longer on the right of companies to convey information but on the right of patients to access it. The rationale is therefore completely different, and that is why patients are the priority. Moreover, we say 'no' to unsolicited information, a move that will reduce the distribution channels and thus the risks of advertising.
Patients themselves will search for the information they want, which will not be forced on them, via the radio or television, newspapers or magazines. That, in fact, is what makes it different from advertising. Some information will therefore need to be pre-vetted. Such pre-vetting must be carried out by national authorities, and it must allow for the creation of specialist, objective websites, and the use of specific printed materials, as Commissioner Dalli has explained.
All the conditions are therefore in place for ensuring good quality information, objective information, information for which patients have long been waiting. This is why the Council absolutely must fulfil its responsibilities and agree to it, because we cannot allow just any information to be found on websites. We have been waiting for 10 years: 10 years for the Council to make its decision.
Alajos Mészáros
(HU) Madam President, Mr Fjellner, too, deserves thanks for the report, for we have long needed a proposal for providing patients with more and better information on the prescription-only medicinal products prescribed to and used by them. Quality information is very important and contributes to improved healthcare conditions. When patients are adequately informed, they are more likely to follow the required treatment and will better understand the decisions relating to their treatment.
What we need is not only harmonisation of European regulations. We must also ensure an improvement in public health through the provision of correct information. Pharmaceutical companies also play an important role in this. However, we must also make sure that there is no excessive drug consumption as a result of commercial promotion.
There are numerous problems with the provision of information on medicines in EU Member States today. In some Member States, patients have difficulty accessing even the most basic information about prescribed medicines. This causes serious inequalities in EU healthcare. In addition to information available on the Internet, we need to provide guidance through traditional channels as well. However, our aim is not to ensure that pharmaceutical companies have the right to provide information, but to give patients the opportunity to obtain information. We need to distinguish between information and advertising. In my view, communication between patients and doctors is also important, since the primary source of information for the patient must be the physician who prescribes the medication. Other information channels should only serve to supplement that information.
Zuzana Roithová
(CS) Madam President, I very much applaud the work of the rapporteur on regulations for improving the accessibility and quality of information on medicines for European patients. As a doctor, I can say that the information on product leaflets is reliable and intelligible to doctors. Now, it must also be written in such a way that lay persons also understand it. However, we are also aiming to put an end to misleading advertisements on the Internet that encourage people to buy products that not only do not cure, but may even harm patients. It is, however, not easy to regulate web content in a globalised digital environment. I would like to emphasise again that the solution is to implement as soon as possible the proposal to introduce reliability marks for safe websites. Only then will it be possible to ensure reliable content concerning medicines on the Internet, regardless of where in the world the website operator is based. Such a plan was also included in my report on consumer confidence in the digital environment.
Mario Pirillo
(IT) Madam President, Commissioner, ladies and gentlemen, the report being discussed is extremely important, since it will enable European legislation on access to information on medicinal products to be harmonised and, above all, because it will ensure that patients obtain more information about prescription medicines.
The posting of this information on websites must be transparent and independent. To ensure this, all information must be examined by the relevant national or European authorities, to prevent it from becoming disguised advertising of medicinal products, perhaps through the action of production companies.
Finally, I call for the same attention to be given to information contained in prescription medicine brochures also. In this regard, I would prefer doctors or pharmacists to be the ones who provide detailed information to patients, to ensure the thorough understanding of medicine administration that is required.
Oreste Rossi
(IT) Madam President, ladies and gentlemen, we believe that the regulation is positive, since it is aimed at providing a harmonised legislative framework with regard to non-promotional information on prescription medicines which pharmaceutical companies may communicate to the public, leaving the advertising ban unchanged.
The motion stresses the difference between advertising and information. The provision of information is based on the principles of active research. Doctors must continue to be the main source of information on medicinal products. Other sources, which are understood to be complementary and which include magazines and newspapers, should be maintained.
The central focus is the patient's right to information, with the active participation of organisations that represent citizens, particularly patients. We voted in favour.
Mairead McGuinness
Madam President, we would all like to see patients using the existing information that is available to them. We need to create awareness among citizens about the use of the information currently available.
I support colleagues here who say that we should not advertise products, and would say to the companies involved that communicating quality information to consumers is the best form of advertising, because if a product works for the citizen, then that is a clear message that it will be used where it is required. Of course, we need to have general practitioners communicating medical and scientific information to their patients. This often does not happen in the best possible way.
Finally, we also need to be clear about how medicaments are allocated to citizens of different age groups. They are prescribed today with no review of the case for a year. This is very dangerous, and we need to have much more rigorous assessment of how patients are cared for, on a regular basis. Otherwise, we will have medical problems.
John Dalli
Member of the Commission. - It is indeed gratifying to see such a level of positive engagement on such an important file and the general agreement that there is on the trust that has been placed in the basic principles and concepts on which this proposal should be moving forward.
As I stated earlier, it was very important that we shift the focus of the original proposal into a patient-orientated proposal based on the patient's perspective.
I have been following the debate in Parliament very assiduously. I have talked to many of you to see what is being talked about, and I believe that what we have - as I stated in my original comments - is a very positive document on which we should be now building in order to come to a final agreement.
I would like to make some short comments on what you have said. Concerning the ex-ante controls by EMA mentioned by Mr Correia, I believe that 120 days would be somewhat excessive and, in fact, what we will be proposing will be in the region of 60 days.
The Internet is a daunting task, and controlling websites containing information for patients is vital - but we all understand that it is also difficult. The points raised by Mr Buşoi and Ms Grossetête concerning strict rules covering the Internet is very important, and this is what we should be developing.
The focal point which the doctor needs to continue to have in the relationship with the patient is also very important, as stated by Mr Schnellhardt and also, in their own ways, by Mr Pargneaux and Mr Parvanova.
I agree that doctors should not be instrumentalised by the pharmaceutical industry but, on the other hand, a doctor should be a good medium through which information should flow. Here, we must ensure that information in the hands of doctors, as Mrs Rosbach has stated, should also be objective.
My last point regards the comprehensive portal on diseases, which was mentioned by Mrs Weisgerber. I have to say that, in the case of medicines, this is already covered by the pharmacovigilance legislation that we are proposing. It is somewhat more difficult in the case of diseases. We already have a portal on rare diseases, but in the case of the overall spectrum of diseases, we have started and are attempting to tackle this issue. However, it is proving to be a very complex and, as you will understand, an extremely extensive exercise.
So I would like to thank you for the work that has been done on this dossier. I would like to thank the rapporteur and the co-rapporteurs again for the work that they have done, and I hope, as I said, that finally, we will have a document on which we can work further.
Commission's position on the amendments tabled by the Parliament:
- C6-0156/2008 -
Amendments:
Directly acceptable: 1, 3, 4, 10, 11, 12, 22, 26, 35, 39, 40, 42, 56, 60, 63, 64, 65, 67 and 69
Acceptable in principle: 9, 13, 14, 16, 19, 20, 21, 23, 27, 32, 34, 36, 37, 41, 46, 48, 50, 52, 58, 62, 66, 72, 74, 75, 76, 77 and 78.
Acceptable subject to rewording: 5, 6, 7, 8, 15, 24, 25, 28, 33, 44, 49, 53, 59 and 70.
Partly acceptable: 2, 29, 31, 43, 54, 55, 61 and 79.
NOT acceptable: 17, 18, 30, 38, 45, 47, 51, 57, 68, 71 and 73
- C6-0517/2008 -
Amendments:
Acceptable: 2 and 7
Acceptable in principle: 6
Acceptable subject to rewording: 1
Partly acceptable: 9, 10 and 12
NOT acceptable: 3, 4, 5, 8 and 11
Christofer Fjellner
Madam President, I am pleased that the Commission started by pointing out precisely the fact that access to information on medicinal products currently varies enormously throughout Europe, because we have tried very hard to ensure that everyone has good access and to harmonise this access. At the same time, I had a requirement of my own and that was that the information must not be worse or sparser in any particular country. I know that this is something that many people were concerned about in some countries, including Sweden, where, for a long time, we have had a system called Fass. I will now address those people directly and say that the way Parliament has voted here not only means that it is possible to retain Fass, but it is also possible for other countries to introduce similar systems.
In other respects, of course, the rules in Europe today are rather strange in that anyone can say whatever they like about medicinal products that are subject to medical prescription except those who manufacture these medicinal products; in other words, those who should know most about them. I am therefore pleased that we have established that they not only have the right, they actually have a duty to disseminate certain basic information. They must also contribute, because after all, they are the ones sitting on a lot of the information.
To the Commissioner I would simply like to say that I am very pleased to see that you and I seem to agree on all of the points that are key for me in this work. I believe that the Commission and Parliament are now in agreement. This puts considerable pressure on the Council to take up this matter in a constructive way and work further on it. To be honest, even with regard to the points in the proposal to which the Commission has stated that it has objections, I would maintain that the essence of what we want to achieve is very similar, for example, as regards printed material and the possibility of helping those countries that have constitutional problems, including Sweden, to solve them in the proposal.
Finally, I would like simply to address those Members here who do not think that we should have an exception for doctors and the information that doctors are to provide. Personally, I think that a doctor who sees a clinical trial published by a company should have the right to give it to a patient if the doctor deems the information to be relevant, or that a doctor who finds a package leaflet in a language other than that Member States' official language should have the right to print out that information and give it to a patient. In that case, however, we must vote for the doctor himself to be able to decide and not for this directive to govern what doctors are to give to patients. It is always the doctors' responsibility and we should not regulate it here.
President
The joint debate is closed.
The vote will take place on Wednesday, 24 November 2010.
Written statements (Rule 149)
John Attard-Montalto
in writing. - Information regarding consumer products has become essential. Information on medicines is especially sensitive. One important distinction which has to be made is between information and advertisement. The European Parliament, in discussing this report, is making safeguards where medicines are concerned. One instance is that printed matter has to be submitted to the European Medicines Agency (EMA) 90 days in advance for analyses before being forwarded to consumers. One important element which is not being addressed is information on prices. During this legislature, I have insisted on the high prices of medicines in Malta when compared to the same medicines elsewhere in the European Union. The difference in price is not minimal but unbelievable. The cost of some medicines in Malta is double or even more than the cost in Europe. When I submitted questions to the Commission on the subject, they always indicated that this is an issue for the national government. I strongly believe that the EMA should not only act as a shield for consumers in relation to information on medicines, but when consumers are being blatantly overcharged for medicines and national governments are unable to tackle the issue, the EMA should have the ability to address the issue.
Slavi Binev
in writing. - I welcome the provisions in the report on the information on medicinal products which emphasise the right of consumers to information. Regarding this, I would like to draw your attention to the online public consultation launched by the EC in connection with forthcoming amendments to the Tobacco Products Directive. Undoubtedly, this initiative is praiseworthy and I support it.
But I would like to see the position of Parliament and the Council because, since I have familiarised myself with the proposals, I define some as extreme, unreasonable and, to some extent, I am even surprised at their inclusion for discussion. I mean some of the proposed options such as the introduction of simplified uniform packing without insignia, a ban on the display of products in sale and prohibiting the use of additives in the production of tobacco products.
I believe that in drawing up new regulations, reality must be considered. Extreme bans and restrictive regulatory measures on tobacco should be treated with caution. This is a growing problem and I don't want this signal to remain without discussion. The Commission proposes, but what it gives us as proposals is not always the best for all Member States. A debate in this case is obligatory!
Siiri Oviir
I think it is a good thing that, as a result of this proposal, the focus of the directive and the regulation has moved from drug manufacturers to patients. It is extremely important to raise patients' awareness of prescription drugs in order to prevent overconsumption of medicines as a result of commercial considerations. Unfortunately, in many Member States, it has become the norm for drug companies to lobby hard, offering a number of benefits which certainly have an influence on doctors' decisions. Needless to say, business interests are not always consistent with the interests of patients, and this is why the amendment to Directive 2001/83/EC and Regulation (EC) No 726/2004 are necessary in order to create a clear framework for giving out information on prescription drugs. A clear framework would help to promote the rational use of drugs and would be in the interest of patients. There should certainly be clearer distinctions made between advertising and information, even though direct advertising of prescription drugs to consumers will remain prohibited under the relevant proposals.
Daciana Octavia Sârbu
in writing. - The Environment Committee has made some important improvements to the Commission's proposal which, in its original form, would not have prevented all forms of advertising of prescription drugs directly to patients. Prescription medicines are not like ordinary consumer goods. They should be supplied by clinical experts, not marketed like cars or cosmetics. So I welcome the continued ban on advertising of prescription medicines on television, radio, and in the print media. Healthcare professionals remain the most trusted source of information about medicines. So I cannot support the rapporteur's amendment which would allow healthcare professionals to distribute additional, unapproved material from the pharmaceutical companies directly to patients. This would represent a clear opportunity to advertise, something which we want to avoid and which would be inconsistent with our position against direct advertising to patients. It is especially inappropriate because the material directly from the pharmaceutical company would, in the patient's eyes, carry the legitimacy of the doctor distributing it. On the whole, the report represents improvements for patients compared to the Commission proposal, and we should not undermine these improvements by allowing pharmaceutical companies to advertise directly to patients in the doctor's surgery.
