Pharmaceutical products package (debate) 
President
The next item is the Commission statement on the pharmaceutical products package.
Günter Verheugen
Madam President, ladies and gentlemen, the proposals in the so-called pharmaceutical package which I am presenting this evening at Parliament's request have a common theme. The intention of the package is to strengthen the rights, needs and interests of patients in our healthcare systems.
In our view patients are not merely the subject of services available from healthcare providers or the subject of the financial interests of the pharmaceutical industry. Patients are responsible citizens whose health is their most important asset and who are entitled to have the best and safest treatments and medicines at their disposal. Patients are the subject of healthcare policy.
However, health or restoration to health is not just a right. It also involves an obligation to take care of oneself by eating healthily, having a healthy lifestyle and playing an active role in one's own treatment, if treatment is required.
Our proposal for more effective monitoring of the actual effects of approved medicines, for example, presupposes this type of active involvement on the part of patients. If patients do not notify the authorities about anomalies relating to medicines that they have taken, the monitoring process will be a waste of time.
This also applies to protection against counterfeit medicines. Patients can, and should, in future ensure that they are not taking fake medicines by checking that all the safety features which will be required on future packaging are in fact in place. If we believe that active, informed patients play an essential role in healthcare, in monitoring medicines and in preventing the spread of counterfeits, it is hard to understand why patients are not allowed access to information about the most important medicines. For this reason, the pharmaceutical package consists of the following four parts: a political communication and three legislative proposals on the safety monitoring of medicines, on counterfeit medicines and on patient information.
The rapidly growing numbers of fake medicines have forced us to act. The number of counterfeit medicines confiscated at the EU's external borders increased almost fourfold between 2005 and 2007. If we do not act now, the first deaths will be caused sooner or later. The problem has also affected the legal supply chain for medicines. We have discovered fake medicines at different stages of the supply chain. Each individual case involves thousands of packages and, therefore, thousands of patients are potentially at risk. In future, patients in Europe must be able to have total confidence in the quality of the medicines which they obtain from legal suppliers, such as pharmacies.
Our proposals are therefore as follows: firstly, clear regulations for all those involved in the legal supply chain; secondly, stricter supervision of medicines in transit or for export; thirdly, the latest safety features on medicines which are particularly at risk, including a seal, an identification feature and a barcode to ensure complete traceability for every package; and, fourthly, regulations for the safety monitoring of active substances.
While the proposal was being drawn up, a misunderstanding arose which I would like to clear up once and for all. The proposal's sole objective is to improve patient safety. It is not intended to prevent a specific form of medicine distribution, such as parallel trade. The sector in question has been responsible for a striking information campaign. In this case you could almost call it a disinformation campaign. However, I would like to clarify once again that the parallel trade in medicines is an activity which is permitted under the EU Treaty and will remain so. Parallel traders simply need to observe the new safety requirements, as do all other participants in the supply chain. No one is being given preferential treatment and no one is being put at a disadvantage.
The legislative proposal on pharmacovigilance, in other words on monitoring approved medicines, will improve patient safety and reduce the unnecessary administrative burden. This is a good example of how less bureaucracy can lead to greater safety. This will be achieved by making responsibilities clearer and reporting obligations more effective. In addition, manufacturers must introduce an efficient monitoring system. Community-wide access to information about undesirable or previously unknown side effects will make Community-wide risk management significantly easier.
Finally, the pharmaceutical package includes a proposal for improved patient information. I know that this is a highly controversial issue which we have often considered in this Parliament and I hope that we will succeed in discussing this issue calmly and objectively and without resorting to polemics.
Patients have a right to information and this applies in particular to medicines. Health is one of our most important assets, if not the most important. The significance of health will continue to increase in our aging society. In a democratic society, it therefore goes without saying that patients must be provided with comprehensive information about matters which affect their health.
I must state very clearly, and this really is a fundamental principle of a democratic society, that we do not need to explain and justify the fact that people should be provided with information. Instead, we need to explain and justify the situation when citizens are not provided with information.
Patients are already actively searching for information. All of us will have come across this situation among our friends, acquaintances or even family members, when a seriously ill person or their relatives and friends search desperately, and in many cases these people really are desperate, for information about whether a better medicine or a better treatment is available.
The first place that these people look is the Internet. They come across information from other parts of the world and are not able to tell whether it is product advertising or factual information. In my opinion this situation is both dreadful and intolerable.
I would therefore like to make it absolutely clear that the current situation does not meet patients' requirements for high-quality information. It also results in discrimination. People who can understand English and can use the Internet have access to information which is unavailable to those people who cannot understand English and cannot use the Internet. These are generally older people and it is particularly important for them to obtain factual information.
As things currently stand in Europe, if a medicine is American, then the information is available, and if it is European, the information is not available. Our considerations are based on the fact that the ban on advertising prescription-only medicines should under no circumstances be relaxed and that there is a significant difference between information and advertising. Our proposal is therefore that certain information should be released and, in particular, the information which has been reviewed by the authorities and can be found, for example, on the package leaflets of medicines. Secondly, this information should only be published on the Internet in written answers to specific questions or in healthcare publications specified by the Member States.
Thirdly, strict quality criteria must be followed and, fourthly, the Member States must put in place effective monitoring mechanisms. The information must be monitored before publication. Exceptions to this will only be permitted in the context of effective systems.
I would like to explain that there is, of course, a grey area relating to patient information and advertising for medical products. Individual patients are not able to see through this grey area in which information of all kinds is made available via media of all kinds, with the media taking editorial responsibility. Very often this information is controlled by interested parties, to put it cautiously, and readers are not able to identify the source of the information or the interested party involved.
I will be working with the media and with the pharmaceutical industry to draw up a code of conduct in order to ensure that this highly questionable practice is brought to an end. However, to achieve this we need to find a better and more modern solution to the problem of patient information.
This package contains very up-to-date and progressive proposals. It draws the obvious conclusions from the increasing importance which citizens place on questions that concern their own health. I hope that I will have the support of the European Parliament for this package. Thank you very much.
John Bowis
on behalf of the PPE-DE Group. - Madam President, I very much welcome the Commissioner's statement and in particular the tone in which he opened it when he was referring to patients as being the centre of this. I am just taking through this Parliament a report on cross-border health, and fundamental to that is the safety of patients. If I may say so, I wish this had come sooner so that we could have completed your package, along with other health measures within this Parliament. That is not going to be possible, but at least we are on the road.
Perhaps you could mention to at least one of your colleagues that we would also like to see something on needle-stick injuries as part of that safety package.
But we are looking now at the three items that you have referred to. You have referred, rightly, to information to patients and you have dwelt on the detail of that. I believe that patients, and particularly the patients with conditions like neurodegenerative diseases, are very anxious to see this information to patients coming in in a way which is certainly not advertising but does give them confidence that what they read - whether it is on the internet, in the package or in advertising or announcements, shall we say - is bona fide and trustworthy. At the moment they cannot do that and so they are, as you say, at risk.
The second one is counterfeiting. Counterfeiting is one of the curses of our age. It is one thing to have a watch or designer clothing counterfeited, but it is far more serious if it is a medicine. If it is a counterfeit medicine, then patients are at risk and patients can die because of counterfeit medicines. As we have heard, the statistics - 2.5 million packages a year seized at EU borders - have greatly increased over the previous two years, from 2005-2007, and the frightening thing is that it is increasingly within pharmacies and it is not just the internet packages.
Thirdly, you referred to pharmacovigilance. We reckon that 5% of all hospital admissions are the result of adverse drug reactions and that adverse drug reactions cause a fifth of the unnecessary deaths in hospitals. So it is vitally important that we have a simplified, more reliable package on pharmacovigilance too.
If we get these in place, then I believe my report and the safety of patients can go hand in hand, and that must be at the top of our agenda tonight, during the rest of this Parliament and in the Parliament that is to come at the end of the summer.
Dorette Corbey
Madam President, Commissioner, ladies and gentlemen, it is good that we are discussing a new piece of pharmaceutical legislation this evening. I would also like to thank Commissioner Verheugen for providing us with this opportunity.
Commissioner Verheugen has rightly raised the fact that a number of amendments to the legislation are necessary. We need a greater focus on safety, better rules concerning information for patients and effective measures against counterfeit medicines. I would also stress the point that the patient must play the central role in this regard.
Medicines are subject to strict supervision, which is why it is not possible to put any old thing on the market. Strict tests are carried out on medicines before they reach the market, but once they are on the market it is extremely rare for them to be tested again. Supervision of a medicine is limited once it reaches the market. Side effects are reported, but there is little research into the effectiveness of medicines. The proposed legislation gives us an opportunity to make very necessary improvements on this front.
For example, cholesterol-lowering medication is taken on a mass scale, although little is known about the effectiveness of various products and very little, indeed, is known about which product is the most effective. The same applies to antidepressants and other drugs which have an impact on people's mental health. It would be a good idea if the pharmaceutical industry were required to undertake more extensive research into the effectiveness and side effects of its products. Independent testing is necessary in this regard.
We all know that patient information about medicines is a controversial topic. Anyone watching prime-time television in the United States can see what trouble this can cause. 'Ask your doctor for x medicine for breast cancer or y medicine for cystitis.' So far, there has been a ban on the advertising of medicines in Europe and, as far as I am concerned, that is how it should remain. We cannot allow anyone to saddle us with a diagnosis or talk us into taking a drug.
The pharmaceutical industry wants to inform patients about its products and thinks that it is the body most capable of doing that. I imagine that that might very well be the case, but independent testing is crucial here, too. The legislative proposal relaxes the rules on the circulation of information via the Internet and printed media. As Commissioner Verheugen himself says, this is a modern and progressive proposal. There must be a very clear dividing line between information and advertising and patients should have the right to reliable information. For this reason, it would be a good idea to collect information in a European database, together with comparative information on the effects and side effects of medicines.
The third proposal in the package tightens the rules intended to prevent counterfeit medicines from being placed on the market. That is only right, because, as my fellow Member Mr Bowis has stressed, placing counterfeit medicines on the market is a serious offence. Commissioner Verheugen is also right in saying that this phenomenon is not so much a consequence of parallel trade as of altogether different mechanisms which we need to tackle. In the upcoming period we should deepen our discussion about the advantages and disadvantages of information for patients, counterfeit medicines and patient safety, because it is certain that we are dealing with a number of public duties here. The industry has a responsibility, patients have a certain amount of responsibility, but so do the authorities as well.
Carl Schlyter
Madam President, I would like to thank the Commission for its statement. I think that it is good to address environmental aspects, for example. Contamination from pharmaceutical products is a growing problem in treatment works.
As regards advertisements for pharmaceutical products, I would like to see the toughest possible restrictions. I have really become quite tired of this issue. One evening when I was watching television, a quarter of all the advertisements were for over-the-counter pharmaceutical products. I would like the Commission to carry out an impact assessment to see how great an effect the advertisements have had on sales of these pharmaceutical products. Is it reasonable to have so many advertisements for pharmaceutical products on the television, even if we are talking about over-the-counter medicines?
In Sweden, we had an example of the vaccine Gardasil, which scarcely falls within the bounds of over-the-counter or epidemiological vaccines. I would therefore like us to tighten up the legislation in this area.
As regards the counterfeiting of medicines, this is probably also connected to our current patent system. There is an extremely large difference in price. I believe that a solution for better steering research in the direction of needs that are in the public interest would perhaps be to introduce the greater use of prize funds for pharmaceutical products. Neglected tropical diseases, for example - that is to say an area where there is no buying power - would then be able to obtain new medicines. This would better enable research to be carried out into producing medicines for groups in society that do not have a strong buying power.
I would like the Commission to look more closely into the possibilities of making greater use of prize funds, whereby a person who develops a new pharmaceutical product receives a one-off sum. Manufacture would then be licence-free. I believe that in certain cases this could be a better system for improving research and, above all, for eliminating the purpose of counterfeiting medicines. I see many advantages to being able, from a political position, to steer research into solving a disease problem instead of treating the symptoms for 30 years with medication that is very lucrative for the undertakings concerned.
Finally, I would just like to say something about nanotechnology. There are nanoparticles in medicine, but we know very little about their toxicological effects. I would like better methods to be introduced for investigating the toxicology of nanoparticles.
Irena Belohorská
(SK) Many of us will probably talk about healthcare subsidiarity in connection with the pharmaceutical package. Nevertheless, the situation on the pharmaceutical market indicates that, for Europe to be competitive in research and development, as well as in the distribution and sale of new medicines, closer cooperation or improved cooperation between the Member States is required in this field.
Patients need to be better informed about medicines and of course about their unwanted side effects, so that they can participate in treatment more effectively. Due to limited funding for pharmaceutical research and development in Europe, the European pharmaceutical industry is unable to compete with America, Japan or Canada. That is why medicine prices have been rising disproportionately on European markets.
We have discussed repeatedly in the European Parliament the insufficient accessibility of certain drugs, for example those for the treatment of cancer or so-called rare diseases. We place patients who are already in a difficult situation in the position of beggars who have to find sponsors in order to obtain treatment. The high price of many medicines forces the healthcare sector to seek cheaper alternatives, in other words generic medicines. Unfortunately, it is precisely these that are frequently counterfeited and often contain no active substance apart from sugar and the tablet compound.
The aforementioned facts show us how important it is to exchange opinions, discuss and subsequently adopt a complete pharmaceutical package ensuring that patients are treated with high-quality and affordable medicines. In this context, I am looking forward to effective cooperation with the rapporteurs appointed for specific parts of the package in the Committee on the Environment, Public Health and Consumer Protection. I have to agree with the Commissioner that it is medicines sold via the Internet that greatly endanger the safety of pharmaceutical policy.
Anne Ferreira
(FR) Madam President, Commissioner, ladies and gentlemen, it always surprises me when health matters are handled by the Directorate-General for Enterprise and Industry. On reading the proposals on patient information, however, it soon becomes apparent that, one or two nuances aside, they treat medicines as if they were any other consumer product.
On this issue, I believe that information provided by the industry itself, other than labelling and statutory notices, is called advertising and it is by repetition that it becomes a competitive commercial asset.
The Commission may well put forward certain provisions to define its proposals, and it may keep telling us that it is patient associations that are impatiently awaiting such provisions. There are many of us who are not fooled by the impact of this 'patient information' directive and know that it will have no benefit in actually improving the health of Europeans.
We can already be certain that, if the text were to be adopted, the pharmaceutical industry's marketing budget would skyrocket, undoubtedly at the expense of research. Already today, 23% of turnover is dedicated to advertising and only 17% to research, and if we look at the United States and New Zealand, where this advertising information is already permitted, we can see that it has led to an increase in the number of prescriptions and health costs, without any visible improvement in the quality of care or in citizens' health. Let this be a lesson to us.
Finally, I would like to conclude by saying that a modern solution would be to have more faith in health professionals, or to train them better, so that they can provide information on treatments and prescription medicines.
Åsa Westlund
(SV) Madam President, Commissioner Verheugen, as you said, this package was much talked about even before it was tabled. This is perhaps not particularly strange, as pharmaceutical products affect everyone. However, they also affect powerful companies with strong interests as well as the use of tax revenue.
I, personally, asked the Commission to include the effect of pharmaceutical products on the environment in the information provided. I am very pleased that the Commission has included this in its proposal as something that may be included in the information that may be provided. However, I think, in fact, that this information probably could be mandatory when providing information about the pharmaceutical product.
I do not want to see advertisements for prescription pharmaceutical products. I am therefore pleased that the Commission appears to share this view. However, like the Commission, I believe that patients and the general public should have the right to sound and accurate information on pharmaceutical products. In several cases this already exists today. In Sweden, for example, we have a system called FASS. It is important for it to be possible, as an ordinary citizen, to find reliable information quickly, particularly in view of the fact that there is plenty of information that is downright misleading, in particular in various chat rooms on the Internet that are easy to find if someone is in a vulnerable situation. However, just as the Commission has proposed, it is necessary for the information to be monitored objectively so that it can be relied upon. It is this part of the Commission's proposal that I am quite dubious about. It will be extremely important to regulate how these information channels can and should be set up, so that they are easily accessible while at the same time only accessible to those looking for the information, so that the information is not given to people who have not asked for it like an advertisement.
I am also a little dubious about whether it is really necessary to have full regulation of this matter at EU level. When all is said and done, this is an area that relates to health services and medical care and that should fall mostly within the competence of the Member States. I would therefore prefer to be a little more convinced that the legislative regulation of this matter at EU level was really necessary.
Erna Hennicot-Schoepges
(FR) Madam President, I have two questions I would like to put to the Commissioner. Do you intend to find a way to prevent a magazine, distributed free of charge in pharmacies in Germany and subtly funded by the pharmaceutical industry, from being affected by this directive?
My other question relates to the names of medicines in cross-border regions. The names are often different despite the fact that the medicines contain identical substances. Could there not be a way to simplify things for those who live in cross-border regions?
Avril Doyle
Madam President, I welcome the Commission's statement tonight and look forward to reading in more detail exactly what is in this package.
Some years ago here we had the pharmaceutical review. That included veterinary medicines, as well as human pharmaceuticals. I am just wondering why the two have been divorced at this stage in the proceedings. The Commission will be aware of my interest through the legislation on maximum residues, which feed into the food chain through veterinary pharmaceuticals. I have been critical of serious shortcomings in the Veterinary Medicines Directive now for some time.
Could the Commissioner just comment on drug interaction and multi-drug therapy and drug-resistance issues in relation to this discussion here tonight? I, like others, feel there should be far more patient information now. Patients should not have to 'compete' - if that is the word - with what is on the internet, where there is sometimes a lot of misinformation. They should get properly reviewed scientific information at first hand with their medicines.
Finally, I also have concerns with the role of drug companies in influencing doctors' prescription habits. Could the Commissioner comment, please?
Günter Verheugen
Madam President, ladies and gentlemen, in response to Mrs Corbey's comments, I would like to say first of all that I gave the go-ahead for a European database of prescription-only medicines several years ago. Work on the database is going well and it will be available in the foreseeable future.
Not only Mrs Corbey but also several other Members of this House have asked the question: is it possible to make a clear distinction between information and advertising? Let me state clearly once again that the Commission is totally opposed to allowing advertising or publicity, or whatever you want to call it, for prescription-only medicines in Europe. We will not permit this under any circumstances. However, I do also have to contradict you when you give the impression that there is no difference between information and advertising. Anyone who says that it is not possible to distinguish between information and advertising is insulting hundreds of thousands of journalists who clearly demonstrate every day in their work in newspapers, on the radio or on television that there is a difference between information and advertising. The regulations which we draw up are so accurate and so precise that there is no question of blurring the lines between information and advertising. The information must be based on data that has already been authorised by the approval authority. It must be authorised before it is published and it is subject to strict quality controls. I really do not understand how anyone could believe that this was advertising.
Mr Schlyter has highlighted the question of vaccines. I must state clearly at this point that vaccines are, of course, not freely available. Vaccines are normally made available to ordinary citizens by the public health authorities in the context of information campaigns which aim to ensure the highest possible vaccination density. That is how things should be, but the difference between information and advertising must, of course, also be taken into account in the case of vaccines. I fully share your opinion in this respect. The issue of counterfeit medicines is unrelated to intellectual property. Fake medicines are not produced as a result of a dispute about intellectual property. The medicines which are being faked have already been approved, which means that any issues of intellectual property have been resolved. Counterfeit medicines are produced for reasons of pure greed. There is no question of violating rights to intellectual property. This is simply a criminal act. At the very least faking medicines involves bodily harm, if not attempted murder, but it has nothing to do with questions of intellectual property.
I would like to draw your attention to statistics produced by the European Medicines Agency which has been investigating the possible effects of improved patient information. In Great Britain, 5% of all the people who are admitted to hospital are there because they have taken the wrong medicine, in other words, a medicine which they are allergic to or which they should not have been given. Of all the patients in hospital in Great Britain, 5% have been hospitalised because they have taken the wrong medicine. We know that in 50% of these cases this could have been avoided if the patient had been informed about the nature of the medicine they received. However, this information was not available to them. I also use this argument in reply to healthcare authorities in the Member States who are not enthusiastic about the prospect of well-informed patients because they believe that well-informed patients are demanding and will ask for more expensive drugs. These statistics show that patient information can even save money.
In answer to Mrs Hennicot-Schoepges' question about brochures and magazines which are made available free of charge, I do not think that it is possible for European legislators to prevent anyone from distributing free brochures. This happens in several Member States. However, the ban on advertising also applies to these magazines and brochures. I am thinking, for example, of the very well-known publication Apothekenumschau in my native country. These publications are not allowed to contain advertising for prescription-only medicines.
I have said something about the grey area, in other words, the surreptitious advertising which you also mentioned. Yes, it does exist. We are familiar with these practices and our proposals are specifically intended to prevent this surreptitious advertising which is found in a number of areas.
As far as the border regions are concerned, the circumstances described are related to the fact that we still essentially have national approval of drugs. European approval is the exception, not the rule. This means that manufacturers have their medicines approved in the different markets in the Member States and no one can prevent them from registering the medicines under different names. This is where the problem lies. If a medicine has European approval, then it is available throughout Europe, including the border regions, under the same brand name.
Mrs Doyle, I do not believe that there is a one-to-one correspondence in the areas which we are discussing between human medicine and veterinary medicine. I think the structures are very different in these cases. For example, animals are not able to find out about medicines themselves. The relationship between demand and availability is quite different. However, I will be very happy to consider this problem further. I would also like to point out that in the case of the question of residues we issued a proposal a long time ago, as you know.
President
The debate is closed.
