Falsified medicinal products (debate) 
President
The next item is the report by Mrs Matias, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source - C6-0513/2008 - 2008/0261 (COD)).
Marisa Matias
Madam President, now that we have arrived at this point, at this time and at the end of this long process, I think that we know what it is that unites us, every man and woman in this room: it is the protection of patients' health. It is our duty to protect the 500 million citizens who live in Europe and who do not know if the medicines they are using are real or falsified. We have to give them the guarantee that the medicines they are using are going to help save their lives, and not contribute to their early death. I think that this problem is far too serious for us to allow it to continue unresolved any longer.
That is why I have referred several times to these falsified medicines as 'silent killers' because that is effectively what they are, because if people who have problems ... We know how falsification networks have changed: a few years ago everybody would be talking about Viagra, but today it is impossible not to talk about drugs that combat, or attempt to combat, diseases such as cancer, diabetes, heart disease and cholesterol.
Therefore, as I said, these are 'silent killers' because, if they are not combating these diseases, they are not helping people.
This commitment that we are discussing here today is one which brings together some of the changes obtained throughout this process. To begin with, we started in the market and ended up in health (and I heartily welcome this move to health); to begin with, we started with physical space, and included the Internet, as we could not leave out the main gateway for falsified medicines in Europe; to begin with, we had merely a monitoring system, and we went on to add sanctions and penalties to this. If we consider that falsification is a crime, we had to add sanctions and penalties.
There is also another important element: this is not confined merely to Europe. We also ensure that third countries, where the situation of falsification is even more serious, are considered within our proposal presented here today.
We know that, in spite of only having random monitoring, since 2005, there has been a 400% increase in the seizure of falsified medicines. We know that this trade represents profits of EUR 45 billion per year for certain criminal networks, but a total disaster for citizens' health.
That is why I wish to make it very clear that the counterfeiting of medicines is not just any counterfeiting, because it is a form of counterfeiting which completely undermines confidence in our health systems. As falsification is an organised crime, as I have already mentioned, I believe that we have to combat it with this legislation, with our commitment, and with our concerted efforts. Therefore, we present a monitoring system which extends all the way from the manufacturer to the patient. This has been a battle for Parliament, and something which I am very pleased is now assured.
This procedure has passed through two Commissioners and four presidencies. We began with the Commissioner for Industry, as I mentioned, and we end now with the Commissioner for Health. It has been a long process and therefore, I would like to end with some words of very special thanks for the rapporteurs from other groups who have followed this procedure with great commitment and dedication, from the beginning to the end: Mrs Grossetête, Mrs Roth-Behrendt, Mr Krahmer, Mr Tremopoulos, Mrs Yannakoudakis and Mrs Rosbach. Without them, this would not have been such an interesting and, at the same time, productive, debate. I know that at times, we have adopted differing stances, but I also know that we have had a common objective, that of protecting patients' health. As I cannot thank all those who have been involved, I would like to offer my symbolic gratitude to all those who worked on this directive by naming Mrs Pantazidou, who gave me immense support throughout the whole procedure.
John Dalli
Member of the Commission. - Madam President, I am very pleased to have this opportunity to address Parliament on this important issue of falsified medicines. The proposal before us today for an amending directive on falsified medicines will, subject to Parliament's approval, take us into new territory. A successful conclusion of this file will mark the first time that the European Union has tackled, with legislation, the specific threat of falsified pharmaceuticals.
This text is going to make our regulatory system fit for the future; making a major contribution to protecting patients from the many dangers of fake medicines. As Members will know, falsified medicines are different from counterfeit products. Falsified medicines are about public health.
I was very pleased that an early agreement on the substance of the proposal was reached between the colegislators just before Christmas. Let me thank all those who worked so hard to make this agreement possible, especially the rapporteur of the lead committee, Ms Matias, as well as the rapporteurs of the committees giving opinions, Ms Sartori and Ms Bastos. I would also like to thank all the shadow rapporteurs.
The Commission stands fully behind the substance of this well-balanced agreement, which introduces rigid and effective measures whilst being risk proportionate and flexible. This is crucial, as not all medicines are the same: the likeliness of falsification varies, as does the risk of public health.
Turning to some of the specific issues, I would like to highlight the following. On safety features: we saw the risk that Member States might, in future, take divergent approaches on the packaging. This would have led to different levels of protection in the European Union. It would have led to a fragmentation of the European Union market for medicines. I am sure Members will share my satisfaction that we have paved the way towards a European safety feature to identify and thus authenticate a medicine. The Commission has always supported a European approach in this regard.
On active pharmaceutical ingredients: the agreed text strengthens inspections and international cooperation in this field. The Commission and the network of European agencies will work more closely with international partners. Only through such cooperation can we achieve a truly effective system of inspection and enforcement.
The legislation, once adopted, will increase the transparency of actors involved in the distribution of medicines. Finally, Parliament insisted on rules concerning online sales of medicines. I consider that Parliament found a strong, pragmatic solution by focusing on issues of transparency. The argument acknowledges that the rules for pharmacies in the EU vary but, in future, it will be easier for patients throughout the EU to distinguish legal operators from illegal online pharmacies.
President, Members, I trust I can count on your full support as regards the next step in the legislative process towards finalising this worthy and much needed initiative.
Regina Bastos
Madam President, I would like to begin by congratulating the rapporteur, Mrs Matias, and thanking everyone who collaborated with her.
Sadly, over the last few years, we have witnessed an increase in the falsification of medicines here in Europe. According to European Union data, currently 1.5 million boxes of falsified medicines are sold every year via the legal supply chain. This is a criminal activity which represents a serious threat to European patients and industry. The purpose of this directive is to block the introduction of falsified medicines into the supply chain, and thereby protect public health.
I would like to highlight the following key points in the opinion that I drafted: the introduction of a definition of falsified medicine, which clearly places the emphasis on consumer protection, the application of safety provisions to those medicines which are subject to medical prescription, the accountability of all participants in the supply chain and, finally, the application by Member States of effective sanctions to deter this criminal activity.
Amalia Sartori
Madam President, ladies and gentlemen, first of all, I would like to congratulate the rapporteur, Mrs Grossetête, on the good work she has accomplished. Falsified medicinal products are dangerous because of their huge public health impact, not to mention their economic impact.
Although the compromise text is a decided improvement over the provisions of the 2001 directive, it does not touch on certain issues that I think are fundamental, which I would like to mention here. Manufacturers of active substances based in third countries should be subject to inspections by the Member State to which those substances are destined, to be mediated by the competent authorities of the third country in question.
Medicinal products should be clearly traceable as regards the manufacturer and the country of origin of the various active substances whenever this information is not specified in the new formulation. The issue of Internet sales remains unresolved.
Nonetheless, I would stress that the report is positive overall and makes improvements, and I support Mrs Grossetête in favour of the compromise.
Françoise Grossetête
Madam President, Commissioner, I would like to start by congratulating the rapporteur, Mrs Matias, on her work. I would also like to congratulate the Council and the Commission, since we have finally reached agreement on this extremely important directive on combating organised crime linked to falsified medicines. The numbers are too high: 34 million falsified medicinal products seized in the European Union in 2008, a massive increase of 380%. Over 50% of medicines sold over the Internet are falsified, representing a real menace to all our fellow citizens.
The directive represents a step forward. I see it as just a step, because unfortunately, we have not gone far enough. We should have moved faster. However, it is a step forward, with stricter inspections for the manufacturers of active ingredients constituting a particularly valuable feature. We are seeking to improve safety and that means we need to identify the responsibilities of each player in the supply chain: manufacturers, wholesalers, parallel importers, brokers and distributors. In the interests of safety, we also need to ensure that every box of prescription medicine is traceable. I would have liked the proposal to go further on this front.
In addition to guaranteeing authenticity by having a unique code for each package, the safety requirements also include rules on tamper-proof packaging for boxes that are handled by parallel importers. We have had lengthy discussions on this matter. It is an important point because we are currently dealing with a real scourge that has ramifications for public health. Pharmacists also need access to trustworthy supplies of quality products. I agree with you, Commissioner, when you say that we need to remain vigilant as we put all of these safety requirements into practice. Yet I do not think our work ends there. We will need to monitor carefully how this directive is implemented.
Dagmar Roth-Behrendt
Madam President, ladies and gentlemen, we can all imagine the nightmare. Someone we know is ill and in a desperate situation. They are given medicines, but the medicines have no effect, because they have been falsified.
We are grateful to the Commission for producing this proposal. It is true that we have been discussing it for some time. We began our debates in the previous parliamentary term and I would like to thank Mr Adamou, who is no longer a Member of this Parliament, for the preliminary work that he did on behalf of Mrs Matias.
I believe that we have reached a good compromise, as Mrs Grossetête has said. Yes, we could have gone further. We are all impatient and we all want greater safety, but this is a good compromise. What have we achieved? We have made patient safety the central feature of the legislation. The safety measures that we have put in place will ensure that products are traceable throughout the entire distribution chain. Medicines can be traced from the manufacturer to the pharmacist. They will have an identifier which makes it immediately obvious if they are falsified or duplicated or if there are any irregularities, which can then be followed up. We have deliberately done this in such a way that the costs of the system remain at a reasonable level for everyone involved and that the system is not excessive. However, we are also not compromising on patient safety.
This traceability is accompanied by the fact that the packaging must be undamaged, so that a patient who is given a pack can see that it has not been opened because it has an intact seal. In addition, there will be no more packs of medicines which are divided in two, as frequently used to be the case. All of this will improve safety levels and increase patients' confidence.
What else have we achieved? We have implemented an early warning system. This is excellent because it is the same system which has been in place for decades for foods and which we take for granted. There is an early warning system throughout the European Union for contaminated food. It is hard to believe that we have not had the same thing for medicines. If a falsified medicine is discovered, it is now possible to send out an early warning. The Member States must identify the patients who are affected, inform everyone involved and make sure that the risk involved in a medicine which is in circulation is made public. We take this for granted in the case of cars and food, but it has not been available so far for something as essential as medicines.
As far as the Internet is concerned, anyone who accesses an illegal website must be able to recognise that it is illegal. This is why we must certify legal websites which, in future, will have a link to the website of the national approval body. They will be able to display a logo which will be developed by the European Commission. Everyone who buys medicines on the Internet can do so independently. They can tell whether they are dealing with a safe, legal website or an illegal one.
All of this is a milestone, a quantum leap forward in patient safety. If we adopt this legislation tomorrow, we can be proud of what we have done and we should also make our achievements clear to the general public.
Holger Krahmer
Madam President, Europe is rightly regarded as having the safest medicines in the world. With this legislation, which we have been discussing for a long time, for two years I believe, we will further improve levels of safety. I would like to thank Mrs Matias very much for taking on such a complex report as a new Member of Parliament. This was a huge task and she has done very well. It also involved a great deal of teamwork and I would like to thank everyone involved for this. We have produced some very good results.
However, we must not lose sight of the fact that we can never achieve complete safety by means of regulations. This is true in every area, not just in the case of medicines. We have rightly concentrated on the essential issues, on the distinctions between different types of packaging and on traceability in the distribution chain. By differentiating between prescription and over-the-counter medicines, we are taking the right approach, because we must remember that every piece of legislation and every attempt to make products safer costs money. Therefore, it is reasonable not to include every pack of aspirins or every over-the-counter medicine automatically right from the start. Instead, the Commission or the agency must be given the task of monitoring the market and investigating developments.
I believe that we can be proud of what we have achieved. We have produced a piece of legislation that brings real benefits. Most patients will probably not be aware that they are the result of EU law and, therefore, we must make this very clear.
Michail Tremopoulos
Madam President, tomorrow, we shall be voting on this revised directive to combat the risk of millions of falsified medicinal products entering the legal supply chain, precisely because we want to protect public health from this silent killer.
The basic issue is that we need to establish a mandatory safety feature for prescription medicinal products, under certain circumstances, and for non-prescription medicinal products at risk of falsification, based on certain risk-assessment criteria, together with strict controls of online sales via authorised Internet pharmacies which display the EU logo.
Following exhaustive dialogue with the Council and the Commission, we have agreed on numerous points in the compromise text. We in the Group of the Greens/European Free Alliance are in favour of extending the scope to all medicinal products at risk of falsification and of stricter regulation of online sales. I am delighted that these issues have been satisfactorily resolved in the final agreement with the Council.
Marina Yannakoudakis
on behalf of the ECR Group. - Madam President, I, too, would like to congratulate the rapporteur.
When we look at medicine in today's global markets, we see that there are no borders. Therefore, we have no option but to deal with the issue of counterfeit medicine in a global manner. Only by a united EU approach can we tackle the increasing counterfeit products available to the public - available not only through the shop floor, but via distribution services such as the Internet.
The directive presses all the right buttons and goes some way towards addressing the problem. Could we have gone further? The answer is yes. Should we have gone further? Here I must say no. We have laid down tighter controls on prescription medicine as a first step. We have addressed the Internet pharmacy issue. We have looked at the safety features. Yes, we could have gone further on the traceability, taking it up to the patient, but this is a battle that we would have lost and it would have delayed the directive.
As they say, Rome was not built in a day. I look forward to building on the foundations of this directive.
Anna Rosbach
Madam President, unfortunately, we are seeing more and more falsified medicinal products on the market in our Member States. That is why this proposal is so important. Patients in the EU need to know how they can avoid falsified medicinal products. They are also entitled to see that we, as legislators, are fighting to combat these products. It is important that we adopt clear definitions. All too often, we adopt legislation that is imprecise and unclear. This must not happen in such an important case as this. Medicinal products must be checked before they come onto the market and not only after patients have, in fact, been acting as guinea pigs for several years. We must satisfy ourselves that medicinal products are only imported if safety and the possibility of verification are given top priority. Falsification of medicinal products harms both the patients and the pharmaceutical companies in the Member States. I therefore hope that we can agree on a more stringent line than that proposed by the Commission, and I would like to thank Mrs Matias for her sterling work.
Peter Liese
(DE) Madam President, Mr Dalli, ladies and gentlemen, I, too, would like to thank the rapporteur, Mrs Matias. My thanks go also to Mrs Grossetête, the shadow rapporteur for the Group of the European People's Party (Christian Democrats), and Mrs Roth-Behrendt. The two of them have done excellent groundwork on this directive during the last parliamentary term.
The falsification of medicines is a growing problem. The number of cases identified amounted to 7.5 million in 2009, which is many more than in previous years. These are only those cases that have come to light. There is a large number of unreported incidents, which is why we can only assume that the problem is a major one.
It is very irritating if lifestyle medicines are found to contain no active ingredients. However, if essential medicines used to treat cancer, for example, contain no active ingredients, the wrong ingredients or the wrong dosage, this can put patients' lives at risk. This is why action was urgently needed. We have taken a reasonable approach. The subject of data protection is a highly sensitive one and we have found the right balance. We are acting on the basis of the risks involved and focusing initially on prescription medicines. There is an opt-out procedure available, if there is reason to assume that there is no risk. There is also an opt-in process for over-the-counter medicines, if there is reason to assume that they have been falsified.
Overall, this is a very good compromise and I would like to express my sincere thanks to everyone involved.
Judith A. Merkies
(NL) Madam President, thank you, Mrs Matias, for an excellent piece of work and for the good cooperation. I believe that this is a very important scheme for the health of consumers, although up until now, they have probably not even been aware that their health has been at risk. Fortunately, at least we have finally got round to tackling all the risks now.
People's health should not be trifled with. Indeed, I believe that, with this scheme, we are taking an important step towards making packaging safe and towards clarifying the situation. I am also very pleased that, at Parliament's insistence, the sale of medicines via the Internet has been included in the directive, because that was a thorn in everybody's side. If you view this situation as gambling with the health of consumers, then Internet sales are tantamount to Russian roulette. You have a 50 to 90% chance of encountering a counterfeit medicine, and then - bang! I am very pleased that this scheme has addressed that issue.
I do think, however, that some further modifications are needed, because we do not yet have cast-iron guarantees of safety. I suppose that is up to each individual Member State. Moreover, there is also the issue of the logo, of whether it will be entirely tamper-proof on the Internet, so we really have to keep an eye on this aspect.
Transparency and reliability for consumers; I hope that consumers can take a punt on medicines without gambling with their health.
Antonyia Parvanova
Madam President, let me first congratulate Marisa and my colleagues for reaching an agreement with the Council on such a complex dossier.
The text now on the table reinforces the security of our legal chain of supply for medicinal products, but let me emphasise that only 1% of falsified medicines reach our patients via this legal chain. The other 99% comes from illegal channels and the black market.
In this regard, I very much welcome the additional provisions focusing on the Internet put forward by the European Parliament. But in order to address this major risk for patients' safety, we must also reinforce EU actions in the field of justice, police and customs cooperation. The Commission should go further in this field and we insist on this to combat falsified medicines properly.
Regarding the specific provisions of the agreement to be voted on tomorrow, and most particularly the new safety features to be implemented, I would like to ask the Commission to clearly monitor the impact of this directive. In its initial report, the Committee on the Environment stated that the measures put in place should respond to three guiding principles: proportionality, cost-effectiveness and independence.
Miroslav Ouzký
(CS) Madam President, I would also like to thank the rapporteur and the shadow rapporteurs for an excellent piece of work. We all know that the pharmaceutical industry is very big business. It is said to be the third largest in the world, after drugs and weapons. It therefore offers rich pickings, and some people will always try to grab these by illegal means. We will never be able to prevent the production of fake medicines. Our task is to minimise the risk that they will get on to the European market and that they will reach our citizens. We know that when someone sells a counterfeit watch, that is an infringement of intellectual property protection, but when a counterfeit medicine is sold, it is a direct health risk.
It is this fact which has led us and is leading us to support this report. We know we cannot solve everything, and we know there is a problem, for example, over the fact that packaging is often produced separately from medicines, and that counterfeit medicines in genuine packaging are in circulation around the world. However, this is a step in the right direction and an attempt at the maximum possible protection.
Oreste Rossi
(IT) Madam President, ladies and gentlemen, although the Commission's proposed changes to the directive on medicinal products for human use are designed to help prevent the entry of falsified medicinal products, we would have expected more concrete results, particularly through the introduction of compulsory inspections of production sites in which active substances are manufactured in third countries.
That option was rejected on the grounds that such checks would be too costly. The fact is that European companies have to meet extremely high quality standards, whereas companies manufacturing in other parts of the world do not.
We are voting in favour, however, since measures are being introduced to make sure that imported pharmaceutical products are safer, including traceability, a ban on repackaging, compliance with EU safety standards, the partial regulation of Internet sales, and the possibility of extending similar measures to over-the-counter medicinal products as well.
Elżbieta Katarzyna Łukacijewska
(PL) Madam President, according to the World Health Organisation, around 10% of the global pharmaceutical market is accounted for by counterfeit medicinal products. It is hard to estimate the exact scale of the problem in the individual Member States of the European Union, but in Poland in 2009 alone, for example, customs officers confiscated over 100 000 falsified products.
Apart from falsified medicines, the problems which patients face include a lack of reliable information on the contents of packaging, and also the issue of repackaging, during which the contents may change. It is also very important for patients to be able to obtain reliable information on the Internet. Unfortunately, as well as much information which is genuine, there is a lot of information on the Internet which is false. Against this background, it is important to introduce a system for monitoring and checking medicines, which will provide patients with reliable information. We are aware, however, that even the best regulations will not bring about the anticipated effect if they include no provisions for appropriate penalties for entities which put counterfeit medicines into circulation. Today's debate is therefore extremely important, as is the introduction of regulations which not only prevent the distribution of counterfeit medicines and put in place a monitoring system, but which, above all, impose penalties on the manufacturers of fakes. Numbers of counterfeit medicinal products will only be reduced and their use made safer if measures of this kind are taken.
Finally, I would like to congratulate the rapporteur, Mrs Matias, on a good report. I am aware that it will not solve every problem, but it is a major step towards increasing patient safety.
President
Colleagues, just to say that you are all doing well in keeping to your speaking time, but you are stretching our interpreters' capacities by speaking very fast. Could we try and find a happy medium, please.
Gilles Pargneaux
(FR) Madam President, Commissioner, in the light of this text, allow me to express my satisfaction and to emphasise one requirement and one point on which we will need to be vigilant.
I am pleased that we have succeeded in extending the legal basis for this directive from the original single market remit to cover public health too.
We have a requirement: we have fought to ensure that online sales form an integral part of this directive so as to be able to create checks and controls that reflect our findings.
There is also one point on which we will need to be vigilant. We know that falsified medicinal products make up 1% to 3% of the market in developed countries, between 10% and 30% in Asia and Latin America, and up to 70% in some African countries. Some studies suggest that trafficking falsified medicines can be 25 times more profitable than drug trafficking.
To summarise: we have successfully established one requirement and one point on which we need to remain vigilant if we are to continue to develop greater international cooperation, which, in turn, will allow the European Union to take the lead in the fight against the blight of falsified medicinal products.
I would like to thank Mrs Matias for her work and also our group's rapporteur, Mrs Roth-Behrendt, who always provides valuable input in this field.
Horst Schnellhardt
(DE) Madam President, Mr Dalli, ladies and gentlemen, I would like to congratulate the rapporteur and also the shadow rapporteurs who have done an excellent job. Initially, we had a very heated discussion on this subject. However, the MEDI-FAKE action in December 2008 may have had an impact in this area. During the course of two months, 34 million falsified tablets were seized on the European Union's external borders. This was a warning which prompted us to speed up our work. We have now produced results that we can be really satisfied with. We have guaranteed the traceability of medicines. Every pharmacist can identify using a scanner whether a product is falsified or genuine.
However, I would like to make one request. It is true that websites are now being monitored and that they have a logo, although this can also be forged, but in the case of sales over the Internet, we need to do some public relations work to explain the risks of Internet purchases to the citizens of Europe. I am very pleased that parallel trade has been retained. It has a worse reputation than it actually deserves and its position has been guaranteed.
I would like to make one final point. We should perhaps consider, for the safety of citizens and to improve understanding, whether it would be a good idea to deal with the problem of widely differing pack sizes in different countries in order to introduce a standardised solution.
Zuzana Roithová
(CS) Madam President, for two years, we have been discussing the alarming growth in counterfeit medicines on our market, including lifesaving medicines. The result is a good directive which tightens up controls both on distributors and retailers, introducing mandatory protective measures and checks against infringement. Producers will also assess risks in respect of processing aids, all of which has been happening for years in the Czech Republic, for example. It is therefore excellent that this will apply throughout the EU.
There is also a need for the system not to be restricted just to prescription medicines. If we wish to avoid losing our fight against counterfeits, Member States must achieve a greater level of integration in the area of health, unite in banning websites offering counterfeits and introduce inspections at third country producers, as is the case already with imported foods. After all, in China alone, there are 500 factories for counterfeit medicines. We simply have to step on the gas if we want to enhance safety on the European market.
Åsa Westlund
(SV) Madam President, I would like to thank Commissioner Dalli, the rapporteur, Mrs Matias, and the shadow rapporteurs for their excellent work on an important matter, because falsified medicinal products clearly represent a serious threat to patients' health. What is particularly serious is the fact that the number of falsifications of life-saving medicines is increasing. These are medicines for the treatment of cancer, heart disease and infections, in other words, situations where someone really is in need of an effective medicine.
We are now taking a major step forward with regard to medicinal products within the EU, but the problem extends beyond the EU's borders. According to the WHO's expert group, many countries in Africa, parts of Asia and Latin America have areas where more than 30% of the medicines on sale may be falsified. It is therefore extremely important for cooperation with third countries to be strengthened, and hopefully the changes that we are now implementing within the EU will also have an impact on the countries outside our Union.
Struan Stevenson
Madam President, fake medicines, as we have heard, are an increasing problem.
Customs officials stopped 32 million counterfeit medicinal products from entering the EU in 2008. The WHO estimates that 50% of drugs supplied over the Internet are falsified and there are even cases when the legitimate supply chain has been infiltrated. For example, between 2005 and 2007 in the UK, there were a number of cases reported by the Medicines and Healthcare Products Regulatory Agency of fake lifesaving products, such as AstraZeneca's prostrate cancer drug, Casodex, and the antiplatelet drug, Plavix, which protects against heart attack and stroke, actually reaching wholesalers and even pharmacy shelves.
That is why we urgently need to tighten the rules on import, export and trade in fake medicines. I very much support this regulation.
João Ferreira
(PT) Madam President, the problem of falsified medicines obviously poses a serious threat to public health, whether these are prescribed drugs or over-the-counter products. Without prejudice to the adoption of some important measures proposed in this report, I wish here to draw attention to an essential element of this problem. As with other illicit activities, medicines are falsified because there are economic factors which stimulate that activity. Therefore, we have to attack the root causes which make medicines big business: one of the biggest businesses on a world scale.
We have to promote the strengthening of public policies in this area; we have to reinforce public capacity in the field of research and development of new drugs, attacking the monopoly of the pharmaceutical industry and its disastrous consequences in terms of access to medication; and we also have to strengthen public capacity in the areas of production, supervision and monitoring of medicines.
Jaroslav Paška
(SK) Madam President, I would like to support the submitted bill, which amends and adds to the directive from 2001 on preventing counterfeit medicines from entering the legal supply chain.
The dramatically worsening situation on the market, where the quantity of fake medicines in legal circulation has recently risen sharply, requires a thorough tightening up of rules on monitoring, as well as sanctions. The situation is all the more serious for the fact that counterfeiters, in a scramble to maximise profits, are progressing from fake dietary supplements to fake lifesaving medicines used for treating infections, heart disorders and cancer. Such counterfeits can have fatal consequences for patients, who may be quite unaware that they have become victims of fraud, and that the tablets they are using are only imitation medicines and will not cure them at all.
It is therefore our duty, ladies and gentlemen, to stand up to this dirty business affecting the lives and health of our citizens.
John Dalli
Member of the Commission. - Madam President, I am very pleased to be part of this positive movement and this very interesting discussion. This, in fact, is the second pillar of the Pharma package that we are delivering and the third pillar, that of information to patients, has already had a very good report here in Parliament. I hope that we will be pushing this quite aggressively during the coming months.
As you have said, and I agree, the emphasis is on protection of consumers. This is what the division should be in actions like the one we are taking today.
A lot of work has been done. A lot of work still needs to be done to develop the details to make this directive operational. But even after that, we cannot rest on our laurels, happy that we have a nice piece of legislation that has a lot of technical details that are very avant-garde. We have to inform our citizens of what it means, and how they can utilise the tools that we are giving them with this directive so that they do not succumb to the pitfall of being drawn into purchasing falsified medicines.
We will do everything in our power to ensure proper traceability. Inspections in third countries are important. We have to realise, however, that, for example, 80% of the ingredients that we use in what we produce in the European pharma industry come from third countries. Therefore, we have to be pragmatic.
We also have to be selective in the type of inspections that we do. There are third countries that have very high levels of inspection and standards and we naturally have to cooperate with these countries to ensure that these standards are being kept to. In other countries that are not as proficient as these, we have to go and see with our own eyes and touch with our own hands. This is the policy we have to push forward. I am looking forward to working with Parliament in the next phases to make this work.
Marisa Matias
rapporteur. - (PT) Madam President, obviously, I would like to thank my fellow Members for all the comments they have made. I am not going to mention them one by one, as this is not my intention. I think that if any doubts existed as to the meaning of the word commitment, it has become very clear here what it means. We do not all have perfect proposals, but more important than knowing whether a proposal is perfect is knowing that we have an instrument in our hands which will allow us not to have to put off the protection of our patients' health any longer. We are also bound not to delay its adaptation; we are bound not to delay putting it into action; and we can only do this if we work together.
I must also say personally - and the Commissioner mentioned the issue of inspections - that in my initial proposal, I presented a change to mandatory inspections in third countries. This is our commitment and yet we win in some areas and we lose in others. The Commission explained to us that this would be impossible to achieve.
I would like to mention something else with regard to this commitment. I think that we all see ourselves as being committed, but I also think and am aware that we must all demand that it is honoured because, otherwise, it will not be effective. This commitment contains guaranteed safeguards to ensure that we can follow the procedure, assess it and have systematic access to information which will allow us to verify whether or not it is being put into practice as it should be, and whether it is necessary to make some changes.
I would therefore like to end by thanking the European Commission for its collaboration and, in particular, the Spanish and Belgian Presidencies with whom we have been working over the last six months. There is no such thing as a perfect proposal, no such thing as a perfect action; there will always be flaws, but I think we have a strong and robust commitment which will allow us to fight for and defend patients' health. As my own speech is also full of flaws, I failed to thank my fellow Members, Mrs Bastos and Mrs Sartori, for the opinions of the other committees. Thank you also for your support.
President
The debate is closed.
The vote will take place at midday tomorrow (Wednesday, 16 February 2011).
Written statements (Rule 149)
Jolanta Emilia Hibner
Falsified medicinal products and the illegal trade in medicines are worldwide problems, both for highly developed countries and developing countries, and the problem is becoming increasingly widespread, posing a threat to patients' safety and lives. One of the reasons for this is that falsified medicinal products and drugs sold in places not authorised to sell them do not meet the quality requirements set for medicinal products, and contain prohibited substances whose use may have unknown consequences. I agree that the problem requires effective and strengthened international coordination and cooperation in order to guarantee an effective strategy for combating falsified medicines. I fully support the proposal that measures should be taken with the aim of minimising the problem of trade in falsified medicinal products, and also of trade in medicines sold in places not authorised to sell them and other falsified products fulfilling the criteria for medicinal products. Attention should be paid to the need to regulate mail-order and Internet sales of medicinal products.
According to information from the World Health Organisation, falsified medicines account for around 50% of products offered on the Internet. I believe that it is essential to plan and implement measures aimed at making information available on falsified medicinal products and medicines from illegal sources, and to run public education campaigns regarding the threats associated with purchasing medicinal products in places not authorised to sell them. I also believe that it would be a reasonable idea to put in place safeguards making it possible to identify medicinal products and to verify their authenticity and traceability.
Bogusław Sonik
Falsified medicinal products are a global problem, and should be examined in a global context. The reasons behind the problem include the high price of medicines and a lack of awareness among patients, but to a large extent, they are also of a legal nature. This situation is exploited by criminal groups throughout the world. I would therefore like to acknowledge the joint measures taken by the EU institutions and the almost unanimous position adopted by all the political groups on the drafting of a compromise legislative act on this matter. I wish to quote a statement by the former Secretary-General of Interpol, Ronald Noble, comparing the number of victims of terrorism and counterfeit medicines: over a period of 45 years, terrorists killed 65 000 people, whereas counterfeit medicines claimed 200 000 victims in China alone.
I believe that monitoring, control measures, tightening up standards and establishing a mutual recognition system, all of which are emphasised, are good solutions from which to begin. As Vice-Chair of the Committee on the Environment, Public Health and Food Safety, I would also like to highlight the role played by information campaigns aimed at patients, and also the imposition of obligations on pharmaceutical companies in this area. Patients should have access to high quality, objective information regarding the way in which medicines are prescribed and their properties.
Marc Tarabella
Falsified medicinal products make up 50% of medicines sold over the Internet and 1% to 3% of medicines sold by dispensing pharmacists. These falsified products are evolving: they now include life-saving medicines as well as lifestyle medicines. We have a duty to protect the health of our fellow citizens who choose to order medicines online in order to save time or money, unaware of the risks that they are running. What is more, these falsified medicines are entering the formal supply chain and finding their way into dispensing chemists' stocks, where they could prove deadly to any one of us. Every year, 200 000 people lose their lives after ingesting falsified medicinal products. This is more than just a worrying trend: we need to fight this scourge with all the means at our disposal. For this reason, I welcome the forthcoming adoption of the directive, which will introduce a unique track and trace code to prove that medicinal products are authentic, together with a standard logo to identify trustworthy websites selling pharmaceutical products. However, I would like to stress that providing this safety, to which patients are entitled, must not be used as a justification for price increases.
Siiri Oviir
The pharmaceutical industry is one of the three most lucrative industries. It is certainly one of the main reasons why counterfeit pharmaceuticals are spreading on to the market. Last year, customs confiscated 384% more counterfeit pharmaceuticals than were confiscated five years ago. In combating this phenomenon, it is very important to accept unified security measures within the European Union, including repackaging. Patients need to have complete confidence that any medication they are taking is indeed what they think it is and that the active ingredient in the prescription corresponds to what is in the medication. From the perspective of national health, it is of the utmost importance that the medication should be effective, high quality and safe. False information campaigns by third-party pharmaceutical companies that have procured a licence to sell from competent institutions must be prohibited. This prohibition should also be extended to information and advertising distributed to medical staff.
Elisabetta Gardini
It is essential to protect the pharmaceutical supply chain against the entry of falsified medicinal products for the sake of the general public and companies that operate correctly and responsibly. The directive being examined by Parliament must therefore be supported wholeheartedly, since it introduces procedures and obligations that I hope can lead to concrete and effective results. In particular, I would like to underline the importance of certain obligations placed on a range of actors involved in the supply chain, from distributors to wholesalers, and, above all, the introduction of 'safety features' on prescription medicinal products with the aim of assuring consumers of the integrity of the manufacturing and supply chain. Stricter rules on inspections, on the traceability of the substances contained in medicinal products, as well as on online sales, are further measures that I think will curb the trade in falsified medicinal products. It should be noted, however, that the compromise text establishes that there will be regular inspections at production sites in third countries, but that they will be carried out by the authorities of the third country in question. It would have been better if they were to be performed by the authorities of the countries to which the medicinal products are destined, because the main threat of falsification comes precisely from third countries.
Cristian Silviu Buşoi
The compromise which has been reached is balanced and marks an important advance for patients' safety and health. I welcome the inclusion of safety devices on the medicines' packaging. To ensure that these devices are really effective, it is crucial that all those involved in the distribution chain are subject to more stringent rules. The involvement of brokers is undoubtedly a positive step.
The compromise also strikes a balance between protecting patients' health and the costs which the new regulations will incur for pharmaceutical manufacturers. It is of paramount importance for us to adopt an approach based on the risk of the relevant medicines being falsified. This is why I believe that restricting the new devices to medicines issued on prescription is a welcome measure. It would be inappropriate for pharmaceutical manufacturers who are not targets for falsification to bear the high cost of the security devices.
Finally, the inclusion of online pharmacies marks significant progress for the safety of patients who tend to purchase medicines via the Internet. We cannot allow counterfeiters to benefit from a legal vacuum, thereby endangering patients' health. Establishing guarantees indicating that a website is selling genuine medicines will assist greatly all those patients who use this purchase method.
Annex - Position of the Commission
Amendments:
Directly acceptable: amendment 120 (Text as a whole, Block No 1, compromise amendment). The Commission is in favour of the adoption of the compromise text by the colegislators
