Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-007"
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".
Mr President, Commissioner, the subject that we are discussing today is one of the most important themes of our parliamentary term, since it ultimately concerns every European citizen. Allow me, first of all, to thank all my fellow Members from all the political groups for the discussions that we have had and the work that they have performed via the 800 amendments. In my opinion, there are rather too many amendments, which may be very detrimental to the quality and coherence of our work.
Lastly, we cannot speak about the revision of European pharmaceutical legislation without addressing the issue of information and the Commission proposal, which seeks to provide authorisation, on an experimental basis, over five years. We must also address the communication, by industry, of information relating to specific medicinal products for the following conditions: asthma, AIDS and diabetes. The medicinal products market is unique and our objective must not be to encourage maximum sales. It is vital to maintain a very clear distinction between information and advertising and to place a strict ban on the latter. There is no better information than that given by a doctor or a pharmacist.
Information systems, however, particularly via the Internet, have been widely developed and it appears quite unfair that only those who have access to the Internet and can speak English are able to gather this data, and not other people. We must avoid, however, any move leading to the development of deceptive and misleading information that seeks to promote the prescription, sale or taking of a specific medicinal product.
The Committee on the Environment rejected the Commission proposal by a huge majority, as it was deemed to be overly ambiguous. This unmitigated rejection poses a problem, however. I hoped that the concepts of information and advertising would be better defined, and I proposed a system for the prior validation of the information by neutral scientific organisations. This proposal could pave the way for the foundation of an exhaustive new study, which we are awaiting from the Commission.
On the other hand, there is an essential source of information. I am referring to package leaflets. All the amendments tabled on this issue seek to improve the way they are written, to make them clearer and easier to understand. This is a very positive point.
To sum up, I must stress the importance of enlargement. We cannot deny the fact that the revision which will be adopted will apply to the incoming countries. That is why I proposed, in particular, what I shall refer to as the ‘euro-generic’ product. Within some of the candidate countries and for historical or economic reasons, reference medicinal products have never been registered. The updating of generic authorisations in accordance with European legal requirements in the candidate countries therefore requires the possibility of referring to a reference product. The absence of such a product could pave the way for an obligation to withdraw generic medicinal products from the market, which nonetheless conform to the requirements of quality, security and effectiveness. This is a situation which causes problems of access to generic medicinal products. It therefore seems important that a reference medicinal product present in another Member State be able to serve as a reference.
Each new candidate country has an important role to play as a fully committed player in the integration and development of this ‘Europe of health’ that we are all hoping and praying will be realised.
The main objective of the proposals is to ensure a high level of health protection for each citizen, particularly by providing rapid access to innovative and safe products, by developing a preventative and on-going system of pharmacovigilance, as well as by improving the competitiveness of the pharmaceutical industry within the framework of its search for new treatments. We must not forget the essential boost which must be given to the generic medicinal products industry. A medicinal product is a product unlike any other. It is not purchased or consumed like an ordinary, everyday consumer item. Its use is unique and everyone expects a medicinal product to be safe and to work effectively. Safety, quality and efficacy are the three essential pillars of the European medicinal products market. Before being made available to patients, medicinal products must pass through specific and restricted phases in order to obtain a marketing authorisation.
At present, there are two procedures for registering medicinal products: the centralised procedure, managed by the European Agency, under which authorisations valid for all EU Member States are issued, and the mutual recognition procedure, for which the Member States have jurisdiction.
It is not our intention to alter the existing dual structure; the main task is to optimise the way it works. In reality, the question raised concerns new, active substances. We all agree that there is a difference between new active substances, which number almost 20 per year, and the new drugs, which amount to between 200 and 300 each year. Therefore, the Commission is proposing to introduce the registration, by means of a centralised procedure, of new molecules, so as to ensure that everyone has access to the most innovative therapies. Some Members wanted to question the principle. I would like to say to them that we are faced with a critical choice. You will choose between either health or the market. By adopting the amendment which calls the scope into question, we must respond to the following: how do we explain to those who are ill that their European neighbours will be able to benefit from an innovative and effective treatment, but that they will have to wait a few years until the authorisation is granted to their country? Faced with this perspective, let us take an extreme case involving enlargement: citizens from Slovenia and Portugal could, for example, be treated with a new therapy, but a German or Cypriot citizen could not have access to it. What do we do, in this case, as regards equality in the area of health? Some Members will say that the centralised procedure is costly for SMEs, but in the case of enlargement, the cost of 25 applications for market authorisation using the decentralised procedure will be much higher.
We are all mindful of the recent examples of medicinal products withdrawn from the market on public health grounds. We know that the issuing of an authorisation for a medicinal product does not, however, mean that checks are no longer needed on its efficacy and safety. It is thus essential to step up pharmacovigilance requirements, in order to offer patients the best possible guarantees, in other words with
inspections at the source of manufacturing, using purely public funding, which is indispensable if independence is to be guaranteed and, lastly, by means of a rapid system for exchanging data collated by all the partners, which will make it possible to achieve coherence in pharmacovigilance systems between Member States.
In order to manufacture a medicinal product, the applicant first needs to carry out extensive research in order to discover new molecules. We all know that innovation comes at a price. Industry therefore needs to guarantee the protection of this data. It is our duty to encourage research to ensure that science moves forward, hence the interest in retaining our best researchers. We also need to ensure patient safety, but equally to prevent Europe’s industries from falling too far behind other countries, from the United States and Asia. Of course, the usefulness of generic drugs has already been demonstrated. They illustrate the success of our European health systems. The introduction of adequate measures, therefore, particularly by means of the Bolar system will speed up their launch on to the market. We must also remember that generic products are only developed due to innovation.
I am also expecting all the Member States to run an information campaign for the general public, in order to explain what a generic product is, whilst stressing it is the therapeutic equivalent of the reference medicinal product.
With regard, more specifically, to veterinary medicinal products, the main challenge is to contend with the problem of the availability of these medicinal products. A balance has been sought between making some provisions more flexible, such as the ‘cascade provisions’ and maintaining the highest level of safety for the consumer, in the case of food-producing animals. When there is no medicinal product available for a condition or a given animal, the cascade system allows the use of medicinal products designed for other species, for other conditions or even the use of medicinal products for human use. This system was improved and broadened for optimal effectiveness and safety.
The Commission is proposing to extend the compulsory prescription to all medicinal products designed for food-producing animals, which poses a problem for some Member States, including Ireland and the United Kingdom. A compromise amendment, adopted by the Committee on the Environment, Public Health and Consumer Policy makes this measure consistent with the national provisions."@en1
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