Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-256"
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"en.20031216.6.2-256"2
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".
Mr President, ladies and gentlemen, our debate this evening concerns the revision of the body of legislation relating to medicinal products in the European Union and its impact on patients and the pharmaceutical industry. In this context, it is important to note that knowledge about the manufacture of medicinal products and the action of any given drug is not general knowledge. Due to the complex scientific interactions and manufacturing processes, very few patients in Europe will be able to evaluate the opportunities, risks and prospects of success of a treatment with any given drug. That is why we need an agency to evaluate the safety, efficacy and quality of medicinal products on behalf of the patient.
I therefore believe that the overall outcome is good and that the compromise is worth supporting. I do not think that initiating a conciliation process with the Council will produce a better result, especially as it will not solve the two issues that I have mentioned. Tomorrow’s vote – and I urge my fellow Members to support the compromise on that occasion – will enable us to launch sustainable legislation on medicinal products. I would like to take this opportunity to thank my fellow rapporteur Mrs Grossetête, as well as the Secretariat, the Council and the Commission, for their cooperation.
This evaluation must meet high scientific standards, not only in the interests of patients but also in the interests of manufacturers. After all, if problems arise as a result of serious adverse reactions to a drug, the manufacturers are likely to forfeit their reputation and have to pay financial penalties, while patients have the physical effects to contend with.
This means that the reform of the legislation on the authorisation of medicinal products, which is the subject of our debate today, must guarantee the safety of medicinal products but also establish general conditions which authorise and underpin research by pharmaceutical companies and thus boost their competitiveness. This not only benefits the companies concerned; it also safeguards jobs. Not least, patients benefit from the research findings and from new and effective medicinal products.
With this legislation, we have, I believe, succeeded in resolving the dilemma between the need for high standards of health protection, on the one hand, and the industry’s calls for better conditions for research and competitiveness, on the other. In a global economy with different legal frameworks in Europe, Asia and the USA, and with the forthcoming enlargement of the European Union, this was not an easy task. The global compromise with the Council that has now been achieved offers us the opportunity to conclude the package reforming the legislation on medicinal products in the second reading.
It is a good compromise, as it generally reflects the views of this House on key issues concerning legislation, pharmacovigilance, the scope of the centralised authorisation procedure, protection and the composition of the Agency's Management Board. I believe that the compromise tailors the legislation to reflect scientific progress and economic developments, and patients will benefit from this.
Let me comment briefly on the key topics. A particularly important aspect of the reform of the legislation on medicinal products is improving pharmacovigilance. This House has successfully enforced a high level of safety in the authorisation procedure as well as an effective system of surveillance and control. With the establishment of a database at the European Agency for the Evaluation of Medicinal Products (EMEA), the Agency will in future play a key role in an effective pharmacovigilance system. This is especially important because a well-functioning pharmacovigilance system is essential for patients’ wellbeing. Although the compromise does not establish a compulsory centralised authorisation procedure for all new active substances – a proposal which was endorsed by this House at first reading – the list of indications has nonetheless been extended to include orphan drugs, with a further extension after four years to include indications for autoimmune and viral diseases. As a result, a wide range of new active substances will be subject to the centralised authorisation procedure in future.
The European Medicines Agency in London will guarantee, through the structures and working methods envisaged in this legislation, that scientific resources are coordinated effectively, thus safeguarding the high standards of the evaluations. Centralised authorisation through the EMEA will ensure that all patients in Europe enjoy the same prompt availability of innovative and effective medicinal products.
The provisions on data protection were another controversial topic. The protection period agreed in the current compromise, of eight years, plus two, plus one, for the centralised and the decentralised procedure, ensures, firstly, that there is an incentive to carry out research, and secondly, that the further development of proven active substances is rewarded. This uniform Europe-wide provision protects the economic interests of manufacturers engaged in research and the interests of generics manufacturers and – unlike the period originally proposed by the Commission – reduces the burden on the national health systems.
The global compromise with the Council places patients’ needs at the heart of the legislation, promotes research and innovation and also safeguards the competitiveness of European industry. That is why I urge you, ladies and gentlemen, to support the Council’s compromise. As is always the case with compromises, not all our proposals have been fulfilled. Nonetheless, I believe that we have found a solution, even on controversial points such as homeopathic medicinal products. Through the mutual recognition procedure, it is now possible for every patient in Europe to access these medicinal products. On the matters concerning the WTO, too, I believe that we have found an acceptable solution, although it is beyond the scope of this legislation to regulate these issues. The Commission has pledged to present a proposal on this topic in the new year."@en1
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