Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-016"
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"Mr President, for our part, the revision of the pharmaceutical legislation must aim, first and foremost, to ensure the safety, quality and efficacy of medicinal products available on the European market, in order to protect public health. The Committee on the Environment, Public Health and Consumer Policy has taken this into account by voting – by a broad majority – against any direct to consumer advertising for prescription medicines, whilst increasing the transparency of market authorisation procedures. Patients have a right to objective and reliable information on illnesses and on the therapies available to treat them. What better information can we give than to make available to the public the database containing all the medicinal products registered at the Agency, together with the evaluation report on these products, the reasons for their authorisation or their rejection and the explanatory leaflet on the results of clinical trials, be they positive or negative?
On the contrary, information obtained by the pharmaceutical industry alone cannot be objective and more or less equates to advertising direct to consumers. Furthermore, it seems important that stricter rules be adopted when promoting medicinal products for use by professionals, which is what, in fact, happens in my own country. We must increase the transparency and independence of the Agency by making it accessible to consumer and patient representatives.
The safety and the quality of medicines are based on a scientific evaluation, which highlights the risks and benefits of the product. The risk/benefit
relationship makes it possible to determine whether or not the market authorisation can be issued. This must be re-assessed, however, in order to take into account the effects related to its use as well as any new scientific data available. The administrative burden involved in the five-yearly renewal of the market authorisation in no way justifies the immediate withdrawal of any periodic re-evaluation of new medicinal products, in particular. That is why we are proposing that at least a re-evaluation takes place once the product has been on the market for five years. Far from running counter to the new provisions on pharmacovigilance, this measure clearly strengthens the safety of medicinal products. Similarly, we are refusing to reduce the time spent on the scientific evaluation of medicinal products, under the centralised procedure as well as the decentralised procedure, and even in the case of the accelerated procedure or the reduction protocol that we support.
Lastly, the effectiveness of a medicinal product can only be demonstrated when it is compared to that of other medicinal products available to treat the same conditions. Is it any good developing new medicines which add nothing in therapeutic terms or to maintain products that have been overtaken by new medical technologies? The initial evaluation, and that carried out after five years, provide the opportunity to weigh up the added therapeutic value of medicinal products. This measure can only motivate European research and innovation.
Finally, we are opposed to the amendments which seek to limit the centralised procedure and to encourage the procedure of mutual recognition, or even to delay generic products coming onto the market. We welcome the adoption in the Committee on the Environment, Public Health and Consumer Policy of the amendments on the impact of medicinal products on the environment. My fellow Members have supported us on this issue and we are rather pleased by this.
To sum up, Mr President, although pharmaceutical companies have, by and large, been backed up in the Commission’s initial proposals, we have a duty – and this must be the mission of the European Parliament – to protect the interests of citizens, patients and consumers."@en1
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