Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-262"
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"en.20031216.6.2-262"2
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"Mr President, we have been working successfully on this project to revise European legislation on medicinal products for two years. It is true that, at that time, I had hoped for a lot more than this compromise package, negotiated with the Council and the Commission, which will be put to the vote tomorrow.
For me, this process of revision of the procedures for European marketing authorisation of human and veterinary medicinal products should lead to a radical development of the criteria for evaluating and authorising medicinal products in the interests of patients, public health and health-care professionals. The principal aim of this revision was to have the European Agency legally recognise all of the new substances. In actual fact, the centralised procedure will only focus on some illnesses. The London Agency has sufficiently enlarged its sphere of activity to ensure its funding, but the national authorities have, for their part, retained the most lucrative classes of medicinal products, namely those regarding neurodegenerative disorders or cardiovascular diseases. The interests of the Commission and the Council are safe, but are they those of the patients?
Over and above introducing Braille, we have improved pharmacovigilance and transparency in patients’ interests, but it is true that some last-minute Council compromises subtly weakened these gains. The majority of the documents relating to the evaluation of medicinal products should be publicly accessible, but what about pharmacovigilance reports? The public authorities responsible for issuing authorisations should be independent of companies but remain, in actual fact, dependent upon private taxation. Patients do not have the means to directly inform the competent authorities of the side effects of medicinal products, and doctors are not obliged to do so. It is a great victory, however, that advertising for medicinal products subject to prescription was rejected, but until when?
In terms of public health, the environmental impact of the new medicinal products should be assessed. This should not be the sole evaluation criteria, but it must be considered in the benefit-risk equation for a medicinal product and, therefore, be one of the conditions for granting a marketing authorisation. The environmental risk goes far beyond the damage to nature; pollution linked to discharges of toxic residue from medicinal products represents a risk to human health. Clearly, treatments for which the medical benefits outweigh the environmental risks should continue to be used. When effective alternatives exist, however, they should be promoted. I am sorry to say that the final wording of the amendments concerned does not recognise the full scale of the problem.
For a doctor such as myself, the evaluation of the effectiveness of medicinal products compared to others is sorely lacking in this new pharmaceutical package. It is only the safety and the quality of the new substances
that
count. It is of little importance whether or not they provide a significant clinical benefit. I endeavoured to make the concept of added therapeutic value acceptable in order to encourage firms to carry out research into substances that are genuinely innovative, and I came up against the opposition of all of the institutions. I was, however, persuaded that this debate will return to this House, because the pharmaceutical industry no longer wants to make do with placing new bogus treatments on the market and overprotecting them for years.
It is true that the major cause of friction related to the authorisation of generic medicinal products. The pharmaceutical industry is trying to delay the sale of generic products, and this is normal. The Commission and some Members shared this reaction, however, by restricting the definition of generic products, tightening the conditions for granting authorisations and extending the periods for authorisation by using various tricks: switch, new indications etc.
Despite opposition from the majority of Member States faced with problems of funding their social security, the first European medicinal products will have the longest protection period of administrative data in the world. I wonder, furthermore, about the compatibility of such protection with the Doha provisions that call for the creation of generic medicines for export. That is certainly the main concern raised by this legislation when it comes to funding public health. Finally, another major disappointment was in the area of homeopathic medicinal products.
In actual fact and in conclusion, I recognise that we have made much progress, and I welcome this, but it is true that there still remains a great deal to do in the years to come."@en1
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