Statement Medicines Availability at Centre of Debate at Second Commission-EMEA PERF Conference
Tallinn, Estonia, 5 April 2002: Central and Eastern European “Candidate Countries” were urged by panel experts at the second Pan-European Regulatory Forum (PERF) not to import the existing western European veterinary medicines availability crisis on their accession to the EU.
The participants of the PERF, which was held in Tallinn, Estonia, April 3-5, were encouraged not to make the same mistake as some of the existing EU Member States had done – insisting on re-examining every single file brought before them – but rather to use the existing provision of “Article 7” as a kind of automatic mutual recognition, in the same way that Luxembourg systematically does.
The veterinary medicines availability crisis is of strong concern to the candidate countries, as it is for the current EU Member States. Proving the point was the fact that one-fifth of the 350 PERF attendees attended the Veterinary track, far more than could have been expected, given the comparative size of the human and veterinary pharma markets.
“The possibility of automatic Mutual Recognition is sometimes overlooked by existing EU Member States,” reported Dr. Johan Vanhemelrijck, FEDESA’s Secretary General. “We wanted to make sure that the Candidate Countries are well-informed that this possibility exists. This gives them the option to use it, rather than importing our own existing EU medicines availability crisis.”
He continued, “We in the EU sometimes forget that the possibility of “automatic Mutual Recognition” exists to make our lives easier. I am very pleased that the Rapporteur, Peter Jones of the EMEA, highlighted this in his conclusions. Maybe if we are faced with the reality of exporting this EU problem, we can take steps to solve it before it happens!”
Furthermore, the attendees were urged to push for the extrapolation of MRLs so that the “All Species” status of an MRL could be re-installed. “The species-specific MRL is one of the major causes for the loss of indications and species, and this is another problem we should learn from and should not be imposing this on the candidate EU Member States,” commented Dr. Vanhemelrijck.
FEDESA expressed overall optimism for the future, following the conference. “It is the first international conference that has officially recognised that there is a medicines availability crisis in its conclusions,” according to Dr. Vanhemelrijck. “And of course, it is only when one recognises a problem that one can begin to seek solutions. So that is a big step in the right direction,” he concluded.
1. The Pan-European Regulatory Forum (PERF) in Tallinn was organised by the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA).
2. PERF aims to report on the progress achieved to date, stimulate discussion of issues topical to the enlargement of the EU and stimulate input and discussion particularly on the theme of practical implementation of the acquis communautaire in the Candidate Countries. 3. FEDESA, the European Federation of Animal Health, represents the animal health industry in Europe. Its membership comprises 15 national associations and 15 companies active in the research, development and marketing of veterinary medicines. FEDESA works towards a European environment where the value of safe and effective animal health products is recognised and where these high-quality products can be developed, registered and provided quickly and economically.
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