During its annual conference yesterday, IFAH-Europe presented the “1-1-1 concept” – its plan to optimise current regulatory framework in preparation for a review of the veterinary medicinal products legislation in2010.
Speaking on behalf of European health commissioner Androulla Vassilious, Philip Tod kicked off proceedings at the opening of the International Federation for Animal Health Europe (IFAH-Europe) annual conference – The 2010 review: one vision, one final step to one market? – by addressing the need for prevention of the occurrence of animal diseases and the reduction of their impact, as well as the ongoing work towards replacing the current complex legal structure by a simpler framework.
During his speech, Mr Tod highlighted how one of the fundamental issues to be addressed in the new Animal Health Law is keeping the animal health legislation up to date with the evolution of relevant technology: the availability and innovative development of veterinary medicines, including vaccines and diagnostic tools, is clearly of major importance to community animal health policy.
Rolf Eriksson, Swedish state secretary for agriculture, underlined the importance of preventive healthcare and improved biosecurity, while acknowledging that pharmaceuticals can be of great value to prevent diseases from spreading and a tool for eradication.
MEP Avril Doyle said: “The EU has a responsibility to ensure that its legislation is not a disincentive to bringing to the market high quality veterinary medicines which are critical to protect both animal health and welfare and the public health through the food chain. An efficient regulatory process is needed to support this common goal and therefore a reform of veterinary medicines legislation is much needed to make it fit for purpose.”
According to IFAH-Europe, one of the ways to tackle this reform is its 1-1-1 concept.
Quality, safety and efficacy described in one single EU dossier as the basis for granting marketing authorisation for veterinary medicinal products, with one single assessment of the dossier employing the best expertise available, resulting in one decision for marketing authorisation.
Representing IFAH-Europe, Neil Craven, senior director of regulatory affairs for Pfizer Europe, said: “This concept appears to be the most simple and straightforward way to address all of the major deficiencies of the current system and to finally achieve the goal of a single market for safe and efficacious veterinary medicines.”
Patrick Dehaumont from the Heads of Medicines Agencies said: “The HMA has agreed a global vision for veterinary medicines legislation that will provide the greatest range of authorised products available in all member states, safeguard food-production, and be responsive to new animal health disease threats; it will help the realisation of the single market in the spirit of the Lisbon agenda.”
To achieve this Dr. Dehaumont noted that the legislation needs to be proportionate to the risks with the least administrative and development costs for companies and it also needs to strengthen cooperation and confidence between national competent authorities.
Closing the conference, IFAH-Europe managing director Declan O’Brien said: “Our annual conference was a key event in developing consensus on ideas for the future review of the legislation on the authorisation of veterinary medicines foreseen in 2010, bringing together all stakeholders in the sector and players along the food chain. IFAH-Europe will continue the open dialogue with these partners so as to agree proposals in 2010 for streamlining the Animal Health legislation.”