On the eve of a unique opportunity to reshape the EU regulatory environment for veterinary medicines and fully implement the single market, the International Federation of Animal Health in Europe (IFAH-Europe) met with European Commissioner for Health and Consumers Tonio Borg and representatives of the Irish and incoming Lithuanian presidencies to the EU alongside interested stakeholders to highlight the need for more harmonised regulation to encourage the development of innovative solutions for the protection of both animal and public health.
Europe has one of the world’s most stringent licensing systems for controlling medicines and with an unusually high administrative burden associated with the licensing of veterinary medicines (double that of human medicines), stakeholders agreed that reducing current processes to one single EU-wide marketing authorisation process would greatly improve the efficiency of the regulatory system. Hand-in-hand with improved data protection, this would have a knock-on effect on today’s dearth of new medicines to fight animal disease by stimulating innovation and encouraging investment in the EU animal health industry.
The disproportionate costs of product maintenance and insufficient data protection along with increasing demands for data on environmental impacts and pharmacovigilance have had a direct impact on innovation with companies having fewer new products in the pipeline. With a more streamlined system wherein a company submits one dossier, for one EU assessment, leading to one pan-European marketing authorisation would not only encourage innovation but it would increase competitiveness as small players as well as big players would have easier access to the EU market.
“It is only through a single market for all veterinary medicines based on one harmonised licensing system that we can hope to achieve our ultimate goal of improving the availability of authorised veterinary medicinal products for the benefit of vets, farmers, pet owners and animals across all EU Member States. We encourage policymakers to seize the opportunity to complete the journey to one true single market in veterinary medicines in the upcoming review of the legislative framework”, said IFAH-Europe Chairman, Alejandro Bernal.