Thursday, 11 April 2013

Working towards a harmonised EU-wide approach on medicated feed and veterinary medicine

The manufacture, distribution and authorisation of medicated feed and veterinary medicines among EU member states are currently under the spotlight.

Why? Under the current legislation, the lack of harmonisation of manufacturing standards of these products leads to very different national regimes, and ultimately inefficient intra-EU trade.

To safely harmonise the marketing of medicated feed and veterinary medicinal products in member states, and to ensure a better functioning of the single market, the Commission has decided to revise both the Directive on Medicated Feed and the Directive on Veterinary Medicinal Products.

Both currently present the same kind of problems when implemented – ill-defined provisions in the legislations lead to a lack of uniformity between member states and ultimately an imperfect functioning of the internal market and health-related risks.

On medicated feed, for example, insufficient and non-binding guidelines and inadequate mechanisms for the authorisation of premixes lead to a high diversity of national systems for the production and distribution of feeding stuffs. Different national systems and requirements then lead to cost differences between producers of these products.

Also, because of the lack of specification of production requirements, especially the provisions relating to incorporation of the medicine into the feed, there is a risk of incorrect dosage and ineffective treatment of animals, which can encourage the development of antimicrobial resistance. It is also deemed that the absence of common standards for carry-over of veterinary medicinal products residues into the feed for non-target animals increases the risks of cross-contamination.

Similarly, on veterinary medicinal products, the complexity of the provisions leads to high diversity in interpretation of the legislation and to lack of standardisation of the products’ components. Administrative difficulties to develop medicines on the EU market result in a high diversity of authorised medicines between member states, most veterinary medicines being authorised in a single national market. This is considered to put some farmers at a competitive disadvantage in the EU when they lack access to sufficient and suitable medicinal products in their country. On the health risk side, it is felt there are not enough incentives for the pharmaceutical industry to develop new medicinal products and that there is ultimately a lack of available medicines, especially for the treatment of rarer conditions.

To address these issues, proposals for two Regulations are expected to be published around the middle of the year, with the aim of being applied in the same binding way in all member states and avoiding interpretational issues.