The European Parliament is considering major changes to how veterinary medical products are regulated in the EU.
At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products.
Veterinary and human medicines regulations in the EU have been developed alongside one another. However, the European Commission has found that veterinary medicines require different approaches to regulation relative to human medicines.
As a result, the European Commission (EC) commissioned an impact assessment on the potential effects of revising veterinary medicines regulations in the EU between 2009 and 2011.
The EC had three major goals it sought to address through the impact assessment:
- increase the availability of veterinary medicinal products
- lessen the administrative regulatory requirements on veterinary products
- improve the functioning of the internal market for veterinary medicinal products
In the midst of the impact assessment, the commission launched a public consultation to poll stakeholders’ opinions of the existing regulations. The consultation received 172 responses from farmers, veterinarians and pharmaceutical companies. The EC used the feedback it received, alongside the recommendations in the impact assessment, to draft the proposed regulation, which was adopted by the EC in 2014.
The Proposed Regulation
Currently, veterinary medicines are regulated in the EU under Regulation (EC) No 726/2004, which establishes authorization procedures for human and veterinary medicinal products, and Directive 2001/82/EC, which establishes regulatory requirements for veterinary medicines.
The regulation being proposed is described in legislative proposal 2014/0257(COD) and would repeal and replace Directive 2001/82/EC. A second legislative proposal, 2014/0256(COD) covers amendments to Regulation (EC) No 726/2004 that would accommodate the new regulation.
The new regulation aims to address the goals determined by the impact assessment and add two new areas of focus. The new focus areas are:
- Stimulating competitiveness and innovation; and
- Addressing the public health risk of antimicrobial resistance (AMR)
Impacts if Adopted
If the new regulation is adopted, its requirements will take effect two years from the date it is enacted and is not expected to have any budgetary implications for the EC or European Medicines Agency (EMA). At the same time, the EC says the proposed regulation will lower costs for industry.
One of the proposed changes intended to boost product development would give companies an additional year of data protection for each additional species the product is approved for. Additionally, the proposal would increase the length of data protection for products approved for minor species, to 14 years, with four additional years added for each subsequent minor species the product is authorized for.
The regulation would also place restrictions on antimicrobial veterinary medicinal products, coinciding with a larger effort to combat antimicrobial resistance (AMR). Some of the changes would include restrictions on advertising, additional data requirements on the risk of AMR from a product’s use and prohibiting the use of certain antimicrobial substances for veterinary uses.
Another major proposed change is to allow retailers to sell their products online to member states in which they are authorized to be used. Individual members will be able to apply restrictions to online sales, but overall the commission thinks this will improve ease of sale.
The regulation will also require the establishment of an EU-wide database containing:
- veterinary medicinal products authorized within the Union by the Commission and by the competent authorities, together with their summaries of product characteristics, package leaflets and lists of sites where each product is manufactured
- homeopathic veterinary medicinal products registered within the Union by the Commission and by the competent authorities, together with their package leaflet and lists of sites where each product is manufactured
- veterinary medicinal products allowed to be used in a Member State