The availability of veterinary medicines in the European Union
Further to the completion of the 2007 Report on Availability of Veterinary Medicines in which a survey on the usefulness of those legal provisions of the Directive 2001/82/EC which were intended to improve availability of veterinary medicines was provided, many Member States expressed the view that it was too early to make a judgement on their adequacy (as the legislation had only recently been transposed into national law). At the HMA meeting in February 2011, it was agreed that a further survey should be undertaken . This was done during the Spring 2011 and was presented to the second meeting of the HMA under the Hungarian Presidency. The Report was adopted by the HMA and is attached.
The availability of an adequate range of veterinary medicines to treat the wide variety of animal species in the European Community has been a growing challenge over the last two decades. During this period, considerable efforts have been made by various stakeholders, including regulators, industry, veterinarians and other users of medicines, to address the problems of medicines availability. Despite these efforts, the situation has continued to deteriorate.
Recognising the gravity of the issue, the Heads of Veterinary Medicines Agencies (HMA-V) established a Task Force (TF) on availability of veterinary medicines in July 2005. The TF was requested to produce a report on the adequacy of current legislative and regulatory measures relating to the availability of veterinary medicines, including:
• medicines for food-producing and companion animals,
• pharmaceuticals and vaccines and,
• the success of initiatives in Member States.
The Task Force provided a Report to the HMA-V in February 2007. The Report contains clear recommendations (short-term, medium-term and long-term) for consideration by Member States, HMAs, the European Medicines Agency, as well as for the Commission to help bring solutions to the problems. The Report states that notwithstanding the economic obstacles and specific problems in smaller markets, there are legislative and regulatory tools available which have the potential to ameliorate the situation. The Report also notes that the free movement of animals and their food products between Member States serves to underscore the need for harmonised interpretation of the available tools at least between neighbouring countries.
In adopting the Report, HMA-V noted that the recommendations contained therein must be taken in the context of an understanding of the need for consumer protection and that implementation measures will respect existing laws and the limits of budgetary provisions.
HMA-V will continue to monitor the situation over the coming years.