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Medicines revisited

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THE title doesn’t exactly trip off the tongue, but a current EC consultation on veterinary medicines is no less important for that. The consultation – ‘Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies’ – was launched by the Commission last month and comments have been invited by July 15.* The outcome could lead to changes in the framework under which veterinary medicines are authorised and used in the EU which, given the need for veterinarians to have access to a range of safe, efficacious and quality-assured medicines to treat and prevent disease in animals, could affect the activities of all practising veterinary surgeons.

At present, the regulatory framework for veterinary medicines in the EU is provided by EC Directive 2001/82 governing the authorisation, manufacturing, marketing, distribution and use of veterinary medicinal products. The framework has been modified at various stages over the past nine years, most notably, perhaps, in 2004, when the changes required led to a major overhaul of UK legislation and the introduction, in 2005, of the UK’s Veterinary Medicines Regulations, which have since been updated annually. Despite the various changes that have been made, concern remains that the framework as it stands is restricting the availability and development of products. The EC’s consultation document seems to recognise this: it seeks views on the strengths and weaknesses of the arrangements and how the framework might be improved.

From the Commission’s perspective, the main purpose of the legislation is to protect objective is to achieve a single European market for pharmaceutical products. Giving an assessment of the current situation, the consultation document suggests that the existing framework has helped to enhance the quality, efficacy and safety of medicines to the benefit of animals, consumers of foods of animal origin, users of medicines and the environment, while also helping to establish consumer confidence. At the same time, it notes concerns that the authorisation processes are overly complex, and that the costs, time and uncertainties involved mean that there are insufficient incentives for companies to develop new products or keep existing products on the market. This problem is particularly acute where the market for products is small and the expected return on investment is low, either because a disease condition is relatively rare or a ‘minor’ species is involved. For some specific species and diseases, the possibilities of treatment with authorised animal medicines are limited which, the consultation document points out, poses significant problems for animal owners, farmers, fish farmers and veterinarians. It also points out that, despite the aims of the legislation, a single European market in veterinary medicines has not become a reality.

Following the consultation the Commission will assess the legal framework and, if appropriate, propose changes. The aim of the review is to increase the availability of veterinary medicines, reduce the administrative burden and improve the functioning of the internal market, without compromising public or animal health. The consultation document outlines various policy options and seeks comment on a number of ‘key issues’. These include the extent to which companies that develop new products can subsequently market those products exclusively, the availability of generics, and the use of national as opposed to centralised licensing procedures. It also seeks views on issues such as product packaging and labelling, pharmacovigilance and monitoring, internet trading, parallel imports, off-label use of medicines and whether EU medicines distribution channels should be harmonised.

Worryingly, given that the overall purpose of the exercise is to make more products available for use in animals, the document also seeks views on a proposal that could actually restrict availability. Specifically, in the light of concerns about antimicrobial resistance, it asks whether the legal framework should be modified to include a requirement to perform a riskbenefit assessment which also takes into account indirect risks related to the use of the veterinary medicine to animal or human health. It also asks whether the framework should be changed to provide a specific legal basis to restrict the use of antimicrobials that are critical for human medicine.

Any legislative review provides an opportunity for improvement but there is always a risk that changes could backfire. At this stage it is not clear how far the Commission will go in proposing changes to the regulatory framework but these are indeed ‘key issues’ and the consultation needs to be taken seriously.

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