Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Veterinary medicinal products authorised for rabbits in the European Union - Causes for insufficient availability and consequences on human and animal health ***

Nicole Dévaud (Abschlußjahr: 2012)

Over the past few years there has been considerable concern about the lack of availability of veterinary medicinal products across the European Union and its consequent negative impacts on animal and human health. The principal cause of insufficient availability of veterinary medicine is clearly found in the implementation of stronger regulatory requirements in the veterinary legislation (new standards for quality, safety and efficacy as well as obligation to establish a maximum residue limit for all pharmacologically active substances intended to be used in food-producing species) that leads to increased costs for the development of new veterinary medicines and for the maintenance of existing marketing authorisations. This problem is particularly acute in relation to availability of medicines for minor uses/minor species, because of the limited market and subsequent small return of investment intended for such veterinary medicinal products. Rabbits are particularly concerned by this issue, not only because of the obligation to establish maximum residue limits for meat-producing rabbits, but also because of their limited economic value. This target species has therefore been chosen to illustrate the current situation of the insufficient availability of veterinary medicines in the European Union.

Without adequate veterinary medicine, animal health care cannot be assured and untreated animals may be exposed to suffering and premature death. Veterinary surgeons are, therefore, often enticed to consider the off-label use of medicines and consequently to administer substances for which no efficacy and safety evaluation in the target species have been performed. As a result, animals are exposed to unexpected side-effects with possible fatal issues. The lack of veterinary medicinal products has also an impact on public health, principally through the impossibility to manage zoonotic diseases and through the increased risk of residues in food of animal origin when unauthorised medicines are misused.

Significant failures in the current veterinary legislation have been pointed out both by the industry and regulators and the lack of availability of veterinary medicinal products has been one of the main key drivers for a premature review of the legislation. The proposals to improve the legislation consist mainly of simplification of procedures with a trend to a single market for veterinary medicines in the European Union, reduction of data requirements and administrative burdens, improvement of data protection for major innovations and increased incentives for companies developing new medicines. All stakeholders (regulators, industry, veterinarians, farmers…) agree about the main necessary changes and proposals but, they have different opinions about some details on the implementation of the solutions. Taking into account available information and proposals received by all stakeholders, the European Commission is currently preparing its proposals for the amended legislation which is intended to be released in late 2012. The co-decision procedure with the European Parliament and the Council is expected in 2013-2014. The outcome of this "Review 2012" will have considerable consequences on registration of veterinary medicines and therefore, is eagerly-awaited by all parties involved.

Pages: 51