One step closer to decoupling veterinary medicines from the human medicines legislation


The European Economic and Social Committee (EESC) has published Opinion (2015/C 24207) which broadly endorses proposals for three new regulations which decouple veterinary medicines from Regulation 726/2004, consolidate and update the legislation to create a new veterinary medicines regulation, and create a new regulation for medicated feed. The regulations will be directly applicable in Member States across Europe, and they aim to address the public health risk of antimicrobial resistance (AMR), stimulate competitiveness and innovation, cut red tape, improve the functioning of the internal market, and increase the availability of veterinary medicinal product.

The EESC is tasked with providing the views of those most directly affected by new legislation. It was therefore not surprising that the EESC was supportive of the new proposals since the existing legislation is widely criticised for creating a disproportionately high administrative burden on companies seeking to obtain and maintain marketing authorisations. The veterinary pharmaceutical industry has noted that red tape diverts potential investment away from new product development, and the industry highlights that such development is currently insufficiently incentivised by regulatory data protection (RDP), creating particular difficulties for the development of drugs for ‘minor species’.

The first proposal (the Regulation for Veterinary Medicinal Products) proposes to repeal Directive 2001/82/EC and will set out a regulatory framework tailored to the unique characteristics and specificities of the veterinary sector. This will include provisions for a streamlined centralised marketing authorisation procedure, the creation of a single product database, and simplified pharmacovigilance rules. The proposed regulation extends RDP protection from 10 years up to a maximum of 18 years dependant on the nature of the medicinal product and the target animal species. The requirement for a marketing authorisation to be renewed every 5 years will also be removed.

To improve the availability of medicines in clinical situations where there is no authorised veterinary medicine available, the existing veterinary prescription ‘cascade’ will be flattened so that veterinarians will be free to chose the best available treatment for the animal under their care. It is hoped that this will not have the inadvertent effect of encouraging off-label use of human medicines rather than incentivising the development of licensed treatments. Whilst the proposed regulation broadly aims to increase the availability of veterinary medicines, it will restrict the use of certain antimicrobials and will reserve certain products for human use only as part of the proposals to tackle AMR.

The second proposal (amending Regulation No 726/2004) proposes to uncouple the centralised marketing authorisation regulations for veterinary products from those regulations governing human medicinal products (the new centralised procedure for veterinary medicinal products will instead be included in the new Regulation for Veterinary Medicinal Products). References to veterinary medicines will be removed from Regulation No 726/2004.

The third proposal for a regulation on the ‘manufacture, placing on the market and use of medicated feed’ proposes to repeal and replace the outdated medicated feed Directive (90/167/EEC). Medicated feed is an important medium for the administration of veterinary medicines to food producing animals, and the commercialisation of medicated feed for companion animal species will be permitted for the first time under the new regulation creating a potential new opportunity for manufacturers. However, due to AMR concerns, the rules on the manufacture, supply and use of antimicrobials in medicated feeds are being tightened, which is likely to raise a number of practical challenges for the industry.

The new legislation is much needed and it is appropriate that veterinary medicines are legislated for separately owing to the differences between the human and veterinary sectors – the veterinary sector is relatively small but high-tech and it must therefore be sufficiently supported by the legislation to ensure that innovation is stimulated, whilst ensuring that consumer and animal safety is protected. It is hoped that the new legislation will drive innovation and relieve the industry from a historically disproportionate administrative burden, whilst also taking steps in the global fight against AMR.