Green Light on the New Veterinary Medicinal Products Legislation in the EU
Last June, the EU Parliament started discussions and issued amendments on the European Commission’s Proposals for two new Regulations. Alongside, the FVE (Federation of Veterinarians of Europe) issued their comments on the amendments of the two proposals made by the EU Parliament, in September 2015.
The first such amendment aims to repeal and replace the Directive 2001/82/EC (Veterinary Medicines Code). After long discussions and consultation by the interested stakeholders, the problems were spotted and the light of new measures was switched on: the current legislation is considered obsolete, does not reflect the scientific advancements in the sector, cannot combat the lack of availability of veterinary medicinal products in certain markets, does not contribute to the smooth functioning of the internal market, by imposing disproportionate administrative burdens and, as a result, hampers innovation.
To start with, the new secondary legislation applies the foundation principles of the primary EU law, regarding, firstly, the establishment and functioning of the internal market as well as the approximation of regulatory and administrative procedures (article 114, Treaty on the Functioning of the EU) and, secondly, the competence of European Union to take measures in order to ensure a high level of public health protection, particularly in the veterinary field according to the article 168 par 4 of the Treaty on the Functioning of the EU.
The main points of the upcoming legislation could be identified as such:
(1) The first significant point of the legislation is that only veterinary medicinal products which meet the standards of safety, quality, and efficacy, set by European Commission and after being authorized by the competent bodies can be placed on the market. The product can be marketed only for the approved indications and use, already included in the terms of marketing authorization. Stricter requirements are foreseen for medicines targeting at food producing animals. The applicants will have the burden to prove the quality, safety, and efficacy of the product by submitting the relevant data, with some exceptions foreseen, however, especially in emergency cases.
(2) In order to reduce packaging costs, the European Commission promotes the idea of one uniform package for all countries, the simplification and limitation of the necessary information and presents harmonized pictograms and abbreviations. Furthermore, the proposed harmonization of product characteristics aims to eradicate the divergences i) between the reference and the generic medicines within the same state or ii) between medicines in different countries.
(3) What is more, the proposal aims to facilitate the marketing authorization of generic products by reducing the documentation required by the competent agency.
(4) The European Commission, with the aim to give incentives to innovation, suggested the extension of the patent protection (from 10 years) by one year for any extension of one veterinary medicinal product to other species (up to a maximum of 18 years). Enhanced protection of 14 years will be also provided for the initial marketing authorization of medicines for minor species, instead of the basic 10-year period. Furthermore, the application for the extension shall be submitted three years prior to the expiry of the protection, which means that, just after the expiry, a generic product can be placed on the market.
(5) An important change constitutes the establishment of the unlimited validity of one authorization, which replaces the current system of renewals every 5 years.
(6) The centralized procedure, in the context of which the authorization is granted by the Commission, becomes optional for any other product, besides the mandatory procedure required for biotechnology products as well as veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. In this way, products shall be marketed in all Member States and the applicant will avoid the extra financial costs for national authorizations.
(7) In order to combat the urgent problem of antibiotic resistance, it has been foreseen that the Commission can restrict or exclude the use of certain antimicrobials in the veterinary sector. However, innovation shall also be reinforced in order to ensure that there are always new products in the pipeline to treat the diseases.
(8) In reference to the post-authorization period, only substantial changes to the safety and efficacy of the products will be subject to prior authorization. Moreover, the periodic safety update reports will no longer be obligatory. On the contrary, a risk-based approach is adopted. The Agency and the national authorities will cooperate to monitor and assess data on adverse events and decide on the actions required. In order to reinforce the traceability of the products and their properties, the Commission suggested the establishment of a central database for all authorized medicinal products which will be updated by national competent authorities.
(9) A new issue covered by the new legislation, which has caused heated debate among policy makers and stakeholders is the online sale of medicinal products. According to the proposal, this will be allowed for products already authorized in the Member state in which the buyer is established.
The new Regulation can be a significant opportunity to support innovation and the development of the European veterinary medicine industries, by ensuring extended intellectual property right protection and by reducing the financial cost of relevant investments. In the same direction, the harmonization of the requirements and the establishment of a common procedure will facilitate the industry functioning and the greater product availability, especially in smaller nation.