Greg Bacon and Janna Lawrence
The European Council has approved the text for a new Regulation that will overhaul the existing rules on the authorisation and use of veterinary medicinal products in the EU. The main changes being introduced are an extension of regulatory data protection to up to 18 years while some products will be prohibited from use in animals.
Proposals for a new Regulation were first submitted by the Commission in 2014 and were approved by the European Council and Parliament on 26 November 2018. Once the new Regulation comes into force, it will replace Directive 2001/82/EC, marking a significant divergence between human and veterinary medicinal product regulation at EU level. The aim of the new Regulation is in part to curtail antimicrobial resistance and to better reflect the individual market pressures experienced by veterinary medicinal products.
New incentives for innovation will be introduced along with a streamlined authorisation procedure. One of the incentives is an extended regulatory data protection period for technical documentation relating to veterinary medicines. Under the new rules data exclusivity will last:
- 10 years for the veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats;
- 14 years for antimicrobial veterinary medicinal products for cattle, sheep for meat production, pigs, chickens, dogs and cats containing an active substance which has not previously been an active substance in a veterinary medicinal product authorised within the Union;
- 18 years for veterinary medicinal products for bees;
- 14 years for veterinary medicinal products for animal species other than listed in paragraph 1(a) and (c).
The period of protection can be extended for additional species the drug is approved for subject to a maximum of 18 years.
Currently, the period of regulatory data protection is broadly in line with that available for human medicinal products, which allows for 8 years of data exclusivity and 10 years before a generic drug can be marketed that relies on that data, i.e. a further 2 years of market exclusivity. The period of protection can currently be extended to up to 13 years for products for bees and for additional food-producing species approvals.
The centralised marketing authorisation procedure is also being broadened to reduce the administrative burden on applicants. This will bring within its scope veterinary medicinal products that consist of: an active substance which has not previously been authorised as a veterinary medicinal product in the EU; biological products containing engineered allogeneic tissues or cells; and novel therapies. In addition, any veterinary product that has not already been granted a marketing authorisation within the EU may also be approved via the centralised procedure.
On the other hand, the Commission will be able to reserve groups of antimicrobials for human use and refuse a marketing authorisation on this basis. This will be done by implementing acts once the Regulation comes into effect.
A number of other rules are also being introduced in the Regulation. For example, there will be a complete prohibition on using antimicrobials for prophylaxis in animals and non-EU countries that wish to export animals or products of animal origin into the EU will have to abide by the rules reserving certain antimicrobials for human use or restricting them from being used for growth promotion.
Veterinary medicines packaging may also be simplified with the possibility of introducing pictograms as an alternative to textual information and pharmacovigilance will be integrated across the EU and include reporting of environmental suspected adverse events.
The new Regulation will start to apply three years after it is enacted, which is anticipated to be the end of 2018 or early 2019.
 The final compromise text is available at https://www.consilium.europa.eu/media/35934/proposal-veterinary-medicinal-products-compromise-text2018.pdf