The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
On February 2, UK regulator the Veterinary Medicines Directorate (VMD) launched a consultation on proposals to update the veterinary medicines legislation on the island of Great Britain (GB).
The proposals aim to align GB laws with EU legislation in certain areas, for example in relation to technical data requirements and variation procedures for marketing authorisations (MAs). However, the proposals would also diverge from EU law in other areas, with the aim of stimulating the GB industry.
Although the proposals aim to reduce regulatory burden, experience from the EU has shown that new veterinary medicines regulations can have the opposite effect. For example, in an industry where labelling compliance already constitutes an estimated 34% of administrative burdens, companies will be keen to ensure the proposals facilitate a reduction, rather than an addition, to this burden. Animal health companies will therefore need to review the full package of proposals carefully to assess the potential impact on their business, and respond to the consultation.
Key changes that could be good news for companies developing innovative products in Britain:
- Data protection periods will be extended to encourage the development of new veterinary medicines. The maximum EU data protection periods were recently extended to protect MA holders’ investments in research and development, particularly where patent protection is not available. The proposals mirror EU law in this regard, but additionally provide the possibility of new protection periods for the development of existing products (see below).
- Narrowing the global marketing authorisation concept. In what would be a major departure from the status quo, MA holders would be entitled to a new period of data protection where an existing MA is varied, for example to add a new species, and where the product is packaged separately with a new MA number. This would in effect disapply the ‘global marketing authorisation concept’ in these cases, pursuant to which an MA holder can currently only obtain one full period of data protection for the same active substance.
- An end to parallel import authorisation. Under a marketing authorisation for parallel import (MAPI), veterinary medicines can currently be imported from a third country if they are identical or therapeutically equivalent to UK authorised products. The proposals would remove this option for MAPIs. Unauthorised medicines could still potentially be imported under the special import scheme, if these complied with the ‘cascade’ (see below).
- The rules on compounding would be tightened. Where no authorised product is available, veterinarians can prescribe medicines in accordance with the cascade, a risk-based decision tree which ultimately allows vets to prescribe extemporaneous preparations (i.e. compounded products) as the final step of the cascade. The proposals would introduce a new offence of manufacturing a compounded product that is the pharmaceutical equivalent of an authorised product, unless there is a recognised supply issue. The proposals would also introduce a new offence of encouraging or facilitating the illegal use of the cascade.
In addition to responding to the consultation by March 31, animal health companies should watch out for a further consultation on batch testing and batch release, as well as a Q&A from the UK regulator on the proposals.
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