One year after the EU Veterinary Medicines Regulation (VMR) came into force, novel medicine developers have an important opportunity to shape its implementation. Chris Boyle and Bronwyn Tonelli look at what’s at stake for an industry which is embracing technological advancement, but which faces twice the administrative burden of the human medicine industry.
It is now one year since the VMR (EU regulation 2019/6) created the legal basis for a new category of ‘novel therapy veterinary medicinal products’ in Europe. The VMR paved the way for development of advanced cell, gene, phage, and RNA therapies for animals – along with other new technologies – through the introduction of bespoke rules.
One of the aims of the VMR – which replaced 20-year old legislation – was to create a clearer and more tailored framework for the development of novel therapies. It also sought to maintain the regulatory flexibilities that are crucial in any rapidly advancing area of science and technology. Specifically, Annex II of the VMR sought to strike a balance between creating new regulatory requirements for novel therapies and allowing for derogations where these are justified.
The challenge now is to ensure that the new legal framework continues to stimulate the innovation that is needed to enable the development of safe and effective veterinary medicines to address unmet need, without unduly and prohibitively adding to the administrative burden placed on developers. A potentially increased administrative burden poses an acute risk to an industry which has estimated that it already faces twice the administrative burden of the human medicines sector.
Veterinary research and development has already been a trailblazer for new medical technology, including the first DNA vaccine and the advancement of the mRNA vaccines that have been so critical in the COVID-19 pandemic. It is still too soon to say whether the VMR will further boost innovation, but practical guidance – for which multi-stakeholder input is vital during the consultation process – will give it the greatest opportunity to do so. Industry input is especially important because the EU Commission emphasized at an EMA information day on 16 February that the VMR will not be re-opened, therefore placing an even greater onus on developers of veterinary medicines to ensure that their voice is heard in the development of guidelines.
Deadlines are drawing near for a number of relevant consultations published by the Committee for Veterinary Medicinal Products (CVMP)’s Novel Therapies & Technologies Working Party (NTWP), including: a draft guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation of these tests to clinical efficacy (deadline for comments 28 February 2023); and a draft guideline on the quality, safety, and efficacy of phage therapies (deadline for comments 31 May 2023). Phage therapies are of particular significance because they have remerged as a potential alternative to antimicrobials, including in proposals for a package of new human medicines legislation contained in the draft of the European Pharmaceutical Review that was leaked at the end of last month.
On 16 February it was also announced that consultations on revisions to DNA vaccine guidelines will be published shortly, amongst many other activities to support product development and innovation.
Sidley runs the Animal Health Legal Forum, #AHLF, a network of in-house lawyers and regulatory affairs professionals, which meets with experts and regulators to discuss the most pressing legal and regulatory issues facing the veterinary medicines industry. For further information, including on joining, contact firstname.lastname@example.org.
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