European Medicines Agency (EMA) and the Heads of Medicines Agencies published the European medicines agencies network strategy to 2025 in December 2020.
There are six priority areas:
- the availability and accessibility of medicines
- data analytics, digital tools and digital transformation
- antimicrobial resistance and other emerging health threats
- supply chain challenges
- the sustainability of the network and operational excellence.
European Group for Generics Veterinary Products (EGGVP) gave input to the consultation process.
We took note that despite being a high-level document, the areas of work, challenges and goals were well identified. We welcomed a more flexible oversight of manufacturing and distribution chains for generics/off patent producers. This would indeed encourage and facilitate access to smaller players, such as SMEs and start-ups, and help tackle shortages.
Two main concerns remain:
- Too strong a focus on human medicines sector
As a consequence, the impact and applicability of the strategy for veterinary medicines is not clear. Some of the crucial topics, such as the availability and accessibility of veterinary medicines are not addressed. Instead they are referred to as part of the implementation of the new veterinary medicines regulation 2019/06.
- Effective implementation and monitoring of the impact of the new regulation
The impact of the legislation on the availability of veterinary medicines, in particular for minor uses/minor species and in smaller markets, should be monitored continuously, as well as the effective reduction of administrative burden both for regulators and industry.
EGGVP hopes these are not a lost opportunity but considered a core element for veterinary medicines. Therefore, EMA and the national authorities should address these issues as part of the planned strategy review in 1.5 years’ time.