Access VetMed presents its Manifesto to safeguard sustainable access to veterinary medicines in Europe  

Access VetMed, the voice of the European generic and added-value veterinary medicines industry, has presented its Manifesto: Advancing Access to Veterinary Medicines in Europe by Streamlining Processes, a policy document urging EU institutions and national authorities to take immediate action to safeguard the long-term sustainability of the sector and thereby protect both animal and human health across the EU.

The association outlines a concerning trend: between May 2024 and May 2025, the industry lost 1,027 marketing authorisations while gaining only 638 new ones — a negative balance unseen in more than two decades.

“Rising regulatory fees, translation costs, IT updates, and administrative burdens have doubled workloads and severely reduced resources for R&D and innovation,” said Xavier Molins, Chair of Access VetMed. “This situation threatens not only the sustainability of our sector but also the long-term availability of essential veterinary medicines throughout Europe.”

“Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC was intended to simplify processes, but in practice it has increased complexity and costs,” the Access VetMed Manifesto warns.

Five pillars for sustainable access: Challenges and calls to action

In its Manifesto, Access VetMed structures its vision around five strategic pillars — One Health, Optimisation, Predictability, Availability, and Harmonisation — which together define the main challenges facing the veterinary medicines industry in Europe and the key actions required to address them.

1. One Health – Balanced Decision-Making

Access VetMed stresses the need for a truly balanced One Health approach, ensuring that decisions taken to protect human health do not undermine the availability of essential veterinary medicines. The association calls for transparent consultation mechanisms with animal health stakeholders and equal consideration during health emergencies, so that veterinary and human health remain aligned under the same overarching principle of public well-being.

2. Optimisation – Smarter regulation

Under this pillar, Access VetMed points out the fragmentation of regulatory systems across Member States as a major source of inefficiency and delay. The association urges greater harmonisation of procedures, the recognition of the Union Product Database (UPD) as the single authoritative reference point, and adequate resourcing of national authorities to ensure faster, more predictable regulatory processes across the EU.

3. Predictability – Transparency and a reliable regulatory environment

For companies to operate effectively, regulatory predictability is essential. Access VetMed emphasises the need for clear and consistent interpretation of Regulation (EU) 2019/6, applied uniformly across all Member States. It calls for timely publication of assessment reports and transparent communication from authorities to strengthen confidence in the regulatory system and create a fair, competitive market environment.

4. Availability – Removing barriers

Maintaining veterinary medicines on the market has become increasingly difficult due to administrative burdens and disproportionate costs, particularly for Small and Medium Sized Enterprises (SMSEs). Access VetMed calls for simplified documentation requirements, fair and proportionate fees, and pragmatic rules for reference products -especially when the original products are no longer available- to ensure that veterinarians and farmers continue to have access to the treatments they need.

5. Harmonisation – Consistency across Europe

Finally, Access VetMed underlines that genuine harmonisation remains the foundation of a sustainable regulatory framework. The association calls for aligned Good Manufacturing Practices (GMPs) standards, clarity on local representation requirements, and a uniform approach to e-labelling, eliminating duplication and inefficiencies between the human and veterinary sectors while improving regulatory coherence across Europe.

“Our five pillars offer practical, science-based solutions to restore market resilience, reduce red tape, and ensure that veterinarians and farmers continue to have access to the medicines they need,” said Access VetMed´s Chair.

With this manifesto, Access VetMed reaffirms its commitment to animal welfare, regulatory efficiency, and fair access to innovation across Europe.

 What is Access VetMed?

Access VetMed was founded in 2002 as the European Group for Generic Veterinary Products (EGGVP) to serve as the voice of the generic veterinary medicines industry in Europe. Today, we represent 30 generic and added-value veterinary medicines companies located in various European countries, including smaller markets. Together, our members have a turnover of over 2,6 billion euros and support more than 8.600 direct jobs, holding 52% of all generic veterinary medicines marketing authorizations in Europe.

We actively and constructively engage with EU regulators and other stakeholders to advocate for transparent, harmonized, pragmatic and balanced animal health regulation. Our primary objective is to increase ACCESS – availability, compliance, convenience, efficacy, safety, and savings – of veterinary medicines to veterinarians, farm, and companion animal owners in Europe.

More information: www.accessvetmed.eu