WAAW - Day Four: Transforming EU legislation: A new era for veterinary medicinal products

Émer Finnegan, Regulatory Affairs Executive at G&L, delves into the links between human and animal health, and the need for swift adaptation to changing legislation.

The profound interconnections between the health of animals, humans, and our environment have become increasingly apparent in recent years.

At the heart of this, evolving legislation plays a pivotal role in addressing these complex issues and catalysing essential changes.

The European Union (EU) Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which became effective on January 28, 2022, has ushered in significant alterations in the EU concerning the authorization, utilization, and monitoring of veterinary medicinal products.¹

A central focus of Regulation (EU) 2019/6 is the reduction in the use of antimicrobials in veterinary medicine, aiming to tackle antimicrobial resistance (AMR).

This is possible through measures such as ensuring the availability of veterinary medicines, reducing administrative burdens on authorities and registration holders, promoting the development of innovative medicines, and fortifying the fight against AMR[1].

Advancing the One Health Action Plan

The World Health Organization (WHO) defines AMR as the phenomenon by which bacteria, viruses, fungi, and parasites evolve, rendering them unresponsive to medicines. This poses challenges in treating infections and heightens the risk of disease transmission, severe illness, and death.²

The EU Committee for Veterinary Medicinal Products (CVMP) is presently dedicated to advancing the EU's 'One Health Action Plan,' which seeks to ensure the availability of effective antimicrobial medicines for treating infectious animal diseases while minimizing risks to animals, humans, and the environment.

Key EU scientific agencies such as the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), and the European Centre for Disease Prevention and Control (ECDC) collaborate in executing and implementing this plan.³

The strategy's objectives encompass advising on the public health risks associated with improper use of veterinary antimicrobials, promoting the development of these products, and cooperating with global human and animal health organizations to combat AMR.

Article 107 of Regulation (EU) 2019/6 states that antimicrobial medicinal products should only be used when the risk of infection or infectious disease spread within animal groups is high, and no suitable alternatives are available.

Consequently, there is an increased focus on vaccination and the establishment of biosecurity measures to reduce disease in animals.

For new applications for antimicrobial VMP, the applicant must submit the following, in addition to the information, technical documentation and summary listed in paragraph 1 of the legislation:

(a) documentation on the direct or indirect risks to public or animal health or to the environment of use of the antimicrobial veterinary medicinal product in animals;

(b) information about risk mitigation measures to limit antimicrobial resistance development related to the use of the veterinary medicinal product.¹

Controlling and reducing antimicrobials

The EMA encourages judicious antimicrobial use by collecting data on the use of veterinary antimicrobials within the EU and providing scientific recommendations. This initiative aims to reduce AMR in humans, as resistant bacteria can be transmitted through the food chain.*

The EU Green Deal's Farm to Fork strategy, which seeks to reduce antimicrobial sales for aquaculture and farmed animals by 50 per cent by 2030, is supported by new legislative provisions for collecting sales data.⁴

The new legislation has also introduced a specialized authorization route for medicines intended for limited veterinary markets in the EU.

This facilitates the recommendation of marketing authorisation by the CVMP for veterinary medicines with less comprehensive data when the benefits for animal or public health outweigh the risks of limited data. The intent here is to enhance the availability of new veterinary medicines for treating rare diseases and minor animal species.⁶

The value of good data

The generation of vast amounts of data in farm management and animal healthcare practices is a recognised opportunity.

The European Veterinary Big Data Strategy 2022-2027 by the EMA and Heads of Medicines Agencies (HMA) seeks to streamline administrative processes and ensure high-quality data capture across the European medicines regulatory network to ‘increase interoperability’ and ‘re-useability of data’ in different regulatory areas.⁷

The implementation of the Union Product Database (UPD), serving as a centralised source of information on authorised veterinary medicines, aligns with the strategy's objectives, illustrating how legislative changes are revolutionizing the regulation of veterinary medicine as outlined in the EU Veterinary Big Data Workplan to 2025.⁸

These legislative shifts underscore the ongoing commitment to addressing issues within veterinary medicines, with far-reaching implications for our environment and public health.

While adapting to these changes may require increased resources, stakeholders consistently review the implementation process to ensure comprehension and alignment with industry needs.

Collaboration is key

Collaborative efforts between government and regulatory agencies have proven effective in improving healthcare and environmental outcomes. A notable example is the collaboration between the EMA and CVMP, which led to the mandatory withdrawal of EU marketing authorizations for orally administered zinc oxide as a preventative for diarrhoea in pigs.

This decision was made based on the CVMP’s conclusion that the environmental risks of zinc oxide outweighed its benefits to pig production. The ability of regulators, the pharmaceutical industry, and end users to swiftly adapt to changing legislation showcases their capacity to pioneer change. ⁹

Émer Finnegan is a Regulatory Affairs Executive at G&L Healthcare Advisors

References:

1. 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 [Internet]. Jul 1, 2019. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R0006&from=EN

2. World Health Organisation. Antimicrobial resistance [Internet]. Who.int. World Health Organization: WHO; 2021. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

3. EMA. CVMP strategy on antimicrobials 2021-2025 - European Medicines Agency [Internet]. European Medicines Agency. 2018. Available from: https://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance/cvmp-strategy-antimicrobials-2021-2025

4. European Commission . Farm to Fork Strategy [Internet]. food.ec.europa.eu. 2020. Available from: https://food.ec.europa.eu/horizontal-topics/farm-fork-strategy_en

5. EMA. Veterinary product information templates [Internet]. European Medicines Agency. 2018 [cited 2023 Apr 03]. Available from: https://www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/product-information/veterinary-product-information-templates

6. Regulation of Veterinary Medicines (no date) Regulation of veterinary medicines | EMA Annual Report 2021. Available at: https://www.ema.europa.eu/en/annual-report/2021/regulation-veterinary-medicines.html (Accessed: 15 August 2023).

7. Ema (2023) Veterinary Big Data, European Medicines Agency. Available at: https://www.ema.europa.eu/en/veterinary-regulatory/overview/veterinary-big-data (Accessed: 11 August 2023).

8. EU Veterinary Big Data Workplan to 2025 - European Medicines Agency. Available at: https://www.ema.europa.eu/en/documents/other/eu-veterinary-big-data-workplan-2025_en.pdf (Accessed: 11 August 2023).

9. Nutrition EW. The Zinc Oxide ban: What led to it, what are the alternatives? [Internet]. EW Nutrition. 2022 [cited 2023 Feb 20]. Available from: https://ew-nutrition.com/the-2022-zinc-oxide-ban-what-are-the-alternatives/

[1] See "The risks of Antimicrobial antimicrobial resistance (AMR) in animals- a brief summary” for more detail on the risks of AMR