On 7 October 2016, the European Medicines Agency (“EMA”) issued a press release to announce the adoption by the Committee for Medicinal Products for Veterinary Use (“CVMP”) of the revised CVMP strategy on antimicrobials for the period 2016-2020.
The present revision of the CVMP strategy on antimicrobials seeks to take into account the scientific and regulatory progresses undertaken since the CVMP’s previous strategy published in 2011. The revised CVMP strategy on antimicrobials sets out the guidance documents updated in the past as well as the new guidance that is under development in the Antimicrobials Advice Ad Hoc Expert Group (“AMEG”).
The CVMP is responsible for preparing opinions on marketing authorisations for veterinary medicinal products. In this respect, one of its key objectives is to promote the availability of effective antimicrobial veterinary medicines in order to protect animal health and welfare. This objective is increasingly challenged by the threat of antimicrobial resistance (“AMR”) in animals.
The aims of the CVMP strategy on antimicrobials 2016-2020
The CVMP vision is to ensure the availability of effective antimicrobial medicines for the treatment of infectious diseases of animals, while, at the same time, minimising the risks to animals or humans arising from their use.
The strategy sets out the CVMP six strategic aims and proposed actions in relation to antimicrobials for the period of 2016-2020:
- to provide opinions for the authorisation of effective antimicrobial veterinary medicinal products ensuring that the necessary risk management measures are applied so that products can be used safely and sustainably;
- to consider and advise on the risk to public health that could arise from the use of antimicrobials in animals, and to balance this against the need to protect animal health. To provide advice in a One Health context, considering the interaction between humans, animals and the environment as sources of antimicrobial resistance gene;
- to maintain the effectiveness of antimicrobial substances that are already authorised in veterinary medicinal products by monitoring and analysing their sales and usage, encouraging surveillance for changes in susceptibility of target pathogens and zoonotic bacteria, and subsequently reviewing the authorisation of substances and/or products, especially when there is evidence that there may be a related change in the benefit-risk of the authorization;
- to encourage the development of new and existing antimicrobial veterinary medicinal products (especially more convenient formulations of older, low risk antimicrobials for treatment of common indications) and alternatives to antimicrobials. To encourage the development of these products especially to fill therapeutic gaps and for minor uses and minor species;
- to support the responsible use of antimicrobials both in accordance with Marketing Authorisations and under the cascade provided for in Article 10 and 11 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
- recognising that AMR is a global problem affecting both animal and human health, to work in partnership with the European Commission and its agencies, competent authorities in the Member States, international regulatory bodies, human and animal health organisations and the pharmaceutical and livestock industries to provide science led guidance on the responsible use of antimicrobials in animals.
Guidance under development
The CVMP strategy highlights the guidance documents that are under development, such as the AMEG Guidance on the data requirements and approach to be taken for the assessment of the risk to public health from the use of antimicrobial VMPs in food-producing species. This Guidance will establish a list of specific substances which are of last resort for treatment of life-threatening disease in humans and should be excluded from veterinary use. It is hoped that the new guidance will provide greater transparency for pharmaceutical companies considering antimicrobial product development and address the “regulatory uncertainty” that has been identified as a contributor to the recent limited development of antimicrobial veterinary medicines.
There are also existing uncertainties linked to the pending adoption of the new Regulation on Veterinary Medicinal Products and agreement of its implementing acts. The proposal contains provisions that aim to strengthen the benefit-risk assessment for antimicrobial veterinary medicinal products, provide a legal tool to preserve certain antimicrobials for human use and strengthen controls around their use.
For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/10/WC500214901.pdf