Q&A on veterinary medicines and medicated feed proposals
European Commission
MEMO
Brussels, 10 September 2014
Q&A on veterinary medicines and medicated feed proposals
Today the Commission adopted proposals on veterinary medicines and medicated feed, which aim to improve animal health and public health, as well as the internal market.
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1)Veterinary Medicines proposal
Why are new EU rules on veterinary medicines needed?
At present, there is an insufficient number and range of medicines to prevent and treat diseases in animals in the EU. This is especially the case for animals considered as ‘minor species’ such as bees, fish and turkeys. The lack of suitable veterinary medicines results in poorer animal health and welfare, increased risks for human health, and economic and competitive disadvantages for EU farmers.
In addition, although EU rules on veterinary medicines have been in place since 1965, stakeholders and Member States claim that a disproportionate regulatory burden is hampering innovation. The Commission acknowledges that current rules for veterinary medicines place an excessive administrative burden on the veterinary pharmaceutical industry, which in turn puts EU farmers at an economic disadvantage, and aims to amend the situation with this proposal.
What does the Commission hope to achieve with this proposal?
Aside from the overarching aims of helping the internal market work better, while protecting animal health and public health, the purpose of this proposal is three-fold:
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1)to simplify the regulatory environment and reduce administrative burden - in other words, to reduce red tape;
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2)to stimulate the development of new veterinary medicines, including those for limited markets (minor use and minor species), while keeping those already on the market;
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3)to facilitate the circulation of veterinary medicines across the EU, through better authorisation procedures, and clear rules on modern forms of retail, i.e. internet sales.
What exactly will change?
The new legislation pays particular attention to combatting the development of antimicrobial resistance (AMR) in animals and humans. With the new rules it will be possible to restrict the use of certain antimicrobials in animals that are reserved for the treatment of human infections.
In addition, to reduce red tape:
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-streamlined marketing authorisation procedures will allow companies to place and maintain a veterinary medicine on the entire EU market; and
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-pharmacovigilance rules (the monitoring of adverse effects of veterinary medicines on the market) will be simplified.
To stimulate the development of new medicines:
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-special rules for the authorisation of veterinary medicines for small markets such as apiculture and aquaculture will be introduced; and
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-a better reward mechanism will be put in place, i.e. extended data protection to innovative veterinary medicines, that will make the companies’ investments worthwhile economically.
To help the circulation of animal medicines across the EU:
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-rules are introduced to facilitate the internet retailing of veterinary medicines within the EU.
How will the new rules address AMR?
The proposal gives new regulatory tools to the Commission and Member States to reduce the risks to human and animal health of the use of antimicrobials in animals. The tools should drive down development and spread of antimicrobial resistance in the veterinary sector.
Who will benefit from the new rules?
Animals, farmers, pet owners, pharmaceutical companies and other businesses will benefit from the revised legislation on veterinary medicines.
For animals, the benefit will come from the increased number and quality of medicines available to treat them.
The changes will benefit veterinary surgeons, farmers (in particular those farming animals considered to be minor species such as bees, goats, turkeys) and pet owners, who will have better access to veterinary medicines to treat animals.
Human health will improve through rules aimed at keeping antibiotics effective.
The pharmaceutical companies will benefit from significantly lower costs related to getting their medicines authorised and keeping them on the market.
Other businesses will benefit from improved competition and the circulation of veterinary medicines across the EU, and the optimal functioning of the internal market.
Whose views were taken into account?
A public consultation was conducted in 2010, to gather the views of all relevant stakeholders, including farmers, pet owners, pharmaceutical companies and other businesses.
For more information on veterinary medicines:
http://ec.europa.eu/health/veterinary-use/index_en
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2)Medicated feed proposal
Why are new EU rules on medicated feed needed?
After veterinary prescriptions, medicated feed is an important route for administering veterinary medicines to animals. An update of the medicated feed legislation which is now nearly a quarter of a century old (the current Directive 90/167/EEC was adopted in 1990) is long overdue. Differing national regimes have negatively affected the internal market and public health is not properly guaranteed with the current rules. Modernisation is needed to reflect technical and scientific progress in the past decades, so that harmonised rules continue to ensure the appropriate safety level of medicated feed in the EU.
As well as being important for animal health, this review is vital for the optimal functioning of the internal market to foster competitiveness, innovation and economic growth in the concerned industries.
Since the 1990 Directive came into force, the situation in the majority of EU countries has gradually deteriorated: scattered and diverging rules have affected the efficient treatment of animals and the availability of medicated feed at competitive prices. In addition, the development of antimicrobial resistance (AMR) has increased dramatically. Finally, under the current system, pet owners in most EU countries cannot treat their animals comfortably and efficiently with medicated pet food.
A consistent set of EU rules, restricting EU action to the minimum, as aimed for with this review, will have both economic and health benefits.
What does the Commission hope to achieve with this proposal?
The proposal is to repeal and substitute Directive 90/167/EEC with a modern Regulation covering the manufacture, placing on the market and use of medicated feed.
By proposing a harmonised set of provisions for the manufacture of medicated feed at the appropriate quality and safety level, the Commission aims to clarify the field for all manufacturers and support viable and economical medicated feed production. The proposed Regulation should allow veterinarians to choose the best way to treat diseased animals taking into account local conditions in each Member State.
Furthermore, the Commission aims to improve legal certainty and clarity for the producers of medicated feed so that they are no longer confused by diverging and/or vague national rules. Exaggerated provisions in some areas will be eliminated so that medicated feed can be produced economically. In parallel, lax rules which lead to negative impacts on animal and public health will be tightened. Finally, the Commission hopes to boost innovation through the explicit permission to use medicated feed for pets.
What exactly will change?
The Regulation will explicitly include medicated feed for pets and it will introduce stricter measures to ensure the correct use of medicated feed. In addition, anticipated production, mobile mixers, on-farm manufacturing of medicated feed and specialised distributors will be allowed EU-wide. Finally, the Regulation will set state-of-the-art measures for the homogeneity of medicated feed and scientifically derived carry-over limits for veterinary medicines in ordinary compound feed.
How will the new rules address AMR?
The proposal addresses AMR by tackling the misuse of antimicrobials in three ways. Firstly it bans the use of medicated feed as a preventative measure or as a growth promoter. Secondly, it establishes an EU-wide residue limit for veterinary medicines in ordinary feed. Finally, it tightens the rules for prescribing and handling medicated feed with antimicrobials.
Who will benefit from the new rules?
Farmed animals - including in aquaculture, pets, farmers, pet owners, veterinarians, businesses producing medicated feed and citizens will benefit from the revised legislation on medicated feed.
The availability of good quality medicated feed at competitive prices will help farmers and lead to better treatment of diseased farm animals.
As treatment can be included in pet food, pets with chronic diseases will no longer have to swallow pills or other forms of medicine, making life easier for them and their owners.
Clearer rules will be an advantage for new companies and also existing companies that wish to expand their business.
Finally, the benefits will extend to public health due to measures to fight AMR.
Whose views were taken into account?
Many stakeholders were consulted during the preparation of the proposal, including farmers and aquaculture organisations, feed and veterinary medicine industry, veterinarians, consumer and pet owner organisations. All Member States, Norway and Switzerland were also consulted.
In addition, an open web-based stakeholder survey took place in 2011 with contributions from normal citizens as well as EU-level associations. Finally, studies, data and scientific opinions from the European Food Safety Authority and the European Medicines Agency have been used as input for the proposal.
For more information on animal nutrition:
http://ec.europa.eu/food/food/animalnutrition/index_en.htm
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