As from 28 January, a revamped legislation on veterinary medicinal products is applicable in the EU.
Adopted three years ago, Regulation (EU) 2019/6 is a cornerstone to support the achievement of the objectives set in the European One Health Action Plan and in the Farm to Fork Strategy against antimicrobial resistance (AMR). The legislation also consolidates the EU’s leading role on the global stage to act against AMR.
The Regulation is central to achieve the Farm to Fork Strategy target to reduce overall EU sales of antimicrobials by 50% for farmed animals and in aquaculture by 2030, through very concrete measures such as banning the preventive use of antibiotics in groups of animals.
Adopted in 2019, the new Regulation (EU) 2019/6 on veterinary medicinal products (VMPs) enters into application on 28 January 2022.
The main objectives of the legislation are to:
- provide for a modern, innovative and fit for purpose legal framework on VMPs,
- give incentives to stimulate innovation for VMPs and increase their availability,
- strengthen the EU action to fight antimicrobial resistance.
In particular, the Regulation provides for a wide range of concrete measures to fight antimicrobial resistance (AMR) and to promote a prudent and responsible use of antimicrobials in animals, such as:
- a ban on the preventive use of antibiotics in groups of animals
- restrictions on metaphylactic use of antimicrobials (control treatment preventing a further spread of infection) in animals,
- a reinforced ban on the use of antimicrobials for promoting growth and increasing yield (in addition to the 2006 prohibition of using antibiotics as growth promoters in feed),
- the possibility to reserve certain antimicrobials for humans only,
- the obligation for Member States to collect data on the sales and use of antimicrobials in animals.
The regulatory framework for VMP needed to be adapted to the scientific progress and to the current market conditions and economic reality, while continuing to ensure a high level of protection of animal health and welfare, safeguarding public health and protecting the environment.
To ensure efficient implementation of this Regulation on the ground, additional legislation has to supplement this Regulation. Since 2019, the Commission has already adopted and published a number of legal acts. The delegated legal acts adopted and published can be found here and the implementing legal acts adopted and published can be found here. More legal acts will follow in the coming months and years.
The Regulation on Medicated feed also enters into application on 28 January 2022.
It will also contribute to the fight against AMR, for example by banning the preventive use of antimicrobials via medicated feed and restricting prescriptions of antimicrobials in medicated feed.
New rules are now established which will ensure an economically-viable production of safe medicated feed throughout the EU. Apart from the harmonisation of the manufacturing standards of medicated feed, the Regulation allows the production in feed mills, mobile mixing, on-farm mixing and anticipated production and thus the choice for the best option according to the respective local conditions.
Moreover, the medicated feed rules fosterinnovationin medicated pet food as they create provisions concerning production, prescription and distribution of medicated feed for pets, which for example allows pet owners to treat their chronically diseased animals with their regular feed whereas currently these pets need to be treated with pills or pastes.
The rules set in the VMP legislation will contribute significantly to reducing the use of antimicrobials in animals, through the concrete measures promoting their responsible and prudent use. In this setting, they will be instrumental to the achievement of the objective set in the Farm to Fork Strategy to reduce by 50% overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. This ambitious - yet realistic - objective aims to curb AMR, while contributing to the development of a more sustainable EU food system.
The obligation for EU Member States to collect data on sales and use of veterinary antimicrobials, set in the legislation, will therefore play an essential role in monitoring the actual consumption of antimicrobials in the EU.
It is also important to keep in mind that the promotion of initiatives that allow the prevention of infections, such as biosecurity (e.g. measures designed to protect farms from the entry and spread of diseases), hygiene, vaccination and good animal husbandry can help reach this objective under the Farm to Fork.
The revised legislation on veterinary medicines, and the medicated feed Regulation, will bring benefits to animals, farmers, pet owners, veterinarians, pharmaceutical companies and other businesses.
But more generally every citizen will gain from this legislation, especially through the measures to fight antimicrobial resistance, for which there are clear links between human health, animal health and the environment.
For animals, the benefit will come from the increased number of medicines available to treat them, as well as from an appropriate use of those medicines whenever they are antimicrobials.
Therefore, veterinarians, farmers and pet owners should have better access to veterinary medicines to treat animals.
Human health is expected to benefit from these legislations, notably through rules aiming at keeping antimicrobials (including antibiotics) effective to treat infectious diseases in humans.
Pharmaceutical companies will benefit for example from an enlarged use of the centralised authorisation procedure and a reduction of administrative burden, as well as from measures to stimulate the development of new antimicrobial VMPs and new VMPs for rare diseases and for so-called 'minor species'.
Other businesses such as suppliers of VMPs and manufacturers of medicated feed will benefit from improved competition, as well as improved circulation of VMPs and medicated feed across the EU. The strengthened functioning of the internal market, combined with enhanced innovation, will contribute to creating more growth and jobs in the EU.
Operators in non-EU countries wanting to export animals and of products of animals origin into the EU will have to respect the ban on the use of antimicrobials for promoting growth and increasing yield, as well as the ban on the use of those antimicrobials designated in the EU as reserved for human use.
Thereby the Regulation contributes to the fight against AMR by adopting a coherent approach and ensuring that animals and products of animal origin on the market in the EU have not been treated with antimicrobials in an irresponsible or imprudent way, regardless of their provenance.
The Commission is currently preparing a legal act on this issue, which should be adopted in the second half of this year (also Q9).
Yes. Promotion of availability of veterinary medicines by stimulating innovation and competitiveness is a key component of the Regulation.
A simplified assessment procedure and a data protection period, which may be extended up to 18 years under certain conditions, are now in place.
Such provisions intend to stimulate the development of new antimicrobial VMPs, as well as the development of new VMPs for rare diseases and for so-called 'minor species' such as bees (in opposition to major food producing species and major companion animal species).
Another example is the setting of a clear definition and of adequate rules for biological VMPs and novel therapy VMPs, which will incentivise the development of new VMPs in those areas.
Finally, opening up the centralised authorisation procedure to any VMP and allowing for exceptional circumstances marketing authorisations is expected to positively broaden the spectrum of VMPs that may be brought to the market.
A third real achievement, through the Regulation, is the establishment of a modern, innovative and fit for purpose legal framework for VMPs, among others by bringing autologous vaccines in the scope of the Regulation, specifying clear and fully harmonised labelling requirements, adopting a simpler system for variation decisions and the risk-based approach for pharmacovigilance and controls.
EMA has been playing a key role over the last three years in the preparation for the entry into application of the VMP Regulation. It has provided the Commission with the scientific advice required for the preparation of the supplementary legislation, key to an efficient implementation of the VMP Regulation. This supplementary legislation consists in a series of important implementing and delegated acts.
Moreover, EMA will play a crucial role in maintaining the Union product database now that it is operational (from 28 January 2022).
EMA will continue to further develop the Union product database to support the implementation of the VMP, in collaboration with the Member States’ competent authorities.
Member States have also provided valuable input to the Commission for the preparation of the supplementary legislation and have a crucial role to play by having appropriate measures in place, and resources earmarked at national level, to support an effective implementation of the EU Regulation on veterinary medicines, in order to make its implementation a shared success.