15 Jul 2015
VETERINARY MEDICINAL PRODUCTS – 15 JULYBrussels Daily
Veterinary medicinal products: Prudent use, better safety monitoring, less side effects
The new EU law, which aims to increase the availability of veterinary medicines on the EU market and encourage research into new ones, must also make their use more responsible to tackle the growing antimicrobial resistance, Agriculture MEPs say in their opinion for the Environment committee adopted on Wednesday. They want more leeway for member states to restrict prescriptions of veterinary products, better monitor their safety, use and side effects and provide more information to end users.
“What is most important, from our perspective, is for the farmer to have available and efficient veterinary medicines, and clear rules on how to use them. We need to take a strong stance against antimicrobial resistance and the increasing problem of leakage into soil and water, while at the same time avoiding to create red tape that hampers the development of new medicines. All of this is provided by today’s vote”, said rapporteur Marit Paulsen (ALDE, SE). The Agriculture committee adopted her opinion by 37 votes in favour to two against, with two abstentions.
Only veterinarian-issued prescriptions to be recognised across the borders
The veterinary medicinal products should always, when possible, be prescribed by veterinarians, the Agriculture committee says, although it backed Commission’s wording of the draft law, which allows member states to permit other individuals to do so. But when it comes to dispensing medicines prescribed in another member state, only prescriptions issued by a veterinarian should be recognised, says the adopted text.
Veterinary prescriptions should include the diagnosis of the disease to be treated and a warning which would explain effects of imprudent use of antimicrobials, Agriculture MEPs say amending the Commission’s draft text. They also want member states to be allowed to impose stricter conditions for the use and retail of veterinary medicinal products on their territory, if justified on grounds of public and animal health and environment protection.
Prudent use of antimicrobials and ban on their prophylactic use
Antimicrobial products should be put in use only for animals, which are under the immediate care of persons allowed by national laws to prescribe them and after the appropriate clinical examination and diagnosis, says the adopted text. The same should apply to veterinary products, which have anabolic, anti-infectious, anti-inflammatory, hormonal or psychotropic properties, although these should always be prescribed by veterinarians, Agriculture MEPs insist.
The routine prophylactic use of antimicrobials should be banned by default, MEPs say adding that preventive use should be allowed only in exceptional cases. They also want to restrict the metaphylactic use of antimicrobials, i.e. treatment of a group of animals after the disease has been diagnosed in part of a group, with the aim to treat sick animals and control the spread of the disease, and request it to be followed by a health plan specifying non-medical measures to avoid use of antimicrobials in the future.
Veterinary medicines in general could be sold online, MEPs say, in line with Commission’s proposal. But they insist such provisions should not apply to antimicrobials.
More information for end users of veterinary medicines
Agriculture committee endorsed Commission’s plans to set up a pharmacovigilance system to monitor the safety of authorised veterinary products but it wants to widen the scope of information healthcare professionals and animal holders should have access to. For instance, the European medicines agency should communicate to end users any lack of efficacy of a veterinary medicinal product, including signs of antimicrobial resistance, all incidents of leakage of antimicrobials into soil and water, any suspected transmission via a veterinary medicinal product of any infectious agent and provide all relevant documents on risks to the environment from the use of antimicrobial veterinary medicines.
Better data on use of antimicrobials
To tackle antimicrobial resistance, better data is needed on how, when, where, why and how much antimicrobials are being used, Agriculture MEPs insist. These data should be analysed by the European medicines agency, which would then prepare annual guidelines and recommendations.
Agriculture committee also wants citizens to have access to information about chemicals contained in the veterinary medicines that might affect their bodies or bodies of other non-targeted species in the wider environment. Commercial sensitivity of such information must not be used as an excuse to deny access to it, MEPs say.
New drugs: Marketing authorisations and protection of know-how
Marketing authorisation for a veterinary medicinal product should be valid indefinitely unless risks to public or animal health or the environment are detected or new scientific knowledge gives grounds for reassessment, MEPs say. They also want the authorisation to expire if a medicinal product has not been on the market in a member state for more than five consecutive years.
Agriculture MEPs also amended provisions on the protection of technical documentation on new veterinary medicinal products. The maximum total protection period, including prolongations due to approved variations, should not exceed 14 years for medicines for cattle, sheep reared for meat, pigs, chickens, dogs and cats and 18 years for antimicrobials for the same species. For all other species, maximum prolonged period of protection should not exceed 18 years. New veterinary drugs for bees should receive 18 years long protection by default.
Amendments approved by the Agriculture MEPs to the Commission’s proposed draft regulation on veterinary medicinal products will now be scrutinised by the Environment committee, which has the lead on this law. Environment MEPs are expected to vote their recommendation for the plenary during their 22 – 23 September meeting.
Wednesday, 15 July 2015
In the chair: Czesław Adam SIEKIERSKI (EPP, PL)
European Parliament Committee on Agriculture and Rural Development