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EU passes new antibiotic legislation

European Parliament backs plans to halt spread of drug resistance from animals to humans.

The European Parliament adopted Oct. 25 plans to limit the use of antibiotics on farms in the European Union in order to keep food free from resistant bacteria.

According to an announcement from Parliament, veterinary medicines must not, under any circumstances, serve to improve the performance or compensate for poor animal husbandry under the new law, which would limit the use of antimicrobials as a preventive measure, in the absence of clinical signs of infection (known as prophylactic use) to single animals and not groups. The drugs can be used only when fully justified by a veterinarian in cases where there is a high risk of infection.

Metaphylactic use (i.e., treating a group of animals when one shows signs of infection) should be a last resort and should occur only once a veterinarian has diagnosed infection and prescribed the antimicrobials, Parliament said.

Reserving antibiotics

To help tackle antimicrobial resistance, the law would empower the European Commission to select antimicrobials to be reserved only for treating humans.

As advocated by members of the European Parliament (MEPs), the lay also imposes that imported foodstuffs will have to meet EU standards and that antibiotics cannot be used to enhance the growth of animals.

To encourage research into new antimicrobials, the legislation provides for incentives, including longer periods of protection for technical documentation on new medicines and commercial protection for innovative active substances, the announcement said. It also protects significant investments in data generated to improve an existing antimicrobial product or to keep it on the market.

The agreement with EU ministers was adopted on a vote of 583 to 16, with 20 abstentions.

Medicated feed

MEPs also approved, in a separate vote of 583-31 with six abstentions, new rules on more responsible ways to produce, sell and use medicated feed to tackle the spread of antimicrobial resistance, Parliament said. More information is available here.

Françoise Grossetête, rapporteur, said, “This is a major step forward for public health. Beyond farmers or animal owners, the use of veterinary medicines concerns us all, because it has a direct impact on our environment and our food -- in short, on our health. Thanks to this law, we will be able to reduce the consumption of antibiotics on livestock farms, an important source of resistance that is then transmitted to humans. Antibiotic resistance is a real sword of Damocles threatening to send our health care system back to the Middle Ages.”

Next steps

According to the European Parliament announcement, the agreement still has to be formally adopted by the European Council before publication in the Official Journal.

In June, the European Feed Manufacturers Federation (FEFAC) said it welcomed the political agreement on medicated feed.

At the time, FEFAC said the deal acknowledges that medicated feed is a safe and legitimate route of administration of medicines to farm animals. The agreement sets proportionate technical requirements for the manufacturing of medicated feed in multipurpose feed mills, which was a key concern for FEFAC. The restrictions on prophylactic and metaphylactic use with a view to bringing down the occurrence of resistance are consistent with the political decisions made in the context of the veterinary medicinal products regulation, FEFAC added.

AnimalhealthEurope announced that it is "happy to see over four years of intense negotiation" come to a finish with the new rules for animal medicines. The association, which represents manufacturers of animal medicines, vaccines and other animal health products in Europe, welcomed the new regulations governing the marketing and use of veterinary medicines and medicated feed as a clear message that Europe takes strong responsibility for the health of its animals. The new rules are expected to become applicable in all EU member states by the end of 2021, at the earliest.

“The new rules include measures to help ensure an ever-safer and continued responsible use of animal medicines, including: the establishment of a list of antibiotics deemed ‘critically important’ for human health to be agreed by Europe’s scientific agencies and improvements for a more responsive and risk-based pharmacovigilance system,” Roxane Feller, secretary general of AnimalhealthEurope, said.

“The devil is, however, in the detail,” Feller added. “There are a considerable number of implementing measures – 29 in total -- meaning that there is still a lot of work to be done to agree on the finer details of how we will implement the changes. AnimalhealthEurope looks forward to continuing the dialogue with decision-makers so as to ensure we do all we can to improve the availability of animal health solutions for more animals in more countries in Europe.”

TAGS: Antibiotics
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