AASV Joins AVMA in Addressing EU Article 118

September 8, 2021 — 

The AASV has joined AVMA and other allied veterinary organizations in the United States sharing animal health concerns with the EU Parliament on the motion for a resolution on the Commission Delegated Regulation supplementing Regulation (EU)2019/6 establishing criteria for the designation of antimicrobials to be reserved for humans. How does EU Article 118 affect you? In short, the EU's changed regulations now prohibit the use of certain antimicrobials for anything but human use. Also prohibited is the import to the EU of animals or animal products which may have been given antimicrobials yet to be determined.

Briefing on Article 118: Complications, Delays, Concerns

[Source: Animal Health Institute 8 July 2021]

Background

Regulation (EU) 2019/6 was passed in 2019. It will be applied from the end of January 2022. Article 118 in the Regulation states that limitations on the use of antibiotics for animals decided in the EU, will also apply to third countries. With six months before implementation, new obstacles leading to delays in three out of four legislative documents necessary to implement the Regulation have occurred. The latest developments are described below.

1. Criteria for designation of antimicrobials reserved for the treatment of certain infections in humans (Delegated Act (DA) 2021/2718).
This document sets out a stepwise process for determining which antibiotics may be used for animals. Overall, the designation assessment process, as developed by the European Medicines Agency and agreed to by EU Member States, is satisfactory. It has consistently been pointed out that adequate data/evidence is needed at each decision step for it to be considered a scientifically sound process.
Situation: This Act is currently passing through the European Parliament which has the right of scrutiny: it cannot change the Act but may object to its adoption. This has occurred: the Greens group has put forward a motion objecting to adoption of the Act, and called for the WHO list of antibiotics to be adopted instead of the Commission stepwise scientific approach. The WHO list was developed for humans only, with no consideration of animal disease. This motion will be voted on 12/13 July and there are indications that some political groups may support it. If it is passed, and this is unclear at this point, it must be voted on in Parliament plenary before 26 September. If it does not pass, it can again be reintroduced at plenary level. This means many months' delay. The Commission has defended its proposal.

2. Implementing Act (IA) for the list of antimicrobials reserved for human use only.
This is the list of antibiotics reserved for human use, to be created applying the criteria. This Act must be published.
Situation: There are two developments. First, the process for adopting the IA has stopped until the Criteria are agreed. Second, there are differences of opinion among the group of experts regarding the evidence needed,in particular for Criteria 2 (determining if there is antimicrobial resistance (AMR) transfer). As there is little or no substantive evidence for this, a number of the experts cannot agree to place antibiotics on the list.

3. Delegated Act for the Implementation of Article 118.
This sets the specifics of implementation.
Situation: The European Commission is working on this. No draft has been seen yet. Must be formally published.

4. Official Controls Regulation.
The mechanism chosen to implement controls on imports of animals and animal products, was to modify Article 1(4)(c) of the Official Controls Regulation 2017/625 .
Situation: This has been completed.

Next steps and impacts:
The EP will vote on the motion again in its plenary session the week of 13 September. Should the outcome be the same, it means that the regulation has not cleared the final hurdle of the legislative process and cannot go into force. The Commission will therefore be required to amend the proposal. As a consequence, it seems highly unlikely that the necessary legislation will be in place in time for the statutory implementation date of 28 January 2022. However, as of today, the European Union still intends to implement the law in January 2022.