In Response to the Public Consultation on the Draft European Commission Delegated Regulation and Annex Supplementing Regulations (EU) 2019/6 of the European Parliament and of the Council by establishing the criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in humans
(SANTE/10274/2021 and SANTE/10274/2021 ANNEX)
This submission represents the joint position and recommendations of the Canadian Animal Health Institute (CAHI), Canadian Association of Swine Veterinarians (CASV), Canadian Association of Bovine Veterinarians, Canadian Cattlemen’s Association (CCA), Canadian Pork Council (CPC), Canadian Meat Council (CMC) and Canada Pork on these draft documents.
The EMA Advice on which the current Draft Delegated Regulation and Annex is founded was scientifically based and balanced. However, important points should be considered in the Draft Delegated Regulation and Annex, given the ultimate role the criteria stipulated therein will play in the creation of the list of banned antimicrobials.
Four Points Highlighted in the Submission:
1. Points which should be preserved in the final Delegated Regulation:
It is particularly important to maintain the following points in the final Delegated Regulation:
- Paragraph 3 - A risk management and evidence-based approach is used to determine which antimicrobials are critically important for humans.
- Paragraph 4 - The criteria to determine which antimicrobials are to be reserved for human use should be clear and pertinent whilst reflecting the latest scientific evidence.
- Paragraph 5 - Banning the use of an antimicrobial in animals is one of the most severe risk management measures that can be taken, which is why it should be used carefully. Whenever possible, other existing risk management measures should be favoured.
2. It is important that listed criteria allow the most current scientific evidence to be used in a transparent risk assessment process which benefits human health and does not compromise animal health.
- Specificity of evidence required: The Draft Delegated Regulation remains high-level and open to interpretation for terms such as “robust evidence” and “scientific evidence”. The Act does not identify the scientific data thresholds or requirements for each criterion. This lack of specificity gives the European Commission significant latitude to act in ways inconsistent with WTO principles and agreements.
- Information about the process: It is unclear whether there will be a guidance document that describes the process for applying the criteria to specific antimicrobials. To ensure a transparent and predictable assessment for each antimicrobial, it is important such a document to be prepared and consulted on before a draft list of reserved antimicrobials is included in the subsequent Implementing Act posted for public consultations.
- Transparency: The Draft Delegated Regulation does not state that the assessment leading to inclusion of a substance on the reserved list should be published. This lack of transparency runs counter to EU policies on transparency as well as the letter and spirit of the WTO SPS Agreement.
- Application of criteria to third countries: Annex section C 1(b) states that antimicrobials meet the criteria of non-essential need if they would have a major impact on animal welfare or public health and “adequate alternatives” are available to prevent significant morbidity or mortality but does not specify how this will be determined. It is unclear how the European Commission intends to assess restricting access to a given antimicrobial may impact animal health and welfare or human health in countries and regions outside the EU. The Draft Annex does not define whether this criterion refers to the availability of alternatives globally, or only within the EU. Additionally, while an adequate alternative may be available in the EU, it may not be approved and/or available in third countries.
- Cooperation Mechanisms: The Draft Delegated Regulation and Annex are intended to strike a balance between animal health, public health, and the welfare of animals that is appropriate for the EU. However, the Act does not include cooperation instruments and mechanisms for weighing issues and topics of import to non-EU countries which are impacted by the Regulation. The European Court of Justice (ECJ) has previously struck down similar provisions in other laws that impacted third countries yet fail to include such mechanisms for international cooperation.
- Inconsistency of wording between Article 37(4) of Regulation (EU) 2019/6 and the Draft Delegated Regulation and Annex: There is a lack of consistency in wording when referring to antimicrobials in the two pieces of legislation. The underlying principle should be the assessment of individual antimicrobials, including specific routes, quantities, formulations, or concentrations for each antimicrobial assessed under the criteria, rather than entire groups of antimicrobials.
- Omission of routes of administration and other important factors: The criteria proposed in the Draft Delegated Regulation and Annex do not include or address the importance of routes of administration, formulations, or concentrations of antimicrobials which have a significant impact on their importance to human and veterinary medicine, as well as the risk of transmission of resistance.
Recommendations to Address Identified Gaps:
- An additional article should be drafted and included in the Delegated Regulation, specifying that the assessment leading to the inclusion of an antimicrobial on the reserved list shall be published to ensure the predictability and transparency of the process.
- Language establishing a process for removing antimicrobials from the reserved list when new medical innovations are discovered, or medical practices change the importance of an antimicrobial to human health, should also be included in the Delegated Regulation.
- In accordance with previous rulings of the ECJ on the issue of cooperation mechanisms, the Delegated Act should include additional provisions for cooperation with third countries and regions outside of the EU which will be impacted by the Delegated Regulation.
- A Guidance document identifying specific definitions and thresholds for “robust evidence” and “scientific evidence”, and the process for assessment of an antimicrobial under the criteria set out in the Delegated Regulation should be developed and published ahead of the drafting of the Implementing Act setting out the list of antimicrobials reserved for human use.
3. Recommendations for clarifications of language or terminology
Further clarification is needed for the terms:
4. Recommended line edits:
- All references to “group(s) of antimicrobials” should be removed from both the Draft Delegated Regulation and the Draft Annex to align with the wording in Article 37(4) of Regulation (EU) 2019/6, under which the Draft Delegate Regulation and Annex will be established.
- In the Draft Annex, Section A.2(a) should be modified to read “the antimicrobial phenotype(s) of the relevant microorganisms causing infection, including multidrug resistance.” The focus on relevance is important for assessing the proportionality of the response and the process of the applying the criteria. Without a focus on relevance, this could be excessively broad and irrelevant to health outcomes.
- In the Draft Annex, Section B.1, the first sentence should be modified as follows “The antimicrobial meets this criterion if one of the following applies for the relevant pathogens”. As above, it is important to make this clear, especially given the current lack of clarity or transparency on the interrelatedness or linkage between the three criteria, and the process of how they will be applied.
- In the Draft Annex, Section C(b) could be strengthened by modifying it to refer to “adequate, safe and effective” alternatives being “available and marketed”. While different products may have a similar indication in terms of disease treatment, they may differ in terms of their respective safety or efficacy profiles.