1.CONTEXT OF THE DELEGATED ACT
Regulation (EU) 2019/6 of the European Parliament and of the Council lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of veterinary medicinal products.
Antimicrobial resistance to medicinal products for human use and to veterinary medicinal products is a major health threat that is growing both at Union and global levels. In order to preserve as long as possible the efficacy of certain antimicrobials in the treatment of infections in humans, including those of ‘last resort’, it has become necessary to reserve these antimicrobials for use in humans only and subsequently to ban their use in animals. It is the scope of the present Delegated Regulation to establish the criteria to designate such antimicrobials to be reserved for the treatment of certain infections in humans, in accordance with Article 37(4) of Regulation (EU) 2019/6.
It is worthwhile mentioning that, in line with Article 37(5) of Regulation (EU) 2019/6, a list of antimicrobials to be reserved for treatment of certain infections in humans shall be established in an implementing act, based on the criteria defined in the present Delegated Regulation. Those antimicrobials, which will have been designated in the Union as reserved for human use will not be authorised for use in animals in the Union. In addition, given the international dimension of antimicrobial resistance, they will not be authorised for use in animals or in products of animal origin to be exported from Third Countries into the Union, in accordance with Article 118 of Regulation (EU) 2019/6.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
In accordance with Article 147(5) of Regulation (EU) 2019/6, the Commission has carried out substantial consultation with Member States’ experts on veterinary medicines, who generally supported the content of the present Delegated Regulation.
In addition, the Commission consulted the European Medicines Agency (EMA) for scientific advice. The advice took into account the views from the European Centre for Disease Prevention and Control (ECDC) and from the European Food Safety Authority (EFSA). It also took into account relevant recommendations from international organisations, such as the World Health Organization (WHO) and the World Organisation for Animal Health (OIE). Moreover, the Commission carried out targeted stakeholder consultations on the scientific advice provided by EMA.
This Delegated Regulation was also made available to the European Parliament and the Council.
There were no comments received from the Council.
There were no comments received from the European Parliament.
In addition, stakeholders' comments on the draft Delegated Regulation were collected in the context of the Better Regulation feedback mechanism during the period between 26 March 2021 and 23 April 2021. Comments from five non-governmental organisations representing veterinarians, one medical association, two business associations and one citizen representing the pharmaceutical industry, six associations/organisations representing the agri-food sector, two consumer organisations, one citizen and three non-EU countries were received via the online platform ‘Have your Say’ 1 . Comments from an additional non-EU country and a public authority from an EU country were sent by email to the relevant Commission services.
A sizeable proportion of the comments requested to add new provisions to clarify the process that would be followed by the Commission to establish the list of antimicrobials to be reserved for use in human medicine, based on the criteria described in the present Delegated Regulation. The comments also included the request to describe, as part of this process, the mechanism that would be followed to determine whether there would be an overriding public health interest that would justify that an antimicrobial is reserved for use in human medicine, provided that the absence of its use in veterinary medicine would only trigger limited morbidity or mortality. Comments indicated that this process should be transparent and that relevant stakeholders should be consulted. The Commission fully agrees that it is essential to have a science-based assessment of which antimicrobials should be reserved for use in human medicine and that national authorities, together with relevant stakeholders, should be consulted on the list of antimicrobials proposed. The list itself will be established in an Implementing Regulation, based on the criteria defined in the present Delegated Regulation. However, this process is outside the scope of the present Delegated Regulation. The scope is indeed, in accordance with Article 37(4) of Regulation (EU) 2019/6 to define the criteria that will be used to establish a list of antimicrobials to be reserved for the treatment of certain infections in humans. For this reason, the Commission did not include any provisions describing the process of the application of these criteria.
Other comments underlined that the criteria partially rely on measurable parameters, such as ‘significant morbidity or significant mortality’ or ‘the limited treatment alternatives available’, without specifying a corresponding numerical value that would allow to indisputably determine whether the criterion is fulfilled or not. The Commission wishes to emphasise that it did not provide such numerical values within the present Delegated Regulation, as these would vary depending on a range of parameters considered, such as, for example, the antimicrobial considered, the micro-organism and disease considered or the animal species concerned, making it unrealistic to draw up an exhaustive list. The Commission, in line with Article 37(6) of Regulation (EU) 2019/6, will take into account the scientific advice of the EMA, the EFSA and the ECDC, whose experts will jointly evaluate on a case-by-case basis, which antimicrobials fulfil the three criteria set in the present Delegated Regulation and should thus be included in the Implementing Regulation establishing the list of those antimicrobials to be reserved for use in human medicine. This scientific assessment will be published by the EMA in a scientific advice report, which will be available to the general public to ensure transparency.
It was also mentioned in some comments that the criterion of ‘risk of transmission of resistance’ was too strict and would likely result in no new antimicrobials being authorised for the veterinary market in the future, as all antimicrobials theoretically have a ‘potential’ for cross-resistance or co-selection of resistance to other antimicrobials. The Commission wishes to clarify that for this criterion to be met, there should be scientific evidence showing that there is such a potential but also scientific evidence showing that this transmission from animal sources to humans would likely be significant and linked to the use of this antimicrobial or group of antimicrobials in animals. In addition, the Commission underlines that an antimicrobial cannot be included in the list of antimicrobials to be reserved for use in human medicine on the sole basis of the fulfilment of this criterion; indeed all three criteria defined in the present Delegated Regulation should be met.
Some stakeholders indicated their regret that the criteria do not make any distinction between the assessment of antimicrobials used in food-producing animal species and the assessment of antimicrobials used in companion animal species. The Commission wishes to specify that Regulation (EU) 2019/6 does not foresee that any distinction should be made in the drafting of the criteria, depending on the animal species in which the antimicrobial may be used. However, Article 107(6) of Regulation (EU) 2019/6 foresees the possibility of restricting the use of certain antimicrobials outside the terms of their marketing authorisation to certain conditions and provides the possibility for the Commission to establish a list of antimicrobials subject to these conditions in an Implementing Regulation. Such conditions could include the restriction of the use of certain antimicrobials outside the terms of their marketing authorisation to certain animal species only, allowing, for example, the use of certain antimicrobials outside the terms of their marketing authorisations in companion animal species, but not in food-producing animal species. This provision thus provides for a very useful complementary tool to promote a prudent and responsible use of antimicrobials in veterinary medicine, while allowing for a more targeted approach.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
In accordance with Article 37(4) Regulation (EU) 2019/6, the present delegated act is to establish the criteria for the designation of the antimicrobials, which are to be reserved for treatment of certain infections in humans in order to preserve the efficacy of those antimicrobials. These criteria should not only apply to antimicrobials that have not yet been authorised for the veterinary market but should also apply to antimicrobials in existing veterinary medicinal products, in line with Article 152(1) of Regulation (EU) 2019/6.
COMMISSION DELEGATED REGULATION (EU) …/...