Antibiotic legislation as a mirror clause

The first priority of the French EU Presidency in the first half of 2022 under the ‘Agriculture and forestry’ heading is to ‘encourage Council discussions on reciprocal environmental and health production standards for European products and products imported from third countries with the aim of subjecting imported products to certain production requirements applied in the European Union where necessary, to strengthen the protection of health or the environment on the largest possible scale, in keeping with World Trade Organization rules (“mirror clauses”)’.

One of the issues on the French Presidency agenda will be the completion of the outstanding legislation necessary to fully implement the Veterinary Medicinal Products (VMP) Regulation (EU) 2019/6. This legislation came into actual effect last Friday 28 January 2022. It can be seen as the first example of the use of a mirror clause for the protection of health. It imposes additional restrictions on the use of antibiotics for animal production in the EU and extends certain of these restrictions to imported animals and animal products. However, despite the three-year transition period to allow for implementation of the new rules, essential elements of legislation necessary to activate this mirror clause remain to be adopted.

The ban on the import of hormone-treated beef into the EU might be seen as an earlier example of a mirror clause. It has many similarities with the proposed ban on the import of animal products produced with the use of antibiotics in ways that are restricted in the EU. However, this was explicitly introduced as a measure to protect the health of EU citizens and was not directly motivated by the principle of reciprocity. The antibiotic ban is both explicitly justified on the basis of the reciprocity principle but it also seeks to address the global public health problem of antibiotic resistance in ways that go beyond the currently-agreed international standards in this area.

This post discusses the background to the mirror clause in the VMP Regulation and the implications of the delay in bringing forward the enforcement legislation.

The mirror clause in the Veterinary Medicinal Products Regulation

The VMP Regulation (EU) 2019/6 aims to ensure the increased availability of veterinary medicinal products as well as strengthened protection for public and animal health. It sets out new rules on the manufacture and use of veterinary medicines. The new regulation has a particular focus on tightening the use of antimicrobials (including antibiotics) in animal production in order to limit the spread of antimicrobial resistance (AMR).

The VMP Regulation, together with the associated Medicated Feed Regulation (EU) 2019/4, reinforces the ban on the use of antimicrobials for growth promotion and increasing yield originally introduced in the EU in 2006. It includes a ban on the preventive use of antibiotics in groups of animals when a disease has not been diagnosed (prophylaxis) and restricts the metaphylactic use of antimicrobials in animals (treating all animals in a group when only a number of them show signs of illness). It also introduces the possibility to reserve certain antimicrobials for human use only.

The Medicated Feed Regulation prohibits the use of antimicrobials via medicated feed for prophylaxis and growth promotion. Prescribed medicated feed is to be used only on veterinary prescription and for the animals for which the veterinary prescription has been issued.

The VMP Regulation, in Article 188(1), further specifies that two of these conditions should also apply to imports from third countries. In order to be eligible to export animal products to the EU, operators in third countries should not use antimicrobials for the purpose of promoting growth or increasing yield, and they also should not use antimicrobials on the EU list of antimicrobials reserved for human use.

The use of antibiotics in animal husbandry in large amounts can result in the appearance of antimicrobial residues in muscle and organs of the animal, posing a health risk to consumers including development of antimicrobial resistance bacteria. To avoid this risk, European legislation sets maximum residue limits for veterinary drug residues in different animal food products. Regulation (EU) No 37/2010 establishes maximum residue limits for residues of veterinary medicinal products in food-producing animals and animal products. Non-EU countries wanting to export to the EU must implement a residue monitoring plan which guarantees an equivalent level of food safety. Article 29 of Directive 96/23/EC requires that third countries provide guarantees on the residue status of commodities eligible for entry to the EU. To be included in the list of countries that are authorised to export to the EU this residue monitoring plan must be approved by the Commission. In addition, imported animal products are subject to the same random checks for residues, including antibiotic residues, as EU products under procedures and standards laid down in the Official Controls Regulation.

However, Article 118(1) in the VMP Regulation goes further. It is not concerned with the detection of residues, but rather with the way antibiotics are used in the exporting country. It extends enforcement beyond the protection of EU consumers from the health risks from consuming contaminated product (a standard issue under the WTO Agreement on Sanitary and Phytosanitary Standards) to laying down rules that exporting countries must meet in order to address the wider global public health problem of antimicrobial resistance (AMR).

This provision was not included in the original Commission proposal in 2014 for the VMP Regulation. It was introduced by the ENVI Committee in the Parliament during its consideration of the legislation. In the initial draft report by the ENVI Committee rapporteur, the prohibition on imports from third countries referred to countries whose legislation permitted the use of antimicrobials on the EU reserved list under different conditions to those set out in EU legislation. This position was endorsed by the Parliament in its mandate for negotiations with the Council. The restriction was justified on the grounds that it ‘introduces the concept of reciprocity so that prohibitions or restrictions applying to antimicrobials in Europe are also applicable to sectors producing animals or food of animal origin for import into the EU’. This legislation can thus be seen as an early example of the use of mirror clauses under which third country producers are expected to meet the same standards as EU producers, albeit in this instance over a public health rather than an environmental issue.

Reactions from trading partners

Given that the EU’s measure is likely to have a significant impact on international trade, it is no surprise that it has been the subject of extensive discussion in the WTO Sanitary and Phytosanitary (SPS) Committee. WTO Members have the opportunity in this Committee to monitor the implementation of the SPS Agreement and to raise particular issues as Specific Trade Concerns (STCs). Argentina first raised the EU measure already in 2018 prior to the adoption of the Regulation and the measure has been raised on a further six occasions (WTO STC 446). This STC has also been raised by the United States, Australia, Brazil, Canada, Uruguay, Paraguay (all exporters of beef and poultrymeat to the EU) as well as several other countries.

Three main arguments have been raised by trading partners:

• Some countries objected because the Regulation would require exporters of animals and animal products to meet EU standards concerning the use of certain antimicrobial medicinal products, as well as specific usage provisions, as a condition for maintaining access to the EU market, despite the differences in the prevailing sanitary conditions. They argued that different conditions and disease prevalence in third countries could result in approved usages of drugs that differed from those in the EU. The EU legislation prevented third countries from taking into account regional conditions and disease prevalence. The United States went further to urge the EU to maintain the use of antimicrobials for growth promotion not medically important for humans (in line with the Codex Code of Practice, see next point).
• A major argument has been that there are global efforts in the Codex Task Force on Antimicrobial Resistance (TFAMR) first established in 2006 to develop standards on antimicrobial resistance, including development of a “Code of Practice to Minimize and Contain Antimicrobial Resistance”. It is argued that unilateral procedures related to AMR trade policies outside the international standard-setting organizations had the potential to undermine collaborative global efforts. The adoption of these measures could undermine the on-going work of international standard-setting organisations developing multilateral harmonised guidelines to deal with AMR. The latest 2021 revision of the Codex Code of Practice does not go as far as EU legislation.  It states that the use of medically important antimicrobials for growth promotion does not represent prudent and responsible use whereas EU legislation has (since 2006) banned the use of all antimicrobials for growth promotion purposes.
• A third argument has been that, through this new regulation, the European Union would be applying a reciprocity approach that lacked scientific basis, preventing access to the EU market for animal products from third countries where antimicrobial medicinal products were subject to different usage authorisation standards. The measure would require foreign producers to abide by EU production methodology requirements related to antibiotic use restrictions in livestock, and would not target residues of concern, or the presence of resistance genes. It was argued that unilateral decisions to ban the use of certain veterinary drugs and prohibit imports from countries where these products had been authorised was incompatible with Article 3 of the SPS Agreement and more trade-restrictive than necessary.

Enforcement of the new import rules

The VMP Regulation applies as of 28 January 2022. What is still unknown is how the new import rules will be applied and enforced. Critical elements such as the list of antimicrobials to be banned for use in animal agriculture in the European Union, how compliance with the requirements will be assessed, and whether a transition period for third countries will be provided, remain unclear. Article 118(2) of the VMP Regulation states that the Commission is to adopt delegated acts to supplement the provisions of Article 118 with detailed rules on the application of paragraph 1 which sets out the new import requirements. Some relevant delegated acts have been adopted, but others are still in the pipeline.

The delegated regulation establishing the criteria to designate the antimicrobials to be reserved for human use was adopted by the Commission in May 2021 (Delegated Regulation (EU) 2021/1760). The European Parliament has the power to object to a delegated regulation. A proposal to object to the Regulation put forward by the Greens/EFA political group on the grounds that the new criteria gave too much emphasis to the role that antibiotics play in animal health was rejected by the Parliament in September 2021 so those criteria are now in place. The Commission must now publish an implementing act establishing the list of antimicrobials reserved for human use based on these criteria. This was to be adopted by 27 January 2022 but has yet to be published.

The other relevant delegated act is one detailing the rules for the importation of animals and products of animal origin. This was also to be adopted by 27 January 2022 and is also delayed. A preliminary step has been taken to amend the Official Controls Regulation (OCR). In its original form, the OCR explicitly did not cover official controls for the verification of compliance with Directive 2001/82/EC (the predecessor of the VMP Regulation which has now been replaced by the latter) on the use of veterinary medicinal products. The amendment to extend the OCR to also check for compliance with the ban on the use of antibiotics for growth promotion and the ban on using antibiotics on the EU list of antibiotics reserved for human use was approved in October 2021 as Regulation (EU) 2021/1756.

However, the delegated act setting out exactly how this compliance will be checked remains to be published. For example, will it become a requirement in the national residue monitoring plans that exporting countries must submit to the Commission before being eligible to export animals and animal products to the EU that these residue plans should also control the use of antibiotics (and not just antibiotic residues as is the case at present)? Will there be a requirement that shipments of animals and animal products should be accompanied by a veterinary certificate confirming that antibiotic use has been in line with EU requirements? If the national legislation of the exporting country is not explicitly in line with the EU requirements, will it be necessary to establish separate supply chains to processors in the exporting countries as is currently the case for non-hormone treated beef exports to guarantee compliance with the EU rules? 

The delay in publishing the delegated act suggests that it is not easy to design a compliance system that is both effective but which also meets the EU’s international obligations and particularly the requirements under the WTO Agreements that the procedures should be non-discriminatory, proportionate, and no more trade restrictive than necessary.

In the inter-institutional trilogue negotiations on Article 118 in the VMP Regulation, the Council had wanted to insert that the ban on the use of antimicrobials for growth promotion and on the use of antimicrobials reserved for human use should apply, provided that this is not incompatible with relevant international agreements. This was unacceptable to the Parliament as it it considered that such a reference was redundant and weakened the political message. The final compromise was to omit this reference in Article 118 but to include a reference in the recitals (Recital 49) that ‘it should also be ensured, in a non-discriminatory and proportionate manner, that operators in third countries respect certain basic conditions relating to antimicrobial resistance for animals and products of animal origin exported to the Union. Any such action should respect Union obligations under relevant international agreements. This should contribute to the international fight against antimicrobial resistance, in particular in line with the WHO Global Action Plan and the OIE Strategy on Antimicrobial Resistance and the Prudent Use of Antimicrobials.’

While this reference in the recitals does not have the same legal effect as if it were directly included in Article 118, it is nonetheless something the Commission must take into account in its design of the compliance rules. Two farm organisations (COPA-COGECA and the Danish Landbrug & Fødevarer), in the feedback provided prior to the adoption of the amendment to the Official Controls Regulation, also urged ‘the European Commission to do its utmost to ensure that this amendment proposal does not include unnecessarily restrictive measures that would compromise the balance of international trade’.

The Commission now expects work on these delayed acts to move forward during the French Presidency, for an adoption during either the French or the Czech Presidency.

Conclusions  

The Veterinary Medicinal Products Regulation provides an early example of the use of a mirror clause that seeks both to ensure reciprocity between the standards that apply to EU producers and to imports while also attempting to address the global health problem of antimicrobial resistance. Some would have wished that it went further in that respect. The European Public Health Alliance, in its feedback on the amendment to the Official Controls Regulation, noted that the Farm to Fork Strategy emphasises that ‘to address the global threat of antimicrobial resistance, products of animal origin imported into the EU will have to comply with strict requirements on the use of antibiotics in line with the recently agreed veterinary medicinal products Regulation. To ensure equivalence of standards with the Regulation and create a level playing field for European farmers, import requirements should therefore also extend to cover routine use, prophylaxis and metaphylaxis (as per Article 107 of the Regulation).’

Antimicrobial resistance (AMR) poses an enormous threat to both public and animal health. It has steadily moved up the global agenda in importance. Three organisations, the World Health Organisation (WHO), the World Organisation for Animal Health (OIE), and the Food and Agriculture Organisation (FAO) have come together to develop policies and tools to combat AMR at a global level. The WHO’s Global Action Plan on Antimicrobial Resistance published in 2015 sets out the current international guidelines. The Action Plan proposes phasing out of use of antibiotics for animal growth promotion and crop protection in the absence of risk analysis; and reduction in nontherapeutic use of antimicrobial medicines in animal health. It also proposes that FAO, in collaboration with WHO, should regularly review and update the FAO/WHO Codex Alimentarius Code of Practice to Minimize and Contain Antimicrobial Resistance to take into account not only residues in food but also the need for standards to minimize and control use of antimicrobial agents in agricultural practice. The EU’s position requiring an absolute ban on using antibiotics for growth promotion as well as reserving certain antibiotics for human use alone thus goes further than current international standards.

The EU’s desire to tackle the problem of antibiotic resistance on a global scale is justified. It has presumably argued for its position in international bodies but has been rebuffed by countries with powerful animal agriculture industries that wish to maintain the status quo. Whether the more aggressive unilateral approach laid out in the VMP Regulation will catalyse progress towards higher international standards or lead to a backlash resulting in complaints to the WTO that the EU’s stance is incompatible with its international obligations remains to be seen. The obligations set out in the yet-to-be-announced legislation detailing the rules for the import of animals and animal products will be significant in determining this outcome.

This post was written by Alan Matthews.

Photo credit: Compassion in World Farming under a CC licence.