STC Number - 446

EU review of legislation on veterinary medicinal products

Maintained by: European Union
Raised by: Argentina; United States of America
Supported by: Australia; Brazil; Canada; Chile; Colombia; Paraguay
First date raised: July 2018 G/SPS/R/92/Rev.1, paras. 4.19-4.30
Dates subsequently raised: November 2018 (G/SPS/R/93, paras. 3.38-3.47)
March 2019 (G/SPS/R/94, paras. 3.68-3.75)
Number of times subsequently raised: 2
Relevant documents: Raised orally
Products covered:
Primary subject keyword: Food safety
Keywords: Food safety; Human health; Risk assessment; Veterinary drugs; International Standards / Harmonization
Status: Not reported
Solution:
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

In July 2018, Argentina raised concerns regarding the European Union's proposed regulation on veterinary medicinal products, stating that the adoption of provisions regarding the use of antimicrobials in the veterinary sector would have a significant impact on international trade. Argentina reiterated its commitment to the fight against AMR; its active participation in Codex Alimentarius and OIE work; and its conviction that an appropriate solution should be reached by consensus within a multilateral setting in a manner compatible to the WTO SPS Agreement.

Argentina was concerned that the proposed text, which was to be formally adopted by the European Parliament and the Council of Europe, 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. Argentina further added that recommendations from international organizations such as Codex Alimentarius, did not suggest that measures of this type should be taken with regard to antimicrobials, which implied a lack of certainty as to the results that could be achieved through these measures, a lack of scientific basis and a disproportionate reaction to the risk.

Argentina contended that the provisions that the European Union deemed appropriate to resolve sanitary matters, specific to the European Union and its regions, could not be applied on an extraterritorial basis to countries that did not share the same sanitary conditions. Further, 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 authorization standards.

Argentina requested the European Union to consider the equivalence of third country regulations on the use of antimicrobial medicines in the veterinary sector based on rigorous scientific assessment vis-à-vis the level of sanitary protection set by the European Union; clarify the criteria used to list antimicrobial medicinal products to which this reciprocity policy would apply; and take appropriate steps to avoid undue restrictions on international trade of animals and foods of animal origin as a consequence of the application of new provisions on the use of antimicrobial medicinal products in the veterinary sector.

The United States shared this concern, emphasising that 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. The United States also informed the Committee that it had joined several WTO Members in addressing concerns over this measure in a joint letter to EU Commission President Juncker. The EU restrictions would require other Members to adopt essentially the same comprehensive EU regulatory programme, without taking into consideration different conditions present in their territories. Applied extraterritorially, these restrictions would undermine multilateral efforts to combat AMR, such as those undertaken through the Codex Task Force on Antimicrobial Resistance, established to develop science-based guidelines on the management of foodborne AMR and to consider development of guidance on integrated surveillance of AMR, among others. In light of the ongoing multilateral efforts to develop standards on AMR, the United States urged the European Union to delay the adoption of new legislation until the guidelines were made available by Codex.

Colombia shared the concern and thanked the European Union for the information provided under item 3(a)(iii).

Chile also expressed interest in this topic, given its potential consequences for international trade. Chile trusted that, through the comments from Members in this Committee, the European Union would take into consideration the work of the OIE and Codex Alimentarius in line with Article 3 of the SPS Agreement on harmonization, as well as science-based risk assessments, as per Article 5 of the SPS Agreement.

Canada expressed concerns that the EU proposed approach would likely have an unnecessary restrictive impact on international trade and that it would undermine the ongoing multilateral efforts to combat this problem. Canada was of the view that AMR was a complex global issue and that tackling AMR requires a coordinated international approach. Canada recognised the coordinated efforts taken by several international bodies, and supported the collaborative leadership of the WHO, OIE, the FAO and Codex to promote a prudent use of antimicrobials in animals and public health to address AMR. Canada was concerned that despite the significant potential impact on trade, the draft regulation had not been notified to the SPS Committee. Canada urged the European Union to notify this measure to allow Members the opportunity to provide comments and to take these comments into account. Different conditions and disease prevalence in third countries could result in approved usages of drugs that differed from those in the European Union. Canada requested that the European Union provide the rationale and scientific justification for prohibiting certain veterinary antimicrobial drugs in the European Union and imports from third countries; the considerations that would be taken into account when preparing the list of medically important antimicrobials to be prohibited for veterinary uses in the European Union and third countries exporting to the European Union; and that the list be shared with third countries at the earliest opportunity.

Brazil shared the concern, underlining that the proposed amendments to the EU legislation could significantly impact trade. Brazil had previously shared its concerns with the European Union, in coordination with other WTO Members. Brazil regretted that the European Union had moved forward with a proposal that might prohibit exporting companies to engage in trade with the European Union if their national governments authorized the use of certain veterinary antimicrobial drugs under different conditions than those permitted by the European Union, or if the exporters did not comply with certain EU requirements. The adoption of these measures could undermine the on-going work of international standard-setting organizations developing multilateral harmonized guidelines to deal with AMR. It was unclear how the EU proposed legislation would converge with the international criteria for maximum residue levels (MRLs) already established in accordance with a scientific risk assessment. Finally, Brazil requested the European Union to take into consideration the multilateral efforts on AMR regulation, particularly the on-going work of international standard-setting organizations to establish international standards on the use of veterinary medicinal products.

Australia expressed its support to the joint work of WHO, OIE and FAO in setting international standards for AMR. The application of risk measures to prevent and reduce AMR should be based on internationally agreed standards, and supported by scientific data. Australia also stressed the importance of retaining access to effective antimicrobials to protect animal health and to avoid adverse animal welfare outcomes. Australia strongly discouraged regional and individual countries' efforts to introduce AMR-related risk management measures inconsistent with agreed standards and not supported by science that could distort trade. Australia encouraged all countries to adhere to their international obligations, stressing that unilateral procedures related to AMR trade policies outside the international standard-setting organizations had the potential to undermine collaborative global efforts. Australia emphasized its commitment to an effective and robust system for the prevention and containment of AMR, and explained that it had adopted one of the most conservative approaches to the use of antimicrobials in livestock production in the world. However, Australia stressed that antimicrobials were important for animal health and welfare, biosecurity and production, and that it was critical for the Australian livestock sector to retain access to these antimicrobials to treat, prevent and control diseases. Australia underlined its low rate of AMR in food animals due to its favourable animal health status, extensive farming systems, stringent border controls, good biosecurity measures to prevent the introduction, establishment and spread of endemic and exotic diseases, and strong regulations governing the registration and the use of antimicrobials. Finally, Australia expressed its concern that any measures to restrict access to the prophylactic use of antimicrobials in food animals would have significant adverse impact on exports of Australian and other livestock animal products.

The European Union recalled the information provided under agenda item 3 (a)(iii), and expressed appreciation for Members' shared recognition of the importance of AMR for global health. The European Union stressed that it promoted prudent and responsible use of antimicrobials worldwide and highlighted the growing international consensus on the need to phase out the use of antimicrobials as growth promoters. The European Union reiterated that the original proposal had been notified under the TBT Agreement because at that time it did not include SPS elements relevant to international trade. In addition, the European Union explained that it had not had the opportunity to notify the current version of the Regulation under any WTO Agreements because the EU co legislators had introduced import-related AMR measures in the draft Regulation at the latest stage of the legislative process. The European Union emphasized that the measure would be notified. Concerning the criteria for antimicrobials reserved for humans, the European Union observed that no decision had been taken yet. However, the European Union emphasised that any implementation would be based on risk assessments provided by the European Medicine Agency, the European Food Safety Authority and other relevant EU agencies, taking into account relevant recommendations from international organizations.

Regarding the impact and the consistency with WTO requirements, the European Union reiterated that detailed rules on how to apply these measures would be available in delegated acts meeting all the relevant requirements, compatible with all the international agreements, including WTO obligations, and would be legally sound, proportionate, non-discriminatory and based on science. The European Union expressed its willingness to continue its engagement with Codex, WHO, FAO and OIE on the development of a consistent international framework and standards related to AMR. Finally, the European Union stated that this Regulation would contribute to the fight against the global spread of AMR.

In November 2018, Argentina reiterated its concern regarding the European Union's proposed regulation on veterinary medicinal products, stating that it was not based on a risk assessment nor in line with Codex guidelines and principles. Further, through this new regulation, the European Union would be applying mutatis mutandis 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 authorization standards. Argentina requested the European Union to consider the equivalence of third country regulations on the use of antimicrobial medicines based on rigorous scientific assessment vis-à-vis the level of sanitary protection set by the European Union.

Argentina noted that the issue of antimicrobial resistance had received greater attention in various international fora, such as the United Nations, G20, FAO, WHO as well as the OIE and Codex Alimentarius. Antimicrobial resistance was a complex topic that posed significant challenges, which required coordinated efforts based on science. Argentina further asked the European Union to develop the new regulation in compliance with the SPS Agreement and to avoid any barrier to trade. Finally, Argentina urged the European Union to provide the list of permitted antimicrobials for human and animal use, and encouraged the European Union to notify the revised measures to both the TBT and SPS Committees.

The United States also reiterated its concern, emphasizing that the measure would require foreign producers to abide by EU production standards regarding the use of antimicrobial veterinary drugs, without taking into consideration animal health conditions in their own territories. The United States further explained that the measure would ban the use of certain veterinary drugs based on approval in the exporting country and would not target residues of concern. Furthermore, the EU legislation prevented third countries from taking into account regional conditions and disease prevalence. The United States urged the European Union to consider the ongoing global effort undertaken in the Codex Task Force on Antimicrobial Resistance (TFAMR) to develop standards on antimicrobial resistance, and to delay implementation of its legislation until after the Task Force concluded its work. Finally, the United States asked the European Union to notify the revised legislation.

Colombia and Paraguay shared the concern raised by Argentina and the United States. Paraguay reiterated its support for the ongoing multilateral efforts to combat AMR, highlighting national initiatives currently under development.

Canada expressed its disappointment with the European Parliament's vote in favour of the new regulation on veterinary medical products to manage health risks from AMR. Canada recognized that AMR represented a serious public health issue that required high attention, but was concerned that the EU approach to managing such risks unnecessarily restricted trade and possibly undermined the ongoing multilateral efforts to combat AMR. Canada was of the view that AMR was a complex global issue and recognized the coordinated efforts undertaken by several international bodies to promote the prudent use of antimicrobials in animal and public health. Canada encouraged the European Union to support these ongoing efforts. Canada urged the European Union to notify the implementing measures given its significant potential impact on trade, to allow Members the opportunity to provide comments and to take these comments into account. Different conditions and diseases in third countries could result in approved usages of drugs that differed from those in the European Union. Canada requested that the European Union provide the rationale and scientific justification for prohibiting certain veterinary antimicrobial drugs in the European Union and imports from third countries and to provide the considerations that would be taken into account when preparing the list of medically important antimicrobials to be prohibited for veterinary use in the European Union and in third countries exporting to the European Union.

Brazil shared the concern, highlighting the ongoing multilateral efforts undertaken by international standard-setting organizations to address AMR. Brazil was of the view that AMR needed to be addressed multilaterally, and that unilateral decisions to ban the use of certain veterinary drugs and prohibit imports from countries where these products had been authorized was incompatible with Article 3 of the SPS Agreement and more trade-restrictive than necessary. Brazil emphasized the work of the Codex TFAMR and the "Code of Practice to Minimize and Contain Antimicrobial Resistance", supported by WHO, OIE, FAO and G20. Finally, Brazil requested the European Union to establish MRLs based on risk assessments.

Australia reiterated its support for the joint work of WHO, OIE and FAO in setting international standards for AMR. The application of risk measures to prevent and reduce AMR should be based on internationally agreed standards and supported by scientific data. Australia also stressed the importance of retaining access to effective antimicrobials to protect animal health and to avoid adverse animal welfare outcomes. Australia discouraged regional and individual countries' efforts to introduce AMR-related risk management measures that were inconsistent with agreed standards, not supported by science, and that could distort trade. Unilateral initiatives related to AMR trade policies outside the international standard-setting organizations had the potential to undermine collaborative global efforts and the integrity of these organizations. Australia emphasized its commitment to an effective and robust system for the prevention and containment of AMR and explained that it had adopted one of the most conservative approaches to the use of antimicrobials in livestock production in the world. However, Australia stressed that antimicrobials were important for animal health, welfare and biosecurity and that it was critical for the Australian livestock sector to retain access to these antimicrobials to treat, prevent and control diseases. Australia underlined its low rate of AMR in food animals due to its favourable animal health status, extensive farming systems, stringent border controls, efficient security measures to prevent the introduction of endemic and exotic diseases, and strong regulations governing the registration and use of antimicrobials. Finally, Australia expressed its concern that any measures to restrict access to the prophylactic use of antimicrobials in food animals would have significant adverse impact on exports of Australian and other livestock animal products.

The European Union noted that the revised regulation on veterinary medicinal products established a framework for the authorisation, distribution and use of veterinary drugs in the European Union. The European Union recalled that the original proposal, drafted in September 2014, had been notified under the TBT Committee in April 2015. Formal adoption, publication and entry into force was expected to take place in November 2018, and the new regulation would be applicable after three years. The European Union further explained that the key objectives of the new regulation aimed at addressing the global public health risk of AMR. The new regulation was based on a wide range of actions following the "One Health" approach internationally recognized as the most effective to tackle AMR. These actions included the strengthening of the principles behind the prudent and responsible use of antimicrobials, a ban on the preventive use of antibiotics in groups of animals, restrictions on metaphylactic use, the possibility to reserve certain antimicrobials for humans only, and compulsory data collection on sales and use of antimicrobials.

The European Union recalled that the ban on using antimicrobials for growth promotion was not new in the European Union, highlighting that the ban on using antibiotics as feed additives, in force since 2006, was based on a scientific opinion. Furthermore, the total ban was also in line with the growing international recognition of the need to phase out the use of antimicrobials as growth promoters, some of which were critically important for human medicine. The European Union recalled that AMR organisms and resistance determinants might spread to humans and animals through the consumption of food and feed originated in and outside the European Union. Therefore, certain non-discriminatory and proportionate provisions were introduced in the regulation to prevent operators in non-EU countries from using antimicrobials for growth promotion or antimicrobials designated in the European Union for human use only, insofar as relevant in respect of animals or products of animal origin exported to the European Union.

The European Union recalled that the new regulation would impose stricter requirements to operators in the European Union than to operators in non-EU countries, in particular for rules related to prophylaxis and metaphylaxis. The European Union noted that the new import requirements should be considered as part of the overall fight against the global spread of AMR, and not as trade barriers. The European Union reiterated its interest in the work carried out by WHO and OIE as well as the work of the UN Interagency Coordination Group (IACG) and the ad hoc Codex TFAMR.

In March 2019, the United States reiterated its concern over Regulation (EU) 2019/6, in particular Article 118 requiring producers of animals and animal products intending to ship to the European Union to comply with EU production standards. The United States appreciated the continuous bilateral engagement with the European Union. The United States recalled that regulatory approaches needed to be appropriate to the circumstances. The United States referred to the EU statement in November 2018 indicating that its legislation was aimed at implementing the global consensus on addressing the global health risk of AMR by preventing the use of medically important antimicrobials for growth promotion purposes. The United States supported the international consensus on AMR, as reflected in the WHO Global Action Plan, the OIE Strategy on AMR and the Codex guidelines. According to the United States, the EU legislation ran contrary to the international consensus on the key point that countries had to adapt policies to their national priorities as well as to regional and local conditions. Further, the United States noted the successful implementation by FDA of the WHO Global Action Plan through a programme of voluntary label changes aiming to phase out the use of medically important antimicrobial drugs for growth promotion. The United States asked the European Union to explain how the adoption of EU standards by its trading partners was consistent with the global consensus and how its legislation would be implemented in the least trade-restrictive manner.

Australia, Brazil, Canada, Chile, Colombia and Paraguay shared the concern, reiterating their support for the joint work of WHO, OIE and FAO in setting international standards and guidelines for AMR as well as the work of the Codex Task Force on Antimicrobial Resistance (TFAMR). They underlined that unilateral initiatives related to AMR trade policies outside the international standard-setting organizations had the potential to undermine collaborative global efforts and the integrity and relevance of these organizations. Canada, with the support of Paraguay and Chile, asked the European Union to share the list it was preparing of antimicrobials reserved for human use; and the basis and considerations being taken into account in the preparation of the list.

Canada thanked the European Union for the ongoing dialogue. Canada underlined the unnecessarily restrictive impact on international trade that the application of the EU veterinary medicinal products regulation could have. It also requested the European Union to notify the implementing and delegated acts supporting Regulation (EU) 2019/6, to provide Members an opportunity to submit comments.

Brazil noted that a safe, harmonized, and scientifically-based framework for trade in animal products was the best possible scenario for promoting food safety and food security. A unilateral ban of several veterinary drugs was not compatible with that goal, and could impose a burden on producers.

Australia wished to discourage regional and individual countries' efforts to introduce AMR-related risk management measures that were inconsistent with agreed standards and not supported by science, as they could distort trade. Australia emphasized its commitment to an effective and robust system for the prevention and containment of AMR and explained that it had adopted a very conservative approach to the use of antimicrobials in livestock production. However, Australia stressed that antimicrobials were important for animal health, welfare, biosecurity, and production. Australia underlined its low rate of AMR in food production animals due to its favourable animal health status, extensive farming systems, stringent border controls, efficient biosecurity measures to prevent the introduction of endemic and exotic diseases, and strong regulations governing the registration and use of antimicrobials. Finally, Australia expressed its concern that any measures to restrict access to the prophylactic use of antimicrobials in food animals would have significant adverse impact on exports of Australian and other animal products.

Chile asked the European Union whether its determination had followed a risk-based or a hazard-based approach.

Norway stated that AMR was a priority for its government and it actively supported work by FAO, WHO, OIE and UNEP. A One Health approach including cooperation of all relevant sectors (health, agriculture, aquaculture and environment) was required to combat AMR. Norway noted that trade might contribute to the spread of AMR. In Norway, the use of antibiotics in fish and animals was low compared to most countries, and Norway insisted that veterinary drugs should mainly be restricted to treatment of diseases affecting animal health and welfare. Routine prophylaxis and the use of antibiotics as growth promotors was not allowed in Norway. Norway underscored the goal to promote prudent and responsible use to minimize the spread of AMR and highlighted that important antibiotics should be reserved for human use and not be allowed for animals.

The European Union referred to its statements made in the Committee meetings in July and November 2018 explaining the rationale and background of Regulation (EU) 2019/6, as accurately reflected in the respective summary reports. The European Union explained that its regulation was a tool to fight AMR rather than a barrier to it. The regulation imposed stricter rules on operators within the European Union concerning prophylaxis and metaphylaxis. Implementing measures would be based on scientific evidence, would take into account international standards and recommendations, and would be consistent with international obligations. Regulation (EU) 2019/6 had been adopted on 11 December 2018, published on 7 January 2019, and would start to apply on 28 January 2022. While the proposal had initially been notified under the TBT Agreement only, the final Regulation had been notified under the SPS Agreement (G/SPS/N/EU/312). The European Union had held bilateral and plurilateral meetings with trade partners. Concerning deadlines, the implementing measures would be prepared and discussed within the European Union first. The Regulation specified timelines for adoption of criteria to designate antimicrobials reserved in the European Union for human use (by 28 September 2021) and the list of antimicrobials concerned by import rules (by 28 January 2022). All relevant implementing measures would be notified under the SPS Agreement. Finally, the European Union agreed on the importance of international cooperation, signalling its commitment to continue working as a driving force in the global fight against AMR. It would keep engaging with trading partners and WTO Members within multilateral organizations and through bilateral channels to promote and support effective strategies to prevent and contain the global threat of AMR.