The successful promotion of EU standards on cross-border health threats: the case of antimicrobial resistance of antimicrobial resistance

Dans le document The promotion of public health in EU external relations (Page 166-187)

The European Union has an opportunity to shape international rules in the area of anti-microbial resistance. AMR occurs when microorganisms become resistant to antianti-microbial

698 It has been suggested that sanctions could be imposed when inappropriate actions are carried out; see Ilona KICKBUSCH, ‘Governing the Global Health Security Domain’ (2016) 12 Global Health Programme Working Paper 1, pp. 18-19.

699 See infra, Part II, Section II, I, B.

146 drugs, such as antibiotics, thus rendering medicines ineffective to heal diseases.700 AMR is caused by the overuse of antimicrobials in humans, foodstuffs and agriculture. It is spreading globally as a consequence of increased movements of people and goods. Both the European Union, at the regional level, and the World Health Organization, at the global level, are seeking solutions. A common approach towards AMR is followed by both organisations (A). While the goals seem to be shared at both levels, the European Union has adopted more complex and evolved measures. AMR is considered a cross-border health threat under Decision No 1082/2013,701 but it strongly differs from other health threats. These differences have allowed the Union to act to a larger extent and to reach a coherent and comprehensive legal framework internally. The European Union has set as one of its main priorities the promotion of the EU model on AMR at the global level and it is argued that there is an opportunity for the Union to become a global leader in this field (B).

A. Convergence at the EU and at the global levels in the field of antimicrobial resistance AMR is considered a cross-border health threat under Article 2 of Decision No 1082/2013.

The increased movement of people and global trade facilitate the spread of AMR throughout the world. There is an agreement that this challenge cannot be faced by each State separately.

Despite the qualification as a cross-border health threat and the security concerns that are accordingly assessed in this field, AMR goes beyond these considerations. Because of the presence of antibiotics in foodstuffs and animals, AMR has also been tackled in the European Union under the internal market provisions and the Common Agricultural Policy. This feature has allowed the Union to develop multiple standards through a variety of legal instruments and to extend its competence in the field, leading to a comprehensive body of legislation and actions to combat AMR (1). The interest in AMR has been met at the international level, where the World Health Organization as well as other institutions are also regularly discussing this issue with a similar approach. However, the EU expertise contrasts with the actions undertaken at the international level, where there does not seem to be a systematic way of approaching AMR despite a growing interest in this phenomenon (2). This weakness at the global level has facilitated the promotion of EU standards on AMR to the global scene.

700 World Health Organization, Antimicrobial Resistance, 15 February 2018, available at https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance (last accessed 30 January 2020).

701 Article 2 Decision No 1082/2013.

147 1. EU actions on antimicrobial resistance: multiple standards for a coherent action plan The European Union has addressed AMR from multiple perspectives, thus developing a wide variety of standards (a). This multi-factorial approach has allowed the Union to use numerous legal bases to legislate, leading to a broad competence in this area. This facet constitutes an important difference with respect to other cross-border health threats. It has contributed to the development of a strong legislative body that has evolved over time to reach, currently, a comprehensive set of rules (b).

a. EU standards in antimicrobial resistance

The approach of the European Union in the field of AMR shares the health-security linkage followed by the Union for all cross-border health threats (i). However, such approach also reveals some important differences. In addition to security concerns, the EU has focused on other aspects related with this topic. The multi-factorial approach of the Union towards AMR has allowed the adoption of a variety of instruments, leading to the broadening of the Union’s competence in this field (ii).

i. Antimicrobial resistance and the health-security linkage

Antimicrobial resistance has been no exception to the securitarian approach adopted by the European Union towards cross-border health threats. The simple fact of qualifying antimicrobial resistance as a cross-border health ‘threat’ by including it within the scope of Decision No 1082/2013 highlights this perspective.

The first conference where EU institutions mentioned AMR was entitled ‘the microbial threat’, thus highlighting the dangers associated with antimicrobial resistance.702 The first EU action plan on AMR validates this approach as it refers to the ‘rising threats from antimicrobial resistance’.703 In its most recent action plan on AMR, the European Commission aims at making an increased use of the Health Security Committee and at increasing prevention, surveillance and the use of biosecurity measures.704 Security has thus always surrounded AMR and has been considered as one of the aims of EU actions.

702 Dik J. MEVIUS, Mark J.W. SPRENGER and Henrik C. WENEGER, ‘EU Conference “The Microbial Threat”’

(1999) 11 International Journal of Antimicrobial Agents 101.

703 European Commission, Action plan against the rising threats from antimicrobial resistance, 15 November 2011, COM(2011) 748 (European Commission, COM(2011) 748).

704 European Commission, A European One Health Action Plan against Antimicrobial Resistance (AMR), 2017, available at https://ec.europa.eu/health/amr/sites/health/files/antimicrobial_resistance/docs/amr_2017_action-plan.pdf (last accessed 31 January 2020) (European Commission, One Health Action Plan against AMR).

148 Some of the measures adopted to address AMR mirror the general approach towards cross-border health threats. Surveillance is a relevant instrument of this policy. The European Commission insists in the action plan on AMR on the need to have strong surveillance mechanisms. It considers that general surveillance programs are not enough and that a more integrated surveillance system dealing specifically with AMR needs to be developed.705 The improvement of infection prevention, biosecurity measures and control practices is also critical.

These results can be reached by making more coherent surveillance data available and by developing innovative approaches to infection prevention and control.706 All these actions are similar to the ones described for all other cross-border health threats. They highlight security concerns and thus focus on surveillance.

However, EU actions towards AMR go further than that. AMR being closely related with the presence of antibiotics in foodstuffs and in animals, the European Union has been able to develop a variety of standards that go beyond security. This has led to a strong legislative body that has enhanced the Union’s competence in the field.

ii. A variety of concerns on antimicrobial resistance

The particularity of AMR rests in the fact that, in addition to security, it raises other concerns.

AMR cannot only be tackled with surveillance mechanisms, as many other actions can have a direct impact in this field. The European Union is aware of it and has taken advantage of the opportunity to use several legal bases to become an active player in this area.

Antimicrobial resistance has been seen from the very first moment as a multi-factorial concern. The first EU action plan on AMR addressed the topic from a variety of perspectives.707 The Union referred in this document to the need to adopt a ‘holistic approach (…) involving many different sectors e.g. medicine, veterinary medicine, animal husbandry, agriculture, environment and trade’.708 These sectors were then analysed in turn. With respect to human medicine, there had to be a more appropriate use of antimicrobials by patients and prescribers.

Such outcome also needed to be reached in relation with therapeutic antimicrobials for animals.

The EU also wanted to strengthen the development of new human and veterinary antimicrobials, for which resistance had not developed yet. This required the involvement of research to this phenomenon. Another area where the Union wished to act was the

705 European Commission, One Health Action Plan against AMR, p. 7.

706 Ibid., p. 10.

707 European Commission, COM(2011) 748.

708 Ibid., p. 4.

149 environmental field because environmental pollution by antimicrobials accelerated the spread of AMR.

The second action plan seems to strengthen the security agenda towards AMR. Nevertheless, other concerns are highlighted. An increased role is granted to the environment. It is stated that

‘the environment is increasingly acknowledged as a contributor to the development and spread of AMR in humans and animals, in particular in high risk areas due to human, animal and manufacturing waste streams’.709

In accordance with those action plans, EU standards on AMR will be based on the development of new antimicrobials, the fight against the presence of antimicrobials in the environment, and the promotion of an appropriate use of antimicrobials in human and veterinary medicine. The analysis will thus turn to how those goals are pursued in the European Union.

The variety of areas that AMR affects has led to a broadening of the EU competence. A comprehensive approach has been followed, favouring a coherent EU action on AMR.

b. A comprehensive approach towards antimicrobial resistance

The variety of concerns related with AMR entails advantages and drawbacks. On the one hand, it has allowed a broadening of the Union’s competence in the field (i). The EU has been able to rely on several legal bases in order to legislate. On the other hand, this could lead to an incoherent set of legal instruments coexisting in the EU legal order. However, the Union has adopted a ‘holistic approach’ through its action plans in order to make all instruments part of a common strategy (ii).

i. EU competence in the field of antimicrobial resistance

Article 168 (5) TFEU allows the adoption of incentive measures to combat major cross-border health scourges. However, those incentive measures cannot consist of any harmonisation of the laws and regulations of the Member States. This legal basis, which is generally used to legislate on cross-border health threats, confers a limited competence to the Union and restricts possible EU action in the field of AMR. There are however other legal bases that could apply to this area.

Article 168 (4) TFEU grants the Union a shared competence in a limited number of areas related with public health, which include the veterinary and phytosanitary fields.710 The adoption of measures limiting the use of antimicrobials in animals could probably be subsumed

709 European Commission, One Health Action Plan against AMR, p. 11.

710 Article 168 (4) (b) TFEU.

150 under this provision. Article 114 TFEU allows the adoption of harmonising measures on consumer protection, food safety or patient safety facilitating the functioning of the internal market. The Union could use its shared competence under this provision to adopt legislation aiming at informing consumers on the presence of antibiotics or antimicrobial resistant organisms in foodstuffs through food labelling. Resistant antimicrobials can easily be found in foodstuffs, both food-producing animals and agricultural products. EU consumers have a right to know whether a specific product contains antimicrobials. The Common Agricultural Policy is regulated in Articles 38 to 44 TFEU and grants the Union large powers to adopt legislation.

This policy also looks as an appropriate legal basis to tackle AMR considering the above-mentioned risks of antimicrobial resistance on agricultural products. The environmental policy could also be used as a legal basis for the adoption of measures aimed at fighting AMR. Article 191 TFEU establishes a link between environmental protection and public health. AMR is partially caused by antibiotics contained in water or the soil. Containment measures to fight AMR can be based on this legal basis.711

All these provisions have been mentioned in the legislative instruments directly or indirectly addressing AMR. Regulation 2016/429 on animal health (Animal Health Law) is based on Article 43 (2), 114 and 168 (4) (b) TFEU.712 This regulation lays down rules for the prevention and control of animal diseases and refers explicitly to AMR.713 Regulation No 1831/2003 on additives for use in animal nutrition is based on Articles 43 and 168 (4) (b) TFEU.714 This instrument forbids the use of antibiotics as growth promoting agents or as feed additives.715 While no AMR-related legislation refers to the environmental policy, the second action plan on AMR seeks an enhancement of actions that aim at making the link between antimicrobial resistance and the environment. Instruments aimed at regulating the presence of antimicrobials in the environment are therefore likely to be adopted in the future.

Despite being qualified as a cross-border health threat to the same extent as communicable diseases, AMR has thus benefitted from the possibility of adopting legislative instruments based

711 Amandine GARDE, ‘Action on Antimicrobial Resistance: EU Competence to Tackle Antimicrobial Resistance’, European Public Health Alliance, 2016, available at https://epha.org/eu-law-and-competence-to-tackle-antimicrobial-resistance-what-can-the-eu-do/ (last accessed 27 January 2020).

712 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health, OJ L 84 of 31 March 2016, p. 1 (Animal Health Law or Regulation 2016/429).

713 Recital 32 and Article 1 (2) (b) (i) Regulation (EU) 2016/429; see Amandine Garde, ‘Action on Antimicrobial Resistance’, op. cit.

714 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, OJ L 268 of 18 October 2003, p. 29 (Regulation No 1831/2003).

715 Recital 26 and Article 5 (4) Regulation No 1831/2003.

151 on broader legal bases. Although this creates the risk of having multiple legislative acts spread all over the EU legal order in a fragmented manner, the EU has adopted a holistic approach through its action plans leading to a comprehensive body of rules.

ii. Development of a holistic approach towards antimicrobial resistance

The European Union is willing to address AMR from a variety of perspectives. This approach has favoured a broad EU competence and has facilitated EU actions. Yet, it also risks creating a messy body of legislation and acts. This risk materialised in the first period of EU actions on AMR. The Council,716 the European Parliament,717 and the European Commission718 adopted several documents. Several legislative instruments were also adopted during this period. Regulation No 1831/2003 banned the use of antibiotics as growth promoting agents or as feed additives in animal nutrition. The Zoonoses Directive of 2003 required Member States to monitor AMR in salmonella and campylobacter.719 EU agencies were also involved in the development of this field, with the adoption of opinions720 and initiatives.721 AMR was subject,

716 Council Recommendation 2002/77/EC of 15 November 2001 on the prudent use of antimicrobial agents in human medicine, OJ L 34 of 5 February 2002, p. 13; Council of the European Union, Conclusions on Antimicrobial Resistance, 22 May 2008, 9637/08; Council of the European Union, Conclusions on innovative incentives for effective antibiotics, 1 December 2009, OJ C 302 of 12 December 2009, p. 10.

717 European Parliament, Resolution on antibiotic resistance, 12 May 2011, P7_TA(2011)0238.

718 European Commission, Community strategy against antimicrobial resistance, 20 June 2001, COM(2001) 333 final.

719 Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EC and repealing Council Directive 92/117/EEC, OJ L 325 of 12 December 2003, p. 31.

720 In 2008, the ECDC launched an annual European Antibiotic Awareness day on November 18; European Centre for Disease Prevention and Control, European Food Safety Authority, European Medicines Evaluation Agency,

‘SCENIHR joint opinion on antimicrobial resistance (AMR) focused on zoonotic infections’ (2009) 7(11) EFSA Journal 1372; European Centre for Disease Prevention and Control and European Medicines Evaluation Agency,

‘The Bacterial Challenge: Time to React’, 2009, available at

https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/0909_TER_The_Bacterial_Ch allenge_Time_to_React.pdf (last accessed 31 January 2020); European Food Safety Authority, ‘Scientific opinion on the public health risks of bacterial strains producing extended spectrum lactamases and/or AmpC β-lactamases in food and food-producing animals’ (2011) 9(8) EFSA Journal 2322.

721 The European Antimicrobial Resistance Surveillance System (EARSS), now European Antimicrobial Resistance Surveillance Network, was launched in 1999 and is now coordinated by the ECDC, see European Centre for Disease Prevention and Control, European Antimicrobial Resistance Surveillance Network, available at https://ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/ears-net (last accessed 30 January 2020); the European Surveillance of Antimicrobial Consumption was launched in 2001 by Recommendation 2002/77/EC and is now coordinated by the ECDC, see European Centre for Disease Prevention and Control, European Surveillance of Antimicrobial Consumption, available at https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/esac-net (last accessed 30 January 2020); the European Surveillance for Veterinary Antimicrobial Consumption was created by EMA in 2010, see European Medicines Agency, European Surveillance for Veterinary Antimicrobial

Consumption, available at

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000302.jsp (last accessed 30 January 2020).

152 during the early years, to a number of research projects.722 The goal was to deepen the knowledge on this area in order to develop appropriate measures to address this concern. All those measures were rather uncoordinated and did not respond to an established strategy.

Accordingly, the European Commission called for the adoption of an action plan on AMR in 2009.723 This actions plan has been followed by a well-established strategy on antimicrobial resistance led by the European Commission and the development of a strong expertise in this field.

The first action plan was adopted in 2011 and covered the period from 2011 to 2016.724 The communication recalled the actions that had already been undertaken by the Union at the time but highlighted the importance of adopting a holistic approach, as it was considered that isolated efforts would not be successful. The idea was to adopt a ‘one health’ approach across all sectors, thus covering human and animal health. The European Commission proposed several actions based on five general goals: the appropriate use of antimicrobials, the prevention of microbial infections, the development of new and effective antimicrobials, the reinforcement of research in this area, and international cooperation in the field. This action plan allowed for important advancements in the area of AMR. The Animal Health Law, mentioned above, was adopted in 2015 in accordance with the second objective of the action plan.725 EU agencies published new documents during this period,726 and the Council discussed the issue of AMR several times in this time lapse.727 Consequently, the first action plan gave EU institutions the chance to continue adopting measures to fight against AMR while at the same time contributing to a more coherent approach based on a limited number of goals.

722 The Seventh Framework Programme, the Innovative Medicines Initiative and the Joint Programming Initiative on Antimicrobial Resistance; see European Commission, COM(2011) 748 final, p. 3.

723 Mark RUSH and Sally C. DAVIES, ‘Combating Antimicrobial Resistance: Building Consensus for Global Action’ in Stephen MATLIN and Ilona KICKBUSCH (eds), Pathways to Global Health (Singapore, World Scientific Publishing, 2017), p. 95.

724 European Commission, COM(2011) 748.

725 Ibid., p. 8.

726 ECDC, EFSA and EMA first joint report; European Food Safety Authority and European Centre for Disease Prevention and Control, ‘The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2014’ (2016) 14(2) EFSA Journal 4380; European Medicines Agency and European Food Safety Authority, ‘EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety (RONAFA)’ (2017) 15(1) EFSA Journal 4666; European Food Safety Authority and European Centre for Disease Prevention and Control, ‘The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2015’ (2017) 15(2) EFSA Journal 4694.

726 ECDC, EFSA and EMA first joint report; European Food Safety Authority and European Centre for Disease Prevention and Control, ‘The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2014’ (2016) 14(2) EFSA Journal 4380; European Medicines Agency and European Food Safety Authority, ‘EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety (RONAFA)’ (2017) 15(1) EFSA Journal 4666; European Food Safety Authority and European Centre for Disease Prevention and Control, ‘The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2015’ (2017) 15(2) EFSA Journal 4694.

Dans le document The promotion of public health in EU external relations (Page 166-187)