3rd Annual WHO-NGO Dialogue Report – April 2017

Consultation on Antimicrobial Resistance with Members of the Antibiotic Resistance Coalition (ARC) and partner organizations

 

At the invitation of the Antibiotic Resistance Coalition (ARC), the representatives from the World Health Organization and other intergovernmental organizations joined the third WHO-NGO Dialogue, an annual discussion between the WHO Antimicrobial Resistance (AMR) Secretariat and ARC members and allies. Over twenty civil society organizations from around the world joined this dialogue either in person at WHO Headquarters in Geneva or via teleconference. The purpose of this three-hour convening was to encourage open discussion between the WHO and the ARC members and allies around the implementation of the Global Action Plan on AMR as well as the role of the tripartite collaboration of the World Health Organization (WHO), Food and Agriculture Organization of the United Nations (FAO), and World Organization for Animal Health (OIE) in assisting countries in their development of national action plans on AMR.

Representatives in attendance from the WHO included:

  • Hajime Inoue, Senior Advisor to the Director-General and Special Representative for Antimicrobial Resistance;
  • Marie-Paule Kieny, Assistant Director-General of Health Systems and Innovation; and
  • Marc Sprenger, Director of the WHO AMR Secretariat.

Ms. Daniela Battaglia, a Livestock Production Officer in the Animal Production and Health Division, represented the FAO.

Dr. Viviana Munoz, Coordinator of the Development, Innovation, and Intellectual Property Programme at South Centre, moderated the Dialogue.

 

Introductions and Discussion Around the UN Inter-Agency Coordination Group on AMR

Opening the WHO-NGO Dialogue, Dr. Munoz welcomed everyone on the call, highlighting the great importance of AMR as a key development and public health issue for developing countries. Dr. Inoue of WHO was then invited to give his opening remarks and speak specifically to the recently established UN Inter-Agency Coordination Group (IACG). He noted that the mandate to establish such a group including organizations across the UN to focus on AMR was a big milestone. Following a nominations process from Member States, the WHO and the UN Secretary-General’s office, as co-Chairs of this group, announced the 27 members on March 17th. Of the 27, 15 are individual members, many of whom hold positions in their country’s government, while the remaining 12 members are representatives of different UN and other intergovernmental agencies. Both the WHO and UN Secretary-General’s office have received continued enquiries and suggestions of additional intergovernmental organizations to consider as part of the group such as Gavi. Dr. Inoue also noted that other external stakeholders such as industry could also be considered to be included in the IACG. Further discussion on the composition will occur at the first meeting of the IACG in early May. He also noted that the IACG is mandated to report back to Member States during the 73rd session (September 2018 – September 2019) of the UN General Assembly, a key opportunity when Heads of State will assemble together. The IACG will also report back at next year’s World Health Assembly.

Dr. Munoz then invited Dr. Reshma Ramachandran of ReAct North America and the IDEA (Innovation+Design Enabling Access) Initiative out of Johns Hopkins Bloomberg School of Public Health to deliver an intervention in response. Dr. Ramachandran noted the large number of IACG members who work within national drug regulatory agencies or research institutes, raising the question of whether these representatives would be able to hold Member States accountable. She also queried if there might be a process for the IACG to engage with independent experts such as an expert advisory group to help further inform the recommendations from this group. During discussion, Dr. Inoue responded that these individuals were selected for their expertise having served in such national positions and had been asked to represent themselves, not their institutions or governments. However, those from UN and intergovernmental agencies would represent their organization.

In terms of the composition of the group, Dr. Ramachandran raised a few concerns and questions including the lack of civil society representation within the IACG, particularly from those who work on the ground on AMR and the rationale behind including a select group of UN and other intergovernmental agencies, noting organizations such as UNDP that have strong country presence and footprint in global health were not included. She also asked if this composition had been set for those already named to the IACG, to which Dr. Inoue responded that this will be further discussed along with the terms of reference at the upcoming in-person IACG meeting and that already named agencies will be nominating their representative to the IACG. Dr. Ramachandran then concluded with some recommendations — that there be transparency of the members of the IACG as well as its process calling for the conflict of interest forms for each member to be publicly posted, that the group’s proceedings be transparent, and that they host open consultations to solicit input from all stakeholders including civil society. Dr. Faith McLellan, another representative from the WHO who has been tasked to the IACG, weighed in stating that it is not protocol for the WHO to publicly post the conflict of interest forms of individual members, but that they would post the parameters by which they examined such conflicts.

 

Global Development and Stewardship Framework – Human Use

For the next section of the WHO-NGO Dialogue, Dr. Kieny discussed the WHO’s efforts around the global development and stewardship framework. She first noted the mandate that both the World Health Assembly Resolution 68.7 and recently adopted Political Declaration on AMR for the WHO to finalize the global development and stewardship framework offers in supporting a path forward towards development, control, distribution, and appropriate use of antimicrobials. The scope would entail both existing and new medicines, encompass a One Health approach, and provide a range of legal instruments.

Peter Maybarduk, Director of Public Citizen’s Access to Medicines Program, then delivered an intervention, noting that there were a number of efforts where taxpayers or the public are putting in a lot of money for antimicrobial R&D with no clear assurance of securing a fair return on public investment. He noted that the WHO could build upon its normative role to do this, highlighting a potential reference point that is part of recently introduced legislation in the United States, the Improving Access to Affordable Prescription Drugs Act (HR 1776/S 771). This bill would create a $2 billion prize fund for truly novel antimicrobials, tying funding to principles of delinkage including both affordable pricing and stewardship. Mr. Maybarduk warned that without such binding terms on public investment, we would instead end up with profit-maximizing arrangements. Dr. Munoz then delivered an intervention on the behalf of the South Centre. She noted the normative role of the WHO in calling for implementation of the principles put forward by the Consultative Expert Working Group on Financing R&D. As part of the global development and stewardship framework, she noted that the WHO might examine delinkage models that allow for pricing close to manufacturing costs. Moreover, the approach taken by product development partnerships for neglected diseases might be applied to bringing novel antibiotics to market or repurposing old antibiotics. She also called for consultations around the global development and stewardship framework to be inclusive of external stakeholders, particularly civil society.

In response, Dr. Kieny noted the advocacy power of civil society organizations in calling for good governance, adoption of CEWG principles, and alternative pathways for R&D. She stated that she is supportive of the CEWG principles, but that it is also important to work on access and rational use in AMR. She also pointed to the role of the G20 in this space and emphasized that the global development and stewardship framework was not yet set. It could be binding or nonbinding, but right now, it is too early to discuss this. When asked if the methodology for the priority pathogens list would be available, Dr. Kieny responded that this is being peer-reviewed and that there would be a report released before formal publication possibly, but that this would happen during the summer.

 

Facilitating Access to Existing and New Drugs, Vaccines, Diagnostics, and Alternative Therapies

Ms. Katy Athersuch, Senior Medical Innovation and Access Policy Adviser for Medicines, then spoke and stressed the multifaceted nature of AMR necessitating a collaborative approach with strong leadership at multiple levels. She outlined a series of critical steps for reducing the burden of AMR in these settings by preventing infectious disease through improved access to vaccines, improving the ability of clinicians to accurately diagnose and treat infections by increasing access to diagnostics and antimicrobials, and changing community perceptions and behaviors. She also highlighted the documented potential of the pneumococcal conjugate vaccine (PCV) in curbing 11.4 million days of antimicrobials, which accounts for 45% of the total cost to vaccinate a child in the poorest countries alone. Over 75 countries have yet to introduce PCV nationally and need additional support to access affordable PCV. She also noted MSF’s work to increase access to standard microbiology labs in the near-term and also support efforts such as the Mini-Lab and a multi-modular fever test to differentiate the causes of occult or prolonged fever. On new drugs, Ms. Athersuch stressed the importance for delinking the cost of R&D investment from the price and volume of sales to facilitate equitable and affordable access to new medical tools. She concluded by urging that tuberculosis not be neglected in the AMR response.

 

Global Development and Stewardship Framework – Non-human use

From the Food and Animal Organization of the United Nations, Ms. Daniela Battaglia began by outlining efforts from the Tripartite Collaboration to ensure implementation of the global action plan and guidance for national action plan development. She highlighted the recent establishment by Codex Alimentarius of an ad hoc Intergovernmental Task Force on Antimicrobial Resistance, hosted by the Republic of Korea. The Task Force will review and revise the Code of Practice to Minimize and Contain Antimicrobial Resistance to address the entire food chain. The task force will also consider developing guidance on integrated surveillance of AMR, taking into consideration guidance developed by WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and relevant OIE documents. FAO is also serving as an observer to WHO’s efforts to develop guidelines on Critically Important Antimicrobials in Food Animals and has engaged in efforts towards finalizing the global development and stewardship with WHO and OIE. At the national level, FAO has not only contributed to Tripartite products offering guidance on national action plans, but also has also adopted its own global action plan on AMR to provide further support towards antimicrobial use in food animals and agriculture.

Ms. Battaglia also noted FAO’s efforts to improve regulatory frameworks across countries to address antimicrobial use in food animals by phasing out antibiotics for growth promotion. Such a regulatory framework would require that antibiotics be administered to food animals only when prescribed by a veterinarian and that critically important antibiotics for human medicine only be used in food animals when justified. FAO’s Development Law Service (LEGN) of the Legal Office also provides assistance to countries and regional organizations to modify or update their national legal frameworks for all areas under FAO Mandate, including good legal practices to prevent AMR and for good antimicrobial use.

In response, Mr. Cóilín Nunan of the Alliance to Save Our Antibiotics emphasized that the FAO, WHO, and OIE’s call for phasing out of antimicrobials for growth promotion is not enough and that there should be an end to preventative mass medication. Banning growth promotion in Europe did not lead to significant reductions in overall farm antibiotic use, as many intensive farmers simply increased prophylactic mass medication. Therefore, mass medication should be restricted to cases where there is an actual disease outbreak diagnosed by a veterinarian and where there is an identified risk the disease is going to spread. He also highlighted the high levels of antibiotic use in intensive farming, particularly in pig, poultry and intensive veal or cattle farming. While there is much talk around biosecurity, in reality, animals raised outdoors tend to have much lower antibiotic use. Cóilín also made further recommendations on the guidance WHO is currently developing. He urged that for the highest priority critically important antibiotics, use be restricted to the treatment of individual sick animals in cases where no other available antibiotic is likely to work. This means critically important antibiotics should never be used for preventative treatment or for mass medication. He also recommended that use of these antibiotics be limited to cases where sensitivity testing has occurred. The Netherlands introduced such a requirement and this has contributed to a lowered use of cephalosporins by 99% and of fluoroquinolones by 90% in just a few years.

Ms. Anna Glayzer of Consumers International then spoke of the need to have stakeholders on board, particularly civil society for the current processes to regulate the use of antimicrobials in food animal production. Referencing the ongoing work to establish the Codex Intergovernmental Working Group on Antimicrobial Resistance, Ms. Glayzer called for all stakeholders to be included and for the process to not be rushed. She further emphasized the importance of NGOs to such a process in providing scientific evidence and other information from their experience within and across countries. She pointed to the work of NGOs in recent years in bringing public awareness to the issue of antimicrobial resistance in food animal production, referencing the Chain Reaction reports and scorecard, which looked downstream at food retailers and their antibiotics use policies. She also stressed the need for the WHO and FAO to make an explicit statement about the importance of non-antibiotic management for animal health in order to prevent the need of these drugs in the first place.

Following this, Matthew Wellington, Program Director of the U.S. Public Interest Research Group’s Antibiotics Program, noted that efforts in the United States have showed that phasing out of antibiotics solely for growth promotion will not reduce overall routine use of these drugs. He asked if the FAO and WHO might consider stronger recommendations to phase out all routine use of antibiotics in an effort to curb their overall use. Speaking on behalf of ReAct, Anna Zorzet pointed out that the UN COMTRADE system currently does not distinguish in its tracking of antibiotics in international trade between those drugs destined for human use as opposed to drugs destined for veterinary use. Looking to colistin as an example, she noted that it is not possible to track the movement of this last-line drug for treatment of human drug-resistant infections for veterinary use. As the UN Interagency Coordination Group now includes the World Customs Organization, she asked if the WHO and FAO might be supportive of calling upon such a body to improve the tracking of these drugs through better coding in international trade. Dr. Inoue acknowledged this suggestion and stated that they would look into this further as the Interagency Group’s work progresses.

Dr. So of ReAct North America and IDEA (Innovation + Designing Enabling Access) Initiative then stressed a point within Coilin’s presentation in calling for the organizations to support the idea of no preventative use and no mass administration of critically-important antimicrobials to humans in animal husbandry. He asked if the WHO and FAO would be supportive of such a call and if so, how might the Tripartite Collaboration of WHO, FAO, and OIE take steps to implement such a policy. To this, the organizations stated that this would require support from Member States for implementation. Shila Kaur of Health Action International Asia-Pacific then chimed in calling for the WHO and FAO to address the marketing practices of pharmaceutical companies across both human and animal health to curb inappropriate use.  Shila commented that marketing practices influence inappropriate antibiotic use by the veterinary sector in developing countries and that the Global Action Plan does adequately not address these inappropriate marketing practices. Carmen Cordova of the Natural Resources Defense Council also stressed the need for this One Health approach stating that an annual integrated report on human and animal use of antibiotics could help to highlight gaps and good practices in curbing resistance. WHO and FAO officials noted that the organizations have indeed developed guidance on integrated surveillance that would be published soon and will provide support to Member States for implementation.

The WHO-NGO Dialogue concluded with a discussion of country progress on national action plans presented by Dr. Sprenger, where he noted the critical role of civil society in building both country capacity and political will to mobilize action on AMR. Mr. Collins Jaguga of the Ecumenical Pharmaceutical Network/ReAct Africa highlighted their experience and challenges in providing technical assistance on national action plans on AMR in the region. He noted the need for WHO and other financial and technical assistance to ensure not only capacity to develop robust plans, but also to implement them. He further noted that there was poor coordination at country level among WHO, OIE and FAO thus compromising the “One Health” approach for minimizing the emergence and spread of AMR. Complementing this presentation, Mr. Amit Khurana of the Centre for Science and Environment gave an overview of their experience as civil society providing input towards development of the Indian National Action Plan on AMR, so that it not only includes components related to human and animal health, but also the environment. He also noted his organization’s efforts in hosting an international workshop to develop strategic and operational guidance for national action plans across developing countries, published earlier this year as a resource.

Throughout the call, ARC members and allies engaged in interactive discussion with WHO and FAO across these themes of implementation of the global action plan on AMR, including the global development and stewardship framework as well as the organizations’ roles within countries for developing and implementing national action plans. In his concluding remarks, Dr. Inoue thanked ARC for their perspectives and remarked that such a convening was a unique and useful experience for him. Dr. Munoz ended the call thanking the WHO, FAO, and participants, particularly those ARC members and allies who delivered interventions during the teleconference.

We would like to thank Dr. Marc Sprenger, Director of the WHO AMR Secretariat and Dr. Hajime Inoue, Senior Advisor to the Director-General and Special Representative for AMR, for joining this important discussion; Viviana Munoz and Mirza Alas of the South Centre for moderating and helping to organize the event; and the members of the Antibiotic Resistance Coalition whose contributions added insight and depth to the policy discussions. In addition, we are grateful to ReAct—Action on Antibiotic Resistance, especially the writing team led by Dr. Reshma Ramachandran and Dr. Anthony So.

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