13 May 2014: WHO Technical Consultation on Innovative Models for New Antibiotics’ Development and Preservation

In a concerted bid to contain the emerging threat posed by antibiotic resistance, in May 2014, the World Health Organization’s (WHO) 67th World Health Assembly (WHA) passed WHA resolution 67.25 on “Antimicrobial resistance” instructing the WHO to “develop a global action plan to combat antimicrobial resistance” by May 2015 (Source: WHO page on Draft Global action plan on antimicrobial resistance). The process of developing an action plan on AMR will be guided by a number of components including WHO’s Strategic and Technical Advisory Group on Antimicrobial Resistance (STAG-AMR), a web-based consultation on the draft global action plan to address antimicrobial resistance (deadline: 1 September 2014), the June 2014 Ministerial conference on AMR hosted by the Netherlands, a November 2014 consultation hosted by Norway to address the use, access and quality of antimicrobial medicine and a December 2014 consultation hosted by Sweden to address the development of global surveillance capacity, systems and standards.

With respect to addressing the moribund R&D pipeline for new antibiotics, the AMR resolution urges Member States:

to encourage and support research and development, including by academia and through new collaborative and financial models, to combat antimicrobial resistance and promote responsible use of antimicrobial medicines, develop practical and feasible approaches for extending the lifespan of antimicrobial medicines and encourage the development of novel diagnostics and antimicrobial medicines.

Anticipating the need to kickstart a global response to develop new incentive models to address the dearth of new antibiotics, the WHO convened a “Technical Consultation on Innovative Models for New Antibiotics’ Development and Preservation” on 13 May 2014 in Geneva. While the meeting was held under “Chatham House” rules, the WHO has published the agenda, list of participants, presentations, short description of the proposed models and background documents. One open question is how the outcome of this expert consultation on innovative models for antibiotic development will feed in into the WHO Action Plan for AMR. Perhaps this is something that can be addressed through the web consultation on the global action plan (comments due 1 September 2014) or at the Executive Board meeting in January 2015.

The WHO summary of the expert consultation stated:

The meeting brought together leading experts to present and discuss innovative models fostering discovery and development of new antibiotics as part of the tool-kit to address challenges related to antimicrobial resistance (AMR).

Antimicrobial Resistance (AMR) is a growing global health threat. WHO is developing a Global Action Plan for AMR (GAP-AMR), endorsed by the 67th World Health Assembly in May 2014, that aims to provide guidance on the development of a multi-sectoral comprehensive, coordinated and sustained approach to address AMR. One goal of the GAC-AMR is to establish a mechanism to promote the discovery and development of novel antibiotics that are safe, effective and available and ensures that new molecules are judiciously supplied and rationally used in order to further avoid the development of resistance.

Market failures in the discovery and development of new antibiotics are well documented which underscore the need for innovate approaches and models to sustainably encourage research and development (R&D) in this area. A number of models have been suggested in recent times and/or currently being tested and this consultation meeting was a venue to present some of these models.

The meeting was held under “Chatham House” rules where comments are not attributed to individual speakers.

The list of participants (excluding staff from the WHO secretariat) includes: James Anderson (GSK), Manica Balasegaram (MSF Access Campaign), Thiru Balasubramaniam (KEI), Sabiha Yusuf Essack (University of KwaZulu-Natal), Nina Grundmann (IFPMA), Martin Khor (South Centre), Jeremy Knox (Department of Health, United Kingdom of Great Britain and Northern Ireland), Joe Larsen, (BARDA, US Department of Health and Human Services), James Love (KEI), Malebona Matsoso, (Department of Health, Republic of South Africa), Kevin McCarthy (DG Development, European Commission), Marc Mendelson, (University of Cape Town), Viviana Munoz (South Centre), Bernard Pecoul (DNDi), Manos Perros (Astra Zeneca), Thomas Pogge (Yale University), Emiliano Riale Verde (McKinsey), John-Arne Rottingen, Norwegian Institute of Public Health, Mike Sharland, (St. George’s University), Anthony So, (Duke University) and Angela Wittelsberger (Innovative Medicines Initiative (IMI)).

The WHO secretariat published two background documents: 1) Antibacterial R&D incentives (by Ramanan Laxminarayan and John H. Powers, originally published in Nature, October 2011) and 2) KEI’s Annex to our proposal for an Antibiotics Innovation Funding Mechanism entitled, ” Approaches to simulating innovation for the development of new antibiotic drugs”.

The KEI background paper provides a brief review of several approaches to funding innovation for antibiotics, including:

(1) R&D Subsidies.
(2) Policies regarding regulatory barriers for registering products.
(3) Extending terms for patents and other intellectual property rights
(4) Innovation inducement prize type incentives to reward innovation and/or conservation

  • Innovation Inducement Prizes
  • Antibiotic Conservation and Effectiveness (ACE) program
  • Strategic Antibiotic Reserve (SAR)
  • Pricing of antibiotics
  • Antibiotics Health Impact Fund (aHIF)
  • Antibiotics Innovation Funding Mechanism (AIFM).

(5) Other

  • Pigouvian Taxes
  • Antibiotic Innovation and Conservation (AIC) fee
  • Transferable Patent Extensions
  • Transferable Priority Review Vouchers
  • Advanced Marketing Commitment (AMC), and Advanced Purchase Commitment (APC)
  • Call options for antibiotics