News and Opinions  –  2016

Consensus around delinkage emerges – of sorts

2016-12-09

In early December a literature review on proposed incentive mechanisms for the development of new antibiotics by the EU-US Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) was published in the Oxford Journal on Clinical Infectious Diseases. The review, which assessed twelve of the most recent and major policy documents, peer-reviewed publications, organization proposals and government-sponsored reviews, showed a broad consensus on recommending delinkage. However, differences in definition are hiding underneath the consensus.

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Photo: Pixabay

The findings of the TATFAR article come after the UNGA Declaration on AMR adopted by Member States in September similarly acknowledged the importance of delinking the cost of research and development from the price and sales volume for the development of new antibiotics.

What is meant by delinkage?

The seemingly broad appreciation of the principle does, however, not reveal underlying widely different understandings of delinkage. Emanating from the The Consultative Expert Working Group on R&D Financing and Coordination (CEWG), delinkage was originally defined as the decoupling of R&D costs from the end product price. In the case of antibiotics removing any reliance on high volume sales has been added as a feature of delinkage. This was the definition Member States made in the UNGA Declaration.

However, proposals to make delinkage only about removing the link to sales volumes has since emerged, including in the pharmaceutical industry’s Davos Declaration (PDF). This complete rewriting of the definition is highly concerning. While it may mean low volume sales, it retains the right to charge high prices, which will have serious negative impacts on patient’s access.

Unclear next steps

It is now an open question where the discussions on delinkage will be taken forward. The WHO, with its full Member States represention, is the best-placed agency to do this. Moreover, it has even been given the formal mandate to finalize a Development and Stewardship Framework by all Member States in the UNGA Declaration. However, the original WHO discussions on delinkage and the creation of global R&D treaty as recommended by the CEWG to address the R&D gaps for market failure diseases have only made minimal progress since the group’s recommendations (PDF, 1MB) were made 2012.

The G20 meeting held under the auspices of Germany in June 2017 may be a likely place for financial commitments to be made towards R&D for new antibiotics. The underlying principle of delinking R&D costs from price and sales volume should not be forgotten in these discussions. Countries like India have made their support for delinkage of price and sales volumes clear, however without the full representation by all Member States at the G20 it is imperative that the need to ensure future access to affordable, suitable and effective antibiotics for all, is a clear goal for all around the negotiating table.