[25 January 2018]
The Global Antibiotic Research and Development Partnership (GARDP) welcomes DRIVE-AB’s acknowledgement that a combination of ways to apply and attract financial investments in research and development (‘push and pull incentives’) are required to effectively stimulate antibiotic innovation. We support many of their recommendations.
The report highlights that GARDP plays an important role both in funding research and as a ‘pipeline coordinator’ working throughout the drug pipeline to patient access. As our presence in the not-for-profit space to develop new drugs and combinations expands, we look to increase our role in both these areas. It is important to clarify that GARDP is not a research funder, rather it actively drives research that addresses public health priorities. Our R&D model invests funding it receives in programmes driven and directly executed by GARDP and/or through equal partnerships (with academia, governments, industry, international organisations) to which we bring appropriate direction and support.
There is also a misconception in the report that not-for-profit antibiotic developers would only be able to work on combinations of existing drugs and can only ‘weakly stimulate innovation’. GARDP was established as a joint initiative by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi). GARDP benefits from and capitalizes on DNDi’s successful track record of delivering, recommending, and implementing seven new treatments since 2003 for neglected diseases, and importantly a pipeline of new chemical entities, as well as from WHO’s expertise and leadership in determining global public health priorities and undertaking pipeline reviews. GARDP supports the proposal that, in addition, WHO develop target product profiles to further guide all developers.
It is clear that if the urgent need for new treatments for drug resistant diseases is to be met, it cannot be business as usual. Any developer whether from the not-for-profit or industry sector must also help address the need for three core elements: namely global conservation, stewardship, and sustainable access to new antibiotic treatments. This highlights the need for the development of guidance on the implementation of the three core elements for all developers.
The stakes for incentive mechanisms for antibiotic research are high. Governments want to ensure a public return on their investment. Given the large market entry rewards proposed in the report, a contractual relationship between payer(s) and recipient(s) with strong governance, definitions around what constitutes innovation (based on public health priorities) and a clear agreement on sustainable access provisions is key. It is also important that the model of delinkage used by any pull incentive pilot follows the definition established by the UN General Assembly 2016. Here, in order to avoid high sales or prices that could undermine stewardship and affordable access, the cost of investment in research and development is separated from both unit prices and sales volumes. A poorly designed pilot market entry reward has the potential to kill off any future alternative pull incentives.
Professor Laura JV Piddock, Head of Scientific Affairs, GARDP