One of my favorite FSG moments was 4 years ago in Karachi, Pakistan conducting research regarding potential new diarrheal treatments for children. My colleague and I were in a small crowded urban clinic in a slum, surrounded by mothers holding their babies. One mother brushed her headscarf from her eyes and placed her 2 month old baby girl in my arms asking whether there were medicines that could make her well. It was rewarding to be able to say yes, and talk about oral rehydration salts that could ensure her little girl stayed hydrated while she regained her strength. But the answer in many cases isn’t a “yes”. In many cases the drugs that patients require are still under development, or are too expensive, or are protected by patents, preventing them from being available to poor populations.
Product Development Partnerships (PDPs) were developed a decade ago to help address these issues by combining the best of commercial pharmaceutical drug development and a commitment to accessible medicines to ensure that key drugs, vaccines and diagnostics are developed with the poor as their intended beneficiaries. There are several success stories from the emergence of this model – a new pediatric formulation of malarial medicine, the launch of an improved treatment for visceral leishmaniasis, and the recent promising outcomes from microbicide trials. But for many PDPs, the challenge of developing new products will take decades or more. In the mean time, they are committed to ensuring that their products are launched successfully, but for many, they struggle with the appropriate level of investment to make in “access strategies” due to the uncertain nature of drug development and the risks of prematurely raising expectations among beneficiaries.
Earlier this year the Concept Foundation supported a cross-PDP effort to examine a number of access-related challenges and commissioned a set of studies to identify some cross-cutting themes and lessons that might support PDPs in their access work. FSG was selected to author a paper on PDP Access Strategies, which examines the current status of access strategies, identifies diverse perspectives around the key challenges associated with developing these strategies, and proposes alternative approaches that PDPs can consider when they are ready to develop their own strategies. These are tricky issues that balance the tensions around unknown product development timelines, sensitive relationships with stakeholders in developing countries, and fulfilling the promise of a new model for developing drugs, vaccines and diagnostics explicitly for the poor.
These ideas were vigorously discussed by PDP access teams in Geneva this summer and we look forward to hearing your thoughts.