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Re-Defining Access: Who's Responsible?

Over the last decade, significant investment and effort has been spent developing products to address diseases of the developing world, including malaria, TB, and AIDS. Product Development Partnerships (PDPs), nonprofit organizations that work with donors, governments, and the industry to develop drugs, vaccines, diagnostics, and vector control methods to address these diseases, have played a critical role in the development of these technologies.

While there is still a long way to go, we’re now beginning to see the results of these investments as more of these technologies launch in the market. The field is now beginning to devote greater attention to issues of access in order to ensure these products achieve their desired health impact.

Sponsored by the Bill and Melinda Gates Foundation and supported closely by the PDP Access Steering Committee, FSG recently engaged the PDP community to collect their input on ways to increase and ensure access to products they are developing. What types of solutions would be helpful for the donor community to work on in partnership with you, we asked. From the many ideas that we heard, I’m sharing below the two most critical ones:

  1. Access activities span the entire product lifecycle: This finding has been the defining guidepost for our research. Many in the field still think of access as activities that happen once a product is in the market – often the “last mile” activities. This narrow view of access puts it in a silo and relegates it to a later stage of the lifecycle to be handled closer to launch. The fact is, access issues should be taken into account throughout the entire product lifecycle. When a TPP incorporates demand forecasting, or a manufacturer researches the formulation, or regulatory processes are streamlined, these all represent actions that lead to greater access. Whether we call them access, delivery, uptake, or by some other term, we need to start thinking about and planning for access from the very beginning. The Global Alliance for TB Drug Development (TB Alliance) has spent considerable effort collecting a range of market data and information to inform its TPP, recognizing the importance of thinking of access early on.
  2. PDPs require tools to identify their access roles: Once you define access broadly, the most consistent challenge you hear is that of the lack of clear roles and responsibilities between the different parties. The clinical development of drugs and vaccines are pretty clearly within the roles of PDPs. But beyond that, things get tricky. Who for example, is responsible for ensuring safety studies in countries once a product is launched – the PDP, the donors, the industry partner, or the country government? One idea to tackle this challenge is for the PDPs to develop product-specific “impact maps” – a graphical and narrative workplan that lists which access activities the PDP would be responsible for, which would be the roles of others, and where gaps currently exist. Such a map would have to be used as a living, dynamic tool in conjunction with partners that allow PDPs to map out all the necessary steps and plan for them, whether they’re primarily responsible or not.

While these ideas represent an initial step, a lot more is needed – tools, data, coordination, and planning. The recent appointment of Dr. Chris Elias, who has led PATH for the last 10 years, to the Gates Foundation to lead the Vaccine Delivery group has been welcomed by many. As the largest private funder in this space, Gates’ role in access in the next few years will be defining for the field. What ideas do you have for what the Foundation and other donors could do in partnership with PDPs to expand access?

Adeeb Z. Mahmud

Managing Director