Product development partnerships (PDPs), local research and development (R&D), regulation, and access 

Promoting local R&D and manufacturing

The engagement of PDPs with target countries has been shown to benefit local health systems in several ways. Since most PDPs conduct clinical trials and work with researchers in low- and middle-income countries (LMICs), they significantly contribute to building local R&D capacity. PDPs also aim to produce locally, thereby promoting the domestic pharmaceutical manufacturing base, and governments in LMICs have used the PDP model as a policy instrument to incentivize innovation in biomedical research. Finally, PDPs often engage with local communities and health care workers to ensure sustainable access to their health products.

Complying with regulatory standards

As entities developing pharmaceutical products, PDPs must comply with the strict requirements set by regulatory authorities to ensure access to high-quality, effective and safe medicinal products. In addition, PDPs’ health research and product development programs must also be comply with ethical standards and regulations (as defined by the Declaration of Helsinki). Underresourced regulatory authorities which cannot implement stringent oversight on medicinal products often rely on the regulatory decisions made by more mature authorities, such as the WHO Listed Authorities (formerly known as Stringent Regulatory Authorities), and/or on the assessments conducted by the WHO Prequalification program. International procurement agencies, such as the Global Fund, Gavi, and United Nations Children’s Fund (UNICEF) – as part of their in-country grant management activities – can then purchase quality-ensured products developed by PDPs and approved by WHO Listed Authorities or prequalified by WHO.

Ensuring access to new health technologies

PDPs recognized early on that developing new health technologies is not in itself enough to prevent disease and improve health – they must also engage in efforts to register, distribute and encourage adoption and equitable access of their products on the ground in countries. To achieve this, PDPs have started allocating more funding to activities relating to access. This does not come without its challenges, since PDPs need to ensure broad and equitable access to their products for those most in need, as well as affordability and extensive coverage. Other difficulties include the fact that PDPs typically lack the funding power to shape markets and to afford post-marketing activities, such as collecting data on the optimal use of health products.