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Access to affordable and quality medicines for all is one of the major commitments of the World Health Organization, and its new medicines and health products strategic framework for the next 15 years calls for new research and development (R&D) models, including delinkage of the R&D costs from the price of products, and fair pricing.

The new WHO Medicines and Health Products Programme Strategic Framework 2016-2030 “Toward Access 2030” [pdf], issued this week underlines the need to increase access to essential, high-quality, safe, effective and affordable medical products for all. The United Nations has agreed a set of Sustainable Development Goals (SDGs) by 2030.

The strategic framework sets a vision for “A world where every child, man and woman has access to the quality essential medicines, vaccines and other health products they need to lead a healthy and productive life.”

The document also underlines challenges to attain that goal, including rising prices of new pharmaceuticals, rapidly changing markets for health technologies, and lack of market incentives for older medicines.

Those factors are challenging health systems in the fulfilment of their mission to provide full and affordable access to health care, the document says. The lack of regulatory capacity in many countries and the rise in substandard and falsified medical products on all markets only adds to those challenges, it says.

According to the document, WHO will follow its vision and mission through two “interlinked and mutually reinforcing strategic agendas.” The first is by supporting needs-based innovation, and the second is strengthening regulatory capacity and practices.

The strategic framework refers to Sustainable Development Goal 3 (Good health and well-being), and in particular 8th target of this goal: “Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”

According to the strategic framework, medicines and health products “often make up the largest portion” of countries and households’ health spending, and the majority of people in low-and middle-income countries pay for their medicines out-of-pocket, “often leading to financial hardship.”

Universal health coverage is fundamental in the face of the rise in non-communicable diseases, with long-term treatment, the document says, adding that many public health needs in developing countries “remain under-served by markets and R&D.”

The document also remarks that the price to be paid for new products as well as existing ones “must be fair to all – affordable to countries working towards UHC [universal health coverage], and sufficient to ensure a sustainable industry to produce them.” “Establishing this fair pricing model is urgent, as many newly available products, such as those for cancer or hepatitis C, are unaffordable even for high-income countries,” it adds.

New Concepts of R&D, Delinkage, Transparency

Among initiatives to reach better access to medicines, and foster R&D, the document cites the implementation of the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPOA). the follow-up work to the report of the Consultative Expert Working Group on Research and Development (CEWG), and the report of the UN Secretary-General’s High-level Panel on Access to Medicines.

Those initiatives have highlighted “the need to change the way R&D is financed,” the document says. “However, and despite many efforts, there is still no global agreement on how to ensure new products are developed that meet priority health needs.”

The WHO, according to the document, in the follow-up to the recommendations of the CEWG, “has fostered the implementation of new concepts of R&D that address global health needs, including delinking the cost of R&D from price and volume to ensure affordability of any new products developed.”

The framework demands needs-driven innovation for new products such as medicines for neglected tropical diseases, epidemic prone pathogens, and antimicrobial resistance.

It also calls for patent transparency for all patented essential medicines, for greater global transparency in price setting, and puts an emphasis on strategic local and regional manufacture.

Going forward, the document states:

“The Programme will coordinate across the three organizational levels to promote and prioritize the following  approaches: responsiveness to Member States’ health needs; recognition of country ownership; adherence to the highest professional and ethical standards in technical work and stakeholder relations; outstanding leadership and service through information and knowledge sharing advocacy; commitment to partnerships;  and  accountability and focus on results by defining clear objectives, and organizing work and resources to achieve them.

“The Programme will establish effective metrics that will demonstrate whether or not we have reached our objectives and take corrective measures when required.”