Public Health-Driven R&D Focus Of Draft HRC Resolution On Access To Medicines & Vaccines

A United Nations Human Rights Council (HRC) draft resolution on access to medicines and vaccines calls for making public health needs more central to the research and development (R&D) of new health products, and for the new products to be priced to ensure access.

The draft resolution, circulated by the Core Group of countries – Brazil, China, Egypt, India, Indonesia, Senegal, South Africa and Thailand – and obtained by Health Policy Watch, includes new language that decries the failures of market-driven R&D to address public health needs, with respect to rare and neglected diseases, as well as antimicrobial resistance (AMR).

The draft resolution – to be tabled at the 41st Session of the HRC, which opened today – calls for member states to find solutions to access challenges, including through “public health-driven research and development, alternative frameworks to adequately reward innovation, pricing and affordability of health products, and leveraging innovative technologies.”

The resolution reflects growing calls by UN member states for R&D actors to address challenges in access to critical medicines and vaccines more effectively, and it urges governments, international organisations, non-governmental organisations, academic institutions, philanthropic foundations and the private sector to work together to find solutions.

The debate follows the May adoption by the World Health Assembly of a milestone resolution on transparency in medicines markets, where proposed language around the “delinkage” of R&D costs from prices was omitted from the final draft, and language calling for greater transparency of R&D costs was watered-down in negotiations by member states that insisted such measures be purely voluntary.

The ongoing debate over these issues was carried over into a revised working draft of the United Nations General Assembly (UNGA) political declaration on universal health coverage, circulated in early June.

As for the HRC, the draft resolution raising the delicate R&D issue once more is being circulated among HRC member states and will be submitted to the Council for consideration in early July, according to sources. Prior to that, informal consultations on the resolution are expected to take place on 27 June, 1 July and 3 July.

The new draft HRC resolution on “Access to medicines and vaccines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” represents an update of a previous HRC resolution (32/15) adopted in 2016, and reflects the recent momentum in the WHA as well as the UN General Assembly on the issue.

A key section of the draft update proposed by the Core Group of member states includes paragraphs referring to the need for “public health-driven R&D” and new approaches to pricing, as follows:

“PP28 Recognizing the need to appropriately address challenges, gaps, market-failures and opportunities regarding the research and development of health technologies, availability and affordability to treat, inter alia, rare and neglected diseases, and respond to the growth of emerging challenges such as antimicrobial resistance, among others, with a view to avoid that exclusively market-driven approaches do not address adequately  public health needs, as well as taking into account the necessity to promote alternative incentive frameworks to meet public health needs while adequately rewarding innovation (NEW);

PP29 Considering the report by the WHO Director-General on cancer medicines, which, pursuant to resolution WHA 70.12, examined the impacts of pricing approaches, including transparency, on availability and affordability of medicines for the prevention and treatment of cancer (NEW);

PP30 Recognizing with appreciation the introduction of new pharmaceutical products based on investment in innovation for cancer treatment in recent years, and noting with great concern the increasing cost to health systems and patients, as well as emphasizing the importance of addressing barriers in access to safe, quality, effective and affordable medicines, medical products and appropriate technology for cancer prevention, detection, screening diagnosis and treatment, including surgery, (NEW, Resolution WHA 70.12, adapted)”

The draft resolution also includes paragraphs that call on all stakeholders to work together to find solutions that ensure access to medicines, including through public health-driven R&D, as follows:

“8. Encourages the engagement between governments, international organizations, non-governmental organizations , academic institutions, philanthropic foundations and the private sector, as well as greater policy coherence and coordinated actions through whole-of government and health-in-all-policies approaches, to find solutions to health challenges, such as the need for public health-driven research and development, alternative frameworks to adequately reward innovation, pricing and affordability of health products, and leveraging innovative technologies, including digital technologies, and solutions for health (NEW,  WHO Roadmap on Access to Medicines and Vaccines, adapted)

9. Urges States, in cooperation with other stakeholders, to redouble efforts to achieve a  continuous  supply  of  quality,  safe,  effective  and  affordable health  products  through  research  and  development  that  meets public health needs, for the efficient application and management of intellectual property standards, to carry out evidence-based selection of health products and seek fair and affordable pricing,  to adopt good procurement and supply chain management and promote appropriate prescribing, dispensing and rational use of health products (NEW, WHO Roadmap on Access to Medicines and Vaccines).”

The resolution finally requests the UN High Commissioner for Human Rights to “convene, before the forty-fourth session of the Human Rights Council, a full-day intersessional seminar on good practices, key challenges and new developments relevant to access to medicines and vaccines,” and to invite “States, relevant United Nations bodies, agencies, funds and programmes, treaty bodies, special procedure mandate holders, national human rights institutions, civil society and other relevant stakeholders, with a view to ensuring their participation in the seminar.”

Image Credits: United Nations.

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