Pharmaceutical transparency
Definition
Pharmaceutical transparency broadly refers to the public availability and public reporting of information generally relating to the markets for medicines, vaccines and other health products across the whole value chain. This includes increasing transparency on the actual costs of clinical trials, which is often kept secret and invoked by product developers and other industry actors to make generally unproven claims about research and development costs. Product developers and other industry actors often then cite those unproven claims about research and development costs to justify high prices of health technologies. Pharmaceutical transparency also includes the need to increase publicly available information about the prices paid by private entities and public procurement agencies to acquire health technologies. Lack of patent status transparency can prevent or delay several types of policy interventions to facilitate equitable access to health technologies, such as compulsory licensing. Pharmaceutical transparency therefore further includes the need for increasing publicly available and reported information about patent status.
States are increasingly recognizing the importance of improving transparency in the market for medicines, vaccines, and other types of health products. This increasing recognition led to the 2019 WHA Resolution on improving the transparency of markets for medicines, vaccines, and other health products, available in the Language Compendium. Further commitments to increase transparency in the market for vaccines, medicines, and other technologies should include mandates to disclose per patient costs of clinical trials, regardless of outcomes.
Precedents
2022 HRC Resolution on access to medicines, vaccines and other health products
“Reaffirming the importance of improving the transparency of markets, costs and supply chains for medicines, vaccines and other health products across the whole value chain, and taking into consideration resolution WHA72.8 of 28 May 2019, adopted by the World Health Assembly at its seventy-second session” (p. 3)
2022 HRC Resolution on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to the coronavirus disease (COVID-19) pandemic
“Stressing the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking note of World Health Assembly resolution WHA72.8 of 28 May 2019” (p. 4)
“Requests all States, international organizations and relevant stakeholders to commit to transparency in all matters relating to the production, distribution and fair pricing of vaccines, in accordance with national and regional legal frameworks, and urges States to take immediate steps to prevent speculation and undue export controls and stockpiling that may hinder affordable, timely, equitable and universal access for all countries to COVID-19 vaccines” (p. 6)
2021 HRC Resolution on ensuring equitable, affordable, timely and universal access for all countries to vaccines in response to COVID-19
“Stressing the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking note of World Health Assembly resolution WHA72.8 of 28 May 2019” (p. 2)
“Requests all States, international organizations and relevant stakeholders to commit to transparency in all matters relating to the production, distribution and fair pricing of vaccines, in accordance with national and regional legal frameworks, and urges States to take immediate steps to prevent speculation and undue export controls and stockpiling that may hinder affordable, timely, equitable and universal access for all countries to COVID-19 vaccines” (p. 5)
2019 WHA Resolution on improving the transparency of markets for medicines, vaccines, and other health products
“Noting the importance of both public- and private-sector funding for research and development of health products, and seeking to improve the transparency of such funding across the value chain” (p. 2)
“Seeking to progressively enhance the publicly available information on inputs across the value chain of health products, the public reporting of the relevant patents and their status, and the availability of information on the patents landscape covering a particular health product as well as its marketing approval status” (p. 2)
“1. URGES Member States in accordance with their national and regional legal frameworks and contexts:
(1) to take appropriate measures to publicly share information on the net prices2 of health products;
(2) to take the necessary steps, as appropriate, to support dissemination and enhanced availability of, and access to, aggregated results data and, if already publicly available or voluntarily provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality;
(3) to work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives;
(4) to facilitate improved public reporting of patent status information and the marketing approval status of health products;
(5) to improve national capacities, including through international cooperation and open and collaborative research and development and production of health products, especially in developing countries and low- and middle-income countries (LMICs), including health products for the diseases that primarily affect them, as well as for product selection, cost-effective procurement, quality assurance, and supply chain management” (p. 2)
2019 HRC Resolution on access to medicines and vaccines
“Reaffirming the importance of improving the transparency of markets for medicines, vaccines and other health products across the whole value chain, and taking into consideration resolution WHA72.8 adopted by the World Health Assembly at its seventy-second session” (p. 2)