KEI comments at HHS listening session on WHA72 concerning the transparency resolution

On Agenda item 11.7 – Access to medicines and vaccines, KEI offers the following comments on the transparency resolution.

1. Transparency should not be controversial. Policy makers and the public need to have better evidence in order to support policies that shape access, affordability and innovation.

2. KEI is among the many groups that have long advocated for greater transparency in markets for biomedical inventions. Our web page on transparency in markets for biomedical inventions is here: Among the items linked on the page is a memo prepared by KEI for the WHA negotiations on transparency, that cites numerous expert reports, resolutions, regulations and directives on transparency, a page that provides links to dozens of U.S. legislative proposals on transparency, and many other items.

3. HHS, the USPTO and other federal agencies have engaged constructively in the negotiations over the draft resolution on transparency. The most recent text of the proposed resolution reflects several changes that address concerns raised earlier by the United States.

4. There is a public goods aspect of several of the proposed disclosures. R&D disclosures have a global benefit. The national disclosures of prices will be more challenging for some countries, as the debate in the US illustrates. Having a longer term goal for pricing transparency is useful, even if it takes a while to get there.

5. The current draft of the transparency resolution has focused on the areas of R&D transparency that are the most manageable. Clinical trial outlays can be directly associated with specific products and services, and the risks can be reasonably evaluated.

6. Pre-clinical R&D transparency is now designated to be addressed later, beginning with a report on challenges and opportunities for transparency on this topic by the WHO R&D observatory.

7. The proposed web-based tool for governments to share information is clearly voluntary, but if helpful, the text can be explicit that the sharing is voluntary.

8. Some countries will not be able to link disclosures and reports in the resolution to registration of products or services without changes in national statutes or European Union regulations. To address this issue, the obligation to make disclosures can be tied to coverage or reimbursements, areas where some governments have more flexibility in requiring information from sellers of products and services.