Transparency

In the area of Transparency, KEI works on several different topics, including for example:

Norm setting. KEI has advocated access to meeting venues, timely disclosures of negotiating texts, and the use of webcasting of meetings, among other measures. Trade negotiations tend to be particularly non-transparent, particularly in recent years.

Medical technologies. KEI is among those advocating transparency of R&D costs, public sector subsidies for R&D, prices, revenues and units sold in different geographic markets, outlays on certain marketing activities, patent landscapes, know-how to manufacture biologic drugs, outcomes from clinical trials, the text of licensing agreements, and other measures.

Freedom of information laws . KEI is concerned about the increasingly poor compliance with U.S. freedom of information laws.

Background Memo on Transparency Norms

• Note prepared for WHA negotiations on transparency resolution.  February 18, 2019.
• Examples of SEC disclosures.

World Health Assembly/WHO, UN General Assembly

KEI has a separate web page on the negotiations in 2019, that lead to the resolution adopted on May 28, 2019:

http://keionline.org/transparency/wha72

Earlier discussions at the WHO on transparency include, but are not limited to:

• 2018: Expert Panel charts a road map for WHO’s engagement on transparency and R&D
• 2018: EB142: KEI statement on the Global Strategy and plan of action on public health, innovation and IP
• 2017: Expert panel recommends that the WHO move forward on transparency and delinkage
• 2016. February 28. “Increasing the Transparency of Markets for Drugs, Vaccines, Diagnostics and other Medical Technologies.” Supported by 17 organizations; 2 individuals; 3 Members of European Parliament and 2 academic experts.
• 2015: KEI Comments on DHHS Session on WHA68, agenda item 14.1, regarding collection of economic data.
• 2009: US guts transparency clause in PAHO R&D resolution
• 2009: PAHO dispute over standards for transparency of economic data for pharmaceutical industry

U.S. Federal Legislation and Regulations

For a list of bills on transparency:

• Proposed Legislation in the U.S. Congress on transparency relating to drugs and other biomedical technologies.

Selected blogs on federal legislation:

• 2019. April 30. KEI Memo on U.S. Legislation to cap price increases on prescription drugs and to enhance the
  transparency of R&D costs.
• 2017: Company disclosures of R&D costs on SEC filings
• 2017: KEI comments in FDA-2017-N-3615
• 2017: Senate proposes to cut Orphan Drug Tax Credit to 27.5 percent, and make it public
• 2017: Senate tax bill will not make orphan drug tax credits transparent as to company, drug and disease
• 2016: When governments mandate transparency of R&D costs, the details are important
• 2014: NIH rulemaking on transparency of clinical trials
• 2012. BIO memo opposing an amendment by Senator Sanders to require transparency of drug development costs, sales, prices, and clinical trial outcomes
• 2010: Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products for Rare and Neglected Pediatric Diseases. Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures

U.S. State Legislation

• 2018. September 21, 2018: State legislation on drug prices and transparency in pharmaceutical market
• 2017: KEI Testifies in Maryland on Drug R&D Cost Transparency Bill (HB666/SB437)
• 2017: KEI Submission to Oregon Senate on R&D Cost Transparency Provisions in SB 793
• 2017 R&D Cost Transparency Proposals in the United States
• 2016: KEI Briefing Note 2016:2: 2015-2016 Pharmaceutical Transparency, State Legislation
• 2015: California AB 463 (Pharmacetical Cost Transparency Act of 2015) Held Over as Two-Year Bill
• 2015: State of California considers AB463, a bill to require disclosure of drug development costs, and more economic data
• 2015: Kassy Perry, speaking on behalf of ?, opposing AB 463, on transparency of drug R&D costs and subsidies
• 2015: KEI Notes on California Assembly Health Committee Markup on AB 463 Pharmaceutical Cost Transparency Act of 2015

Misc memos on transparency issues

• 2016: Transparency of patents on medicines and other technologies, 2016:1 KEI Briefing Note
• 2016: NIH FOIA office withholds all records related to exclusive license on HER2+ breast cancer treatment technology
• 2014: US Policy Making Transparency: A Good Example and a Really Bad Example
• 2012: What we don’t know, and why, about incentives to stimulate biomedical R&D

Transparency and Patents

Bayh-Dole rights

• Failures to disclose U.S. government Bayh-Dole rights in patented inventions

Patent landscapes

• 2018, July 12. SCP28: Chair’s text (version 1) on future work mandates the sharing of state practice on compulsory licensing of medical technologies and transparency of medical patents
• 2016, April 26. Transparency of patents on medicines and other technologies

The Freedom of Information Act (FOIA)

• Page related to KEI FOIA requests

Trade Negotiations

Here are a few additional blogs on transparency topics.

2009: Obama trade officials promise thorough review of transparency policies
2009: NGO Letter to USTR on transparency

2009: ACTA is secret. How transparent are other other global norm setting exercises?
2009: Transparency of negotiating documents in selected fora
2009: Participation by the public in selected negotiations

2009: USTR’s February 10 memo on Transparency Soup
2009: USTR’s system of NDAs to provide private sector access to ACTA position
2009: White House shares the ACTA Internet text with 42 Washington insiders, under non disclosure agreements
2009: USTR statement on use of NDAs to provide access to ACTA Internet text
2009: White House: ACTA still “secret in the interest of national defense or foreign policy”
2009: Letter to President Obama on ACTA Transparency
2011: Judge rejects USTR claim that negotiating position in FTAA investment chapter is exempt from FOIA
2011: Civil Society on transparency, public health in TPPA; 28 Senators call for highest standards of protection IP in agreement
2012: KEI asks Senator Leahy (D-VT) to demand greater transparency in the TPPA
2012: Wyden files legislative amendments to require transparency in TPPA and Congressional approval for ACTA
2013: KEI Comments on US/EU Trade negotiations (TTIP), Docket No. USTR-2013-0019
2013: White House refuses FIOA request for documents on country positions on transparency of ACTA negotiations
2014: EU’s TTIP Anti-Transparency Rules laid out in DG-Trade letter to USTR
2014: TTIP: Anti-Transparency Rules laid out in USTR letter to DG-Trade