14 March 2017 – Senate Finance Committee grills Robert Lighthizer (USTR nominee) on trade and IPR policies

Posted on by Thiru

On 14 March 2017, the U.S. Senate Finance Committee held confirmation hearings for Robert Lighthizer, President Donald Trump’s appointee for United States Trade Representative. During the Reagan administration, Lighthizer served as Deputy US Trade Representative with the rank of Ambassador (Source: http://www.presidency.ucsb.edu/ws/?pid=41174). Prior to his tenure as Deputy USTR, from 1981 to 1983, Lighthizer served as Chief Counsel for the U.S. Senate Finance Committee. Currently, he is a partner at Skadden Arps. Continue Reading →

KEI Testifies in Maryland on Drug R&D Cost Transparency Bill (HB666/SB437)

Posted on by Zack Struver

James Love and Andrew Goldman represented KEI on March 16, 2017, in a working group meeting of a subcommittee of the Maryland General Assembly House of Delegates Health & Government Operations Committee, where they testified on HB666/SB437, a bill that would establish transparency of R&D costs for prescription drugs sold in Maryland.

Vincent DeMarco of at Health Care for All! and Dr. Reshma Ramachandran of the Johns Hopkins Bloomberg School of Public Health also testified at the hearing.
Continue Reading →

HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals’ Spinraza

Posted on by Zack Struver

The Department of Health and Human Services Office of Inspector General (OIG) informed KEI that it would not move forward with an investigation into whether Isis Pharmaceuticals, now known as Ionis Pharmaceuticals, failed to report federal funding in patents on Spinraza.

In a letter dated March 13, 2017, Matthew Charette, the Special Agent in Charge of the Investigations Branch of OIG, explained that OIG counsel believes that OIG has limited authority, and that the obligation to “monitor[] invention reporting and remedy[] noncompliance” “rests with NIH’s Office of Policy for Extramural Research Administration (OPERA).”

On January 18, 2017, KEI submitted a 22-page letter to OIG containing evidence that the patents on Spinraza benefited from federal grants. KEI did not just ask OIG to investigate Isis’ alleged failure to report this funding, in violation of the Bayh-Dole Act and federal regulations, but also urged the OIG “to investigate whether the National Institutes of Health failed to conduct proper oversight in administering its grants” and to “recommend appropriate action to remedy the situation in line with the statute and prior decisions with regard to failure to disclose a subject invention.”
Continue Reading →

2017 R&D Cost Transparency Proposals in the United States

Posted on by Zack Struver

On March 9, 2017, KEI was scheduled to testify before the Maryland House Committee on Health on HB 666, a bill that would require an annual report on R&D costs from drug companies that sell high-priced medicines in the state of Maryland.

In advance of the hearing, I prepared a note that summarizes provisions in both transparency and pharmaceutical price gouging legislation that would require the disclosure of the costs associated with research and development. This note is a less detailed version of this 2016 summary.

This year, so far, legislators in 13 states have introduced 21 bills that would require some degree of transparency.

map of states with transparency bills
Continue Reading →

Uncategorized

8 March 2017 – Statement of Portugal – HRC 34 – Panel on Access to Medicines

Posted on by Thiru

On 8 March 2017, the Permanent Representative of Portugal, Ambassador Pedro Nuno Bártolo, made a powerful intervention at the Human Rights Council’s panel discussion on access to medicines. Portugal stressed that access to medicines is a fundamental element of the right to health and highlighted how the high prices of hepatitis C and cancer medicines made them unaffordable to large segments of the population in industrialized countries. Continue Reading →

8 March 2017 – Statement of the European Union – HRC 34 – Panel on Access to Medicines

Posted on by Thiru

On 8 March 2017, the European Union (EU) delivered the following statement to the Human Rights Council’s panel discussion on Access to Medicines. As the Human Right Council imposed a strict two minute limit on interventions, the EU was not able to raise the following two questions contained at the end of its intervention.

I have two questions for the Panel.

Could the panellists suggest further measures to promote a holistic approach to access to medicines?

Continue Reading →

8 March 2017 – Statement of the World Trade Organization – HRC 34 – Panel on Access to Medicines

Posted on by Thiru

On 8 March 2017, the World Trade Organization delivered the following statement at the Human Rights Council’s panel on Access to Medicines.

WTO statement – Antony Taubman

It’s an honour for the WTO Secretariat to join this distinguished panel. Today’s discussion is a welcome step forward in the journey together towards the shared goal of access to medicines for all, and promoting the development of urgently needed new medicines, recognizing the centrality of the human rights perspective for this collective effort.

Continue Reading →

Uncategorized