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Dr. Elias Zerhouni defends Sanofi/Army proposed license on Zika patents, and KEI responds

On March 21, 2017, the New York Times published a letter signed by Dr. Elias Zerhouni, defending the proposed Sanofi monopoly on the US Army patents to the Zika virus. The letter is available from the NYT from the following link, and also reprinted here, followed by commentary.

https://www.nytimes.com/2017/03/21/opinion/developing-a-zika-vaccine.html

To the Editor:

Re “Trump Should Avoid a Bad Zika Deal” (Op-Ed, March 11):

Maryland House of Delegates passes bill on prescription drug price gouging by vote of 137 to 4

On March 20, 2017, the Maryland House of Delegates approved a prescription drug price gouging bill by a vote of 137-4. A copy of the bill, as it passed the House, is attached.

This is a March 20, 2017 Report by Erin Cox, published in the Baltimore Sun:

Maryland's attorney general could sue drug companies for price gouging under a bill approved by the House of Delegates Monday.

Leaked document: March 15, 2017 Note by Switzerland on India EFTA TEPA IP Chapter

Attached is a March 15, 2017 note by Switzerland on the India EFTA TEPA IP Chapter.

The EFTA is the The European Free Trade Association. The EFTA member states are Iceland, Liechtenstein, Norway and Switzerland. The document refers to a proposed "Trade and Economic Partnership Agreement," or TEPA, between India and the four members of the EFTA. The EFTA page on this negotiation is here.

Patients, Members of Congress Ask Chilean Government to Issue Compulsory Licenses on Prostate Cancer and HCV Drug Patents

21 MARCH 2017
PRESS ADVISORY
FOR IMMEDIATE RELEASE

CONTACT: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670 (office) / +1 (914) 582-1428 (cell)
Luis Villarroel, info@innovarte.cl, +56 9 9827 9673

Santiago, Chile — Members of the Chilean Congress and a group of 6 patients visited the Chilean Ministry of Health yesterday to ask that the government use its authority under Chilean law to end patent monopolies on the prostate cancer drug enzalutamide (U.S. brand name Xtandi) and on sofosbuvir-based combination drugs for the treatment of hepatitis C virus (HCV).

The patients and members submitted a petition that outlined the legal authority and public policy rationale for the grant of compulsory licenses on the patents for the drugs described in the petition. Those compulsory licenses would allow prescription drug manufacturers to produce affordable generic versions of the drugs, subject to a reasonable royalty.

Leaked: Three documents from RCEP negotiations

The Regional Comprehensive Economic Partnership (RCEP) is a proposed trade agreement involving 16 countries in the Asia/Pacific region, that have a combined population of 3.5 billion persons, and about 30 percent of world GDP. They include the members of the Association of Southeast Asian Nations (ASEAN) (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam), and six additional countries: Australia, China, India, Japan, South Korea and New Zealand.

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

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.

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

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.

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

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."

KEI 10 March 2017 Comments on Army Exclusive License on Zika Virus Vaccine Patents to Sanofi

On March 10, 2017, KEI filed our 3rd set of comments with the U.S. Army Medical Research and Material Command (USAMRMC) on their proposed grant of an exclusive license on Zika virus vaccine patents to the French pharmaceutical company Sanofi.

2017 R&D Cost Transparency Proposals in the United States

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

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

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.

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

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?

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

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.

8 March 2017 - Statement of Deputy High Commissioner (Kate Gilmore, OHCHR) on the Right to Health

On 8 March 2017, Kate Gilmore, United Nations Deputy High Commissioner for Human Rights, delivered this opening address to the Human Rights Council's panel on Access to Medicines. Deputy High Commissioner Gilmore identified the following challenge posed by intellectual property rights:

KEI Submission to Oregon Senate on R&D Cost Transparency Provisions in SB 793

Today, KEI submitted written testimony on SB 793 — a bill that is designed to allow the Oregon Department of Consumer and Business Services to investigate price increases for prescription drugs — in advance of a hearing before the Oregon Senate Committee on Health Care at 1:00 P.M. (PST) on March 9, 2017.

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