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. Continue Reading

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.”
Continue Reading

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. Continue Reading

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?

Continue Reading

Notes on 2017 Special 301 Submissions

Wednesday, March 8, 2017, the Office of the United States Trade Representative (USTR) will hold the first Special 301 Hearing of the Trump administration. This year, USTR received 63 submissions in advance fo the hearing from governments, civil society organizations, and industry groups.

This blog post pulls out interesting selections from the various submissions, and includes as attachments the submissions of selected organizations.
Continue Reading

8 March 2017 – Human Rights Council’s Access to Medicines panel set to discuss Report of UN HLP

On 8 March 2017, the Human Rights Council will convene a three hour Access to Medicines panel which will take place from 3 PM to 6 PM in Room XX of the Palais des Nations in Geneva. This panel is mandated by resolution 32/15 which passed at 32nd session of the Human Rights Council (June/July 2016). The resolution directed the Human Rights Council to convene an access to medicines panel at its 34th session in March 2017.

Continue Reading

1 March 2017 – WTO TRIPS Council – India’s intervention on the Report of the UN High-Level Panel on Access to Medicines

On 1 March 2017, India delivered the following statement during WTO TRIPS Council discussions on the United Nations Secretary-General’s High Level Panel Report on Access to Medicines.

Agenda item 12: the United Nations Secretary-General’s High Level Panel Report on Access to Medicines

Thank you Chairman.

At the outset, I would like to thank delegations of Brazil, China and South Africa who are also co-sponsors of this agenda item.

Continue Reading

1 March 2017 – WTO TRIPS Council – Brazil’s intervention on the Report of the UN High-Level Panel on Access to Medicines

On 1 March 2017, Brazil delivered the following statement during WTO TRIPS Council discussions on the Report of the United Nations High-Level Panel on Access to Medicines.

High Level Panel

As we all know, on 19 November 2015, United Nations Secretary General Ban Ki-moon announced the creation of the High-Level Panel on Innovation and Access to Health Technologies. Responding to this invitation, two chairs were designated to the panel, namely, Ms. Ruth Dreifuss, from Switzerland, and Festus Mogae, from Botswana.

Continue Reading

Ambassador Shameem Ahsan (Bangladesh) remarks on UN HLP – Opportunities to Advance Health Technology and Access

On 1 March 2017, Bangladesh, Brazil, India and South Africa, the Secretariat of the United Nations Secretary-General’s High-Level Panel on Access to Medicines and the South Centre convened a side event at the World Trade Organization (WTO) on the United Nations Secretary-General’s High Level Panel on Access to Medicines: Opportunities to Advance Health Technology and Access. This event took place on the margins of the WTO TRIPS Council.

Continue Reading

CDC FOIA shows US, WHO opposed request to discuss UNSG’s High-Level Panel on Access to Medicines Report at EB

Email records and memoranda released by the Centers for Disease Control (CDC) in response to a Knowledge Ecology International Freedom of Information Act (FOIA) request show that representatives of the World Health Organization (WHO) and the United States government opposed including India’s proposed agenda item on the United Nations Secretary-General’s High-Level Panel on Access to Medicines for discussion at the 140th WHO Executive Board meeting.

The full set of documents, which was released to KEI without redaction, are available here:

Continue Reading