2017: GeneXion Oncology Prospective Grant of Exclusive Patent License for Mutant IDH1 Inhibitors Useful for Treating Cancer

(More on government funded inventions here. Other KEI comments on NIH licenses are found here.) On May 31, 2017, we sent the following comment to the NIH regarding the proposed exclusive license on certain patents for cancer treatment to GeneXion Oncology. May 31,… Continue Reading

WHA70: Statement of Portugal on the Global shortage of, and access to medicines and vaccines

Portugal delivered the following statement at the 70th World Health Assembly on agenda item, 13.3 – Global shortage of, and access to medicines and vaccines.

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In relation to the Report of the United Nations High-Level Panel on Access to Medicines (UNHLP), the delegation of Portugal quoted the intervention delivered by the Portuguese Minister of Health, Professor Campos Fernandes at the plenary of the 70th World Health Assembly.

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WHA70: Statement of Knowledge Ecology International on review of the GSPOA-PHI

On Friday, 26 May 2017, Knowledge Ecology International delivered the following intervention on the Evaluation and review of the global strategy and plan of action on public health, innovation and intellectual property. This statement was read by Manon Ress.

13.4 Evaluation and review of the global strategy and plan of action on public health, innovation and intellectual property

The GSPOA evaluation conducted by Capra International was disappointing, raising questions about the terms of reference, and low ambition.

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WHA70 – Side Event on Addressing Access Barriers and Affordability Challenges for Cancer Drugs – 24 May 2017

On Wednesday, 24 May 2017, Knowledge Ecology International (KEI), Oxfam and Stichting Health Action International (HAI) are convening a side event on addressing access barriers and affordability challenges for cancer medicines. This panel will take place in Salle IX of the United Nations Palais des Nations from 18:00 to 19:30.

Date: Wednesday, 24 May 2017
Time: 18:00 to 19:30
Location: Salle IX, United Nations Palais des Nations

Panelists:

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Experts, NGOs ask WHA delegates to support feasibility study of funding cancer research without high prices

On May 3, 2017, 29 civil society organizations and 33 health professionals, activists, and economists — including Nobel Prize laureate Joseph Stiglitz — asked delegates to the World Health Assembly (WHA) to support a feasibility study on the progressive delinkage of the costs of research and development from the price of cancer medicines. The groups and experts sent a letter to the delegates.

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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.”
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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?

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