Blogs

NIH to taxpayers — we don't care about high prices in US for Xtandi.

National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.

Differences between the march-in, royalty free right, and government use options

I wanted to post a brief note about three separate mechanism to overcome patent monopolies in current US law. All are useful, in the right context, and all have some limits.

1. The Bayh-Dole March-In rights under 35 U.S.C. 203, as defined by 35 U.S.C. 201(f).

National Association of Manufacturers told USTR the EU position on LDC extension made a mockery of international trading system

On September 10, 2015, the National Association of Manufacturers (NAM), wrote to USTR expressing alarm at the European Union support of an indefinite extension of a WTO waiver of obligations to grant patents on pharmaceuticals for UN defined least developed countries (LDCs). In 2015, there were 954 million persons living in LDCs, with a per capita income of $964, according to the World Bank. The EU had aligned itself with health advocates trying to protect the bottom billion access to life saving medicines.

500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies

Knowledge Ecology International recently obtained extensive email correspondence between officials at the National Institutes of Health (NIH), the Foundation for the National Institutes of Health (FNIH), and the National Football League (NFL), which shed light on accusations of NFL attempts to control the NIH research agenda related to repeat concussion injuries in football players.

The records, which we received through FOIA, are available here:

NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs

The National Institutes of Health, from 2011 through May of 2015, appears to have granted all requests for waivers of a requirement under federal law that patent holders who benefit from U.S. taxpayer-funding ensure that their patented inventions are manufactured in the United States.

The Bayh-Dole Act imposes various requirements on the grant of exclusive licenses by the patent holders of federally-funded inventions. In particular, the act generally requires that exclusive licensees “substantially” manufacture the invention in the United States.

The Act, however, also allows for the patent holder to obtain a waiver on the U.S. manufacturing requirement from the Federal agency that provided for the funding of the invention. According to a FOIA response recently obtained by Knowledge Ecology International, the NIH seems to grant every manufacturing waiver request that comes its way.

Summary of Report of United Nations Secretary-General's High-Level Panel on Access to Medicines

On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]

KEI Statement on United Nations Secretary-General's High-Level Panel on Access to Medicines Report

On September 14, 2016, the United Nations Secretary-General's High-Level Panel on Access to Medicines issued its long-awaited report, which addressed the policy incoherencies between intellectual property, trade, human rights, innovation, and public health.

The report is available here: http://www.unsgaccessmeds.org/final-report/

Cancer Moonshot Blue Ribbon Panel Does Not Address Pricing, Alternative Funding Models

On September 7, 2016, the National Cancer Advisory Board Blue Ribbon Panel issued a draft report with recommendations directed to the Cancer Moonshot Task Force.

The draft included 10 interesting and useful recommendations (see A - J) related to cancer research, but none to address the pricing or affordability of products.

German Court Issues Compulsory License on HIV Drug Patent

A German patent court has ordered a compulsory license under Section 24 of the Patent Act, allowing Merck (US) to continue to market the HIV drug raltegravir (marketed as Isentress).

Commentary on Hillary Clinton's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs

Democratic presidential nominee Hillary Clinton has published a factsheet presenting, "Hillary's Plan to Respond to Unjustified Price Hikes for Long-Available Drugs."

Today via Twitter, KEI Director James Love offered a six point commentary on Secretary Clinton's proposal to address drug price hikes:

KEI Briefing Note 2016:2: 2015-2016 Pharmaceutical Transparency Legislation

The attached briefing note analyzes transparency legislation that has been proposed in 14 states in 2015 and 2016. The bills would require various degrees of transparency for research and development (R&D) and marketing costs, as well as for drug prices and price changes.

Bloomberg: CVS Will Exclude Xtandi From Formulary in 2017

Bloomberg reported on August 2, 2016, that CVS Health announced that it plans to exclude 35 drugs from its formulary beginning in 2017, including Xtandi, bringing the total number of excluded drugs to 131.

Vivendi-SFR lobbyist nominated to WIPO

Vivendi-SFR lobbyist nominated to WIPO by Hervé Le Crosnier

On July 14, 2016, the former Vivendi-SFR lobbyist Sylvie Forbin was named Deputy Director General of the WIPO “Culture and Creative Industries Sector” (the World Intellectual Property Organization is a United Nations agency). Incidentally the new name of the Sector, “Copyright and Creative Industries,” is revealing of her future professional activities.

Harvoni & Sovaldi, Xtandi in Top 20 Costliest Medicare Drugs

The Associated Press recently released a chart from the Centers for Medicare and Medicaid Services' Office of the Actuary that outlines spending for the top 20 costliest drugs to Medicare in 2015 after reaching Medicare's catastrophic spending threshold: http://www.nytimes.com/aponline/2016/07/25/us/ap-us-medicare-pricey-drugs-glance.html.

UPDATE: The AP also released another story, on July 24, 2016, outlining the overall program costs of catastrophic spending and explaining various spending increases: http://www.nytimes.com/aponline/2016/07/24/us/politics/ap-us-medicare-pricey-drugs.html.

top-20-medicare-drugs-2015.png

Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiatives

20 July 2016
For Immediate Release

Contacts
Knowledge Ecology International: Zack Struver, zack.struver@keionline.org, +1 (202) 332-2670
Public Citizen: Peter Maybarduk, pmaybarduk@citizen.org, +1 (202) 588-7755

Public Health, Human Rights, and Faith Organizations Question State Department Pressure Against Global Access to Medicines Initiatives

Evidence shows pattern of interference in national and international efforts to improve access to affordable medicines, according to Doctors Without Borders (MSF USA), Knowledge Ecology International, Public Citizen, Oxfam, and other leading public interest groups.

Washington, DC — More than 50 public interest organizations and experts asked Secretary of State John Kerry today to explain evidence that the State Department recently pressured the United Nations and the governments of Colombia and India against taking action to improve access to affordable medicines, citing U.S. business interests and implying that relations with Washington would suffer.

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