April 3, 2017. Sanofi agreed to pay $19.9 million to resolve allegations under the False Claims Act that the company overcharged the U.S. Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011. According to the DOJ press release:
4 APRIL 2017
FOR IMMEDIATE RELEASE
CONTACT: Zack Struver, zack.struver@keionline.org or +1 (202) 332-2670
In a letter sent today, Representative Lloyd Doggett, D-Texas, and 50 other democratic members of Congress requested that President Donald J. Trump issue guidance for the use of Bayh-Dole Act march-in rights in order to protect taxpayer’s rights in federally-funded patented inventions.
The following statement should be attributed to James Love, Director of Knowledge Ecology International (KEI):
“The letter from members of Congress on the need to protect taxpayer’s rights in the inventions they fund is important, timely, and directly related to the challenge of providing affordable health care to everyone. Federally-funded inventions are now routinely placed on the market at extremely high prices. Astellas charges more than $350 per day for the prostate cancer drug Xtandi, and BioGen is charging $1.125 million for the first two years of Spinraza, which is used to treat spinal muscular atrophy in mostly young children. The notion that the federal government will not engage on the pricing of these products runs counter to the explicit provisions in the Bayh-Dole Act that require inventions be made ‘available to the public on reasonable terms.’ The President can curb high prices for these drugs without new legislation, and without putting patients at risk.”
KEI filed the most recent march-in request with the federal government on the prostate cancer drug Xtandi.
The letter is available as a PDF here and below in plain text.
Representative Doggett’s office issued the following press release: https://doggett.house.gov/media-center/press-releases/congressional-democrats-trump-we-re-calling-your-hand-lower-prescription
On Monday, 27 March 2017, Knowledge Ecology International (KEI) delivered the following oral statement to the Open Session of the 21st Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines. The program for the open session can be found here.
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.
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.
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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.
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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
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?
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:
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.