Sanofi’s recent fines for fraud, kickbacks, etc: /sanofi-fines
On December 9, 2016, the U.S. Army announced its intent to grant an exclusive license to Sanofi on patents for a U.S. Army-developed Zika vaccine. KEI and various other non-profit groups have filed comments with the Army. This page is organized by categories. For a timeline of events and a description of the various collaborations between Sanofi and the U.S. government, see here: /zika-timeline.
KEI Comments, 2016-2017
- 25 July 2017. KEI and Médecins Sans Frontières propose contractual terms to protect access and affordability of Zika vaccine
- 17 July 2017. KEI response to Sanofi letter to Senators who asked Army for hearing on Zika vaccine license.
- 19 May 2017. KEI and others file appeal of Army decision.
- 10 March 2017. KEI filed comments with regards to practical application, reasonable terms, and reasonable price in the context of exclusive licensing obligations in the Bayh-Dole Act.
- 16 February 2017. Note by Diane Singhroy, PhD., on Zika vaccine manufacturing.
- 12 January 2017. Comments filed by KEI, American Federation of State, County and Municipal Employees (AFSCME), People of Faith for Access to Medicines (PFAM), Public Citizen, Social Security Works, Universities Allied for Essential Medicines (UAEM), and Dean Baker of the Center for Economic and Policy Research. “An exclusive license to patents on a new Zika vaccine to Sanofi is contrary to the provisions of 35 U.S.C. 209(a)(1).” Submitted in response to a Federal Register notice (81 Fed. Reg. 89087) posted 9 December 2016, titled “Intent to Grant an Exclusive License of U.S. Government-Owned Patents.”
- 21 December 2016. KEI Initial Comments regarding Department of the Army Intent to Grant an Exclusive License of US Governement-Owned Patents for patents on Zika Virus Vaccine and Methods of Production to Sanofi Pasteur, Inc.
- 9 December 2016. KEI request for information submitted to Barry Datloff, Office of Research & Technology Assessment, Department of the Army.
Other KEI Blogs and commentary
- 2 March 2016. “DHHS declared public health emergency for Zika virus.
Other NGO Comments
- 23 January 2017. MSF filed comments with the US Army in opposition to the grant of an exclusive license to patents on a new vaccine for the Zika Virus.
- May 19, 2017. MSF appeal.
Members of Congress and Governors
- 26 June 2017. Six Senators Call on Army to Hold Public Hearing on Proposed Exclusive License of Zika Vaccine to Sanofi. Copy of letter to Army. Copy of letter to Sanofi.
- 14 June 2017. Florida members in House and Senate Object to Proposed Exclusive License of Zika Vaccine. Copy of Senator Nelson’s letter to Army here. House letter here.
- 24 February 2017. [Eleven] House Democrats demand affordable prices for taxpayer-funded Zika vaccine. Copy of letter to Army here.
- 10 March 2017. Senator Bernie Sanders in the New York Times: Trump Should Avoid a Bad Zika Deal. Copy of letter to Army here.
- 17 May 2017. Louisiana Governor John Bel Edwards sends a letter to the U.S. Army on including a reasonable pricing provision in the Zika vaccine license.
Federal Register Notices
- 27 January 2017. Intent To Grant an Exclusive License of U.S. Government-Owned Patents. Department of the Army. 82 Fed. Reg. 8611.
- 11 January 2017. Comment Period Extension: Intent to Grant an Exclusive License of U.S. Government-owned Patents. 82 Fed. Reg. 3295.
- 9 December 2016. Intent to Grant an Exclusive License of U.S. Government-Owned Patents. Department of the Army. 81 Fed. Reg. 89087.
News Stories, Press Releases, and Blogs
- 26 September 2016. Sanofi Pasteur Press Release. BARDA Grants $43.2 Million USD To Sanofi Pasteur For Zika: Funds will be used for phase II development and manufacturing.
- 2 August 2016. Col. Nelson L. Michael and Col. Stephen J. Thomas. Army researchers developing Zika vaccine. Walter Reed Army Institute of Research.
- 9 November 2016. Cheryl Pellerin. Human trials begin for Army-developed Zika vaccine. DoD News, Defense Media Activity.
- 22 December 2016. Ed Silverman. US Army license being awarded to Sanofi for a Zika vaccine raises questions. Pharmalot, Stat News.
- 28 December 2016. Patrick Adams And Cameron Nutt. A Zika Vaccine, but for Whom? New York Times.
- 10 January 2017. Eric Sagonowsky. U.S. Army’s planned Zika vaccine license to Sanofi raises nonprofit’s ire. Fierce Pharma.
- 19 January 2017. Kim Treanor. Groups Seek Assurance Of Affordable Zika Vaccine From US Army Exclusive Licence. IP-Watch.
- 24 January 2017. Zachary Brennan. Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine. RAPS.
- 27 January 2017. Sophie Edwards. Zika vaccine could be delayed, unaffordable after US Army grants exclusive rights to pharma company. Devex.
- 22 February 2017. Ed Silverman. Lawmakers urge US Army not to issue exclusive license to Sanofi for a Zika vaccine. Pharmalot, Stat News.
- 23 February 2017. Eric Sagonowksy. Lawmakers decry Army’s planned Zika vaccine license to Sanofi. FiercePharma.
- 10 March 2017. Senator Bernie Sanders. Trump Should Avoid a Bad Zika Deal. New York Times.
- May 17, 2017. Ed Silverman. Sanofi rejects US Army request for ‘fair’ pricing for a Zika vaccine. Stat.
- May 29. Ed Silverman. US taxpayers are funding a Zika vaccine. Let’s make sure US patients can afford it. Stat.
- May 30, 2017. Alison Kodjak, States Fear Price Of New Zika Vaccine Will Be More Than They Can Pay, Heard on Morning Edition, NPR.
- May 30, 2017. Editorial. Trump should put consumers first in Zika deal. The Boston Globe.
- May 30, 2017. John Pacenti. Could a Zika vaccine be too expensive? Palm Beach Post.
- June 4, 2017. James Love. Eight takeaways from the Army/Sanofi/Zika license fiasco. Medium.
- June 6, 2017. Alexander C. Kaufman. This Pharma Company Won’t Commit To Fairly Pricing A Zika Vaccine You Helped Pay For. Huffington Post.
- June 12, 2017. Daniel Chang. Zika vaccine is being funded by U.S. taxpayers. But the drugmaker rejects ‘fair price’. Miami Herald.
- June 14, 2017. Daniel Chang. Florida congressional members want U.S. Army to hold public hearings on Zika vaccine. Miami Herald.
- June 14, 2017. Ed Silverman. Lawmakers ask U.S. Army to hold a hearing on Zika vaccine licensing. Stat.
- June 15, 2017. Eric Sagonowsky. Lawmakers in hard-hit Florida want public hearing in Sanofi Zika vaccine scuffle. Fierce Pharma.
- June 20, 2017. Richard Eskow. “The Government Created This Zika Vaccine. Why Should Big Pharma Reap the Profits? Lawmakers are concerned that giving a drug company a monopoly on the promising vaccine could make it unaffordable.” the Nation.
- June 26, 2017. Ed Silverman. “More lawmakers want the Army to hold a hearing on Zika vaccine pricing,” Stat.
- June 27, 2017. Eric Sagonowsky. “Senators lay into Sanofi for Zika vaccine deal, call for public hearing,” Fierce Pharma.
- 14 July 2017. Eric Sagonowsky. Amid dustup over taxpayer-funded research, Sanofi executive says it never rejected a Zika vaccine fair pricing request. Fierce Pharma.
- 17 July 2017. Ed Silverman. Sanofi denies rejecting Army request for a fair price on a Zika vaccine, Stat.
- 17 July 2017. Jean-Yves Paillé. Sanofi tente d’éteindre la polémique sur le prix du futur vaccin anti-Zika, La Tribune.