Support for the Delinkage of the Costs of R&D and the Price of Medicines

The concept of delinkage refers to an model of incentivizing innovation in pharmaceutical research and development wherein the price of a medical technology is not linked to the cost of R&D. The application of delinkage in the medical technologies market has been gaining broad based support from NGOs, IGOs, and governments. Below are a selection of public statements, resolutions, bills, and papers that call for the need for delinkage in ensuring global access to medicines.

Endorsements by Governments

European Union:
European Parliament legislative resolution of 19 May 2015 on the proposal for a regulation of the European Parliament and of the Council on the safeguard measures provided for in the Agreement between the European Economic Community and the Swiss Confederation (codified text) (COM(2014)0305 – C8-0009/2014 – 2014/0158(COD) ) (Ordinary legislative procedure – codification). Recommendations regarding antibiotic use in human medicine, Nos.62, 63. Collaborative approaches within the European Union, No. 77.
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+20150519+ITEMS+DOC+XML+V0//EN&language=EN#sdocta9

Informal EU Health Ministers’ Council, Riga Latvia (20-21 April 2015). Speech of Greek Health Minister Mr. Panayotis Kouroumplis. http://tacd-ip.org/archives/1329

United Kingdom:
Review of Antimicrobial Resistance commissioned by the UK Prime Minister. 2015 May. “Securing New Drugs for Future Generations: The Pipeline of Antibiotics.” http://amr-review.org/wp-content/uploads/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf

UK All-Party Parliamentary Working Group. 2014 December. “Access Denied – Report of the Inquiry of the All Party Parliamentary Group on HIV and AIDS into access to medicines in the developing world.” http://www.appghivaids.org.uk/wp-content/uploads/pdf/2014/access-denied14.pdf

United States:
2012. S.3187 (112th Congress) Food and Drug Administration Safety and Innovation Act. SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT MODEL. https://www.govtrack.us/congress/bills/112/s3187

2007. S.2210 (110th Congress) Medical Innovation Prize Fund Act of 2007. Bill proposed by Senator Bernie Sanders. https://www.congress.gov/bill/110th-congress/senate-bill/2210

Endorsements by Intergovernmental Organizations

World Health Organization:

Director General Margaret Chan at a news conference at the WHO headquarters in Geneva, Switzerland, October 19, 2015. http://www.reuters.com/article/2015/10/20/us-health-who-chan-idUSKCN0SE29S20151020

SIXTY-EIGHTH WORLD HEALTH ASSEMBLY A68/20; 27 March 2015. “Antimicrobial resistance: Draft global action plan on antimicrobial resistance.” http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_20-en.pdf

Special session on Ebola EBSS3.R1; 25 January 2015. “Ebola: ending the current outbreak, strengthening global preparedness and ensuring WHO’s capacity to prepare for and respond to future large-scale outbreaks and emergencies with health consequences.” http://apps.who.int/gb/ebwha/pdf_files/EBSS3/EBSS3_R1-en.pdf

SIXTY-SEVENTH WORLD HEALTH ASSEMBLY 24 May 2014 “DECISIONS WHA67(15); Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination.” http://www.who.int/tdr/about/governance/documents/wha67.15_div3-en.pdf

SIXTY-SIXTH WORLD HEALTH ASSEMBLY WHA66.22; 27 May 2013. “Follow up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination.” http://www.who.int/phi/resolution_WHA-66.22.pdf

SIXTY-FIRST WORLD HEALTH ASSEMBLY WHA61.21; 24 May 2008.”Global strategy and plan of action on public health, innovation and intellectual property.” http://apps.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf

SIXTIETH WORLD HEALTH ASSEMBLY WHA60.30; 24 May 2007. “Public health, innovation and intellectual property.” http://apps.who.int/gb/ebwha/pdf_files/WHA60/A60_R30-en.pdf

WHO/WTO/WIPO trilateral report:
2013. “Promoting Access to Medical Technologies and Innovation Intersections between public health, intellectual property and trade.” https://www.wto.org/english/res_e/publications_e/who-wipo-wto_2013_e.htm

World Trade Organization:
WTO TRIPS Council. 2014 October. Indian Intervention regarding Agenda Item 12: Intellectual Property and Innovation: Promoting Awareness; Case Studies. /node/2200

Endorsements by Non-Governmental Organizations

Chatham House:
Chatham House Report. 9 October 2015. “Towards a New Global Business Model for Antibiotics: Delinking Revenues from Sales.” Report from the Chatham House Working Group on New Antibiotic Business Models. https://www.chathamhouse.org/sites/files/chathamhouse/field/field_document/20151009NewBusinessModelAntibioticsCliftGopinathanMorelOuttersonRottingenSoEmbargoed2.pdf?dm_i=1TY5,3PTM2,BVPPTG,DDKI5,1

Chatham House Report. February 2014. “New Business Models for Sustainable Antibiotics.” Centre on Global Health Security Working Group Papers. https://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/0214SustainableAntibiotics.pdf

Médecins Sans Frontières/Doctors without Borders:

MSF Access Campaign, The ‘3P’ Project. March 2015. “Proposal to accelerate innovation and access to new treatment regimens for TB.” http://www.msfaccess.org/wp-content/uploads/IP_TBDemoProject_ENG_2015.pdf

Rohit Malpani in WHO Global Technical Consultative Meeting. December 2013. “MSF intervention at WHO R&D demonstration projects meeting.” http://www.msfaccess.org/content/msf-intervention-who-rd-demonstration-projects-meeting

MSF Access Campaign. November 2013. “The Open Source Fever Diagnostic Project.” Proposal for a CEWG Demonstration Project by Médecins Sans Frontières (MSF). http://www.msfaccess.org/content/proposal-cewg-demonstration-project-m%C3%A9decins-sans-fronti%C3%A8res-msf-november-2013

Buddhima Lokuge. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Universities Allied for Essential Medicines:

Ethan Guillen. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Transatlantic Consumer Dialogue:
2014 November. TACD DOC No: IP 16-14 Resolution on Access to Medicines. http://tacd.org/wp-content/uploads/2013/09/TACD-IP-Resolution-on-access-to-medicines.pdf

2012. HAI/TACD Policy Paper: Time for the EU to lead on innovation.
Subtitle: EU policy opportunities in biomedical innovation and the promotion of public knowledge goods. http://haieurope.org/wp-content/uploads/2012/04/HAI-Europe_TACD-EU-Innovation-Paper.pdf

2011 June. TACD DOC No. IP 14-11 Resolution on Innovation and Access to Medical Technologies. http://test.tacd.org/wp-content/uploads/2013/09/TACD-IP-14-11-Innovation-and-Access-to-Medical-Technologies.pdf

2001 May. TACD DOC No. TRADE-10-01 TACD resolution on global access to health care. http://test.tacd.org/wp-content/uploads/2013/09/TACD-TRADE-10-01-Global-Access-to-Healthcare.pdf

Consumers Union:

2007 October. Bill Vaughan. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

US PIRG:

Edmund Mierzwinski, Consumer Programs Director, U.S. PIRG. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Consumer Federation of America:

Mark Cooper. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Center for Economic and Policy Research:

Dean Baker. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Health GAP:

Brook K. Baker. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

AIDS Treatment News:

John S. James. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Essential Action:

Rob Weissman. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Individuals and Academics:

Merrill Goozner. 2007 October. Author, The $800 Million Pill: The Truth Behind the Cost of New Drugs. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

Burton A. Weisbrod. 2007 October. John Evans Professor of Economics, Northwestern University.

Steven Shavell. October 2007. Director, John M. Olin Center for Law, Economics, and Business and Samuel R. Rosenthal Professor of Law and Economics, Harvard University.

Kevin Outterson. October 2007. Associate Professor of Law, Boston University.

James Boyle. October 2007. William Neal Reynolds Professor of Law and co-founder of the Center for the Study of the Public Domain at Duke Law School.

Frederick M. Abbott. October 2007. Edward Ball Eminent Scholar, Professor of International Law, Florida State University College of Law.

Arti Rai. October 2007. Duke University School of Law.

Aidan Hollis. October 2007. Associate Professor, Department of Economics, University of Calgary.

Sean Flynn. October 2007. Associate Director, Program on Information Justice and Intellectual Property, American University, Washington College of Law.

Roma Enid Sohn. October 2007. Montgomery County Medical Reserve Corps, Retired Chief of Medical House staff at Southside Hospital, Bayshore, New York.

Knowledge Ecology International:

Delinkage.

James Love. 20 October 2007. “Sanders Bill Would Replace Drug Monopolies with Prizes.” Huffington Post. http://www.huffingtonpost.com/james-love/sanders-bill-would-replac_b_69219.html

James Love. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.

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