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. [1] October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
Universities Allied for Essential Medicines:
Ethan Guillen [2]. 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. [3] In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
US PIRG:
Edmund Mierzwinski [4], 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 [5]. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
Center for Economic and Policy Research:
Dean Baker [6]. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
Health GAP:
Brook K. Baker. [7] October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
AIDS Treatment News:
John S. James [8]. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
Essential Action:
Rob Weissman [9]. October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.
Individuals and Academics:
Merrill Goozner [10]. 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. [11] 2007 October. John Evans Professor of Economics, Northwestern University.
Steven Shavell [12]. 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. [13] October 2007. Associate Professor of Law, Boston University.
James Boyle [14]. 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 [15]. October 2007. Edward Ball Eminent Scholar, Professor of International Law, Florida State University College of Law.
Arti Rai. [16] October 2007. Duke University School of Law.
Aidan Hollis. [17] October 2007. Associate Professor, Department of Economics, University of Calgary.
Sean Flynn. [18] October 2007. Associate Director, Program on Information Justice and Intellectual Property, American University, Washington College of Law.
Roma Enid Sohn. [19] October 2007. Montgomery County Medical Reserve Corps, Retired Chief of Medical House staff at Southside Hospital, Bayshore, New York.
Knowledge Ecology International:
Delinkage [20].
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. [21] October 2007. In reference to Sanders bill S.2210 The Medical Innovation Prize Act of 2007.