Assessing the Public and Philanthropic Financial Contribution to the Development of New Drugs: A Bibliographic Analysis
Science, Technology & Public Policy
Volume 4, Issue 1, June 2020, Pages: 8-14
Received: Mar. 29, 2020;
Accepted: Apr. 20, 2020;
Published: May 15, 2020
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Louise Schmidt, Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria
Claudia Wild, Austrian Institute for Health Technology Assessment (AIHTA), Vienna, Austria
Background: There is wide debate on the cost of some pharmaceutical products and the impact this has on access to medicine. Little publicized knowledge on the public and philanthropic contribution to research and development costs exists so far. The objective of work reported here was to collect information on public contributions to research funding and thus contribute to the discussion on return on public investment. Methods: A multi-level search process was developed to search for public and philanthropic research funding based on 3 main steps: (1) identification of all generic and molecular names and terms, (2) systematic search for pre-marketing pathway information and related research funding, (3) systematic search for corresponding research funding amounts. Three Paediatric Orphan Drugs (Spinraza®, Brineura®, Crysvita®), which were approved by the European Medicines Agency (EMA) in 2017, were chosen to pilot the methods. Results: We estimated that public/philanthropic contributions to funding of product-related research ranged between approximately € 20 million (Spinraza®) and € 31 million (Brineura®). However, this is a very conservative estimate since pharmaceutical development calls upon basic research, which does not mention product-specific terms. For instance, for research into SMA as a whole, public and philanthropic research funding contributions totalling € 165 million were identified. Conclusions: Researching public and philanthropic R & D funding proved to be difficult and time consuming. Further piloting including the refinement and standardisation of the search strategy is underway.
Assessing the Public and Philanthropic Financial Contribution to the Development of New Drugs: A Bibliographic Analysis, Science, Technology & Public Policy.
Vol. 4, No. 1,
2020, pp. 8-14.
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/
) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
European Parliament. Study for the ENVI Committee. Links between Pharmaceutical R&D Models and Access to Affordable Medicines. European Parliament; 2016; Available from: http://www.europarl.europa.eu/RegData/etudes/STUD/2016/587321/IPOL_STU(2016)587321_EN.pdf.
Nass S, Madhavan G, Augustine N. Making Medicines Affordable: A National Imperative. Sciences, National Academy of Sciences (editor). Washington (DC): National Academies Press; 2017.
Global Justice Now. Pills and profits. How drug companies make a killing out of public research. 2017; Available from: https://www.globaljustice.org.uk/sites/default/files/files/news_article/pills-and-profits-report-web.pdf.
Mazzucato M. The Entrepreneurial State – Debunking Public vs Private Sector Myths: Penguin Random House UK; 2015.
Institute of Medicine (IOM) Forum on Drug Discovery DaT. Chapter 2: Current Model for Financing Drug Development: From Concept Through Approval. Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies: Workshop Summary. Washington (DC): National Academies Press; 2009.
Sampat B. The Impact of Publicly Funded Biomedical and Health Research: A Review of National Academies Committee on Measuring Economic and Other Returns on Federal Research Investments, Measuring the Impacts of Federal Investments in Research: A Workshop Summary. Washington (DC): National Academies Press; 2011.
Kneller R. The importance of new companies for drug discovery: origins of a decade of new drugs. Nature reviews Drug discovery. 2010; 9 (11): 867-82. Epub 2010/10/30.
Cockburn I, Henderson R. Public–private interaction in pharmaceutical research. Proceedings of the National Academy of Sciences. 1996; 93 (23): 12725-30.
Roy V. The Financialization of a Cure: A Political Economy of Biomedical Innovation, Pricing, and Public Health (Doctoral thesis). University of Cambridge KsC, editor2017.
Cassedy C. KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead. 2019; Available from: https://www.keionline.org/31269.
Cleary E, Beierlein J, Khanuja N, McNamee L, Ledley F. Contribution of NIH funding to new drug approvals 2010-2016. Proceedings of the National Academy of Sciences of the United States of America. 2018; 115 (10): 2329-34. Epub 2018/02/15.
Wooding S. Setting the historical context for Project Retrosight RAND Europe, 2007.
European Medicines Agency (EMA). Annual Report 2017. 2018; Available from: https://www.ema.europa.eu/en/documents/annual-report/2017-annual-report-european-medicines-agency_en.pdf.
European Medicines Agency (EMA). Human medicines highlights 2017. 2017; Available from: https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2017_en.pdf.
Viergever R, Hendriks T. The 10 largest public and philanthropic funders of health research in the world: what they fund and how they distribute their funds. Health research policy and systems. 2016; 14: 12. Epub 2016/02/20.
Dorsey E, de Roulet J, Thompson J, Reminick J, Thai A, White-Stellato Z, et al. Funding of US Biomedical Research, 2003-2008. Jama. 2010; 303 (2): 137-43.
Dorsey E, Thompson J, Carrasco M, de Roulet J, Vitticore P, Nicholson S, et al. Financing of U.S. Biomedical Research and New Drug Approvals across Therapeutic Areas. PLoS One. 2009; 4 (9): e7015.
Expert Panel on Effective Ways on Investing in Health (EXPH). Innovative payment models for high-cost innovative medicines. 2018; Available from: https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/docsdir/opinion_innovative_medicines_en.pdf.
Organisation for Economic Co-operation and Development (OECD). Pharmaceutical Innovation and Access to Medicines. Paris2018; Available from: http://www.oecd.org/health/pharmaceutical-innovation-and-access-to-medicines-9789264307391-en.htm.
World Health Organizatin (WHO). Resolution: Improving the transparency of markets for medicines, vaccines, and other health products 2019; Available from: https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2Rev1-en.pdf.