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Applied Health Economics and Health Policy
Published in: Applied Health Economics and Health Policy 5/2017

01-10-2017 | Current Opinion

Is Compulsory Licensing Bad for Public Health? Some Critical Comments on Drug Accessibility in Developing Countries

Author: Samira Guennif

Published in: Applied Health Economics and Health Policy | Issue 5/2017

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Abstract

As one of the flexibilities provided by the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishing minimum standards for the protection of property rights, compulsory license (CL) represents a means towards the protection of public health issues within a context of stringent protection of intellectual property rights (IPRs), most notably in poor-resource settings. However, recent literature asserts that CL constitutes a serious limitation to the full enjoyment of property rights by innovators and may therefore threaten drug accessibility in developing countries. This paper outlines the impact of CL on drug accessibility in developing countries by addressing the three main dimensions of accessibility (availability, affordability and quality) and proceeding to a literature survey of key arguments for and against CL. It concludes that CL inhibits neither the availability of essential drugs nor the affordability of life-saving treatments or the supply of high-quality drugs in developing countries, in particular antiretroviral drugs.
Footnotes
1
There are few studies relating to the impact of CL on innovation in the pharmaceutical sector, and they concern only developed countries [26]. In addition, there are no studies on the impact of CL on the decision-making process of firms in the pharmaceutical sector.
 
2
Chien studied six CLs ordered by the US Free Trade Commission between 1980 and 1997, under antitrust consent decrees for treatments against communicable and non-communicable diseases such as diabetes, herpes or HIV/AIDS.
 
3
The example of Canada is enlightening in terms of how CL can be deployed as a means towards the capacity building of the local pharmaceutical sector. Accordingly, a proper IPR regime and large provisions for CL were designed to promote industrial capabilities in the sector and increased the competitiveness of domestic firms compared with foreign companies. As for today, developing countries such as Brazil and India are concerned both by the promotion of a competitive pharmaceutical industry and the protection of public health.
 
4
More accurately, firms prefer to develop and market drugs in countries where they can set a high price, presumably to recover their high R&D expenditures (see further).
 
5
For a discussion on price differentiation for essential drugs and the implementation of this mechanism in developing countries see Tetteh [38].
 
6
Particularly for vaccines, firms practice tiered pricing where the price in higher-income countries allows to support the supply of vaccines in lower-income countries, as well as to continue efforts to develop new vaccines.
 
7
The announcement of a CL may lead to price negotiation for a patented drug and brings about substantial reduction without a CL even being issued [32, 40].
 
8
This is all the more likely regarding the high costs of R&D claimed by the pharmaceutical industry. While it cost US$500 million to develop a new drug in the 1990s, today it costs US$2.6 billion [41]. However, the debate is vivid about the calculation and the real costs of R&D in the sector. Among others, inflated trial costs and capital costs are largely integrated in the calculation, whereas tax savings are omitted [42, 43]. Thus, the median costs of R&D may be less than US$45 million for a pharmaceutical firm in 2011 [42]. Besides, for neglected diseases, R&D costs yield between US$100 and 150 million according to the DNDi [36].
 
9
All the more so as firms seek to prevent the parallel imports of drugs (the importation of drugs marketed at lower prices in other countries) and to minimize the adverse impact of ‘international price benchmark’ (a cost-containment tool largely adopted in the world to reduce prices for drugs, especially for patented drugs).
 
10
In the 1970s, India noticed that the prices of medicines were among the highest in the world, higher than those set by multinational firms in developed countries. Accordingly, one of the poorest countries in the world at that time amended its patent law and introduced price control mechanism to ensure the development of a domestic industry producing generic drugs at lower prices [44].
 
11
For example, when Uganda launched a national program to fight HIV/AIDS and progressively started to treat people in the 1990s, it had to spend US$12,000 per year and per patient for a therapy, the price charged by patent holders in developed countries [46]. Because of high prices, providing ARVs was not considered by international agencies (first of all by the World Bank) as a cost-effective measure. At that time, the prevailing consensus within international agencies was that developing countries should allocate their limited resources to prevention in order to curb the epidemic.
 
12
Firms set differential pricing according to the HIV/AIDS prevalence and per capita income observed in the developing countries. This helped to lower ARV prices and to increase the number of patients treated—less than 50,000 in 2000 and nearly 828,000 in 2006 [47].
 
13
These studies establish that the drug candidate is strictly equivalent to the original one already marketed. In the absence of such studies, the drug cannot be defined as a generic, but otherwise as a similar.
 
14
The submission of this file sets up the traceability of an active substance incorporated into the manufacturing of a drug, and ensures its quality.
 
15
According to a recent study about the generic medication regulatory features in 21 developing countries [54], only two-thirds of the countries had specific requirements for generics.
 
16
In 2001, the WHO launched its prequalification program. For HIV/AIDS, it periodically publishes a list of prequalified medicines; the organization certifies the high quality of these drugs through audits conducted in the manufacturing units of firms. These prequalified drugs can then be supplied in AIDS programs implemented in developing countries with the support of international donors: the World Bank, the Global Fund to Fight against HIV/AIDS, Tuberculosis and Malaria, The US President's Emergency Plan for AIDS relief, the Clinton Foundation, UNITAID, etc.
 
17
An AIDS cocktail therapy is composed of several ARVs produced in the form of one tablet taken several times a day. This presentation reduces the number of drugs taken daily, increases patient compliance and reduces the risk of resistance. The cocktail produced by the GPO, the GPO-VIR, consisting of three ARVs, comes in the form of a tablet taken twice daily. In 2002, it was celebrated as the cheapest triple therapy in the world. This tablet cost US$1.1 per day against US$6.9 a day for the version marketed by multinationals [59, 61].
 
18
Numerous Indian producers of ARVs are prequalified today by the WHO, providing 246 treatments, approximately 69 % of all prequalified products [66]. As a result, reputed as producers of affordable high-quality ARVs, Indian firms accounted for over 80 % of the drug purchases funded by international donors in developing countries between 2005 and 2010 [67].
 
19
A ‘TRIPS plus’ provision settles higher obligations on developing countries compared with those defined in the TRIPS agreement. For instance, such a provision may consist of listing the diseases eligible for CL, while the TRIPS agreement does not restrict the use of CL to specific diseases [68].
 
Literature
1.
2.
Scherer FM. Watal J Post-TRIPS options for access to patented medicines in developing countries. J Int Econ Law. 2002;5(4):913–39.CrossRef
3.
Gold R, Lam DK. Balancing trade in patents public non-commercial use and compulsory licensing. J World Intell Prop. 2005;6(1):5–31.CrossRef
4.
Musungu SF, Oh C. The use of flexibilities in TRIPS by developing countries: can they promote access to medicines?. Geneva: South Report/World Health Organization; 2006.
5.
Durojaye E. Compulsory licensing and access to medicines in post-Doha era: what hope for Africa? Neth Int Law Rev. 2008;55:33–71.CrossRef
6.
Dutfield G. Delivering drugs to the poor: will the TRIPS amendment helps? Am J Law Med. 2008;24(2):107–24.CrossRef
7.
8.
Hilty RM, Liu KC. Compulsory licensing: practical experiences and way forward. Heidelberg: Springer; 2015.CrossRef
9.
Rozek RP. The effects of compulsory licensing on innovation and access to health care. J World Intell Prop. 2000;3(6):889–917.CrossRef
10.
Skees S. Thai-ing up the TRIPS agreement: are compulsory licenses the answer to Thailand’s AIDS epidemic? Pace Int Law Rev. 2007;19(2):232–85.
11.
12.
13.
14.
Outterson K. Should access to medicines and TRIPS flexibilities be limited to specific diseases? Am J Law Med. 2008;24(2):279–301.CrossRef
15.
Lybecker KM, Fowler E. Compulsory licensing in Canada and Thailand: comparing regimes to ensure legitimate used of the WTO rules. J Law Med Ethics. 2009;37:222–40.CrossRefPubMed
16.
Bird R. Developing nations and the compulsory license: maximizing access to essential medicines while minimizing investment side effects. J Law Med Ethics. 2009;37:209–22.CrossRefPubMed
17.
Borowski SM. Saving tomorrow from today: preserving innovation in the face of compulsory licensing. Fla State Univ Law Rev. 2009;36(2):275–317.
18.
19.
DeRoo P. Public non-commercial use compulsory licensing for pharmaceutical drugs in government health care programs. Mich J Int Law. 2011;32:347–95.
20.
Abbas MZ. Pros and cons of compulsory licensing: an analysis of arguments. Int Jo Soc Sci Humanit. 2013;3(3):254–9.CrossRef
21.
Halajian D. Inadequacy of TRIPS and the compulsory license: why broad compulsory licensing is not a viable solution to the access to medicine problem. Brook J Int Law. 2013;38(3):1191–231.
22.
23.
24.
Grabowski H. Patents, innovation and access to new pharmaceuticals. J Int Econ Law. 2002;5:849–60.CrossRef
25.
Fisch AM. Compulsory licensing of pharmaceutical patents: an unreasonable solution to an unfortunate problem. Jurimetrics. 1994;34(3):295–315.
26.
Chien C. Cheap drugs at what price to innovation: does the compulsory licensing of pharmaceutical hurt innovation? Berkeley Technol Law J. 2003;18(3):853–907.
27.
Scherer FM. The economic effects of compulsory patent licensing, Monograph Series in Finance and Economics. New York: Center for the Study of Financial Institutions; 1977.
28.
McFetridge DG. Intellectual property, technology diffusion, and growth in the Canadian economy. In: Anderson RD, Gallini NT, editors. Competition policy and intellectual property rights in the knowledge based economy. Calgary: University of Calgary Press; 1998. p. 64–104.
29.
Gorecki PK. Changing Canada’s drug patent law: the Minister’s proposals. Can Public Policy. 1984;10(1):77–80.
30.
Global Forum for Health Research. The 10/90 report on health research 2003–2004. Geneva: Global Forum for Health Research; 2004.
31.
Rottingen J, Regmi S, Young AJ, Viergever RF, Ardal C, Guzman J, et al. Mapping of available health research and development data: what’s there, what’s missing, and what role is there for a global observatory. Lancet. 2013;382(9900):1286–307.CrossRefPubMed
32.
Pedrique B, Strub-Wourgaft N, Some C, Olliaro P, Trouiller P, Ford N, et al. The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment. Lancet. 2013;1(6):371–9.
33.
Ridley DB, Grabowski HG, Moe JL. Developing drugs for developing countries. Health Aff. 2006;25(2):313–24.CrossRef
34.
World Health Organization. Working to overcome the global impact of neglected tropical diseases. First WHO report on neglected tropical diseases. eneva: World Health Organization; 2010.
35.
Banerji J, Pecoul B. Pragmatic and principled: DNDi’s approach to IP management. In: Krattiger A, Mahoney RT, Nelsen L, Thomson JA, Bennett AB, Satyanarayana K, et al., editors. Intellectual property management in health and agricultural innovation: a handbook of best practices. Oxford: MIHR; 2007. p. 1775–83.
36.
Drugs for Neglected Diseases Initiative. Annual report 2014. Partnerships to bridge innovation and access. Geneva: Drugs for Neglected Diseases Initiative; 2014.
37.
Flynn S, Hollis A, Palmedo M. An economic justification for open access to essential medicine patents in developing countries. J Law Med Ethics. 2009;37:184–210.CrossRefPubMed
38.
Tetteh EK. Implementing differential pricing for essential medicines via country-specific bilateral negotiated discounts. Appl Health Econ Health Policy. 2009;7(2):71–89.CrossRefPubMed
39.
Stavropoulou C, Valletti T. Compulsory licensing and access to drugs. Eur J Health Econ. 2014;16(1):83–94.CrossRefPubMed
40.
Beall R, Kuhn R, Attaran A. Compulsory licensing often did not produce lower prices for antiretrovirals compared to international procurement. Health Aff. 2015;34(3):493–501.CrossRef
41.
DiMasi J, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20–33.CrossRefPubMed
42.
Light DW, Warburton R. Demythologizing the high costs of pharmaceutical research. BioSocieties. 2011;5:1–17.
43.
Avorn J. The $2.6 billion pill: methodologic and policy considerations. N Engl J Med. 2015;372:1877–9.CrossRefPubMed
44.
Guennif S, Ramani S. Explaining divergence in catching-up in pharmaceuticals between India and Brazil using the National System Innovation framework. Res Policy. 2012;41(2):430–41.CrossRef
45.
UNICEF, UNAIDS, WHO and Médecins Sans Frontières. Sources and prices of selected medicines and diagnostics for people living with HIV/AIDS. Geneva: World Health Organization; 2004.
46.
World Health Organization and UNAIDS. Accelerating access initiative: widening access to care and support for people living with HIV/AIDS. Progress report. Geneva: World Health Organization and ONUSIDA; 2002.
47.
UNAIDS and WHO. Accelerating Access Initiative: fact sheet. Geneva: UNAIDS and World Health Organization; 2006.
48.
Médecins Sans Frontières. Untangling the web of antiretroviral price reductions. 17th ed. Geneva: Médecins Sans Frontières; 2014.
49.
de Albuquerque CP. Compulsory licensing in the real world: the case of ARV drugs in Brazil. In: Coriat B, editor. The political economy of HIV/AIDS in developing countries: TRIPS, public health systems and free access. Cheltenham: Edward Elgar Publishing; 2008. p. 150–69.
50.
Nunn A. The politics and history of AIDS treatment in Brazil. New York: Springer; 2009.CrossRef
51.
Guennif S. Derrière le succès du programme antisida brésilien, les performances industrielles indiennes en pharmacie. J d’économiemédicale. 2012;2(30):111–21.
52.
Flynn M. Origins and limitations of state-based advocacy: Brazil’s AIDS treatment program and global power dynamics. Politics Soc. 2013;41(1):3–28.CrossRef
53.
World Health Organization. The world medicines situation. Geneva: World Health Organization; 2004.
54.
Alfonso-Cristancho R, Andia T, Barbosa T, Watanabe JH. Definition and classification of generic drugs across the world. Appl Health Econ Health Policy. 2015;13(Suppl 1):5–11.CrossRefPubMedCentral
55.
Ministry of Public Health and the National Health Security Office. Facts and evidences on the 10 burning issues related to the government use of patents on three patented essential drugs in Thailand. Document to support strengthening of social wisdom on the issue of drug patent. Bangkok: Ministry of Public Health and the National Health Security Office; 2007.
56.
Kuanpoth J. Give the poor patients a chance: enhancing access to essential medicines through compulsory licensing. J Generic Med. 2008;6(1):15–28.CrossRef
57.
Krikorian G. The politics of patents: conditions of implementation of public health policy in Thailand. In: Haunss S, Shadlen KC, editors. The politics of intellectual property: contestation over the ownership, use, and control of knowledge and information. Cheltenham: Edward Elgar Publishing; 2009. p. 29–56.
58.
Kuek V, Phillips K, Kohler JC. Access to medicines and domestic compulsory licensing: Learning from Canada and Thailand. Glob Public Health. 2011;6(2):111–24.CrossRefPubMed
59.
Guennif S. Access to essential drugs in Thailand: intellectual property rights and other institutional matters affecting public health in a developing country. In: Shadlen K, Guennif S, Guzman-Chavez A, Narayanan L, editors. Intellectual property, pharmaceuticals and public health: access to drugs in developing countries. Cheltenham: Edward Elgar Publishing; 2011. p. 286–310.
60.
Thanitcul S, Braslow ML. Compulsory licensing of chronic disease pharmaceuticals in Thailand. Thai J Pharm Sci. 2013;37:61–83.
61.
Rosenberg S. Assessing the primacy of health over patent rights: a comparative study of the process that led to the use of compulsory licensing in Thailand and Brazil. Dev World Bioeth. 2014;14(2):83–9.CrossRefPubMed
62.
Sukasem C, Churdboonchart V, Sirisidthi K, Riengrojpitak S, Chasombat S, Watitpun C, et al. Genotypic resistance mutations in treatment-naïve and treatment-experienced patients under widespread use of antiretroviral drugs in Thailand: implications for further epidemiologic surveillance. Jpn J Infect Dis. 2007;60:284–9.PubMed
63.
Sungkanuparph S, Sukasem C, Kiertiburanakul S, Pasomsub E, Chantratita W. Emergence of HIV-1 drug resistance mutations among antiretroviral-naïve HIV-1-infected patients after rapid scaling up of antiretroviral therapy in Thailand. J Int AIDS Soc. 2012;15(12):1–6.PubMedPubMedCentral
64.
Kuanpoth J. Patent rights in pharmaceuticals in developing countries: major challenges for the future. Cheltenham: Edward Elgar Publishing; 2010.CrossRef
65.
Government Pharmaceutical Organization. Compulsory licensing of pharmaceutical products. Bangkok: Government Pharmaceutical Organization; 2015.
66.
World Health Organization. WHO list of prequalified medicinal products. Geneva: World Health Organization; 2014.
67.
Waning B, Diedrichsen E, Moon S. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. J Int AIDS Soc. 2010;13(35):1–10.
68.
69.
Abbott FM, van Puymbroeck RV. Compulsory licensing for public health: a guide and model documents for implementation of the Doha Declaration. Paragraph 6, Decision, World Bank Working paper No. 61. Geneva: The World Bank; 2005.
70.
Waning B, Kyle M, Diedrichsen E, Soucy L, Hochstadt J, Bärnighausen T, et al. Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets. Glob Health. 2010;6(9):1–19.
Metadata
Title
Is Compulsory Licensing Bad for Public Health? Some Critical Comments on Drug Accessibility in Developing Countries
Author
Samira Guennif
Publication date
01-10-2017
Publisher
Springer International Publishing
Published in
Applied Health Economics and Health Policy / Issue 5/2017
Print ISSN: 1175-5652
Electronic ISSN: 1179-1896
DOI
https://doi.org/10.1007/s40258-017-0306-1

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