Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of factors at the drug and country level. We used a dataset of all attempted CL that occurred from 1995 to 2014, calculated the duration as the difference in years between the year of global marketing of a certain drug and the year of attempted CL in a certain country, and applied a nonparametric event history model. We found that the Doha Declaration was quite effective in shortening the time to attempted CL. Additionally, even though global justice movements have encouraged some countries to attempt CL for various medicines since 2012, the time to CL attempts in this period became significantly longer compared to those that occurred immediately after the Doha Declaration. Our findings show that the subject of CL has not successfully expanded to oncology medicines from HIV/AIDS medicines and that recently approved medicines are not yet subjects of CL. Furthermore, our duration model suggests a learning-by-doing effect in attempting CL: previous experience of CL not only triggers CL for the same drugs in other countries but also accelerates CL for other drugs within the country.
FM’t HoenE.Private Patents and Public Health: Changing Intellectual Property Rules for Access to Medicines.
Amsterdam, The Netherlands:
Health Action International; 2016.
3.
GuennifS.Is compulsory licensing bad for public health? Some critical comments on drug accessibility in developing countries.Appl Health Econ Health Policy. 2017;
15(5):557–565.
4.
FordNWilsonDChavesGCLotrowskaMKijtiwatchakulK.Sustaining access to antiretroviral therapy in the less-developed world: lessons from Brazil and Thailand.AIDS. 2007;
21:S21–S29.
5.
AbbottFMReichmanJH.The Doha Round’s public health legacy: Strategies for the production and diffusion of patented medicines under the amended TRIPS provisions.J Int Econ Law. 2007;
10(4):921–987.
6.
SonKBLeeTJ.The trends and constructive ambiguity in international agreements on intellectual property and pharmaceutical affairs: Implications for domestic legislations in low- and middle-income countries. Glob Public Health. 2018;
13:1169–1178.
7.
GoldERLamDK.Balancing trade in patents.J World Intellect Prop. 2003;
6(1):5–31.
8.
SchererFMWatalJ.Post‐TRIPS options for access to patented medicines in developing nations. J Int Econ Law. 2002;
5(4):913–939.
9.
BeallRKuhnR.Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.PLoS Med. 2012;
9(1):e1001154.
10.
SonKBLeeTJ.Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to medicines. Glob Public Health. 2018;
13(10):1430–1440.
11.
GuennifS.Evaluating the usefulness of compulsory licensing in developing countries: a comparative study of Thai and Brazilian experiences regarding access to AIDS treatments.Dev World Bioeth. 2017;
17(2):90–99.
12.
KuekVPhillipsKKohlerJ.Access to medicines and domestic compulsory licensing: Learning from Canada and Thailand.Glob Publ Health. 2011;
6(2):111–124.
13.
FlynnM.Origins and limitations of state-based advocacy: Brazil’s AIDS treatment program and global power dynamics.Polit Soc. 2013;
41(1):3–28.
14.
CohenJCIllingworthP.The dilemma of intellectual property rights for pharmaceuticals: the tension between ensuring access of the poor to medicines and committing to international agreements.Dev World Bioeth. 2003;
3(1):27–48.
15.
LybeckerKMFowlerE.Compulsory licensing in Canada and Thailand: comparing regimes to ensure legitimate use of the WTO rules.J Law Med Ethics. 2009;
37(2):222–239.
16.
ChienC. Cheap drugs at what price to innovation: does the compulsory licensing of pharmaceuticals hurt innovation? Berkeley Technol Law J.2003;18(3):853–907.
17.
World Health Organization. Briefing Note: Access to Medicines-Country Experiences in Using TRIPS Safeguards.
Geneva, Switzerland:
World Health Organization; 2008.
18.
MellstedtHNiederwieserDLudwigH.The challenge of biosimilars.Ann Oncol. 2007;
19(3):411–419.
19.
DavisCNaciHGurpinarEPoplavskaEPintoAAggarwalA.Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ. 2017;
359:j4530.
20.
TannockIFAmirEBoothCMet al.
Relevance of randomised controlled trials in oncology.Lancet Oncol. 2016;
17(12):e560–e567.
21.
ZafarSYNewcomerLNMcCarthyJFuld NassoSSaltzLB.How should we intervene on the financial toxicity of cancer care? One shot, four perspectives.Am Soc Clin Oncol Educ Book. 2017;
37:35–39.
22.
RootesC. Globalisation, environmentalism and the global justice movement. Environmental Politics. 2005;14(5):692–696.
23.
SonKBKimCYLeeTJ. Understanding of for whom, under what conditions and how the compulsory licensing of pharmaceuticals works in Brazil and Thailand: A realist synthesis. Glob Public Health. 2018 May 9:1–3.
24.
von FalckA.Compulsory licenses as a defense in pharmaceutical and biotech patent litigation. Pharm Pat Anal. 2016;
5:351–353.
KesslerDAHassAEFeidenKLLumpkinMTempleR.Approval of new drugs in the United States: comparison with the United Kingdom, Germany, and Japan.JAMA. 1996;
276(22):1826–1831.
28.
World Health Organization. The world medicines situation. No. WHO/EDM/PAR/2004.5. Geneva: World Health Organization; 2004.
29.
LiuMLa CroixS.The impact of stronger property rights in pharmaceuticals on innovation in developed and developing countries.
Honolulu, HI:
University of Hawaii at Mānoa; 2014.
30.
RamaniSVUriasE.Access to critical medicines: When are compulsory licenses effective in price negotiations?Soc Sci Med. 2015;
135:75–83.
31.
StavropoulouCVallettiT.Compulsory licensing and access to drugs.Eur J Health Econ. 2015;
16(1):83–94.
32.
LiuMLa CroixS.A cross-country index of intellectual property rights in pharmaceutical inventions.Res Policy. 2015;
44(1):206–216.
33.
La CroixSLiuM.The effect of GDP growth on pharmaceutical patent protection, 1945–2005. Brussels Econ Rev. 2009;
52(3/4):355–375.
34.
KleinJPMoeschbergerML.Survival analysis: techniques for censored and truncated data.
Berlin, Germany:
Springer Science & Business Media; 2005.
35.
XiongCZhuKYuK.Statistical survival analysis with applications. In: PhamH, ed. Springer Handbook of Engineering Statistics.
Berlin, Germany:
Springer; 2006:347–367.
36.
FreemanJAHillA.The use of generic medications for hepatitis C.Liver Int. 2016;
36(7):929–932.
37.
KaszubskaK.Compulsory licensing under India’s new model bilateral investment treaty.Rev Market Integrat. 2018;
9:139–154.
