의약품 특허의 강제실시청구에 관한 심사기준 고찰 -인간기능이론을 중심으로- = Review of Standards for Compulsory Licensing of Pharmaceutical Patents -From the Perspective of Human Functioning Theory-

다국어 초록 (Multilingual Abstract)

Compulsory licensing of pharmaceutical patents is an issue closely related to social justice. As such, the view of government actors and agents - such as intellectual property officers and judges on social justice issues will affect their decisions on the issuance of compulsory licenses that facilitate access to patented medicines. However, neither treaty nor any domestic legislation has yet defined the standards for the issuance of compulsory licenses in detail. Under these circumstances, theories of social justice can be useful references for such government agencies to identify key factors that should be considered for their decisions. From the perspective of utilitarianism, for example, government agencies should not focus on the possible conceptual consequences-whether legal or moral-that result from compulsory licensing, but try to evaluate, quantify and compare the extents of possible health benefits and damages to the patentee for their balancing tests. From the perspective of social contract theory, they will be required to exploit the legal system of compulsory licensing fully so that patent protection for pharmaceuticals does as little as possible to prevent fair distribution of medicines (primary goods), and that legal decisions are made to exact the greatest benefit to the least-advantaged members of society. This paper argues, based on Nussbaum`s human functioning theory which argues that social justice requires governments to secure basic capabilities of human functioning, that governments are specifically required to consider for their balancing test that: (1) how great the necessity is for the medicine to ensure the basic capabilities of human functioning, (2) whether it is particularly necessary to protect the lives and health of those who suffer from rare diseases, (3) whether it is particularly necessary to protect the lives and health of minority groups such as children, women, the aged and HIV/AIDS patients, (4) whether other medicines are available that can be substantial and economic alternatives to the medicine, and (5) whether fast, effective, sustainable and enforceable alternative measures are available. In addition, this paper further argues, with regard to the Korean Intellectual Property Office`s rejection to the issuance of compulsory licenses for Glivec and Fuzeon, that governments should not put too much weight on whether the need for compulsory license is urgent, or whether the medicine can be imported to Korea without the approval of the Minister of Knowledge Economy according to the Foreign Trade Act, and supports the decision of the National Human Rights Commission of Korea that recommended the Commissioner of the Korean Intellectual Property Office to issue a compulsory license to facilitate access to Fuzeon, which is close to the view of human functioning theory.

참고문헌 (Reference)

1 조영선, "특허법 주해 1" 도서출판 박영사 2010

2 이익희, "특허발명의 권리회복제도와" 2005

3 한남대학교 산학협력단, "특허권의 수용․실시에 관한 법령 개정방안 연구" 특허청 2010

4 이의경, "퇴장방지의약품 관리기준연구 보고서" 한국보건사회연구원 건강보험심사평가원 2006

5 양철호, "의약특허의 강제실시에 관한 연구" 인하대학교 대학원 2006

6 정보공유연대 IPLeft, "왼쪽에서 보는 지적재산권"

7 건국대학교, "신기술분야에서의 강제실시제도의 적용에 관한 연구 : TRIPs 협정개정에 따른 강제실시제도의 적용 사례를 중심으로" 특허청 2009

8 이소영, "보험의약품 가격 관리" 3 (3): 2008

9 이준구, "미시경제학" 법문사 1998

10 김연미, "권리의 본질에 대한 세 가지 시험적 고찰" 법학연구소 26 (26): 21-47, 2009

11 Nussbaum, M. C., "Women, Culture, and Development : A Study of Human Capabilities" Oxford University Press 2001

12 Sen, A. K., "Resources, Values and Development" Harvard University Press 1984

13 Miller, D., "Recent Theories of Social Justice" 21 (21): 1991

14 Nagel, T., "Rawls on Justice" 82 (82): 1973

15 Stolk, P., "Rare Essentials? : Drugs for Rare Diseases on the Essential Medicines List" WHO Expert Committee on the Selection and Use of Essential Medicines 2005

16 DiMasi, J. A., "R&D Costs and Returns by Therapeutic Category" 38 : 2004

17 Gostin, L. O., "Public Health Law : Power, Duty, Restraint" Univeristy of California Press 2008

18 Correa, C. M., "Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing" South Centre 2011

19 Gostin, L. O., "Meeting Basic Survival Needs of the World’s Least Healthy People : Toward a Framework Convention on Global Health" 96 (96): 2008

20 Munos, B., "Lessons from 60 Years of Pharmaceutical Innovation" 8 : 2009

21 Dworkin, R., "Law’s Empire" Fontana Press 1986

22 Merges, R. P., "Intellectual Property in the New Technological Age" Aspen Publishers 2007

23 Sen, A. K., "Human Rights and Capabilities" 6 (6): 2005

24 Nussbaum, M. C., "Human Functioning and Social Justice : In Defense of Aristotelian Essentialism" 20 (20): 1992

25 오윤희, "HIV 감염자의 삶에 관한 연구" 여성건강간호학회 11 (11): 110-119, 2005

26 Bowen, A., "Global Challenges in the Development and Delivery of Paediatric Antiretrovirals" 13 (13): 2008

27 Crocker, D. A., "Functioning and Capability : The Foundations of Sen’s and Nussbaum’s Development Ethic, Part 2, In Women, Culture, and Development : A Study of Human Capabilities" Oxford Universty Press 1995

28 Crocker, D. A., "Functioning and Capabilities : The Foundations of Sen’s and Nussbaum’s Development Ethic" 20 (20): 1992

29 Ruger, J. P., "Ethics and Governance of Global Health Inequalities" 60 (60): 2006

30 Roberts, M. J., "Ethical Analysis in Public Health" 359 (359): 2002

31 Sen, A. K., "Capability and Well-Being, In The Quality of Life" Clarendon Press 1993

32 Nussbaum, M. C., "Capabilities as Fundamental Entitlements : Sen and Social Justice" 9 (9): 2003

33 Nussbaum, M. C., "Capabilities and Human Rights" 66 (66): 1997

34 Rawls, J., "A Theory of Justice" Harvard University Press 1972

35 Bentham, J., "A Fragment on Government" Clarendon Press 1981

36 Ram-Tiktin, E., "A Decent Minimum for Everyone as a Sufficiency of Basic Human Functional Capabilities" 11 (11): 2011

37 Laing, R., "25 Years of the WHO Essential Medicines Lists: Progress and Challenges" 361 (361): 2003