의약품 접근권과 특허권의 충돌 문제에서 나타나는 건강권의 비용과 법적 고찰
A Clash of Rights and Costs: An Examination of Restrictions to the Realization of the Right to Health from the Perspective of International Human Rights Law
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초록
오늘날 건강은 하나의 존엄한 가치로 인식되고 있으나 그것이 사법적인 차원에서 건강권으로 보장되고 있는지에 대해서는 연구가 부족하다. 이 연구는 건강권과 특허권의 충돌에서 나타나는 국제인권법적 문제를 비용의 관점에서 고찰하였다. 백혈병 환자에게 필수적인 항암제인 글리벡(Gleeve)이나 HIV/AIDS 환자에게 항레트로바이러스제(antiretroviral drugs)를 대체하는 치료제인 푸제온(Fuzeon)의 경우 신약의 특허권을 보호하기 위해 환자가 높은 가격을 지불하여야 했다. 다시 말해, 신약에 특허를 가지고 있는 다국적 제약회사들은 대부분 본사가 선진국에 있기 때문에 R&D 기반이 취약한 개발도상국이나 저개발국의 환자들은 가격 장벽으로 인해 필수 의약품에 대한 접근성이 낮았다. 이러한 문제를 타결하기 위하여 세계무역기구의 지적재산에 관한 협정(Trade-Related Aspects of Intellectual Property Rights; TRIPS)에 강제실시권 등을 두어 위기상황에 직면한 국가들이 국민의 건강 보호하기 위해 특허를 제한할 수 있도록 규정하였다. 그러나 이것은 예외주의적 관점에서 제한적으로만 적용되어서 건강권을 두텁게 보호하는데 한계가 있었다. 게다가 특허권을 보호해주어야 신약의 R&D를 활성화하여 인류 전반에 더 큰 혜택을 가져다 줄 수 있다는 인권 제한적인 주장을 옹호하는 입장은 과도한 제약회사화(pharmaceuticals) 경향을 부추기고 있다. 이에 대해 남아프리카공화국의 HIV/AIDS 문제에 대해 전지구적 비영리단체들이 주도한 이른바 치료접근성캠페인(Treatment Action Campaign; TAC)은 많은 교훈을 준다. TAC는 풀뿌리 단체들을 조직화하여 아프리카에서 건강권의 사법심사가능성을 보장하였고 특허권보다 건강권이 더 본질적인 가치로 인정받을 수 있도록 국제인권법의 지평을 확장하였다. 오늘날 여러 국가들이 의약품 접근권에 대한 사법심사가능성을 용인하여 TRIPs가 국제법의 체계 내에서 인권을 보장하는 방향으로 더 개선될 여지를 보여주고 있다. 그러므로 저개발국을 포함하여 인류가 보편적으로 건강권을 향유할 수 있기 위해서 건강권의 보호법익과 상충되지 않는 방향으로 의약품 개발에 대한 인센티브를 보장하면서 저개발국의 국가보건의료시스템을 확충할 필요가 있다.
Abstract
Although health is recognized as a dignified value today, research on whether it is guaranteed as a right to health on the juridical level remains insufficient. The present study examines problems related to international human rights law that arise in the clash of the right to health and patent rights from the perspective of costs. In the case of Gleevec, an anti-cancer drug indispensable to leukemia patients, or Fuzeon, a therapeutic agent that replaces antiretroviral drugs for HIV/AIDS patients, patients have had to pay high prices to protect patent rights to new drugs. However, because most of the multinational pharmaceutical companies that possess patents to new drugs are based in advanced countries, patients in developing countries or low-development countries, which have weak research and development (R&D) foundations, have had low accessibility to indispensable pharmaceutical drugs due to price barriers. To resolve such problems, the right to compulsory licensing has been included in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) so that nations faced with crises can limit patents in order to protect their citizens’ health. However, this has been applied only in a restricted way, from the perspective of exceptionalism, and therefore has been limited in strongly protecting the right to health. Restrictive of human rights, the argument that the protection of patent rights activates the R & D of new drugs, thus bringing even greater benefits to the entire human race, has aggravated a tendency toward excessive pharmaceuticalization. Regarding this, the Treatment Action Campaign (TAC), led by non-governmental organizations (NGOs) worldwide in sub-Saharan Africa, has taught many lesions. Organizing grassroots groups, the TAC has guaranteed the justiciability of the right to health in Africa and expanded the horizons of international human rights law so that the right to health can be recognized as a value more fundamental than that of patent rights.
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