| Summary: | 碩士 === 國立中正大學 === 財經法律學研究所 === 102 === Indian pharmaceutical industry is the fourth largest in the world in terms of volume. However, Indian Patent Controller issued the first compulsory license to Natco Pharma Ltd. on 9 March 2012, and it reflected a potential problem that patients' right to access to medicines is not completely protected in India.
There are many ways to enhance the right to access to medicines, including pharmaceutical patents, parallel imports, production of generic drugs and compulsory licensing. Compulsory license is the most efficient way to improve the right to access to medicines, but it usually results in low revenue, letting pantentee lack of funds to research on new drugs and give up invention. Secondly, developing countries usually choose to reject compulsory application to maintain good relationships with developed countries for the sake of attracting investment and technology transfer. Thirdly, the Council for TRIPs adopted the instruction of paragraph 6 of the Doha Declaration and made a resolution waiving obligation under Article 31(f) of the WTO members with insufficient or no manufacturing capacities in pharmaceutical sector, permitting them to import medicines made under compulsory license from other members. However, many members which have excellent pharmaceutical technology are not willing to apply compulsory license to produce patented medicines and export to other members with insufficient or no manufacturing capacities in pharmaceutical sector because selling medicines made under compulsory licensing only makes a meager profit. Patients' right to access to medicines is still not completely protected in the end.
In order to solve defects caused by compulsory licensing, it is necessary to reach worldwide consensus on building a healthy world. Developed countries would be willing to invest, apply for patents and produce patented medicines under compulsory license for developing countries with WTO, NGOs, governments and various industries’ cooperation and formulating relevant regulations about compulsory license in domestic law. Besides, pharmaceutical industry would continue developing new medicines and developed countries would stop trade sanction against developing countries which approved compulsory license if an impartial third party-DSB analysis conditions about compulsory license of TRIPs Agreement openly and make a decision on compulsory license publicly.Following these steps, patients' right to access to medicines would be completely protected and they could increase chances of taking new medicines to cure diseases. Therefore, the goal of building a healthy world would be achieved more easily.
Our patent law was amended comprehensively in 2011, and it increased "other circumstances of extreme urgency" as a reason of compulsory license. However, observing many countries' reasons of compulsory license, we can find that most of them include public interests and failure to worke in domestic territory. Therefore, it is necessary to include non-working or insufficient-working as thr cause of compulsory license by conferring our 1994 Patent Law. By doing so, the system of compulsory license would be more completed, and our patent law would be more in compliance with Article 2 of TRIPs Agreement which requires members to comply with Articles 5 of the Paris Convention.
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