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Patent Protection of Pharmaceutical Products within the Frame of Public Health

Tarasenko, Valeriya (2009)
Department of Law
Abstract
This Thesis examines the legal mechanisms of patent protection under the TRIPS with regards to the pharmaceutical products. It also reviews the law requirements of public health needs and available legal instruments to overcome the protection given by a patent to provide an access to medications. This research does not analyze the other related issues which are applicable to the chosen topic. The TRIPS Agreement was introduced by the WTO, for member countries, in order to establish a universal system of the protection of intellectual property rights and to encourage the R&amp&semicD in the most significant industries, in particular, a pharmaceutical sector of economy. Introduction of TRIPS standards strengthened patent protection of... (More)
This Thesis examines the legal mechanisms of patent protection under the TRIPS with regards to the pharmaceutical products. It also reviews the law requirements of public health needs and available legal instruments to overcome the protection given by a patent to provide an access to medications. This research does not analyze the other related issues which are applicable to the chosen topic. The TRIPS Agreement was introduced by the WTO, for member countries, in order to establish a universal system of the protection of intellectual property rights and to encourage the R&amp&semicD in the most significant industries, in particular, a pharmaceutical sector of economy. Introduction of TRIPS standards strengthened patent protection of medical products and processes, but stimulated tension between the patent rights holder and public interests. On the one hand, patent protection under TRIPS became a strong instrument for world-known pharmaceutical companies. On the other hand, TRIPS triggered the public health issues: to access essential medicines by poor population and to fight HIV/AIDS crisis in African countries. In order to provide balance between commercial interests of pharmaceutical industry and public health needs, TRIPS reconfirmed the application of two legal instruments: compulsory licensing and parallel importing. Both of these instruments are allowed under TRIPS for member countries and provide for the utilization of patented medicines without consent of patent holders in certain conditions. Compulsory licensing and parallel importation are two flexibilities for developed and developing countries to have access to cheap and available generic versions of patented drugs to satisfy the public health needs. However, this provision had not greatly affected the supply of drugs to the Third World, but restricted countries like India and Brazil from exporting cheap generic medicines. In an effort to address this situation and to ensure the availability of drugs for developing counties the Doha Declaration was adopted by the WTO. The WTO Doha Declaration was forwarded to establish a legal basis for the applicability of compulsory licensing. However, the Doha Declaration failed to address Art. 31(f) TRIPS which limited the application of a compulsory licensing predominantly for the supply in domestic market and prohibited the importation of cheaper pharmaceuticals produced under compulsory licenses to other countries to deal with national emergencies. This gap was removed by the Decision of the General Council of the WTO which allowed an exporting Member to waiver to Art. 31 (f) of TRIPS to supply an eligible importing Member products issued under a compulsory licensing in case of health crisis and other public health needs. This Decision has become a permanent amendment to TRIPS. However, currently, the majority of Members (especially developed countries) are failed to ratify this Decision. Nowadays, the WHO plays a key role in the enforcement of the obligations under the Decision by developing strategies, and monitoring them. (Less)
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author
Tarasenko, Valeriya
supervisor
organization
year
type
H2 - Master's Degree (Two Years)
subject
keywords
International Human Rights Law and Intellectual Property Rights
language
English
id
1555336
date added to LUP
2010-03-08 15:23:24
date last changed
2010-03-08 15:23:24
@misc{1555336,
  abstract     = {This Thesis examines the legal mechanisms of patent protection under the TRIPS with regards to the pharmaceutical products. It also reviews the law requirements of public health needs and available legal instruments to overcome the protection given by a patent to provide an access to medications. This research does not analyze the other related issues which are applicable to the chosen topic. The TRIPS Agreement was introduced by the WTO, for member countries, in order to establish a universal system of the protection of intellectual property rights and to encourage the R&amp&semicD in the most significant industries, in particular, a pharmaceutical sector of economy. Introduction of TRIPS standards strengthened patent protection of medical products and processes, but stimulated tension between the patent rights holder and public interests. On the one hand, patent protection under TRIPS became a strong instrument for world-known pharmaceutical companies. On the other hand, TRIPS triggered the public health issues: to access essential medicines by poor population and to fight HIV/AIDS crisis in African countries. In order to provide balance between commercial interests of pharmaceutical industry and public health needs, TRIPS reconfirmed the application of two legal instruments: compulsory licensing and parallel importing. Both of these instruments are allowed under TRIPS for member countries and provide for the utilization of patented medicines without consent of patent holders in certain conditions. Compulsory licensing and parallel importation are two flexibilities for developed and developing countries to have access to cheap and available generic versions of patented drugs to satisfy the public health needs. However, this provision had not greatly affected the supply of drugs to the Third World, but restricted countries like India and Brazil from exporting cheap generic medicines. In an effort to address this situation and to ensure the availability of drugs for developing counties the Doha Declaration was adopted by the WTO. The WTO Doha Declaration was forwarded to establish a legal basis for the applicability of compulsory licensing. However, the Doha Declaration failed to address Art. 31(f) TRIPS which limited the application of a compulsory licensing predominantly for the supply in domestic market and prohibited the importation of cheaper pharmaceuticals produced under compulsory licenses to other countries to deal with national emergencies. This gap was removed by the Decision of the General Council of the WTO which allowed an exporting Member to waiver to Art. 31 (f) of TRIPS to supply an eligible importing Member products issued under a compulsory licensing in case of health crisis and other public health needs. This Decision has become a permanent amendment to TRIPS. However, currently, the majority of Members (especially developed countries) are failed to ratify this Decision. Nowadays, the WHO plays a key role in the enforcement of the obligations under the Decision by developing strategies, and monitoring them.},
  author       = {Tarasenko, Valeriya},
  keyword      = {International Human Rights Law and Intellectual Property Rights},
  language     = {eng},
  note         = {Student Paper},
  title        = {Patent Protection of Pharmaceutical Products within the Frame of Public Health},
  year         = {2009},
}