Drug regulatory status database
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Patents have become one of the most debated issues on access to essential medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant role. Patents and intellectual property rights may directly affect the production and procurement of HIV/AIDS medicines and supplies in the developing countries.
The TRIPS agreement has introduced a multilateral framework for the protection of intellectual property rights, but there still exists flexibility within the provisions of the Agreement to permit countries to determine how intellectual property rules should be applied, consistent with their national public interest and priorities. This concept of flexibilities available within the TRIPS Agreement was reinforced with the adoption of the Ministerial Declaration on the TRIPS Agreement and Public Health at the Doha WTO Ministerial Conference, in November 2001 (the Doha Declaration).
Drug registration, patents and intellectual property rights are complicated subjects but knowledge of these is essential as they directly affect the procurement of HIV/AIDS medicines and supplies. Getting accurate information on issues such as registration of ARVs, patents for manufacturing processes and products in general can be challenging as the information is not always readily available. A helpful introduction on the subject can be found in "Drug patents under the spotlight: sharing practical knowledge about pharmaceutical patents" (MSF, 2003) as well as in "Battling HIV/AIDS: A Decision Maker's Guide ot the Procurement of Medicines and Related Supplies (World Bank)". More information can also be obtained from WHO Commission of Intellectual Property rights, Innovation and Public Health (CIPIH).
Patents
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a. Remuneration guidelines for non-voluntary use of a patent on medical technologies
pdf, 650kb - b. Drug patents under the spotlight: Sharing practical knowledge about pharmaceutical patents (MSF, 2003) (English, Spanish, Portuguese)
- c. Determining the patent status of essential medicines in developing countries
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d. Access to Medicines. Intellectual Property Protection: impact on public health, WHO Drug Information, Volume 19, N.3, 2005
pdf, 33kb - e. Integrating Intellectual Property Rights and Development Policy, Report of the UK Commission on Intellectual Property Rights (CIPR, 2002). (English, French, Spanish, Chinese, Arabic and Russian)
- f. Integrating Patent Health concern into patent legislation in developing countries (English)
- Intégration de considérations de santé publique dans la législation en matière de brevets des pays en développement
- Integrando la Salud Pública en la Legislación sobre Patentes de los Países en Desarrollo
Regulatory status
- a. The Global Fund's new quality assurance policy
- b. Recommendation on fixed-dose combinations (US Department of Health and Human Services)
TRIPS
- a. The use of flexibilities in TRIPS by developing countries: Can they promote access to medicine? (WHO)
- b. Access to Medicines (papers from studies commissioned by DFID, 2004)
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c. Globalization, TRIPS and access to pharmaceuticals (No.3, March 2001)
pdf, 180kb -
d. TRIPS and changes in pharmaceutical patent regime in India
pdf, 287kb -
e. Globalization and Access to Drugs: Perspectives on the WTO TRIPS Agreement
pdf, 289kb -
f. Implications of the Doha Declaration on the TRIPS Agreement and Public Health
pdf, 159kb -
g. Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health
pdf, 540kb