A Review of Recent Developments at the Multilateral Level with Respect to Intellectual Property and the Pharmaceutical Industry

2009 ◽  
Vol 6 (4) ◽  
pp. 323-331
Author(s):  
Maximiliano Santa Cruz ◽  
Pedro Roffe
Keyword(s):  
Public Health ◽  
Intellectual Property ◽  
Patent Protection ◽  
Pharmaceutical Products ◽  
Global Strategy ◽  
World Intellectual Property Organization ◽  
World Health ◽  
Compulsory Licensing ◽  
The World ◽  
Recent Developments

The adoption in 1994 of the World Trade Organization's Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) meant the incorporation of intellectual property as an important component of the international trading system. It meant also an end to the exclusive treatment of intellectual property issues in the World Intellectual Property Organization (WIPO). TRIPS meant also, the end of the accepted practice of excluding pharmaceutical products and or processes from patent protection, a practice that was particularly important for developing countries. This note reviews recent developments at the multilateral level after the adoption of TRIPS, namely the adoption of the Declaration on the TRIPS Agreement and Public Health in 2001 and the subsequent decision to amend the TRIPS for the effective use of the compulsory licensing system; the adoption of the Development Agenda by the WIPO General Assembly in 2007 and related recent developments in WIPO; and finally the adoption of the Global strategy and plan of action on public health, innovation and intellectual property by the 61st World Health Assembly in 2008. One common feature of these developments is the attempt to bring some balance to the international intellectual property system that has been characterised by an upward tendency to strengthen private rights and their enforcement to the detriment of public interest considerations.

scholarly journals Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options

2009 ◽  
Vol 37 (2) ◽  
pp. 247-263 ◽  
Author(s):  
Jerome H. Reichman
Keyword(s):  
Intellectual Property ◽  
Patent Protection ◽  
Uruguay Round ◽  
World Intellectual Property Organization ◽  
International Convention ◽  
Compulsory Licensing ◽  
Multilateral Trade ◽  
The World ◽  
The One ◽  
Patented Inventions

Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

Intellectual Property and Development at WHO and WIPO

2008 ◽  
Vol 34 (2-3) ◽  
pp. 257-277 ◽  
Author(s):  
Jack Lerner
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Research And Development ◽  
Technical Assistance ◽  
Global Strategy ◽  
World Intellectual Property Organization ◽  
World Health ◽  
Governmental Organization ◽  
Development Agenda ◽  
The World

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (“WIPO”) recently approved a historic “Development Agenda” – a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (“WHO”) has launched its own development agenda of sorts – an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) that is tasked with preparing “a global strategy and plan of action” aimed at “securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

Compulsory Licensing under India’s New Model Bilateral Investment Treaty

2017 ◽  
Vol 9 (3) ◽  
pp. 139-154 ◽  
Author(s):  
Katarzyna Kaszubska
Keyword(s):  
Intellectual Property ◽  
Patent Protection ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Public Access ◽  
Compulsory Licensing ◽  
Bilateral Investment Treaty ◽  
Compulsory Licence ◽  
Investment Treaty ◽  
The World

The traditional lack of patent protection for pharmaceutical products allowed India’s generic sector to expand and become ‘the pharmacy of the world’ supplying affordable medicines to both developed and developing countries. With the entry into force of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 2005, the mechanism of compulsory licensing was incorporated as a flexibility to ensure that the protection of intellectual property (IP) rights does not undermine the public access to affordable medicine. Following the issuance of the first compulsory licence by the India’s patent office to Natco for Nexavar in 2012, various domestic companies requested a licence for production of generic copies of patented drugs. The recourses and litigation over the compulsory licensing provisions under India’s Patent Act 1970 indicate the importance of the institution of compulsory licensing for ‘Indian pharma’ and its desire to rely on it in the future. This article attempts to assess the legal consequences of the new India’s Model Bilateral Investment Treaty providing investment tribunals with the jurisdiction to examine the compliance of domestic decision to grant compulsory licence with the World Trade Organization (WTO) TRIPS Agreement. JEL: K33, P45, F21, O34, O53, O19

scholarly journals The Role of Intellectual Property Rights on Access to Medicines in the WHO African Region: 25 Years after the TRIPS Agreement

2020 ◽  
Author(s):  
Marion Motari ◽  
Jean-Baptiste Nikiema ◽  
Ossy Muganga Julius Kasilo ◽  
Stanislav Kniazkov ◽  
Andre Loua ◽  
...  
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Pharmaceutical Products ◽  
World Health ◽  
Situational Analysis ◽  
African Region ◽  
African Countries ◽  
Compulsory Licensing

Abstract Background It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. Methods: We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries. Results Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. 39 countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions. Discussion Countries of the WHO African Region operate within a multi-layered –intellectual property regulatory landscape globally and at regional level which is characterized by inconsistencies and misalignment which limit the extent to which countries can implement TRIPS flexibilities. Conclusions Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

scholarly journals Alcohol marketing versus public health: David and Goliath?

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Mary Madden ◽  
Jim McCambridge
Keyword(s):  
Public Health ◽  
Global Health ◽  
World Health Organisation ◽  
Global Strategy ◽  
World Health ◽  
Health Improvement ◽  
Alcohol Policies ◽  
Alcohol Marketing ◽  
The World ◽  
David And Goliath

Abstract Background Alcohol harms are rising globally, and alcohol policies, where they exist, are weak or under-developed. Limited progress has been made since the formulation of the World Health Organisation (WHO) Global Strategy in 2010. WHO is seeking to accelerate progress in implementing international efforts to reduce the harmful use of alcohol. The threat to global health posed by tobacco is well understood by policy communities and populations globally; by contrast alcohol is much less so, despite available evidence. The competition for epistemic authority Global alcohol corporations have sought to become trusted sources of advice for policy makers and consumers, while continuing to grow their markets. Evidence-informed public health messaging faces formidable competition from transnational corporations as the worlds of corporate and political communications, social and mainstream media become increasingly linked, presenting new opportunities for corporate actors to shape global health governance. Alcohol messaging that uses means of persuasion tied to industry agendas does not tell a clear story about commercial determinants of health, and does not contribute to health improvement. On the contrary, the basic tenets of an evidence-informed population-based approach are denied and the policy measures supported by high quality evidence are being opposed, because they are inimical to commercial interests. A David and Goliath metaphor for this state of affairs, which seems to fit at first glance, may unwittingly reinforce the status quo. Conclusion Public opinion on alcohol and policy issues varies across time and place and can be influenced by dedicated public health interventions. Alcohol marketing dominates people’s thinking about alcohol because we currently allow this to happen. Greater ambition is needed in developing countermarketing and other interventions to promote evidence-informed ideas with the public. Alcohol policies need to be further developed, and implemented more widely, in order to arrest the growing burden of alcohol harms across the world.

scholarly journals Traditional medicinal knowledge, recognition and regulation

2021 ◽  
Author(s):  
Nicole Aylwin
Keyword(s):  
Intellectual Property ◽  
Political Institutions ◽  
Biological Diversity ◽  
World Intellectual Property Organization ◽  
World Health ◽  
Convention On Biological Diversity ◽  
The Social ◽  
The World ◽  
Health Organization ◽  
Key Questions

As a number of global legal and political institutions grapple with ways to recognize and integrate TMK into their institutional frameworks, how traditional practices are 'recognized', and what work 'recognition's being asked to do become key questions. Three international frameworks that play a key role in recognizing TMK in the international arena are the Convention on Biological Diversity, the World Intellectual Property Organization and the World Health Organization. By examining the way in which these three bodies have recognized and integrated TMK into their respective regimes, while and drawing on the scholarship of anthropologists, critical legal scholars, intellectual property experts and legal and policy literature, I will argue that the recognition of TMK in the international legal and political arena has led to the creation of complex legal and political spaces where recognizing traditional medicinal knowledge has fragmented it, siphoning off the social, cultural and spiritual aspects of it that remain incompatible with the current neoliberal paradigms. Simultaneously, recognition and integration have been used to co-opt traditional knowledge in order to extend governance regimes that integrate TMK and its holders without challenging the basic, outdated and highly unequal and unethical power relations on discourses of recognition are based.

scholarly journals The Role of Intellectual Property Rights and Access to Medical Products in the WHO African Region: 25 Years After the Trips Agreement

2020 ◽  
Author(s):  
Marion Motari ◽  
Jean-Baptiste Nikiema ◽  
Ossy Muganga Julius Kasilo ◽  
Stanislav Kniazkov ◽  
Andre Loua ◽  
...  
Keyword(s):  
Public Health ◽  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Health Needs ◽  
World Health ◽  
African Region ◽  
Compulsory Licensing ◽  
Medical Products

Abstract BackgroundIt is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medical products, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by Ebola and COVID-19 pandemics. The World Health Organization’s mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on innovation and access to medical products in the African Region. Methods:We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to show trends and to identify the main diseases covered and how they correspond with top causes of morbidity and mortality. We also review legislation to assess how TRIPS flexibilities are implemented in countries.ResultsPatenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. 39 countries have applied TRIPS flexibilities, with the most common being compulsory licensing and LDC transition provisions. A third of the compulsory licensing application were not executed following voluntary licensing agreements. No country had legislated on research and regulatory review exceptions and patent term extension.DiscussionThere’s modest alignment between innovation and health challenges. Compulsory licensing applications may have served to encourage voluntary licensing arrangements. Countries have enacted laws that allow them to deploy TRIPS flexibilities for public health needs. ConclusionsThere’s need to develop and strengthen health innovation systems in the region. Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

scholarly journals The Role of Intellectual Property Rights on Access to Medicines in the WHO African Region: 25 Years After the TRIPS Agreement

2020 ◽  
Author(s):  
Marion Motari ◽  
Jean-Baptiste Nikiema ◽  
Ossy Muganga Julius Kasilo ◽  
Stanislav Kniazkov ◽  
Andre Loua ◽  
...  
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Pharmaceutical Products ◽  
World Health ◽  
Situational Analysis ◽  
African Region ◽  
Compulsory Licensing

Abstract Background It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. Methods We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries.Results Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. 39 countries have applied TRIPS flexibilities, with the most common being compulsory licensing and LDC transition provisions. Discussion Countries of the WHO African Region operate within a multi-layered IP regulatory landscape globally and at regional level which is characterized by inconsistencies and misalignment which limit the extent to which countries can implement TRIPS flexibilities. Conclusions Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

scholarly journals The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marion Motari ◽  
Jean-Baptiste Nikiema ◽  
Ossy M. J. Kasilo ◽  
Stanislav Kniazkov ◽  
Andre Loua ◽  
...  
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Pharmaceutical Products ◽  
World Health ◽  
Situational Analysis ◽  
African Region ◽  
Compulsory Licensing

Abstract Background It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medicines, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by the Ebola and COVID-19 pandemics. The World Health Organization’s (WHO) mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS flexibilities in collaboration with stakeholders. This study analyses the role of intellectual property on access to medicines in the African Region. Methods We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to provide a situational analysis of patenting activity and trends. We also review legislation to assess how TRIPS flexibilities are implemented in countries. Results Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively. Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. Majority countries have legislation allowing for compulsory licensing and parallel importation of medicines, while the least legislated flexibilities were explicit exemption of pharmaceutical products from patentable subject matter, new or second use of patented pharmaceutical products, imposition of limits to patent term extension and test data protection. Thirty-nine countries have applied TRIPS flexibilities, with the most common being compulsory licensing and least developed country transition provisions. Conclusions Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

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