Risking Health: Failing to Balance Access to Essential Medicines and the Protection of Intellectual Property in Developing Countries Facing a Continuing HIV/AIDS Disaster

2009 ◽  
Author(s):  
Heinz Klug
2008 ◽  
Vol 3 (3) ◽  
pp. 229-256 ◽  
Author(s):  
JILLIAN CLARE COHEN-KOHLER ◽  
LISA FORMAN ◽  
NATHANIEL LIPKUS

AbstractDespite myriad programs aimed at increasing access to essential medicines in the developing world, the global drug gap persists. This paper focuses on the major legal and political constraints preventing implementation of coordinated global policy solutions – particularly, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and bilateral and regional free trade agreements. We argue that several policy and research routes should be taken to mitigate the restrictive impact of TRIPS and TRIPS-plus rules, including greater use of TRIPS flexibilities, advancement of human rights, and an ethical framework for essential medicines distribution, and a broader campaign that debates the legitimacy of TRIPS and TRIPS-plus standards themselves.


Author(s):  
Jakkrit Kuanpoth

The important relationship between pharmaceutical patents and problem of inaccessibility of medicines by poor nations is exemplified more clearly by the experiences of developing countries in Asia. Thailand is one of these developing countries which has the most experience of the negative impact of stronger patent protection. The paper provides a general view of the problem of the inaccessibility of lifesaving medicines in Thailand. It also discusses the attempts of the Thai Government to use an available legal measure (ie compulsory licensing) to control the abuse of pharmaceutical patent rights, and provides a theoretical and practical analysis of various legal issues relating to the use of the non-voluntary licensing scheme to improve access to essential medicines.


2009 ◽  
Vol 37 (2) ◽  
pp. 222-239 ◽  
Author(s):  
Kristina M. Lybecker ◽  
Elisabeth Fowler

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.


2010 ◽  
Vol 4 (1) ◽  
pp. 41-53
Author(s):  
Kanikaram Satyanarayana ◽  
Sadhana Srivastava

The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable, other better formulations and second line ARVs for adults and more drugs and formulations for paediatric groups, that are still to be widely available in India and other developing countries. To examine whether strong intellectual property (IP) protection systems are to be considered important barriers for the limited or lack of access to ARVs, we studied the patent profile of the ARVs of the originator companies within and outside India. We could record 93 patents in the United States Patent & Trademark Office (USPTO). The originator companies have been also aggressively filing and enforcing patents in India. There have been a few efforts by companies like Gilead and GSK to grant licenses to generic manufacturers in developing countries, ostensibly to promote access to ARVs through lower (two-tier) pricing. These steps are considered as too little and too late. There is an urgent need to look for alternative strategies to promote access to ARVs both linked to and independent of IPRs. Patent pooling as a viable strategy mooted by the UNITAID should be seriously explored to promote access to ARVs. India is ideally suited for trying out the patent pool strategy as most of the global requirement of affordable ARV drugs for HIV/AIDS treatment is sourced from Indian generic companies.


2021 ◽  
Author(s):  
Matthew Rimmer

This paper explores intellectual property and access to essential medicines in the context of the coronavirus COVID-19 public health crisis. It considers policy solutions to counteract vaccine nationalism and profiteering by pharmaceutical companies and vaccine developers. This paper considers the campaign for the development of a People's Vaccine led by the People’s Vaccine Alliance, UNAIDS, Oxfam and Public Citizen. The WHO has established the ACT Accelerator in order to boost research, development, and deployment of COVID-19 technologies. However, the operation of COVAX thus far has been falling short of its original ambitions. The Medicines Patent Pool has expanded its jurisdiction to include the sharing of intellectual property related to COVID-19. Meanwhile, Costa Rica has proposed a COVID-19 Technology Access Pool – an idea for a new institutional structure which has been taken up by the WHO. In the context of the coronavirus public health crisis, there has also been discussion of the use of compulsory licensing and crown use to counteract profiteering and anti-competitive behavior. There has been a push by Universities Allied for Essential Medicines (UAEM) and others for the public licensing of COVID-19 technologies developed with government funding. The Open COVID Pledge has been taken by a number of intellectual property owners. In response to the assertion of proprietary rights in respect of COVID-19 technologies, the open movement has championed the development of Open Science models of science. India and South Africa have put forward a waiver proposal in the TRIPS Council to enable countries to take action in respect of COVID-19 without fear of retribution under trade laws. While the United States has been willing to support a TRIPS Waiver for vaccines, there remain a number of opponents to a TRIPS Waiver – including the European Union, Germany, Japan, and Switzerland. This paper makes the case that international intellectual property law should accommodate a People's Vaccine.


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