|Year : 2017 | Volume
| Issue : 1 | Page : 30-34
The Doha declaration in action: An examination of patent law flexibilities in the South African acquired immunodeficiency syndrome epidemic
Sophie Huddart1, Madlen Nash2, Aya Abdelrasoul3, Inna Bacearnicova4, Kyla Bourque5, Lipi Mishra6
1 Department of Epidemiology and Biostatistics; McGill International TB Center, McGill University, Montreal, Canada
2 McGill International TB Center; Department of Microbiology and Immunology, McGill University, Montreal, Canada
3 Faculty of Science, McGill University, Montreal, Canada
4 Department of Epidemiology and Biostatistics, McGill University, Montreal, Canada
5 Department of Biology, McGill University, Montreal, Canada
6 Faculty of Law, McGill University, Montreal, Canada
|Date of Web Publication||20-Jan-2017|
Department of Epidemiology and Biostatistics, McGill University, 1020 Pine Ave West, Montreal, QC H3A 1A2
Patent law flexibilities outlined in the Trade-related Aspects of Intellectual Property Rights agreement make it possible for low-income nations to provide affordable essential medicine during health crises. During the rise of the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in South Africa, multinational pharmaceutical companies challenged the implementation of these flexibilities. In response to this lawsuit, the World Trade Organization enacted the Doha Declaration, an affirmation of the right of low-income nations to import and produce generic versions of patented essential medicines. This case study assesses the Doha Declaration's impact on access to HIV/AIDS treatment in South Africa by examining drug pricing, antiretroviral treatment coverage and drug licensing fees. The declaration ultimately contributed to the decrease in HIV/AIDS treatment costs and the subsequent increase in availability and affordability of life-saving drug regimens.
Keywords: Drug accessibility, global health, human immunodeficiency virus/acquired immunodeficiency syndrome, patent law, South Africa
|How to cite this article:|
Huddart S, Nash M, Abdelrasoul A, Bacearnicova I, Bourque K, Mishra L. The Doha declaration in action: An examination of patent law flexibilities in the South African acquired immunodeficiency syndrome epidemic. J Health Spec 2017;5:30-4
|How to cite this URL:|
Huddart S, Nash M, Abdelrasoul A, Bacearnicova I, Bourque K, Mishra L. The Doha declaration in action: An examination of patent law flexibilities in the South African acquired immunodeficiency syndrome epidemic. J Health Spec [serial online] 2017 [cited 2019 Jul 20];5:30-4. Available from: http://www.thejhs.org/text.asp?2017/5/1/30/198802
| Introduction|| |
Much of public health focusses on technical advancement: Better drugs, improved diagnostics and the development of new vaccines. These technologies undoubtedly play an indispensable role in ensuring health for all, but medicines, vaccines and assays cannot result in a positive impact unless the most vulnerable populations gain access to such treatments.
This case study focusses on an often overlooked factor of getting drugs through the 'last mile:' Patent law. In order for companies to risk investing in new technologies, they must be assured that they will make a profit from their investment, yet the resultant pricing may hinder the accessibility of such products to the most vulnerable populations. Here, we analyse how life-saving pharmaceuticals were made accessible to a population in desperate need through patent law flexibilities. Specifically, we will examine the increase in accessibility of antiretroviral (ARV) drugs in South Africa. We will link this improved accessibility to the patent flexibilities laid out in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and subsequent Doha Declaration.
We begin with a description of the relevant legal documents outlining patent flexibility and the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) crisis in South Africa. The intervention of interest in this case study, the Doha Declaration, is then described followed by a quantitative and qualitative assessment of its impact.
| Background|| |
Trade-Related Aspects of Intellectual Property Rights and its flexibilities
Broadly speaking, intellectual property rights seek to protect inventors by giving them exclusive control over intangible 'creations of the mind'. Intellectual property issues have played a significant role on the international stage vis-à-vis the TRIPS agreement. The agreement entered into force for members of the World Trade Organization (WTO) in 1995. This agreement outlines the minimum standards for intellectual property rights protection for the WTO members.
The intent of the TRIPS agreement is to increase global incentives in research and development. The TRIPS agreement compels all member countries to abide by a minimum level of intellectual property protection in all fields, with respect to both the processes and the products. Non-compliance is subject to the WTOs dispute settlement mechanism, which may lead to a variety of trade sanctions.
The critical feature of the TRIPS agreement with respect to this topic is its provision of a degree of flexibility for certain member countries. These flexibilities are designed to 'allow developing countries and least developed countries (LDCs) to adopt measures necessary to protect public health and nutrition, and to promote public interest in sectors of vital importance to their socioeconomic and technological development'. Thus, in the development of their national intellectual property laws, developing countries and LDCs are empowered to focus on promoting the public interest without being impeded by the stringency of the TRIPS obligations.
The TRIPS flexibilities that are of particular interest for our purposes include:
- Transition periods: LDCs were not obliged to implement the provisions of the TRIPS agreement on pharmaceutical products until January 1st 2016. LDCs were eligible for extensions of this transition period if they had not built a viable technological base by that deadline
- Compulsory licensing: The government can authorise a third party to produce a patented invention without the consent of the patent holder. This flexibility requires that the holder of the compulsory license produce strictly for the domestic market
- Parallel importation: Parallel importation grants governments the right to import drugs, without the authorisation of the patent holder, from countries where the cost is lower
- The Bolar provision: The Bolar provision allows competitors (often, generic manufacturers) to prepare production and regulatory procedures before patents expire.
Cumulatively, these TRIPS flexibilities attempt to address the unique needs of low resource settings by offsetting the harshness of the TRIPS obligations themselves.
One way to apply these flexibilities was for a developing country to demonstrate that it was in the midst of a public health emergency. By the late 1990s, no one could deny that the HIV/AIDS epidemic in South Africa had reached catastrophic proportions.
Human immunodeficiency virus, acquired immunodeficiency syndrome in South Africa
As the world came to realise the dangers posed by HIV, South Africa was the epicentre of the epidemic with an estimated 5 million people infected by the year 2000. This amounted to about one in nine South Africans.
While ARV treatment was becoming readily available in industrialised countries throughout the 1990s, South Africa, where the burden of disease was highest, still had limited access to these medicines.
Since 1994, the country's healthcare system had been functionally two-tiered. Close to 20% of the population, predominately white, were covered by private healthcare, whereas the remaining population relied on the public system. The existing public healthcare was characterised by 'irrational use of resources, poor working conditions and inadequate infrastructure'. Many South Africans simply could not afford to buy these essential drugs from the private system. Three-drug ARV therapy combinations cost 10,000–15,000 USD per person per year, whereas 11% of South Africans were living on <1 USD a day and 34% were living on <2 USD a day.
The first antiretroviral treatment (ART) approved for HIV infection, zidovudine, became available in 1987. However, since zidovudine cost about 1000 USD per month, most individuals in South Africa could not afford the regimen., As a result, in 1996, the South African government began a healthcare reform, the aim of which was to increase the access and affordability of essential medicines. Part of this reform was the implementation of the National Drug Policy, which included a set of objectives to improve the public health system including reducing drug prices, developing a local pharmaceutical industry for the production of drugs and increasing the number of prescriptions of generic drugs in both private and public sectors.,
The medicine act amendment
In 1999, South Africa took legislative action to amend the South African Medicines and Related Substances Control Act to add Section 15C, known as the Amendment Act. This act created the legal framework to relax domestic patent laws and enable access to affordable medicines, thereby allowing the South African government to use the generic substitutions of off-patent drugs and to permit parallel importation of patented drugs. While the right to take this action had been outlined in the TRIPS agreement, it had not yet been exercised on a national scale. In response, fifty pharmaceutical companies sought to prevent the enactment of the Amendment Act and subsequently took the South African government to court, claiming that the amendment was unconstitutional and violated the TRIPS agreement, which South Africa had signed. The European Commission and the US government were lobbied by the Pharmaceutical Researchers and Manufacturers of America to apply pressure on the South African government to withdraw the Amendment Act. The US Trade Representatives (USTR) placed South Africa on a special 301 'watch list', and in March 1998, the USTR withheld trading of South African products and threatened to apply further trade sanctions.
The lawsuit brought the fight against HIV in South Africa to the forefront of global media and exposed the measures that the pharmaceutical companies, supported by the US government, were prepared to take to protect their intellectual property. The activism of several HIV advocacy groups played an essential role in pressuring the US government to modify its policies with regard to intellectual property rights. The South African Treatment Action Campaign (TAC) called for international protests around the world against 'drug profiteering'. HIV activists generated negative publicity targeting presidential candidate Al Gore regarding his role as co-chairman of the US/South African Bi-national Commission. Nongovernmental organisations (NGOs) including Consumer Project International, Health Protect International and Doctors without Borders (Médecins sans Frontières, MSF) united to organise a conference in opposition to the WTO ministerial session. Known as the Amsterdam Conference, the aim was to interpret the provisions of the TRIPS agreement with public health in mind and to better understand how the WTO agreements affect resource-poor countries. The conference was attended by 350 participants representing 50 countries and their success overshadowed the Seattle WTO conference, which was bombarded with demonstrations. The coordinated efforts of the NGOs and activists caused the US government to distance itself from the litigation. By late 2000, the pharmaceutical companies could no longer rely on their governments for support, and in April 2001, the lawsuit was dropped.,
The Doha Declaration
While the lawsuit was ultimately dropped, the question remained: would developing countries actually be allowed to use the flexibilities outlined in the TRIPS agreement or would each attempt be met with lengthy and expensive legal action?
WTO members met in Doha, Qatar, to resolve this issue and in November 2001, the WTO adopted the Doha Declaration on the TRIPS agreement and public health. The declaration sought to reaffirm the right of governments to employ TRIPS flexibilities to protect public health. This document clarified that each WTO member had the freedom to determine what constitutes a national emergency, assess the need for and grant compulsory licensing and utilise parallel importation. The Doha Declaration marked a pivotal change in global policy with regard to Trade-related Intellectual Property law by unequivocally stating that developing countries could and should take advantage of the flexibilities outlined in the TRIPS agreement. The ultimate goal of this document was to enable greater access to much needed essential medicines such as ART.,
Unfortunately, while the Doha Declaration upheld the right to use patent law flexibilities to improve access to life-saving ARV drugs, the newly elected President of South Africa opposed the use of ARVs entirely.
At the beginning of 2000, President Mbeki sent a letter to his international counterparts expressing his skepticism that HIV was truly the root cause of AIDS. He argued that other factors, such as socioeconomic status, may be the origin of AIDS. In addition, President Mbeki, together with the Minister of Health, Dr. Manto Tshabalala-Msimang, claimed zidovudine was poisonous and publicly advocated for the use of alternative treatments and nutritional interventions to treat AIDS. Despite the extensively documented clinical benefit of zidovudine, the government refused to implement the ART treatment. In 2001, the government even declined Boehringer Ingelheim (BI) offers to donate the necessary medicines for a treatment programme for HIV-infected pregnant women, claiming that the drug's efficacy and side effects had not been sufficiently studied by the South African government. The government's mistrust towards Western medicine was due in part to the historically present racial segregation and oppression of the black population during the colonial regime. As a result, some black South Africans feared further marginalisation and harm through various methods such as the distribution of poisonous medications. It is estimated that by withholding available ART, the government contributed to approximately 30,000 AIDS-related deaths and the infection of 35,000 babies with HIV by denying ART treatment to the South African population. In the 2000s, the Treatment Action Campaign played a pivotal role in stopping the anti-ART campaign. The TAC successfully promoted the implementation of ART therapy for the prevention of mother-to-child transmission by suing the government over its inaction. Based on these advocacy efforts, the issue of ART access gained momentum at the local and international levels. In 2003, the Mbeki government responded to national and international pressure by approving a programme of national access to ART and prevention of mother-to-child transmission programmes.
This protracted opposition to ART occurred simultaneously with the efforts of NGOs and generic pharmaceutical companies who were working tirelessly to increase the availability and use of ARV drugs. While the effect of the political opposition to ART is not the central question of interest for this case study, it undoubtedly hampered the uptake and use of ARVs. It is likely that without President Mbeki's opposition, the effects of the Doha Declaration may have been even more dramatic.
The goal of this case study was to evaluate whether the Doha Declaration was successful in reducing the price of and increasing access to ARV drugs. To evaluate its effectiveness, we will examine:
- Legal proceedings that cited the Doha Declaration
- Drug prices pre- and post-Doha Declaration
- ARV coverage rates pre- and post-Doha Declaration
- Licensing fees pre- and post-Doha Declaration
In 2003, the TAC filed a complaint with the South African Competition Commission (a government body designed to ensure equality and efficiency in the South African economy) against two major pharmaceutical companies, GlaxoSmithKline (GSK) and BI. The TAC alleged that the companies were overpricing essential ARV drugs and blocking access to generic production. The suit was ultimately settled. The settlement documents directly cited the Doha Declaration as evidence that GSK and BI were legally bound to allow generic licensing.
The Doha Declaration's support for TRIPS flexibilities also spurred the South African pharmaceutical company, Aspen Pharmacare, to begin requesting voluntary licenses to manufacture generic ARV drugs. In 2007, it held eleven licenses to produce generic AIDS drugs and remains one of the largest generic producers in South Africa.
Without the Doha Declaration, pharmaceutical companies would have little to no incentive to grant generic licenses without large royalty fees. Forcing companies to give compulsory licenses encourages companies such as Aspen to produce generic drugs. Furthermore, competition between multiple generic manufacturers can contribute significantly to reducing drug prices.
Drug pricing, ARV coverage and licensing fees are indirect measures of the Doha Declaration and it is important to remember that these measures are likely to be affected by multiple factors in addition to patent law including political will, advocacy, improvements to manufacturing and foreign aid. However, the Doha Declaration is fundamental to many of these measures. Without the clarity provided in the Doha Declaration, generic licenses would be unlikely to be granted without a lawsuit, drug prices would not fall until patents fully expired and licensing fees would remain high. Thus, while we cannot fully attribute these changes to the Doha Declaration, we remain confident that this document is a major driver of the following observed phenomenon.
[Table 1] shows the prices of several ARV drugs sold in South Africa immediately before the TAC complaint against GSK and BI and the reduced prices for the same drugs using the parallel importation clause in the TRIPS agreement to import these medicines from generic drug manufacturers outside of South Africa. The right to exercise parallel importation for essential generic drugs was not exercised before the Doha Declaration.
|Table 1: A comparison of antiretroviral drug prices in 2003 in South Africa and prices available through parallel importation of generics|
Click here to view
While parallel importation rights affirmed in the Doha Declaration dramatically reduced the price of ART, cost is not the only barrier to treatment. Patent flexibilities can result in lower prices, but unless there is government support and adequate health infrastructure, even low-cost drugs can fail to reach the patient.
After 2001, ARV coverage began to rise rapidly [grey line, 8 [Figure 1] began to increase throughout Sub-Saharan Africa., A multitude of factors contributed this upward trend including advocacy, education, international aid and most importantly, the advent of generic drugs.
|Figure 1: Grey line shows the percentage of the South African human immunodeficiency virus-positive population estimated to be using antiretroviral treatment between 1990 and 2013. The red and blue lines show the number of human immunodeficiency virus infections and deaths, respectively.|
Click here to view
While ART use has increased in South Africa, coverage remains far from universal. The ultimate goal of the Doha Declaration is to provide access to life-saving medicines for the world's most marginalised populations. Despite the progress in ARV coverage rates, failing to reach even 50% of the affected population in need indicates that, along with weaknesses in the general health system, the licensing systems supported by the Doha Declaration are not being utilised to their full extent.
Immediately after the Doha Declaration, the proportion of purchased ARVs that were generic began to increase throughout Sub-Saharan Africa.
Before the Doha Declaration and the settlement set by the Competition Commission, Aspen Pharmacare had only been able to license generics from GSK and BI for a 30% and 15% royalty fee, respectively. In the settlement between the TAC, GSK and BI, the companies agreed to license drugs with a 5% maximum royalty fee.
| Conclusion|| |
In sum, the Doha Declaration has made a meaningful impact on several aspects of ART availability and accessibility in South Africa. Government bodies ordering pharmaceutical companies to grant generic licenses directly cited the declaration. Pharmaceutical companies also cited it as a motivator to diversify into generic drug production. The downstream effects of the declaration also include reduced drug pricing, increased generic licensing and increased coverage. While the gain in accessibility and use of ART drugs in South Africa is not solely caused by the Doha Declaration's support of the TRIPS flexibilities, it is likely that without it, many of the public health advancements would not have occurred as quickly. As such, the authors believe that the Doha Declaration was successful in its aim to promote access to essential medicines.
There are, however, limitations to its effect. The TRIPS flexibilities apply only to essential medicines in developing countries who have declared health emergencies. This narrow definition means that second-line therapies are often barred from the same patent law flexibilities that first-line ART drugs benefit from. In fact, second-line ART drug pricing has remained largely stagnant over the last decade. There is, however, a benefit to the high prices of these second-line therapies. The profit margins for these newer drugs are not threatened by TRIPS maintain the incentive for pharmaceutical companies to continue researching new drugs.
In closing, the Doha Declaration affirmed that pharmaceutical companies should not profit at the cost of the world's most vulnerable populations. Born out of a South African lawsuit, it produced real and hopefully long-lasting impacts on the availability and use of ART in the AIDS epidemic.
The patent flexibilities outlined in the TRIPS agreement are under threat whenever a new international trade agreement is brokered. In October 2015, the Trans-Pacific Partnership (TPP) was signed. According to the US Manager and Legal Policy Adviser for the MSF Access Campaign, Judit Rius Sanjuan, the TPP will 'go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies'. Unfortunately, the full impact of the Doha Declaration may be revealed when its flexibilities are reversed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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