BALANCING PATENTS AND ACCESS TO MEDICINE
| Author | Elizabeth Siew Kuan NG LLB (London), LLM (Cambridge); Barrister-at-Law (Middle Temple, London), Advocate & Solicitor (Singapore); Associate Professor, Faculty of Law, National University of Singapore. |
| Published date | 01 December 2009 |
| Date | 01 December 2009 |
The controversy arising from the HIV/AIDS pandemic and global health crisis has triggered and spurred the call for better access to medicines and medical treatments. Some developing countries have expressed concerns that patents on medicines and treatments may impede access to affordable healthcare. This article builds on the works of eminent scholars in relation to patents and public health. It seeks to highlight the need to persevere with the quest to achieve an appropriate trade-off between protection of ideas to encourage innovation and investment thereof and ensuring that protection itself does not stifle further innovation and access to medicine for public health. This is particularly so in the development of new technologies and medicines which entail considerable investment in research and development that is fraught with significant risks and uncertainties. It will also provide some observations on selected avenues of reform.
1 The controversy arising from the HIV/AIDS pandemic and global health crisis has triggered and spurred the call for better access to medicines and medical treatments. Major concerns have been expressed by some developing countries that the implementation of strong intellectual property regimes may “affect their efforts to improve public health”1 and that patents on medicines and treatments “may be hampering governments’ attempts to deal with urgent policy issues” by “unacceptably imped[ing] access to affordable healthcare, thus frustrating public health programs”.2 This has also be reiterated by the Coalition for Intellectual Property Rights (“CIPR”) which regards the “cost of pharmaceutical products as an important concern in developing countries” since most poor people in these countries “pay for their own drugs and state provision is normally selective and resource-constrained. This is generally not the case in the developed world where costs are mainly met by the state or through insurance schemes”.3
2 Since one of the key objectives of the patent system is to reward innovation by allowing innovators to charge “higher prices” for protected products, it has been argued that a fully functional patent system would result in an inverse relationship between the cost of such products and affordability of access.4 This has led some to suggest that the global intellectual property system may be facing a crisis of public legitimacy as questions are being raised, for example, on how patents
may be blocking the access of ordinary people to medicines5 and their “right to health”.6
3 This can be contrasted with the views expressed by those in the pharmaceutical industry that it is “more strongly dependent on the patent system than most other industrial sectors to recoup its past R&D [research and development] costs, to generate profits, and to fund R&D for future products”.7 Indeed, the CIPR noted that:8
[S]urveys have shown that the pharmaceutical companies, more than any other sector, think patent protection to be very important in maintaining their R&D expenditures and technological innovation. The industry understandably takes a close interest in the global application of IPRs [intellectual property rights], and generally resists the contention that they constitute a major barrier to access or a deterrent to development in developing countries.
4 Whilst it may be easy to give in to the temptation for enhanced protection as a means of “promoting the public good”, some critics have cautioned against shifting “control and ownership over technology from the public to the private, serving to commodify vital technological information that they argue should remain in the public domain”.9 Its impact, particularly in relation to access to medicine in developing countries, needs to be carefully assessed, since if prices are raised this will “fall especially hard upon poor people, particularly in the absence of
widespread provision for public health as exists in most developed countries”.10
5 This paper will build on the works of eminent scholars in relation to patents and public health issues. It will seek to highlight the need to persevere with the quest to achieve an appropriate trade-off between protection of ideas to encourage innovation and investment thereof and ensuring that protection itself does not stifle further innovation and access to medicine for public health. This is particularly so in the development of new technologies and medicines which entail considerable investment in research and development that is fraught with significant risks and uncertainties. It will also provide some observations on selected avenues of reform.
6 In 2001 alone, HIV/AIDS, malaria and tuberculosis have together claimed 5.7 million lives and “caused debilitating illness in many millions more”.11 By 2020, AIDS will have “caused more deaths than any other disease epidemic in history”.12 With the tremendous progress that has been made in scientific and technological development, “these diseases should have been brought under control. Yet, in developing countries today they continue to kill at an alarming rate. And at times — as in recent outbreaks of influenza — they also kill at an alarming rate in the industrialized countries”.13 The table below reveals further information on the health crisis:
| HIV/AIDS, tuberculosis and malaria — the basic facts, 2000 14 | |||
| Disease | Deaths per year | New cases per year | Percentage in developing countries |
| HIV/AIDS | 3 million | 5.3 million | 92% |
| Tuberculosis | 1.9 million | 8.8 million | 84% |
| Malaria | More than 1 million | 300 million | Nearly 100% |
7 The need to alleviate suffering arising from the global health crisis, particularly those in developing and least-developed countries that are facing a critical need for urgent access to medicines to treat these and other diseases,15 merits serious attention. This has prompted some to argue that:16
[H]ealthcare considerations must be the main objective in determining what IP regime should apply to healthcare products. IP rights are not conferred to deliver profits to industry except so that these can be used to deliver better healthcare in the long term. Such rights must therefore be closely monitored to ensure that they do actually promote healthcare objectives and, above all, are not responsible for preventing poor people in developing countries from obtaining healthcare.
8 In this context, the CIPR has also succinctly noted the dilemma facing healthcare in developing countries as follows:17
How can the resources necessary to develop new drugs and vaccines for diseases that predominantly affect developing, rather than developed, countries be generated when the ability to pay for them is so limited? Even when there is a developed country market from which these resources can be recovered through high prices, how can the affordability of these drugs in developing countries be secured?
How can conflicts between the two objectives — covering R&D costs and minimizing consumer costs — be resolved?”
9 Apart from the IP issues, access to affordable medicine also involves a complex web of intricate “non-patent related” obstacles such as poverty; corruption; civil strife, economic and societal problems, poor healthcare infrastructure, diagnostics and medical workforce; poor supply, distribution and delivery systems particularly to rural areas; substandard medicines; financial and administrative mismanagements, taxes and custom duties, complexity of medical therapy, etc. These have been succinctly discussed elsewhere18 and are beyond the scope of this article.
10 Article 8 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provides that:
Members may … adopt measures necessary to protect public health … and to promote the public interest in sectors of vital importance to their socio-economic and technological development.
11 This has been affirmed by the World Trade Organization (“WTO”) Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”):20
We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.
12 The ultimate goal in this discussion is to ensure that medicines can fulfil their central role in improving their access for some and health for all. In this regard, it is important to note that adequate safeguard to ensure the safety of drug supply is imperative. Similarly, the recommendations proceed solely on the basis of improving access to and affordability of medicines. It does not purport to analyse other “non-patent related” factors contributing to problems relating to medical access and affordability which have been mentioned above.
13 Numerous options proposed include the call to incorporate a general exception into the draft Substantive Patent Law Treaty (“SPLT”) that deals with the protection of public health and environment.21 Other policy avenues include compulsory licensing, parallel imports, limiting patentability, price control and differential pricing, patent pools, centralised drug purchase facility,22 competition law, charity (drug donation), provision of aid, voluntary licensing and appealing for greater corporate responsibility to society. In conjunction with the other published studies on the laws and other related issues,23 some observations on a few of the selected proposed options will be discussed.
14 It has been noted that the vast majority of...
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