1.1 The Problem of Access to Affordable Medicines in Developing Countries
Payment for pharmaceutical products has long been identified as one of the potential causes of poverty in developing countries.Footnote 1 Moreover, there is a cyclical relationship between poverty and poor health.Footnote 2 In relation to developing countries, the health challenges confronting them is exacerbated by the high incidence of both communicable and non-communicable diseases in these countries. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), as at 2019, it is estimated that about 7.5 million people live with human immunodeficiency virus (HIV) in South AfricaFootnote 3 and around 1.5 million people live with the same disease in Kenya.Footnote 4 Furthermore, in 2020, there were over 1.3 million new cases of cancer in India, over 100,000 new cases in South Africa, and over 42,000 new cases in Kenya.Footnote 5 These figures indicate that, in the years to come, poor patients in these and other developing countries will continue to require access to medicines at affordable prices in order to sustain a healthy and productive lifestyle.Footnote 6
It is therefore imperative for the governments of these three developing countries (i.e., India, Kenya, and South Africa), and indeed for the governments of other developing countries facing similar health challenges, to take the necessary steps to facilitate access to medicines at affordable prices for their citizens. However, one crucial impediment that can hinder the ability of governments to make medicines affordable in their countries is the current global system for the protection of intellectual property rights as embodied in the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) which was signed in Marrakesh, Morocco, on 15 April 1994.Footnote 7 By making it mandatory for all WTO members (except the least developed countries) to grant patents on pharmaceutical products, the TRIPS Agreement has encroached on the policy space hitherto enjoyed by countries with regard to the design of their national patent laws.Footnote 8
Patent rights on pharmaceutical products can prevent the sale of patented drugs at competitive prices in the market and empowers the patent owner to sell its patented drug at exorbitant prices. The pricing of patented drugs beyond the reach of poor patients in developing countries can further impoverish poor patients in these countries and this invariably perpetuates the deadly cycle of poverty and ill health.Footnote 9 It should, however, be noted that, despite the strictures imposed by the current global regime on intellectual property rights, developing countries can still secure access to affordable medicines for their citizens by taking steps to preserve their patent policy space.
1.2 Access to Medicines and Patent Policy Space
A very apt description of the term ‘policy space’ that approximates to a definition is provided by the United Nations Conference on Trade and Development (UNCTAD) in the Sao Paulo Consensus document of 2004.Footnote 10 In that document, UNCTAD describes ‘policy space’ as ‘the space for national economic policy, i.e. the scope for domestic policies, especially in the area of trade, investment and industrial development’.Footnote 11 Policy space is the freedom that a country has to design its national policies, including intellectual property policy, in a manner that suits its needs and level of economic development.
According to Chang, developing countries experienced ‘exceptional economic growth during the 1950s to the 1970s’.Footnote 12 During this period, developing countries enjoyed a wider policy space, unlike now.Footnote 13 This demonstrates the crucial importance of policy space to economic growth and development. However, between the 1980s and 2000s, there was a shrinkage of the policy space available for developing countries.Footnote 14 Several factors have been identified as being responsible for this shrinkage of policy space, including the conditionalities attached to the loans obtained from international financial institutions such as the World Bank and the IMF, the aid policies of developed countries, and the establishment of the WTO in 1995.Footnote 15
Even after the establishment of the WTO, developed countries have continued to utilize bilateral and regional free trade agreements to further constrain the ability of developing countries to utilize the policy space available to them within the WTO framework.Footnote 16 The globalization of neoliberal policies and the attendant shrinkage of policy space in recent decades has, however, not led to increased economic growth in a number of developing countries.Footnote 17 It is noteworthy that at the Summit of the Heads of State and Government of the Group of 77 (G77) held in Bolivia in June 2014, the developing countries adopted a declaration which, among other things, called for ‘the international trading system to respect and reinforce the policy space of developing countries for the promotion and growth of [their] industrial development and for the design and implementation of [their] industrial strategies’.Footnote 18
One particular area where there has been a significant shrinkage of policy space is the area of intellectual property (especially patent policy). Prior to the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), countries (both developed and developing) enjoyed wide policy space with regard to intellectual property rights. Specifically, patent laws have always reflected the stage of technological and economic development of each country.Footnote 19 Importantly, the level of patent protection usually depended on whether the country was an innovator or an imitator.Footnote 20 It was during this period, prior to the emergence of the TRIPS Agreement, that countries like India were able to deny patent protection for pharmaceutical products, and this was one of the crucial factors that assisted the growth of the Indian generic drugs industry.Footnote 21 In addition, countries such as Japan and South Korea also made productive use of the wide policy space available in the area of intellectual property law during this period to permit copying and assimilation of foreign patented technology, and this contributed to their growth and development.Footnote 22
All these developments were possible because the Paris Convention for the Protection of Industrial Property of 1883 (Paris Convention),Footnote 23 which preceded the TRIPS Agreement, preserved the policy space of state parties in the field of patent law. Under the Paris Convention, countries were permitted to exclude any invention from patent protection, there was no fixed duration for patent rights, and (in comparison to the TRIPS Agreement) there were fewer restrictions on the grant of compulsory licences.
However, the TRIPS Agreement has significantly reduced the policy space that countries have in the area of intellectual property law.Footnote 24 Members of the WTO (except least-developed countries) are now required to design their intellectual property laws in accordance with the minimum standards stipulated in the TRIPS Agreement. For instance, prior to the TRIPS Agreement, more than 40 countries did not provide patent protection for pharmaceuticals and many countries provided only process patents but not product patents for pharmaceuticals.Footnote 25 This is however not possible anymore because WTO members (except least-developed countries) are forbidden from denying the grant of patent protection for pharmaceutical products by virtue of Article 27 of the TRIPS Agreement. Thus, the freedom hitherto enjoyed by countries to design their intellectual property laws in a manner that corresponds with their level of economic and technological development has been significantly reduced. There has been a shrinkage of intellectual property policy space, including patent policy space.Footnote 26
Though there has been shrinkage of policy space in the general area of intellectual property law, the focus of this book is on the shrinkage of patent policy space. Specifically, the focus is on the effects of the shrinkage of patent policy space on access to medicines in developing countries. It needs to be stressed, however, that, even though intellectual property policy space has been reduced, the TRIPS Agreement does not completely eliminate policy space in the area of intellectual property law.Footnote 27 Countries are still free to utilize the limited intellectual property policy space that still exists within the framework of the TRIPS Agreement.
In this regard, it is pertinent to note that the TRIPS Agreement contains certain flexibilities that countries can use to facilitate access to affordable medicines and address the health challenges in their countries. Such flexibilities include the freedom to exclude new forms of known drugs from patent protection, the freedom to adopt the principle of international exhaustion of patent rights to facilitate the parallel importation of drugs (Article 6), regulatory review exemption for producers of generic drugs, research exception, compulsory licences (Article 31), and delinking the grant of marketing approval for generic drugs from the patent status of branded drugs.
However, several developing countries have failed to utilize the available policy space (or flexibilities) in the TRIPS Agreement due to political and economic pressure from certain developed countries.Footnote 28 In addition, some developed countries have continued to take steps to ratchet up the current global standards on intellectual property rights through the use of bilateral and regional free trade agreements.Footnote 29 Developing countries need to muster the political will to preserve and utilize the existing policy space available to them under the TRIPS Agreement and steadfastly resist pressures to implement intellectual property standards that are incongruent with their current state of economic and technological development. In this regard, it is necessary to highlight some of the reasons why developing countries need to preserve their patent policy space.
Firstly, the current shrinkage of patent policy space affects the ability of developing countries to discharge their human rights obligations, especially their right to health obligations.Footnote 30 The right to health is recognized in several international instruments, including Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR).Footnote 31 One of the essential components of the right to health is access to essential medicines.Footnote 32 In General Comment No. 14 on Article 12, the UN Committee on Economic, Social, and Cultural Rights (CESCR) explained that state parties are obliged to respect, protect, and fulfil the right to health.Footnote 33 The CESCR further noted that one of the core obligations of state parties in relation to the right to health, from which no derogation is permissible,Footnote 34 is the provision of essential drugs.Footnote 35
States who are parties to the ICESCR, including developing countries, therefore have an obligation to provide access to essential medicines for their citizens. But, as Carlos Correa rightly points out, the current global regime on intellectual property ‘has increasingly limited the room left to countries to exercise their sovereign rights and discharge their obligations in public health, including those subsumed under the right to health’.Footnote 36 Patent rights have an impact on the enjoyment of the right to health, especially in developing countries where the monopoly rights conferred by patent law on producers of pharmaceutical products enable them to inflate the price of drugsFootnote 37 and prevent competition from producers of cheaper generic drugs. Thus, in order to fulfil their right to health obligations in relation to the provision of access to essential medicines, it is imperative for developing countries to preserve their patent policy space.Footnote 38 In this book, it will be contended that developing countries can preserve their patent policy space by incorporating a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws.
Secondly, the current global patent regime primarily serves as an incentive for the production of drugs for diseases affecting patients in rich countries.Footnote 39 Thus, developing countries need to think outside the ‘patent box’ in order to address the problems of neglected diseases affecting poor patients in their countries. The current global patent regime not only impedes access to essential medicines in developing countries, it also fails to incentivize the production of drugs for the treatment of diseases primarily affecting poor patients in developing countries. It could be argued that there would be no new drugs in the absence of patent rights. But this argument, as Sunder rightly points out, ‘denies that patents are but one among many alternatives for stimulating and rewarding innovation, including prizes and subsidies. Furthermore, drug companies often benefit from enormous public investment, including basic research conducted in universities and research supported by non-profit foundations and governments.’Footnote 40
Thirdly, encouraging the production of drugs for diseases primarily affecting patients in developing countries requires a lot more than the implementation of patent laws. Developing countries need to channel their limited funds into areas such as the training of local scientists and the funding of scientific research in their educational institutions. As Correa notes, ‘in countries lacking capital and required scientific and technological infrastructure, patents operate as a levy collection mechanism and not as a stimulus of local R&D’.Footnote 41 In fact, high levels of patent protection can impede technological development in countries with lesser technical capacity because, as Sunder points out, ‘patents may impede their ability to gain technical knowledge by copying more advanced industries abroad’.Footnote 42 The importance of investing in scientific research and technological infrastructure has been further highlighted by the current COVID-19 pandemic. Crucially, in the absence of domestic manufacturing capacity to produce the needed medicines and vaccines, most of the flexibilities available under the TRIPS Agreement are of no use to developing countries during pandemics such as COVID-19.
1.3 Historical Background
1.3.1 Patent Policy Space Prior to the TRIPS Agreement
The globalization of patent law is inextricably and remotely linked with the growth of cross-border trade in the nineteenth century and the growing desire of inventors at that time to obtain patent protection for their inventions outside their own countries.Footnote 43 However, the immediate reasons for the globalization of patent law can be traced to the 1873 World Exposition in Vienna. American and German inventors refused to participate in the exposition due to fears that their inventions would not be adequately protected.Footnote 44 In order to allay the fears of the American and German inventors and encourage them to participate in the exposition, the Austrian government adopted a temporary law that provided protection for foreign inventors for the duration of the exposition.Footnote 45
The Austrian government subsequently convened a conference in the same year with the objective of establishing a system where states would recognize and protect the rights of foreign inventors.Footnote 46 The venue for subsequent conferences on the establishment of an international patent system was Paris, where three conferences were held in 1878, 1880, and 1883. At the 1883 conference, the Paris Convention for the Protection of Industrial Property (covering patents, trademarks, and industrial designs) was approved and signed.Footnote 47 The Paris Convention is currently administered by the World Intellectual Property Organization (WIPO).Footnote 48 The Paris Convention has subsequently been revised in 1900 (Brussels), 1911 (Washington), 1925 (The Hague), 1934 (London), 1958 (Lisbon), and 1967 (Stockholm).Footnote 49
The Paris Convention contains several provisions aimed at ensuring that inventors can obtain patent protection in multiple countries. For instance, the principle of national treatment is contained in Article 2(1) of the Paris Convention.Footnote 50 The principle of national treatment requires that all member states are to ensure that both citizens and foreigners enjoy the same level of patent protection and legal remedy against any infringement of their rights.Footnote 51 Thus, under the Paris Convention, a country is not permitted to grant patent protection for pharmaceutical products belonging to its citizens while refusing to grant the same protection to pharmaceutical products belonging to foreigners.
It needs to be stressed, however, that the Paris Convention does not really attempt to harmonize the substantive patent laws of the various member countries.Footnote 52 For instance, Article 4bis of the Paris Convention specifically provides that patents applied for in the various member states by nationals of the member states shall be independent of patents obtained for the same invention in other countries, whether or not those other countries are members of the Paris Convention.Footnote 53 In other words, even though an inventor obtains a patent on the same invention from two different countries, both patents may not necessarily last for the same duration. More importantly, this means that, under the Paris Convention, member states are free to specify their own grounds for nullifying a patent.Footnote 54
The Paris Convention also contains provisions on compulsory licences. Article 5A(2)Footnote 55 of the Paris Convention provides that member states ‘shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work’. Article 5A(2) of the Paris Convention thus permits member states to grant a compulsory licence in order to prevent a patentee from abusing his exclusive rights by, for instance, failing to work the patented invention in the country where the patent was granted. This provision therefore permits member states to incorporate ‘local working requirements’ into their patent law and deems the failure to work a patented invention as an abuse of a patent right.Footnote 56 However, the grant of a compulsory licence is circumscribed by the provisions of Article 5A(4) of the Paris Convention which provides that a compulsory licence ‘may not be applied for on the ground of failure to work or insufficient working before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last …’. In addition, pursuant to the same Article 5A(4), a compulsory licence can be refused if the patentee justifies his inaction (i.e., failure to work or insufficient working) by legitimate reasons.
The Paris Convention does not attempt to supplant the substantive patent rules of member states, neither does it impose any minimum standards of patent protection on the member states. It is noteworthy that two of the original signatories to the Paris Convention, Switzerland and the Netherlands, did not have patent laws at the time they signed the Convention.Footnote 57 Furthermore, the Paris Convention permits member states to utilize compulsory licences to facilitate the transfer of technologyFootnote 58 to their territories by ensuring that failure to work a patented invention constitutes a valid ground for encroaching on the exclusive rights granted to patentees. Thus, even though the Paris Convention created an easier path for inventors seeking to obtain patent protection for their inventions in multiple jurisdictions, it equally preserves the policy space of member states to design their patent laws to suit their domestic needs.
Compared to the current TRIPS Agreement, the Paris Convention is an extremely flexible agreement that imposes minor constraints on member states. There are at least six key flexibilities in the Paris Convention: one, freedom to determine the substantive criteria for granting patents; two, freedom to decide whether to exclude certain subject matter from patent protection; three, freedom to determine the duration of patent rights; four, freedom to grant compulsory licences for failure to work a patented invention within a country; five, freedom to determine what constitutes failure to work a patented invention; and six, freedom to determine whether to grant compulsory licences in the public interest.Footnote 59
1.3.2 Attempts to Reclaim Patent Policy Space at the Multilateral Level
The TRIPS Agreement mandates all the members of the WTO to provide minimum levels of protection for certain intellectual property rights, such as copyright and related rights, trademarks, patents, geographical indications, industrial designs, layout designs of integrated circuits, and undisclosed information. The provisions of the TRIPS Agreement that deal with patents are located in Articles 27–34. According to Article 27.1 of the TRIPS Agreement:
… patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application … [and] patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
In other words, all forms of inventions are covered by this provision, including pharmaceutical products, once all the requirements for patentability are satisfied.Footnote 60 Thus, apart from the permissible exceptions contained in Articles 27.2 and 27.3,Footnote 61 the scope of patentable subject matter under the TRIPS Agreement is quite broad.
Article 28 of the TRIPS Agreement confers on the patentee the exclusive rights to prevent third parties from making, using, offering for sale, selling, or importing the patented product without its consent. If the patent is on a process (as opposed to a product), the patentee has the exclusive right to prevent third parties from using the process without its consent, and from using, offering for sale, selling, or importing the product obtained directly by that process. Article 33 provides that the duration of a patent shall be at least 20 years from the filing date.
Even though the TRIPS Agreement has as one of its principles in Article 8.1 that ‘members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition’, it soon became obvious to some developing countries (particularly Brazil and South Africa) that this may not necessarily be the case in practice. For instance, flexibilities that were not prohibited by the TRIPS Agreement and which could be used by developing countries to address public health challenges such as the local working requirements contained in Brazil’s Industrial Property Law of 1996Footnote 62 and the provision on parallel importation of drugs introduced into South Africa’s Medicines and Related Substances Control Act in 1997Footnote 63 were opposed by the United States and the pharmaceutical industry.Footnote 64
The opposition faced by Brazil and South Africa prompted other developing countries in 2001 to demand for a discussion on the relationship between intellectual property rights and access to medicines at the WTO Council for TRIPS (TRIPS Council). The developing countries wanted to clarify and confirm the flexibilities within the TRIPS Agreement that they could use to facilitate access to medicines in their countries. The first special discussion on intellectual property and access to medicines at the TRIPS Council was held during their meeting of 18–22 June 2001.Footnote 65
During this special discussion, the African Group (a group composed of all African WTO members) proposed that there should be a special declaration on the TRIPS Agreement and access to medicines at the next WTO Ministerial Conference which was scheduled for November 2001.Footnote 66 They proposed that the special declaration should affirm that ‘nothing in the TRIPS Agreement should prevent Members from taking measures to protect public health’.Footnote 67 The African Group also presented its own interpretation of certain key provisions in the TRIPS Agreement. The African Group adopted the position that ‘each provision of the TRIPS Agreement should be interpreted in the light of the objectives and principles set forth in Articles 7 and 8’ of the TRIPS Agreement.Footnote 68
The least-developed countries (LDCs) also presented their own concerns about the TRIPS Agreement. Essentially, the LDCs were concerned about the implications of Article 31(f) of the TRIPS Agreement,Footnote 69 which states that compulsory licences can only be used ‘predominantly for the supply of the domestic market of the Member’. This means that countries with insufficient or no local manufacturing capacity would not be able to use compulsory licences to import patented products in large quantities from other countries. Conversely, countries could not grant compulsory licences in order to export large quantities of patented products to other countries. Compulsory licences could only be granted for the ‘predominant’ purpose of supplying the domestic market of the country where the compulsory licence was granted. This foreclosed the option of granting compulsory licences on patented drugs for many LDCs that could not afford to locally manufacture patented drugs.
The second special discussion on intellectual property and access to medicines at the TRIPS Council was held during their meeting of 19–20 September 2001.Footnote 70 At this meeting, the African Group and other developing countries (including Brazil and India) presented the text of a draft WTO Ministerial Declaration on the TRIPS Agreement and public health.Footnote 71 A list of the fourteen demands made by the developing countries and contained in their Draft Ministerial Declaration is reproduced in Table 1.1.
It should be noted that some of these demands had already been addressed within the provisions of the TRIPS Agreement.Footnote 72 In other words, to satisfy some of the demands, it would not be necessary to amend the TRIPS Agreement.Footnote 73 However, some of the other demands do not concern issues specifically addressed by the TRIPS AgreementFootnote 74 and, in order to satisfy at least one of them, that is, the fifth demand, an amendment to the TRIPS Agreement would be required.Footnote 75
The ‘Doha Declaration on the TRIPS Agreement and Public Health’ (Doha Declaration)Footnote 76 was adopted at the WTO Ministerial Conference on 14 November 2001 and addressed only some of the demands of developing countries. The seven paragraphs contained in the Doha Declaration are reproduced in Table 1.2.
| 1 | We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria, and other epidemics. |
| 2 | We stress the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address these problems. |
| 3 | We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices. |
| 4 | 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. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. |
| 5 | Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: a. In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. b. Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. c. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria, and other epidemics can represent a national emergency or other circumstances of extreme urgency. d. The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4. |
| 6 | We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. |
| 7 | We reaffirm the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement. |
When compared with the original fourteen demands made by developing countries in their proposed Draft Ministerial Declaration, the Doha Declaration can only really be regarded as a modest achievement, at least from the perspective of developing countries. Crucially, out of the fourteen demands made by developing countries, only the first to fifth and thirteenth demands were addressed by the Doha Declaration. Also, even with regard to the thirteenth demand, only the aspect of that demand that involved least-developed countries was addressed by the Doha Declaration. The remaining eight demands made by developing countries were not addressed by the Doha Declaration. What follows is an analysis of how the Doha Declaration responded to those demands that were addressed in the Declaration. In this regard, the focus will be on the first to fifth demands contained in the proposed Draft Ministerial Declaration submitted by the developing countries prior to the adoption of the Doha Declaration.
Concerning the first demand, paragraph 4 of the Doha Declaration provides that:
the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly … 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.
Paragraph 4 further affirms the right of WTO Members to use, to the full, the flexibilities in the TRIPS Agreement. In addition, paragraph 5(a) of the Doha Declaration states that ‘each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives [Article 7] and principles [Article 8]’.
One unique feature of paragraph 4 of the Doha Declaration is that it contains a statement that the TRIPS Agreement ‘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’. As noted in Section 1.2, one of the essential components of the right to health is access to essential medicines.Footnote 77 It was further noted in Section 1.2 that one of the core obligations of state parties in relation to the right to health, from which no derogation is permissible,Footnote 78 is the provision of essential drugs.Footnote 79
Paragraph 4 of the Doha Declaration therefore goes one step further than Article 8.1 of the TRIPS Agreement, which states that WTO members ‘may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition’ without mentioning the need to promote access to medicines. By providing that the TRIPS Agreement should be interpreted and implemented in a manner supportive of the right of countries to promote access to medicines, paragraph 4 of the Doha Declaration therefore permits WTO members to incorporate a right to health perspective into the interpretation and implementation of the TRIPS Agreement at the national level. This is because access to medicines is an integral component of the right to health, and the promotion and provision of access to essential medicines is a non-derogable obligation for countries that are parties to the ICESCR.
Concerning the second demand, paragraph 5(d) of the Doha Declaration states that the ‘effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge’. The Doha Declaration therefore affirms the right of countries to engage in parallel importation. With regard to the third demand, paragraph 5(b) of the Doha Declaration provides that each member ‘has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted’. Thus, the Doha Declaration supports the view that countries can, for instance, grant compulsory licences on the grounds of the failure of a patentee to satisfy local working requirements.
In relation to the fourth demand, while the Doha Declaration does not directly address the question about whether countries should obtain prior authorization from a patentee before issuing a compulsory licence in an emergency situation, a combined reading of paragraphs 4, 5(a), and 5(c) of the Declaration reveals that it affirms the waiver contained in Article 31(b) of the TRIPS Agreement. Article 31(b) provides that countries need not seek authorization from a patentee before issuing a compulsory licence during an emergency or other circumstances of extreme urgency or in cases of public non-commercial use. Since paragraph 4 of the Doha Declaration affirms the right of countries to use to the full the flexibilities contained in the TRIPS Agreement, the Doha Declaration therefore affirms the waiver contained in Article 31(b) with respect to emergency situations. Furthermore, paragraph 5(c) of the Doha Declaration provides that each country ‘has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency’. Thus, for the purposes of applying the waiver in Article 31(b), countries are free to define what they deem to be an emergency, which can cover all types of crises from natural disasters to epidemics.
However, these first four demands have already been addressed by the TRIPS Agreement and, in this regard, the Doha Declaration merely confirms the provisions of the TRIPS Agreement. The only exception in this regard is the unique statement in paragraph 4 of the Doha Declaration that the TRIPS Agreement should be interpreted and implemented in a manner that supports the right of countries to promote access to medicines.
The fifth demand is addressed by paragraph 6 of the Doha Declaration. Paragraph 6 of the Doha Declaration acknowledges that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face real difficulties in making effective use of compulsory licences under the TRIPS Agreement. The TRIPS Council was therefore directed to find a solution to this problem and report back before the end of 2002. But it was not until 2003 that the WTO General Council adopted a decision that waived the requirements of Article 31(f) and permitted member countries to export drugs manufactured under compulsory licenses to countries that lacked local capacity to produce such drugs.Footnote 80 This became known as the ‘Paragraph 6 Solution’ after paragraph 6 of the Doha Declaration.Footnote 81 Thus, in a hypothetical scenario, country A (a country with insufficient or no domestic capacity to manufacture pharmaceutical products) can obtain essential drugs through a compulsory licence that allows importation from country B (a country with sufficient manufacturing capabilities).Footnote 82
The waiver under the ‘Paragraph 6 Solution’ was subsequently codified as an amendment to the TRIPS Agreement and it is contained in Article 31bis of the Agreement.Footnote 83 However, there are strenuous requirements that must be satisfied before this waiver can be used. There are onerous requirements on eligibility, notification, and provision of safeguards to prevent diversion of the drugs to other countries.Footnote 84 There are different requirements to be fulfilled by the importing country and the exporting country. Thus, this waiver has failed to achieve its aim as it has only been used once by Canada to supply anti-retroviral drugs to Rwanda. This failure can be blamed on the cumbersome procedures that countries are required to follow before they can utilize the waiver.Footnote 85
Thus, the attempt made by developing countries to re-shape the TRIPS Agreement and reclaim some patent policy space only yielded marginal gains in the form of the confirmation of the flexibilities that are already contained in the TRIPS Agreement and the introduction of a waiver system that is more burdensome and less beneficial to both developing and least-developed countries. The experience of developing countries with regard to their attempt to re-shape the TRIPS Agreement demonstrates how difficult it is for developing countries to re-shape the global patent system at the multilateral level. Apart from the fact that it is quite difficult for developing countries to re-shape the global patent law system at the multilateral level, developed countries have continued to ratchet up the global patent law standards through the extensive use of bilateral and plurilateral trade agreements.
Nevertheless, the statement contained in paragraph 4 of the Doha Declaration to the effect that the TRIPS Agreement should be interpreted and implemented in a manner that supports the right of countries to promote access to medicines offers an avenue for developing countries to preserve their patent policy space. In other words, paragraph 4 of the Doha Declaration provides a linchpin that developing countries can use to preserve their patent policy space as it sanctions the incorporation of a right to health perspective, and invariably the incorporation of a model of human rights, into the design, implementation, interpretation, and enforcement of their national patent laws. How developing countries can preserve their patent policy space and secure access to affordable medicines through the incorporation of a model of human rights, and more specifically through the incorporation of a right to health perspective, into their national patent law framework is therefore the central focus of this book.
1.4 The Roadmap for the Rest of the Book
Flowing from the analysis above, this book answers two key questions: (1) How should the relationship between patent rights and human rights be conceptualized? (2) In resolving the tension between patent rights and the right to health and in trying to discharge their right to health responsibilities, what should inform the design, implementation, interpretation, and enforcement of patent rights by the organs of the state in developing countries? In answering these two key questions, this book adopts a combination of methodologies. Thus, the book adopts a socio-centric view of intellectual property rights and a human rights framework in answering these two basic questions.
This book contends that, while inventions are usually understood from a creator-centric perspective, inventions should be properly approached from a socio-centric perspective because inventors usually draw and build on the efforts of other members of society. Thus, properly construed, patent law should be viewed from a socio-centric perspective, and this should inform the design, interpretation, and enforcement of patent rights.
This book examines how three select developing countries (i.e., India, Kenya, and South Africa) have reacted to the impact of the TRIPS Agreement on access to medicines in their countries. Essentially, the book examines how these countries have addressed the tension between patent rights and the right to health in their respective jurisdictions. These countries have been selected for analysis primarily because they all face, in varying degrees, similar challenges with regard to facilitating access to affordable medicines. Furthermore, all these three countries are members of the WTO and are thus obligated to provide patent protection for pharmaceutical products. In addition, the right to health is a justiciable right in all three countries. Thus, these three countries serve as ideal jurisdictions for the purposes of investigating how developing countries can address the tension between patent rights and the right to health in the design, implementation, interpretation, and enforcement of their patent laws.Footnote 86
Importantly, the three selected countries are key actors in their respective regions of the world, and one of them (i.e., India) is a key actor at the global level. India is considered as the ‘pharmacy of the developing world’ because of its strong generic drug industry.Footnote 87 Kenya is a key actor in eastern AfricaFootnote 88 and South Africa is a key actor in Africa.Footnote 89 While it is true that there are other countries that equally have to confront the tension between patent rights and human rights in their attempts to facilitate access to medicines,Footnote 90 factors such as language barriers, and constraints of time and space render it impracticable to include these countries within the scope of this book. Furthermore, this book adopts the view that it is preferable to conduct in-depth case-studies on three key countries with a view to distilling key principles that can be of general application to all the developing countries confronted with the tension between patent rights and human rights instead of engaging in a cursory overview of the laws and court decisions from a large number of countries.
With regard to the application of a human rights framework in answering the two key questions outlined above, as Yamin notes, ‘[t]o assert that health is an issue of rights is to assert that the state and other actors bear some responsibility in ensuring fair distributions of the social determinants of health as well as availability and access to care.’Footnote 91 Yamin further contends that, in applying a human rights framework to health, ‘our starting point should be to take suffering seriously’ because doing so will challenge us ‘to reconfigure our approaches to both health and rights’.Footnote 92 Jochnick contends that
[t]he real potential of human rights lies in its ability to change the way people perceive themselves vis-à-vis the government and other actors. Rights rhetoric provides a mechanism for reanalysing and renaming ‘problems’ as ‘violations’, and, as such, something that need not and should not be tolerated … Rights make it clear that violations are neither inevitable nor natural, but arise from deliberate decisions and policies.Footnote 93
The application of a human rights framework to health helps to define the relationship between rights-holders and duty bearers and it equally enables the establishment of mechanisms of accountability.Footnote 94
Applying a human rights framework to health compels us to challenge our narrow conception of health as the mere absence of disease or infirmity; it compels us to shift from the biomedical paradigm to a broader paradigm that understands health in the social, political, historical, and economic contexts in which people live.Footnote 95 In addition, applying a human rights framework to health equally compels us to challenge our narrow conception of rights; it challenges us to move away from a narrow conception of rights to a broader perspective.Footnote 96 This book therefore agrees with Barratt that it is impossible to resolve the tension between patent rights and access to medicines by relying only on the internal principles contained in intellectual property law and that the best way to resolve this tension is by utilizing the norms contained in the human rights system.Footnote 97 This book therefore contends that developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws.
As noted in Section 1.3, countries are permitted to incorporate a model of human rights into their national patent law system because paragraph 4 of the Doha Declaration provides that the TRIPS Agreement can and should be interpreted and implemented in a manner that supports the right of countries to promote access to medicines. At this point, it is helpful to examine the views expressed by WTO members about the nature of the relationship between patent rights and the human right to health during the discussions that preceded the emergence of the Doha Declaration. This should provide a better understanding of the unique statement in paragraph 4 of the Doha Declaration that the TRIPS Agreement should be interpreted and implemented in a manner that supports the right of countries to promote access to medicines.
During the first special discussion on intellectual property and access to medicines at the TRIPS Council that was held on 18–22 June 2001, the Indian delegation stated that ‘affordable access to medicines for what are life-threatening diseases for people in developing countries is a fundamental human right’.Footnote 98 The Indian delegation further noted that the ‘governments in these countries therefore have a duty and responsibility to ensure both availability and affordable prices for medicines’.Footnote 99 The relationship between access to medicines, the human right to health, and patent rights was further explored by the Kenyan delegation in its statement thus:
[P]harmaceutical products cannot be regarded as ordinary goods or products, because access to essential, life-saving and vitally needed drugs are an integral part of the realization of a fundamental human right, i.e. the right to health. It means that policies pursued by all concerned in the sector must aim to make drugs available for all who need to have them and at affordable prices. Patents affect prices by creating market monopolies, greatly hindering access to the patented products by those who need them, predominantly poor people who lack health insurance. Price is a key factor to health delivery, and it becomes to us a health concern when it impedes access to health care. This special impediment must be overcome as a priority in order to reverse the human suffering we are faced with.Footnote 100
The relationship between access to medicines, the human right to health, and patent rights was equally emphasized by other developing countries from Latin America, Asia, and Africa.Footnote 101 However, it needs to be stressed that, during these discussions that preceded the Doha Declaration, developing countries did not seem to make any clear demand that the nature of the relationship between access to medicines, patent rights, and human rights should be clarified. Nevertheless, it is significant to note that the concerns expressed by these countries about how patent rights under the TRIPS Agreement should be interpreted and implemented is reflected in paragraph 4 of the Doha Declaration. Thus, the statement in paragraph 4 of the Doha Declaration that the TRIPS Agreement ‘can and should be interpreted and implemented in a manner supportive of WTO members’ right … to promote access to medicines for all’ can be construed as a response to the concerns expressed by developing countries about the impact of patent rights on access to medicines and the human right to health.
Thus, the overriding question remains this, why is it crucial for developing countries to incorporate a model of human rights into their national patent law systems? Since patent rights have an impact on access to medicines,Footnote 102 there exists a tension between patent rights and the right to health (as the right to have access to medicines is an integral component of the right to health).Footnote 103 According to Barratt, it is impossible to resolve the tension between patent rights and access to medicines by relying only on internal principles contained in intellectual property law. She suggests that the best way to resolve this problem is by using external norms contained in the human rights system. According to her:
Negotiations over patents and public health are impossible to finalise using only internal principles of intellectual property law because the debate straddles the tension inherent in the patent system – benefits of patent monopolies versus consequent social costs. Intellectual property law does not tell us when the social costs of the system become legally unacceptable. States need, in addition, to use an ‘external’ argument and look for norms outside of intellectual property law and principles to resolve this impasse. The human rights system provides clear standards and benchmarks which give legal content to the term ‘public benefit’ and demarcate a bottom line below which the social costs of the international patent system become non-negotiable and potentially unlawful.Footnote 104
Barratt further contends that human right norms ‘provide specific limitations on what is negotiable, while identifying precise minimum conditions that are beyond negotiation’.Footnote 105 Thus, unlike the internal principles contained in intellectual property law which are quite ambiguous and open to multiple interpretations, human right norms contain certain minimum core obligations that are beyond negotiation. More importantly, with the elucidation provided by the CESCR on certain economic and social rights through its various General Comments, it is now very difficult to argue that economic and social rights such as the right to health are vague rights with no identifiable obligations. General Comment No. 14 has clarified the essential components of the right to health. It is, therefore, beyond negotiation that states have an obligation to provide access to medicines for their citizens and to ensure that their legal framework on patent rights does not impede the enjoyment of the right to health.
Incorporating a model of human rights into a country’s patent law system will not only help to preserve the country’s patent policy space, it will also help to facilitate access to medicines. By relying on both paragraph 4 of the Doha Declaration and their obligations under Article 12 of the ICESCR, it is possible for developing countries to incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their patent laws at the national level. In order to demonstrate how this can work in practice, in subsequent chapters of this book, the incorporation of a model of human rights into the national patent law system of three developing countries (India, Kenya, and South Africa) will be critically examined.
The remainder of this book is made up of six chapters. Chapters 2 and 3 focus on the first key question identified here regarding how the relationship between patent rights and human rights should be conceptualized. Chapter 2 contends that the appropriate justification for patent rights is one that is constructed on a socio-centric approach to patent law. It critically examines some of the popular theoretical justifications that have hitherto been postulated as explanations for the existence of intellectual property rights in general and patent rights in particular, and it concludes with the view that the regulatory theory of intellectual property is the only theory that adopts a broad socio-centric approach. The broad socio-centric approach of the regulatory theory of intellectual property law permits the incorporation of a model of human rights into a country’s patent law system.
Building on the discussion in Chapter 2, Chapter 3 deals with the nature of the relationship between patent rights and the right to health under international human rights law. Chapter 3 proceeds to answer two key questions that are integral to the issues addressed in this book. First, are patent rights human rights? Second, is the incorporation of a model of human rights compatible with the TRIPS Agreement? Chapter 3 concludes with the view that patent rights cannot be considered as human rights under international human rights law, and that the model of human rights is compatible with the TRIPS Agreement. There is therefore nothing that prohibits a developing country from insisting on the primacy of human rights obligations when attempting to resolve the tension between patent rights and the right to health at the national level.
Chapters 4–6 thereafter proceed to address the second key question identified here, that is, in resolving the tension between patent rights and the right to health and in trying to discharge their right to health responsibilities, what should inform the design, implementation, interpretation, and enforcement of patent rights by the organs of the state in developing countries? The analyses contained in Chapters 4–6 focus mainly on how the national courts and tribunals in Kenya, South Africa, and India, respectively, have incorporated a model of human rights into their decisions when adjudicating disputes that involve a tension between patent rights and the right to health. The cases examined in these three chapters demonstrate that the incorporation of a model of human rights into the adjudication of such disputes can be useful in preserving patent policy space and securing access to medicines.
The final chapter of this book, Chapter 7, contains the concluding thoughts based on the answers provided to the two key questions that this book addresses. This book provides a systematic analysis of court decisions from three key developing countries and it assesses how the national courts in these countries resolve the tension between patent rights and the right to health. Essentially, the book demonstrates how a model of human rights can be incorporated into the adjudication of disputes involving patent rights in national courts.
