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Intellectual Property and Public Health in the Developing World

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Monirul Azam

1. Setting the Scene

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1.1 Background

  • 1 Agreement on Trade-related Aspects of Intellectual Property Rights, 15 April 1994, Marrakesh Agreem (...)

1Prior to the creation of the World Trade Organization in 1995, individual countries were free to determine their own patent laws. This position has now changed. All members of the WTO are required to adopt patent laws that comply with the Agreement on Trade-related Aspects of Intellectual Property Rights,1 including the implementation of patent protection for pharmaceuticals. The developed members of the WTO negotiated mandatory protection for pharmaceutical products and processes in the TRIPS Agreement on the basis that such mandatory protection will provide the necessary incentives for continued pharmaceutical innovation. In contrast, the developing countries and the Least Developed Countries argued that enacting patent laws that comply with TRIPS may restrict production and supply of low-cost generic medicines by their local pharmaceutical industries or by the pharmaceutical industries in other developing countries, and hence could increase the price of pharmaceuticals to the point that pharmaceuticals become inaccessible to their populations.

  • 2 There are no World Trade Organisation definitions of ‘developed’ or ‘developing’ countries. Least-d (...)
  • 3 See for details, WTO, ‘Responding to Least Developed Countries’ Special Needs in Intellectual Prope (...)

2The LDCs need to reorganise and restructure national IP legislation and related institutional and infrastructural set-ups for the implementation of the TRIPS Agreement. Given the extent of the reorganisation and the restructuring required, LDCs2 (of which Bangladesh is one) were granted several transition periods.3 The initial transition period ended on 31 December 2005. Later, by a decision of the Council for TRIPS on 29 November 2005, LDC members as a group were granted an extension of the transitional period for 7.5 years to apply the provisions of the TRIPS Agreement “until 1 July 2013, or until such a date on which they cease to be an LDC member, whichever date is earlier”. The Council for TRIPS took the decision following the request by the LDCs as a group, pursuant to Article 66.1 of the TRIPS Agreement, for a 15-year extension of the transition period in order for those LDCs to be able to apply the provisions of the agreement. The group had cited socioeconomic, administrative and financial constraints, as well as the need to create a viable technological base, as reasons duly motivating the request. The decision was negotiated between the LDCs and some key developed countries during informal consultations and was adopted by the formal Council for TRIPS meeting on 29 November 2005. However, during the consultations, several developed country members, particularly the United States of America (the US), insisted that each LDC member should request an extension on an individual basis and that extensions would be granted on a case-by-case basis.

  • 4 See WTO, ‘Decision of the Council for TRIPS on the Extension of the Transition Period under Article (...)

3Nevertheless, given the recognition of the extent of the restructuring required and the vulnerability of the LDCs, the transition period did not prove to be long enough to introduce protection for pharmaceutical patents and to take adequate measures to ensure access to medicines. Therefore, the Doha Declaration on the TRIPS Agreement and Public Health (known as the Doha Declaration) was adopted by the WTO Ministerial Conference of 2001 in Doha on 14 November 2001, extending the transitional period for LDCs to introduce pharmaceutical patent protection until 1 January 2016.4

  • 5 WTO, ‘Decision of the Council for TRIPS of 11 June 2013’ (Document IP/C/64).
  • 6 WTO, ‘Communication from Bangladesh on behalf of the LDC Group’, 23 February 2015 (Document IP/C/W/ (...)
  • 7 Ibid.
  • 8 Ibid.

4On the other hand, WTO members agreed on 11 June 2013 to further extend the deadline for LDCs until 1 July 2021 to protect IP under the TRIPS Agreement.5 It was noted that the decision could not prejudice the extension of pharmaceutical patents granted under the Doha declaration and that LDCs could seek further extensions to this period. Accordingly, on behalf of the LDC group, Bangladesh submitted a document requesting extension of the waiver for the LDCs with respect to pharmaceutical patents as long as the WTO Member remains a Least Developed Country pursuant to Article 66.1 of the TRIPS Agreement.6 The LDC group stated that LDCs are “struggling to provide their population with prevention, treatment and care. Patent protection contributes to high costs, placing many critical treatments outside the reach of LDCs”.7 Justifying the request for extension, the LDCs further pled “special needs and requirements of least developed country Members, their economic, financial and administrative constraints and their need for flexibility to create a viable technological base”.8

  • 9 WTO, ‘Decision of the Council for TRIPS of 6 November 2015’ (Document IP/C/73).
  • 10 M. Monirul Azam and Mahesti Okitasari, ‘Environmental Governance and National Preparedness towards (...)
  • 11 UN, Report of the Open Working Group of the General Assembly on Sustainable Development Goals, Reso (...)

5The Council for TRIPS approved the waiver for pharmaceutical patents until 1 January 2033 or until such a date on which the least developed countries cease to be LDC Members, whichever date comes first.9 Granting the extension is seen as being in line with both the Doha Declaration and the Sustainable Development Goals. The SDGs were adopted by the United Nations General Assembly in September 2015, approving seventeen goals to be pursued by all countries to end poverty and to fight inequality and injustice. They represent an important milestone in envisioning what the world could look like in 2030, if global development is put on an inclusive and sustainable path. Among the seventeen goals, the third set targets to ensure healthy lives and promote wellbeing for all ages and also to achieve universal health coverage, including access to safe, effective, quality and affordable essential medicines and vaccines for all.10 It (SDG 3) further affirmed the right of developing countries to utilise TRIPS Agreement flexibilities to ensure access to medicines for all.11 With the deadlines of 2033 (the extension) and 2030 (the SDGs) in mind, it is important for the LDCS to take concrete and coherent steps to improve intellectual property and health-related infrastructure to ensure healthy lives and access to medicines for their citizens.

6Therefore, it is vital for the LDCs to utilise the transitional period properly to initiate infrastructural and institutional capacity building, so that after the expiration of the transitional period, they will be able to balance pharmaceutical innovation and access to medicines.

  • 12 For details of the 34 LDCs that are WTO members, see WTO, ‘WTO and the Least Developed Countries’, (...)
  • 13 Mohammad Abu Yusuf and Qamrul Alam, ‘WTO TRIPS Agreement: Current State of Pharmaceutical Industry (...)
  • 14 Mohammad Monirul Azam and Kristy Richardson, ‘Trips Compliant Patent Law and the Pharmaceutical Ind (...)
  • 15 See for details, ‘Reports and Statistics from Directorate of Drug Administration in Bangladesh’, ht (...)

7Among the 48 countries classified as LDCs (of which 34 are WTO members),12 Bangladesh is one of the few with an adequate pharmaceutical manufacturing capability, and it is nearly self- sufficient in pharmaceuticals.13 Bangladesh’s pharmaceutical industry now accounts for 97% of the country’s pharmaceutical needs (the remaining 3% includes insulin, vaccines and high-end, anti-cancer drugs, the production of which are very capital intensive and hence not economically feasible for Bangladesh), which amounts to around US$ 1.7 billion.14 Pharmaceuticals from Bangladesh are exported to 107 countries in Asia, Africa and Europe.15

  • 16 Anne St Martin, ‘The Impact of Trade Related Aspects of Intellectual Property Rights (TRIPS) on Acc (...)
  • 17 Shawkat Haider, ‘Access to Medicines for All’, Dhaka Tribune, 20 November 2015, http://www.dhakatri (...)

8Being an LDC, Bangladesh can still produce generic versions of patented pharmaceuticals, so the country can serve the pharmaceutical needs of poorer countries with no or low manufacturing capacity by supplying cheap generic versions of patented drugs.16 Bangladesh is in a unique situation, as it is the one of the few LDCs with sufficient capacity to produce and export generic medicines where this is legally possible, at least until January 2033. Considering this unique feature of the Bangladeshi pharmaceutical industry, one industry expert in Bangladesh stated that “Medicine price in Bangladesh is among the lowest in the world and that has been possible because the country has much competitive generic drug skills, and it doesn’t have to pay royalty to innovators for producing patented medicines. For example, cholesterol lowering drug Crestor 10mg (rosuvastatin) tablet costs around $ 7.25 in the US versus a comparable Bangladeshi generic price of $ 0.25 while diabetes drug Januvia 50mg (sitagliptin) is priced at $ 11.25 against the local generic price of $ 0.25. Bangladesh has [also] introduced the generic version of revolutionary hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir+ledipasvir) which are available locally at $ 6.5 and $ 13 per tablet compared to the originator brands at $ 1,000 and $ 1,125 respectively”.17

9Therefore, it has become an important research area to investigate whether Bangladesh’s pharmaceutical sector can gradually evolve to provide low-cost substitutes for important patented drugs to other developing countries and LDCs, and whether it can contribute to global access to cheap medicines. Given its position, it is important to explore how Bangladesh can exploit the opportunities available to it, while also considering how Bangladesh may initiate capacity-building processes to implement a TRIPS-compliant patent law that balances the interests of pharmaceutical producers with the need to ensure access to drugs for local populations (in anticipation of the introduction of pharmaceutical patents not only for process, but also for product and future TRIPS‑ compliant patent law in Bangladesh). Apart from pro-development TRIPS-compliant national patent law, it is necessary to investigate how Bangladesh can achieve institutional and infrastructural capacity building to progress from being simply a generic producer to having an innovative pharmaceutical industry, and thus graduating from the LDCs.

10This study makes a contribution to knowledge because it focuses on the pharmaceutical industry in Bangladesh and also analyses policy options required for an LDC such as Bangladesh to become TRIPS compliant on the basis of experiences of developing countries such as India, China, Brazil and South Africa, who all played vital roles as producers and exporters of generic copies of brand-name patented products.

11This study uses a research method that involves legal doctrinal analysis and a comparative review to analyse the patent laws of India, Brazil, China, South Africa and Bangladesh. The aim is to understand the nature, scope, effectiveness and weaknesses, if any, of ensuring access to medicines and preserving the local pharmaceutical industry while making progress towards TRIPS compliance.

12This study also investigates stakeholders in the pharmaceutical industry in Bangladesh by way of a case study using a survey instrument, in addition to interviews with relevant stakeholders to gain an understanding of their strategies for TRIPS compliance. As participants in the research presented in this book, the stakeholders represented different categories of companies within the pharmaceutical industry operating in Bangladesh: multinationals and national pharmaceutical producers (small, medium and large). The study also investigates the perceptions of other stakeholders such as public health groups, IP and pharmaceutical academics, researchers and the national regulatory bodies: the Patent Office and Directorate of Drug Administration (DDA).

13This study makes a contribution to the literature in the field of global and comparative IP law as follows:

  • First, it evaluates implications of the pharmaceutical patent regime, as an integral part of the globalising standard of patent protection in WTO law, for the relevant laws, regulatory bodies and pharmaceutical industry in Bangladesh.

  • Second, it analyses both the contemporary literature examining TRIPS and its effect on access to medicines in developing countries and the LDCs and the policy options for public health-oriented patent law reforms in developing countries (particularly, India, Brazil, China, South Africa and Bangladesh).

  • Third, it identifies future research directions to provide an ongoing consideration of the policy options needed to reach the right balance between pharmaceutical innovation, access to affordable pharmaceuticals and TRIPS compliance.

  • 18 For human rights perspectives on intellectual property (IP), see R.D. Anderson and H. Wager, ‘Human (...)

14Although human rights perspectives are becoming increasingly important in reforms of IP policies and laws, and could be useful in exploring the balance between the rights of inventors and creators and the public interest, this study has not examined human rights-based approaches as potential policy options within the TRIPS Agreement.18 Further, this study does not deal with issues relating to medicine arising out of traditional knowledge and how that may be affected by TRIPS. Finally, this study does not explore in detail effects of enforcement mechanisms under the TRIPS Agreement; rather, it focuses on the patent law reforms, in particular on the context of pharmaceutical patents.

1.2 The Advent of TRIPS and Pharmaceutical Patents

  • 19 See Mohammad Monirul Azam and Morshed Mamud Khan, ‘WTO TRIPS Agreement: Implications for the Develo (...)
  • 20 Member countries have agreed to be bound by the commitments under various WTO agreements. These inc (...)
  • 21 This has been the most important argument for the opponents of the WTO, as decision making on impor (...)
  • 22 Membership of the WTO is conditional on the full acceptance—without reservation—of almost all WTO a (...)
  • 23 Mohammad Monirul Azam, ‘Establishment of the WTO and Challenges for the Legal System of Bangladesh’ (...)

15The establishment of the WTO has been an important exercise in a number of ways. First, it represents an entirely new chapter in the jurisprudence of post-World War II international organisations through the establishment of a multilateral trading system that provides a binding dispute settlement mechanism for its members.19 Second, the WTO has also undertaken the onerous task of evolving a binding law of international trade among the member countries.20 Third, the WTO has in many ways replaced the internal sovereignty of the member countries.21 This is because every member is required to adjust its domestic laws to conform to the WTO agreements.22 Indeed, as a founding member, Bangladesh’s legal system has been subject to reorganisation to satisfy the requirements of the WTO.23

  • 24 Earlier IPR conventions such as the Berne Convention of 1886 and the Paris Convention of 1883 under (...)
  • 25 The exceptions are utility models and plant breeders’ rights, although TRIPS members are obliged to (...)
  • 26 J.J. Simons, ‘Cooperation and Coercion: The Protection of Intellectual Property in Developing Count (...)

16The TRIPS Agreement is one of the most controversial agreements of the Uruguay Round in terms of its objectives and consequences, which established global minimum standards of IPR protection. It represents a major departure from previous international IPR treaties and agreements, which aimed not to standardise IPR legislation between countries, but to guarantee non-discrimination under national IP systems.24 The TRIPS Agreement is particularly distinctive with respect to earlier international IPR agreements in three important ways. First, TRIPS makes it mandatory for WTO members to provide existing types of IPR protection that include patents, copyright, trademarks, trade secrets, industrial designs, layout designs for integrated circuits, and geographical indications, which removed the flexibilities in previous IPR agreements regarding the granting of IPRs based on the stage of development of a particular country.25 Second, it specifies the minimum standards for national IPR legislation, such as the extent of coverage, the terms of protection and the mechanisms for enforcement. Third, it brings national IPR legislation under the coverage of the WTO’s dispute settlement procedures, which include the option of cross-retaliation in cases of non-compliance.26

  • 27 Sylvia Ostry, Intellectual Property Protection in the WTO: Misuses in the Millennium Round (Fraser (...)
  • 28 John Madely, Hungry for Trade (Zed Books, 2000), pp. 96–97.
  • 29 A text codifying the Intellectual Property Rights Commission’s (IPC’s) consensus position was relea (...)
  • 30 Mansfield claimed that 65% of pharmaceuticals and 30% of chemical inventions would not have taken p (...)
  • 31 However, the evidence linking intellectual property rights (IPRs) to foreign direct investment (FDI (...)
  • 32 See for details, WHO, Globalization and Access to Drugs: Implications of the WTO/ TRIPS Agreement, (...)
  • 33 Jane O. Lanjouw, ‘The Introduction of Pharmaceutical Product Patents in India: “Heartless Exploitat (...)

17The TRIPS Agreement was the brainchild of an industry coalition of developed nations including the US, the European Union (EU) and Japan. The main impetus for the agreement came from the pharmaceutical, software and entertainment industries, with the chief executive officer (CEO) of Pfizer playing a lead role as chair of the Intellectual Property Rights Committee (IPC).27 The IPC was created during the Uruguay Round of negotiations with the goal of putting IPRs firmly on the agenda.28 The pharmaceutical industry was primarily interested in eliminating what it felt was unfair discrimination against the patenting of medicines, but it was also motivated to try to gain control over uses of its clinical and regulatory data to delay registration of generic equivalents—in essence seeking another form of exclusive rights. One of the arguments advanced by the developed countries for including IPRs in the negotiations was that stronger IPRs would create an incentive for innovation and would stimulate the development of new technologies, such as patent protection for pharmaceuticals.29 This incentive for innovation would consequently encourage greater domestic and foreign investment in research into new pharmaceuticals and tropical diseases.30 The argument propounded was that foreign investment and technology transfer would, in turn, benefit developing countries and LDCs.31 In contrast, developing countries argued that the introduction and strengthening of patents for pharmaceutical products would not lead to an increase in research and development (R&D) investment by enterprises in developing countries because of the non- existence of technical infrastructure and financial and human resources. That is why “the non-patentability of pharmaceutical products existing prior to the TRIPS Agreement gave developing countries the opportunity to progress and to acquire basic technology through reverse engineering before being able to invest in R&D”.32 Consequently, almost 50 developing countries, which were not granted patent protection for pharmaceuticals during the Uruguay Round, fiercely resisted including pharmaceuticals under the patent regime, claiming that vastly higher drug prices would be associated with such patents.33

  • 34 Martin Khor, ‘Rethinking Intellectual Property Rights and TRIPS’, in Global Intellectual Property R (...)
  • 35 Ma El Farag Balat and M.H. Loutifi, ‘The TRIPS Agreement and Developing Countries: A Legal Analysis (...)
  • 36 For example, after the introduction of patent protection for pharmaceuticals in India in line with (...)

18Therefore, developing countries and the LDCs are apprehensive of strong patent protection as it may be harmful to their pharmaceutical industries and may have severe negative consequences for their citizens in terms of access to affordable medicines.34 A potential consequence of the introduction of pharmaceutical patents is that prices of pharmaceuticals will increase and the availability of cheap pharmaceuticals for poorer citizens will diminish.35 Here the apprehension of the negative consequences of patent protection for pharmaceuticals is not only applicable to the LDCs that are WTO members, but may also place non-WTO member LDCs at a disadvantage, given such countries’ dependence on imports of cheap generic medicines.36

  • 37 Xuan Li, ‘The Impact of Higher Standards in Patent Protection for Pharmaceutical Industries under t (...)
  • 38 Ibid.
  • 39 Ibid.
  • 40 Ibid.
  • 41 Ibid.
  • 42 M. Boldrin and D.K. Levine, Against Intellectual Monopoly (Cambridge University Press, 2008), pp. 2 (...)
  • 43 Edwin Cameron and Jonathan Berger, ‘Patents and Public Health: Principle, Politics and Paradox’, SC (...)
  • 44 Sanjaya Lall, ‘Indicators of the Relative Importance of IPRs in Developing Countries’ (UNCTAD-ICTSD (...)
  • 45 The Introduction of Pharmaceutical Product Patents in India’, p. 2.
  • 46 S. Srinivasan, ‘How TRIPS Benefits Indian Industry and How It May Not Benefit the Indian People’, I (...)

19Historically, product patent protection was excluded in most developed countries as well.37 For example, in France, product patent protection was prohibited under the law of 5 July 1844 and limited patent protection was only permitted on 2 January 1966.38 In Germany, product patents were explicitly excluded under the law of 25 May 1877, but were then introduced from 4 September 1967.39 In Switzerland, product patents for pharmaceuticals were prohibited by the constitution and were only introduced in 1977.40 In Italy, pharmaceutical patents were prohibited until 1978.41 In Spain, product patents were introduced in 1986 just after its accession to the European Economic Community, and the relevant laws came into effect from 1992.42 The rationale behind the non-granting of product patent protection for pharmaceuticals in each of these example countries was to allow local pharmaceutical companies to imitate and produce patented medicines by using new processes.43 Over the years, these developed countries gained self-sufficiency in pharmaceutical manufacturing and invested in R&D,44 which enabled and facilitated the transformation of their pharmaceutical industries into innovative and research-based industries by using imitated technology.45 Now, given the advent of TRIPS, the argument being mounted is that these countries are acting in a hypocritical way: they are supporting the implementation of IP protection for pharmaceuticals only after experiencing maturity for their own pharmaceutical industries.46

  • 47 In a case study of the United Nations Conference on Trade and Development (UNCTAD) in Bangladesh (2 (...)
  • 48 Padmashree Gehl Sampath, ‘Innovation and Competitive Capacity in Bangladesh’s Pharmaceutical Sector (...)

20For LDCs, the freedom to rely on imitated technology until such time as pharmaceutical production is at a similar stage of development— before the implementation of pharmaceutical patent protection—is no longer an option,47 given the immediate obligation of WTO member countries to implement the TRIPS Agreement. In that context, the transitional period to implement the TRIPS Agreement or to implement the pharmaceutical patent provisions is quite meaningless for those countries that do not have the technological capabilities to produce generic pharmaceuticals.48 Although Bangladesh is an LDC, it is in a somewhat unique position.

21Bangladesh has a considerable number of generic producers who can reduce the price of pharmaceuticals by utilising the freedom of imitation. Bangladesh also exports to the less regulated markets of Asia and Africa and to some countries in Europe. However, the apprehension is that after the introduction of pharmaceutical patents, as required by TRIPS, the local pharmaceutical industry will face the issue of survival. If the industry fails, there will be an effect on access to pharmaceuticals. Thus, multinationals and other large pharmaceutical companies in Bangladesh believe that by lowering protection for pharmaceuticals, Bangladesh has missed out on the opportunity to encourage an innovative and R&D‑ based pharmaceutical industry.

22Thus, the debate centres on how to reach a balance between meeting the high costs of pharmaceutical R&D and creating incentives to stimulate access to those pharmaceuticals in developing countries and LDCs. By focusing on Bangladesh, this study contributes to the debate by providing a better understanding of the implications of a TRIPS‑ compliant patent regime on pharmaceutical patents for an LDC.

1.3 The Requirements of TRIPS

  • 49 The law relating to patents in Bangladesh is the Patents and Designs Act, 1911 (PDA) with some mino (...)

23The existing patent law of Bangladesh needs to be amended and updated to conform to the TRIPS Agreement’s requirements, as in its current form it can neither promote access to medicines, nor facilitate innovation in the local pharmaceutical sector, nor encourage investment in R&D and technology transfer. The Patents and Designs Act, 1911 (PDA) of Bangladesh is a century-old colonial law inherited from the then British Government in the Indian subcontinent without any major modification.49 That is why, in the context of pharmaceutical patents, Bangladesh will have to consider the following provisions of the TRIPS Agreement when amending its patent law:

    • 50 Article 27.1 of the TRIPS Agreement.

    to ensure that the patent is available and enjoyed without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced50

    • 51 Although patents were always issued to protect the production process, without patent restrictions (...)

    patents for both products and processes51

  1. to incorporate patentability requirements such as novelty, inventive steps and industrial application considering national developmental goals and provisions of the TRIPS Agreement

  2. the status/exclusion of pharmaceutical patents during the waiver period until 1 January 2033 and the likely provision for a “mailbox” during the transitional period

    • 52 Articles 6, 7, 30 and 31 of the TRIPS Agreement.

    utilisation of flexibilities such as exceptions for government use, compulsory licenses, parallel imports, experimental use and public interest52

  3. provisions for the use of patents without the authorisation of patent holders, but with a number of conditions and limitations

    • 53 See Article 33 of the TRIPS Agreement.

    a minimum 20‑year term for patent protection.53

24While the necessary reforms are being implemented for TRIPS compliance, the wider issue that needs to be given due consideration is how Bangladesh can strike a balance between the competing interests of a variety of stakeholders, including domestic generic-medicine producers, the domestic R&D community, multinational pharmaceutical companies (MNPCs) and the citizens of Bangladesh.

1.4 TRIPS Flexibilities and the Doha Declaration

  • 54 See WIPO, Study on Patent Related Flexibilities in the Multilateral Legal Framework and Their Legis (...)
  • 55 Ibid, para. 34.

25The TRIPS Agreement provides “flexibility” for members to determine their own approach regarding the relationship between IPRs and access to pharmaceuticals in a number of ways. The World Intellectual Property Organization (WIPO) Committee on Development and Intellectual Property (CDIP) defines “flexibilities” as “legal tools that countries can use as they see fit in their national developmental plans and within the framework of the mandatory standards of international obligations”.54 In the context of the TRIPS Agreement, it further states, “the term flexibilities means that there are different options through which TRIPS obligations can be transposed into national law so that national interests are accommodated and yet TRIPS provisions and principles are complied with”.55 The TRIPS Agreement permits the following flexibilities to:

  • Define the nature of invention and to regulate the criteria of patentability within the broad framework of TRIPS Agreement rules.

  • Establish exceptions to patent rights.

  • Grant government use and compulsory licenses.

  • Have recourse to a range of options with respect to the protection of data submitted for regulatory purposes.

  • Determine country-based policies with respect to exhaustion of rights and to allow parallel importation of medicines.

    • 56 Article 39.3 of the TRIPS Agreement requires member countries to establish protection for submitted (...)

    Restrict the “unfair commercial use” option of “protection of undisclosed test data” to promote generic competition and reduce prices.56

  • 57 Carlos Correa, Intellectual Property Rights, The WTO and Developing Countries: The TRIPS Agreement (...)

26However, these flexibilities are ambiguous and therefore need to be operationalised and implemented at the national level while adjusting to national developmental goals, the public interest and the stage of development of a particular country.57

  • 58 Case No 4138/98 in the High Court of South Africa; see, M. Monirul Azam, ‘The Experiences of Patent (...)
  • 59 WTO, ‘Measures Affecting Patent Production—Request for Consultation by the United States’ (WT/DS199 (...)
  • 60 See Sharifah Rahma Sekalala, ‘Beyond Doha: Seeking Access to Essential Medicines for HIV/AIDS throu (...)
  • 61 Ibid., p. 5.

27Therefore, the countries had difficulties in exploiting the flexibilities contained in the TRIPS Agreement, particularly in the context of dealing with public health emergencies and ensuring better access to medicines. In particular, three conflicting situations urgently raised the need to address ambiguity and inconsistency in the TRIPS agreement in the context of public health. First, in 1997 the South African government introduced the Medicines and Related Substances Control Act to ensure the availability and affordability of HIV/AIDS-related medicines. This law employed parallel imports and compulsory license, which triggered a legal battle between South Africa and 39 pharmaceutical companies, and involved strong pressure from the US government and trade bodies.58 Second, in 2001 disputes erupted between the U.S. and Brazil regarding the compatibility of the working requirements in the national patent law, in which the US government argued that the provision for granting compulsory licenses in case of the patent’s non-working in Brazil within 3 years of its issuance was tantamount to a protective measure and hence inconsistent with the TRIPS Agreement.59 Third, the anthrax scare after the September 11th, 2001 terrorist attack in New York had created a potential health threat, which caused developed countries like the U.S. and Canada to threaten to use compulsory licenses to stockpile an adequate supply of Cipro (an antibiotic used in the treatment of anthrax).60 These measures by the US and Canada revealed “a hypocritical behavior [by them] in its eagerness to use the threat of a compulsory license for what it perceived as a health emergency while on the other hand forcing developing countries to stick to restrictive patent laws in the face of increasingly dire health crises”.61

  • 62 WTO, ‘Submission by the African Group to the TRIPS Council for Special Discussion on Intellectuel P (...)
  • 63 Ibid.

28Considering the inconsistency and ambiguity of how to define a national public health emergency, and on what grounds it might be permissible for a national government to grant compulsory licenses pursuant to the TRIPS Agreement, the anthrax scare created an impetus to clarify TRIPS flexibilities. The African countries had a strong conviction that the TRIPS Agreement should not prevent them from using measures vital to ensure access to medicines and to fulfil public health needs.62 That is why the African group requested the TRIPS Council to arrange a special discussion on intellectual property and access to medicines.63

29During the discussion, the developing countries not only sought clarity through a declaration but support for their efforts to use the flexibilities in the TRIPS Agreement to deal with national public health needs.64 But the meeting triggered strong protest from the U.S., which argued, along with Japan, Switzerland, Australia and Canada, that strict patent protection for pharmaceuticals was an important incentive for pharmaceutical innovation and hence vital for public health.65 However, on 14 November 2001, the WTO Doha Ministerial Conference adopted a declaration on TRIPS and Public Health which offered a much needed clarification, confirming 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”.66 The Doha declaration in particular confirmed the public health-oriented use of the TRIPS Agreement.

  • 67 Carlos Correa, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health’ (WHO (...)

30First, Para. 5a of the Doha Declaration indicates that the pressures to obstruct the use of available flexibilities run counter to the objectives and purpose of the TRIPS Agreement (as mentioned in Articles 7 and 8 of the TRIPS Agreement). Carlos Correa argued that “in legal terms, it means that panels and the Appellate Body must interpret the Agreement and the laws and regulations adopted to implement it in light of the public health needs of individual Members”.67

  • 68 Para. 5b, Doha Declaration.
  • 69 Correa (WHO, 2002).

31Second, Para. 5b confirms that “each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted”.68 Carlos Correa stated that “the use of this terminology [compulsory licences] may help to create awareness, particularly among health ministries in developing countries and LDCs, about the possible utilization of compulsory licences to meet public health and other objectives”.69

  • 70 Ibid.

32Third, Para. 5c states that “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”. The Declaration further places “the burden on a complaining Member to prove that an emergency or urgency does not exist”.70 This recognition is considered an important achievement for developing countries in the Doha Declaration, as it implies that specific measures to deal with an emergency may be adopted based on the national situation and be preserved until the underlying situation ceases, without temporal restrictions.

  • 71 Para. 5d, Doha Declaration.

33Fourth, Para. 5d clarifies Members’ right to adopt the principle of exhaustion of rights and determine by which parallel imports may be determined. The Declaration states that “the effect of the provisions in the TRIPS Agreement … is to leave each Member free to establish its own regime for such exhaustion without challenge”.71 This provision approved the Members’ freedom to apply an international exhaustion principle, confirming that it would be legitimate and fully consistent with the Agreement to do so.

  • 72 See for details, WTO, ‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement (...)
  • 73 Although it was originally to be adopted by 1 December 2007, the General Council decision of 30 Nov (...)
  • 74 For details on the operational procedure of the August 30th Decision, see chapter 3 of this study.

34Fifth, Para. 6 identifies the problem inherent in Article 31(f) of the TRIPS Agreement, which stipulates that a compulsory license can only be issued to serve the domestic market. This had caused grave concerns to many developing countries, since they did not have enough manufacturing capability or infrastructure to take advantage of the compulsory licensing provisions. Although the declaration instructed the TRIPS Council to find an expeditious solution by 2002, it took nearly two years of negotiations to reach a solution. On 30 August 2003, the General Council of the WTO adopted the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (the August 30th Decision). It granted rights to developing countries to waive the provisions under Article 31(f) and also allowed member countries to export generic pharmaceutical products made under compulsory licenses to meet the needs of importing countries subject to certain conditions.72 The provisions of the August 30th Decision were formally approved as an amendment to the TRIPS Agreement on 6 December 2005, and it will formally be inserted into TRIPS once it has been ratified by two-thirds of WTO members.73 Nevertheless, delays in the ratification procedure have no material implications. The waivers of the Decision became operational on 30 August 2003 and will remain so until the amendment is in effect.74

  • 75 Mohammad Monirul Azam, ‘Establishment of the WTO and Challenges for the Legal System of Bangladesh’ (...)

35Despite having endorsement for the public health-oriented measures for implementing the TRIPS agreement, most of the developing countries and the LDCs have not properly implemented the Doha Declaration and the flexibilities in the TRIPS Agreement. The reasons behind this are the complexity of patent-related legal provisions, lack of institutional support, fear of trade retaliation, and limited skills in the negotiations and diplomacy necessary to exploit the technical and financial cooperation of the developed countries.75 In this context, the experiences of India, Brazil, China and South Africa could lead to a better understanding of different approaches to dealing with public health-oriented patent law reforms and to implementing TRIPS- compliant patent laws by utilising the TRIPS flexibilities and other governmental interventions in ways that do not conflict with the TRIPS obligations. The policy options used by Brazil, China, India and South Africa generate important lessons for the LDCs in determining which legislative and other policy options they use.

1.5 The Experiences of Brazil, China, India and South Africa

  • 76 Mathew Flynn, ‘Corporate Power and State Resistance: Brazil’s Use of TRIPS Flexibilities for Its Na (...)

36Brazil’s experience regarding TRIPS-compliant patent law for pharmaceuticals, and enforcing societal and national obligations to ensure access to medicines, represents a situation in which exploitation by MNPCs was not only largely thwarted, but gave way to significant reforms in public health policy and the reinstating of local drug companies as viable contenders in the domestic market.76

  • 77 Brazil, Industrial Property Law, No 9.279, 14 May 1996.
  • 78 Médecins Sans Frontières (MSF) and other public health groups, along with 120 Brazilian non-governm (...)
  • 79 Brazil, ‘Presidential Decree on Compulsory Licensing’, Decree No. 3, 201, 6 October 1999.

37In Brazil, the government decided to take measures to facilitate access to pharmaceuticals in the context of the HIV/AIDS crisis while making TRIPS-compliant patent law. This included, for instance, a strong compulsory licensing regime.77 As part of the compulsory licensing regime, inventors had the duty to manufacture the product in Brazil. The US Government objected to this requirement and initiated a WTO dispute. However, the dispute was later withdrawn due to pressure imposed upon the US by public health organisations and human rights groups.78 Brazil has also adopted a decree that establishes certain rules concerning the granting of compulsory licenses in cases of national emergency and public interest.79 The definition of “public interest” is broad and includes such matters as public health, nutrition, the protection of the environment and elements of primordial importance for technological, social or economic development. The possibility of being able to issue compulsory licenses in each of these cases implies that the country’s most basic health needs would be fulfilled. In contrast, China initially tried to attract more foreign investment in the pharmaceutical sector rather than adopt an explicitly public health-oriented approach while introducing TRIPS-compliant patent law.

38China has experienced the transformation from a communist economy to a socialist market economy. Accordingly, its patent legislation has undergone several changes since 1978, due first to constant pressure from US foreign trade policy and then to maintain the availability and affordability of medicines while also adjusting to TRIPS obligations. China was primarily concentrated on the low-cost source of pharmaceutical ingredients and generics, and continued to revise its patent law to attract more investment in the pharmaceutical sector. It had raised the bar for entering the pharmaceutical business by passing laws since 1998, including the Drug Management Law and Regulations on Pharmaceutical Manufacturing.

  • 80 Statement by Paul Cawthorne, coordinator for MSF’s Access Campaign in Asia; see for more details, h (...)
  • 81 Said by Paul Cawthorne, coordinator for MSF’s Access Campaign in Asia; quoted in Tan Ee Lin,‘China (...)

39Subsequent to its accession to the WTO, Chinese regulations in 2002 extended pharmaceutical patents to 20 years and data exclusivity for six years. But considering the potential threat to the availability and affordability of patented medicines, in 2012 China amended its patent law further to allow eligible companies compulsory licenses for producing generic versions of patented drugs during state emergencies or unusual circumstances, or in the interests of the public. Again, for “reasons of public health”, eligible drug makers can also ask to export these medicines to other countries, including members of the WTO. It is interesting to note that since the change in China’s patent law, Gilead has offered certain concessions, including giving China a substantial donation of HIV drugs (Tenofovir) if it continues to buy the same amount.80 It was further stated that “this is all a negotiation game; this offer from Gilead came about once the news that the Chinese was considering issuing a CL [Compulsory License] came out. The end game is okay, you get a better deal or you use the CL, it’s a strategy that many countries use”.81 Therefore, the Chinese experience of transformation towards a market economy, and its ability to improve innovation and maintain the availability and affordability of medicines, will have important lessons for other developing countries and the LDCs.

  • 82 Katia Gomez, ‘Inside the TRIPS Agreement’, Journal of International Affairs at UCSD 8 (2009).
  • 83 Ibid, p. 9.

40India’s experience is different from those of Brazil and China. It tried to promote the availability and affordability of pharmaceuticals by changing its patent laws in such a way as to promote generics and the innovative capabilities of local industries.82 India entered into the WTO in 1995 and went through a long process of amendments to create a TRIPS-compliant patent regime, effective from beginning of 1 January 2005. The effect of stronger intellectual patent rights created problems for the larger Indian drug firms and greatly damaged smaller local firms’ abilities to meet the rising costs of remuneration for experienced and efficient pharmacists and other technical people.83

  • 84 Philippe Cullet, ‘Patent Bill, TRIPS and Right to Health’, Economic and Political Weekly 36.43, 27 (...)
  • 85 Ibid.

41The Indian TRIPS-compliant patent law was criticised by public health organisations such as Oxfam as being “likely to bring about a legal regime that is less favourable from the point of view of access to drugs for the people of this country”.84 Public health organisations such as the Affordable Medicines and Treatment Campaign (AMTC), an Indian advocacy group, also argued that the new patent law in India generally provided stronger protection to patent holders, which implied that the balance of interests between inventors and the general public was being shifted in favour of the former.85

  • 86 Dipika Jain, ‘Access to Drugs in India: Exploration of Compulsory Licensing as an Effective Tool’ ( (...)
  • 87 Ibid., pp. 6–7.

42However, like Brazil, India also incorporated options concerning compulsory licenses for use in cases of public interest. Now India is also using compulsory licensing options to encourage local production in casesof inadequate supplyor excessive price of particular medicines. This is based on the earlier experiences of Brazil, which has both effectively and consistently managed to control the costs of several patented drugs by constantly threatening the use of the “national emergency” clause provided for under the TRIPS Agreement with regard to compulsory licensing.86 Another important provision in the Indian Patent Act, 2005, which Bangladesh may replicate, is that generic drugs that were already on the market at the time the Act was passed (i.e. before 2005) were exempted and thus could remain on the market.87

  • 88 William W. Fisher III and Cyrill P. Rigamonti, ‘The South Africa AIDS Controversy: A Case Study in (...)

43Compared to India, China and Brazil, South Africa has a larger health crisis to deal with, including a large number of HIV/AIDS patients and enormous problems of medicine access. Thus, the case of South Africa (economically the strongest African country) is particularly illustrative of a public health crisis and showcases the role that domestic and international patent laws and policies may play in this context.88

  • 89 South African Department of Health, ‘National Drug Policy for South Africa’, 3 (1996), p. 3.

44Despite its problems, South Africa has never used compulsory licenses. Prior to the revision of drug policy undertaken by its post- apartheid government, approximately 20% of the population, mostly white, was covered by private healthcare, while the black majority relied on public sector care, which was blighted by “irrational use of resources, poor working conditions and inadequate infrastructure”.89

  • 90 Articles 27(1)(a) and 27(2) of the Constitution of the Republic of South Africa, Act. 108 of 1996.

45Therefore, the vast majority of South Africans did not have access to healthcare at all, making healthcare reform one of the most important items on the agenda of the post-apartheid government. The post- apartheid constitution also mandated the state to take reasonable measures to provide access to healthcare services for everyone,90 which is why the then government appointed a National Drug Policy Committee to revamp South Africa’s healthcare system.

  • 91 South African Department of Health, ‘National Drug Policy for South Africa’, 4 (1996), pp. 10–11.

46After a series of investigations and consultations with stakeholders, including representatives of the pharmaceutical industry and the World Health Organization (WHO), the National Drug Policy Committee found that among the most notable deficiencies were the lack of equity in access to essential drugs, the comparatively high prices for pharmaceuticals in the private sector and the losses of drugs through poor security in the public sector.91

  • 92 Sabin Russell, ‘New Crusade to Lower AIDS Drug Costs’, The San Francisco Chronicle (24 May 1999), A (...)

47The pharmaceutical companies in South Africa argued that simply lowering drug prices could not solve the access problem, because South Africa did not have adequate infrastructure for the distribution of drugs. They cited the example of India where, despite the availability of generic versions of AIDS drugs, accessibility to medicines remained a problem.92

  • 93 Medicines and Related Substances Control Amendment Act No. 90 of 1997, South African Government Gaz (...)

48However, considering excessive pricing ofmedicines by multinational corporations (MNCs) in South Africa, the government inserted the new section 15C into the South African Medicines and Related Substances Control Act, 1997 (MRSCA).93 The primary purpose of this amendment was to enable South Africa to benefit from lower prices abroad for the same drugs.

  • 94 US subsidiaries accounted for 27% of the pharmaceutical market in South Africa, which was greater t (...)
  • 95 Quoted in ‘The South Africa AIDS Controversy’, p. 13.
  • 96 For details, see also ‘Notice of Motion in the High Court of South Africa’ (Transvaal Provincial Di (...)
  • 97 Heinz Klug, ‘Pharmaceutical Production and Access to Essential Medicines in South Africa’, in Intel (...)

49The MNCs, mostly led by the US pharmaceutical industry, vigorously opposed the enactment of section 15C, arguing that it was tantamount to a complete abrogation of patent rights and that it violated South Africa’s obligations under the TRIPS Agreement.94 As a representative of Bristol-Myers Squibb put it, “Patents are the lifeblood of our industry. Compulsory licensing and parallel imports expropriate our patent rights”; the spokesman added that the only beneficiary of the erosion of patents would be the generic drug industry.95 Nevertheless, the planned modifications, including section 15C, were signed into law by President Nelson Mandela on 12 December 1997. In an attempt to block the implementation of the amendments, the pharmaceutical companies took the matter to court and challenged the constitutionality of the amended MRSCA before the High Court of South Africa in February 1998.96 The position taken by South Africa was the reflection of a struggle between excessive pricing of patented medicines by the pharmaceutical companies and the societal and constitutional obligation to ensure access to medicines and right to health. Again, it was also fairly representative of the broader international struggle over the meaning of TRIP, especially over the scope of and exceptions to internationally recognised IPRs.97 However, due to numerous legal and political challenges such as settlement of court cases, delays in the formation of a pricing committee and effective implementation of MRSCA only began in 2007.

50While the experience of India, China, Brazil and South Africa offer important lessons for the LDCs like Bangladesh, relevant policies and recommendations of the World Health Organisation (WHO) can also help the LDCs gain wider international support and access to relevant financial and technical support to deal with the public health consequences of the TRIPS Agreement.

1.6 The Role of the WHO

  • 98 The UN adopted the WHO under Article 57 of the UN Charter. For details, see the agreement between t (...)
  • 99 S. Sell, ‘TRIPS-plus Free Trade Agreements and Access to Medicines’, Liverpool Law Review 28.1 (200 (...)

51The WHO is a specialised agency of the UN system of agencies and has a membership of 193 countries, making it one of the biggest organisations in terms of country membership in the world.98 After the introduction of the TRIPS Agreement under the WTO, the role of the WHO and its involvement in the area of IP and public health have grown immensely during the past decade. Sell stated rightly that “[since TRIPS, the] WHO increasingly has been drawn into trade issues [including IP issues], and NGOs have had considerable access to the institution” (emphasis added).99

  • 100 M. Volansky, ‘Achieving Global Health: A Review of the World Health Organization’s Response’, Tulsa (...)

52Considering the influence of the WHO in the field of global public health and relevant policymaking, Volansky remarked that the “WHO remains the predominant figure that guides, monitors, teaches, and even regulates Member States on global health”.100

  • 101 The World Health Assembly (WHA) is the supreme decision making body for the WHO. It generally meets (...)
  • 102 See for details, Mohammed K. El Said, Public Health Related TRIPS-Plus Provisions in Bilateral Trad (...)

53The WHO has issued several resolutions of vital importance in the area of IP and public health through its General Assembly.101 The World Health Assembly (WHA) in May 2003 was particularly important as it dealt with improving access to essential medicines. During the discussions, the US presented an industry-friendly resolution that ignored the Doha Declaration on the TRIPS Agreement and Public Health. Further, the US’s proposal recommended that the WHO should refrain from becoming involved in issues related to the implementation of TRIPS and should rather direct any such issues raised by member states to the WTO and WIPO for assistance.102

  • 103 WHO, Resolution of the World Health Assembly: Intellectual Property Rights, Innovation and Public H (...)

54After a prolonged and contentious discussion, a compromise was worked out by the US and the developing countries, which culminated in the establishment of a time-limited independent commission: the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).103 The CIPIH was set up by the director general of the WHO in February 2004. Its main focus was on reviewing existing R&D efforts, examining the role of IP in stimulating innovation and making concrete proposals for action by national and international stakeholders to encourage research on diseases prevalent in developing countries and LDCs.

  • 104 For details, see WHO, ‘Commission on Intellectual Property Rights, Innovation and Public Health’, h (...)
  • 105 Ibid.
  • 106 See WHO, Public Health, Innovation, Essential Health Research and Intellectual Property Rights: Tow (...)
  • 107 See Third World Network Brief on WHO: WHA strengthens WHO’s Mandate on IP and Health (27 May 2008), (...)

55In April 2006, CIPIH issued its final report (the CIPIH Report), making numerous recommendations for improving public health in developing countries and LDCs.104 These recommendations cover many areas related to institutional, legislative, health and negotiation policies.105 Following the issuance of the CIPIH Report at the WHA in May 2006, member states adopted a resolution entitled “Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action”.106 The global strategy underscores that the “WHO shall play a strategic and central role in the relationship between public health and innovation and intellectual property within its mandates”.107

  • 108 See for details, ‘The Global Strategy and Plan of Action on Public Health, Innovation and Intellect (...)
  • 109 Ibid.

56Again, the WHA adopted resolution WHA61.21 and resolution WHA62.16 in May 2008, which approved a global strategy and plan of action on public health, innovation and IP (hereafter “the global strategy”) to foster innovation and improve access to medicines for people in developing countries.108 The eight elements of the global strategy are designed to promote innovation, build capacity, improve access and mobilise resources. The global strategy includes prioritising R&D needs, promoting R&D, building and improving innovative capacity, the transfer of technology, and the application and management of IP to contribute to innovation and promote public health, among other measures.109

57The CIPIH Report and global strategy, along with relevant recommendations and discussion at the WHA, should be of great importance for the developing countries and the LDCs when formulating policy options for making TRIPS-compliant patent law and also promoting public health.

58However, the individual cases of Brazil, China, India and South Africa provide both optimistic and multifaceted perspectives on how leading developing countries can operate within the confines of TRIPS standards. The experiences of Brazil, China, India and South Africa indicate that the provisions they have adopted are now considered as justified under the TRIPS Agreement, although these were challenged in their initial stages by the US and other developed country members of the WTO, and by a number of MNPCs. The limits of permissible exceptions are not known, but there is no reason to think that TRIPS cannot be further qualified to foster the realisation of basic health needs. Bangladesh has the potential to become a substantial producer of generic medicines and could supply cheaper generic medicines to other developing countries and to the LDCs. On the other hand, there is a concern that the local pharmaceutical industry may not survive and that the price of pharmaceuticals may increase substantially after the introduction of TRIPS-compliant patent law in Bangladesh. Therefore, there may be good grounds for heeding the Indian, Brazilian and South African experiences in a way that takes into account the needs of the local population and industry. The subject of a multilateral trading system and the challenges induced in complying with the WTO system nationally and internationally has generated intense academic interest, with a consequently enormous output of literature.

1.7 Research Questions and Methodology

59The aims of the research are to identify how developing countries like India, Brazil, China and South Africa created a policy space not only for preserving their local pharmaceutical sector and promoting innovation and investment in it, but also for maintaining the affordability and availability of medicines domestically. Considering the critical socioeconomic conditions, the infrastructural and institutional limitations in the LDCs, this study intends to explore how LDCs like Bangladesh can ensure the promotion of pharmaceutical innovation but still provide affordable pharmaceuticals by building on the experiences of Brazil, China, India and South Africa and also the guidelines of the WHO. The thesis examines three underlying research questions:

  1. What are the policy options used by Brazil, China, India and South Africa for the implementation of the TRIPS Agreement and the preservation of the local pharmaceutical sector?

  2. What (potential) policies can the LDCs (such as Bangladesh) use to promote local pharmaceutical industry and access to medicines?

  3. What are the infrastructural and institutional issues that need to be addressed by the LDCs to deal with a post-TRIPS patent regime?

  • 110 Chris Armstrong, Jeremy de Beer, Dick Kawooya, Achal Prabhala and Tobias Schonwetter, Copyright and (...)
  • 111 Lorenzo Cotula, ‘Property Rights, Negotiating Power and Foreign Investment: An International and Co (...)

60This study combines doctrinal analysis, a comparative review and a case study using field research and employing a survey instrument and interviews to explore the identified research questions. This kind of combined research method has been applied in several legal research studies. For example, in the IP law field (the subject area within which this book lies) a study on copyright and access to knowledge in eight African countries applied the research method of combining doctrinal analysis, qualitative impact assessments and a comparative review.110 Moreover, Lorenzo Cotula, in his PhD thesis on property rights, negotiating power and foreign investment in Africa, applied doctrinal and comparative legal analysis along with a further component of field studies for data collection.111

61The doctrinal analysis here uses interpretive methods to examine relevant sources of patent law and to construct the protection of pharmaceutical patents in India, Brazil, South Africa and China from the perspective of both the local pharmaceutical industry and in terms of access to medicines. As the core research question involves options to be adopted in Bangladesh to promote the local pharmaceutical industry and access to medicines, the doctrinal analysis assesses those options adopted by India, Brazil, China and South Africa while adopting TRIPS- compliant patent law based on flexibilities available within the TRIPS Agreement. Therefore, the doctrinal analysis explores whether options adopted by these countries are compatible with TRIPS obligations, and to what extent these options are viable for an LDC such as Bangladesh. The legal analysis relies on both primary and secondary sources (patent law, government reports, regulations, orders and judicial decisions, and academic literature). As the research questions cut across different bodies of law (from the TRIPS Agreement to various branches of national law, patent law and pharmaceutical regulations), the spectrum of primary sources used is quite broad.

  • 112 H.L.A. Hart, The Concept of Law (Clarendon Press, 1961).
  • 113 H.W. Arthurs, Law and Learning: Report to the Social Sciences and Humanities Research Council of Ca (...)
  • 114 Terry Hutchinson, Researching and Writing in Law, 3rd edn (Law Book Co, 2010), p. 22.

62The advantage of doctrinal research is that it is a systematic formulation of the law in particular contexts, it clarifies ambiguities within rules, and it places them in a logical and coherent structure to describe their relationship to other rules.112 Doctrinal research is therefore concerned with the discovery and development of legal doctrines, and it clarifies the nature of a law. The validity of doctrinal research findings is unaffected by the empirical world. Doctrinal research makes no attempt to explain, predict or even to understand human behaviour, which is considered one of its major disadvantages. In asking “what is the law?”, doctrinal research takes an internal, participant-oriented epistemological approach to its object of study and, for this reason, is sometimes described as research in law.113 This is the source of the criticism that doctrinal research is not research about law at all.114

  • 115 Ibid., p. 23.

63There have been many other criticisms made of doctrinal methodology; for example, that it is too theoretical, too technical, uncritical and narrow in its choice and range of subjects, and that it does not take full account of the social and economic significance of the legal process. In response to these criticisms, doctrinal research is defended on the grounds that it provides the foundations for further socio-legal research and may be combined with other non-doctrinal research.115

  • 116 F. Cownie, Legal Academics: Culture and Identities (Hart Publishing, 2004), pp. 55–56.

64Therefore, it is important to understand that doctrinal research is not simply a single isolated category of scholarship. Some element of doctrinal analysis will be found in all but the most radical forms of legal research. For example, although legal reform-oriented research and socio-legal research appear as separate categories, their practitioners emphasise the importance of doctrinal legal analysis within their socio-legal work.116 This particular study uses doctrinal analysis to understand “what the patent law is” in Bangladesh, Brazil, India and South Africa. However, it also analyses the historical, political and local pharmaceutical industry motivations behind the patent law reforms in these countries. To better formulate policy options for Bangladesh, it also uses a comparative review.

  • 117 V.V. Palmer, ‘From Lerotholi to Lando: Some Examples of Comparative Law Methodology’, American Jour (...)
  • 118 Olu Fasan, ‘Commitment and Compliance in International Law: A Study of the Implementation of the WT (...)
  • 119 Jakkrit Kuanpoth, Patent Rights in Pharmaceuticals in Developing Countries: Major Challenges for th (...)
  • 120 See ‘Fault Lines in the World Trade Organization’.

65Comparative legal research methods have long been used in cross- national studies to identify, analyse and explain similarities and differences among countries’ legal systems and practices. The benefit of this kind of comparative review is to gain a deeper understanding of other countries and their legal process so as to identify best practices and draw important lessons that may be replicated in other countries. Comparative legal research is very beneficial in a legal development process where modification, compliance, amendment and changes to the law are required.117 It is typical for those who undertake this kind of research to examine the law as it is, while providing ideas and views for future legal development. For example, Olu Fasan investigated implementation of the TRIPS Agreement with a comparative study of Nigeria and South Africa.118 Jakkrit Kuanpoth undertook a comparative analysis between the patent laws of India and Thailand and identified some lessons for developing countries in general119 Daya Shanker analysed the TRIPS Agreement with reference to some specific TRIPS flexibility categories, including compulsory licenses and parallel imports, as used in Argentina, Brazil and India, and thus suggested possible options for developing countries.120

66The current study employs a comparative review to compare and contrast the perspectives of India and Brazil and to some extent South Africa and China, to identify all possible options used by them in the context of the implementation of the TRIPS Agreement and to draw lessons for LDCs such as Bangladesh.

67To answer the selected research questions on Bangladesh, this study further adopts field research in Bangladesh, which is conducted as a case study using a survey instrument and undertaking interviews of some selected stakeholders in the relevant area of research. This component mainly draws on the data from field studies conducted in Bangladesh. The purpose of this component is to complement the doctrinal analysis and comparative review by addressing the research questions in a way that better reflects the perceptions of the relevant stakeholders. A case study is conducted in a selected geographical area or with a very limited number of individuals as subjects of study; the aim is to collect factual background on a problem and draw inferences for possible strategies.121 Case studies, in their true essence, explore and investigate contemporary, real-life phenomena through detailed contextual analysis of a limited number of events or conditions, and their relationships. There are several categories of case study: exploratory, descriptive, explanatory, interpretive and evaluative.122 For example, Robert Lewis-Lettington and Peter Munyi conducted a case study in Kenya regarding willingness and ability to use TRIPS flexibilities, using doctrinal analysis and a descriptive and explanatory case study approach. Amy Kapczynski conducted a case study on TRIPS implementation in India’s pharmaceutical sector based on field research and interviews.123 In the current case study, I follow interpretive and evaluative case study methods.

68Through interpretive case studies, I aim to interpret the data by developing conceptual categories, supporting or challenging the assumptions made regarding them and, in terms of evaluative case studies, going further to add my own judgment on the phenomena found in the data. Gaining both qualitative and quantitative data enables the researcher to examine the views of all stakeholders regarding the introduction of pharmaceutical patents, including their conflicting positions, so as to provide policy options for the smoother implementation of a TRIPS-compliant patent law.

69The survey instrument is designed to gain an understanding of the perceptions of different stakeholders regarding TRIPS-compliant patent law and pharmaceutical patent protection. It was also useful to collect some qualitative data about the pharmaceutical companies, their strategies and innovation capacities. Obtaining qualitative and quantitative data was also useful in answering the research questions by pinpointing major concerns and motivations for the transition from a pre-TRIPS to a TRIPS-compliant patent regime. Obtaining qualitative and quantitative data via interviews was also helpful in understanding institutional details about the pharmaceutical industry, the DDA, the Patent Office, research and educational institutions, and public health groups. Interviews, in particular, were very valuable in understanding the required policy directions needed for the reform of patent law from the participants’ perspectives, showing how they weighed the costs and benefits for themselves, and the extent to which they trusted in the change to a TRIPS-compliant pharmaceutical patent system.

1.8 Chapter Summary

70This book is structured in five chapters. Chapter 1 offers an overall summary. It also includes a statement of the importance of this research regarding its contribution to the existing body of research, background information about the TRIPS Agreement, an introduction to pharmaceutical patents and a description the research method adopted. Chapter 2 focuses on the situation in Bangladesh and contains an overview of the current patent law and the pharmaceutical industry of Bangladesh. In focusing on Bangladesh, the opportunities and challenges for the pharmaceutical industry are presented in the context of the requirement for TRIPS-compliant patent law. The chapter also examines the effect of TRIPS on the pharmaceutical regulation and pricing of drugs, considering the situation before TRIPS and possible implications of the introduction of TRIPS and pharmaceutical patents. Chapter 3 examines the situations in Brazil, China, India and South

71Africa with reference to the options these countries have used in their progress to TRIPS compliance. This forms the basis of the analysis of possible options for Bangladesh to proceed to TRIPS compliance.

72Chapter 4 presents the policy options identified in the research as an outcome of the globalising standard of patent protection in WTO law. There are two categories of policy options. The first involves a focus on various legislative changes that will be required to the existing patent law of Bangladesh; the second focuses on potential governmental/policy interventions and discusses changes in policy direction that may be needed.

73Chapter 5 discusses the infrastructure and institutional issues that are needed for LDCs such as Bangladesh—while implementing TRIPS successfully—to progress towards innovation and graduate from the LDC category. The chapter concludes by summarising this work’s contributions to knowledge and the options for further research in relevant fields.

Notes

1 Agreement on Trade-related Aspects of Intellectual Property Rights, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, U.N.T.S. 299, 33 I.L.M. 1197, art. 65 (1994) [hereinafter TRIPS Agreement], https://www.wto.org/english/docs_e/legal_e/27-trips.pdf

2 There are no World Trade Organisation definitions of ‘developed’ or ‘developing’ countries. Least-developed Countries, ‘Understanding the WTO: The Organization’, World Trade Organization, https://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm. “The WTO recognizes as [LDCs] those countries which have been designated as such by the United Nations. There are currently 48 [LDCs] on the UN list, 34 of which to date have become WTO members” (ibid.). According to the United Nations, LDCs are countries that exhibit the lowest indicators of socioeconomic development, with the lowest human development index (HDI) ratings of all the countries in the world. A country is classified as an LDC if it meets three criteria: low income (three-year average GNI per capita of less than $ 992, which must exceed $ 1,190 to leave the list), human resources weakness (based on indicators of nutrition, health, education and adult literacy) and economic vulnerability (based on instability of agricultural production, instability of exports of goods and services, economic importance of non-traditional activities, merchandise export concentration, handicap of economic smallness and the percentage of population displaced by natural disasters). However, countries “graduate” from the LDC classification when indicators exceed these criteria (ibid.). See for details, Criteria for Identification and Graduation of LDCs, UN-OHRLLS, http://unohrlls.org/about-ldcs/ criteria-for-ldcs

3 See for details, WTO, ‘Responding to Least Developed Countries’ Special Needs in Intellectual Property’, http://www.wto.org/english/tratop_e/trips_e/ldc_e.htm

4 See WTO, ‘Decision of the Council for TRIPS on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-developed Country Members for Certain Obligations with Respect to Pharmaceutical Products’, 27 June 2002 (Document IP/C/25).

5 WTO, ‘Decision of the Council for TRIPS of 11 June 2013’ (Document IP/C/64).

6 WTO, ‘Communication from Bangladesh on behalf of the LDC Group’, 23 February 2015 (Document IP/C/W/605).

7 Ibid.

8 Ibid.

9 WTO, ‘Decision of the Council for TRIPS of 6 November 2015’ (Document IP/C/73).

10 M. Monirul Azam and Mahesti Okitasari, ‘Environmental Governance and National Preparedness towards 2030 Agenda for Sustainable Development: A Tale of Two Countries’, Global Environmental Research Japan 19.2 (2015): 217.

11 UN, Report of the Open Working Group of the General Assembly on Sustainable Development Goals, Resolution 68/970, 2014.

12 For details of the 34 LDCs that are WTO members, see WTO, ‘WTO and the Least Developed Countries’, https://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm

13 Mohammad Abu Yusuf and Qamrul Alam, ‘WTO TRIPS Agreement: Current State of Pharmaceutical Industry and Policy Options for Bangladesh’, International Business Research 1.1 (2008): 135–45.

14 Mohammad Monirul Azam and Kristy Richardson, ‘Trips Compliant Patent Law and the Pharmaceutical Industry in Bangladesh: Challenges and Opportunities’, LAWASIA Journal (2010b): 141–54.

15 See for details, ‘Reports and Statistics from Directorate of Drug Administration in Bangladesh’, http://www.dgda.gov.bd/index.php

16 Anne St Martin, ‘The Impact of Trade Related Aspects of Intellectual Property Rights (TRIPS) on Access to Essential Medicines in the Developing World’ (a research report submitted to Worcester Polytechnic Institute, 1 May 2006), p. 2.

17 Shawkat Haider, ‘Access to Medicines for All’, Dhaka Tribune, 20 November 2015, http://www.dhakatribune.com/op-ed/2015/nov/20/access-medicine-all

18 For human rights perspectives on intellectual property (IP), see R.D. Anderson and H. Wager, ‘Human Rights, Development and The WTO: The Cases of Intellectual Property and Competition Policy’, Journal of International Economic Law 9.3 (2006): 707–47; L.R. Helfer, ‘Towards a Human Rights Framework for Intellectual Property, UC Davis Law Review 40.3 (2007): 971–1020; D.B. Barbosa, M. Chon and A. M. von Hase, ‘Slouching towards Development in International Intellectual Property’, Michigan State Law Review 1 (2007): 114–23.

19 See Mohammad Monirul Azam and Morshed Mamud Khan, ‘WTO TRIPS Agreement: Implications for the Developing Countries’, Journal of the Institute of Bangladesh Studies 27 (2004): 23; see also, for background study, John H. Jackson, The Jurisprudence of GATT and the WTO (Cambridge University Press, 2000).

20 Member countries have agreed to be bound by the commitments under various WTO agreements. These include the principles of national treatment and the “Most Favoured Nation” clause to ensure non-discrimination between nationals and foreign nationals, as well as goods and services. Similarly, members have to introduce patent protection for pharmaceuticals under the WTO TRIPS Agreement.

21 This has been the most important argument for the opponents of the WTO, as decision making on important issues of national interest has been encompassed within the WTO framework. See WTO and Implications for South Asia, ed. by K.C. Reddy (Serials Publications, 2006), p. 1.

22 Membership of the WTO is conditional on the full acceptance—without reservation—of almost all WTO agreements; see General Agreement on Tariffs and Trade: Multilateral Trade Negotiations (The Uruguay Round): Final Act Embodying the Results of the Uruguay Round of Trade Negotiations, 15 December 1993 (1994), 33 I.L.M. 1 [referred to as WTO agreements]. The WTO Agreement has four annexures, the first three of which are integral parts of the agreement. Annexure 1 deals with agreements on trade in goods, trade in services and trade-related aspects of IPRs. Annexure 2 deals with dispute resolution, with Annexure 3 providing for a process of multilateral surveillance of national trade policies. Only Annexure 4 deals with agreements that are not necessarily binding on member states. Article XVI(4) of the WTO Agreement provides that “each Member shall ensure the conformity of its laws, regulations and administrative procedures with its obligations as provided in the annexed Agreements”. See Michael J. Trebilcock and Robert Howse, The Regulation of International Trade, 2nd edn (Routledge, 1999).

23 Mohammad Monirul Azam, ‘Establishment of the WTO and Challenges for the Legal System of Bangladesh’, Macquarie Journal of Business Law 3 (2006): 23.

24 Earlier IPR conventions such as the Berne Convention of 1886 and the Paris Convention of 1883 under the auspices of the World Intellectual Property Organization (WIPO) provided some general principles regarding copyright, related rights and industrial property, but they lacked effective enforcement mechanisms, and there were no binding guidelines for making national intellectual property laws; see Mohammad Monirul Azam, WTO, Intellectual Property and Bangladesh (New Warsi Book Corporation, 2008).

25 The exceptions are utility models and plant breeders’ rights, although TRIPS members are obliged to provide some kind of effective plant variety protection.

26 J.J. Simons, ‘Cooperation and Coercion: The Protection of Intellectual Property in Developing Countries’, Bond Law Review 11.1 (1999): 1.

27 Sylvia Ostry, Intellectual Property Protection in the WTO: Misuses in the Millennium Round (Fraser Institute Conference, Santiago, 19 April 1999), p. 3.

28 John Madely, Hungry for Trade (Zed Books, 2000), pp. 96–97.

29 A text codifying the Intellectual Property Rights Commission’s (IPC’s) consensus position was released on 14 June 1988 in Washington, Brussels and Tokyo, with the title Basic Framework of GATT Provisions on Intellectual Property: Statement of Views of the European, Japanese and United States Business Communities. For a more complete history of the TRIPS negotiations and pharmaceutical patents, see P. Drahos, Who Owns the Knowledge Economy: Political Organizing behind TRIPS (2004), http://www. thecornerhouse.org.uk/resource/who-owns-knowledge-economy

30 Mansfield claimed that 65% of pharmaceuticals and 30% of chemical inventions would not have taken place without patent protection; see E. Mansfield, ‘Intellectual Property Protection, Direct Investment and Technology Transfer: Germany, Japan and the United States’ (Discussion Paper No. 27, World Bank and International Finance Corporation, 1995); E. Mansfield, ‘Patents and Innovation: An Empirical Study’, Management Science 32.2 (1986): 173–81; Other studies reaching similar conclusions include Scherer et al. (1959), Taylor and Silberston (1973), Arundel and van de Paal (1995) and Cohen et al. (1997); see W.M. Cohen, R.R. Nelson and J. Walsh, ‘Appropriability Conditions and Why Firms Patent and Why They Do Not in the U.S. Manufacturing Sector’ (Working Paper, Carnegie Mellon University, 1997); A. Arundel and G. van de Paal, Innovation Strategies of Europe’s Largest Industrial Firms (unpublished manuscript, Maastricht Economic and Social Research and Training Centre [MERIT], 1995); C.T. Taylor and Z.A. Silberston, The Economic Impact of the Patent System (Cambridge University Press, 1973); F.M. Scherer, S.E. Herzstein, A.W. Dreyfoos, W.G. Whitney, O.J. Bachman, C.P. Pesek, C.J. Scott, T.G. Kelly and J.J. Galvin, Patents and the Corporation: A Report on Industrial Technology under Changing Public Policy (Harvard University Press, 1959).

31 However, the evidence linking intellectual property rights (IPRs) to foreign direct investment (FDI) and technology transfer is mixed. Stronger IPR protection has been found to encourage FDI and technology transfer in certain industries, most notably in chemicals and pharmaceuticals. As with trade, IPRs may play less of a role in high-tech industries due to the difficulty in imitating these industries’ products, while in low-tech industries other factors such as market size, cheap labour and political stability may be more important in determining FDI flows than IPRs. Smarzynska (2004) finds that weak IPR regimes deter FDI in high- tech sectors (i.e. drugs, cosmetics and healthcare products, chemicals, machinery and equipment, and electrical equipment), with some evidence suggesting that FDI is deterred in other industries also. She also finds evidence to suggest that stronger IPR protection encourages firms to set up local production facilities rather than focusing solely on distribution networks. Branstetter et al. (2004) suggest that technology transfer is higher following IPR reforms, with an increase in technology transfer, as measured by intra-firm royalty payments from parent firms to affiliates located in IPR-reforming countries. See for details, B. Smarzynska, ‘The Composition of Foreign Direct Investment and Protection of Intellectual Property Rights: Evidence from Transition Economies’, European Economic Review 48 (2004), 39–62; L.G. Branstetter, R. Fisman and C.F. Foley, ‘Do Stronger Intellectual Property Rights Increase International Technology Transfer? Empirical Evidence from U.S. Firm-level Panel Data’ (Working Paper No. 3305, World Bank Policy Research, 2004). However, Primo-Braga and Fink (1998) found no evidence of a relationship between FDI flows and IPR protection, and Maskus et al. (2005) argued that strong IPR protection is not a necessary condition for firms to invest in particular countries. If it were, then large countries with high growth rates but weak IPR regimes, such as Brazil and China, would not have received the large foreign investment inflows that they have. See for details, C.A. Primo-Braga and C. Fink, ‘The Relationship between Intellectual Property Rights and Foreign Direct Investment’, Duke Journal of Comparative and International Law 9 (1998): 163–88, and K.E. Maskus, S.M. Dougherty and A. Mertha, ‘Intellectual Property Rights and Economic Development in China’ in Intellectual Property and Development: Lessons from Recent Economic Research, ed. by C. Fink and K.E. Maskus (World Bank/Oxford University Press, 2005).

32 See for details, WHO, Globalization and Access to Drugs: Implications of the WTO/ TRIPS Agreement, Health Economic and Drugs Series, No. 007 (1998), p. 46, http://apps.who.int/medicinedocs/en/d/Jwhozip35e/3.5.html

33 Jane O. Lanjouw, ‘The Introduction of Pharmaceutical Product Patents in India: “Heartless Exploitation of the Poor and Suffering”?’ (Working Paper No. 6366, Yale University and the NBER, 26 August 1997), p. 2.

34 Martin Khor, ‘Rethinking Intellectual Property Rights and TRIPS’, in Global Intellectual Property Rights—Knowledge, Access and Development, ed. by Peter Drahos and Ruth Mayne (Palgrave Macmillan, 2002), pp. 201–13.

35 Ma El Farag Balat and M.H. Loutifi, ‘The TRIPS Agreement and Developing Countries: A Legal Analysis of the Impacts of the New IPR’s Law on the Pharmaceutical Industry in Egypt’, Web JCILI 2 (2004): 3.

36 For example, after the introduction of patent protection for pharmaceuticals in India in line with the TRIPS Agreement, Bhutan (a non-WTO member and LDC) is now facing problems of cheap availability of drugs; see Tandi Dorji, ‘Effects of TRIPS on Pricing, Affordability and Access to Essential Medicines in Bhutan’, Journal of Bhutan Studies 16 (Summer 2007), 128–41.

37 Xuan Li, ‘The Impact of Higher Standards in Patent Protection for Pharmaceutical Industries under the TRIPS Agreement—A Comparative Study of China and India’, The World Economy 31.10 (2008): 14.

38 Ibid.

39 Ibid.

40 Ibid.

41 Ibid.

42 M. Boldrin and D.K. Levine, Against Intellectual Monopoly (Cambridge University Press, 2008), pp. 212–42.

43 Edwin Cameron and Jonathan Berger, ‘Patents and Public Health: Principle, Politics and Paradox’, SCRIPT-ed 1.4 (2004): 532. http://www2.law.ed.ac.uk/ahrc/ script-ed/docs/cameron.asp

44 Sanjaya Lall, ‘Indicators of the Relative Importance of IPRs in Developing Countries’ (UNCTAD-ICTSD Project on IPRs and Sustainable Development, 1 June 2003), p. 1.

45 The Introduction of Pharmaceutical Product Patents in India’, p. 2.

46 S. Srinivasan, ‘How TRIPS Benefits Indian Industry and How It May Not Benefit the Indian People’, Indian Journal of Medical Ethics 5.2 (2008): 68.

47 In a case study of the United Nations Conference on Trade and Development (UNCTAD) in Bangladesh (2007), it was revealed that without imitation, learning would be made extremely difficult for countries with low technological capabilities. See for details, Padmashree Gehl Sampath, ‘Intellectual Property in Least Developed Countries: Pharmaceutical, Agro-processing, and Textiles and RMG in Bangladesh’ (study prepared for UNCTAD as a background Paper for The Least Developed Countries Report, Geneva: UNCTAD, 2007a).

48 Padmashree Gehl Sampath, ‘Innovation and Competitive Capacity in Bangladesh’s Pharmaceutical Sector’ (Working Paper Series, Paper No. 2007–031, United Nations University, Maastricht Economic and Social Research and Training Centre [UNU- MERIT], September 2007b), p. 2.

49 The law relating to patents in Bangladesh is the Patents and Designs Act, 1911 (PDA) with some minor amendments to date.

50 Article 27.1 of the TRIPS Agreement.

51 Although patents were always issued to protect the production process, without patent restrictions on products, pharmaceutical companies were still able to use reverse engineering techniques on essential medicines to understand their molecular structure and develop new ways to recreate those drugs. Compounds produced through these alternate processes were then sold as “generic” versions of the original drug, which drove down the price of the original product through market competition. However, if product patent is granted, for the duration of patent protection, even if they are using an alternative process, other companies cannot introduce generic products to the market; hence, the monopolised price of the patent holder is protected.

52 Articles 6, 7, 30 and 31 of the TRIPS Agreement.

53 See Article 33 of the TRIPS Agreement.

54 See WIPO, Study on Patent Related Flexibilities in the Multilateral Legal Framework and Their Legislative Implementation at the National and Regional Levels (WIPO Committee on Development and Intellectual Property [CDIP], Fifth Session, WIPO Secretariat, Geneva, 26–30 April 2010), p. 8.

55 Ibid, para. 34.

56 Article 39.3 of the TRIPS Agreement requires member countries to establish protection for submitted test data. However, this requirement is in fact narrowly drawn, and countries maintain substantial flexibility in its implementation. The public interest in limiting protection for data is to promote competition and to ensure that data protection does not become the means to block the timely entrance of generic competitors to off-patent drugs, because generic competitors drive down price, thereby promoting greater accessibility to medicines. See Carlos Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: Implementing the Standards of the TRIPS Agreement (South Centre, 2002).

57 Carlos Correa, Intellectual Property Rights, The WTO and Developing Countries: The TRIPS Agreement and Policy Options (Zed Books, 2000); Christopher May and Susan K. Sell, Intellectual Property Rights: A Critical History (Lynne Rienner Pub., 2005).

58 Case No 4138/98 in the High Court of South Africa; see, M. Monirul Azam, ‘The Experiences of Patent Law Reforms in Brazil, India and South Africa and Lessons for Bangladesh’, Akron Intellectual Property Journal 7.2 (2014): 61–100.

59 WTO, ‘Measures Affecting Patent Production—Request for Consultation by the United States’ (WT/DS199/1); WTO, ‘Brazil—Measures Affecting Patent Protection—Request for the Establishment of a Panel by the United States’ (WT/ DS199/3); see also, Azam (2014).

60 See Sharifah Rahma Sekalala, ‘Beyond Doha: Seeking Access to Essential Medicines for HIV/AIDS through the World Trade Organisation’, p. 5, http://siteresources.worldbank.org/INTRAD/Resources/SSekalala.pdf

61 Ibid., p. 5.

62 WTO, ‘Submission by the African Group to the TRIPS Council for Special Discussion on Intellectuel Property and Access to Medicines’, 20 June 2001 (Document IP/C/W/296) https://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm

63 Ibid.

64 Sekalala, p. 6.

65 See, ‘US Statement at TRIPS Council Meeting’, 20 June 2001, https://www.wto.org/english/news_e/news01_e/trips_drugs_010620_e.htm

66 WTO, ‘Declaration on the TRIPS Agreement and Public Health (Doha Declaration)’, 14 November 2001 (WT/MIN(01)/DEC/2), para. 4, https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

67 Carlos Correa, ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health’ (WHO, 2002).

68 Para. 5b, Doha Declaration.

69 Correa (WHO, 2002).

70 Ibid.

71 Para. 5d, Doha Declaration.

72 See for details, WTO, ‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, Decision of the General Council of 30 August 2003’ (WT/L/540 and Corr.1), https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm

73 Although it was originally to be adopted by 1 December 2007, the General Council decision of 30 November 2015 (Document WT/L/965) extended the deadline to 31 December 2017, as the August 30th Decision is yet to be ratified by two-thirds of the members.

74 For details on the operational procedure of the August 30th Decision, see chapter 3 of this study.

75 Mohammad Monirul Azam, ‘Establishment of the WTO and Challenges for the Legal System of Bangladesh’, Journal of Business Law 3 (2006): 23–45.

76 Mathew Flynn, ‘Corporate Power and State Resistance: Brazil’s Use of TRIPS Flexibilities for Its National AIDS Program’, in Intellectual Property, Pharmaceuticals and Public Health, ed. by Kenneth C. Shadlen, Samira Guennif, Alenka Guzman, and N. Lalitha (2011).

77 Brazil, Industrial Property Law, No 9.279, 14 May 1996.

78 Médecins Sans Frontières (MSF) and other public health groups, along with 120 Brazilian non-governmental organisations (NGOs) requested that the United States government withdraw its request for a WTO dispute settlement procedure on the Brazilian patent law. The US brought a complaint before the WTO Dispute Settlement Body (DSB) in Geneva, requesting measures that might handicap the successful Brazilian AIDS programme, which is largely based on Brazil’s ability to manufacture affordable treatment. See WT/DS199/1 (8 June 2000), Brazil: Measures Affecting Patent Protection, 30 December 2009, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds199_e.htm

79 Brazil, ‘Presidential Decree on Compulsory Licensing’, Decree No. 3, 201, 6 October 1999.

80 Statement by Paul Cawthorne, coordinator for MSF’s Access Campaign in Asia; see for more details, http://www.aljazeera.com/news/asia-pacific/2012/06/2012694923223634.html

81 Said by Paul Cawthorne, coordinator for MSF’s Access Campaign in Asia; quoted in Tan Ee Lin,‘China Changes Patent Law in Fight for Cheaper Drugs’, 8 June 2012, http://www.reuters.com/article/us-china-medicines-patents-idUSBRE8570TY20120608

82 Katia Gomez, ‘Inside the TRIPS Agreement’, Journal of International Affairs at UCSD 8 (2009).

83 Ibid, p. 9.

84 Philippe Cullet, ‘Patent Bill, TRIPS and Right to Health’, Economic and Political Weekly 36.43, 27 October 2001, http://www.ielrc.org/content/a0108.pdf

85 Ibid.

86 Dipika Jain, ‘Access to Drugs in India: Exploration of Compulsory Licensing as an Effective Tool’ (unpublished LLM Paper, Harvard Law School, 2009), p. 8.

87 Ibid., pp. 6–7.

88 William W. Fisher III and Cyrill P. Rigamonti, ‘The South Africa AIDS Controversy: A Case Study in Patent Law and Policy, Harvard Law School’, 10 February 2005, http://cyber.law.harvard.edu/people/tfisher/South Africa.pdf

89 South African Department of Health, ‘National Drug Policy for South Africa’, 3 (1996), p. 3.

90 Articles 27(1)(a) and 27(2) of the Constitution of the Republic of South Africa, Act. 108 of 1996.

91 South African Department of Health, ‘National Drug Policy for South Africa’, 4 (1996), pp. 10–11.

92 Sabin Russell, ‘New Crusade to Lower AIDS Drug Costs’, The San Francisco Chronicle (24 May 1999), A1.

93 Medicines and Related Substances Control Amendment Act No. 90 of 1997, South African Government Gazette No. 18, 505 of 12 December 1997 (amending the Medicines and Related Substances Control Act No. 101 of 1965, as amended by Act Nos. 65/1974, 17/1979, 20/1981 and 94/1991).

94 US subsidiaries accounted for 27% of the pharmaceutical market in South Africa, which was greater than the share of the South African local pharmaceutical industry; for details, see Lynne Duke, ‘Nkosazana Zuma—Activist Health Minister Draws Foes in S. Africa’, Washington Post, 11 December 1998, A41.

95 Quoted in ‘The South Africa AIDS Controversy’, p. 13.

96 For details, see also ‘Notice of Motion in the High Court of South Africa’ (Transvaal Provincial Division), Case No. 4183/98.

97 Heinz Klug, ‘Pharmaceutical Production and Access to Essential Medicines in South Africa’, in Intellectual Property, Pharmaceuticals and Public Health—Access to Drugs in Developing Countries, ed. by Kenneth C. Shalen, Samira Guennif, Alenka Guzman and N. Lalitha (Cheltenham: Edward Elgar, 2011), pp. 29–56.

98 The UN adopted the WHO under Article 57 of the UN Charter. For details, see the agreement between the UN and the WHO, 12 November 1948.

99 S. Sell, ‘TRIPS-plus Free Trade Agreements and Access to Medicines’, Liverpool Law Review 28.1 (2007): 41–75.

100 M. Volansky, ‘Achieving Global Health: A Review of the World Health Organization’s Response’, Tulsa Journal of Comparative International Law 10 (2002): 223–24.

101 The World Health Assembly (WHA) is the supreme decision making body for the WHO. It generally meets in Geneva in May each year, and is attended by delegations from all 193 member states.

102 See for details, Mohammed K. El Said, Public Health Related TRIPS-Plus Provisions in Bilateral Trade Agreements: A Policy Guide for Negotiators and Implementers in the Eastern Mediterranean Region (WHO and ICTSD, 2010), p. 1.

103 WHO, Resolution of the World Health Assembly: Intellectual Property Rights, Innovation and Public Health, WHA56.27 (Geneva: WHO, 2003), http://www.who.int/intellectualproperty/documents/en/

104 For details, see WHO, ‘Commission on Intellectual Property Rights, Innovation and Public Health’, http://www.who.int/intellectualproperty

105 Ibid.

106 See WHO, Public Health, Innovation, Essential Health Research and Intellectual Property Rights: Towards a Global Strategy and Plan of Action, A59/A/Conf. Paper No. 8 (Geneva: WHO, 2006), http://www.who.int

107 See Third World Network Brief on WHO: WHA strengthens WHO’s Mandate on IP and Health (27 May 2008), http://www.twn.my/title2/health.info/2008/twnhealthinfo20080602.htm

108 See for details, ‘The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property’, http://www.who.int/phi/implementation/phi_globstat_action/en/

109 Ibid.

110 Chris Armstrong, Jeremy de Beer, Dick Kawooya, Achal Prabhala and Tobias Schonwetter, Copyright and Access to Knowledge in Eight African Countries (2010).

111 Lorenzo Cotula, ‘Property Rights, Negotiating Power and Foreign Investment: An International and Comparative law Study on Africa’ (unpublished PhD thesis, University of Edinburgh School of Law, 2009).

112 H.L.A. Hart, The Concept of Law (Clarendon Press, 1961).

113 H.W. Arthurs, Law and Learning: Report to the Social Sciences and Humanities Research Council of Canada by the Consultative Group on Research and Education in Law (Information Division, Social Sciences and Humanities Research Council of Canada, 1983).

114 Terry Hutchinson, Researching and Writing in Law, 3rd edn (Law Book Co, 2010), p. 22.

115 Ibid., p. 23.

116 F. Cownie, Legal Academics: Culture and Identities (Hart Publishing, 2004), pp. 55–56.

117 V.V. Palmer, ‘From Lerotholi to Lando: Some Examples of Comparative Law Methodology’, American Journal of Comparative Law 53 (2005): 261–2.

118 Olu Fasan, ‘Commitment and Compliance in International Law: A Study of the Implementation of the WTO TRIPS Agreement in Nigeria and South Africa’, African Journal of International and Comparative Law 20.2 (2012): 191–228.

119 Jakkrit Kuanpoth, Patent Rights in Pharmaceuticals in Developing Countries: Major Challenges for the Future (Edward Elgar, 2010).

120 See ‘Fault Lines in the World Trade Organization’.

121 Zaidah Zainal, Case Study as a Research Method, http://psyking.net/htmlobj-3837/case_study_as_a_research_method.pdf

122 Ibid.

123 Amy Kapczynski, ‘Harmonisation and Its Discontents: A Case Study of TRIPS Implementation in India’s Pharmaceutical Sector’, California Law Review 97 (2009): 1571–650.

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