Chapter 10 Patents and Public Health: Patents and Access to Medicines – The Exhaustion Dimension

In: Patent Exhaustion and International Trade Regulation
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10.1 Historical Perspective of Patents, Public Health Concerns and Access to Medicines: The Indian Experience

In this book it has been discussed how patent laws existing in industrialised nations since centuries, were introduced to their colonies forming the patent laws in most of today’s developing countries and ldcs. The colonial governments’ policies were regressive and promoted exclusively their monopolistic interests. The Indian experience is shared in this chapter given its path to becoming the largest global supplier of generic pharmaceutical drugs and seen as a model for other developing countries. India’s experience with trade under the colonial rulers had a serious impact on accessibility of medicines at reasonable price,

India was forced to absorb Britain’s surplus of increasingly obsolescent and non-competitive industrial exports. By 1910 this included two-fifths of the UK’s finished cotton goods and three-fifths of its exports of electrical products, railway equipment, books and pharmaceuticals (Emphasis added).649

This is not an isolated example that one might think the local industry in India and other developing countries of today were unable to produce enough at that period. On the contrary, colonies like India did not just cater to the local market, but also contributed generously to global markets. But unfortunately, systematically this eroded during colonial rule. The table below reflects the statistics on share of world manufacturing and the dramatic difference between the years 1750 and 1900, hence presents a clear picture of the global manufacturing in this period.650 The influence of industrial revolution can be seen in the numbers of Europe from 1860 onwards but until then the statistics favoured the developing countries of today, the erstwhile colonies.

Table 1

Shares of World Manufacturing Output (in %), 1750–1900

Countries

1750

1800

1830

1860

1880

1900

Tropics

76.8

71.2

63.3

39.2

23.3

13.4

China

32.8

33.3

29.8

19.7

12.5

6.2

India

24.5

19.7

17.6

8.6

2.8

1.7

Europe

23.1

28.0

34.1

53.6

62.0

63.0

UK

1.9

4.3

9.5

19.9

22.9

18.5

In such backdrop where colonial rulers had choked local industrial development and where indigenous production was destroyed, patent law made its entry into some of these countries. The patent law aimed to protect the rights of the colonial rulers who mainly used it to import among other things, bulk drugs, active ingredients and formulations for pharmaceutical drugs to sell them in the captive colony markets at exorbitant prices. In India it was noticed that 90% of the patents were never worked locally creating constant shortage and high medicine prices.651 Interesting to note that while colonies had no choice but to follow their rulers’ laws, at the same time some other countries like France, Germany, and Switzerland adopted weak patent laws enabling legitimate reverse engineering and growth of local pharmaceutical industry.652 In fact the Swiss legislature initially rejected proposals for enacting patent law until 1887 when it finally passed it. Similarly, Netherlands had repealed their patent law in 1869 and re-enacted it only after the home industry was ready, after more than 40 years in 1910.653

The example of India is important since its patent law was the main pillar behind the growth of the country’s generic pharmaceutical industry and it became an example for other developing countries. After gaining independence, prices of medicines in India were still exorbitant, leading to serious problems related to access to medicines, hindering a meaningful solution to the plethora of diseases and epidemics.654 The government commissioned a detailed study under the leadership of retired Lahore High Court judge Dr. T.B. Chand in 1948 and later another study was commissioned in 1957 under the leadership of Justice N. Rajagopala Ayyangar. These two studies analysed patent laws of different countries of the world as they had evolved as well as industrial policies related to pharmaceutical production and recommended sweeping changes. The ‘Tek Chand Committee Report’ and the ‘Ayyangar Committee Report’ formed the foundation of the Indian Patent Act 1970.655 India was one of the first developing countries to assess the patent law as one of the main reasons for high price and lack of access to pharmaceutical medicines and subsequently change their patent law.

With the new patent law in effect from 1971, India transformed from a medicine-starved country to not only self-sufficiency, but also became the global supplier of high quality low-priced generic pharmaceutical drugs. Gradually following this example other developing nations also excluded pharmaceutical products from product-patents so that their local industries could reverse engineer and manufacture its generic equivalents locally or be able to legally import generics into their countries.656 This undoubtedly had a global welfare enhancing effect, enabling the low-income nations access pharmaceutical drugs at reasonable prices in absence of patents.657 However the divide between the industrialised countries as introducers of these drugs globally and the developing countries manufacturing high quality legitimate copies and marketing globally, became a matter of serious contention.

While most of the developing countries were at a very nascent stage of industrialisation during the 1980–1990s, the industrialised countries had moved well ahead. With countries increasingly moving towards laissez faire economy, government support in pharmaceutical production kept reducing while private sector investments in pharmaceutical industry kept increasing. The multinational pharmaceutical giants operating in the global market are some of the lead spenders in r&d across industry with a rapidly expanding investment throughout the years.658 While it is true that unlike government backed research, profit motive runs the private pharmaceutical companies and one cannot negate their contribution to new drug discoveries. In such scenario their demand for lead-time over their competitors through patents, were legitimate and the possibility of reverse engineering through weaker patent laws obviously would free-ride on their costs. While the pharmaceutical companies needed sufficiently strong patent laws to recuperate their r&d investments, the patents often lead to a monopoly-pricing situation that increased the drug prices leading to an access problem.659 The trips Agreement was introduced within the new wto regime at this juncture in 1994, coming into effect in 1995, with developing countries getting 10 more years with certain conditions and the ldcs are still under extended transition period.

10.2 Post-trips Scenario: Patents, Public Health Concerns and Access to Medicines

It has already been discussed while elaborating on the negotiating history of trips that trips was introduced at this juncture bringing sweeping changes including patent protection for all technologies and minimum 20 years patent term upon filing.660 This had an adverse impact on the hiv/aids related drugs since most of them were patented except the basic conventional ones on the who list. This gave considerable leverage to the research-based pharmaceutical companies to negotiate pricing favourable to them while affected countries had already lost the possibility to procure cheaper generic versions post-2005 after the transition period for developing countries lapsed.661 Historically, cl had been extensively used by the US not as a provision in its patent law (since it does not exist in patent law) but as measure to remedy anti-competitive practices. Brazil, Canada, France and Israel had also used it to a considerable extent.662 Hence using cl should not have been a problem hence developing countries facing public health crisis, tried to use the trips provisions of using cl as well as allowing parallel imports to access pharmaceutical drugs at reasonable prices during their national emergencies.

One also needs to understand that cl provisions in the trips Article 31 are extra-ordinary measures to address extra-ordinary circumstances, hence there are elaborate conditions to be met for such grant. Meanwhile when countries were gradually coping with the new compliance requirements introduced by trips, hiv/aids had become a serious health crisis in Brazil and South Africa with most of the African continent affected. It was found that although 95% of the existing essential drugs were not under patents,663 they did not work while the more modern anti-retroviral drugs were under patents and emr and were too expensive. At the same time on the other hand, it was also argued that patents were not responsible for the high price of medicines there were other factors664 and it would be wrong to deduce that patent was the only reason since in some of the ldcs patents were not even filed.665

10.3 Public Policy Implications of Public Health Crisis Leading to trips Amendment

As mentioned earlier, the hiv/aids problem had already reached a pandemic stage and was posing a worldwide threat particularly in Africa, Asia and Latin America.666 Brazil raised the problem at multiple international forums. It moved a resolution before the United Nations Commission on Human Rights claiming that access to medicines for diseases like hiv/aids was a basic human right that needed protection. It also moved a resolution in the Economic and Social Council where it was passed by 52 out of 53 voting members (the US abstained from voting) with the UN General Assembly adopting the Declaration of Commitment on hiv/aids in 2000.667 The United Nations General Assembly also held a Special Session on hiv/aids next year from 25th through 27th June 2001, pledging for “Global Crisis – Global Action”.668 The resolution emphasised the need to reduce cost of pharmaceutical drugs and related technologies in close collaboration with the private pharmaceutical sector to promote innovation and development of domestic industries in the developing nations.669

Brazil and South Africa also initiated domestic measures to make the medicines available at the cheapest possible price by using available trips flexibilities. Hence while Brazil tried to negotiate with the multinational pharmaceutical companies to lower the price of hiv/aids drugs through the threat of issuance of cl, South Africa brought legislation to allow both parallel importation and cl. However, this resulted massive retaliation from the powerful pharmaceutical industry, 41 companies organised under the Pharmaceutical Manufacturer’s Association (pma), moved locally in South Africa. The pma brought a suit before the Pretoria High Court in 1998 alleging that the cl and parallel imports were in violation of the South African patent law and were not in compliance with the trips Agreement.670 On the other hand the pharmaceutical companies convinced the US government to bring a complaint against Brazil at the wto dsb on 30 May 2000, alleging that Brazil’s ip law relating to cl was in violation of trips.671

Given that trips Agreement was not only a legal document but also a political one, inability to use trips flexibilities by sovereign members due to existing power asymmetries between manufacturers and users of medicine, raised international concern.672 At the wto this time there was already growing discontentment amongst developing nations on multiple gatt issues like trade in agricultural goods, non-agricultural market access (nama). The trips enforcement issue in the background of the health crisis heightened the conflict between developing and industrialised countries. As a result, the Seattle Ministerial meeting of wto failed leading the path to a development round673 in the next ministerial meeting in Doha Qatar from 14th–19th November 2001. The Director General of the wto, Mr. Mike Moore acknowledged the pitiful state of public health in many developing countries and assured that the trips was balanced enough to provide necessary flexibilities on public health.674

The Doha ministerial meeting saw distinct division among members not just on cl but also parallel importation through international exhaustion which the developing countries preferred. The paper submitted by the developing countries to the trips Council Special Discussion on ‘Intellectual Property and Access to medicines’ made it clear,

adoption of the principle of international exhaustion of rights [allowing parallel trade] can be a useful tool for health policies. Where the prices of pharmaceutical products are lower in a foreign market, for instance, a government may allow importation of such products into the national market, so as to allow offers of drugs at more affordable prices.675

The US vehemently opposed both allowing any inclusion of parallel imports and cl, even in case of serious public health problems. Although ironically it did not hesitate considering cl itself when there was a threat of public health crisis.676

Following the 9/11 terrorist attacks in USA, there were a series of bio-terrorism scare through use of anthrax-embedded postal mails resulting death of some postal employees. ‘Ciproflaxin’ was the only drug effective in treating anthrax and Bayer held the patent over it. US government tried to negotiate a cheaper price for the drug in US, failing which, after some time joined Canada threatening to issue cl to enable generic production of the drug. This double standard of the US could not help it sustain its negotiating stand at the trips negotiations and it had to accept the developing countries demand. At the same time, there was finally a breakthrough and both Canada and US could negotiate an agreeable royalty rate without using cl. While the cl threat proved credible, the entire episode also exposed the gap in arguments de-linking patents and access to pharmaceuticals drugs.677

The intent of the framers of the trips Agreement enabling a wto Member to use necessary flexibilities to take policy decisions in the wake of any public health crisis was confirmed when the Doha Declaration on the trips and public health was adopted on 14th November 2001 affirming Article 8.1 of trips.678 The Doha Declaration acknowledged the seriousness and magnitude of the health problems in many developing countries and ldcs with diseases like hiv/aids, tuberculosis, malaria and others and reaffirmed the flexibility available under the trips Agreement.679 The declaration brought to the front much-debated issues like cl and exhaustion of rights and in paragraph 5.d stated, ‘The effect of the provisions in the trips Agreement that are relevant to the exhaustion of ipr is to leave each member free to establish its own regime for such exhaustion without challenge, subject to the mfn and nt provisions of Article 3 and 4’ (Emphasis added).680

The confirmation of a member to adopt international exhaustion provided clarity amidst different emerging opinions on the contrary.681 Explained lucidly by Prof. Frederick Abbott, ‘further argument from the US, Switzerland, and the pharmaceutical sector that while Article 6 of the trips Agreement precludes trips dispute settlement on the issue of exhaustion, Article 28 nonetheless prevents parallel importation of patented drugs.’ was proven wrong.682 The Doha Declaration thus reaffirmed that the member countries can set up any exhaustion mode and adopt international exhaustion allowing parallel importation.683 Amidst unnecessary clutter of contradicting views, the Doha Declaration reiterated what was already provided for in the trips Agreement.684 Often raised doubts about its eligibility being a political document, the Doha Declaration even being a political document, helped to move the discussions on iprs from bilateral levels in fta negotiations back to the multilateral level in an effective manner.685 It also provided much needed clarity on the processes for execution of the trips flexibilities without imposing additional legal implications.686

In the Cancun Ministerial meeting procedural work to operationalise the Doha Declaration continued at the trips Council. Council chair, Mexican Ambassador Eduardo Pérez Motta presented a solution to the impasse through a self-imposed moratorium on any complaint by members for use of cl until the trips was amended to that effect.687 The US refused to accept the Chairman’s proposed dispute coverage and wanted to restrict the diseases only to hiv/aids, Tuberculosis and Malaria. The developing countries were strongly opposed to any dilution of the Doha declaration and were not ready to accept any alteration of the declaration through the footnote since paragraph 1 of the Doha Declaration already stated, ‘from hiv/aids, tuberculosis, malaria and other epidemics.(emphasis added). Finally, EU suggested a list of at least 23 other infectious diseases that could be extended on recommendation by the who and US agreed with a footnote to their earlier proposal to include other epidemics of comparable gravity and scale. US, EU and Switzerland joined the moratorium as a stop-gap measure until the final decision to implement the Doha declaration was reached by the General Council of the wto on the 30th August 2003.688

Initially there was disagreement on whether production under the cl can be only for the domestic market or in cases of national emergencies or extreme urgencies or for public non-commercial use, could also be for another country.689 The implementation of the waiver in Doha declaration confirmed that it would not only be for cases of national emergencies or cases of extreme urgencies or for public non-commercial use in domestic market but also for export to another developing country. Subsequently amidst concerns of misuse, elaborate and stringent procedures were introduced for import and export under cl.690 The decision to implement the Doha Declaration was taken on 30th August 2003 following which, the first amendment to the trips Agreement was adopted on 6th December 2005 while the temporary waiver continued until countries adopted the decision.691 The amendment came in to effect on 17th November 2017 with two-third of the wto members formally accepting it.692

It introduces Article 31bis, which states,
  1. 1.The obligations of an exporting Member under Article 31(f) shall not apply with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out in paragraph 2 of the Annex to this Agreement.
  2. 2.Where a compulsory licence is granted by an exporting Member under the system set out in this Article and the Annex to this Agreement, adequate remuneration pursuant to Article 31(h) shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member. Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall not apply in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.
  3. 3.With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products: where a developing or least developed country wto Member is a party to a regional trade agreement within the meaning of Article xxiv of the gatt 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question.
  4. 4.Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article xxiii of gatt 1994.
  5. 5.This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the trips Agreement and Public Health (wt/min(01)/dec/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f).

10.4 trips Amendment: Patent Exhaustion Enabling Parallel Trade

A careful study of the global discourse to address the hiv/aids public health crisis that led to the amendment of the trips Agreement will show that a balanced relationship between iprs and human rights is necessary.693 Developing countries needed to carefully incorporate these flexibilities into their laws to enable them to utilise them in time of need.694 It has been noticed that the ratification itself and the adoption of Article 31bis has been very slow due to cumbersome administrative requirements for implementation.695 After the amendment, countries without the capacity to manufacture pharmaceutical products domestically under grant of cl, should be able to import the patented products from another country under cl however practically that has not been the case. If a country facing public health crisis does not have the capacity to manufacture the medicines domestically under cl and needs to import, the conditions under trips Article 31bis are even more stringent.696

This raises the question as to whether the amendment of the trips Agreement and insertion of Article 31bis has provided the much-needed solution of availability of patented medicines at reasonable price in developing countries and developing countries. From its slow and reluctant implementation, the answer would not be difficult to guess however the reasons are many. Multitude of administrative requirements starting from notification to the trips Council, to labelling and listing requirements increase the administrative burden of a resource crunched ldc.697 There has been an over dependency on access of patented medicines through grant of cl either within the country domestically or through importation when the alternate option of using international exhaustion and allowing parallel trade is being neither cumbersome nor such restrictive is more favourable.

A wto Member can exercise policy options that it considers most suitable to address access to patented products at low price. Parallel importation is an effective solution, which can be adopted broadly for all products and specifically for making the medicines available at reasonable (lower) price.698 Earlier chapters have dealt at length how international exhaustion is the most suitable option from either the perspective of international trade due to its trade-enhancing ability or from the perspective of patent law where one would note that the purpose of a grant of patent is to protect the invention from unauthorised usage and not to allocate geographical markets. Parallel trade is possible only if a country adopts international exhaustion of iprs and the Doha Declaration had clearly reconfirmed that a wto Member can adopt any mode of exhaustion.

Following international exhaustion, allows parallel importation from markets where the price of the medicine is lowest enabling more patients to access the medicines at the same time not undermining the patent rights.699 Hence experts often solicit in favour of parallel imports especially for pharmaceutical products as an appropriate option.700 The problem occurs when countries have different modes of exhaustion, since parallel trade would likely be considered illegal in the country practicing national exhaustion and infringement proceedings or border measures executed. To add to this problem of uncertainty, there has been an increasing tendency by proponents of national exhaustion to export it to other countries through contractual bindings often under prerequisites of bilateral trade agreements and ftas.701 These agreements are executed often conditional that the partner country also follows national exhaustion hence actually removing the country’s ability to adopt any mode of exhaustion and engage in parallel trade.

The confusion in allowing or disallowing parallel trade is since some experts see parallel imports as a solution to the public health crisis while others see it as a problem. Those against parallel imports state,

The problem, however, is most acute in that sector because, directly or indirectly, all the governments of Member States control the price of medicines at levels that vary – some by limiting the price that may legally be charged, others by negotiating with the ip holders to reduce their prices if they want the cost of the medicines to be paid or reimbursed by a national health service, etc.702

It is argued that if it is illegal to charge over certain bound rates in one country, the pharmaceutical company should be able to choose to sell it at higher rate in another country where it is possible, without having the profit neutralised by international exhaustion.

It is also often argued that the medicines sold for the developing countries at a relatively low price compared to the global market, would be bifurcated to industrialised-country markets as parallel imports, thus not serving the purpose of supplying the markets they are meant for. However, research by the World Health Organisation (who) has shown otherwise. who studies show that often pharmaceutical drugs are sold in developing countries at prices even higher than in industrialised countries hence these arguments do not hold ground.703 It has also been addressed in earlier chapters that the argument of countries no longer choosing price differentiation hence the price in countries practicing international exhaustion will go up, is erroneous. Markets for pharmaceutical products are highly segmented where companies price same products differently depending on their demands and not necessarily paying capacity, which has been clearly established in the who study.704 The only reason against parallel imports is it hinders their ability to make higher profits through dividing markets based on patent rights, hence banning of parallel imports by adopting national exhaustion. There might be indeed some valid concerns in specific cases that need to be addressed through appropriate checks and balance measures on a case-by-case basis.

Here while adopting international exhaustion, it must only be applicable to products manufactured under valid patent that has not been subjected to cl. Since in case of a cl the patent is effectively kept in abeyance as such the question of exhaustion cannot arise, thus cannot be included in parallel trade.

649

Davis Mike, “Late Victorian Holocausts El Niño Famines and the Making of the Third World”, Verso New York, pg. 298,Table 9.3, 2001. Reproduced from Tomlinson B. R., “Economics: The Periphery”, in Porter Andrew edited, “The Oxford History of the British Empire: The Nineteenth Century”, Oxford pg. 69, 1990.

650

Ibid at 649.

651

Barnes Stephen, “Pharmaceutical Patents and trips: A Comparison of India and South Africa”, 91 Kentucky Law Journal, pg. 911, 2003.

652

Balasubhramaniam K., “Access to Medicines and Public Policy Safeguards under trips”, in Bellmann Christopher, Dutfield Graham and Meléndez-Ortiz Ricardo (eds.), “Trading in Knowledge – Development Perspectives on trips, Trade and Sustainability”, pg. 139 (135–142) Earthscan 2003.

653

Scherer F.M., “The Political Economy of Patent Policy Reform in the United States”, Volume 7 Journal on Telecomm & High Tech. Law, pg. 168, 169 (167–216), 2009.

654

Ibid at 2.

655

History of Indian Patent system available at, http://www.ipindia.nic.in/history-of-indian-patent-system.htm.

656

Sterckx Sigrid, “Patents and access to drugs in developing countries: An ethical analysis”, 4 Developing World Bioethics, Blackwell Publishing, pg. 61 (58–75) November 2004.

657

Scherer Sigrid and Watal Jayashree, “Post-trips Options for Access to Patented Medicines in Developing Nations”, 5 Journal of International Economic Law, (913–940) 2002; Scherer F. M., “Global Welfare in Pharmaceutical Patenting”, Presentation made at the conference on “Markets for Pharmaceuticals and the Health of Developing Nations” in Toulose, France, 5th–6th December, 2003. Available at, www.idei.fr/doc/conf/pha/scherer.pdf.

658

The pharmaceutical industry spending in r&d is one of the top among different sectors and the graph shows how the spending is increasing. Data available at, https://www.statista.com/statistics/265645/ranking-of-the-20-companies-with-the-highest-spending-on-research-and-development/.

659

Nielsen Jane and Nicol Dianne, “Pharmaceutical Patents and Developing Countries: The Conundrum of Access and Incentive”, 13 Australian Intellectual Property Journal, pg. 21 (21–40) February 2002.

660

Article 27 of the trips Agreement obligated all members to introduce both product and process patent protection for all inventions from 2005 and a pipeline protection for the transition period of 1995 to 2000 for industrialised countries and 1995 to 2005 for developing countries under Articles 70(8) and 70 (9) of trips.

661

Cottier Thomas, “The Doha Waiver and Its Effects on the Nature of the trips System and on Competition Law. The Impact of Human Rights”’ in Govaere Inge and Ullrich Hanns (eds.), “Intellectual Property, Public Policy and International Trade”, “College of Europe Studies No.6”, p.i.e. Peter Lang, pgs. 176, 177, (73–199), 2007.

662

Correa Carlos, “Integrating Public Health Concerns into Patent Legislation in Developing Countries”, South Centre, pg. 93, 94, 2000.

663

Beall F. Reed, “Patents and the who Model List of Essential Medicines (18th Edition): Clarifying the debate on ip and access”, wipo Global Challenges Brief, 2016. Available at, https://www.wipo.int/edocs/mdocs/mdocs/en/wipo_gc_ip_ge_16/wipo_gc_ip_ge_16_brief.pdf.

664

Reinhardt Eric, “Intellectual Property Protection and Public Health in the Developing World” 17 Emory International Law Review, pg. 485 (475–489) 2003.

665

Thorpe Phil, “Study on the implementation of the trips Agreement by developing countries” Study Paper No. 7 of the Commission on Intellectual Property Rights, UK, 2002.

666

unaids, “Aids Epidemic Update: December 2000”, pg. 5 unaids Report, Geneva 2000. It points out that among the 36.1 million people who were infected with aids at that time, 25.3 million lived in Sub-Saharan Africa, 5.8 million in South Asia and South-East Asia and 1.4 million in Latin America.

667

The U.N. High Level Meeting Polictical Declarations can be found at, https://www.hrw.org/legacy/backgrounder/hivaids/ungass0806/3.htm.

668

The Resolution “Global Crisis – Global Action”. Details available at, http://www.unaids.org/sites/default/files/sub_landing/files/aidsdeclaration_en_0.pdf.

669

unaids press release of 11 December 2001 available at, www.unaids.org.

670

Case No. 4138/98. For more details see, Colvin Christopher and Heywood Mark, “Negotiating arv Prices with Pharmaceutical Companies and the South African Government: A Civil Society / Legal Approach”, in “Negotiating and Navigating Global Health – Case Studies in Global Health Diplomacy”, World Scientific Publishing co. Pte. Ltd., pgs. 355 and 356, 2012.

671

Brazil – Measures Affecting Patent Protection. See, https://www.wto.org/english/tratop_e/dispu_e/cases_e/ds199_e.htm.

672

Sell Susan, “Legal Movements in Trade & Intellectual Property – Trade Issues & hiv/aids”, 17 Emory International Law Review, pg. 591 (591–601) 2003.

673

McManis Charles and Contreras Jorge, “Compulsory Licensing of intellectual property: A viable policy lever for promoting access to critical technologies?” In, Ghidini Gustavo, Peritz Rudolph and Ricolfi Marco (eds.), “trips and Developing Countries Towards a New ip World Order?”, Edward Elgar Publishing Ltd. 2014, pages 109, 110 (109–131).

674

Moore Mike, dg wto Secretariat in regular Press Statement “ip and Access to Medicines” dated 20th June 2001.

675

See, paper submitted by the Africa group, Barbados, Bolivia, Brazil, Dominican Republic, Equador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, the Philippines, Peru, Sri Lanka, Thailand, and Venezuela to the trips Council for the special discussion on intellectual Property and access to medicines, 20th June 2001, wto Geneva. See, Developing countries’ group paper ip/c/w/296, available at https://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm.

676

Raghavan Srividhya, “Patent and Trade Disparities in Developing Countries”, in “The international trade regime in perspective”, Oxford University Press, pg. 184, 185 (168–199), 2012.

677

Sell Susan, “Life after trips – Aggression and Opposition”, in Maskus Keith (ed.), “The wto, Itellectual Property Rights and the Knowledge Economy”, Edward Elgar Publishing Ltd., pgs. 110,111 (72–119), 2004.

678

Cottier Thomas, “trips, the Doha Declaration and Public Health”, pgs. 386, 385–388, Vol. 6, No. 2 The Journal of World Intellectual Property, 2003. Based on the remarks made by the author at the 9th Geneva Global Arbitration Forum held on 4th–5th December, 2002 in Geneva, Switzerland; Also see paragraph 4 of the Doha Declaration on the trips Agreement and Public Health, Doha wto Ministerial 2001: trips, wt/min(01)/dec/2, available at, https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.

679

Matthews Duncan, “Lessons from negotiating an amendment to the trips Agreement: Compulsory Licensing and access to medicines” in Westkamp Guido (ed.), “Emerging Issues in Intellectual Property”, Edward Elgar Publishing Ltd. 2007, pgs. 225, 226, (222–249).

680

Declaration on the trips Agreement and Public Health, Doha wto Ministerial 2001: trips, wt/min(01)/dec/2, available at, https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.

681

The Road to Doha and Beyond – A Road Map for Successfully Concluding The Doha Development Agenda, wto 2001. Available at, https://www.wto.org/english/res_e/booksp_e/roadtodoha_e.pdf.

682

Abbot Frederick, “The Doha Declaration on the trips Agreement and Public Health: Lighting a dark corner at the wto”, 5 (2) Journal of International Economic Law, pg. 494 (469–506) 2002.

683

Kongolo Tshimanga, “trips, the Doha Declaration and Public Health”, 6 (2) The Journal of World Intellectual Property, pg. 374 (373–378) 2003. Based on the remarks made by the author at the 9th Geneva Global Arbitration Forum held on 4th–5th December, 2002 in Geneva, Switzerland.

684

Noehrenberg Eric, “trips, the Doha Declaration and Public Health”, 6 (2) The Journal of World Intellectual Property, pg. 379 (379–383) 2003. Based on the remarks made by the author at the 9th Geneva Global Arbitration Forum held on 4th–5th December, 2002 in Geneva, Switzerland; Also see, Bloche Gregg, “wto Difference to National Health Policy: Toward an interpretive Principle”, 5 (4), Journal of International Economic Law, pg. 839 (825–848) 2002 and Thuo Gathii James, “The Legal Status of the Doha Declaration on trips and Public Health Under the Vienna Convention on the Law of Treaties”, 15 Harvard Journal of Law and Technology, pg. 308, 309 (291–317) 2002.

685

United States Trade Representative (ustr) Mr. Robert Zoellick referred to the Doha declaration as a ‘political declaration’ in the ustr Press Release dated 14th November, 2001.

686

Schott Jeffrey, “Comment on the Doha Ministerial”, 5 (1) Journal of International Economic Law, pg. 195 (191–219) 2002.

687

Draft Proposal presented by the Chairman of the trips Council on 16th December 2002.

688

Decision of the General Council of the wto taken on 30th August 2003, Document No. wt/l/540, available at, https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm.

689

Roffe Pedro, Spennemann Christoph and von Braun Johanna, “From Paris to Doha: The wto Doha Declaration on the trips Agreement and Public Health”, in Roffe Pedro, Tansey Geoff and Vivas-Eugui David (eds), “Negotiating Health – Intellectual Property and Access to Medicines”, Earthscan, pg. 19–22, 2006.

690

Fact Sheet: trips and Pharmaceutical Patents, Obligations and Exceptions. See, https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm#importing. Also see, Vandoren Paul and Van Eeckhaute Jean Charles, “The wto Decision on Paragraph 6 of the Doha Declaration on the trips Agreement and Public Health – Making it Work”, 6 The Journal of World Intellectual Property, pg. 789, November 2003.

691

Decision of 30th August 2003, to implement the Doha Declaration available at, https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm; For further details of countries which have already accepted the decision and other details see: http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm.

692

Out of total 164 members 110 needed to ratify by 31st December 2019 and the amendment took effect on 17.11.2017. See https://www.wto.org/english/tratop_e/trips_e/amendment_e.htm.

693

Gumbel, Mike, “Is Article 31Bis Enough? The Need to Promote Economies of Scale in the International Compulsory Licensing System”, Vol. 22, Temple International & Comparative Law Journal, No. 1, pg. 164, 2008.

694

Global initiatives to create technologies for human development, Human Development Report, released by the United Nations Development Programme (undp), pg. 105, 2001.

695

Ibid at 693, pgs. 185–190.

696

See https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm.

697

Vincent Nicholas, “trip-ing Up: The Failure of trips Article 31bis”, Gonzaga Journal of International Law, pg. 21, 22, 23, 2020.

698

Europe Economics, “Medicines Access and Innovation in developing countries”, pg. 23, Chancery House, September 2001.

699

Abbot Frederick, “The trips Agreement, Access to Medicines, and the wto Doha Ministerial Conference”, 1 The Journal of World Intellectual Property, pg. 34, 2002.

700

The Indian delegation to the wto trips Council supported this view. See Minutes of the trips Council Special Discussion on Intellectual Property and Access to Medicines, 18th–22nd June 2001. wto Doc. No. ip/c/m/31, wto, Geneva.

701

Some examples of it can be found in the ftas signed by US with Singapore (2003), Australia (2004), Morocco (2004).

702

Korah Valentine, “Intellectual Property Law in the context of Competition Law: ‘Consent’ in relation to curbs of parallel trade in Europe”, Fordham International Law Journal, pg. 973 (972–981) April 2002.

703

who, “More Equitable Pricing for Essential Drugs: What do we mean and what are the issues?”, pg. 3, Background Paper prepared by the who Secretariat for the whowto Secretariat Workshop on Differential Pricing and Financing of Essentail Drugs, Hosbjor, Norway from 8th–11th April 2001. The paper states that because pharmaceutical purchases in developing and are mainly financed by individuals where they are negotiated individually prices of medicines are ldc often higher than those in developed countries where the prices are often negotiated by insurance companies or the government.

704

Ibid at 703.

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