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The Human Right to Health: Reflecting on the Implications of IPRs as Endorsed by the Trans-Pacific Partnership Agreement

verfasst von : Sunita Tripathy

Erschienen in: International Economic Law

Verlag: Springer International Publishing

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Abstract

With the aim of technology innovation, transfer and capacity building, the World Trade Organisation established a new regime for harmonizing the laws related to intellectual property which included certain flexibilities in the nature of compulsory licensing and parallel imports. At the same time a progressive concept of development which includes a mandate for Member countries to adopt a “right to health” within the economic, social and cultural rights framework emerged. The Agreement on Trade Related Aspects of Intellectual Property Rights required Member States to include relevant amendments to the existing laws within its policy space to ensure adherence to the minimum agreed criteria of intellectual property protection. The Trans-Pacific Partnership (TPP) agreement seems to be shifting this regime towards extreme privatization of R&D and stronger protection of intellectual property rights. The author analyses the implications of the TPP while focusing on chapters pertaining to intellectual property and reflects on the right to health as a human right in such context. It is argued that stringent intellectual property protection in the TPP will disadvantage trade, economic development and patient welfare objectives. The TPP should be revised to include suggestive changes for consensus building and dispute resolution that can aid in developing modern international economic law and practice.

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Vorheriges Kapitel A Waiver for Europe? CETA’s Trade in Services, and Investment Protection Provisions and Their Legal-Political Implications on Regulatory Competence

Nächstes Kapitel Can (and) Should the WTO Tame Private Standards? Antitrust Mechanism as an Alternative Roadmap: Lessons from the WTO Telecommunications Reference Paper

Beall and Kuhn (2012), p. 9. The study specifically describes the classification of compulsory license episodes by outcome, disease and national income groups. Panel C which is devoted to income groups explains that High Income Countries (HICs) allowed 3 compulsory licenses, Upper Middle Income Countries (UMICs) allowed for 13, Low Income Countries (LICs) allowed for 5 while the Least Developed Countries (LDCs) allowed only 3 such compulsory licenses during the same period of time.

Correa (2011), p. 12. See also UNAIDS, UNDP and WHO (2011). For report discussing dire consequences of unpaid medical bills in US, see Hamel et al (2016).

The National Health Policy 2015 draft (2015) para 2.10; see also Planning Commission of India High Level Expert Group on Universal Health Coverage for India Report (2011).

Intellectual Property Appellate Board, Chennai (IPAB), Bayer v Natco, 14 September 2012.

Supreme Court of India, Novartis v Union of India 1 April 2013, AIR 2013 SC 1311. As also the decision in Roche v. Cipla (Delhi High Court, Roche v. Cipla, 19 March 2008, I.A 642/2008 IN CS (OS) 89/2008) upholding the generic manufacturer’s public interest defence of having served patient needs by ensuring that affordable versions of the patented drug are available as a ground for not awarding any interim injunction but only account for profits so made to compute damages.

The Trans-Pacific Partnership Agreement is part of a triad of free trade agreements led by US. The triad comprises of the Trans-Pacific Partnership Agreement (TPP), Transatlantic Trade and Investment Partnership Agreement (TTIP) and Trade in Services Agreement (TiSA).

This paper limits its scope to discussing relevant provisions in the TPP only, mainly because access to the other two agreements were not made available to any other save the multinational firms for review, scrutiny or critical comments. They will be traversed as future work by this author.

The negotiations include 12 States of the Asia Pacific region, including Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam, with South Korea considering its incorporation. See TPP Full text as available on USTR.

For references, see Rajagopal (2015). According to Kajal Bhardwaj of India’s Lawyer Collective, other negotiations such as the Regional Comprehensive Economic Partnership which involves India and 16 ASEAN countries are also likely to be impacted by the TPP.

See Oxfam Briefing Paper (2011). This Author finds it unsuitable for the US to rely on World Bank’s income classification to judge a country’s capacity to afford costly medicines; for two specific reasons. Firstly, it is an old classification drawn in 1980s and secondly, it only deals with a country’s per-capita average of total income. In the last three decades the poverty map has changed considerably and world’s poor people no longer live in poor countries, but rather in rich countries with high inequalities. The US social health programme (Medicaid) defines poverty line at $21.50 per person/day. The research by Doctors-without-Borders and Oxfam reveals that more than a quarter of a billion people will live below this line in eight Member countries of TPP. Accordingly, the high-income countries of TPP which have to adopt all the provisions of the agreement will have huge percentage of population living under poverty line. Following this flawed method will cause increased poverty.

See specifically WHO Report (2006) “[W]hile developing countries (excluding least developed countries) with little technological and innovative capacity are bearing the cost of implementing the TRIPs Agreement, there are no documented cases of positive impact on innovation in the medical field yet”. For references on previous discussion on difficulty in accessing pharmaceuticals in developing countries, see WHO (2001). See also UNDP (2010), p. 9 (“However, since the signing of the TRIPs Agreement in 1995, consumers have not witnessed a significant increase in the output of new medicines, despite the substantially higher levels of IPR protection on a global scale”). See, Economist (2015) in “Time to fix patents”. Arguably, the patent system could benefit from a shortening of its term of protection depending on the nature of inventions in specific sectors of innovation.

It is to be conclusively proven whether every increase in intellectual property protection, especially in developing countries, necessarily leads to increase in investment, innovation or well-being which can be understood as indicators of development. For references, see Fink and Braga (1999), p. 21; Su (2000); Raghavan (2004), p. 777.

WTO doc. WT/MIN(01)/DEC/2, Ministerial Declaration on the TRIPS Agreement and Public Health, 14 November 2001.

Ibid. WTO doc. WT/L/540 and Corr.1, Implementation of paragraph 6 of the Declaration on the TRIPS Agreement and Public Health, 30 August 2003, also known as “August 30th Decision”.

WTO doc. WT/L/641, Amendment of the TRIPs Agreement, 6 December 2005, https://www.wto.org/english/tratop_e/TRIPs_e/wtl641_e.htm (accessed 6 February 2016).

UN doc. E/C.12/2000/4 (2000): Committee on Economic, Social and Cultural Rights, General Comment 14, The right to the highest attainable standard of health (Twenty-second session, 2000). This can be read with Article 12 of the International Covenant on Economic, Social and Cultural Rights.

Marks (2012).

Research findings indicate that 1/3 to 2/3 of world’s constitutions include health rights/access to health care. See also Backman et al. (2008), pp. 2047–2085 and Todres (2014).

Articles 42 and 47 of the Part IV of the Constitution of India.

Ramachandran SK (1 January 2015).

Supreme Court of India, Francis Coralie Mullin v. The Administrator, Union Territory of Delhi, 13 January 1981, AIR 1981 SC 746, pp. 752–753. Other examples include the matter of Minister of Health and Others v. Treatment Action Campaign and Others (No 2), 2002 (5) SA 721, 2002 in South Africa.

AIR 1984 SC 802.

Consumer Education and Research Centre v. Union of India (1995) 3 SCC 42.

Ibid.

Supreme Court of India, Pachim Baga Khet Mazdoor Samiti v State of West Bengal, 6 May 1996, AIR 1996 SC 2426. See also Supreme Court of India, Parmanand Katra v. Union of India, 28 August 1989, 4 SCC 286, where the Court held that no procedure as prescribed under the CrPC should hinder a medical practitioner from treating an emergency case, saving a patient’s life should be the primary action and other legal formalities ought to be secondary in such cases.

Hogerzeil et al. (2006), pp. 305–311.

See specifically p. 5 of the India’s draft National IPE Policy 2015, and for comments see Tripathy et al. (2014). See also Government of India, “The National IPR Policy” (2016) http://dipp.gov.in/English/Schemes/Intellectual_Property_Rights/National_IPR_Policy_12.05.2016.pdf (accessed 30 January 2016).

Liberti (2010).

UNITAID’s Policy brief (2014), p. 101. To retain the benefits of TRIPs flexibilities, countries at a minimum should avoid entering into FTAs that contain TRIPs-plus obligations that can impact pharmaceutical price or availability.

http://www.oxfam.org/en/files/bp102_jordan_us_fta.pdf/download (accessed 10 January 2016).

Pharmacotherapy Department of the Costa Rica Social Security System, 2003.

The TPP includes 29 chapters ranging from issues of market access, technical barriers to trade, sanitary and phytosanitary measures, rules of origin, customs cooperation, investment, services and legal and institutional aspects of the negotiation, and it further includes government procurement, competition, intellectual property, labour and environment issues.

PSI Strategic briefing (2014). In order to achieve “competitive neutrality” TPP advocates restricting the type and number of advantages such as subsidies, low cost credit, preferential access to government procurement, and trade protection available for SOEs. These advantages which are not enjoyed by private companies, when restricted will threaten public health care institutions leading to degradation and eventual removal of government health insurance programs. See also Doctors Without Borders (2012), p. 1. TPP will increase the price of medicine for nearly 800 million people across the Pacific Rim region.

TPP Article 2.3 provides for the principle of national treatment. In the international context, a State must provide equal treatment to those citizens of other States that are participating in the agreement. Imported and locally produced goods should be treated equally—at least after the foreign goods have entered the market. When TRIPs-plus provisions in the TPP outweigh corporate interests over better access to medicines and healthcare for the patients, it will lead to an incorrect application of this principle.

Geist (2016). Developed economies such as Canada have opposed the alteration. For reference, see the Early versions of the draft IP Chapter of TPP (2016) and Later drafts of the IP Chapter of TPP (2016). See also, TPP Investment Chapter (2015).

See generally Bharadwaj et al. (2014).

For references, see Managing IP (May 2006).

Lopes (2013).

Natco Pharma Limited v. Bayer Corporation, Compulsory License Application No. 1 of 2011; and as directed by the Controller of Patents in NATCO Pharma Limited v. Bayer Corporation. Similarly, in (2013) 6 SCC 1, while Novartis’s patented medicine (Gleevec) for blood cancer care is priced at Rs. 1,20,000/- per month, the generic version (Imatinib Mesylate) is priced at Rs. 10,380/- per month by NATCO Pharma and Rs. 9,000/- per month by Cipla in India.

For references on the Indian pharmaceutical sector, see Gopakumar (2010).

See specifically Articles 4.2 and 4.6 of the US proposal (TPP Article 2.12) which extends the term of copyright to “life of the author plus 70 years” or “not less than 95 years from the first publication or 120 years from creation”. At the International trade level, this implies that even if the patent rights are exhausted by the importing country’s exhaustion regime, if the copyright over the product information and labels of a pharmaceutical product subsists within the packaging material, the originator company can sue for copyright infringement, prevent parallel importation and consequently delay market entry of competing generics. Similarly, TPP reformulates the justification for trademark protection and term extensions from being consumer centric to being a return on the investment made by the originator company in advertising and promoting its pharmaceutical products and services (TPP, Article 2.3 read with Article 2 and its sub-clauses Articles 2.1 and 2.4 especially and Article 2.5). These provisions will impair the effectiveness of trademark regimes and increase the instances of originator companies suing generics for trademark infringement.

For references, see WHO SEARO WPRO (2006).

For references, see Baker (2008), pp. 303–344; For discussion concerning ambiguity in investment clauses of TPP, see also Baker (2012) p. 8.

For references, see Bouchard et al (2010), p. 174.

TPP Transparency and Anti-corruption Chapter https://ustr.gov/sites/default/files/TPP-Final-Text-Transparency-and-Anti-corruption.pdf (accessed 2 January 2016).

Ibid.

Doctors Without Borders (2014).

For reference, see Lester (2015), p. 1. Also see Weisman (2015).

Eli Lilly and Co. v The Government of Canada, Notice of intent to submit a claim for arbitration under NAFTA Chapter Eleven, 7 November 2012.

For a set of principles that might guide such a fuller agenda, see Washington Declaration on Intellectual Property and the Public Interest (2011).

Basheer (2015).

Backman et al (2008) Health systems and the right to health: an assessment of 194 countries Lancet 372:2047–2085

Baker B (2008) Ending drug registration apartheid – taming data exclusivity and patent/registration linkage. Am JL & Med 34:303–344

Baker B (2012) Leaked TPP investment chapter presents a grave threat to access to medicines. In: School of Law Faculty Publications. http://works.bepress.com/brook_baker/7. Accessed 25 Mar 2015

Basheer S (2015) Affordable drugs need a compensatory patent commons. In: The Wire. http://thewire.in/2015/12/17/affordable-drugs-need-a-compensatory-patent-commons-17509. Accessed 5 Jan 2016

Beall R, Kuhn R (2012) Trends in compulsory licensing of pharmaceuticals since the Doha declaration: a database analysis. PLoS Med 9(1):e1001154. doi:10.1371/journal.pmed.1001154: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001154. Accessed 12 Feb 2015

Bharadwaj K et al (2014) The trans-pacific partnership agreement: implications for access to medicines and public health. UNITAID Secretariat. http://www.unitaid.eu/images/marketdynamics/publications/TPPA-Report_Final.pdf. Accessed 12 Jan 2016

Bouchard RA et al (2010) Empirical analysis of drug approval drug patenting linkage for high value pharmaceuticals. Northwest J Technol Intell Prop 8:174. http://scholarlycommons.law.northwestern.edu/njtip/vol8/iss2/2. Accessed 3 Feb 2016

Correa CM (2011) Pharmaceutical innovation, incremental patenting and compulsory licensing. South Centre, Geneva, http://www.southcentre.int/wp-content/uploads/2013/05/RP41_Pharmaceutical-Innovation_EN.pdf. Accessed 3 Feb 2016

Doctors Without Borders (2012) Trading Away Health: How the US’s Intellectual Property demands for the Trans-Pacific Partnership Agreement threaten access to medicines. MSF Issue brief. p 1 http://aids2012.msf.org/wp-content/uploads/2012/07/TPP-Issue-Brief-IAC-July2012.pdf. Accessed 22 Feb 2015

Doctors Without Borders (2014) http://www.doctorswithoutborders.org/article/trans-pacific-trade-partners-must-stand-against-higher-medicine-prices-and-take-harmful. Accessed 5 Mar 2015

Early versions of the draft IP Chapter of TPP https://wikileaks.org/tpp-ip2/ Accessed 10 January 2016

Economist (August 8, 2015) Time to fix patents. http://www.economist.com/news/leaders/21660522-ideas-fuel-economy-todays-patent-systems-are-rotten-way-rewarding-them-time-fix#XUu2UL01WIebqovo.99. Accessed 8 Aug 2015

Fink C, Braga C (1999) How Stronger Protection of Intellectual Property Rights Affects International Trade Flows in Intellectual Property and Development in World Bank Policy Research Working Paper No 2051

Geist M (2016) The Trouble with the TPP, Day 1: US Blocks Balancing Objectives. http://www.michaelgeist.ca/2016/01/the-trouble-with-the-tpp-day-1-u-s-blocks-balancing-objectives. Accessed 5 Jan 2016

Gopakumar KM (2010) Landscape of pharmaceutical patent applications in India: implications for access to medicines. In: Chaudhari et al (eds) Five years into the product patent regime: India’s response. UNDP, New York. http://apps.who.int/medicinedocs/documents/s17761en/s17761en.pdf. Accessed 2 Jan 2016

Hamel L et al (2016) The Burden of Medical Debt: Results from the Kaiser Family Foundation/ New York Times Medical Bills Survey Report. https://kaiserfamilyfoundation.files.wordpress.com/2016/01/8806-the-burden-of-medical-debt-results-from-the-kaiser-family-foundation-new-york-times-medical-bills-survey.pdf Accessed 2 Feb 2016

Hogerzeil et al (2006) Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts? Lancet 368:305–311

Later drafts of the IP Chapter of TPP https://wikileaks.org/tpp/static/pdf/Wikileaks-secret-TPP-treaty-IP-chapter.pdf Accessed 10 January 2016

Lester S (2015) The leaked TPP Investment Chapter: National Treatment Issues In: International Economic Law and policy blog: http://worldtradelaw.typepad.com/ielpblog/2015/03/tpp-isds-national-treatment.html. Accessed 1 Dec 2015

Liberti L (2010) Intellectual Property Rights in International Investment Agreements, an Overview In: OECD Working Papers on International Investment. OECD Publishing. oecd.org/daf/inv/workingpapers. Accessed 10 December 2015

Lopes GL (2013) Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India. Ann Oncol 24(Suppl 5):v13–v16. doi:10.1093/annonc/mdt323 CrossRef

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Titel: The Human Right to Health: Reflecting on the Implications of IPRs as Endorsed by the Trans-Pacific Partnership Agreement
verfasst von: Sunita Tripathy
Verlag: Springer International Publishing
Buch: International Economic Law
Print ISBN: 978-3-319-44644-8

Electronic ISBN: 978-3-319-44645-5

Copyright-Jahr: 2017
DOI: https://doi.org/10.1007/978-3-319-44645-5_4