Journal of Intellectual Property Rights

Open Access Open Access  Restricted Access Subscription Access

Impact of TRIPS on Providing Easy Access to Affordable Medicines in India


Affiliations
1 Cluster Innovation Centre, University of Delhi, Delhi-110007, India
 

Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement affected on 1st January 1995 have provided minimum standards for protecting nearly all forms of intellectual property. Product patents were introduced in pharmaceuticals sector in the amended Indian Patent Act (1970) to make it TRIPS compliant. Many eminent IP experts from industry, academia, policy makers, IP practitioners, government officials and regulatory personnel had expressed concern about increase in drug prices, discouragement in R&D, limited manufacturing of drugs and restriction of competition that may impact the access to drugs and new technologies. To curtail the possible adverse impact of patents on access to medicines, flexibilities have been provided in the TRIPS Agreement. These include certain provisions of Indian Patent Act such as compulsory licensing (Section 84), restriction on grant of patent for new use of a known substance as well as for new forms unless they exhibit significant efficacy (Section 3d) and provision of two-tier patent opposition i.e pre-grant and post-grant opposition [(Section 25 (1) and 25 (2)]. Implementation of these provisions has improved access to drugs to some extent in the post-TRIPS era. There are certain regulations concerning interests of the public with which the Government also controls the drug price and the access of drugs to the public. Drug Price Control Order (DPCO) controls price of the drugs in India. The Government has also raised the ambit of DPCO to include all the drugs in the National List of Essential Medicines (NLEM) including the combination drug where one or more drugs fall under NLEM. The procedure for calculating the ceiling price of the drugs has been changed from a cost based approach to a market based approach. Further, an external reference pricing system has been suggested by the National Pharmaceutical Pricing Authority (NPPA) to negotiate the prices of patented medicines so that availability of drugs improves. Keeping several factors into consideration that exerts influence on the drug prices that in turn have a direct effect on the access to medicine to the Indian public, this article mainly discusses the impact of TRIPS on the specific sections of the Indian Patent Act based on flexibilities provided by TRIPS to the developing countries. Contribution of the pharmaceutical industry, the Indian Government, research-based multinational drug companies, medical professionals, drug research policy, drug production, drug pricing on access to medicines is also discussed.

Keywords

TRIPS, WHO, DPCO, Patent, Generic Drug, Compulsory License, Drug, Pharmaceutical Company.
User
Notifications
Font Size

  • WHO, Intellectual Property Rights and Access to Medicines: A South-East Asia perspective on global issues, (2008), http://www.searo.who.int/entity/intellectual_property/trh.pdf.

  • Nair M D, Impact of emerging IPR regime on India pharmaceutical industry, National Intellectual Property Organization Souvenir, 2004, p. 29.

  • Nair M D, TRIPS and access to affordable drugs, Journal of Intellectual Property Rights, 17 (7) (2012) 305-314.

  • Donoso E A, Global Solution for the Protection of Inventions, 2014, http://pdf-directory.org/ebook.php?id=a51nAwAAQBAJ.

  • WTO OMC FACT SHEET, TRIPS and pharmaceutical patents, 2006, https://www.wto.org/ENGLISH/ tratop_e trips_e/tripsfactsheet_pharma_2006_e.pdf.

  • World Health Assembly, Resolution WHA28.66, Geneva, World Health Organization, 1975.

  • Laing R, Waning B, Gray A, Ford N & Hoen E, 25 years of the WHO essential medicines lists: Progress and challenges, R - The Lancet, 361 (5) (2003) 1723-1729.

  • Sinha K, Govt. to bring essential medicines under price control, Times of India, 28 September 2012, http://articles.timesofindia.indiatimes.com/2012-09-28/india/34147534_1_price-controlnlem-essential-medicines.

  • NLEM, 2011, http://pharmaceuticals.gov.in/pdf/NLEM.pdf.

  • Kumar R S P, Balamuralidhara V, Kumar P T M & Dave A J, Need for drug price control in India, Adv J Pharm Life Sci Res, 1 (1) (2013) 22-30.

  • What are Neglected Diseases?, News Medical, 2011, http://www.newsmedical.net/health/what-are-neglected-diseases.aspx (accessed on 27 October 2016).

  • Neglected Tropical Diseases, World Health Organization (WHO), 2013, http://www.who.int/neglected_diseases/en/ (accessed on 27 October 2016).

  • Bors C, Christie A, Gervais D & Clayton E W, Improving access to medicines in low-income countries: A review of mechanisms, The Journal of World Intellectual Property, 18 (1-2) (2015) 1-28.

  • Vacca R, Intellectual Property and Public Health - A White Paper, Akron Research Paper No. 13-11, School of Law, University of Akron, 2013.

  • Cameron A, Ewen M, Ross-Degnan D, Ball D & Laing R, Medicine prices availability and affordability in 36 developing middle-income countries: A secondary analysis, The Lancet, 373 (2009) 240-49.

  • Drug Spending in OECD Countries Up by Nearly a Third Since 1998, According to New OECD Data, Organization for Economic Co-operation and Development, 2005, http://www.oecd.org/general/drugspendinginoecdcountriesupbynearlyathirdsince1998accordingtonewoecddata.htm.

  • The World Medicines Situation, WHO, 2004, http://apps.who.int/ medicinedocs/pdf/s6160e/s6160e.pdf, (accessed on 27 October 2016).

  • Health Expenditure Per Capita, World Bank, 2014, http://data.worldbank.org/indicator/SH.XPD.PCAP.

  • Business News, 26 February 2016, http://www.firstpost. com/business/budget-2016-healthcare-cannot-wait-mr-jaitley-healthy-india-can-hasten-wealthy-india-2644650.html.

  • WHO National Health accounts, Global Health Expenditure Database, http://www.who.int/health-accounts/ghed/en/.

  • Annual Report, MHFW, December 2011, http://www.mohfw.nic.in/showfile.php?lid=121.

  • Niens L M, Cameron A, Van D P E, Brouwer W B F & Laing R, Quantifying the impoverishing effects of purchasing medicines: A cross-country comparison of the affordability of medicines in the developing world, PLoS Medicine, 7 (8) (2010), e1000333. doi: 10.1371/journal.pmed.1000333.

  • Greene W, The emergence of india’s pharmaceutical industry and implications for the U.S. generic drug market, Office of Economics Working Paper U.S. International Trade Commission, 2007, https://www.usitc.gov/publications/332/EC200705A.pdf.

  • TRIPS Agreement, https://www.wto.org/english/docs e/legal_e/27-trips.pdf.

  • Implications of the Doha Declaration on the TRIPS Agreement and Public Health WHO, 2002, http://apps.who.int/medicinedocs/pdf/s2301e/s2301e.pdf.

  • Ellen F M & Hoen T TRIPS, Pharmaceutical patents and access to essential medicines: Seattle, Doha and beyond, 2003, http://www.who.int/intellectualproperty/ topics/ip/tHoen.pdf.

  • Arora S & Chaturvedi R, "Section 3 (d): Implications and key concerns for pharmaceutical sector, Journal of Intellectual Property Rights, 21 (2016) 16-26.

  • Amended Indian Patent Act, 2005, http://www.ipindia.nic.in/.

  • The Value of Incremental Pharmaceutical Innovation, U.S-India Business Council, 2009, http://www.indiaenvironmentportal.org.in/files/USIBCIncrementalInnovationReport Final.pdf (accessed on 20 November 2016).

  • Rodriguez V, Patent pools: Intellectual property rights and competition, Open AIDS Journal, 4 ( 2010) 62-66.

  • Nair G G, Fernandes A & Nair K, Landmark pharma patent jurisprudence in India, Journal of Intellectual Property, 14 (2014) 79-88.

  • 558/DELNP/2003, Crystalline Tiotropium Bromide Monohydrate and Process Thereof, http://ipindiaservices.gov.in/decision/00558-DELNP-2003-9637/ 558-delnp-2003%2025(2)%20decision.pdf (accessed on 25 September 2016).

  • Gopakumar K M, Product patents and access to medicines in India: A critical review of the implementation of TRIPS patent regime, The Law and Development Review, 3 (2) (2010) Art. 11.

  • Nair G G & Fernandes A, Patent policies and provisions relating to pharmaceuticals in India, Journal of Intellectual Property Rights, 19 (1) (2014) 7-17.

  • Ramani S V & Urias E, Access to critical medicines: When are compulsory licenses effective in price negotiations? Social Science & Medicine, 135 (6) (2015) 75-83.

  • Kaur A & Chaturvedi R, Compulsory licensing of drugs and pharmaceuticals: Issues and dilemma, Journal of Intellectual Property Rights, 20 (9) (2015) 279-287.

  • WHO/TCM/2005, Remuneration guidelines for non-voluntary use of a patent on medical technologies, http://www.who.int/hiv/amds/WHOTCM2005.1_OMS.pdf.

  • Kochhar R, Indian pharmaceutical industry: Policies, achievements and challenges, Current Science, 106 (10) (2014) 1345.

  • Hirschler B, Bayer fails to block generic cancer drug in India‟s top court, Reuters, 2014, http://in.reuters.com/article/2014/12/12/us-bayer-indiaruling-idINKBN0JQ1XA20141212.

  • Hoffman S J & So K, Assessing 15 proposals for promoting innovation and access to medicines globally for the global access to medicines, Reform Study Team Ann Glob Health, 80 (6) (Nov-Dec 2014) 432-43.

  • Bermudez J & 't Hoen E, The UNITAID patent pool initiative: Bringing patents together for the common good, Open AIDS J, 4 (2010) 37-40.

  • Clark J, Patent pools: A solution to the problem of access in biotechnology patents? 2000, www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf, (accessed on 27 October 2016).

  • Danzon P M & Towse A, Differential pricing for pharmaceuticals: Reconciling access, R&D and patents, International Journal of Health Care Finance and Economics, 3 (2003)183-205.

  • Wheeler C & Berkley S, Initial lessons from public-private partnerships in drug and vaccine development Bulletin of the World Health Organization, 79 (8) (2001) 728.

  • Golechha M, Healthcare agenda for the Indian government, Indian J Med Res, 141 (10) (2015) 151-153.

  • Golechha M, The National Health Assurance Mission for India, 384 (9949) (11) (2016) 1185-1186.

  • High level expert group report on universal health coverage for India, Planning Commission of India, 2011, http://planningcommission.nic.in/reports/genrep/rep_uhc0812.pdf, (accessed on 6 November 2016).

  • Basant R & Srinivasan S, Intellectual Property Protection in India and Implications for Health Innovation: Emerging Perspectives, No. WP2015-04-01,Indian Institute of Management Ahmedabad, Research and Publication Department, 2015.

  • Lalitha N, Tamil Nadu Government intervention and prices of medicines, Economic and Political Weekly, 2008, 66-71.

  • Nautiyal S, IMA to promote affordable and efficacious branded generics through Nirmalaya, (2015), http://www.pharmabiz.com/NewsDetails.aspx?aid=86804&sid=1, (accessed on 20 November 2016).


Abstract Views: 289

PDF Views: 170




  • Impact of TRIPS on Providing Easy Access to Affordable Medicines in India

Abstract Views: 289  |  PDF Views: 170

Authors

Shalini Arora
Cluster Innovation Centre, University of Delhi, Delhi-110007, India
Rekha Chaturvedi
Cluster Innovation Centre, University of Delhi, Delhi-110007, India

Abstract


Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement affected on 1st January 1995 have provided minimum standards for protecting nearly all forms of intellectual property. Product patents were introduced in pharmaceuticals sector in the amended Indian Patent Act (1970) to make it TRIPS compliant. Many eminent IP experts from industry, academia, policy makers, IP practitioners, government officials and regulatory personnel had expressed concern about increase in drug prices, discouragement in R&D, limited manufacturing of drugs and restriction of competition that may impact the access to drugs and new technologies. To curtail the possible adverse impact of patents on access to medicines, flexibilities have been provided in the TRIPS Agreement. These include certain provisions of Indian Patent Act such as compulsory licensing (Section 84), restriction on grant of patent for new use of a known substance as well as for new forms unless they exhibit significant efficacy (Section 3d) and provision of two-tier patent opposition i.e pre-grant and post-grant opposition [(Section 25 (1) and 25 (2)]. Implementation of these provisions has improved access to drugs to some extent in the post-TRIPS era. There are certain regulations concerning interests of the public with which the Government also controls the drug price and the access of drugs to the public. Drug Price Control Order (DPCO) controls price of the drugs in India. The Government has also raised the ambit of DPCO to include all the drugs in the National List of Essential Medicines (NLEM) including the combination drug where one or more drugs fall under NLEM. The procedure for calculating the ceiling price of the drugs has been changed from a cost based approach to a market based approach. Further, an external reference pricing system has been suggested by the National Pharmaceutical Pricing Authority (NPPA) to negotiate the prices of patented medicines so that availability of drugs improves. Keeping several factors into consideration that exerts influence on the drug prices that in turn have a direct effect on the access to medicine to the Indian public, this article mainly discusses the impact of TRIPS on the specific sections of the Indian Patent Act based on flexibilities provided by TRIPS to the developing countries. Contribution of the pharmaceutical industry, the Indian Government, research-based multinational drug companies, medical professionals, drug research policy, drug production, drug pricing on access to medicines is also discussed.

Keywords


TRIPS, WHO, DPCO, Patent, Generic Drug, Compulsory License, Drug, Pharmaceutical Company.

References