Impact of the Trade-Related Aspect of Intellectual Property Rights Agreement on Pharmaceutical Industry in Developing Countries: A Scoping Review

Document Type : Review Paper


Department of Pharmacoeconomics and Pharma Management, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran



Pharmaceutical companies in developing countries are heavily influenced by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and economic liberalization rules. To adjust to the new patent regime, pharmaceutical companies had to adopt some strategies. A systematic review was conducted on the experiences of the pharmaceutical industry in developing countries and strategies adopted by local pharmaceutical companies to survive after the TRIPS agreement. Scopus, PubMed, and ProQuest databases were searched, and twenty-five papers were reviewed. The pharmaceutical industry experiences have been classified into successful and unsuccessful experiences based on criteria developed by the authors. Firm strategies were also divided into four categories based on external and internal factors: aggressive, conservative, competitive, and defensive strategies. Companies were able to survive and even grow after the TRIPS agreement by rebuilding their structures, improving their competencies, and adopting appropriate strategies in line with the new conditions.

Graphical Abstract

Impact of the Trade-Related Aspect of Intellectual Property Rights Agreement on Pharmaceutical Industry in Developing Countries: A Scoping Review


(1) Bloom DE, Canning D, and Sevilla J. The effect of
health on economic growth: a production function
approach. World Dev. (2004) 32: 1–13.
(2) Kumar M, Mohanty B, Narayan M, and Vadera ML.
Sustainability Reporting Pattern in Pharmaceutical
Sector: A Study of Top 10 Economies across the
Globe. Int. J. Res. Pharm. Sci. (2020) 11: 460–465.
(3) Akhtar G. Indian pharmaceutical industry: an
overview. IOSR J. Humanit. Soc. Sci. (2013) 13:
(4) Ugbam OC and Okoro EA. A Strategic Study of the
Nigerian Pharmaceutical Sector: Organizational
Leadership, Market-share, and Competitive
Performance. Int. J. Business, Humanit. Technol.
(2017) 7: 1–10.
(5) Islam S, Rahman A, and Al Mahmood AK.
Bangladesh Pharmaceutical Industry: Perspective
and the Prospects. Bangladesh J. Med. Sci. (2018)
17: 519–525.
(6) Aamir M and Zaman K. Review of Pakistan
pharmaceutical industry: SWOT analysis. Int. J.
Bus. Inf. Technol. (2011) 1: 114–117.
(7) Nurpeisov BG, Nabiev EN, Mukashev TA,
Daribekov SS, Raimbekov BK, Asanova MK, et
al. The Pharmaceutical Sector of Kazakhstan’s
Economy: Trends and Problems. Int. J. Environ.
Sci. Educ. (2016) 11: 5086–5093.
(8) Kumar A, Zavadskas EK, Mangla SK, Agrawal V,
Sharma K, and Gupta D. When risks need attention:
adoption of green supply chain initiatives in the
pharmaceutical industry. Int. J. Prod. Res. (2019)
57: 3554–3576.
(9) Asif M and Awan M. Pakistani pharmaceutical
industry in WTO regime, Issues and prospects. J.
Qual. Technol. Manag. (2005) 1: 21–34.
(10) Malpani R. All costs, no benefits: how the USJordan Free Trade Agreement affects access to
medicines. J. Generic Med. (2009) 6: 206–17.
(11) Ahmadi M and Ahmadi L. Intellectual Property
Rights of Nanobiotechnology in Trade Related
Aspects of Intellectual Property Rights Agreement
(TRIPS). J. Bionanoscience (2012) 6: 56–64.
(12) Hemphill TA. Pharmaceutical patent expropriation
and technology strategy: strategic options to
compulsory licensing. Technol. Anal. Strateg.
Manag. (2010) 22: 19–41.
(13) Raju KD. Compulsory v Voluntary Licensing : A
Legitimate way to Enhance Access to Essential 
Fathi M et al. / IJPR (2021), 20 (4): 339-351
Medicines in Developing Countries. J. Intellect.
Prop. Rights [serial online] 2017 22: 23–31.
Available from: URL:
(14) Azam MM. The impacts of TRIPS on the
pharmaceutical regulation and pricing of drugs in
Bangladesh: In search of policy direction (March
5, 2013). Accept. Publ. Int. J. Law Manag. (2016)
59: 3.
(15) Alam T and Rastogi R. Pre TRIPS, post TRIPS
patent regime and the Indian pharmaceutical
industry: An empirical study. Indian J. Sci. Technol.
(2016) 9: 1–7.
(16) Sun H. The road to Doha and beyond: Some
reflections on the TRIPS agreement and public
health. Eur. J. Int. law (2004) 15: 123–150.
(17) Duggan M, Garthwaite C, and Goyal A. The
market impacts of pharmaceutical product patents
in developing countries: Evidence from India. Am.
Econ. Rev. (2016) 106: 99–135.
(18) Safari H, Arab M, Rashidian A, Kebriaee-Zadeh
A, and Gorji HA. A comparative study on different
pharmaceutical industries and proposing a model
for the context of Iran. Iran. J. Pharm. Res. IJPR
(2018) 17: 1593.
(19) Chan L and Daim TU. Multi‐perspective analysis
of the Chinese pharmaceutical sector. J. Technol.
Manag. China (2011) 6: 171–190.
(20) Lockhart M, Babar ZU-D, and Garg S. Evaluation
of policies to support drug development in New
Zealand. Health Policy (New. York). (2010) 96:
(21) Sahu SK. Globalization, WTO, and the Indian
pharmaceutical industry. Asian Aff. An Am. Rev.
(2014) 41: 172–202.
(22) Rentala S, Anand B, and Shaban M. Technological
capabilities and firm resources as determinants
of export competitiveness: Evidence from Indian
pharmaceutical industry using quantile regression
approach. J. Med. Mark. (2014) 14: 133–144.
(23) Chittoor R, Ray S, Aulakh PS, and Sarkar
MB. Strategic responses to institutional
changes:‘Indigenous growth’model of the Indian
pharmaceutical industry. J. Int. Manag. (2008) 14:
(24) Yin H and Salmon JW. Strategic Restructuring
of China’s Pharmaceutical Industry: Mergers and
Acquisitions. J. Pharm. Mark. Manage. (2003) 15:
(25) Ng LF-Y and Tuan C. Industry technology
performance of manufacturing FDI: micro-level
evidence from joint ventures in China. Int. J.
Technol. Manag. (2005) 32: 246–263.
(26) Benoliel D and Salama B. Towards an intellectual
property bargaining theory: The post-WTO era. U.
Pa. J. Int’l L. (2010) 32: 265.
(27) McCabe A. Rhetorics of power and development:
intellectual property rights and the pharmaceutical
industry in Brazil. Perspect. Glob. Dev. Technol.
(2007) 6: 585–610.
(28) Arksey H and O’Malley L. Scoping studies:
towards a methodological framework. Int. J. Soc.
Res. Methodol. (2005) 8: 19–32.
(29) Valentin EK. SWOT analysis from a resourcebased view. J. Mark. theory Pract. (2001) 9: 54–
(30) Nikolaou IE and Evangelinos KI. A SWOT
analysis of environmental management practices in
Greek Mining and Mineral Industry. Resour. Policy
(2010) 35: 226–34.
(31) Yüksel İ and Dagdeviren M. Using the analytic
network process (ANP) in a SWOT analysis–A
case study for a textile firm. Inf. Sci. (Ny) (2007)
177: 3364–82.
(32) Wasike CB, Magothe TM, Kahi AK, and Peters
KJ. Factors that influence the efficiency of beef and
dairy cattle recording system in Kenya: A SWOT–
AHP analysis. Trop. Anim. Health Prod. (2011) 43:
(33) Arslan O and Er ID. SWOT analysis for safer
carriage of bulk liquid chemicals in tankers. J.
Hazard. Mater. (2008) 154: 901–913.
(34) Cassidy CM, Glissmeyer MD, and Capps III CJ.
Mapping an internal-external (IE) matrix using
traditional and extended matrix concepts. J. Appl.
Bus. Res. (2013) 29: 1523–1528.
(35) Atul G. Enterprise resource planning: the emerging
organizational value systems. Ind. Manag. Data
Syst. (2000) 100: 114–8.
(36) Kubo K. Product patents and vertical integration
in the post TRIPS Indian pharmaceutical industry.
Retrieved from http//
ken.pdf. (2004) 3: 146–163.
(37) Chadha A. Destination India for the pharmaceutical
industry. Delhi Bus. Rev. (2006) 7: 1–8.
(38) Dhar B and Gopakumar KM. Effect of product
patents on Indian pharmaceutical industry.
Retrieved 8 May 2012, from http//wtocentre.iift. (2008).
(39) Kale D and Little S. From imitation to innovation:
The evolution of R&D capabilities and learning
processes in the Indian pharmaceutical industry.
Technol. Anal. Strateg. Manag. (2007) 19: 589–
(40) Rai RK. Battling with TRIPS: emerging firm
strategies of indian pharmaceutical industry postTRIPS. J. Intellect Prop. Rights [serial online]
2008 13: 301–317. Available from: URL: http://
Impact of the Trade-Related Aspect of Intellectual Property Rights Agreem
(41) Nair MD. TRIPS, WTO and IPR: Impact of Indian
Patent Act 2005 on Indian Pharmaceutical Industry.
J. Intellect. Prop. Rights [serial online] 2010 15:
474–476. Available from: URL: http://nopr.niscair.
(42) Mahajan MM. The Emergence of New R & D
Paradigms in the Indian Pharmaceutical Industry :
Post TRIPS Period. J. Intellect Prop. Rights (2011)
16: 321–329.
(43) Kiran R and Mishra S. Research and development,
exports and patenting in the Indian pharmaceutical
industry: a post TRIPS analysis. Eurasian J. Bus.
Econ. (2011) 4: 53–67.
(44) Sariola S, Ravindran D, Kumar A, and Jeffery
R. Big-pharmaceuticalisation: Clinical trials and
contract research organisations in India. Soc. Sci.
Med. (2015) 131: 239–246.
(45) Kiran R. IPR scenario and factors for promoting
IPR culture: a post-TRIPS period analysis of
selected pharmaceutical firms in North India. Econ.
Res. istraživanja (2017) 30: 873–891.
(46) Zuniga MP and Combe E. Introducing patent
protection in the pharmaceutical sector : a first
evaluation of the mexican case. Revenue Reg. Dev.
(2002) 106–112.
(47) Mahajan MM. The emergence of new R&D
paradigms in the Indian pharmaceutical industry:
post TRIPS period. J. Intellect. Prop. Rights [serial
online] 2011 16: 321–329. Available from: URL:
(48) Chao RO and Kavadias S. R&D intensity and the
new product development portfolio. IEEE Trans.
Eng. Manag. (2013) 60: 664–75.
(49) Bank E. Indian pharmaceutical industry: surging
globally. Occas. Pap. (2007).
(50) Akhtar G. Indian Pharmaceutical Industry : An
Overview. (2013) 13: 51–66.
(51) Zúñiga MP and Combe E. Introducing Patent
Protection in the Pharmaceutical Sector: A First
Evaluation of the Mexican Case “. Rev. Région
Développement (2002) 16: 191–221.
(52) Houben G, Lenie K, and Vanhoof K. A knowledgebased SWOT-analysis system as an instrument
for strategic planning in small and medium sized
enterprises. Decis. Support Syst. (1999) 26: 125–
(53) White S and Linden G. Organizational and
industrial response to market liberalization: The
interaction of pace, incentive and capacity to
change. Organ. Stud. (2002) 23: 917–948.
(54) Hasenclever L and Paranhos J. The development
of the pharmaceutical industry in Brazil and
India: technological capability and industrial
development. Unpubl. manuscript, Econ. Innov.
Res. Group, Econ. Institute, Fed. Univ. Rio Janeiro
(2009) 1–25.
(55) Haley GT and Haley UC V. The effects of patentlaw changes on innovation: The case of India’s
pharmaceutical industry. Technol. Forecast. Soc.
Change (2012) 79: 607–619.