Compulsory Licensing of Pharmaceutical Patents in Pakistan Patent Ordinance

Muhammad Riaz

doi:10.69971/tipr.2.2.2024.28

Authors

Muhammad Riaz Department of Pharmacy, Shaheed Benazir Bhutto University, Sheringal18050, Khyber Pakhtunkhwa, Pakistan

DOI:

https://doi.org/10.69971/tipr.2.2.2024.28

Keywords:

Compulsory licensing, Pakistan patent ordinance, pharmaceutical patent, Trade-Related Aspects of Intellectual Property Rights

Abstract

In Pakistan, access to affordable medicines is a critical challenge due to high disease burdens and exorbitantly priced patented drugs that leave millions without essential healthcare. Compulsory licensing (CL) under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement provides a legal mechanism for the production or importation of generic versions of patented medicines to ensure their affordability and availability. This article considers how CL can be used as one avenue to begin bridging the gap between intellectual property rights (IPRs) and public health imperatives in Pakistan. The study focuses on the prevailing health-related condition of both high prices for patented medicines and healthcare expenditure by out-of-pocket expenses. Under this context, it evaluated the compulsory licensing regime in Pakistan in conformity with the provisions under Patents Ordinance 2000.Several issues have been encountered in that course including institutional inefficiency, weak technical capacity, and international pressures being in the front lines. Drawing from worldwide experience in countries as varied as India, Brazil, and Thailand, this article explains precisely how CL allows equity in medical access, with an assurance of the need for the local manufacture of pharmaceutical products and cuts off healthcare costs. The recommendations are policy priorities on the strengthening of legal frameworks, enhancement of regulatory capacity, promotion of local production, and tapping into international support. The article concludes that CL is not only a legal tool but an ethical commitment to the right to health. With bold action and coordinated efforts, it is possible for Pakistan to employ CL as a tool in transforming its healthcare system and ensuring that life-saving medicines are truly affordable and accessible to all.

References

Adalja, Amesh. 2012. Anthrax: has the clinical milieu changed since 2001? Journal of Community Hospital Internal Medicine Perspectives 2: 3402. https://doi.org/10.3402/jchimp.v2i2.18191

Asok, Aswathy. 2017. Compulsory licensing of patented drugs under national emergency. Journal of Intellectual Property Rights 22: 270-275. https://nopr.niscpr.res.in/handle/123456789/43406

Atif, Muhammad, Ahmad Mahmood, Saleem Quratulain, Curley Louise, Qamar-uz-Zaman Muhammad, Babar Zaheer-Ud-Din. 2017. Pharmaceutical Policy in Pakistan. In: Babar, ZUD. (Eds) Pharmaceutical Policy in Countries with Developing Healthcare Systems. Adis, Cham. https://doi.org/10.1007/978-3-319-51673-8_3

Basit, Abdul, Fawwad Asher, Qureshi Huma, Shera. 2018. Prevalence of diabetes, pre-diabetes, and associated risk factors: Second National Diabetes Survey of Pakistan (NDSP), 2016-2017. BMJ Open 8: e020961. https://doi.org/10.1136/bmjopen-2017-020961corr1

Binder, Christina. 2024. Emergencies in the Inter-American Human Rights System: The example of Ecuador in times of COVID-19. Yearbook of International Disaster Law Online 5: 58-76. https://dx.doi.org/10.2139/ssrn.4807343

Bognar, Cinthia Leite Frizzera Borges, Bychkovsky Brittany L, Lopes Jr Gilberto de Lima 2016. Compulsory licenses for cancer drugs: Does cir-cumventing patent rights improve access to oncology medications? Journal of Global Oncology 2: 292-301. https://doi.org/10.1200/JGO.2016.005363

Bombach, Kara. 2001. Can South Africa fight AIDS: Reconciling the South African Medicines and Related Substances Act with the TRIPS Agreement. Boston University International Law Journal 19:273. https://eur-int-comp-law.univie.ac.at/fileadmin/user_upload/i_deicl/VR/VR_Personal/Marboe/Internetpublikationen/a_grosse_2013_trips.pdf

Bonadio, Enrico, Contardi Magali. 2023. Compulsory Licenses during the COVID-19 Pandemic: A European and International Perspective. In: Ottavio Quirico, Katarzyna Kwapisz Williams (Eds.) The European Union and the Evolving Architectures of International Economic Agree-ments. Springer Singapore. https://dx.doi.org/10.2139/ssrn.4282886

Chamboredon, Roman, Colson. 2020. COVID‐19 pandemic in France: Health emergency experiences from the field. International Nursing Review 67:326-333. https://doi.org/10.1111/inr.12604

Chan, Huan-Keat, Hassali Mohamed Azmi, Said Rosaida Hj Md, Hassan, Muhammad Radzi Abu. 2020. Treatment coverage and drug expenditure in hepatitis C patients from 2013 to 2019: A journey of improving treatment accessibility in Malaysia through government-led initiatives. Hepatitis Monthly 20:e107372. http://dx.doi.org/10.5812/hepatmon.107372

Chaudhuri, Shubham, Goldberg Pinelopi, Barwick Panle. 2003. The effects of extending intellectual property rights protection to developing countries: A case study of the Indian pharmaceutical market. National Bureau of Economic Research, NewYork, USA. https://dx.doi.org/10.2139/ssrn.3417228

Chirawu, Slyvia. 2006. Till death do us part: Marriage, HIV/AIDS, and the law in Zimbabwe. Cardozo Journal of Law & Gender 13: 23. https://law.bepress.com/expresso/eps/1419/

Chopra, Naval Satarawala, Muthappa Dinoo. 2012. The curious case of compulsory licensing in India. Competition Law International 8: 34-40. https://heinonline.org/HOL/LandingPage?handle=hein.journals/cmpetion8&div=26&id=&page

Correa, Carolas Maria. 2000. Intellectual Property Rights, the WTO and Developing Countries: The TRIPS agreement and Policy Options. Zed Books, London: UK.

Correa, Carolas Maria. 2011. Pharmaceutical Innovation, Incremental Patenting, and Compulsory Licensing. South Centre, Geneva: Switzerland. https://www.econstor.eu/handle/10419/232159

Possas, Cristina de Albuquerque. 2008. Compulsory Licensing in The Real World: The Case Of ARV Drugs In Brazil. In: Coriat, Benjamin (Ed.) The Political Economy Of HIV/AIDS In Developing Countries: TRIPS, Public Health Systems, and Free Access. Edward Elgar Publishing, Chel-tenham: UK. http://dx.doi.org/10.4337/9781848444898.00016

Demeke, Belay. 2021. LL. M. thesis. https://www.academia.edu/78920511/Demeke_Thesis

DiMasi, Joseph, Hansen Ronald, Grabowski Henry. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22: 151-185. https://doi.org/10.1016/S0167-6296(02)00126-1

Ewing. 2020. Covid-19: Government by decree. King's Law Journal 31: 1-24. http://dx.doi.org/10.1080/09615768.2020.1759398

Färber, Gisela. 2021. Germany's fight against Covid-19: The Tension Between Central Regulation and Decentralised Management. In: Stytler, Nico (Ed,) Comparative Federalism and Covid-19. Routledge, Oxfordshire:UK. https://doi.org/10.4324/9781003166771

Ford, Nathan, Wilson David, Chaves Gabriela Costa, Lotrowska Michel, Kijtiwatchakul Kannikar. 2007. Sustaining access to antiretroviral therapy in the less-developed world: Lessons from Brazil and Thailand. AIDS 21: 21-29. https://doi.org/10.1097/01.aids.0000279703.78685.a6

Galvão, Jane, Teixeira Paulo Roberto, Vitória, Marco, Schechter Mauro. 2009. How the pandemic shapes the public health response: The case of HIV/AIDS in Brazil. In: Celentano, D.D, Beyrer C. (Eds.) Public Health Aspects of HIV/AIDS in Low- And Middle-Income Countries: Epi-demiology, Prevention, and Care. Springer, UK. http://dx.doi.org/10.1007/978-0-387-72711-0_7

Galvão, Jane. 2002. Access to antiretroviral drugs in Brazil. The Lancet 360: 1862-1865. https://doi.org/10.1016/s0140-6736(02)11775-2

Guharoy, Roy, Noviasky John. 2021. Executive order on ensuring essential medicines—All bark, no bite? Mayo Clinic Proceedings 96:1714-1717. https://doi.org/10.1016/j.mayocp.2020.12.028

Gujjar, Muhammad Waqas, Hussain Syyad Arslan, Anees Attiya, Gondal Tahir Mahmood. 2024. Intellectual property laws in Pakistan. Bulletin of Business and Economics 13: 282-289. https://doi.org/10.61506/01.00489

Habib, Muhammad Atif, Soofi Sajid, Cousens Siman, Anwar Saeed, ul Haque Najib, Ahmed Imran, Ali Noshad, Tahir Rehman, Bhutta Zulfiqar Ali. 2017. Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: A cluster ran-domised controlled trial. The Lancet Global Health 5: e593-e603. https://doi.org/10.1016/S2214-109X(17)30184-5

Hill, Andrew, Khoo Saye, Fortunak Joe, Simmons Bryony, Ford Nathan. 2014. Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clinical Infectious Diseases 58: 928-936. doi: 10.1093/cid/ciu012.

Ibrahim, Jamal, Abdullah Mohammad Jamshed. 2021. Impact of compulsory licensing on research & innovation with reference to Indian pharma companies. Webology 18: 2986-2988. http://webology.org/abstract.php?id=4913

Iqbal, Maham, Rabbani Azkah, Haq Fatima, Bhimani Sunainah. 2022. The floods of 2022: Economic and health crisis hits Pakistan. Annals of Medicine and Surgery 84:104800. https://doi.org/10.1016/j.amsu.2022.104800

Jiménez, Guillermo, Hidalgo Pablo Grez, Marshall Pablo Marshall. 2022. Chile: Legal response to Covid-19. In: King , Jeff, Octávio LM Ferraz et al (Eds.) The Oxford Compendium of National Legal Responses to Covid-19. Oxford University Press, Oxford: UK.

Kazi, Afaq, Chandani Seema. 2020. Challenges of Pakistani pharmaceutical industry: Pakistan case. International Journal of Experiential Learning & Case Studies 5: 193-203. http://dx.doi.org/10.22555/ijelcs.v5i2.51

Kazmi, Tahseen, Nagi Mlf, Razzaq Shama, Hussnain Shamaila, Shahid Noor, Athar Unsa. 2022. Burden of noncommunicable diseases in Pakistan. Eastern Mediterranean Health Journal 28: 798-804. https://doi.org/10.26719/emhj.22.083

Khalid, Faraz, Raza Wajeeha, Hotchkiss David, Soelaeman Rieza. 2021. Health services utilization and out-of-pocket (OOP) expenditures in public and private facilities in Pakistan: An empirical analysis of the 2013-14 OOP health expenditure survey. BMC Health Services Research 21:1-14. https://doi.org/10.1186/s12913-021-06170-4

Khan, Salman, Asif Muhammad, Aslam Sadia, Khan Wahab, Hamza Syed Ali. 2023. Pakistan’s healthcare system: A review of major challenges and the first comprehensive universal health coverage initiative. Cureus 15: e44641. https://doi.org/10.7759/cureus.44641

Khor. 2009. Patents, compulsory licences, and access to medicines: Some recent experiences. Intellectual Property and Access to Medicines: Papers and Perspectives 8:87-105. https://twn.my/title2/IPR/pdf/ipr10.pdf

Matthias. 2005. Kashmir earthquake of 2005. Encyclopedia Britannica. Available Online: https://www.britannica.com/event/Kashmir-earthquake-of-2005 (accessed on 12 December 2024)

Meyer, Mortiz. 2023. Poverty and equity brief: Pakistan. Available Online: https://databankfiles.worldbank.org/public/ddpext_download/poverty/987B9C90-CB9F-4D93-AE8C-750588BF00QA/current/Global_POVEQ_PAK.pdf (accessed on 12 December 2024)

Mietmer, Marcus. 2020. Economic capacity, regime type, or policy decisions? Indonesia's struggle with COVID-19. Taiwan Journal of Democracy16: 1-29. https://www.airitilibrary.com/Article/Detail?DocID=18157238-202012-202011300008-202011300008-1-29

Mohara, Adun. 2017. Implementation of compulsory licensing of pharmaceuticals in Thailand. Master’s thesis, London School of Hygiene & Tropical Medicine,UK. https://doi.org/10.17037/PUBS.04652829

Moon, Suire, Jambert Elodie, Childs Michelle, von Schoen-Angerer Tido. 2011. A win-win solution? A critical analysis of tiered pricing to improve access to medicines in developing countries. Globalization and Health 7:1-11. https://doi.org/10.1186/1744-8603-7-39

Morikawa, Kenichi, Nakamura Akihisa, Shimazaki Tomoe, Sakamoto Naoya. 2018. Safety and efficacy of elbasvir/grazoprevir for the treatment of chronic hepatitis C: Current evidence. Drug Design, Development and Therapy 12:2749-2756. https://doi.org/10.2147/dddt.s133697

Nishtar, Sania, Bhutta Zulfiqar Ali, Jafar Tazeen, Ghaffar Abdul, Akhtar Tasleem, Bengali Kaisar, Isa Qazi Asmat, Rahim Ejaz. 2013. Health reform in Pakistan: A call to action. The Lancet 381: 2291-2297. http://dx.doi.org/10.1016/S0140-6736(13)60813-2

Noguera, Alt, Hirschhorn Maponga, Osewe Sam-Abbenyi. 2003. HIV/AIDS Humanitarian Supply Chain Management: The Case of Zimbabwe. In: Transactions on Engineering Technologies. Springer Singapore. https://doi.org/10.1007/978-981-10-2717-8_33

Prada, Sergio, Garcia-Garcia Maria Paulo, Guzman Javier. 2022. COVID-19 response in Colombia: Hits and misses. Health Policy and Technology 11: 100621. https://doi.org/10.1016/j.hlpt.2022.100621

Ranjan, Prabhash, Praharsh Gour. 2023. The TRIPS waiver decision at the World Trade Organization: Too little too late! Asian Journal of Interna-tional Law 13: 10-21. https://doi.org/10.1017/S2044251322000571

Reichman, Jerome. 2009. Comment: Compulsory licensing of patented pharmaceutical inventions: Evaluating the options. Journal of Law, Medicine & Ethics 37:247-263. doi: 10.1111/j.1748-720X.2009.00369.x.

Rodrigues, William, Soler Orenzeo. 2009. Licença compulsória do efavirenz no Brasil em 2007: Contextualização. Revista Panamericana de Salud Pública 26:553-559.

Rumbold, Benedict, Baker Rachel, Ferraz Octavio, Hawkes Sarah, Krubiner Carleigh, Littlejohns Peter, Norheim Ole F, Pegram Thomas, Rid Annette, Venkatapuram Sridhar, Voorhoeve Alex, Wang Daniel, Weale Albert, Wilson James, Yamin Alicia Ely. 2017. Universal health coverage, priority setting, and the human right to health. The Lancet 390: 712-714. https://doi.org/10.1016/s0140-6736(17)30931-5

Sell, Susan. 2003. Private Power, Public Law: The Globalization of Intellectual Property Rights. Cambridge University Press. https://doi.org/10.1017/CBO9780511491665

Shaikh, Babar, Hatcher Juanita. 2005. Health-seeking behaviour and health service utilization in Pakistan: Challenging the policymakers. Journal of Public Health 27: 49-54. https://doi.org/10.1093/pubmed/fdh207

Shukar, Sundas, Anjum Rehan, Zhang Jinwei, Babar Zahir ul din, Mobeen Iqra, Yang Cenji. 2024. Anticancer medicines in Pakistan: An analysis of essential medicines lists. Journal of Oncology Pharmacy Practice 30: 46-54. https://doi.org/10.1177/10781552231167809

Siddiqui, Mustaqeem, Rajkumar Vincet. 2012. The high cost of cancer drugs and what we can do about it. Mayo Clinic Proceedings 87:935-943.

Son, Kyoung Bok, Lee Tae Jin. 2018. Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to med-icines. Global Public Health 13: 1430-1440. doi: 10.1080/17441692.2017.1407811.

Srinivasan. 2012. The compulsory license for Nexavar: A landmark order. Economic and Political Weekly 47:13-14. https://www.jstor.org/stable/23214668?seq=1

Supreme Court of the Russian Federation. 2021. Russian Constitution, Arts. 2, 17, 18, 55; Federal Constitutional Law of 6 November 2020, Arts. 5, 16, 24; Civil Code of the Russian Federation, Arts. 1229, 1360; Decree of the President of the Russian Federation of 23 May 1996 No. 763; Federal Law of 21 November 2011 No. 323-ФЗ “On the Basics of Health Protection of Citizens in the Russian Federation”, Art. 2. “Remdesivir”. International Review of Intellectual Property and Competition Law 52: 1258-1265. https://doi.org/10.1007/s40319-021-01111-4

Urias, Eduardo, Ramani Shyama V. 2020. Access to medicines after TRIPS: Is compulsory licensing an effective mechanism to lower drug prices? A review of the existing evidence. Journal of International Business Policy 3: 367-384. https://doi.org/10.1057/s42214-020-00068-4

Vincent, Gonzaga. 2020. Trip-ing up: The failure of TRIPS Article 31bis. Gonzaga Journal of International Law 24:1. https://ssrn.com/abstract=3778945

Waheed, Yasir, Shafi Talha, Safi Sher Zaman, Qadri Ishtiaq. 2009. Hepatitis C virus in Pakistan: A systematic review of prevalence, genotypes, and risk factors. World Journal of Gastroenterology 15: 5647-5653. http://dx.doi.org/10.3748/wjg.15.5647

WHO. 2024. Global tuberculosis report 2024. World Health Organization. Available online https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2024 (accessed on 12 December 2024)

Wong, Hilary. 2020. The case for compulsory licensing during COVID-19. Journal of Global Health, 10(1). doi: 10.7189/jogh.10.010358

WTO. 2001. Doha Declaration on the TRIPS Agreement and Public Health. Fourth WTO Ministerial Conference, Doha, Qatar, 14 November 2001.Available online: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm (accessed on 12 December 2024)

Yu, Yuanyuan, Cao Jie, Pan Hongqiu, Zhong Hui, Wu Xiaocui, Yang Jin -hui, Cheng, Li.-Ping, Qu, Qingrong, Wang Lie, Lu Fuihi. 2023. Real-world effectiveness and safety of prolonged bedaquiline course in the treatment of drug-resistant tuberculosis: A multi-center retrospective cohort study in a country with a high burden of drug-resistant tuberculosis. The Lancet 7: 16:5055-5064. https://dx.doi.org/10.2139/ssrn.5058472

Zaidi, Shehla, Bigdeli Maryam, Aleem Noreen, Rashidian Arash. 2013. Access to essential medicines in Pakistan: Policy and health systems research concerns. Plos One 8: e63515. https://doi.org/10.1371/journal.pone.0063515