Abstract
This article aims to discuss the main consequences of the implementation of the Trans-Pacific Partnership Agreement (TTPA) in the pharmaceutical sector in regard to public health, focusing on the accessibility and affordability of medicines. This paper also looks at the likely impact of the TPP agreement on access to affordable medicines. The potential effects of provisions in the final text are explored based on the context of developed and developing countries. A meta-synthesis study design was used. The thematic analysis technique was used to generate themes and a decision tree of the TTPA meta-synthesis. PubMed, EBSCOhost, Ovid, and Scopus databases from inception until the first week of January 2016 were used. Only peer-reviewed journals that discussed TPPA’s impact on the pharmaceutical sector were included. Data were extracted by 2 reviewers and then verified by 3 senior researchers. The extracted data were imported into Excel spreadsheets and coded line by line. Codes were organized into descriptive themes. The identified themes were cross-checked against original articles to ensure consistency. A total of 85 full articles and reports were reviewed and, finally, 32 of them were used in the meta-synthesis. Two central themes to the TTPA emerged: intellectual property rights and transparency. Five subthemes were identified under intellectual property rights: patent subject matter (representing scope of patentability), patent term adjustment for patent office delays (representing patent term extension), protection of undisclosed test or other data (representing data exclusivity), protection of undisclosed test or other data (representing patent linkage), and compulsory licensing. Meanwhile, transparency and anti-corruption-procedural fairness, which presents restriction of coverage program and reimbursement, were identified as the subthemes of transparency. Findings indicate that the TPPA could potentially hinder the affordability and accessibility of medicine, which could increase risks to public health.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Ustr.gov. Trans-Pacific Partnership Ministers’ Statement [Internet]. https://ustr.gov/about-us/policy-offices/press-office/press-releases/2016/February/TPP-Ministers-Statement. Published 2016. Accessed October 19, 2016.
Ustr.gov. Summary of the Trans-Pacific Partnership Agreement [Internet]. https://ustr.gov/about-us/policy-offices/press-office/press-releases/2015/october/summary-trans-pacific-partnership. Published 2015. Accessed October 19, 2016.
PwC Advisory Services Sdn Bhd. Study on potential economic impact of TPPA on the Malaysian economy and selected key economic sectors. 2015.
Will the TPP transform intellectual property regulation in Asia? [Internet]. East Asia Forum. http://www.eastasiaforum.org/2016/02/17/will-the-tpp-transform-intellectual-property-regulation-in-asia. Published 2016. Accessed April 15, 2016.
Trans-Pacific Partnership Agreement [Internet]. Electronic Frontier Foundation. https://www.eff.org/issues/tpp. Accessed April 15, 2016.
Intellectual Property—The Trans-Pacific Partnership [Internet]. US Trade Representative. https://medium.com/the-trans-pacific-partnership/intellectual-property-3479efdc7adf#.m8wfs3u34. Published 2015. Accessed April 15, 2016.
TPP, US, and TRIPS IP Law Comparison [Internet]. 1st ed. Hong Kong. https://www.law.cuhk.edu.hk/en/research/cfred/download/TPP_US_IP_Provision_Comparison.pdf. Published 2016. Accessed April 18, 2016.
Implications for Access to Medicines and Public Health [Internet]. Geneva: UNITAID; 2014. http://www.unitaid.eu/images/marketdynamics/publications/TPPA-Report_Final.pdf.
Sha DG. Intellectual property watch. Impact of the TPP on the pharma industry [Internet]. http://www.ip-watch.org/2015/12/02/impact-of-the-tpp-on-the-pharma-industry/. Published 2015. Accessed October 21, 2016.
Public Citizen. Trans-Pacific Partnership Agreement: harmful provisions for access to medicines [Internet]. https://www.citizen.org/documents/specific%20provisions%20final%20draft%20w.o.pdf. Accessed October 19, 2016.
WTO intellectual property (TRIPS)—TRIPS and public health: Compulsory licensing of pharmaceuticals and TRIPS [Internet]. Wto.org. https://www.wto.org/english/tratop_e/trips_e/public_health_faq_e.htm. Published 2016. Accessed April 19, 2016.
Trading away health: how the U.S.’s intellectual property demands for the Trans-Pacific Partnership Agreement threaten access to medicines [Internet]. 1st ed. MSF Access Campaign; 2012 https://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_TPP_ENG_2012_update.pdf. Accessed April 19, 2016.
Knowledge Ecology International. KEI TPP Briefing note 2015:1 Compulsory licenses on patents and the 3-step test. Knowledge Ecology International [Internet]. Keionline.org. http://keionline.org/node/2231. Published 2015. Accessed April 19, 2016.
Flynn S, Kaminski ME, Baker BK, Koo JH. Public interest analysis of the US TPP proposal for an IP chapter. PIJIP Research Paper Series [Internet]. Paper 21. http://digitalcommons.wcl.american.edu/research/21/. Published 2011. Accessed April 19, 2016.
Implications for Access to Medicines and Public Health [Internet]. UNITAID; 2014. http://www.ftamalaysia.org/article.php?aid=333.
Fields of intellectual property protection. WIPO Intellectual Property Handbook: Policy, Law and Use [Internet]. 2nd ed. Geneva: WIPO Publication; 2004. 17–160. http://www.wipo.int/export/sites/www/about-ip/en/iprm/pdf/ch2.pdf. Accessed April 19, 2016.
Saha CN, Bhattacharya S. Intellectual property rights: an overview and implications in pharmaceutical industry. J Adv Pharm Technol Res 2011;2:88–93.
World Health Organization. WTO and the TRIPS agreement [Internet]. http://www.who.int/medicines/areas/policy/wto_trips/en/. Published 2016. Accessed October 15, 2016.
Kapczynski A. The Trans-Pacific Partnership—is it bad for your health? N Engl J Med. 2015;373:201–203.
Kessomboon N, Limpananont J, Kulsomboon V. Impact on access to medicines from TRIPS-Plus: a case study of Thai-US FTA. Southeast Asian J Trop Med Public Health 2010;41:667–77.
Flynn SM, Baker B, Kaminski M, Koo J. The U.S. proposal for an intellectual property chapter in the Trans-Pacific Partnership Agreement. Am Univ Int Law Rev. 2013;28:105–205.
Moir H, Tenni B, Gleeson D, Lopert R. Assessing the impact of alternative patent systems on the cost of healthcare: the TPPA and HIV treatment in Vietnam. Paper presented at the Asia-Pacific Innovation Conference, University of Technology, Sydney, 2014. http://papers.ssrn.com.ezproxy.lib.monash.edu.au/sol3/papers.cfm?abstract_id=2536254M.
Linh NN, Huong NT, Thuy HT. Evolving trade policy and the Trans-Pacific Partnership Agreement: does it threaten Vietnam’s access to medicine and its progress towards scaling up HIV prevention, treatment and care? Glob Public Health 2015;10(suppl 1):S149–S160.
Gleeson D, Lopert R, Reid P. How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand. Health Policy. 2013;112:227–233.
Gleeson D. Analysis of the June 2011 leaked TPP Transparency Chapter Annex (Annex on Transparency and Procedural Fairness for HealthCare Technologies) [Internet]. Submission to the Department of Foreign Affairs and Trade; 2012. https://dfat.gov.au/trade/agreements/tpp/negotiations/Documents/tpp_sub_gleeson_120911.pdf. Accessed April 19, 2016.
Monasterio E, Gleeson D. Pharmaceutical industry behaviour and the Trans Pacific Partnership Agreement. N Z Med J. 2014;127:6–12.
Flynn S, Kaminski M, Baker B, Koo J. Public interest analysis of the US TPP proposal for an IP chapter, draft version 1.3, December 6, 2011. Program on Information Justice and Intellectual Property, American University Washington College of Law, at 3.
Gleeson D, Moir H, Lopert R. Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement. Med J Aust. 2015;202:306–308.
World Health Organization. United States of America [Internet]. http://www.who.int/countries/usa/en/. Published October 19, 2016.
OECD Indicators. Research and development in the pharmaceutical sector. Health Glance. 2015;188–189.
Phrma.org. About PhRMA. PhRMA [Internet]. http://www.phrma.org/about. Accessed October 19, 2016.
PhRMA. PhRMA urges President Obama to secure an ambitious Trans-Pacific Partnership Agreement. http://www.phrma.org/media/releases/phrma-urges-president-obama-secure-ambitious-trans-pacific-partnership-agreement#sthash.3cUGSZjJ.dpuf [Internet]. http://www.phrma.org/media/releases/phrma-urges-president-obama-secure-ambitious-trans-pacific-partnership-agreement. Published 2012.
Policymed.com. Prescription Drug Sales 2009 — IMS Data — Policy and Medicine [Internet]. http://www.policymed.com/2010/04/prescription-drug-sales-2009—ims-data.html. Published 2010. Accessed October 19, 2016.
Amin T, Kesselheim AS. Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades. Health Aff. 2012;31:2286–2294.
Ehrlich & Fenster: Patent & Trademark Attorneys. The Novartis decision: “evergreening” and the future of Generics [Internet]. http://www.ipatent.co.il/the-novartis-decision-evergreening-and-the-future-of-generics/. Published 2013.
Rajagopal D. EU, Australia, Canada may follow India’s Patent Law. India times [Internet]. http://articles.economictimes.indiatimes.com/2013-04-04/news/38278712_1_patent-act-patent-protection-patent-quality. Published 2013. Accessed April 19, 2016.
Fda.gov. PDUFA Performance Reports [Internet]. http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm2007449.htm. Accessed October 19, 2016.
Food and Drug Administration. FY 2014 Performance Report to Congress for the Prescription Drug User Fee Act [Internet]. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM440181.pdf. Published 2014.
Harris T, Nicol D, Gruen N. Pharmaceutical Patents Review Report, Canberra, 2013. https://www.ipaustralia.gov.au/sites/g/files/net856/f/2013-05-27_ppr_final_report.pdf.
Harvey EB. Encouragement of New Clinical Drug Development: The Role of Data Exclusivity [Internet]. Whole Health Organisation 2000. www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf. Accessed October 21, 2016.
Kilic B, Pine C. Inside views: decision time on biologics exclusivity: eight years is no compromise [Internet]. Intellectual Property Watch; 2015. http://www.ip-watch.org/2015/07/27/decision-time-on-biologics-exclusivity-eight-years-is-no-compromise/.
Health at a Glance: Asia/Pacific 2012. Paris: OECD Publishing; 2012. http://www.oecd-ilibrary.org/docserver/download/8112131e.pdf?expires=1461030060&id=id&accname=guest&checksum=70031FDBE9DFA0A17526CD07ED52979D.
All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines [Internet]. Oxfam Briefing Paper; 2007. https://www.oxfam.org/sites/www.oxfam.org/files/all%20costs,%20no%20benefits.pdf. Accessed April 19, 2016.
Behind the Numbers. The TPP and the cost of drugs [Internet]. http://behindthenumbers.ca/2015/10/09/the-tpp-and-the-cost-of-drugs/. Published 2015. Accessed October 21, 2016.
Lexology.com. Patent linkage in Asian countries compared to the US Lexology [Internet]. http://www.lexology.com/library/detail.aspx?g=73ee9ee5-1873-457e-b24f-8af6e96721ff. Published 2016. Accessed October 21, 2016.
Hirono K, Haigh F, Gleeson D, Harris P, Thow AM. Negotiating healthy trade in Australia: health impact assessment of the proposed Trans-Pacific Partnership Agreement. Liverpool, NSW: Centre for Health Equity Training Research and Evaluation, part of the Centre for Primary Healthcare and Equity, Faculty of Medicine, UNSW Australia, 2015.
Thow AM, Gleeson DH, Friel S. What doctors should know about the Trans-Pacific Partnership Agreement. Med J Aust. 2015;202:165–166.
Pacific Bridge Medical. Reimbursement for Pharmaceuticals in Asia [Internet]. http://www.pacificbridgemedical.com/regulatory-services/pharmaceutical/reimbursement/. Published 2014. Accessed October 21, 2016.
Ngorsuraches S, Meng W, Kim B, Kulsomboon V. Drug reimbursement decision-making in Thailand, China, and South Korea. Value Health. 2012;15:S120–S125.
Holloway KA. Thailand: drug policy and use of pharmaceuticals in healthcare delivery. New Delhi: World Health Organization, Regional Office for South East Asia; 2012.
Lee KS, Khan TM, Ming LC. Review of data exclusivity provisions in the Trans-Pacific Partnership agreement. Res Social Adm Pharm. 2016;12:545–547.
Lee KS, Khan TM, Ming LC. Impact of the Trans-Pacific Partnership Agreement on cost of medicine. Res Social Adm Pharm. 2016;12:660–661.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Yap, Y.Y., Wong, C.P., Lee, K.S. et al. Trans-Pacific Partnership Agreement and Its Impact on Accessibility and Affordability of Medicines: A Meta-synthesis. Ther Innov Regul Sci 51, 446–459 (2017). https://doi.org/10.1177/2168479017697253
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479017697253