Patents versus Patients: An Analysis of the Restrictive Effect of Patent Law under Trips on Access to Medicines in Low-Income Countries and Proposals for Effective Reform

• Date: 01 January 2024

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Patents versus Patients: An Analysis of the

Restrictive Eect of Patent Law under Trips on

Access to Medicines in Low-Income Countries

and Proposals for Eective Reform

AMY DOOLAN*

Introduction

Medical advancements have facilitated incredible strides in healthcare in recent

decades and have allowed us to cure and manage many diseases that were formerly

fatal.1 Unfortunately, access to these health technologies has not been and currently

is not equitable, with almost 2 billion people (mostly in low income countries)

globally without access to essential medicines due to availability and aordability

problems.2 One of the key causes of inequitable pharmaceutical access is patent laws

under the Trade Related Aspects of Intellectual Property Agreement (‘TRIPS’).3 A

patent can be dened as a legal device that grants the holder a dened period of

exclusive rights over the invention during which they may exploit the invention for

prot, in exchange for making the invention public and allowing it to be recreated

by third parties aer the patent term has expired.4 e TRIPS Agreement5 is a

binding WTO treaty that requires all 164 Member states to enforce and abide

by the same standard of intellectual property protection in all elds including

pharmaceuticals, regardless of their economic status.6

Patents incentivise innovation and large expenditure on research and development

of products, especially pharmaceuticals.7 In many industries, patents function

* BCL & LLM(UCD). e author would like to extend her thanks to Dr. Cliona Kelly in Sutherland

School of Law for her guidance on the dissertation that inspired this article.

1 Max Roser and others, ‘Eradication of Diseases’ (Our World in Data, October 2018)

ourworldindata.org/eradication-of-diseases> accessed 4 August 2023.

2Sachiko Ozawa and others, ‘Access to medicines through health systems in low- and middle-income

countries’ (2019) 34(3) Health Policy and Planning, iii.

3Saeed Ahmadiani and Shekoufeh Nikfar, ‘Challenges of access to medicine and the responsibility

of pharmaceutical companies: a legal perspective’ (2016) 24(13) DARU Journal of Pharmaceutical

Sciences, 1-2 <10.1186/s40199-016-0151-z> accessed 4 August 2023.

4Catherine Seville, EU Intellectual Property Law and Policy (2nd edn, Elgar 2016) 103.

5Agreement on Trade-Related Aspects of Intellectual Property, Annex 1C of the Marrakesh

Agreement Establishing the World Trade Organization (15 April 1994) (‘TRIPS Agreement’).

6 Aisling McMahon, ‘Patents, Access to Health and COVID-19 – e Role of Compulsory and

Government-Use Licensing in Ireland’ (2021) 72 (Supplementary Issue) Northern Ireland Legal

uarterly 117, 129.

7 Kurt Rd Brekke and Odd Rune Straume, ‘Pharmaceutical Patents: Incentives for Research and

Development or Marketing?’ (2009) 76(2) Southern Economic Journal 351, 351.

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Patents versus Patients: An Analysis of the Restrictive Eect of Patent Law 27

well as an innovation incentive that both suciently rewards the inventor and

will eventually allow the public to benet from the invention once it is no longer

patent protected. Patents confer exclusive rights on the patent-holder that allow

only them to manufacture, sell or license the invention, meaning that the holder

has a monopoly for the rst 20 years.8 is monopoly allows the rights holder

to sell or license the invention on whatever terms and for whatever price they

choose.9 Conceptually, patents are accepted as the sole exception to the golden

rule of economics that monopolies are undesirable (and indeed illegal if abused)

for economic eciency in competitive markets because they lead to price-xing.10

However, they are accepted as a trade-o where the inventor receives monopoly

power and prot for a xed term so that the public can eventually benet from

the invention.11 Pharmaceutical patents should be treated as legally unique to all

other patents because of their relationship to human health.12 Drug patents do not

mean that a person cannot aord to buy the latest in vacuum cleaner technology;

for patients, access to pharmaceuticals means the dierence between life and death,

or life with a chronic treatable illness.

Access to essential medicines can not only be viewed as a moral right to which all

people should be entitled, but the right to health is also enshrined in international

treaties,13 and is a key objective of the 2030 Sustainable Development Goals.14 e

right to health is an internationally-agreed human rights standard, and it is key to

and dependent upon the realisation of other human rights.15 Every country has

ratied at least one international human rights treaty that enshrines the right to

health, and states have further committed themselves to protecting the right to

health through international declarations and domestic policies.16 e right to

health necessarily includes the availability and accessibility of essential drugs.17

It is estimated that almost 2 billion people are without access to basic medicines,

causing much preventable suering and death.18 An estimated ve million people

8Seville (n 4) 110.

9Fernando Antonanzas and others, ‘Pharmaceutical patents, R&D incentives and access to new

drugs: new ways of progress at the crossroad’ (2011) 12(5) European Journal of Health Economics

393, 393–394.

10 Benjamin Charles Warren, ‘Flexible Drug Patent Terms: A Proposed Mechanism to Stimulate

Global Innovation and Health’ (2013) 26(1) Seoul Journal of Economics 95, 97.

11Seville (n 4) 103.

12Warren (n 10) 97.

13Universal Declaration of Human Rights (adopted 10 December 1948) UNGA Res 217 A(III)

art 25; International Covenant on Economic, Social and Cultural Rights (adopted 16 December

1966) UNGA Res 2200A XXI) art 12.

14United Nations, Sustainable Development Goals (A/RES/70/1, 15 October 2015) goal 3.

15World Health Organization, ‘Human Rights’ (WHO.int, 10 December 2022)

int/news-room/fact-sheets/detail/human-rights-and-health> accessed 1 August 2023.

16 Oce of the United Nations High Commissioner for Human Rights (OHCHR) and World

Health Organization (WHO) ‘e Right to Health – Fact Sheet 31’ (2008) .

org/sites/default/les/Documents/Publications/Factsheet31.pdf> accessed 30 July 2023, 1.

17ibid 5, 25.

18World Health Organization, ‘Access to medicines: making market forces serve the poor’ (2017)

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