Research Stream: Social Structures
Author: Lauren Kane, Research Assistant, PatentsInHumans Project, ALL Institute and Department of Law and Criminology
World Intellectual Property Day took place on the 26th of April 2025. On this day, many people celebrate the role of intellectual property rights (IPRs) such as patents, trademarks, industrial designs and copyright, in incentivising creativity and innovation. Indeed, IPRs have an important role in incentivising innovation, in certain contexts. For example, patents allow the rightsholders an exclusive right over the patented technology which they can use to develop new health technologies to generate an income stream from that technology. In this way, such rights are often seen as incentivising the development of new medicines. However, in this context, it is also important to reflect on the broader impacts of certain uses of IPRs on society, including their potential impact on access to technologies (such as medicines) in the healthcare context. Such issues are particularly timely in 2025, as this year marks the 30th anniversary of the coming into force of the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, an international agreement which provides for uniform minimum standards in relation to the protection and enforcement of intellectual property rights.
Intellectual Property Rights in the Healthcare Context
Intellectual Property rights, including patents, can have a significant impact for access to health-technologies. For context, a patent is a type of intellectual property right which confers the rights-holder an exclusionary right to control key aspects, including the sale, supply, production of their patented technology for commercial purposes, generally for a period of twenty years.
In practice, for health-technologies, patents can provide rights-holders with legal avenues to prevent others from developing an equivalent (generic) version of a patented medicine during this period and therefore, rightsholders have significant power to control competition. This, in turn, can enable rightsholders to command high prices which in some cases can be greatly in excess of production costs. It is acknowledged that such prices are often justified as necessary to compensate for the investment costs of research and development (R&D) of developing new and more effective drugs. Nonetheless, in such contexts, such prices (and IPRs can be a key role in this) can potentially impede access to medicines, with implications for healthcare and the right to health.
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What is the Human Right to Health?
A human right to health was first proclaimed at the global level within the World Health Organisation (WHO) Constitution, which was adopted in 1946 and came into force in 1948. The right to health is now articulated in various international and regional instruments, and over 100 national constitutions worldwide.
A key provision in this context is Article 12 of the International Covenant on Economic, Social and Cultural Rights 1966 (ICESCR), which provides that:
“The States Parties to the present Covenant recognise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”
States Parties that have ratified the Convention are required to respect, protect and fulfil the right to health, through progressive realisation, and within the limits of their individual resources. Additionally, the Committee of Economic, Social and Cultural Rights, the UN body responsible for monitoring the implementation of the ICESCR, has also confirmed under General Comment 14 (2000) that a key component of the right to health is that States must ensure accessibility of medicines, including economic accessibility. However, the right to health may be negatively impacted by patents, for example, if medicines (or other health technologies) necessary for health are marketed at a price which significantly impedes access, which can create conflict between the human rights and intellectual property regimes.
The Impact of the TRIPS Agreement
Moreover, since the TRIPS Agreement came into force on the 1st of January 1995, the tensions arising in the relationship between human rights and intellectual property rights have arguably been heightened, and these tensions have been the subject of significant discussion and debate. Prior to the establishment of the TRIPS Agreement, countries used a diverse range of approaches to intellectual property protection, including tailoring their individual level circumstances to meet the health needs of populations. For example, pre-TRIPS era, developing countries could acquire equivalent, generic medicines from countries that did not offer patent protection to pharmaceuticals at that time, such as India. Under the minimum standards set down by TRIPS, this is longer possible as all TRIPS Contracting States must ensure protection of IPRs over all fields of technology. Consequently, such States have limited discretion under TRIPS over IP protections, and for this and other reasons, LMICs may struggle to provide access to expensive patented medicines for those who require them.
Some examples of the impacts IPRs can have on access to health in the health emergency context are discussed in detail elsewhere and include the HIV/AIDS crisis during the 1990s/2000s, and more recently, the COVID-19 pandemic. Increasingly, such impacts are also evident in everyday healthcare contexts, particularly in relation to novel medicines which treat cancer and rare diseases. This means that high costs are increasingly posing access issues for LMICs and high-income countries (HICs). While it is important to acknowledge that IPRs are not the sole factor contributing to such costs, how such rights can be used arguably represent a key element contributing to this.
The TRIPS Agreement did provide for some exceptions or ‘flexibilities’ to better enable developing countries to apply TRIPS in a manner which allows them to effectively balance the protection of IPRs with public health needs, affirmed by the 2001 Doha Declaration. For instance, a compulsory license is one type of flexibility that can issued by national States to allow for cheaper, generic production of a patented health technology in certain circumstances. Such measures have traditionally faced several limitations, including but not limited to the threat of potential retaliation in the form of trade sanctions against States that have utilised such flexibilities. Such issues and other factors can deter States from using TRIPS flexibilities. Nonetheless, the ability to use such measures when needed to provide access to health technologies is important to better allow States to deliver on access to health and to fulfil States human rights obligations.
To conclude, as we reflect on IPRs and World IP Day in 2025, alongside some of the benefits of IPRs for society, there is also a need for greater consideration of the potential human rights implications of how IPRs can be used in the healthcare context. There is a need to ensure the incentivising function of IPRs is balanced in a manner which appropriately takes patients’ need for access into account. Such issues, including the role of the right to health, and the extent to which this right can offer an avenue for greater accessibility of patented health-technologies is a key theme explored within the ERC PatentsInHumans Project at Maynooth University.
With Prof Aisling McMahon (Principal Investigator, ERC PatentsInHumans), we are currently examining the impact of IPRs on the accessibility component of the right to health. We are also developing a deeper analysis of the role and scope of the right to health to be used at a national level by individuals and States to facilitate a greater balance between IP rightsholder interests and patients’ access to medicines. The theme of ‘accessibility’ including of health technologies, aligns with a core value of the ‘Assisted Living and Learning’ (ALL) Institute where this project is co-hosted with the School of Law and Criminology, Maynooth University.
You can find out more about the PatentsInHumans project, including ongoing work at: www.patentsinhumans.
This research is funded by the European Union (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are however those of the author only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.