Short Abstract:

This paper is focused on the analysis of the power of patents and their role in the current confrontation between the right to (public) health and the right to Intellectual property (patents), which are both human rights recognised by the Universal Declaration of Human Rights. The COVID-19 pandemic showed again the impact of the high prices of patented vaccines on global health.

Long Abstract:

Research context

The research context of this paper is the impact of biotechnological patents on public health. These problems derived form the lack of access of new innovation drugs and medicines owned by Big Pharma.

My research analyses the power of patents from a legal and ethical perspective, as well as their role in the current confrontation between the right to (public) health and the right to Intellectual property (IP) in the form of patents, which are both human rights recognised by the Universal Declaration of Human Rights. This economical and biopolitical power is based on the monopoly granted to the holders of patents, who have exclusive rights over their inventions during 20 years since the filing date. This is especially critical in the case of biotechnological patents, also known as “patents of life”, allowing to protect biological material and intended to produce new pharmaceutical products (i.e, vaccines), for treating or curing different conditions, such as COVID-19.

Methodology

The methodology used is the analysis of different real cases of drug patents, such as the COVID-19 vaccines the gene editing (CRISR-CAS9), and also medicines for treating AIDS, which had created a large number of access problems to different countries and populations all around the world. This analysis also includes the reference to the current legal framework protecting Intellecutal Property (IP) Rigths represented by the TRIPS agreement of the World Trade Organization which includes legally accepted measures (but difficult to implement) to protect public health.

Analsysis

From a legal perspective, a patent as “a title recognising the right to exclusively exploit an invention, preventing third parties from manufacturing, selling or using it without prior consent of the owner”. A patent is granted following technical criteria, which are represented by three patentability requirements: novelty, inventive step and industrial applicability.

This monopoly involves that the holder of the patent can establish high prices for patented products, condemning thousands of people to what we call “Bioprecariousness” defined as structural violence against life due to the lack of access to basic patented products (such as, vaccines for COVID-19, seeds, medicines, treatments and tests).

In the context of the COVID-19 pandemic, Bioprecariousness has also been due to the lack of access of vaccines against COVID-19 and the unequal distribution thereof between different countries (high-income countries versus low-income countries).

In order to prevent that IP rights collide with the right to health and to set limit to the power of patents, we propose to create new ethical framework applicable by ethical patent committees aimed at granting patents not only according to the above-mentioned technical criteria, but also to ethical standards, such as the approach of capability and human development of Martha Nussbaum.

The capability approach considers that human beings can only flourish in societies which respect and promote the quality of life of their populations, not according to economic indicators as the GDP, but to the respect of human dignity. In this regard, Nussbaum has defined a set of 10 capabilities (life, bodily health, bodily integrity, senses, imagination and thought, emotions, practical reason, affiliation, other species, play and control over one’s environment), i.e., opportunities based on personal and social circumstances. The governments should guarantee a minimum threshold of these ten capabilities to guarantee a good life for individuals in society.

In the framework of biotechnological patents, some of these capabilities are profoundly affected by Bioprecariousness. In fact, when a new drug, treatment or vaccine (as in the pandemic scenario) is not available due to the high prices of patented products, the capabilities of life, bodily health, bodily integrity and even control over one’s environment are being deeply harmed. In fact, the lack of access to these new treatments directly affects the quality and duration of life and therefore, the health of people.

But patents could also have an impact on the relation with other species and the environment, given that biotechnological patents have also developed transgenic plants, gene drives (making mosquitoes unable to transmit malaria) genetically modified seeds and even animals (i.e. Harvard oncomouse), which are now the subject-matter of patents.

Conclusion

The impact of drug patents in public health is a critical issue which needs to be addressed from an ethical perspective. The capability approach could serve the purpose of providing a new ethical framework, parallel to the legal one (TRIPS Agreement of the World Trade Organization), in order to grant scientifically innovative, cost-effective and morally acceptable patents, which should be implemented in ethical patent committees.

These ethical committees should be formed by an interdisciplinary team ((bio)lawyers, philosophers/bioethicists, scientists, engineers, and patient’s associations)) to represent each and all the involved stakeholders. If we do not apply ethical limits to the power of patents, life shall become another “commodity” subject to the laws of market and to Bioprecariousness, with a high impact on public health.