The Patentability of Medical Products: Identifying Responsibilities of Pharmaceutical Corporations towards the Right to Health

Stuhldreier, Marc André (2019) The Patentability of Medical Products: Identifying Responsibilities of Pharmaceutical Corporations towards the Right to Health. Doctoral thesis, Northumbria University.

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Abstract

Each year, billions of people lack adequate access to urgently required medicines, leading to unnecessary suffering and the loss of millions of lives from preventable conditions. One of the main causes of this situation is that individuals living in extreme poverty cannot afford the prices of essential medicines, and the health-care systems of poverty-ridden developing countries are incapable of providing the required medications to their population. Exclusive patent rights contribute to the severity of this situation by providing the legal frameworks which enable pharmaceutical corporations to charge exorbitant prices for their patented drugs. Therefore, the global introduction of the patentability of pharmaceutical products under the WTO's TRIPS Agreement constitutes one of the main threats to the realisation of the Right to Health in developing countries.
This thesis addresses conflicting provisions of the human right to health and patent rights under international trade agreements, scrutinising whether there exists a legal hierarchy between human rights and trade law, or whether there are moral reasons suggesting that one should be superior to the other. Identifying that currently a legal hierarchy cannot be established, but that moral reasons suggest the superior importance of human rights, this thesis addresses the justifiability of the current international patent regime.
The main findings of this thesis suggest that the current international patent regime cannot be regarded as justified; either from a human rights perspective, or within itself. It is therefore submitted, that the international patent system urgently requires to be changed with respect to its regulations on the patentability of medical products. This thesis then proposes that the international patent regime offers the distinct opportunity of implementing direct responsibilities of pharmaceutical patent holders as requirements for patentability within international trade law itself, for example by an amendment of the TRIPS Agreement. In presenting these possibilities, this thesis contributes a further dimension to ongoing debates about how the human rights responsibilities of the private business sector can be identified and effectively enforced.

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