Have TRIPS Flexibilities Made Medicine More Accessible?

Introduction

TRIPS stands for agreement on Trade-Related Aspects of intellectual property rights. It is a multilateral agreement between the member states of the World Trade Organisation (WTO) for the protection of intellectual property rights and their recognition across jurisdictions. The TRIPS agreement inhibited unethical trade practices in which goods were traded between countries without giving due monetary credit or royalties to the IPR holders or manufacturers/creators. TRIPS flexibilities on the other hand are relaxations under the provisions of this agreement that help developing nations trade goods of public importance or for emergency use, evading the IPR restrictions.

What Is The Need For TRIPS Flexibilities?

Before the adoption of the TRIPs agreement, goods of public importance like pharmaceuticals and generic medicines could be traded easily at cheaper rates between countries. However, after the agreement, such pharmaceuticals could be sold and purchased only through the original producers. Millions of people, particularly in low- and middle-income countries, suffered because of this as they lacked access to effective pharmaceuticals, often because they were unaffordable. In response to such high prices, the developing nations along with NGOs demanded relaxation in the pharma sector. Hence, the Doha declaration was signed wherein the TRIPS member agreed to take measures to support public health globally.

The Doha Declaration

The declaration outlined measures, known as TRIPS flexibilities that WTO Members could take to ensure access to medicines for all. These measures include compulsory licensing of medicine patents and a grace period to transition to TRIPS laws for least-developed countries.

Compulsory licensing allows a government to allow a third party to make patented products without the consent to the patent holder. In India, the conditions for this are outlined in Section 84 of the Patents Act. This provision allows for the usage of life-saving medicines and medical equipment essential for securing public health, in the absence of the patent holder not exercising their rights. In addition to compulsory licensing the government can authorize the use of a patent for its own purposes. This is called public non-commercial use or government use.

Making Use of TRIPS Flexibilities

Despite the flexibilities in patent protection, the Least Developed Countries (LDCs) have limited success in securing public health. The utilization of TRIPS flexibilities is subject to a country’s domestic IP laws and diplomatic relations. In the case of Brazil, the government was able to leverage TRIPS flexibilities and make Roche generic drugs at a cheap price. However, this is not the case for other, smaller countries.

Compulsory licences issued by Brazil, India and Thailand caused widespread controversy because of the harsh responses they provoked by USA and EU. The political pressure used by rich countries against poorer countries to dissuade them from using their rights under the TRIPS agreement and the Doha declaration has also increased. Other problems observed are the fact initiatives by pharmaceutical companies to increase access to medicines outside the field of HIV/AIDS are weak and predominantly based on donations or small-scale, patient-based price discounts. In addition, global funding is lacking for medicines for diseases other than HIV infection, tuberculosis and malaria, which increases the importance of efficient access to lower-cost medicines.

Added to the list of problems, the issue also lies in the policy itself. The definition of emergency use has been made at the country’s discretion. Further such flexibility is only available to LDC, whose categorization is not static.

Conclusion

The use of TRIPS flexibilities is an important tool that can help countries fulfil their human rights obligation to provide access to essential medicines as part of the progressive realization of the right to health. Besides governments, pharmaceutical companies have a responsibility to ensure that lifesaving drugs could be available to middle and lower-income countries through voluntary licensing.

The idea of having IP protection on an international level was to provide IP protection to all innovators evading jurisdictional barriers. HIV/AIDS pandemic in the nineties, and most recently, the search for effective treatment and vaccine for COVID-19 highlighted the tensions between intellectual property rights and public health interests. The speed with which countries such as Canada, Germany, Chile and Ecuador have amended their respective patent laws to prohibit market exclusivities and to allow for compulsory licensing has shown how the TRIPS flexibilities can be used to address health issues, especially for the densely populated, poorer counties.

Some countries like Brazil and Bangladesh have also, successfully utilized the flexibilities however public health is still a serious concern in lower-income continents inhabited by a majority of the world’s populations. Effective usage of these is only possible with leveraging of political power and international actions, as it’s often fear that keeps smaller nations from making use of the flexibilities.

Author: Sejal Chaturvedi, Legal Intern at PA Legal.

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