In October 2020, in response to the pandemic, a group of developing countries, led by India and South Africa, submitted a proposal to the World Trade Organisation (“WTO”) to obtain a waiver of international intellectual property protection (“Waiver Proposal”) under the Trade Related Aspects of Intellectual Property Agreement (“TRIPS”). The purpose of the waiver was to improve access to affordable medicinal products in light of the COVID-19 global pandemic in developing countries. The proposal was discussed at the end of February 2021, when the WTO members failed to reach a decision.
Last week, the discussion made its way to Dáil Éireann. While the Cabinet is tasked with outlining whether the extent of the population's ‘trips' will extend beyond their immediate 5km, broader concerns about TRIPS and worldwide “vaccine nationalism” were brought to the attention of an Taoiseach.
The Waiver Proposal resurrected the decades-long dispute within the WTO over the appropriate balance between the protection of intellectual property rights (“IPR”), and affordable access to public health in developing and least developed countries.
TRIPS Agreement – Critics and Advocates
TRIPS is an international legal agreement between all members of the WTO which sets out minimum standards of protection and enforcement that each WTO member must give to the IPRs held by nationals of other WTO members. Since its introduction, TRIPS has been criticised for acting as a contributing factor to public health disparity.
Novel medicines are ordinarily protected by patents. A medicinal product patent confers its owner a monopoly on the exploitation of the medicinal product thus allowing the owner the best opportunity to profit from the invention by preventing others from manufacturing, using, or selling it. Public health advocates argue that prohibitive medicine prices are the result of strong intellectual property protection and that enforcement of WTO rules negatively impacts manufacturing capacity and thus removes a source of generic quality drugs on which developing countries rely.
TRIPS advocates, on the other hand, insist that TRIPS does offer safeguards, such as licensing, to remedy the negative effects of patent protection or patent abuse.
Licensing allows a patent holder to permit others to make or trade the protected product . In the case of public health emergencies (such as a global pandemic), so called “compulsory licences” can be issued to local manufacturers, authorising them to make patented products or use patented processes even in the absence of a licence from the patent owner.
Compulsory licensing under TRIPS is the ability of a government to allow a third party to produce a patented product or process without the consent of the patent owner, or to use the patented invention itself. The patent owner has a right to be paid compensation for the products made under the compulsory licence. TRIPS lists a number of conditions for issuing compulsory licences which the law of the WTO member must respect.
The precise scope of the compulsory licensing provisions varies considerably from country to country in Europe and globally. In the light of the COVID-19 pandemic, some countries such as Canada, Chile and Israel, recently strengthened their national compulsory licensing provisions.
In Ireland, Section 70 of the Patents Act 1992 sets out the conditions applicable to compulsory licences regardless of the subject matter of the patent, which includes the following:
- the patent must have been in existence for three years;
- the demand in Ireland for the subject matter of the patent must not be met or must not be met on reasonable terms;
- any licence granted must be non-exclusive and predominantly for the supply of the market in Ireland; and
- the scope and duration of the licence must be limited to the purpose for which it is granted.
Developing countries argue that TRIPS is cumbersome and lengthy as it applies on a case‐by‐case and product‐by‐product basis, which inhibits the ability of countries to scale up production of COVID-19 medicinal products.
The Waiver Proposal, if agreed and enacted, would temporarily remove patent rights over Covid-19 medicines, diagnostics and most pertinently, vaccines. This would create higher production levels, allowing greater access to these life-saving technologies for those who currently find themselves at the ‘back of the queue'.
Proponents of the Waiver argue that it should last a specific number of years, to be agreed by the General Council, until widespread vaccination is in place globally and the majority of the world's population is immune. It is proposed that WTO Members would review the waiver annually until termination.
Pro-waiver commentators saw the Waiver Proposal as an enabler of meaningful knowledge-sharing and technology transfer. They noted that much of the COVID-19 research was publicly funded, and as such pharmaceutical companies' argument that IPRs protect their investment is weak.
Other commentators quickly expressed views that the waiver is too sweeping and that in order to ensure the proportionality of any measures taken in response to the COVID-19 global pandemic, it should be demonstrated that the option of compulsory licensing and other flexibilities under TRIPS are inadequate to address public health concerns.
The Waiver Proposal met with the disapproval of the United States, the European Union, and other high-income countries and failed to progress even to the stage of text-based negotiations.
“A Third Way”
While the Waiver Proposal's progress seems to have been stalled, the discussion around alternative routes to achieving equivalent results continues. Director-General Dr. Ngozi Okonjo-Iweala (the first African to be chosen as Director-General of the WTO) proposed a “third way” to facilitate equitable access to COVID-19 medicinal products, namely a technology transfer within the framework of multilateral rules.
A proposal from the Ottawa Group at WTO (Australia, Brazil, Canada, Chile, the European Union, Japan, Kenya, Republic of Korea, Mexico, New Zealand, Norway, Singapore and Switzerland) which calls for easing of export restrictions and tariffs that might be restricting the flow of COVID-19 medicinal products is also in discussion.
While the Irish Government considers the viability and impact of trips outside 5km, or perhaps even our own counties, there are more global considerations afoot with regard to TRIPS. Open Access Government reports that current projections suggest many will have to wait at least three, and up to seven years for substantial global immunity through vaccines, leaving developing and least developed countries behind. There is a legitimate concern that until those in these countries have sustained access to vaccination, that the world is not safe from the potential mutations and variants that the Covid-19 virus has already displayed a propensity for.
At the same time, in attempting to combat the COVID-19 crisis, those at the global decision-making table are faced with the difficult task of balancing public health disparity with encouraging innovation through private ownership rights.
Originally Published by Ronan Daly Jermyn, March 2021
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.