You may have felt a cold chill from the storm brewing among member states of the World Trade Organisation (WTO), resulting from inequality in the sale and distribution of COVID-19 vaccines.
Amid growing calls for vaccine equity, there is increasing pressure to temporarily waive patents for COVID-19 vaccines and other coronavirus-related medical products. At the core of the discussion stands a proposal by South Africa and India to suspend the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the duration of the coronavirus pandemic.
On US President Joe Biden’s 100th day in office, the US agreed that it, too, would support a temporary and targeted waiver of COVID-19 vaccine intellectual property protections, with Canada, New Zealand and the European Patent Office following suit.
The rationale for the proposal is that, if patent rights are waived, vaccine production facilities can be established throughout the world, resulting in increased vaccine supply and expedited roll out.
Based on this reasoning, the time to global immunity would be reduced, with benefits that are professed to far outweigh the costs of research and development incurred by Big Pharma in bringing the vaccines to market.
Concerns about global vaccine inequality
It is understandable that some countries are concerned about the way in which COVID-19 vaccine distribution has played out to date: by end-February 2021, only 10 countries had administered 75% of the world’s available COVID-19 vaccine supply, while more than 130 countries hadn’t even received their first doses, says United Nations Secretary-General António Guterres.
It has been pointed out that, at this rate, it would take about five years to vaccinate 75% of the world’s population (assuming a two-dose vaccination).
The countries opposing (or withholding support for) the waiver are the UK, Australia, Japan, Switzerland, Norway, and Brazil. Most are home to pharmaceutical companies benefiting from TRIPS extended patent protections. All have inked advanced purchase agreements with vaccine companies.
But the counter-argument is that South Africa and other developing nations can avail themselves of mechanisms that already exist in the TRIPS Agreement, to overcome these challenges; namely those enabling the grant of compulsory licences.
The role of the TRIPS Agreement and its interpretation
The WTO was established to regulate international trade between nations. Member states are party to the Trade-Related Aspects of Intellectual Property Agreement (TRIPS), which establishes multi-lateral international standards for the protection and enforcement of IP rights.
These exist to prevent:
- the abuse of IP rights,
- practices that unreasonably restrain trade, or
- practices that adversely affect the transfer of technology.
You may remember that, in the thick of the Aids pandemic, IP came under fire for handicapping the fight during a major health crisis. Members states decided then that the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of members’ rights to protect public health and, in particular, to promote access to medicines for all.
Member states also agreed that all patent systems should provide for the grant of compulsory licences and that each country should be free to determine the grounds on which such licences are justified and what would constitute a national emergency or other circumstances of extreme urgency.
SA’s legislation on the issue
South Africa is fully compliant with TRIPS in this regard. Our Patents Act has, since 1997, had compulsory licensing provisions to prevent the abuse of patent rights. In fact, a compulsory licence may be granted by the Commissioner of Patents:
- if the demand for the patented article in South Africa is not being met to an adequate extent and on reasonable terms; or
- if the demand for the patented article is being met by importation and the price charged by the patentee is excessive in relation to the price charged in countries where the patented article is manufactured by the patentee.
Aside from compulsory licensing, our legislation also permits a minister to use an invention for public purposes, on conditions that are either agreed with the patentee or determined by the Commissioner of Patents on application made by the minister, after hearing the patentee.
Rule of law requires that public power be exercised in compliance with the law, and this often requires that the rights of one party be constrained for the public good. Our legislation provides a process by which the patentee’s rights can be weighed against the benefit to be had – and yet, as far as we know, no applications have been made by the state for the grant of any compulsory licences or use rights for any COVID-19-related inventions.
Instead, advocates of the proposal expect a blanket declaration of non-enforcement of all COVID-19-related IP, with implications that are significant for private entities.
As we have seen in relation to the thorny issue of land appropriation: where ownership rights are uncertain, there is reluctance to invest. If the intellectual property rights of private pharmaceutical companies are declared unenforceable in one broad stroke, without carefully balancing conflicting rights in each specific case, are we confident that they would invest in devising solutions to combat the next health crisis?
By Dina Biagio, Partner, Spoor & Fisher South Africa