In a sign of their increasing frustration with global efforts to ensure that all people everywhere will have access to COVID-19 vaccines, a number of developing countries have asked other members of the World Trade Organization to join with them in a sweeping waiver of the intellectual property rights relating to those vaccines. Their request raises anew the recurring debate within the WTO over the right balance between the protection of intellectual property rights and access in poorer countries to urgently needed medicines.
The proposed waiver brings back bad memories for all in the WTO of the long and contentious dispute between developed and developing countries over the compulsory licensing of HIV/AIDS drugs nearly two decades ago. And it does so at a time when the very last thing the WTO needs amidst an existential crisis is yet another acrimonious debate over perceived trade obstacles to public health.
As discussed in my new Cato Free Trade Bulletin (published today), India and South Africa have asked the members of the WTO to waive protections in WTO rules for patents, copyrights, industrial designs, and undisclosed information (trade secrets) in relation to the “prevention, containment or treatment of COVID-19…until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity….”
They and other developing countries want to give all WTO members the complete freedom to refuse to grant or enforce patents and other intellectual property rights relating to COVID-19 vaccines, drugs, diagnostics, and other technologies for the duration of the pandemic.
So far, the members of the WTO have failed to muster the required consensus to move forward with the proposed waiver. The European Union, the United States, and other developed countries have opposed the waiver request. They say there is no evidence to prove that intellectual property rights are a genuine barrier to access to COVID-19 related medicines and technologies.
The pharmaceutical industry agrees with these developed countries, pointing to the role of IP rights as incentives to innovations such as new medicines. Civil society activists disagree, saying that the anticipated COVID-19 vaccines should be treated as global public goods. Usually, such concerns in developing countries are addressed through compulsory licensing, which authorizes local manufacturers to make patented products or use patented processes even though they do not have the permission of the patent holders. Drug makers do not like compulsory licensing, but the option of compulsory licensing is part of the bargain that has been struck by WTO members in balancing IP rights against public access to essential medicines.
What is missing from the waiver request is a clear explanation by those who seek the waiver of why they believe the right to compulsory licensing they already possess under WTO IP rules will prove insufficient to ensuring access to COVID-19 vaccines.
In their waiver request, India and South Africa stated that “many countries especially developing countries may face institutional and legal difficulties when using flexibilities available” under the existing WTO rules. They also said that a “particular concern for countries with insufficient or no manufacturing capacity” is that the rule that allows countries that produce generic medicines under compulsory license to export all of those generic medicines to least‐developed countries that lack their own manufacturing capabilities will lead to a “lengthy and cumbersome process….”
But India and South Africa did not offer any further explanation or provide any evidence to support these general assertions.
Before such a sweeping waiver of IP rights is taken up, it should first be demonstrated that the option of compulsory licensing and other flexibilities under the current trade rules will not suffice. At this point, the developed countries that have opposed the waiver are correct. There is no evidence of the need for such a waiver.
For this reason, at this point, the proposed waiver is unnecessary. Action by the WTO should be contemplated only if, and when, the current flexibilities in WTO rules prove to be inadequate. Should that happen, any such action should be no broader than necessary to meet the urgent global medical need.
This waiver proposal exists only because of legitimate concerns by developing countries that multilateral endeavors to make certain that all people everywhere have early access to the upcoming COVID-19 vaccines are proceeding at a slow pace and with uncertain success. The answer to these real concerns is, however, not another impassioned and prolonged multilateral impasse inside the WTO. It is instead a redoubling of cooperative international efforts to reach solutions in those efforts outside the WTO.
The right balance in the WTO trade rules on intellectual property is a balance that provides all countries with sufficient flexibility to protect intellectual property rights while also promoting access to life‐saving medicines. For COVID-19 medicines, there is no proof at this time that this right balance does not currently exist. Maintaining this balance must remain the aim of the WTO, and it must be the aim of every endeavor of multilateral cooperation in the fight to end this pandemic.