The Vaccine Waiver

Given the urgency to vaccinate the world there is an urgent need to ramp up production of vaccines. All that is coming in the way of that is the intellectual property rights over vaccine recipes. What is required is a temporary vaccine waiver of intellectual property rights in order to encourage worldwide manufacture.

This article was first published in The Mint. You can read the original at this link.

Last week Bill Gates got himself into a bit of a soup with a controversial comment. When asked, in an interview on Sky News, whether global intellectual property laws should be amended to allow the recipe to manufacture COVID-19 vaccines to be more widely distributed, he replied with a categoric “no”. The bottleneck, according to him was not intellectual property law but vaccine manufacturing capabilities. “There are only so many vaccine factories in the world” he said, “and people are very serious about the safety of vaccines”. Not unsurprisingly, these comments attracted considerable outrage, with commentators questioning this rather dismal view of the world.

I admire Bill Gates for many things - his success as a true pioneer of the IT industry and for the breadth and vision of his philanthropy. But I simply cannot wrap my head around his refusal to endorse the waiver of intellectual property rights that we need in order to increase the global production of COVID-19 vaccines.

Let us break down the facts.

Vaccine Facts

Our global vaccine production capacity is about 3.5 billion doses a year. In order to cover even 70% of the global population, we need to increase that to 10 billion doses (most vaccines require 2 doses per person to be effective). There is no way to reach that number unless we radically expand our current manufacturing capacity.

Bill Gates is against sharing the intellectual property to the recipes because he says COVID vaccines (particularly the new mRNA vaccines) are particularly difficult to manufacture. Factories in developing countries, he argues, will not be able to produce the kind of pharmaceuticals that we need to safely inoculate the global population against the disease.

However, a recent Foreign Policy article suggests that, to the contrary, there are many facilities in low and middle income countries that can easily be re-tooled to manufacture mRNA vaccines. This view was echoed by a former director of chemistry at Moderna who went so far as to say that all that was needed was the blueprint and some technical assistance and any modern factory would be able to get vaccine production up and running in three to four months. It appears that the concerns around production capabilities are somewhat misplaced.

Which brings us back to intellectual property.

Intellectual Property

All countries of the world (that are members of the World Trade Organisation) are bound by the Agreement on the Trade Related aspects of Intellectual Properties (TRIPs) and have to comply with its stipulations with regard to patents, copyrights and other intellectual property laws. The manufacture of COVID-19 vaccines are, for the most part, protected under patent law, with various ancillary but essential technologies protected under copyright, trade secret and industrial design regulations. Thanks to their obligations under the TRIPs agreement, countries that have the capabilities and are willing to invest in funding the re-tooling of existing factories, are unable to contribute to the global demand for vaccine production because they need to first secure the right to manufacture from the holders of the intellectual property rights over these recipes.

The TRIPs Agreement does permit countries to exercise special powers under extraordinary circumstances. All member countries are within their rights to compel the compulsory licensing of intellectual property if they feel this is required in order to deal with a public health emergency.

As useful as this option might seem, in the current circumstance, it will be of no practical benefit considering that the production mRNA vaccines also requires access to over 100 key components that are, themselves manufactured across over a dozen countries. In addition we will need access to various other non-chemical intellectual properties - such as algorithms, software and training materials - without which the vaccines cannot be usefully deployed.

Compulsorily licensing the recipe from the manufacturer is, therefore, just one part of the problem. In order to be useful we will need to negotiate arrangements with a multitude of entities that have collectively established a thicket of patents around all of the information required.

All this is further complicated by the WTO restrictions on production-for-export. While countries can invoke compulsory licensing provisions for the manufacture of COVID vaccines, they will need to source essential ingredients and supplies required from other countries where they are manufactured. Even if those countries, in turn, compulsorily license the technology for their manufacture to increase production, they cannot export those supplies because of the WTO rules on production-for-export.

Need for a Waiver

What all this boils down to is unless we can put in place a broad TRIPs waiver that will allow a swathe of countries to temporarily remove the intellectual property restrictions that currently restrict the ramping up vaccine manufacture, we will simply not be able to increase vaccine production to the levels that we need.

Last October, India and South Africa proposed exactly this to the Council of TRIPs. Over 100 other countries joined in, expressing their support along with global humanitarian organisations such as Office of the High Commissioner of United Nations Human Rights. However, due in large part to the strong opposition of the US and other European nations that are home to big pharmaceutical companies, nothing has come of the proposal - a state of affairs that one Nobel Laurette has referred to in disgust, as “morally wrong and foolish”.

As a technology lawyer who has been practicing in the field for over a quarter of a century, I understand, better than most, the importance of intellectual property for innovation. Yet, once in a while, there comes a time when we have to set aside commercial imperatives in the larger interests of all mankind.

This is that moment.