Four months ago, the U.S. became one of 100 countries supporting the proposal presented a year ago to the World Trade Organization (WTO) by India and South Africa that intellectual property protection for COVID-19 vaccines be temporarily suspended in an effort to allow generic pharmaceutical companies to quickly produce doses. With developed countries consuming much of the available vaccine stock, it’s been no surprise that the world has looked very lopsided with respect to COVID-19 inoculations. The thought was that by suspending IP protections for the vaccines developed by big pharma, drug manufacturers in poorer countries would be able to start churning out vaccines and increase global vaccinations without fear of infringement. But is it really that simple?
Let’s take a quick look at what patents do. At the heart of every patent is a basic quid pro quo. In exchange for limited exclusivity over manufacturing, use and sales of the medicines, inventors invest sometimes billions of dollars into research and development to concoct lifesaving innovations and share them with the rest of the world. In the case of COVID-19 vaccines, this global innovation incentive has brought about effective inoculations in record time. So, it’s no wonder that the WTO proposal, which is a waiver of the obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS), has been met with strong opposition. While opposers to the proposal acknowledge the need to make the vaccine globally available, they argue that IP is only one of many factors affecting the manufacture and exempting the vaccines from patent protection will not miraculously increase vaccine production by generic manufacturers. Unfortunately, the patent waiver doesn’t address larger issues such as: (1) deficiencies in supply chains, (2) the need to secure regulatory approval, (3) the need for large-scale funding to buy new machinery and adapt production to the new technology, and (4) mastering of the formulation of complex compounds (some of which involve mRNA). In other words, if patent rights are ultimately suspended, will generic manufacturers be ready in the wings to immediately start producing doses? Likely not.
The WTO is set to reconvene on this debate in late November but what bears noting in the meantime is that vaccine manufacturers are diligently working to get more shots in arms by increasing capacity to send doses to developing nations. So whatever solution is ultimately handed down, the hope is that the outcome does improve global access and equity of COVID-19 vaccines.