(Expansion) – On May 5, the president of the United States, Joe Biden, announced that he would support the exemption of the protection of intellectual property (IP) rights in relation to vaccines to face the COVID-19 pandemic, the which is being discussed within the World Trade Organization.
Many applauded the decision as a victory for greater equity in vaccine distribution, where low- and middle-income countries lag far behind the rich. However, the exemption could have a negative impact on medical innovation, as well as on the transfer and dissemination of this type of technology for social and economic well-being in the medium and long term, affecting the right of access to health.
The underlying assumption leading to support is that IP, especially patents, is a barrier that blocks vaccine manufacturers from producing COVID-19 vaccines, especially in developing countries. However, there is no evidence that patents are an obstacle to accessing drugs or technologies related to COVID-19.
Indeed, patents and other IP figures have contributed to the advancement of science and innovations in medicine and public health. The newly developed COVID-19 vaccines are the result of years of research backed precisely by IP. Without IP, it is very likely that today we would be much further from having the technological solutions that are tackling the pandemic, witnessing what is possibly the most important scientific enterprise in decades.
The manufacture of biological products, especially those innovative such as mRNA or vectorized vaccines that are popular today, is not only a question of access to patents. The production of the complex lipid-coated mRNA molecules, recombinant viruses, or even the inactivated proteins or viruses used in older generation vaccines, requires a high level of sophistication, far greater than that required to produce traditional drugs.
Patents provide the “recipe”, but to be able to do them you need specialized skills and expertise. In addition, getting to the point of having a vaccine on hand is also a huge economic and commercial endeavor. Vaccine production must meet strict quality assurance and control requirements, as well as regulatory oversight.
Thus, marketing a vaccine requires more than simply putting a patent on the table for someone to take it, as that someone may not have the technical capacity or infrastructure to manufacture and distribute. The challenge actually involves a collaborative effort, where IP is an innovation tool that works in the context of an efficient technology transfer process from whoever (s) develops the technology to who is in charge (s) of the commercial effort, also considering those who finance the project.
Furthermore, the effective transfer of such complex technologies requires an entire ecosystem of suppliers and supply chains that can take years, sometimes decades, to build. The generation of a multilevel infrastructure of this type implies an investment (public and private) and a considerable risk.
Therefore, in the face of the COVID-19 pandemic, international cooperation to transfer these manufacturing capabilities will be essential for the future production of vaccines in developing countries, in order to accelerate the adoption of technical and commercial capabilities where they are not available today. there are.
This is why few nations currently have the capacity to produce new vaccines, regardless of patents.
Therefore, there is a need to promote more sophisticated and innovative technology-based companies. These companies will require financing; access to raw materials, inputs and components that are currently in short supply (eg, nucleotides or lipids); knowledge in manufacturing, quality controls, regulatory processes; and, in fact, they must have the incentives that only IP rights can provide to ensure that all their efforts will be sustainable over time.
The infrastructure for the production of vaccines that is built today, in harmony with a fair and robust IP system, could be a bulwark against future pandemics. This requires thinking long-term and worrying about fully understanding innovation processes. In this sense, the exemption to IP rights is not emerging as a solution, or even as the most urgent first step.
Let us hope that the debate that is taking place finds a suitable global approach to really contribute to solving the problems posed by the pandemic, giving priority to the right to health and also safeguarding the patent system that has proven its effectiveness in promoting the innovation and enable the world to reach a stage of technological development advanced enough to develop, produce and deploy multiple cutting-edge responses to pressing global challenges in record time.
Editor’s note: Mariana González is a partner in the area of Intellectual Property and Technology Transfer at BC&B, with 10 years of experience. Follow her on. The opinions published in this column belong exclusively to the author.
