Since the pandemic seems to lose its impact and life is returning to normal, it may be a good time to look into the lessons learned so far from the Covid-19 pandemic and make necessary preparations against a possible new one. Indeed, pandemics have been an integral part of human history from the very beginning and diligently addressing the problems and their reasons faced during these times is quite important. However, most of the problems and, most importantly, the reasons for the problem of inequity of access to drugs/vaccines faced during the pandemic remain unsolved today, and the discussions are expected to continue in 2023.
The pandemic brought many discussions on IP rights from day one. As we all know, compulsory licensing was the first solution mechanism depended on by the governments as it was thought that the existing patent rights were the only obstacle to reaching a cure against Covid-19. Together, we experienced a journey where innovators and researchers are expected to develop an innovative cure in the shadow of the compulsory licensing threat. Meanwhile, many innovative pharma companies opened their patented technologies, IP rights and know-how to the public and shared what they have for humanity’s sake.
Eventually, BioNTech came up with the first Covid-19 vaccine; however, this initiated another problem, which is yet to be solved, vaccine inequity. Intellectual property rights came back into focus during the discussions of reasons for vaccine inequity, and this time, waiver of these rights was discussed as a solution.
However, just as compulsory licensing was not the solution to developing a cure for Covid-19, waiving intellectual property rights is far from a solution for vaccine access. India and South Africa first brought in October 2020 via the World Trade Organisation (WTO) proposal to temporarily waive intellectual property (IP) protection on coronavirus vaccines. However, the proposal did not explain how the elimination of intellectual property rights disclosing the treatment of Covid-19 will suddenly enable states to produce vaccines and vaccinate their populations in case of problems regarding manufacturing capacity, having the know-how, having good manufacturing sites, providing adequate raw materials, and especially, people being not informed and persuaded about the vaccination.
Nonetheless, while these discussions were ongoing, it was not questioned why the countries in need did not operate their “granting compulsory licensing” provisions in their domestic laws and suspend intellectual property rights being the reason for this problem. In particular, India, as a co-leader for the IP Waiver proposal, had a special provision under Section 66 of its Patents Act, entitling the Central Government to revoke a patent in the public interest, which means that it has a direct legal tool to suspend all patents allegedly hindering its access to vaccine via one single decision of the government.
On June 17, 2022, two years after the discussions began, during the 12th Ministerial Conference of the WTO, a ministerial decision was issued on the flexibilities brought with TRIPS regarding Covid-19 vaccines by authorizing members having developing country status to use patented inventions necessary for Covid-19 vaccine production and supply, without the right holder’s consent. However, although 7 months have passed since the issuance of this decision, the problem of access to the vaccine has not been resolved by February 2023. Indeed, according to “Our World In Data”, 69.4% of the world population received at least one dose of the Covid-19 vaccine. However, only 26.4% of people in low-income countries received at least one dose as of January 26, 2023.
One of the fundamental reasons that compulsory licensing mechanisms or IP waivers did not help manufacturing a vaccine is the limited information provided in the patent documents, especially in vaccine-related inventions. The patent document does not have to or need to disclose, for example, how to access the raw materials, without which it may not be possible to put a vaccine together. It is important to remember that compulsory licenses or IP waivers do not create and cannot create legal mechanisms forcing patent owners to transfer their know-how or trade secrets. This emphasizes the importance of voluntary solutions and finding ways to persuade the patent owners willingly collaborate.
Additionally, compulsory licenses or IP waivers cannot provide or create manufacturing facilities, equipment and raw materials in vaccine manufacturing. In the lack of those, even the patent owner is hopeless. We should keep in our mind that the vaccine that saved the whole world could be found thanks to the research and development that were started to conduct years before the pandemic to treat cancer. Without previous research, tests or data, it would be impossible to find and develop a vaccine within one year.
Therefore, if we want to be prepared against a possible new pandemic and extend access to the vaccine, we need to encourage research and development and inventive activities today. Our most powerful tool is adequate intellectual property protection, which is not meaninglessly threatened in every possible crisis. In addition to genuinely supporting R&D, we must find creative and efficient ways to incentivize the transfer of technology and know-how when needed, and we must think about the structures in which innovators/IP holders will be willing to cooperate and establish them from today. This is the only proper solution if the sincere aim is finding a cure, accessing the vaccine or fighting against a pandemic.