At the end of 2019, humanity was faced with a new infectious disease caused by a new coronavirus, covid-19 which led, on March 11, 2020, to the World Health Organization (WHO) to declare the state of a global pandemic. .
The fight against this new virus required several technical innovations and, besides the vaccine, many inventions required patent protection: retroviral drugs, diagnostic tests or medical devices, such as ventilators are some of these. examples. However, the most visible face of this fight has been the vaccine, which has put pharmaceutical companies in a race for its development.
At the time of writing, vaccines from Pfizer-BioNTech, Moderna, AstraZeneca, Janssen, Sinovac (CoronaVac) and Sputnik are administered worldwide and most developed countries in Europe and then the United States of America, the Russia and China plan to obtain group immunity by the end of 2021.
This situation is only possible because of the economic power available to countries, either to develop vaccines or to buy the same ones. Unfortunately, none of these possibilities are viable when it comes to underdeveloped countries, a situation which is currently unfolding across Africa. Indeed, African countries are devastated by the covid-19 pandemic, however, the fight against the same is not as fair as the fight taking place in developed countries.
Access to vaccines by these countries is a problem that has found a solution in the Covax incentive, an international mechanism co-led by Gavi (The Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization. health with the objective of accelerating the development and manufacture of vaccines against covid-19, and guaranteeing fair and equitable access for all countries of the world. The international mechanism plans to distribute two billion doses of vaccines until the end of the year to underdeveloped countries, and it has agreements with AstraZeneca, Pfizer-BioNTech and Moderna.
Ghana was the first African country to receive vaccines under the international Covax mechanism in February: 600,000 doses of the vaccine developed by AstraZeneca. Since then, Algeria, Malawi and Uganda have also received doses of the vaccine from the same laboratory. In early March, Rwanda was included in Pfizer-BioNTech’s vaccine batch under Covax. However, this situation is far from ideal, as the percentage of the population that currently has access to the vaccine in Africa is extremely small.
Many were the public statements of António Guterres, the current Secretary General of the United Nations, in which he criticized the “extremely unequal and unfair” distribution of vaccines and called for the solidarity of countries to join this international. mechanism. Thus, only a comprehensive strategic vaccination plan would avoid future mutations of the virus in countries where vaccination has not progressed and would make it possible to fight effectively against the virus. It is important to note that two mutations of the virus have taken place in Brazil and South Africa and it is certain that if the pandemic is combated on a global level, it would be possible to avoid future mutations which would only delay the recovery. economy of the country and the return to a certain normality.
Patent system and collision with the right to health
Access to pharmaceutical products, in particular access to covid-19 vaccines can also be solved by the application of intellectual property rules.
The vaccines currently administered are protected by patent. A patent is a right granted by the government, in which the inventor has the exclusive right to explore the invention for a period of 20 years. To be granted, the patent must meet certain requirements, including novelty, inventive step and industrial applicability. Pharmaceuticals protected by patent are sold at a higher cost relative to the cost of production, to compensate for the investment in I&D. The purpose of granting a patent is to promote technological and scientific progress by offering the inventor market exclusivity.
However, the patent system as it is conceived comes up against a commensurable ethical aspect: the right to health.
For this reason, the patent system is not strict and determines mechanisms allowing access to pharmaceutical products, especially vaccines protected by patents. The most relevant limitations and exceptions to the patent system can be invoked as follows:
- Temporal and territorial limitation: patents are valid for a limited period of time and are only protected in the jurisdictions in which protection has been requested.
- Private use of the patent without commercial purposes: there is no patent infringement when there is use by a third party of the invention for private purposes and without commercial purposes.
- Experimental use does not constitute a patent infringement, provided the use is made in testing or for experimental purposes.
- Exhaustion of right: the rights conferred by the patent do not allow the patent owner to prohibit any act relating thereto after the invention has been legally placed on the market by the patent owner.
- Compulsory license: when a government allows someone else to produce a patented product or the patented process without the consent of the patent holder.
Compulsory license as a mechanism for accessing pharmaceutical products (vaccines)
As noted above, compulsory licensing is when a government allows someone else to produce a patented product or patented process without the consent of the patent holder.
The license may be granted when (i) there is a lack or insufficient exploration of the invention; (ii) there is a dependence on patents; or (iii) where there are reasons of public interest, in which public health is, of course, included.
The granting of compulsory licenses depends on a judgment of proportionality between the right to patent and public health, however, it has been indicated as the main instrument of access to patented medicines and vaccines.
Article 31 of the TRIPS Agreement allows countries to make arrangements for the granting of a compulsory license to third parties without the authorization of the patent owner and sets out certain conditions which must be taken into account when the granting of a compulsory license.
“Despite this legal mechanism that allows underdeveloped countries to access vaccines or other patented medicines, there is no record of African countries using the same during the covid-19 pandemic until today. hui. “
Until 2001, when the Doha Declaration was signed at a WTO ministerial conference, compulsory licenses were not eligible for export. This amendment allowed underdeveloped countries to import patent-protected pharmaceuticals under the issuance of a compulsory license. This was an extremely important amendment because underdeveloped countries would have the power to issue compulsory licenses, but would not have the capacity to produce pharmaceuticals. Under this amendment, these countries can import products from countries that have the capacity to produce the same ones. The Doha Declaration expressly mentions the importance of the amendment, recognizing “the seriousness of the public health problems which afflict many developing and least developed countries, particularly those resulting from HIV / AIDS, tuberculosis , malaria and other epidemics ”and that the“ TRIPS Agreement does not and should not prevent Members from taking action to protect public health ”.
Despite this legal mechanism that allows underdeveloped countries to access vaccines or other patented medicines, there is no record of African countries using the same during the covid-19 pandemic until today. . Indeed, only Israel issued a compulsory license for the importation of a retroviral drug (Kaletra), due to the inability of the patent holder to produce it.
Considering that the pandemic is still far from being brought under control, depending on the effectiveness of the Covax initiative or any other mechanism that could be used (has the raising of the rules of the TRIPS Agreement defended by some), it is possible that some African countries issue compulsory licenses to access covid-19 vaccines.
Use of compulsory licenses by African countries
The use of compulsory licenses by underdeveloped countries is not new. The Doha Declaration helped ensure that underdeveloped countries did not fear trade sanctions when issuing compulsory licenses on patented pharmaceuticals.
One example is Mozambique, which in 2004 issued a compulsory license for the importation of three retroviral drugs, lamivudine, stavudine and nevirapine, to combat the HIV / AIDS epidemic, given the rates of mortality and transmission at the time, which made Mozambique one of the 10 countries most affected by the disease. In the same year, further compulsory licenses were issued by the governments of Zambia and Swaziland for the same effect.
In 2005, in Cameroon, Ghana, Guinea and Eritrea, governments issued compulsory licenses for the importation of retroviral products to combat the HIV / AIDS pandemic.
This article originally appeared in China IP Magazine.