Legal Regulation of Certain Issues Related to Vaccination

Vaccination is one of the most important tools for combating infectious diseases, including COVID-19. The legal regulation of certain issues related to the development and production of vaccines and the vaccination process exists at the universal, regional, and national levels. In the context of the COVID-19 pandemic, it is crucial to determine whether the existing regulation is effective and identify ways to improve it. The International and Comparative Law Research

Center prepared a research, the purpose of which was to find effective mechanisms for legal regulation of certain issues related to the development and production of vaccines and the vaccination process at the universal, regional, and national levels. It examines international legal regulation at the universal and regional levels, including the law of the Eurasian Economic Union and the European Union, as well as the legislation of seven states: the Russian Federation, Germany, Sweden, the United Kingdom, the United States, China, and India.

Key conclusions
To date, international legal regulation at the universal level does not contain legally binding norms regulating the issues of immunoprophylaxis of infectious diseases, research and development of vaccines. In this regard, in the context of the COVID-19 pandemic, a global public health emergency, the principles of state cooperation, mutual assistance, and solidarity come to the fore. For example, in the absence of the resources necessary for conducting clinical trials, a large number of States are interested in gaining access to vaccines against new infectious diseases, including COVID-19. In this regard, at the international level, the procedure for mutual recognition of studies to register a vaccine could be simplified with the increase of its transparency.

At the same time, given the shortage of medicines, including vaccines, during the COVID-19 pandemic, some States and regional associations temporarily restricted or banned their export. Despite the fact that, as a general rule, quantitative restrictions are prohibited in international law, there are some exceptions that have been used to introduce them. At the same time, in any case, the introduction of temporary restrictions should result from the urgent need of the situation and has to be carried out in compliance with the proportionality principle. Otherwise, such restrictions may contradict both the UN principles and Sustainable Development Goals and other international legal obligations of States. From the human rights perspective, the failure of a State to take all reasonable measures to treat infected persons, as well as to ensure that all citizens can receive a vaccine, may lead to a violation of the State’s obligation of due diligence and the exercise of the right to life.

In the context of human rights, the question of the legality of issuing passports or certificates of vaccination against COVID-19 granting the right of free movement also arises. Issuing such documents exclusively to persons who have been vaccinated against COVID-19 may lead to discrimination against those who have not been vaccinated. The granting of different scope of rights to individuals depending on the vaccination should be based on a legitimate goal and a fair balance between protecting the interests of society as a whole and respecting the rights and freedoms of a particular person or group of persons. Compliance with these criteria will prevent violation of the principle of non-discrimination.

In the context of the COVID-19 pandemic, the EAEU law did not have a significant impact on aspects related to the creation, registration, introduction into civil circulation, import, and export of vaccines against COVID-19. In 2021, the Russian Federation introduced amendments to civil legislation, expanding the competence of the Government to allow the use of an invention, including medicines, without the consent of the patent owner in case of extreme necessity related to the protection of life and health of citizens. The removal of patent protection in an emergency situation is not only consistent with the provisions of international law but also allows ensuring the safety of life and health of the population of other States by providing the opportunity to use technologies for the production of vaccines and other medicines without any obstacles. The study of national regulation also revealed a tendency to limit the responsibility of the COVID-19 vaccine manufacturers due to insufficient grounds for it.

In general, the legal regulation of vaccination during the COVID-19 pandemic represents a unique experience of applying existing legislation and legislation adopted during the pandemic in the context of a health emergency. The analysis of the relevant national legal regulation has demonstrated the need for its harmonization by taking into account the experience of other States in the development and introduction of COVID-19 vaccines into civil circulation.

Considering that States and large pharmaceutical companies have been making efforts to harmonize the standards for conducting clinical research and developing medicines over the past years, the proposal to adopt a model law could be relevant.