SOMATIC AND OTHER BIOLOGICAL ASPECTS OF COVID-19 VACCINATION: LEGAL MEASURES TO SUPPORT SOCIETY AND BUSINESS DURING THE POST-PANDEMIC ERA IN RUSSIA1 ASPECTOS SOMÁTICOS E OUTROS ASPECTOS BIOLÓGICOS DA VACINAÇÃO COVID-19: MEDIDAS LEGAIS PARA APOIAR A SOCIEDADE E OS NEGÓCIOS DURANTE A ERA PÓS-PANDEMIA NA RÚSSIA

The purpose of the review is to comprehend the current trends in emergency rule-making in Russia and the restrictive practices introduced in the context of the COVID-19 pandemic. In response to new challenges, the Russian authorities have developed a kind of "rule-making vaccine". The introduction of new legislation, especially at the local level of Russian Federation, was accompanied by both long-term state support of business structures and the "freezing of the Russian economy." The situation of "unofficial testing" of a vaccine against COVID-19, facts of violation of the fundamentals of clinical trials, the norms of Russian legislation and generally recognized international standards in the field of clinical testing of drugs are analyzed. According to the position of the World Health Organization (WHO) the right to health imposes on the States a legal obligation to ensure timely access to adequate levels of high-quality health care, clean and safe drinking water, sanitation, adequate nutrition, shelter, health-related information and education, gender equality. As a result, the considerable amount of attention is paid to the analysis of the content of general and specific legal instruments at the national level to Support Society and Business During the Post-Pandemic  Era in Russia.

Abstract: The purpose of the review is to comprehend the current trends in emergency rule-making in Russia and the restrictive practices introduced in the context of the COVID-19 pandemic. In response to new challenges, the Russian authorities have developed a kind of "rule-making vaccine". The introduction of new legislation, especially at the local level of Russian Federation, was accompanied by both long-term state support of business structures and the "freezing of the Russian economy." The situation of "unofficial testing" of a vaccine against COVID-19, facts of violation of the fundamentals of clinical trials, the norms of Russian legislation and generally recognized international standards in the field of clinical testing of drugs are analyzed. According to the position of the World Health Organization (WHO) the right to health imposes on the States a legal obligation to ensure timely access to adequate levels of high-quality health care, clean and safe drinking water, sanitation, adequate nutrition, shelter, healthrelated information and education, gender equality. As a result, the considerable amount of attention is paid to the analysis of the content of general and specific legal instruments at the national level to Support Society and Business During the Post-Pandemic Era in Russia.

INTRODUCTION
According to the nomenclature of the World Health Organization (WHO) and the International Committee on Taxonomy of Viruses (ICTV), the virus from the Chinese city of Wuhan was given an official name "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" and the disease it caused was called "coronavirus disease " (see the ICTV decision of February 11, 2020).
From the legal point of view, this fact is non-trivial since having included COVID-19 into the International Classification of Diseases (ICD), the WHO has the right to announce measures for maintaining emergency preparedness and urge the countries of the world to respond to the disease. For example, on March 11, 2020, the WHO declared the first coronavirus pandemic in history. This pandemic can be controlled but it is impossible to avoid adverse consequences for the global economy and trade.
On March 30, 2020, a joint statement of the directors-general of FAO, the WHO, and WTO on mitigating impacts of COVID-19 on food trade and markets was adopted. In this statement, the states of the world were encouraged to "…ensure that information on food-related trade measures, levels of food production, consumption, and stocks, as well as on food prices, is available to all in real time", to allow "… producers, consumers and traders to make informed decisions", as well as to contain "panic buying and the hoarding of food and other essential items" 4 .
took unprecedented measures to combat the coronavirus through quarantine and the restriction of human rights. On September 11, 2020, the UN General Assembly adopted an omnibus resolution on a comprehensive and coordinated response to the COVID-19 pandemic. The resolution was supported by 169 countries, including Russia, only the USA and Israel were opposed to it.
In March 2020, Russia faced the escalation of the coronavirus problem. That is why the federal government sealed off the external borders and introduced regional lockdowns. The lockdowns meant a strong recommendation to the citizens to voluntarily stay home and a ban on going to work, school, or public places. Russian regional authorities ordered to close public places (except for groceries and drugstores), introduced distance learning in all schools, made employers transfer riskgroup employees to a remote working regime, and imposed sanctions for organizations (enterprises) for violating the "high-alert mode" 5 .
The COVID-19 measures resulted in the serious deterioration of the Russian economy. The crisis was accompanied by the global stock market crash, lower economic activity, and labor market collapse. The price war between Russia and Saudi Arabia on the hydrocarbon market, wide swings in oil prices, and other downsides also contributed to the critical situation. Russian businesses were severely tested; many organizations (enterprises) were facing bankruptcy. Not every organization could adapt to the remote working regime (it was true for cafes, restaurants, libraries, parks, etc.).
Many businesses had to suspend their activities (tour operators, air carriers, betting shops, cinemas, fitness clubs, beauty parlors, etc.).
At the same time, the pandemic lockdown in Russia triggered a high demand for streaming platforms content and remote services (the delivery of foods, disinfectants, and other products).
The issue of supporting the citizens in the face of mass unemployment and the general crisis of the Russian economy became particularly urgent. In April 2020, the Russian President Vladimir Putin signed important federal laws, including the empowerment of the Russian federal government with the opportunity to declare the state of emergency or the high-alert mode. The reason for the declaration could be the spread of hazardous diseases. The government also got the right to establish rules, which Russian organizations (enterprises) would have to follow under the described circumstances. The President also signed a Decree on the Prolongation of a Non-Working Days Period in Russia. The regional leaders got additional powers to determine how rigid their regional lockdowns were going to be (for example, companies' activities suspension, regardless of the ownership structure) and it raised additional concerns among economists 7 . At the same time, Russian businesses, which suffered from the lockdown more than others, got repayment holidays. The Government Commission identified 22 industries to provide them with targeted state support 8 .

LEGAL MEASURES TO SUPPORT SOCIETY AND BUSINESS
A new term "national guarantee system for supporting small and medium-sized businesses" appeared. It means systematic private obligations guarantees (protection) for businesspersons who are using bank loans and other financial resources 9 . Bankruptcies of small and medium-sized businesses at creditors' requests, rent increases (when the premises are state-owned), tax audits, customs inspections, and other investigations of this type are going to be suspended up to the end of 2020. The Supreme Court of the Russian Federation issued special guidelines to explain the way laws should be applied during the pandemic. 11 The document covered contracts, force majeure, statutes of limitations, procedural deadlines, and bankruptcies as well as criminal and administrative responsibilities. Everyone could postpone the fulfillment of obligations after the pandemic had become a force majeure for a debtor (Article 401 (3) of the Russian Civil Code). Nevertheless, the debtor had to prove that the force majeure existed and it had been provoked by the pandemic.
The debtor also had to show that he/she had taken reasonable measures to diminish the harmful consequences. Besides, the procedural deadlines included the non-working days, i.e. the claims were accepted during the lockdown. People were allowed to start the proceedings, even if the deadlines had been missed because of coronavirus. In the end, the Supreme Court explained what was meant by the automatic moratorium on bankruptcies and it did not matter if the bankruptcies had nothing to do with the pandemic. This approach differed from the one that was used, for example, in Germany.
The legally recognized "shock freezing of the Russian economy" during the COVID-19 pandemic caused lots of problems for many businesses, they did not survive the suspension and went bankrupt.
The credit portfolios of large Russian banks got worse. Anyway, the government understood how important it was to restructure private and corporate loans on time. The World Health Organization claimed that in summer 2020, more than 120 companies from various countries were busy with developing a COVID-19 vaccine. More than 10 medications were only at the first phase of clinical trials at that time.   In the early autumn of 2020, the Health Ministry published the eighth version of the Temporary Guidelines on Prevention, Diagnosis, and Treatment of COVID-19. However, the dangerous substance called hydroxychloroquine is still being used in the treatment of patients with mild and medium forms of the disease. The guidelines recommend preventing COVID-19 in adults through the Sputnik V vaccine developed in the Gamaleya Center and this recommendation is controversial from the legal viewpoint. Sputnik V is recommended even for people who have neither coronavirus nor antibodies to SARS-Cov-2 24 . The eighth version of the Guidelines advises first to immune the representatives of the following groups: 1) health workers, teachers, police officers, public transport staff, retailers, social welfare workers, fast food employees, and other employees, contacting with the clients in hotels, hairdressers, barbershops, laundries, banks, etc.; 2) students in educational institutions of all levels; 3) subjects to conscription.

LEGAL AND BIOLOGICAL ASPECTS OF COVID-19 VACCINATION
Finally, we will describe another controversial issue with lots of legal, international, and ethical aspects. The development of the Sputnik V vaccine was finished in the Gamalaya Center on July 20, 2020. The Ministry of Defense announced that clinical trials were over; the vaccine had been tested on about 40 volunteers. On August 12, 2020, the medication was registered 25 . However, the Registration Certificate, issued pursuant to the above-mentioned Government Decree No 441, had been obtained before the clinical trials started. This fact is, for sure, against the international legal practice. The Russians consider the registration of the vaccine to be valid up to the beginning of 2021 in case a large-scale phase 3 clinical trial, involving 40,000 volunteers, begins.
Anyway, the Russian Sputnik V was the first registered coronavirus vaccine in the world.
Vladimir Putin emphasized this fact and said that he knew, the vaccine worked rather effectively, formed a stable immunity, and passed all the necessary inspections. The President also insisted that vaccination in Russia should only be carried out on voluntarily. In addition, Mr. Putin's daughter and several Government Ministers tested the vaccine on themselves. By early autumn 2020, the third and final phase 3 trials were already in progress. Thousands of people in Moscow and the Moscow region were involved. The first shipments of the drug reached all Russian constituencies to immune people from the risk groups.
In legal terms, we are critical about the fact that the Russian Direct Investment Fund has made verbal agreements with about 50 countries (Brazil, Mexico, India, Middle East countries, etc.) to supply the Sputnik V vaccine to them. According to Western experts, the Russian drug has not been tested enough to prove that it is really effective and safe. It is too soon to use it, especially when all the necessary procedures have not been followed. And there is an ethical point… People now have the medication to protect themselves against COVID-19 but it is still unknown whether it is effective and safe.
Against this backdrop, on September 04, 2020, the Lancet, a respected medical journal, published the results of the 2-phase trial of the vaccine conducted in Russia 26 . On September 21, 2020, the journal published an open letter from the international group of health workers and researchers led by Professor Enrico Bucci from Temple University. The foreign experts paid attention to some statistical inconsistencies in the Russian scientists' studies. In particular, the antibody levels in the blood of different participants coincided after immunization 27 . There are two steps in the trials of any vaccine: a pre-clinical step (animal testing) and a clinical step (human subject research).
The details of the Russian vaccine animal testing have not been published yet. The criticized article in the Lancet journal was submitted by the Russian vaccine developers and based on the volunteer clinical trials. Then, the Russian scientists responded to the criticism. They admitted that there were not so many participants but they did not explain why the number of participants was so small. And they did not explain why the first and the second phases of the trial were combined 28 . To be honest, all the other COVID-19 vaccines are being developed and tested on samples that are more reliable.
Another shortcoming, restricting the citizens' rights during the pandemic, was a flawed system of online medical services. For example, during the lockdown and distance working it was a problem to get a sick leave online. Under the new Health Ministry Order 29 , during a lockdown (quarantine) or when there is a threat of dangerous diseases, a person can get a sick leave for the whole quarantine period. It should be noted that a sick leave can be registered online only by a federally registered doctor, working in a federally registered medical facility. It is done for fraud prevention.
A kind of guarantee that the medications, used during a pandemic, are safe is the information letter from the Federal Service for Surveillance in Healthcare (FSSH) 30 . It is about probable side effects or inefficacy of COVID-19 vaccines. The FSSH reminds the citizens that it is necessary to inform the relevant authorities about every instance of an unwanted reaction or the absence of a therapeutic effect from a COVID vaccine.

HUMAN RIGHTS IN THE CONTEXT OF LEGAL REGIME OF COVID-19
In conclusion, we will focus on the problem of restricting human rights in the context of legal regime changes under the influence of COVID-19. Unlike other countries, Russia did not introduce a "high-alert mode" or "emergency mode", which is possible under the Federal Law on Emergencies (Article 8). Consequently, additional rules for the Russian citizens (restrictive measures) could not be legitimately introduced at the will of local authorities. Nevertheless, the decrees of regional governors and mayors of federal cities were passed to save the population and territories from emergencies.
If a "high alert mode" or an "emergency mode" had been introduced by a presidential decree in the whole country or a particular region, it would have only been possible to restrict the access of people and vehicles to certain places. In fact, the measures, restricting human rights and freedoms are prohibited by law. However, in many regions, the citizens' right to freedom of movement was restricted, e.g. even uninfected people were prohibited from walking outside (in parks, etc.). In some Russian regions, the authorities did not care that according to the WHO, the coronavirus infection was not transmitted by air. On the contrary, in some European countries, a daily one-hour walk in a park was even recommended. In addition, under Article 27 (1) of the Russian Constitution, every person has the right to move freely and choose where to be.
Some regional prescriptions contradicted Article 11 of the Federal Law on Emergencies 31 .
Moreover, these by-laws contradicted the Presidential Decree of April 2, 2020 No 239. By the Decree, the restrictive and other measures could be implemented till April 30, 2020, inclusive. That is why we believe that to exceed the term was illegal. It was no less illegal to set up an indefinite ("endless") period, during which human rights could be restricted, especially the rights of uninfected citizens.
Under Article 8 of the Law on the Citizens' Right to Free Movement and the Choice of Residence, this right can be restricted in an emergency case when there is a danger of mass diseases and poisoning. Anyway, the restriction is allowed only by the federal legislation.
The new Presidential Decree of April 28, 2020 No 295 specified that regional senior officials had to take measures to provide for the sanitary and epidemiological welfare in the context of COVID-19 from 1 through 11 May 2020.
At the same time, the Sanitary Regulations of the Russian Federation do not prescribe the restrictions in relation to healthy people, i.e. for the citizens who are uninfected and non-dangerous to everybody around.
In the case of a pandemic, the Russian legislation allows to apply the so-called "measures of social disunity". These are a temporary shutdown of catering facilities, retailers (except essential commodities sellers); a switch to remote working and distance learning; restrictions on public events (or complete prohibition); anti-epidemic regimes in hospitals, schools, and penitentiaries; obligatory use of disinfectants, masks, and gloves, etc. The Russian Administrative Code has been amended and now there are sanctions for ignoring the behavioral norms in an emergency or when there is a threat of emergency (Article 20.6.1). The Article covers both federal and regional restrictions. The violation of sanitary and epidemiological restrictions is described in Article 6.3 (2). So, it is impossible to impose a penalty under both Articles for the same violation. Article 6.3 (2) is applied where, for example, people must be quarantined but they are walking in a park. We believe that the use of Article 6.3 (2) to sanction healthy people is illegal.

CONCLUSION
At the end of our critical overview of the Russian measures to support people and businesses in the context of COVID-19, we believe that a serious restriction of human rights is unacceptable unless it is about an emergency. The serious COVID-19 measures should have been introduced without breaching the constitutional principles of transparency, proportionality, reasonableness, necessity, sufficiency, etc. The universal international legal institutions establishing special rights for vulnerable groups will continue to be applied by member states in the context of a situational response to the global needs of families, women and children, international migration, armed conflicts, environmental conditions, and bioethical issues.