The Practice of International Bodies on the Problems of Using Genetic Medical Technologies: Classification, Overviews of the Legal Cases

Gazina Nayana Igorevna ORCID: 0000-0002-8642-4458 Postgraduate student of the International Law Department, Kutafin Moscow State Law University (MSAL) 123001, Russia, Moscow, Sadovaya-Kudrinskaya str., 9 nayana.gazina@mail.ru Other publications by this author

The research was carried out at the expense of the grant of the Russian Science Foundation No. 19-18-00422, https://rscf.ru/project/19-18-00422 /.

The use of genetic technologies is a sphere of legal relations, which are regulated at the international level for the most part by acts of a recommendatory nature. Yvonne A. Stevens attributes this to the fact that it is "soft law" that allows humanity to keep up with the times, regulating new legal relations that arise dizzyingly quickly ^[1]. The formation of contract law requires compliance with a number of conditions, including significant time resources, which are not always in abundance due to the pace of development of new technologies and the need for rapid response and the establishment of international legal standards in new areas. The international treaties that enshrine human rights directly related to genetic technologies are the Convention on the Protection of Human Rights and Dignity in Connection with the Application of Advances in Biology and Medicine (Oviedo Convention) and Additional Protocols thereto. The Oviedo Convention and its Additional Protocols are binding on their parties. However, not all countries of the Council of Europe are parties to the treaties under consideration ^[2]. At the same time, in fact, the protection of human rights in situations involving the use of genetic technologies is carried out through the use of mechanisms (for example, the possibility of applying to the UN Committee on Economic, Social and Cultural Rights, the European Court of Human Rights (hereinafter – the ECHR, the European Court, the Court) created by international human rights acts of a general nature (International Covenant on Economic, Social and Cultural Rights, European Convention on Human Rights (hereinafter – ECHR). In this regard, the practice of these organizations is of great importance. In this article we turn to the practice of the European Court of Human Rights. There is a need to analyze not only cases directly related to the use of genetic technologies, but also similar, fundamentally important cases related to the protection of the right to privacy, to health, to access to medical technologies, to the protection of personal data.

I consider it appropriate to divide cases that are important for understanding the legal framework for the use of genetic medicine into two large categories:

1. cases directly arising in connection with the use of genetic technologies, in which private issues of human rights protection in the application of these technologies are considered,

2. cases in which the fundamental legal positions applicable to medical activity in general are approved. Such cases may not be directly related to the use of genetic technologies, but affect, in particular, their application.

The first category includes cases arising directly in connection with the use of genetic technologies, which may be different in subject matter (protection of medical data, the use of a human embryo, the problem of access to the use of genetic technologies, such as genetic diagnostic tests, etc.). In such cases, the emphasis is on the presence or absence of human rights violations by on the part of the state, the degree of legal certainty, consistency and consistency of national legislation is assessed.

The second category – cases that affirm the principles – can include those that relate to voluntary informed consent and confidentiality of medical data. They are mainly related to medical activities, but not always directly related to genetic research or gene therapy. Nevertheless, the Court's positions interpreting contracts that can be found in such cases are also applicable to genetic medicine. They differ from the previous category in that the positions expressed in them are applicable to medical activities in general, are fundamental, non-compliance with these fundamental provisions naturally leads to a violation of human rights.

In addition to the above, it is possible to classify the bodies that resolve cases: judicial (ECHR, EU Court) and non-judicial (UN Committee on Economic, Social and Cultural Rights), universal (UN Committee on Economic, Social and Cultural Rights) and regional (ECHR, EU Court), as well as on the issues under consideration (protection of medical data, use of the human embryo, the problem of access to the use of genetic technologies, such as genetic diagnostic tests). However, I believe that such classifications are obvious and do not require further explanation.

The positions that we can find in "medical affairs" are extremely important due to the fact that practice is currently developing, common positions are being developed in this area, this is especially significant in light of the lack of consensus on such sensitive issues as the use of reproductive and genetic technologies at the international level.

Cases arising in connection with the use of genetic technologiesLet's consider the category of cases directly arising from the use of genetic technologies, using the example of the problem of access to prenatal genetic diagnostics.

Genetic testing technologies allow carriers of serious genetic diseases to avoid transmission of the disease to their future children, make it possible to detect fetal development pathologies in time and make an informed decision about maintaining or terminating pregnancy, can help doctors and parents when choosing the option of pregnancy and childbirth to improve the prognosis for the child ^[3]. Prenatal, in particular preimplantation, genetic diagnostics allow parents to ensure the protection of reproductive rights and, as a result, the right to health protection and the right to protection of private and family life.

Preimplantation genetic testing is an early form of prenatal genetic diagnosis, in which abnormal embryos are detected, which allows the transfer of genetically normal embryos ^[4].

Despite the rapid development of medical science, patients' access to genetic testing is not always open, it is provided, restricted and prohibited by national legislation. The ECHR in cases related to reproductive health, the use of genetic technologies, quite often refers to the concept of "wide margin of appreciation" of states ^[5]. Due to the lack of a pan-European consensus on such sensitive issues, States can use wide opportunities for legal regulation in this area. At the same time, the ECHR quite often recognizes the violation of rights related to reproductive health by the participating States. In some cases, national legislation is applied (or not applied) in such a way that it leads to a violation of the right to privacy. In others, the national legislation itself is so vague or contradictory that its application naturally leads to a violation of human rights.

In the case "R.R. v. Poland" ^[6], the medical staff deliberately refused to conduct timely genetic tests for a woman pregnant with a third child, if the fetus was suspected of having a serious genetic defect.

By the time she received the results confirming that the fetus suffers from Turner syndrome, the period in which it is possible to have a legal abortion in accordance with Polish law had passed. The European Court found a violation of Article 3 (prohibition of torture) The ECHR, because the applicant, who was in a very vulnerable position, was subjected to humiliation and "unworthy" treatment. Determining the possibility of access to genetic tests recommended by doctors was hampered by procrastination, ambiguity in the decision-making process and lack of proper advice and information. The ECHR concluded that the authorities had not fulfilled their positive obligations to ensure the applicant's right to respect for her private life, there had been a violation of article 8 (right to respect for private and family life) ECHR.

The case of A.K. v. Latvia is similar. The applicant was 40 years old at the time of pregnancy. In accordance with national legislation, she had to be treated as a patient with a high-risk pregnancy. The applicant claimed that her gynaecologist had failed to provide the prenatal screening test that should have been carried out. She gave birth to a daughter with Down syndrome. Referring to article 8 (right to respect for private and family life) ECHR, A.K. claims that she was denied adequate and timely medical care in the form of an antenatal screening test, which would indicate the risk of a genetic disease of her fetus and would allow her to decide whether to continue pregnancy ^[7]. The Court found that the cumulative effect of the violations revealed was that the domestic courts did not properly consider the applicant's claim that she had not received medical care and information in accordance with national legislation in a manner sufficient to ensure the protection of her interests. Accordingly, there has been a violation of article 8 of the ECHR in its procedural aspect.

Despite the broad discretion in cases related to reproductive health, in the case of Costa and Pavan v. Italy ^[8], the Court recognized the inconsistency of Italian national legislation in the regulation of preimplantation diagnostics and the use of assisted reproductive technologies, which led to human rights violations. Partners who were carriers of a genetic disease – cystic fibrosis, but were not sick themselves, used the IVF procedure to avoid transmitting the disease to the child. The applicants were denied preimplantation diagnostics. The couple was denied the possibility of embryo screening, but artificial termination of pregnancy was allowed if the fetus showed symptoms of the same disease. Such interference with the applicants' right to respect for their private and family life was disproportionate. The Court found a violation of article 8 (right to privacy protection) ECHR from Italy.

In cases where artificial insemination and termination of pregnancy for medical reasons are permitted in national legislation, prenatal diagnostics should not be prohibited, which makes it possible to make a decision on maintaining or terminating pregnancy if a fetal defect is detected.

It can be concluded here that despite the concept of broad discretion for States in dealing with such sensitive issues as the establishment of permits, prohibitions, and the procedure for conducting genetic testing, national legislation should be consistent and specific, allowing individuals to properly exercise their rights. This is a general requirement, compliance with which makes it possible not to violate human rights when States choose different approaches to legal regulation in the area under consideration.

Cases containing fundamental provisions for ensuring human rights in the implementation of medical activities Let us briefly consider some cases concerning voluntary informed consent, in which the European Court expressed principled positions on this issue.

The principle of informed consent is a continuation of the concept of personal autonomy, is based on the ability and right of a person to make an independent choice and expresses one of the aspects of the human right to respect for private life. Any medical intervention, including genetic, regardless of whether it is of a research or therapeutic nature, can be carried out only with the consent of the patient or the person participating in the medical study. The Oviedo Convention in article 5 contains a provision on the need for voluntary informed consent to medical intervention. Consent presupposes that a person receives relevant information in advance about the purpose and nature of the intervention, as well as about its consequences and risks, and can freely withdraw his consent at any time ^[9].

At the moment, in many countries, the requirements for what information should be provided to persons signing an informed consent document are quite clearly formulated. For example, in the USA, the requirements for the form of expression of consent are defined in detail in articles 50.25, 50.27 of Section 21 of the Code of Federal Regulations ^[10]. In Russia, this principle is enshrined in Federal Law No. 323-FZ of 21.11.2011 "On the basics of protecting the health of citizens in the Russian Federation", and the procedure for giving consent to medical intervention and refusing medical intervention is approved by order of the Ministry of Health of the Russian Federation ^[11].

Voluntary informed consent in relation to children has its own characteristics. The general approach is that consent to the treatment of a child, including with the use of genetic technologies, is given by parents. An illustration of this procedure is the case "Glass v. United Kingdom (Glass v. UK)" ^[12], considered in the European Court of Human Rights. The child was hospitalized several times with a respiratory system disease. There were disagreements between the hospital staff and Ms. Glass about the methods of treating a child in the event of a crisis: to conduct intensive therapy or not. In one case, doctors believed that the child was in a near-death state, and in order to reduce pain, diamorphine was injected into his body against the wishes of the mother. In addition, an entry was entered into the patient's card without the mother's knowledge: "do not carry out resuscitation." There was a serious conflict between doctors and family members of the child. The child survived.

The ECHR considered that imposing a course of treatment on a child, despite the constant objections of the mother, was an act of interference in the exercise of the child's right to respect for his private life. The fact that the doctors were dealing with a crisis situation for the child's life did not justify the fact of such an intervention. The Court particularly noted that at the initial stages of the applicant's conflict with the hospital, the hospital administration did not attempt to resolve this conflict by resorting to the intervention of the court. The burden of the initiative to resolve the conflict on the eve of the next crisis of the patient lay on the hospital administration. Instead, the doctors used the limited time available to them in this situation to try to impose their point of view on the mother.  The European Court considered that the decision of the authorities to ignore the objections of the mother of a minor patient about the proposed treatment in the absence of permission from the judicial authorities led to a violation of article 8 of the ECHR.

At the same time, there are situations in which the actions of doctors against the will of the parent or the legal representative of the child are recognized as permissible. In the case "The Religious Community of Jehovah's Witnesses in Moscow v. the Russian Federation" ^[13], the European Court pointed out that the provision of Russian legislation ^[14] in force at the time of the case that the decision of parents to refuse treatment provided to a child in order to save his life can be overcome by a court decision, protects the rights of the child ^[15]. It can be concluded that the decision on medical intervention in relation to a minor, who, in accordance with national legislation, does not have the right to make such a decision independently, lies with his parents (legal representatives). At the same time, in cases requiring a quick response from medical personnel in order to save a child, when a parent (legal representative) prevents this, doctors can act at their discretion after applying to the court.

The rule on parental consent also applies to gene therapy for children, experimental treatment, and their participation in genetic research ^{[16, 17]}. In some countries, there are features that do not exclude the general rule, such as, for example, the possibility of a minor upon reaching the age of 16, in accordance with UK law, to independently make a decision regarding his treatment ^[18].

Consent may be required not only in cases of treatment or participation of a person in biomedical research, but also when using his genetic material by third parties: medical, scientific institutions or family members, spouses, partners. Thus, in the case "Evans v. the United Kingdom" ^[19], the legality of a ban on the use of embryos by one partner, the carrier of genetic material, without the consent of the second is considered. Natalie Evans suffered from ovarian cancer. Before their removal, she and her partner D. resorted to in vitro fertilization. The resulting embryos were placed in storage. The couple's joint relationship did not work out. D. withdrew his consent to the use of embryos, not wanting to become the genetic father of the applicant's children. According to the national law, the embryos had to be destroyed. Natalie Evans was deprived of the opportunity to ever have her own, genetically native children.

The European Court in its decision expressed sympathy with the applicant, but found no violation of articles 2 (right to life), 8 (right to respect for private and family life) and 14 (prohibition of discrimination) of the ECHR ^[20]. One of the criteria for making such a decision was that the rule on the consent of both partners was clearly formulated in national law, and Natalie Evans was familiar with it before the fertilization procedure. According to the court, the balance of competing interests in the case was observed.

In another case, Parillo v. Italy, in which the issue of the transfer of embryos for scientific research was considered, the European Court noted that it did not have evidence indicating that the applicant's partner, who at the time of in vitro fertilization had the same rights to embryos as her, also accepted there would be a decision on the transfer of these embryos for scientific research (the applicant's partner died before the dispute arose and its consideration in the ECHR).

Voluntary informed consent is a prerequisite for a person to participate in genetic research, to undergo genetic testing or treatment. Informed consent is not just a document signed by a patient or his legal representative, it is a procedure that requires compliance with certain criteria.

Summing up the above, it can be concluded that when analyzing the practice of international bodies in order to determine the general trends of legal regulation and protection of human rights in the field of the use of genetic technologies, it is inappropriate to limit oneself only to the practice in cases in which the problems of the use of genetic technologies are raised. It is also important to analyze "medical cases" that are not related to new technologies, since some of them contain fundamental legal provisions on the observance of human rights in medical activities. For example, it is the analysis of practice in such medical cases that makes it possible to find out how the ECHR discloses the principle of voluntary informed consent through the interpretation of the right to privacy enshrined in Article 8 of the ECHR. So, in this article, based on the analysis of several cases, the features of voluntary informed consent in relation to the treatment of children were revealed, the approach of the ECHR to solving the issue of using a partner's reproductive material without his consent was considered. This is a small set of questions taken to illustrate the need for a broader view of the study of the practice of international bodies in order to understand the permissible framework and legal guidelines in the field of application of genetic technologies.

At the same time, the category of cases directly arising from the use of genetic technologies is not so numerous, however, decisions on such cases also attract considerable attention due to the fact that it is currently with each new decision that the practice of protecting human rights in this relatively new area is being formed. Thus, a narrowly focused analysis of this category of cases allows us to deduce general requirements for legal regulation and ensuring human rights in such subject areas as, for example, genetic testing.