“Aravot” has interviewed the Head of Human Rights and Biomedicine Division of the Council of Europe.
-Ms Lwoff, first of all I would like to know basically about the project which Council of Europe is implementing in Armenia in the sphere of bioethics, as I know Council of Europe has conducted an event, training applying bioethics in medical research for newly formed Research Ethics Committees.
-The Project on “Protection of Human Rights in Biomedicine” is the first cooperation Project in the field of biomedicine implemented in a Council of Europe member state. The Project was implemented within Council of Europe Action Plan for Armenia for 2019-2022. The Project aimed at raising awareness on and facilitating the implementation of European standards in the field of biomedicine, such as informed consent, medical confidentiality, prohibition of financial gain during transplantation of organs and tissues and etc. The project’s ultimate goal was to help prepare Armenia for the ratification of the Convention on Human Rights and Biomedicine (Oviedo Convention). The Project is centred around two main pillars: firstly, supporting Armenian authorities in bringing legal norms and law-enforcement practices in the biomedical field closer to the European human rights and ethical standards, and, secondly, strengthening the capacities of healthcare and legal professionals to apply human rights standards in biomedical fields in their daily work. The training for the members of Research Ethics Committees last October was organized within the second pillar with the aim to strengthen the capacities of Research Ethics Committee members in line with the European standards. Those include namely the relevant provisions of the Oviedo Convention and its Additional Protocol concerning biomedical research. The training session was organized in close collaboration with the European Network of Research Ethics Committee and experts who participated in the development of the CoE’s “Guide for research ethics committee members”.
-In Armenia, research ethics committees have not functioned until recent years, they used to have a formal nature. They functioned only within the Medical University and the Center of Genetics, but they were of a local nature. Research Ethics Committee under the National Institute of Health of Armenia and of the Research Ethics Committee under the National Centre for Infectious Diseases of Armenia are newly formed. Does Armenia a lot stay behind from other European countries in this field?
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-If I am not mistaken, all committees have been formed at the same time. When devising the capacity-building session, we did approach the request for training without making distinction. The request to conduct the training session for research ethics committees was made with the aim to bring the statute and legal base of the functioning of research ethics committees closer to European standards in the field, as well as to strengthen the capacities of newly appointed members of committees based on the abovementioned legal instruments and the Guide. There are some specific aspects, such as conflict of interest, or financial matters of the research, as well as the evaluation of the research proposals, on which training was requested.
The situation with regard to the functioning of research ethics committees in European states is very diverse. The participation in the training of experts from the European Network of Research Ethics Committees (EUREC) was very useful in this context. The exchange during the session were very fruitful and we trust that it will lead to closer links between Armenian research institutions and EUREC, and thereby research ethics committees in other European countries.
-The rules of ethics for medical workers have only been adopted in RA in the beginning of 2022․ Don’t you think that this decision should have been adopted many years ago and also is this the reason that a medical worker has been subjected to violence in Armenia several weeks ago?
-The willingness of the authorities to move forward with the adoption of ethical rules has to be acknowledged and the adoption of the code of ethics was a very important and positive step. The adoption of ethical rules for healthcare professionals and establishment of ethics committees for healthcare professionals are defined by the RA Law on “Medical care and Assistance to the population”. The ethical rules for healthcare professionals adopted by the RA Government decision N-182-N from 17 February 2022 regulate ethical aspects of doctor-patient, doctor-doctor, doctor-third part relationships, as well as define some ethical aspects for public health emergencies. The overall aim of these rules is to increase the quality of the healthcare services provided to patients. At the same time, the cases of violations against healthcare professionals by patients or their relatives are not the subject of the abovementioned decision, and criminal law legislation is more relevant here.
–According to the New Criminal Code of the Republic of Armenia, the responsibility for obstructing the professional activity of medical workers does not apply, while it existed in the Criminal Code of 2017. What risks do you see in this alteration?
-We did not specifically examine this question in the course of our work. However, if I am correctly informed, the criminal code provides for specific sanctions according to the severity of the damage caused. This would also apply if the victim is a healthcare professional.
-Armenia has not yet adopted Oviedo Convention, as we know it contains international standards such as connected to medical secret etc. Is this an urgent problem for Armenia in this sphere?
-In terms of medical secrecy, RA legal regulations are generally in line with European approaches and in particular with the requirements of the Oviedo Convention. The large-scale amendments and additions made in 2020 in the RA Law on “Medical Care and Assistance to the Population” have regulated the field as much as possible. Nevertheless, there are issues that can become the subject of further elaboration, such as.
1) Specifics related to the processing of confidential medical data of deceased persons
2) Medical secrecy in situations where the health situation of a person may affect the health of others. e.g. information on genetic characteristics which may be relevant to other members of the biological family of the person concerned
3) the provision of information toa person on his/her health situation when the situation is critical and this information risks worsening the patient’s condition.
-How will you evaluate the situation in Armenia and which are the urgent problems which Armenia should solve in order to take equal steps with European countries?
-The Covid-19 has been a wakeup call, in particular when it comes to the importance of human rights in the health field, in the Council of Europe members states and beyond. All healthcare systems where heavily impacted by the pandemic and lessons are to be learned from this crisis.
It is important though to acknowledge that the priority given by the Armenian authorities to the protection of human rights in biomedicine in the cooperation activities with the Council of Europe was decided before the Covid-19 crisis. Furthermore, Armenia had to face both the pandemic and the ongoing conflict which has had a severe impact on the overall situation. The high – and increasing – interest expressed by all stakeholders with whom we have worked in the context of the cooperation project, and the request for more activities in several biomedical fields (such as mental health, research, public dialogue on health-related matters) are demonstrative of the awareness of problems encountered and willingness to address them. This includes trust building with the society, which is a problem identified as critical in a large number of countries in the context of the pandemic. Armenia is not an exception and the work achieved in the context of the first cooperation project will also be very useful for other countries. We will continue this work in the context of the new Council of Europe Action Plan for Armenia.
TATEV HARUTYUNYAN
“Aravot” Daily, 25.01.2023
