General characteristics of approaches as to the construction of legal mechanisms for the social protection of a physician-scientist.

As it was defined in the first chapter of this paper, a physician-scientist was also determined as a subject that needs social protection during the CT along with the patient in order to ensure the stability of his social position and his interests in the process of clinical research, which include not only scientific and pharmaceutical activities, but, first of all, medical activities.

As T.I. Akulina correctly notes, medical activity, due to the specifics of the area of its application (life and health of individuals), is predetermined by specific features of the labour of medical workers, and among that it is necessary to highlight its exposure to the risk, uncertainty of the final result, the need for independent and self-sufficient decision-making in each case, imperative character, supervision of the patient, trust between the doctor and the patient.[376] These features of medical activity give rise to its special social significance and certain requirements as to the person who performs it.

First of all, it is necessary to determine the legal status of the physician- scientist who conducts the CT and is at the same time exposed to social (professional) risks arising out of the specifics of the process of the trial of an untested medicine.

The sponsor of the trial (in accordance with the requirement of the Law on the circulation of medical products) is obliged to obtain permission from the Ministry of Health of the Russian Federation to conduct the CT, which is carried out on the basis of a contract concluded between the Trial Sponsor and the Medical

Entity (Articles 39, 41 of the Law on the circulation of medical products). The targeted orientation of the CT contract, which is characterized by interference in the physical component of a human, determines its close relationship with medical and pharmaceutical activities, which implies the presence of a special subject composition.

Therefore, the Contractor under the CT contract can only be a Medical Entity that has a license to carry out medical activities and possesses organizational and technical facilities necessary for carrying out the CT, and has also received accreditation for the right to conduct the CT.[377]

The obligation to conduct the CT belongs to the area of research activities, and as to the focus of its results it should be considered as an obligation to provide services, among which he holds a special place.[378] It is necessary to agree with the position of the representatives of civil law science, investigating the legal nature of the CT contract,[379] that the activities of the Contractor performing the present obligation locate themselves in the plane of the civil law relationship from the external point of view.

One the other hand, there are also internal relations between the entity and its personnel engaged in the CT, since the research activities (and, together with them, the associated medical activities) cannot be carried out directly by a legal entity.

Such activities are carried out directly by the physician-scientist (scientists) who interacts with the Medical Entity, which is the Contractor under the CT, in the course of labour-law relations. This position is an imperative establishment of the Russian legislation, since, in accordance with Art. 40 of the Law on the circulation of medical products, after the conclusion of the contract, the head of the Medical Entity conducting the CT shall appoint the physician-scientist responsible for conducting the study. The law established certain qualification requirements for such a person (as detailed below). At the suggestion of the physician-scientist, coinvestigators from among the doctors of this Medical Entity are appointed. It follows from the construction of the given legal norms that a physician-scientist (co-investigator) appointed by the head of the Medical Entity can only be a person who is in labour relations with the Medical Entity.[380] Also, section 4.3 of the Order contains the wording that defines the physician-scientist as an official appointed by the health care institution and responsible for conducting the CT.

In this context, it is important to point out the opinion of Roszdravnadzor, which, when carrying out the supervision detailed in the second chapter of this paper, specifies appointing a co-investigator that is not labour relations with the medical entity as a separate violation of esction 1 of Article 40 of the Law on the circulation of medical products.[381]

Thus, the given legal regulations and implementation practice make it possible to conclude that national legislation presumes that both the physician- scientist and the co-investigators have the status of employees at a Medical Entity that has concluded the CT contract. After all, in the absence of labour law relationship, the administrative powers of the head of the entity could not extend onto the physician-scientist, while the rule governing his involvement in the work would contain other legal grounds for the establishment of the relevant legal status, for example, by concluding a civil law contract. Moreover, the fact that the Order established the status of a physician-scientist as of an official, that is, a person performing organizational, administrative or economic functions in an organization, clearly indicates the existence of an employment relationship between the Medical Entity and the investigating physician.

In addition, it will be correct to draw attention to the fact that the above normative acts do not contain any indication that the physician-scientist may be a private practitioner or otherwise having no labour relations with the Medical Entity. In this context, the fact that in modern legal realities the main subject to provide any medical assistance to the Russian Federation is the Medical Entity, which has a license to carry out medical activities and entered into labour contracts with medical workers, raher than private practitioners who have obtained their licenses independently.

The statement of the fact of the labour law status of the physician-scientist during the CT is important both from the theoretical point of view and from the point of view of the practice of determining and analyzing the effectiveness of the mechanism of social protection of a physician-scientist, determined by the norms of labour law that have a pronounced social orientation.

When solving the these research tasks, which consist in evaluating the protective measures laid down in the legislation that ensure the stability of the social position of a physician-scientist, it is necessary to proceed from the fact that the social function inherent to the labour law is carried out in several directions, one of which is the protection of rights and legitimate interests of workers.

The labour law status of a physician-scientist is characterized by the fact that he is a special subject of labour law[382] due to the special requirements imposed by the legislation on medical workers, and also separately on investigating physicians carrying out the CT. So, the physician-scientist is a medical worker (he has a medical specialty), and therefore he must meet special criteria established by legal regulations, such as: education (both primary higher and secondary higher education in certain specialties), professional retraining no less than once every five years, confirmed by a certificate of a specialist (certificate of accreditation), compliance with health status conditions.[383] At the same time, with respect to the physician-scientist, there is a special rule setting additional qualification requirements as to this kind of a doctor, that must be met in order to be able to conduct the CT. He must have a medical specialty corresponding to the CT in question, the work experience under the CT programs of at least three years (section 1, Article 40 of the Law on the circulation of medical products).[384]

These special qualification requirements represent a protective legal mechanism incorporated in the legislation with a view to provide more effective protection to the patient in the course of the CT, since it is assumed that an experienced doctor will be able to properly treat and adequately respond in the event of a risk to the life and health of the subject of the experiment.

In the first chapter of this paper, we have found out a direct correlation between the patient's risks in the CT and the professional risks of the physician- scientist, and therefore, it is necessary to conduct a more detailed analysis of the professional risks to which he is exposed during the CT to determine the most effective measures for the social protection of the physician-scientist.

In this regard, it should be pointed out that many legal scholars, noting in general on the risky nature of any medical activity, offer different approaches as to how to differentiate professional risks. So, Z.V. Kameneva divides such risks as physical, material, legal, social, psychological and moral ones. [385] In turn, N.A. Sokolova points out that the professional risk of medical workers can be considered in various aspects: socio-economic, medical and legal ones. The presence of these aspects illustrates the need for increased protection of this category of workers against professional risks.[386]

Given the experimental nature of drug research in the absence of reliable data on their therapeutic effect, as well as side effects affecting the patient's body, and, accordingly, on the range of medical activities that may be necessary to protect the life and health of the patients, and while the physician-scientist is responsible for them, his professional risks are extremely high.

As it is already demonstrated above, these professional risks, to the arguments already presented are social risks that have a legal component, which, among other things, is characterized by the establishment of legal liability for the commission of professional violations by medical professionals. It is this aspect of professional risk that should be pointed out when studying the legal mechanisms for the social protection of the physician-scientist, since this aspect, by virtue of the specificity of the CT process, poses the greatest threat and generates adverse consequences for the physician-scientist. In addition, the moral component of the professional risk of a physician-scientist, which, according to Z.V. Kameneva, is associated with the situation of moral choice in making a decision that does not meet the requirements of professional ethics, which triggers an intrapersonal conflict affecting all other areas of life of a person.[387]

In the context of occupational hazards, it is important to pay attention to the essential role in regulating the CT process played by professional clinical norms, since the physician-scientist must not only strictly follow certain medical standards, but also "think clinically".

In other words, the physician-scientist must take on an increased responsibility, guided at the same time by a reasonable combination of clinical (medical), ethical and professional regulators of his activity. This aspect of scientific research attracts most attention in connection with the protection of patients' rights.[388] However, it seems that in the conditions of competition between different social regulators, it is necessary to recognize that a physician-scientist who, while conducting the CT, is need for protection from the

risks of negative consequences as to the life and health of the patient and, accordingly, from his professional risks.

Hence, there is a reason to believe that the interests of the patient and of the physician-scientist in this case should be comparable to each other and should be aimed at least at preventing the deterioration of the health of the subject taking part in the CT. Given the goals of this paper related to the protection of the persons participating in the CT, this conclusion is legally significant. It defines the essence of a single legal construction, according to which the legal protection of a physician-scientist, patient, and potential consumers of medicines, having a common goal-setting, must contain inseparable connection and interdependence of mechanisms directly aimed at preventing the CT-related social risks for the physician-scientist and for the patient, and in the event of their occurrence, to minimize the negative impact of such risks, indirectly ensuring the protection of the insterests of an indefinite range of potential consumers of medicines.

Thus, the approach as to the selection of legal mechanisms that effectively fulfill the protective function for the physician-scientist should be formed taking into account the interests of the subjects of the experiment, i.e. the patient (as well as the entire population of the country that will consume these new drugs). But, at the same time, it is necessary to understand that the priority of the patient's rights and interests is the main principle that has been reflected in the legal and deontological norms of the relationship between the medical worker and the patient. It consists in the fact that the use of certain medical instruments and technologies is aimed at minimizing the risk to the patient, while the protection of the doctor in such cases is of secondary priority.[389] Therefore, it seems extremely important to work out exactly such a legal regulation that will allow the physician- scientist to be in the conditions of social security while performing his professional duties, and, at the same time, exclude the possibility of developing a conflict of

interests between the participants in the CT, the objective nature of which was discussed in the first chapter of this paper.

So, for a patient who finds himself in a difficult life situation connected with a disease, and in some cases with a very difficult, hardly curable disease, it is extremely important to have access to new, innovative, more effective experimental medical products for cure. Moreover, the subject of the experiment has, as a rule, an immediate and urgent need for the use of such medicines. For an indefinite circle of people who are potential consumers of medicines, there is a similar need for safe and effective medicines, but only with deferred demand. However, the investigator, while conducting the CT, has not only his professional medical interest, which is to achieve a positive effect in the treatment of the patient, since he is also interested in obtaining new knowledge about the drug and its effect on the human body, which may influence the prioritization of his activities .

In addition, the conflict of interests in the CT process may be due to the financial interest of the investigating physician in carrying out this work, which is paid additionally as not included in his labour function as defined by the employment contract, and is carried out outside the main workload (as will be discussed further). There may be a situation in which a physician-scientist in certain circumstances will be interested in the positive results of CT, which is obviously capable of entailing not only a violation of patients' rights, but also a reflection on the results of the safety test of a drug, and this, in turn, will lead to violation of the rights of an indefinite circle of people. Such a situation is established by the law as a "conflict of interests" and is regulated under Article 77 of Federal Law 323-FZ186 "Conflict of interests of a medical or a pharmaceutical worker", defined as a situation in which a medical or a pharmaceutical worker, in the exercise of his professional activity, received personally or through a representative of the company (the Organizer) a material gain or other advantage, which affects or may affect the performance of their professional duties due to a conflict between the personal interest of the medical or pharmaceutical worker and the patient's interests. Furthermore, according to section 7.1 of Art. 81 of the LC RF[390], an employee's failure to prevent or resolve a conflict of interests, to which he or she is a party, serves as an independent basis for the dismissal of an employee. The fact that these norms are provided for both in the special rule of Federal Law 323-FZ and in the RF LC, does indicate a high degree of public concern with the existing legal reality, as well as the desire to ensure the optimal legal impact on the processes that are taking place, in particular, in the sphere of the CT. Taking into account the stated position, it is necessary to stress the following bases for the research, allowing to analyze the legal mechanisms of social protection of a physician-scientist.

Firstly, it appears that the effectiveness of the legal protection mechanisms of a physician-scientist should be evaluated on the basis of his inherent special labour law personality, mediating his legal status and thus determining the system of legal means and methods of regulation in the given area and aimed at maintaining the stability of his social status .

Secondly, it should be adopted as an established presumption that the social protection of the physician-scientist in the CT should be in tune with the social protection of the patient and of an indefinite range of people that are potential consumers of the tested medicines and be built on legal mechanisms that exclude the development of a conflict of interests between the said persons. This legal and ethical postulate " to exclude the development of a conflict of interests between the parties" is the "cornerstone" of the organization of the CT process, as it seeks to comply with the most important principles of the Standard, consisting in the primary protection of the rights, safety and well-being of the subjects of the research and the reliability of the CT data.

Also, relying on the approach chosen in this dissertation to classify legal mechanisms of social protection of individuals taking part in the CT based on the way society reacts to social risk, both the antecedent and the prospective ones (in accordance with which one may idendify preventive and compensatory protective mechanisms), it seems appropriate to use these legal constructions also in assessing the protective measures for the physician scientist.


<< | >>
Источник: Маценко Елена Игоревна. Социальная защита лиц в клинических исследованиях лекарственных препаратов для медицинского применения. Диссертация на соискание ученой степени кандидата юридических наук. Санкт-Петербург, 2017. 2017

Скачать оригинал источника

Еще по теме General characteristics of approaches as to the construction of legal mechanisms for the social protection of a physician-scientist.:

  2. Introduction
  3. General characteristics of social protection and its legal mechanisms for individuals participating in clinical studies of medicines for medical use
  4. General characteristics of approaches as to the construction of legal mechanisms for the social protection of a physician-scientist.
  5. Compensatory legal mechanisms of social protection of a physician- scientist
- Акушерство и гинекология - Анатомия - Андрология - Биология - Болезни уха, горла и носа - Валеология - Ветеринария - Внутренние болезни - Военно-полевая медицина - Восстановительная медицина - Гастроэнтерология и гепатология - Гематология - Геронтология, гериатрия - Гигиена и санэпидконтроль - Дерматология - Диетология - Здравоохранение - Иммунология и аллергология - Интенсивная терапия, анестезиология и реанимация - Инфекционные заболевания - Информационные технологии в медицине - История медицины - Кардиология - Клинические методы диагностики - Кожные и венерические болезни - Комплементарная медицина - Лучевая диагностика, лучевая терапия - Маммология - Медицина катастроф - Медицинская паразитология - Медицинская этика - Медицинские приборы - Медицинское право - Наследственные болезни - Неврология и нейрохирургия - Нефрология - Онкология - Организация системы здравоохранения - Оториноларингология - Офтальмология - Патофизиология - Педиатрия - Приборы медицинского назначения - Психиатрия - Психология - Пульмонология - Стоматология - Судебная медицина - Токсикология - Травматология - Фармакология и фармацевтика - Физиология - Фтизиатрия - Хирургия - Эмбриология и гистология - Эпидемиология -