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XVII Юридический форум России
19 марта 2021 г. в Москве состоится XVII Юридический форум России. Организатор – «Ведомости. Конференции».
Полный текст

Working with the medical community

Working with the medical community

Elena Lvova,
Senior Associate, coordinator of pharmaceuticals and healthcare at Pepeliaev Group

Federal Law No. 323-FZ dated 21 November 2011 On the fundamentals of protecting individuals’ health in the Russian Federation (the “Health Protection Law”) introduced restrictions on the interaction between medical employees  and the managers of medical  (collectively referred to as “medical employees”) and companies engaged in developing, producing and/or selling medicines or medical devices, companies that have rights to use a trade mark for such a medicine, companies engaged in the wholesale of medicines, and pharmacies (or their representatives, or other individuals and legal entities acting on behalf of such companies) (referred to, as appropriate, as a “Company” or a “Company Representative”).

In this article, we analyse certain legal issues relating to interaction with the medical community under the conditions of the new legal regulation that have arisen owing to the above restrictions being imposed.

Under article 74 of the Health Protection Law, medical employees may receive Company Representatives only in the following cases:
1) in relation to carrying out clinical studies of medicines (“clinical studies”), and clinical trials of medical devices (“clinical trials”);
2) in relation to participating in meetings of medical employees and other events in accordance with a procedure established by the administration of a healthcare institution. Such meetings and events may relate to:
•     improving their professional skills,
•     providing the information indicated in article 64(3) of Federal Law No. 61-FZ dated 12 April 2010 On the circulation of medicines (“information on adverse side effects of medicines”), namely information regarding:
o     all incidents of side effects not indicated in the instructions for using the medicine,
o     serious adverse reactions,  or unforeseen adverse reactions when the medicine is applied,
o    particular features of the interaction of the medicines with other medicines that were revealed during clinical studies and when other medicines, or
•     providing information specified in article 96(3) of the Health Protection Law (“information on side effects of medical devices”), in particular information regarding:
o    all incidents of side effects revealed that are not set out in the instructions for use or guidelines for operating the medical device,
o    adverse reactions when it is used,
o    particular features of the way medical devices  interact with one another,
o    facts and circumstances creating a threat to the life and health of individuals and medical employees when medical devices are used and operated.

Visits relating to clinical studies and clinical trials

As it is seen from article 74 of the Health Protection Law, visits of Company Representatives in connection with clinical studies and clinical trials are not regulated in detail by legislation and do not require any additional regulation from the healthcare institution, for which the medical employee works. However, this does not mean that everything is allowed in this area. We consider that when Company Representatives visit medical employees, the principles of reasonableness and integrity should be observed.  Companies may follow these principles by complying with the following rules that are not stipulated by legislation:
1) visiting medical employees in connection with clinical studies and clinical trials should not be a cover for Companies’ marketing activities;
2) visits should be related to realistic clinical studies and clinical trials that are planned to be conducted, are being conducted or are at the completion stage, and fully or partly in Russia. In addition, the purposes of such visits should be clearly determined. This should be either be negotiations regarding the opening (or closing) of a trial centre, or scheduled work of the Company in monitoring a study in progress. The target of such visits is not to communicate with the doctor, but to verify the accuracy of the trial process. For instance, the scope of visits that relate to clinical studies may include checking that the documentation maintained is correct, checking the conditions of storage of the medicines  and observation of the procedures stipulated by the study protocol;
3) a visit to medical employees should be connected with the relevant Company Representative performing duties or obligations under an employment or civil law contract;
4) Company Representatives must be received by medical employees working for healthcare institutions that are entitled to carry out clinical studies or clinical trials within the competence of the relevant medical employee. Under current legislation a clinical study is carried out in healthcare institutions that are accredited for such work by the relevant state executive authority. In accordance with the draft order of the Russian Ministry of Health and Social Development (http://www.minzdravsoc.ru/docs/mzsr/projects/1347), clinical trials may be carried out by healthcare institutions that are licensed to carry out medical activity in the area of using medical devices.

Overall, it should be noted that if the “intended audiences” in terms of medical employees coincide when clinical studies and clinical trials are carried out and when marketing activity is undertaken, this occurs only to an insignificant degree. As a rule, in clinical studies, for instance, it is not rank-and-file medical employees that are involved, but the leading experts. It is scarcely possible to meet a monitor (a representative of a Company that is checking the progress of the study) in a corridor of a district outpatients’ clinic at the door of a medical employee who is conducting a public surgery at that time. Monitoring visits are planned in advance, agreed and, as noted above, have as their genuine purpose not delivering knowledge about new medicines to the doctor but checking his work as a person implementing a specified clinical study programme.

It seems that, should the supervisory authorities discover that Companies visit medical employees in relation to clinical studies and clinical trials in for so that they can carry out marketing, this may result in there being included in the Health Protection Law prohibition on such visits or a requirement for the management of a medical institution to regulate them.

Visits in relation to improving professional skills

The Health Protection Law stipulates that medical employees have the right to receive Company Representatives with a view to improving such medical employees’ professional skills. However, the term “professional skills” is not defined, which has resulted in there being two approaches to interpreting that term, entailing completely different legal consequences.

According to the first approach, ‘professional skills’ is the “knowledge, skills and ability” [of a medical employee]. The relevant definition is contained in legislation relating to the state civil service, which is not directly applicable to the activity of medical employees but from which several legal constructs have been taken while developing the Health Protection Law for individuals. When this approach is used, the professional skills may be improved by any permissible method, including by way of receiving medical information from Company Representatives during visits or events, training (including self-learning) of medical employees, the exchange of information with colleagues, including at events held with the support of Companies, and so on.

Under the second approach, “raising the professional skills” should be understood as “improving professional qualification”, i.e. professional retraining and increasing the level of qualification [of a medical employee] , which is only carried out by educational institutions offering higher, mid-level and additional professional education, and which have state accreditation. When this approach is followed, Company Representatives may be received only if they are employees of educational institutions and are delivering educational programmes under which the relevant company employees are studying.

Under either approach, medical employees may receive Company Representatives in relation to improving their professional skills only after the medical institution passes a local regulation establishing rules for events to be held which are aimed at improving the professional skills of medical employees and allowing Company Representatives to be received to this end.

From our side, we consider it prudent to adhere to the first approach to interpreting the term “professional skills”, since it reflects to a greater degree the reality of the times and in particular the need to receive topical medical information to ensure that patients can exercise their right to receive the high-quality medical assistance contemplated by the Health Protection Law. However, it should be noted that there have been no instances in which anyone has been held liable for violating this rule, which means that only supposition is possible in terms of which of the approaches described above the regulatory authority will adhere to.

It also seems necessary to add to the Health Protection Law a definition of the term “increasing the professional skills”, with a view to eliminating the legal uncertainty examined in this part of this article.

Procedure for receiving Company Representatives

As already mentioned, under the Health Protection Law, medical employees may receive Company Representatives by taking part in a procedure established by the management of a healthcare institution, in meetings of medical employees and other events associated with improving their professional skills, and with providing the information about the adverse events of medicines and side effects of medical devices. This rule means that a healthcare institution must adopt local regulations (“Rules”) before medical employees may receive Company Representatives in connection with the above issues.

It should be noted that the Health Protection Law establishes no requirements as to the contents of the Rules. This means that healthcare institutions have significant independence when it comes to determining their contents.

Types of events

In particular, healthcare institutions may, at their discretion, establish types of events that may be held in the medical institution in question. It seems prudent for the Rules to provide, as a minimum, for the following events:

1) a meeting – a joint session of two and more persons to present and/or receive information, discuss and/or decide defined issues, in which medical employees of the relevant healthcare institution and Company Representatives may take part;

2) a conference – a joint session of 10 and more persons to present and/or receive information, discuss and/or decide defined issues, in which the following may take part: medical employees of the relevant medical institution, medical employees of other medical institutions, Company Representatives, representatives of state authorities and/or professional associations, journalists and other persons;

3) a visit of a Company Representative to a medical employee – a short, official visit by one Company Representative to one medical employee at the premises of the healthcare institution.

It should be noted that the Rules may provide for and regulate other ways in which medical employees interact with Companies. However, if such forms of interaction are not related to a medical employee meeting (receiving) a Company Representative (for example, telephone conversations and video conferences, or email correspondence), then restrictions as to content do not extend to them (i.e. medical employee may receive marketing information at them).

Content of events to improve professional skills

The Rules may also set out methods which may be used to help improve the professional skills of medical employees, such as:
1) holding training and/or instruction regarding work with a particular type of medical device;
2) having Company Representatives provide information (including in the form of answers to questions) about medical devices and medicines, including information about:
• new medicines and medical devices that have come to light,
• changes to guidelines for application or operation,
• the experience that exists about applying a specific medicine or medical device, etc.;

3) the medical employee hearing a lecture devoted to the prevention, diagnosis and treatment of diseases, the specifics of treating particular diseases among specified groups of patients, the application of a particular medical device or medicine and other similar topics, as well as a discussion of the above issues by medical employees for the purposes of exchanging information, etc.

Maintenance of medical devices

One of the aspects which has remained ‘off limits’ for the Health Protection Law is the interaction with medical employees in terms of maintaining the type of medical goods that constitute medical devices. This includes actions keeping medical device in good order and functioning, and restoring it to that condition, when used for its designated purpose (“Maintenance”).

Today, most types of modern medical devices cannot function safely and effectively without Maintenance, including the installation of software when medical device is installed and operated. Further, specialist knowledge, which medical employees do not and cannot have, is necessary for such Maintenance. Therefore, it is unavoidable that Company Representatives and medical employees will interact in relation to Maintenance. However, such Maintenance does not always relate to gathering information about the side-effects of medical devices and to improving the professional skills of medical employees. Therefore, if visits relating to Maintenance are regarded as a way that medical employees may receive Company Representatives, then it will not always be possible to receive them based on a literal interpretation of the Health Protection Law.

According to unofficial information, up to now, the state authorities that have been carrying out the main work on the text of the draft Health Protection Law, the Federal Antimonopoly Service and the Ministry of Health and Social Development, have supplied clarifications on this issue at the request of particular Companies. However, one of the above state authorities adopts the stance that Maintenance may be undertaken if it is stipulated by Rules. This clarification is not entirely applicable in practice since, as noted above, the purpose of a visit that is associated with Maintenance does not always tally with the purposes stipulated in the Health Protection Law. The stance of the other authority is that Maintenance may be undertaken in accordance with the terms of a state contract for the supply of medical devices and does not relate to Rules being adopted by a healthcare institution. Unfortunately, this clarification is also not fully applicable in practice, since medical device under state contracts is supplied by distributors but the Maintenance of it is carried out by representatives of the manufacturers.

It seems that, in general, Maintenance should not be regarded as a form of a medical employee receiving a Company Representative. We may even say that carrying out Maintenance should be regarded as a visit to medical device and not to a medical employee. Therefore it should not depend either on the provisions of the Rules or on the terms of a state contract for the supply of medical technology.

In addition, within the scope of interaction with a Company Representative from a manufacturer in relation to Maintenance, the only information that should be exchanged is that which is necessary for the Maintenance to be performed at a high level, including receiving the comments and wishes of medical employees regarding the work of devices, software, the quality of reagents, and the quality of services provided by professionals directly carrying out Maintenance. A medical employee who carries out employment activity that relates to using medical device must supply detailed and accurate information that is sufficient for the Maintenance and must bear liability for causing harm to the medical device or the health of a patient if information is provided that is incomplete or inaccurate.

In connection with the above, it seems that a provision should be added to the Health Protection Law making clear that Maintenance is not a form of receiving Company Representatives and may be carried out to the extent necessary irrespective of the adoption of the Rules and the terms of a state contract for the supply of medical device.


Какие законодательные инициативы, по вашему мнению, наиболее значимы и нуждаются в скорейшем принятии?



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