Legal support for interaction with healthcare professionals
Legal services (legal assistance) in structuring the interaction with healthcare professionals
Legal support for pharmaceutical companies in structuring their interaction with healthcare professionals is an important area of practice of BRACE Law Firm.
Healthcare and pharmaceuticals are key areas of industry specialization for lawyers at BRACE Law Firm, in which we provide legal services to manufacturers and distributors of medicines, medical devices, dietary supplements and other healthcare organizations on issues of Russian and international law.
Interaction between pharmaceutical companies and healthcare professionals
Federal Law “On the Basics of Protecting the Health of Citizens in the Russian Federation” introduced restrictions on medical and pharmaceutical workers in terms of interaction with organizations involved in the development, production and (or) sale of medicines and medical devices. In particular, it is forbidden from such companies to accept gifts, money, including to pay for entertainment, leisure, travel to the place of rest, as well as to participate in entertainment events held at the expense of companies, company representatives, or to conclude any distribution agreements among the population or on the appointment of certain drugs to patients.
Health workers are also prohibited from hosting pharmaceutical business representatives. The exceptions are receptions associated with conducting clinical trials of drugs, clinical trials of medical devices, participation in the manner prescribed by the administration of a medical organization, in meetings of medical workers and other events aimed at improving their professional level or providing information related to safety monitoring medicines and safety monitoring of medical devices.
In addition, an acceptable way of interaction between pharmaceutical companies and medical workers is contractual interaction when conducting clinical trials of drugs, clinical trials of medical devices, and it is also possible to receive rewards related to the implementation of pedagogical and (or) scientific activities by a medical worker.
Many organizations working in the field of medicine circulation make a huge contribution to the development of medical and pharmaceutical sciences due to the possibility of conducting scientific events, accompanying clinical trials and clinical trials.
In this regard, there is an urgent need to share knowledge with the medical community, as well as interact with healthcare professionals in order to improve the manufactured or distributed pharmaceutical products.
Pharmaceutical organizations are required to notify Federal Service for Surveillance of Healthcare about ongoing scientific activities.
However, not all measures can be evaluated by the control body as meeting the requirements of the current legislation. In practice, quite often, a number of events are regarded when checking as payment for recreation and recreational activities of healthcare professionals. It is also important that handouts distributed to participants in scientific events are not regarded as gifts.
Thus, when conducting scientific events with the participation of pharmaceutical and medical workers, it is necessary to conduct a comprehensive analysis of contracts concluded both with the organizers of the event, speakers, and with administrations of pharmacy and medical institutions, as well as a detailed legal examination of handouts, booklets, and a plan or other event.
- Legal support in interaction with healthcare professionals, including the organization of scientific events, clinical trials of medicines and clinical trials of medical devices
- Development and legal examination of agreements concluded with speakers at scientific events, agreements concluded with administrations of medical institutions of pharmacy organizations and other agreements necessary to accompany scientific events
- Preparation of draft agreements, appeals, notifications and other documents necessary for legal support of interaction with healthcare professionals
- Preparation of legal opinions on questions posed by the client regarding interaction with healthcare professionals