The Russian Ministry of Health is initiating significant changes, proposing amendments that would prevent pharmaceutical companies from directly remunerating physician-researchers for their participation in clinical trials. Under this new scheme, all financial transactions related to clinical research would be channeled exclusively through medical organizations. The primary objective behind this reform is to enhance transparency in the healthcare sector and mitigate potential conflicts of interest.
Expert Concerns: Potential Impact on Research Quality and Timelines
While the goal of increased transparency is lauded, experts express considerable apprehension that this proposed system could negatively impact the speed and quality of clinical investigations. Svetlana Zavidova, Executive Director of the Association of Clinical Research Organizations, points out that the current regulatory framework allows for a flexible system, often involving direct contractual agreements between pharmaceutical sponsors and physician-researchers. She warns that introducing a ban on direct payments could severely diminish physician motivation, complicate patient recruitment efforts, and significantly extend the timelines for conducting clinical trials. Ultimately, such delays could adversely affect the drug registration process and the overall quality of new pharmaceutical products entering the market. Zavidova further emphasizes that the Russian clinical research market has already experienced a substantial downturn since 2022, particularly in the international multicenter trials sector, with very few new studies being initiated.
Svetlana Zavidova
Executive Director, Association of Clinical Research Organizations«Currently, the system is flexible, without legislative prohibitions. While there`s a requirement for the sponsor company to contract with the medical organization, a second agreement is often made directly with the physician-researcher. Most companies prefer this approach. If this proposed ban takes effect, we anticipate a significant decline in patient recruitment due to decreased physician motivation, leading to severe delays in clinical trial timelines, which will ultimately impact drug registration. Quality could also suffer, as an inability to guarantee fair compensation will inevitably affect the product entering the market. Since 2022, we`ve seen a substantial reduction in trials in Russia, especially international multicenter ones; new initiations are rare. We used to get over 300 permits annually; now it`s barely a dozen. The market is already struggling, and such proposals, one might say, are nailing its coffin.»
A Balanced Perspective: State`s Role in Healthcare Infrastructure
Conversely, Nikolay Bespalov, Development Director at RNC Pharma, offers a more nuanced perspective. He suggests that the current practice of direct payments to doctors is not entirely equitable, given that these physicians utilize the extensive infrastructure of state clinical institutions. Bespalov argues that the state has a legitimate claim to a portion of these revenues to ensure the ongoing functionality and resource allocation for the entire healthcare system.
Nikolay Bespalov
Development Director, RNC Pharma«It is rational for the state to claim a share of these incomes, as the entire infrastructure and its upkeep demand substantial resources, including for remunerating specific doctors. While these changes may be unwelcome for pharmaceutical companies and service providers, I believe they are ultimately fairer and aim to ensure the healthcare system`s viability. This includes a revenue stream for state medicine and the national budget. However, physician motivation in clinical trials remains crucial. It would be wise to address budget replenishment without overlooking the significant labor doctors invest. Specialists often work overtime managing patients and protocols. Therefore, payment options should be clearly delineated, or specific payments to doctors should be stipulated and fixed within contracts with medical institutions. Organizationally, this shouldn`t be difficult, so current anxieties are likely overblown. If this process is initiated proactively, I foresee no significant delays.»
Key Steps for a Smooth Transition
To effectively mitigate the potential risks highlighted by experts, several concrete measures will be essential. These include the development of clear and transparent standards for the distribution of funds, the establishment of simplified procedures for making adjustments to research teams, and the creation of efficient and timely mechanisms for processing remuneration payments.
