Pharmaceutical companies are concerned about the postponement of the implementation of clinical recommendations

The full transition to clinical recommendations for the provision of medical care is actually postponed until 2026, the association of foreign pharmaceutical companies Inpharma indicates in its letter to the Ministry of Health. This is due to the fact that the department proposed to the government to shift the deadline for completing the transition to mandatory use of recommendations by a year – to January 1, 2025, and the program of state guarantees of medical care in practice is being formed a year in advance. The association notes that the delay will delay access to innovative therapy for certain categories of patients, and proposes to take into account clinical recommendations adopted before July 1, 2024 when forming a state guarantee program for 2025.

Pharmaceutical companies are asking the Ministry of Health to clarify the timing of completing the transition to providing medical care in hospitals and clinics based on clinical recommendations. The association of foreign pharmaceutical companies “Inpharma” sent a corresponding letter to the department.

Let us explain that since 2018, the Russian Federation has been reforming the standards of medical care. According to the updated law “On the Fundamentals of Protecting Citizens’ Health,” all cases of treatment, except those provided as part of clinical testing, must be carried out in accordance with clinical recommendations. These documents contain information on the issues of prevention, diagnosis, treatment and rehabilitation of patients, including patient management protocols, intervention options and a description of the sequence of actions of a health care worker, taking into account the course of the disease. The purpose of the recommendations is not only to provide health workers with an evidence base for choosing treatment tactics, but also to provide the opportunity for an objective assessment of their actions when auditing the quality of medical care by insurance organizations and the court.

The development and updating of clinical recommendations is carried out by specialized non-profit organizations, and the Center for Expertise and Quality Control of Medical Care of the Ministry of Health is involved in testing. In 2019–2022, its specialists reviewed more than 720 draft recommendations for the treatment of various diseases, which allowed the Ministry of Health to approve approximately 90% of the planned documents.

According to the plan for the transition to clinical guidelines approved in 2021, work on them should have been completed by mid-2023, and they should have become mandatory for use from January 1, 2024. However, at the end of last year the government postponed this deadline to January 1, 2025. In January, the Ministry of Health presented a draft government resolution that makes appropriate amendments to the document on a phased transition. This means that already published clinical recommendations are mandatory, but those that will be formed this year will become mandatory for medical organizations only from next year. Previously, the standard period from the publication of recommendations to the moment of their implementation was considered to be six months.

“Individual clinical recommendations published, for example, in February of this year, will actually be implemented within the framework of the state guarantee program only two years later, which will significantly delay access to innovative therapy for patients,” says Vadim Kukava, executive director of Inpharma, in a letter. The association proposes to indicate in the resolution that when forming a state guarantee program for 2025, clinical recommendations adopted before July 1, 2024 should be taken into account, that is, an additional stage of their implementation should be introduced.

We note that delays in the actual implementation of clinical guidelines have occurred before. State purchases of certain drugs included in them did not always increase immediately after the transition, since regional authorities are not always able to promptly increase funding (for more details, see “Kommersant” dated April 27, 2022).

According to a Kommersant source in the pharmaceutical industry, the change in deadlines now proposed by the Ministry of Health occurs for the same reason. “Yes, federal budget spending on healthcare in 2024 will increase by 8%, to 1.33 trillion rubles, but the capabilities of regional budgets are much more modest, especially taking into account the obligations that they now have. In such a situation, it makes no sense to demand additional expenses for government procurement of drugs,” he says. The Ministry of Health itself, however, associates the postponement of the completion of the transition to clinical guidelines with the desire to synchronize it with the end of the national project “Healthcare,” designed to update the healthcare system throughout the country.

Anastasia Manuilova