The status of clinical guidelines is changing

Pepeliaev Group advises that the President of the Russian Federation has signed Federal Law No. 489-FZ[1] dated 25 December 2018, which significantly changes the status of clinical guidelines.

Key developments

Clinical guidelines (CGs) will serve as the basis underlying all decisions that doctors take when determining the approach to therapy. Medical care, including the care covered by compulsory medical insurance, and an expert assessment of its quality must be provided and conducted based on CGs. It is established that CGs should serve as the basis for developing the standard of medical care.

Clinical guidelines are documents containing structured and scientifically proven information on the issues of prevention, diagnostics, treatment and rehabilitation, including patient care (treatment) protocols, options for medical intervention and a description of the sequence of a healthcare practitioner’s actions with account being taken of the disease progression, possible complications and concomitant conditions, as well as other factors that have an effect on the results of medical care.

We believe that in future CGs will become the basis for amendments to regulatory and legal acts governing the issues of medical insurance and payment for medical care.

CGs are developed by medical professional non-profit organisations for individual diseases or medical conditions (groups of diseases or medical conditions) with an indication of medical services laid down in the medical services directory. The list of diseases and medical conditions (groups of diseases and medical conditions) with respect to which clinical guidelines are developed is drawn up by an authorised federal executive body (FEB) based on the criteria that the FEB has established. At the same time, medical professional non-profit organisations have the right to develop CGs for diseases and medical conditions (or groups of diseases and medical conditions) that are not included in such list.

CGs are to be examined by a research and practice council founded by the authorised FEB. The council decides whether to approve CGs, decline them or send them to be further revised. The research and practice council consists of representatives of scientific institutions accountable to the authorised FEB, institutions of higher education and medical organisations. CGs approved by the research and practical council are validated by medical professional non-profit organisations.

The authorised FEB approves the procedure and timeframes of developing the CGs, typical form of the CGs and requirements for their structure, as well as requirements for the content and scientific validity of the information included in them, procedure and timeframes of approval and validation, criteria underlying the adoption by the research and practical council of a decision to approve the CGs, decline them or send them for a follow-up revision.

Some of the developments are in force from 1 January 2019, and others will apply from 1 January 2022. The latter include the provisions to the effect that: (i) medical care must be organised and provided on the basis of CGs; (ii) CGs should be taken into account in the development of a programme of state guarantees ensuring that medical care is provided to citizens free of charge; and (iii) account of CGs should be taken during an expert assessment of the quality of medical care. CGs that had been approved by medical professional non-profit organisations before the developments came into force apply, until revised, as established by the Federal Law, but not later than 31 December 2021.

It is specifically noted that, if there are medical grounds (such as an individual intolerance or life-saving need) and a resolution of a medical board, it is permitted to prescribe and apply pharmaceuticals, medical products and specialised nutritional care products despite them not being mentioned in the standards of medical care and even if there is no relevant CG.

With respect to each disease or medical condition (or group of diseases and medical conditions) suffered by grown-ups and children, not more than one CG may be approved and validated. CGs are reviewed at least once every three years.

What to think about and what to do

The amendments are aimed at raising the quality of medical care by shifting the focus from the standards of medical care to CGs as the fundamental document for the choice of a treatment pattern.

When developing, positioning and launching products on the market, pharmaceutical companies must bear in mind that CGs, including transitional provisions, will have the status of a key document for determining a pattern of treating a patient.

Medical organisations should also take account of the latest developments when planning their activities.

Help from your adviser

Pepeliaev Group’s lawyers are ready to provide comprehensive legal assistance in connection with the new developments in legislation, including assessing the market-access strategy for products, advising on relevant issues including from the perspective of healthcare legislation.