The Ministry of Health of the Russian Federation has developed a draft law on the introduction of mandatory ethical review for biotechnological medicinal products (BTMP), which will take effect on September 1, 2026. The document was published for public discussion on Wednesday.
According to the draft, a special committee will be created to assess the use of such drugs. BTMPs are made individually for each patient in a medical organization using their own cells or tissues. They are used to treat life-threatening diseases, including oncological, autoimmune, and cardiovascular diseases.
As indicated in the explanatory note, the purpose of the ethical review is to guarantee the safety and protection of patients' rights. The committee will assess the appropriateness of the drug's use, the patient's awareness of the risks and benefits, and the absence of conflicts of interest.
The initiative was prepared on the instructions of Deputy Prime Minister Tatyana Golikova. Currently, such drugs are used selectively, mainly in federal centers as part of scientific research or internal protocols.
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