The Ministry of Health plans to update the rules for forming a commission responsible for the list of vital drugs

Representatives of patient organizations fear that they want to be removed from control over the list of vital and essential drugs (VED). The reason was the plans of the Ministry of Health to update the rules for the formation of the commission, which is responsible for including drugs in the list of vital and essential drugs. Public organizations drew attention to the fact that they were not mentioned in paragraph 11 of the new edition of the document, which sets out the composition of this body. The Ministry of Health assured Kommersant that the adjustments would not affect the powers of representatives of the patient community.

In February, the discussion on the normative and legal acts proposed by the Ministry of Health ended on the portal changes V resolution Government of the Russian Federation No. 871, which regulates the rules for the formation of lists of medicines for medical use and the minimum range of medicines necessary for the provision of medical care. We are talking about a list of essential drugs (VED), a list of expensive drugs and a minimum range of drugs.

Prices for medications from the Vital and Essential Drugs list are regulated by the state. Such drugs are used in the treatment of patients as part of a program for providing free medical care to citizens. In total, the list of vital and essential drugs contains more than 800 items.

The decision to include or exclude new drugs from the VED list is made by a special commission.

According to the current version of the government resolution, it includes representatives of the Ministry of Health, the Ministry of Industry and Trade, the Ministry of Labor, Roszdravnadzor, Rospotrebnadzor, FAS, the Federal Medical and Biological Agency, the Ministry of Education and Science, other federal executive bodies and executive government bodies of constituent entities of the Russian Federation in the field of health care, federal state educational organizations of higher medical and pharmaceutical education, as well as federal state medical and pharmaceutical scientific organizations.

At the meeting of the commission, as stated in paragraph 11 of the mentioned document, “a representative of the subject of circulation of medicines and (or) a public association operating in the fields of healthcare, circulation of medicines and protection of the rights of citizens in these areas” is present, subject to a prior request in writing. – that is, a public or patient organization.

The Ministry of Health proposed changing the composition of the commission. The explanatory note to the draft updated resolution states that “in order to eliminate the possibility of a conflict of interest,” it is proposed to exclude from its composition representatives of educational organizations of higher medical education and educational organizations of higher pharmaceutical education, subordinate to federal executive authorities, as well as medical, pharmaceutical and scientific organizations carrying out comprehensive assessments.

Social activists noticed that the new version of the rules also disappeared the mention of participation in committee meetings of patient organizations.

Instead, paragraph 11 talks about the possibility of participation in meetings of “representatives of all drug manufacturers and (or) owners (holders) of registration certificates.” Public associations are now mentioned in paragraph 6. It says that medicines are excluded from the lists “at the proposal of the chief freelance specialist of the Ministry of Health, the subject of the circulation of medicines and (or) a public association operating in the fields of healthcare, circulation of medicines and protection of rights citizens in these areas.”

Director of the Interregional public charitable organization for disabled people “Mutual Aid Society for Ankylosing Spondylitis” Natalya Shatalova is worried that such amendments may cause a contradiction between the new edition of government decree No. 871 and the current order of the Ministry of Health of Russia dated September 9, 2014 No. 498n (as amended on March 15, 2019 ), where clause 13 provides for the possibility of participation of representatives of public associations in commission meetings.

“Such disagreements can seriously limit the rights of representatives of patient organizations,” Ms. Shatalova believes. “Experience shows that the participation of social activists in the work of the commission contributes to a comprehensive assessment of the drugs under consideration, and the opinions of patients are taken into account when making final decisions.”

The head of the organization “Skin and Allergic Diseases” Olesya Mishina, the President of the Russian Rheumatological Association “Nadezhda” Polina Pchelnikova, representatives of the All-Russian Union of Patients (VSP) and other patient associations are also asking for paragraph 11 to be stated in the new version of the resolution with a mention of public organizations.

“As far as we know the position of the Ministry of Health, the department is interested in the participation of representatives of patient organizations in the work of the commission,” said co-chairman of the VSP Yuri Zhulev. “This is one of the fundamental elements of building patient-oriented healthcare. In accordance with Order No. 498n, we have the right to do this, but this possibility must be secured in the government resolution itself.”

The Ministry of Health explained that “due to the need to change the text of the rules for creating lists,” the mention of public organizations from clause 11 was moved to clause 6.

“If changes are made to the rules for creating lists, the formats for the participation of patient public organizations in the work of the commissions will not change. The corresponding norms are already contained in the regulations on the commission. Thus, the fears of the patient community are unfounded,” the press service assured.

Natalia Kostarnova