How vital and essential medicines are procured. How vital and essential medicines are purchased

1. Approve:

a list of vital and essential drugs for medical use for 2016 in accordance with Appendix No. 1;

list of medicines for medical use, including medicines for medical use prescribed by decision of medical commissions medical organizations, according to Appendix N 2;

a list of drugs intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after organ and (or) tissue transplantation, according to Appendix N 3;

the minimum range of medicines necessary for the provision of medical care, according to Appendix N 4.

2. Establish that until March 1, 2016, the list of vital and essential drugs for medical use for 2015, approved by the Decree of the Government of the Russian Federation of December 30, 2014 N 2782-r, is applied.

3. Recognize as invalid the order of the Government Russian Federation dated December 30, 2014 N 2782-r (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2015, N 3, art. 597).

Prime Minister

Russian Federation

Regional state control over the application of prices for medications included in the list of vital and essential medicines

In the city of Moscow, regional state control over the use of selling prices for medicines included in the list of vital and essential medicines (hereinafter referred to as regional state control), is carried out by the Department for Control over the Application of Prices for Medicines of the Moscow Health Department (hereinafter referred to as the Department) in accordance with the Administrative Regulations for the implementation of the state function for the implementation in the city of Moscow regional state control for the application of prices for medicines included in the list of vital and essential medicines (hereinafter - Vital and Essential Drugs), approved by the Decree of the Government of Moscow dated November 18, 2014 No. 669-PP.

The procedure for exercising regional state control is established by the Regulations on regional state control over the application of prices for medicines included in the Vital and Essential Drugs List, approved by Decree of the Government of the Russian Federation No. 434 of May 6, 2015.

The subject of regional state control is the verification of compliance by the subjects of circulation medicines mandatory requirements for the formation of selling prices for medicines included in the list of vital and essential medicines (hereinafter referred to as mandatory requirements).

The list of mandatory requirements and the list of regulatory legal acts containing mandatory requirements can be found by clicking on the link: "Department" / "Regional state control over the application of prices for Vital and Essential Drugs" tab "Regulatory legal acts".

The methodology for setting by the executive authorities of the constituent entities of the Russian Federation the maximum wholesale markups and the maximum retail markups to the actual selling prices set by drug manufacturers for drugs included in the Vital and Essential Drugs List was approved by order of the Federal Tariff Service No. 442-a dated 11.12.2009 .

On the territory of the city of Moscow, when setting selling prices for drugs included in the list of Vital and Essential Drugs, trade markups are applied, approved by Decree of the Government of Moscow dated February 24, 2010 No. 163-PP “On setting the maximum amounts of trade markups for drug prices”.

The list of Vital and Essential Drugs is annually approved by the Government of the Russian Federation. The current list of Vital and Essential Drugs for 2020 was approved by the Decree of the Government of the Russian Federation dated October 12, 2019 No. 2406-r.

The plan of inspections of wholesale and retail trade in medicines, pharmacy organizations and individual entrepreneurs licensed for pharmaceutical activities for 2020 can be found on the official websites of the General Prosecutor's Office of the Russian Federation (www.genproc.gov.nз) in the section "Unified Register of Inspections Consolidated plan of inspections and the Prosecutor's Office of the city of Moscow (www.mosproc.ru) in the section "Useful links" / "Useful information" / "Consolidated plan of inspections", as well as by clicking on the link "Department" / "Regional state control over the application of prices for Vital and Essential Drugs »/“Regional State Control over the Application of Vital and Essential Drug Prices”/“Inspection Plans”/“Inspection Plans”/“Inspection Plan for 2020”.

Part 2 of Article 8.2 of Federal Law No. 294-FZ dated December 26, 2008 N 294-FZ “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Implementation of State Control (Supervision) and Municipal Control” provides that in order to prevent violations of mandatory requirements, state control bodies (supervision), municipal control bodies issue warnings about the inadmissibility of violation of mandatory requirements.

The rules for the purchase of medicines have their own subtleties and require special knowledge. One of the categories of such medicines is the group of vital and essential medicines (VED).

Definition

So, let's consider what such a class of medicines is, what regulatory legal documents regulate it, and what are the features of such a purchase. We will also tell you where to see the list of Vital and Essential Drugs for 2020.

First you need to decide on the basic terms used in the procurement of medicines. 61-FZ of 04/12/2010 gives the basic concepts. Medicines are substances or their combinations that come into contact with the human body and are used for the prevention, diagnosis, treatment of a disease, and rehabilitation. There can be two types:

• pharmaceutical substances (one or more active substances intended for the manufacture of medicines and which determine their effectiveness);
• drugs, or drugs (used for prevention, diagnosis or treatment).

The latter come in several forms, they differ in the method of administration: solution, tablet, powder, and others.

Any medicinal product has either an international non-proprietary name (INN) - a name recommended by the World Health Organization, or a grouping name - a name in the absence of an INN. In this case, the manufacturer must also assign a trade name. For example, ibuprofen is INN, and there are such trade names on sale: Mig (manufactured by Berlin-Chemie), Nurofen (from Reckitt-Benkiser), Next (manufactured by OTCPharm). Different manufacturers assign medicines with the same active substance different trade names to identify the drug of a particular developer.

The state register of all registered drugs is maintained by the Ministry of Health of the Russian Federation on the official website.

Where to find the 2020 Vital and Essential Drug List

In order to meet the priority needs of health care, prevention and treatment of diseases, including those prevailing in the structure of morbidity in the Russian Federation, the Ministry of Health maintains a list of so-called special drugs - VED. It is approved annually. Below you can download the updated list of Vital and Essential Drugs for 2020.

Since 2012 the list is called VED and not VED, i.e. medicines, rather than the broader concept of medicines. And, although both abbreviations are still in use today, it is important to remember that the second option is not entirely correct.

You can download the list of Vital and Essential Drugs for 2020 (approved by Decree No. 2738-r dated December 10, 2018) on various pharmaceutical websites, however, in order to obtain reliable information, it is more expedient to use the Government's order.

Download free list of vital and essential drugs for 2020

Features of purchases of Vital and Essential Drugs

Particular attention should be paid to the peculiarities of ordering this category of drugs:

1. Additional reasons for the rejection of participants: the maximum price of Vital and Essential Drugs is not registered or the proposed price exceeds their maximum selling price under the conditions specified in clause 2, part 10, article 31.
2. Mandatory indication in the documentation of INN (in their absence - chemical grouping names), and when conducting a request for proposals for the purchase by decision medical commission for one patient during the treatment period - the trade name may be included in the documentation.
3. Approved Rules for the formation of a list of medicinal products, the purchase of which is carried out in accordance with their trade names(Decree of November 28, 2013 N 1086), however, the list has not yet been created.
4. Restrictions on the purchase of drugs of foreign origin in accordance with the Decree of November 30, 2015 N 1289.

The list of Vital and Essential Drugs for 2017 was approved by Decree of the Government of the Russian Federation No. 2885-r dated December 28, 2016 and signed by the head of the Government D.A. Medvedev

The list of Vital and Essential Drugs for 2017 was approved by Decree of the Government of the Russian Federation No. 2885-r dated December 28, 2016 and signed by the head of the Government D.A. Medvedev.

This list was not expanded as expected, and contains 646 drug names, which corresponds to about 30,000 drugs of various dosage forms.

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List of Vital and Essential Drugs 2017

AT new version VED contains about 30 thousand medicines or 646 international generic names medicines.

Many patients and the medical community as a whole hoped for a significant expansion of the list, however, this issue was postponed by the Government until the end of 2017.

Earlier, the commission of the Ministry of Health of the Russian Federation approved the inclusion of a list of drugs for 2017 of certain drugs for the treatment of many serious illnesses including acute heart failure, multiple sclerosis and cancer.

Ignoring the initiative of the Ministry of Health The government explains the difficult macroeconomic situation in the Russian Federation and the lack of budget funding.

At the same time, Veronika Skvortsova, Minister of Health of the Russian Federation, believes that the list of vital and essential drugs for 2017 is sufficient. It is noted that in the period from 2015 to 2016, the list was supplemented by a large number of vital important drugs, which amounted to 96 positions (they will be discussed later).

Expecting criticism from the medical community, the Government of the Russian Federation announced that now the list of Vital and Essential Drugs will be supplemented with new drugs not annually, but as new drugs are registered.

Note that about 6 subjects of the Russian Federation for preferential groups of patients only from the list of Vital and Essential Drugs.

Compared to 2016, the Decree of the Government of the Russian Federation No. 2885-r left the following lists of medicines unchanged:

• drugs for the treatment of patients under the programs "7 nosologies";
• drugs that are prescribed to patients by decision of the medical commissions of medical institutions;
• drugs that are included in the minimum pharmacy assortment, necessary for the provision of medical care.

Growth in the number of Russian drugs in Vital and Essential Drugs

The trend towards an increase in the share of domestically produced drugs in the list of vital drugs continues, which is due to the creation of new, innovative drugs.

In 2016, the share of Russian drugs in the list was 76.8% (compared to 2015 - 72%). We believe that this trend will also continue in the future.

New drugs of domestic production will be included in the list as clinical trials are completed and their state registration. The addition will take place according to the recommendations of the Government of the Russian Federation.

At the same time, special attention is paid to the fact that we are talking not only about well-known generics, but also about innovative products that are not currently represented on the world pharmaceutical market. This is stated by Deputy Prime Minister for Social Affairs Olga Golodets.

Control of regional purchases of Vital and Essential Drugs 2017

In January 2017, a new project of the Health Independent Monitoring Fund was announced. Within the framework of this project, social activists, together with representatives of the All-Russian Popular Front, plan to introduce a system for controlling the purchase of medicines from the preferential list in the constituent entities of the Russian Federation.

Members of the Health Foundation cite the results of independent monitoring, according to which, in 79 Russian regions, lists subsidized medicines not brought into line with the list of Vital and Essential Drugs.

The situation is stable only in 6 regions - Moscow, Khabarovsk Territory, Orel, Kursk and Rostov regions, as well as in the Republic of Mari El.

In other regions, the statistics are disappointing. For example, in the Kirov region, more than 36% of subsidized medicines were not included in the list of Vital and Essential Drugs 2017. The maximum figures are noted in the Altai Territory (more than 41%) and in the Republic of Dagestan (more than 43%).

The current situation leads to huge financial losses in the procurement of medicines, which in some regions amount to up to 30%.

On changing the list of Vital and Essential Drugs in 2016

Latest Big changes in the list of Vital and Essential Drugs occurred precisely in 2016 and were approved by the Decree of the Government of the Russian Federation No. 2724-r dated December 26, 2015.

Next, we will look at the new drugs on the list. Note that for some drugs, only other dosage forms have been added, for example, for pramipexole - prolonged-release tablets. The total number of new items on the list is 45.

Prime Minister Dmitry Medvedev approved the list of vital and essential medicines for medical use (VED) for 2018. The corresponding order, prepared by the Ministry of Health, was published on the Government website on October 23.

Government Decree No. 2323 r dated October 23, 2017 approved lists of vital and essential drugs, drugs prescribed by decision of the medical commission, drugs from the “7 nosologies” program, as well as a list of the minimum range of medicines.

Summary table of new INNs included in the list of Vital and Essential Drugs for 2018

Materials about Vital and Essential Drugs and other lists: