Regional State Control over the Application of Prices for Oil and Gas. How vital and essential medicines are procured Decree 2724 list of essential drugs
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 non-proprietary names of 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";
- medications prescribed to patients medical commissions 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. As part of this project, social activists, together with representatives of the All-Russian Popular Front, plan to introduce a system for monitoring 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 others are added. dosage forms, for example, for pramipexole - prolonged-release tablets. The total number of new items on the list is 45.
|
No. p / p |
Medications (INN) | Anatomical Therapeutic Chemical Classification (ATC) | Dosage form |
|
Drugs for the treatment of diabetes |
|||
| 1 | insulin degludec insulin aspart | insulins medium duration action or long-acting and their analogues in combination with short-acting insulins for injection | |
| 2 | Insulin degludec | Long-acting insulins and their analogues for injection | Solution for subcutaneous administration |
| 3 | Linagliptin | Dipeptidyl peptidase-4 (DPP-4) inhibitors | |
| 4 | Dapagliflozin | Other hypoglycemic drugs other than insulin | Film-coated tablets |
|
Other drugs for the treatment of diseases of the gastrointestinal tract and metabolic disorders |
|||
| 5 | Laronidase aldurazyme | Enzyme preparations | Concentrate for solution for infusion |
| 6 | Sapropterin | Other drugs for the treatment of diseases of the gastrointestinal tract and metabolic disorders | Dispersible tablets |
|
Preparations for the treatment of diseases of the blood and the hematopoietic system |
|||
| 7 | Ticagrelor | Antiplatelet agents other than heparin | Film-coated tablets |
| 8 | Apixaban | Direct factor Xa inhibitors | Film-coated tablets |
| 9 | noncog alpha | clotting factors | |
| 10 | Blood coagulation factors II, VII, IX, X c. combinations [prothrombin complex] | clotting factors | Lyophilizate for solution for intravenous administration |
| 11 | fibrinogen thrombin | Local hemostatics | Hemostatic sponge |
| 12 | Iron carboxymaltose | Antianemic drugs. Parenteral preparations of ferric iron | |
|
Dermatological preparations |
|||
| 13 | epidermal growth factor | Other drugs that contribute to normal scarring | Lyophilisate for solution for injection |
|
Hormonal preparations of systemic action, except for sex hormones and insulins |
|||
| 14 | Terlipressin | Vasopressin and its analogues | Solution for intravenous administration |
| 15 | Pasireotide | Somatostatin and analogues | Solution for subcutaneous administration |
|
Antibacterial drugs of systemic action |
|||
| 16 | Tigecycline | Tetracyclines | Lyophilisate for solution for infusion |
|
Antivirals |
|||
| 17 | Lopinavir ritonavir | Solution for oral administration; film-coated tablets | |
| 18 | Simeprevir | HIV protease inhibitor | Capsules |
| 19 | Rilpivirine tenofovir emtricitabine | Combined antiviral drugs for the treatment of HIV infection | Film-coated tablets |
|
Anticancer drugs and immunomodulators |
|||
| 20 | Bendamustine | Anticancer drug, analogue of nitrogen mustard | Powder for the preparation of a concentrate for the preparation of a solution for infusion |
| 21 | Pertuzumab trastuzumab [set] | Anticancer drug. Monoclonal antibodies | Set: concentrate for solution for infusion lyophilisate for preparation of concentrate for solution for infusion |
| 22 | Vandetanib | Anticancer drug. Protein kinase inhibitors | Film-coated tablets |
| 23 | Ibrutinib | Capsules | |
| 24 | Eribulin | Other anticancer drugs | Solution for intravenous administration |
| 25 | Buserelin | Gonadotropin-releasing hormone analogues | Lyophilizate for the preparation of a suspension for intramuscular injection prolonged action |
| 26 | Abiraterone | Other hormone antagonists and related compounds | Tablets |
| 27 | Leflunomide | Selective immunosuppressants | Film-coated tablets |
| 28 | Teriflunomide | ||
| 29 | Golimumab | Tumor necrosis factor alpha (TNF-alpha) inhibitors | Solution for subcutaneous administration |
|
Muscle relaxants |
|||
| 30 | Botulinum toxin type A | Other peripheral muscle relaxants | |
| 31 | Buprenorphine | Phenylpiperidine derivatives | Transdermal patch |
| Drugs affecting the structure and mineralization of bones | |||
| 32 | Denosumab | Other drugs that affect the structure and mineralization of bones | Solution for subcutaneous administration |
|
Analgesics |
|||
| 33 | Naloxone oxycodone | Natural opium alkaloids | Long-acting film-coated tablets |
|
Psychostimulants and nootropics |
|||
| 34 | Animal cerebral cortex polypeptides | Other psychostimulants and nootropics | Lyophilizate for solution for intramuscular injection |
|
Drugs for the treatment of obstructive airway diseases |
|||
| 35 | Indacaterol | Selective beta2-agonists | |
| 36 | Beclomethasone formoterol | Adrenergic agents in combination with glucocorticoids or drugs other than anticholinergics | Aerosol for inhalation dosed |
| 37 | Mometasone formoterol | ||
| 38 | Glycopyrronium bromide | Anticholinergics | Capsules with powder for inhalation |
| 39 | Omalizumab | Other systemic agents for the treatment of obstructive airways disease | Lyophilisate for preparation of solution for subcutaneous administration |
|
Other medications |
|||
| 40 | Bacteria allergen [TB recombinant] | Allergens | Solution for intradermal administration |
| 41 | Sugammadex | Antidotes | Solution for intravenous administration |
| 42 | Deoxyribonucleic acid plasmid [supercoiled circular double stranded] | Other medicinal products | Lyophilizate for solution for intramuscular injection |
|
Contrast media |
|||
| 43 | Gadoveretamide | Paramagnetic contrast agents | Solution for intravenous administration |
| 44 | gadobenic acid | ||
| 45 | gadoxetic acid | ||
To control the circulation of medicines, not only a register of vital and essential medicines was created, but also a register of marginal selling prices on Vital and Essential Drugs (2020). Let's take a closer look at both registers. In order to find out the maximum wholesale and retail price of the drug of interest, open the excel file.
ZhNVLP, transcript
Vital and essential drugs (VED, until 2011 the abbreviation "Vital and essential drugs" was used, or Vital and essential drugs) is a list of drugs approved by the Government of the Russian Federation for the purpose of state regulation of drug prices. This is done to increase their accessibility for the population and medical institutions.
The Vital and Essential Drug List contains a list of medicines under international generic names and covers almost all types medical care provided to citizens Russian Federation within the framework of state guarantees, in particular, emergency medical care, inpatient care, specialized outpatient and inpatient care, and also includes a significant amount of medicines sold in the commercial sector.
In addition, the Vital and Essential Drug List serves as the basis for the development of regional lists of constituent entities of the Russian Federation and formulary lists of medicines. medical organizations stationary type.
All information can be easily obtained online, including the Vital and Essential Drugs Register for 2020 - the official website is a section on the website of the Ministry of Health.
You just need to fill in the fields and click "Search".
Price limit
State regulation of the cost of medicines from the list of Vital and Essential Drugs has been carried out since 2010.
Control is carried out at the following levels:
- Ministry of Health of the Russian Federation - fixes the maximum selling prices of VED manufacturers. More expensive factories cannot sell medicines to wholesale and retail trade. The cost of a medicine depends on the cost of packaging materials, medicinal substances, etc. Since a number of medicines and substances are imported, their cost is affected by changes in the exchange rate.
- In each subject of the Russian Federation - the maximum size of wholesale and retail allowances is established. The allowances are used to compensate for the associated costs of trade for the sale of medicines: delivery, storage, rental of premises, wages of pharmacists. The margins applied by them cannot exceed the size of the maximum established markups on the cost of the manufacturer. For example, in the Tyumen Region, retail markups, for example, for drugs in the price range of 50-500 rubles, are limited to 25%. For comparison, in the subjects of the Urals Federal District, the maximum level of retail allowances is set in the range of 27-70%.
The final cost, which we see on the price tag in a pharmacy, consists of:
- the actual price of the manufacturer, not exceeding the established limit;
- wholesale surcharge to the actual price of the manufacturer;
- retail markup on the manufacturer's price.
Thus, the state limits the maximum cost of vital and essential drugs, above which no pharmacy can sell such a drug. All pharmacies contain information about medicines indicating names, dosages, forms of release, manufacturers, as well as the maximum allowable retail price at which they can be sold, so every buyer can find out. The placement of this information is regulated by the federal law "On the circulation of medicines" dated April 12, 2010 No. 61-FZ (clause 3 of article 63).
Maximum allowable prices for Vital and Essential Drugs 2020
The register of maximum selling prices for Vital and Essential Drugs 2020 can be found on the website of the Ministry of Health.
In addition, the current list of funds and their prices can be downloaded at the end of the article as an excel file.
Operational monitoring of prices for vital drugs of Roszdravnadzor is carried out in the same place where the registry of essential drugs for 2020 is located - the official website of the Ministry of Health places this information in a special section. The purpose of monitoring is to check the assortment and pricing policy of polyclinics and pharmacies. Vital and essential drugs monitoring is the responsibility of medical and pharmacy organizations of any form of ownership. Every month, by the 25th day, a report is prepared, which lists the stocks for the 15th day of the reporting period for medicines from the list of vital and essential drugs.
Regional state control for the application of prices for medicines included in the list of vital and essential medicines
In the city of Moscow, regional state control over the application 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 City Health Department (hereinafter referred to as the Department) in accordance with the Administrative Regulations for the performance of the state function for the implementation in the city of Moscow of regional state control over the use of prices for medicines included in the list of vital and essential medicines (hereinafter referred to as VED), approved by 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 dated 06.05.2015 No. 434.
The subject of regional state control is the verification of compliance by the subjects of medicines circulation with the 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 mark-ups and the maximum retail mark-ups 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 medicines included in the list of Vital and Essential Drugs, trade markups are applied, approved by Decree of the Government of Moscow No. 163-PP dated 24.02.
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.
With a plan for inspections of wholesale and retail trade organizations 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 "Useful Links"/"Useful Information"/ "Consolidated Inspection Plan" section, as well as by clicking on the link "Department"/"Regional State Control over the Application of Vital and Essential Drugs Prices"/"Regional State Control over the Application of Prices for Vital and Essential Drugs"/"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.
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 medicinal products for medical use, prescribed by decision of medical commissions of medical organizations, in accordance with Appendix No. 2;
a list of medicines intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasms lymphoid, hematopoietic and related tissues, multiple sclerosis, persons after transplantation of organs and (or) tissues, 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 of the Russian Federation of December 30, 2014 N 2782-r (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2015, N 3, art. 597).
Prime Minister
Russian Federation
Decree of the Government of the Russian Federation of October 23, 2017 N 2323-r On approval of the list of vital and essential drugs for 2018, the list of drugs for medical use, the list of drugs intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation, as well as the minimum range of drugs required for medical care (repealed)
- Annex N 1. List of vital and essential drugs for medical use for 2018 Annex N 2. List of drugs for medical use, including drugs for medical use prescribed by decision of medical commissions of medical organizations Annex N 3. List of drugs drugs intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as people after organ and (or) tissue transplantation Appendix N 4. Minimum range of drugs needed to provide medical care
1. Approve:
a list of vital and essential medicines for medical use for 2018 in accordance with Appendix No. 1;
a list of medicinal products for medical use, including medicinal products for medical use, prescribed by decision of medical commissions of medical organizations, in accordance with Appendix No. 2;
a list of drugs intended to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as people 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. Recognize as invalid the order of the Government of the Russian Federation of December 26, 2015 N 2724-r (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 2016, N 2, art. 413).
The list of vital and essential drugs (VED) for medical use for 2018 was approved. Compared to the list of VED for 2017, the new list has been supplemented with new drugs and dosage forms.
A new list of medicines was also approved to provide preferential categories of citizens, a list of expensive medicines under the program "7 nosologies" ("orphan" drugs) to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher's disease, malignant neoplasms of the lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation.
