Order of the Government of the Russian Federation dated 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, a list of medications intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation, as well as the minimum range of medications necessary to provide medical care (repealed)
- Appendix No. 1. List of vital and essential medicines for medical use for 2018 Appendix No. 2. List of medicines for medical use, including medicines for medical use prescribed by decision of medical commissions of medical organizations Appendix No. 3. List of medicines drugs intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation Appendix No. 4. Minimum range of drugs necessary to provide medical care
1. Approve:
list of vital and essential drugs for medical use for 2018 according to Appendix No. 1;
list of medications for medical use, including medications for medical use prescribed by decision of medical commissions medical organizations, according to Appendix No. 2;
a list of medications intended to provide persons with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation, in accordance with Appendix No. 3;
the minimum range of medications necessary to provide medical care, in accordance with Appendix No. 4.
2. Declare the order of the Government invalid Russian Federation dated December 26, 2015 No. 2724-r (Collected Legislation of the Russian Federation, 2016, No. 2, Art. 413).
The list of vital and essential drugs (VED) for medical use for 2018 has been approved. Compared with the list of VED for 2017. new list supplemented with new drugs and dosage forms.
A new list of drugs has also been approved to provide benefits to categories of citizens, a list of expensive drugs under the “7 nosologies” program (“orphan” drugs) to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of the lymphoid, hematopoietic and related tissues, multiple sclerosis, as well as persons after organ and (or) tissue transplantation.
The list of vital and essential drugs for 2017 was approved by order 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 order 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 names of drugs, which corresponds to approximately 30 thousand drugs of various dosage forms.
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List of Vital and Essential Drugs 2017
IN new version Vital and Essential Drugs contain about 30 thousand drugs or 646 international non-proprietary names of drugs.
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.
Previously, the commission of the Ministry of Health of the Russian Federation approved the inclusion of a list of drugs for 2017 for the treatment of many serious illnesses, including acute heart failure, multiple sclerosis and cancer.
The government explains the ignoring of the initiative of the Ministry of Health by 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 with a large number of vital important drugs, which amounted to 96 positions (they will be discussed further).
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 benefit groups patients only from the VED list.
Compared to 2016, the following lists of medicines were left unchanged by Decree of the Government of the Russian Federation No. 2885-r:
- drugs for treating patients under the “7 nosologies” programs;
- drugs that are prescribed to patients by decision of medical commissions of medical institutions;
- drugs that are included in the minimum pharmacy range required to provide medical care.
Growing number of Russian drugs in vital and essential drugs
The trend continues to increase the share of domestically produced drugs in the list of vitally important drugs, which is due to the creation of new, innovative drugs.
In 2016 the share Russian drugs in the list was 76.8% (compared to 2015 - 72%). We believe that this trend will also be observed in the future.
New domestically produced drugs will be included in the list as the clinical trials and them 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 on the global pharmaceutical market. this moment not presented. The Deputy Prime Minister for social issues Olga Golodets.
Control of regional purchases of vital and essential drugs 2017
In January 2017, a new project of the independent monitoring fund “Health” was announced. Social activists within the framework of this project, together with representatives of the All-Russian popular front, plan to introduce a system for monitoring the purchase of drugs from the preferential list in the constituent entities of the Russian Federation.
Participants of the Health Fund cite the results of independent monitoring, according to which in 79 Russian regions the lists of preferential drugs are not brought into line with the list of vital and essential drugs.
The situation is stable only in 6 regions - Moscow, Khabarovsk Territory, Oryol, 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 drugs were not included in the list of vital and essential drugs 2017. The maximum numbers are observed in the Altai Territory (more than 41%) and in the Republic of Dagestan (more than 43%).
The current situation leads to huge financial losses when purchasing medicines, which in some regions amount to up to 30%.
On changes to the list of vital and essential drugs in 2016
The last major changes to the list of vital and essential drugs occurred precisely in 2016 and were approved by 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. Please note that for some drugs only others have been added dosage forms, for example, for pramipexole - extended-release tablets. Total there are 45 new items in the list.
|
No. |
Medicines (INN) | Anatomical-therapeutic-chemical classification (ATC) | Dosage form |
|
Medicines for the treatment of diabetes mellitus |
|||
| 1 | Insulin degludec insulin aspart | Insulins average duration actions or long acting and their analogues in combination with insulins short acting 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 insulins | Film-coated tablets |
|
Other drugs for treating diseases gastrointestinal tract and metabolic disorders |
|||
| 5 | Laronidase aldurazyme | Enzyme preparations | Concentrate for the preparation of solution for infusion |
| 6 | Sapropterin | Other drugs for the treatment of diseases of the gastrointestinal tract and metabolic disorders | Dispersible tablets |
|
Drugs for the treatment of diseases of the blood and hematopoietic system |
|||
| 7 | Ticagrelor | Antiplatelet agents other than heparin | Film-coated tablets |
| 8 | Apixaban | Direct factor Xa inhibitors | Film-coated tablets |
| 9 | Nonacog Alpha | Clotting factors | |
| 10 | Blood clotting factors II, VII, IX, X centuries. combinations [prothrombin complex] | Clotting factors | Lyophilisate for the preparation of solution for intravenous administration |
| 11 | Fibrinogen thrombin | Local hemostatics | Hemostatic sponge |
| 12 | Iron carboxymaltose | Antianemic drugs. Parenteral ferric iron preparations | |
|
Dermatological preparations |
|||
| 13 | Epidermal growth factor | Other drugs that promote normal scarring | Lyophilisate for the preparation of solution for injection |
|
Hormonal drugs systemic action, except sex hormones and insulins |
|||
| 14 | Terlipressin | Vasopressin and its analogues | Solution for intravenous administration |
| 15 | Pasireotide | Somatostatin and analogues | Solution for subcutaneous administration |
|
Systemic antibacterial drugs |
|||
| 16 | Tigecycline | Tetracyclines | Lyophilisate for the preparation of solution for infusion |
|
Antiviral drugs |
|||
| 17 | Lopinavir ritonavir | Oral solution; 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 |
|
Antitumor drugs and immunomodulators |
|||
| 20 | Bendamustine | Antitumor drug, analogue of nitrogen mustard | Powder for the preparation of a concentrate for the preparation of a solution for infusion |
| 21 | Pertuzumab trastuzumab [kit] | Antitumor drug. Monoclonal antibodies | Kit: concentrate for preparing a solution for infusion, lyophilisate for preparing a concentrate for preparing a solution for infusion |
| 22 | Vandetanib | Antitumor 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 | Lyophilisate for preparing a suspension for intramuscular injection long-acting |
| 26 | Abiraterone | Other hormone antagonists and related compounds | Pills |
| 27 | Leflunomide | Selective immunosuppressants | Film-coated tablets |
| 28 | Teriflunomide | ||
| 29 | Golimumab | Tumor necrosis factor alpha (TNF-alpha) inhibitors | Solution for subcutaneous administration |
|
Muscle relaxants |
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| 30 | Botulinum toxin type A | Other peripherally acting muscle relaxants | |
| 31 | Buprenorphine | Phenylpiperidine derivatives | Transdermal patch |
| Drugs affecting bone structure and mineralization | |||
| 32 | Denosumab | Other drugs affecting bone structure and mineralization | Solution for subcutaneous administration |
|
Analgesics |
|||
| 33 | Naloxone oxycodone | Natural opium alkaloids | Extended-release film-coated tablets |
|
Psychostimulants and nootropic drugs |
|||
| 34 | Livestock cerebral cortex polypeptides | Other psychostimulants and nootropics | Lyophilisate for preparing a solution for intramuscular administration |
|
Drugs for the treatment of obstructive airway diseases |
|||
| 35 | Indacaterol | Selective beta2-agonists | |
| 36 | Beclomethasone formoterol | Adrenergic agents in combination with glucocorticoids or other 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 airway diseases | Lyophilisate for the preparation of solution for subcutaneous administration |
|
Others medications |
|||
| 40 | Bacteria allergen [tuberculosis recombinant] | Allergens | Solution for intradermal administration |
| 41 | Sugammadex | Antidotes | Solution for intravenous administration |
| 42 | Plasmid deoxyribonucleic acid [supercoiled circular double-stranded] | Other medicinal products | Lyophilisate for preparing a solution for intramuscular administration |
|
Contrast media |
|||
| 43 | Gadoveretamid | Paramagnetic contrast agents | Solution for intravenous administration |
| 44 | Gadobenic acid | ||
| 45 | Gadoxetic acid | ||
1. Approve:
list of vital and essential drugs for medical use for 2016 according to Appendix No. 1;
a list of medications for medical use, including medications for medical use prescribed by decision of medical commissions of medical organizations, in accordance with Appendix No. 2;
a list of medications 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, in accordance with Appendix No. 3;
the minimum range of medications necessary to provide medical care, in accordance with Appendix No. 4.
2. Establish that until March 1, 2016, the list of vital and essential drugs for medical use for 2015, approved by Decree of the Government of the Russian Federation of December 30, 2014 N 2782-r, is applied.
3. Decree of the Government of the Russian Federation dated December 30, 2014 No. 2782-r (Collected Legislation of the Russian Federation, 2015, No. 3, Art. 597) is declared invalid.
Chairman of the Government
Russian Federation
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 VED (2020). Let's take a closer look at both registries. In order to find out the maximum wholesale and retail price drug of interest, open the excel file.
VED, transcript
Vital and essential drugs (VED, until 2011 the abbreviation “VED” 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 Drugs list contains a list of medicines under international non-proprietary names and covers almost all types of medical care provided to citizens of the Russian Federation within the framework of state guarantees, in particular, ambulance 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 List of Vital and Essential Medicines serves as the basis for the development of regional lists of constituent entities of the Russian Federation and formulary lists of medicines for inpatient medical organizations.
All information can be easily obtained online, including the VED registry for 2020 - the official website is a section on the website of the Ministry of Health.
You just need to fill out the fields and click “Find”.
Maximum permissible price
State regulation of the cost of drugs from the list of vital and essential drugs has been carried out since 2010.
Control is carried out at the following levels:
- The 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 the medicine depends on the cost of packaging materials, medicinal substances etc. Since a number of drugs and substances are imported, their cost is affected by changes in exchange rates.
- In each subject of the Russian Federation, the maximum amounts of wholesale and retail markups are established. Allowances serve to reimburse associated trade costs for the sale of medications: delivery, storage, rental of premises, wages for pharmacists. The markups they apply cannot exceed the maximum established markups to the manufacturer's cost. Thus, in the Tyumen region, the amount of retail markups, for example, for drugs in the price category of 50-500 rubles, is limited to 25%. For comparison, in the subjects of the Ural federal district The maximum level of retail markups is set in the range of 27-70%.
The final cost, which we see on the price tag at the pharmacy, consists of:
- the actual price of the manufacturer, not exceeding the established limit;
- wholesale markup to the manufacturer's actual price;
- retail premium to 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 pharmacy organizations post information about medications, indicating names, dosages, release forms, manufacturers, as well as the maximum permissible 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 permissible 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 products and their prices can be downloaded at the end of the article as an excel file.
Operational monitoring of prices for vital drugs by Roszdravnadzor is carried out in the same place where the register of vital drugs for 2020 is located - the official website of the Ministry of Health posts this information in a special section. The purpose of monitoring is to check the assortment and pricing policy clinics and pharmacies. Vital and Essential Drugs monitoring is the responsibility of medical and pharmacy organizations any form of ownership. Every month, before the 25th day, a report is prepared that lists stocks on the 15th day of the reporting period for drugs 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 drugs (hereinafter referred to as regional state control) is carried out by the Office for Control over the Application of Prices for Medicines of the Moscow City Health Department (hereinafter referred to as the Office) in accordance with the Administrative Regulations for the execution of the state function of exercising regional state control in the city of Moscow over the application of prices for drugs included in the list of vital and essential drugs (hereinafter referred to as VED), approved by Decree of the Moscow Government dated November 18, 2014 No. 669-PP .
The procedure for implementing regional state control is established by the Regulations on regional state control over the application of prices for medicines included in the list of vital and essential drugs, approved by Decree of the Government of the Russian Federation dated May 6, 2015 No. 434.
The subject of regional state control is the verification of compliance by subjects of medicines circulation with 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”.
Methodology for establishing by authorities executive power subjects of the Russian Federation size limits wholesale markups and maximum retail markups to the actual selling prices established by drug manufacturers for drugs included in the list of vital and essential drugs, approved by order Federal service according to tariffs dated December 11, 2009 No. 442-a.
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 the Moscow Government Decree No. 163-PP dated February 24, 2010 “On establishing the maximum size of trade markups on the prices of medicines.”
The list of vital and essential drugs is approved annually by the Government of the Russian Federation. The current list of vital and essential drugs for 2020 was approved by order 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 having a license for pharmaceutical activities, for 2020 can be found on the official websites of the Prosecutor General's Office of the Russian Federation (www.genproc.gov.nз) in the section “Unified register of inspections Consolidated plan of inspections and the Moscow City Prosecutor’s Office (www.mosproc.ru) in the section “Useful links”/“ Useful information"/"Summary inspection plan", 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 prices for vital and essential drugs"/"Inspection plans"/"Inspection plans "/"Inspection plan for 2020."
Part 2 of Article 8.2 Federal Law No. 294-ФЗ dated December 26, 2008 N 294-ФЗ “On the protection of rights legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control” it is stipulated that in order to prevent violations of mandatory requirements, state control (supervision) bodies and municipal control bodies issue warnings about the inadmissibility of violating mandatory requirements.
