The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations, was rich on expectations, events and legislative proposals aiming to reverse pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.
Some of the major developments that are yet to be shaped into regulations are captured below.
Launch of the national project “Health Care ”
The national project has significantly increased the volume of benefit drugs reimbursement for patients suffering from cancer and cardiovascular diseases. As a result, in 2019, revenues of almost all manufacturers and other participants of the pharmaceutical market have been highly increased in the public procurement segment. 1
The 12 Nosologies programme has turned into 14 Nosologies programme
The following rare (orphan) diseases have been included in the programme:
- aplastic anemia unspecified (D61.9);
- inherited deficit of factors II (fibrinogen), VII (labile), X (Stuart-Prower) (D68.2).
Expenses on high-cost drugs for treatment of these diseases are reimbursed from the federal budget now. 2
New procedure of entry into drugs civil circulation
This sphere has been excluded from technical regulation legislation. Under the new procedure 3 there is no need to obtain a certificate of conformity or to register a declaration of conformity for each series or batch of drugs.
Entry into circulation of drugs manufactured in Russia shall be made upon submission of a document by the manufacturer which confirms the quality of the drug and its compliance with the requirements established within its state registration.
In case of drugs import into the Russian Federation, the importer shall provide a manufacturer’s certificate which certifies compliance of the imported drugs with the requirements of the pharmacopoeia article or another regulatory act. 4
The above-mentioned documents are provided via Roszdravnadzor’s automated information system. 5
The deadline for introducing drugs mandatory labeling has been postponed till July 1, 2020
The labeling of drugs has not been introduced since January 1, 2020 as it was expected. 6
According to the amendments, most of drugs, produced before July 1, 2020, can be stored, transported, released, sold, transferred, used without identification (labeling) until expiration of best before date.
In August, 2019 manufacturers managed to reduce the cryptographic code.
In October, 2019 the labeling for high-cost nosology has been introduced.
Before labeling came into force medical drugs were entered into civil circulation and tracked by batches.
Law on drug interchangeability has been adopted
A list of interchangeable drugs will appear, where drugs will be grouped together. It will be formed by an expert institution — the Federal State Budgetary Institution “Scientific Centre of Expertise of Medicinal Products ” of the Russian Ministry of Healthcare (MOH).
Most of the amendments to the procedure for determining the interchangeability of drugs will enter into force from March 1, 2020.
Interchangeability will not be determined for herbal and homeopathic medicines.
For drugs that are recognized as interchangeable before March 1, 2020 in the process of their state registration, there will be no need to determine the interchangeability again. 7
Rules for re-registration of price limits for vital and essential drugs (VED) have come into effect
From June 7, 2019 in certain cases, pharmaceutical manufacturers are obliged to reduce the price limits on VED. For example, it should be done when the prices for imported drugs are higher in Russia than in the country of their origin.
The Governmental Regulation came into force on December 17, 2019 and, inter alia, defined:
- rules for mandatory re-registration of manufacturers’ price limits for VED in 2020;
- the procedure of calculating of such price limits when they are re-registered in order to reduce them.
Starting from 2021, VED without mandatory re-registration of their price limits will be forbidden for selling.
Another important novelty: the MOH and Federal Antimonopoly Service FAS will be able to revise and reduce the registered price limits without pharmaceutical manufacturer application. 8
The procedure of determining the maximum (starting) price of contract (MSPC) for public procurement of drugs has been changed
Methods of determining the MSPC per drug unit have not been changed. However, there are new peculiarities. 9 E. g., when applying the method of comparable market prices, the customer will be obliged to send requests to suppliers along with the use of publicly available price information.
The rules of forming the weighted average price have been changed. When determining it, the customer will have the right not to take into account, in particular, the price of supplied drugs:
- with the remaining shelf life, which is 20% or more different from the remaining shelf life of the other purchased goods;
- for contracts under which the suppliers were subject to penalties;
- circulation of such drugs was suspended at the time of MSPC calculation.
Reference prices will be calculated in a different way: they will be automatically determined not four times, but twice a year.
Prolongation of the transition period for re-registration of medical devices with member-state registration according to Eurasian Economic Union (EEU) rules till 31 December, 2026
Till 2021 Manufacturer or authorized representative save the right to choose whether to register a medical device under EEU rules or rules of member-state. Starting from 2021 registration will be executed only under EEU rules.
From 2026 marketing authorizations issued under national registration procedure will be cancelled. 10
1 Passport of the national project “Health Care ” (approved by the Presidium of the Presidential Council for Strategic Development and National Projects, Protocol dd 24.12.2018 No. 16), available at: http://static.government.ru/media/files/gWYJ4OsAhPOweWaJk1prKDEpregEcduI.pdf (Last Accessed January 27, 2020).
2 Federal Law dd. 27.12.2019 No. 452-FZ “On Amendments to the Law “On fundamental healthcare principles in the Russian Federation ”, available at: http://publication.pravo.gov.ru/Document/View/0001201912280022 (Last Accessed January 27, 2020).
3 Federal Law dd. 28.11.2018 No. 449-FZ “On Amendments to the Law “On drugs circulation ” available at: http://publication.pravo.gov.ru/Document/View/0001201811280057 (Last Accessed January 27, 2020).
4 Ibid.
5 Roszdravnadzor’s automated information system, available at: http://momi.roszdravnadzor.ru/?type=logon ( Last Accessed January 27, 2020)
6 Federal Law dd. 27.12.2019 No. 462-FZ “On Amendments to the Law “On drugs circulation ” and to the Law “On Amendments to the Law “On drugs circulation ” available at: http://publication.pravo.gov.ru/Document/View/0001201912280029 (Last Accessed January 27, 2020)
7 Federal Law dd. 27.12.2019 No. 475-FZ “On Amendments to the Law “On drugs circulation ”, available at: http://publication.pravo.gov.ru/Document/View/0001201912280038 (Last Accessed January 27, 2020).
8 Governmental Regulation dd. 16.12.2019 No. 1683, available at: http://static.government.ru/media/files/1riw7sArETmZp70rvcRLUywCOHOotEPk.pdf (Last Accessed January 27, 2020).
9 Order of the MOH dd. 19.12.2019 No. 1064n, available at: https://cdnimg.rg.ru/pril/180/22/21/56926.pdf (Last Accessed January 27, 2020).
10 Order of the Board of the Eurasian Economic Commission dd. 02.09.2019 No. 142 “On the draft Protocol amending the Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union dd. December 23, 2014 ”, available at: https://www.alta.ru/tamdoc/19r00142/ (Last Accessed January 27, 2020).