In this issue:
- Expert Council discusses draft on medical products localization
- The Ministry for Industry and Trade agrees with the Ministry for Healthcare on the list of medical products that should only be procured from domestic manufacturers
- Draft roadmap on GMP transition prepared
- GMP transitional period could take up to three years
- The Ministry for Health and Roszdravnadzor create medical products classifier
- Ministry for Healthcare and Federal Antimonopoly Service have agreed upon determining the pharmaceuticals interchangeability
- Ministry for Industry and Trade to vaidate the intended purpose of imported equipment for the medical industry
- Ministry for Industry and Trade has developed the procedure for issuing a pharmaceutical certificate
- Expert Council for Contractual Relations is established
Expert Council discusses draft on medical products localization
On 27 March participants of the working group meeting of the Expert Council for Healthcare under the Government of Russia discussed the draft Resolution of the Government prepared by the Ministry of Industry and Trade “On Establishing a Ban on Access for Goods (Certain Types of Medical Products) Originating from Foreign States, for the Purpose of Targeted Procurements to Meet State and Municipal Needs for the Purpose of Protecting the Domestic Market of the Russian Federation”.
The meeting discussed the potential ban on state and municipal procurements of foreign medical products. Most of the participants noted that the draft law needed to be modified owing to the low quality of certain domestic medical products, whose use could have a negative impact on the quality of medical service. According to the participants, a conciliation commission needs to determine the specific foreign medical products, whose access to state procurements will be restricted.
Based on the results of the discussion the opinion of the working group of the Expert Council will be prepared and transferred to the Minister for Open Government Mikhail Abyzov.
The Ministry for Industry and Trade agrees with the Ministry for Healthcare on the list of medical products that should only be procured from domestic manufacturers
The Ministry for Industry and Trade conducted a briefing commenting on progress on the draft Government Resolution “On Establishing a Ban on Access for Goods (Certain Types of Medical Products) Originating from Foreign States, for the Purpose of Targeted Procurements to Meet State and Municipal Needs for the Purpose of Protecting the Domestic Market of the Russian Federation”.
A list of foreign-made medical products not subject to the ban on state procurement in Russia has also been drafted. At present the document has undergone the initial public discussion stage. The list of products that should only be procured from domestic manufacturers will be updated. The optimal list of Russian equipment, which meets all the necessary criteria and may fully satisfy the requirements of healthcare institutions, is also being determined. In addition, the draft will be agreed with the Ministry for Economic Development and the Federal Antimonopoly Service for approval of the most transparent pricing mechanism and in order to guarantee competition.
It was disclosed that the list would not apply to medical equipment that is not manufactured in Russia. The final draft resolution will be prepared during the next quarter.
Draft roadmap on GMP transition prepared
The Association of Russian Pharmaceutical Producers (ARPhP) has announced completion of a draft roadmap on the transition to GMP standards. Even though the GMP rules entered into force from 1 January 2014, many issues remain unresolved. For example, they do not include a part regulating risk management and the pharmaceutical quality system (Part 3), there is no state inspectorate, while the liability of inspectors, authorized regulators and etc., has not been spelled out.
The draft roadmap has been distributed to trade and industry associations and the federal executive authorities for further discussion, amending and submission of the final version to the Russian Government.
GMP transitional period could take up to three years
According to the Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry for Industry and Trade of Russia, it could take up to three years for approximately 600 licensees to make the transition to GMP standards.
The Ministry for Industry and Trade, jointly with the Office of the Prosecutor General, plans to audit those companies that do not apply for the licenses renewal due to planned internal changes: change of platforms, expansion of production, etc. As part of the license renewal process, companies will receive a note on compliance with GMP standards. In cases of formal changes (for example, change of address), the license will be renewed based on formal criteria without making an entry on GMP compliance.
A new Federal Budgetary Institution has been established as the partner in licensing control – “The State Institute for Pharmaceutical Products and Good Practice” (on the basis of the State Institute of Blood Substitutes and Medicinal Preparations).
The Ministry for Health and Roszdravnadzor create medical products classifier
According to representatives of the Ministry for Healthcare, the upgrade of the medical industry requires: development and industrial manufacturing of competitive diagnostics medical equipment, ensuring visualization of pathological processes within a human body at early stages; the manufacturing of testing systems to identify socially significant diseases at early stages subject to effective treatment; and also expendables, including medical products implanted into a human body.
At present, the Ministry for Healthcare is working jointly with Roszdravnazdor to create the classifier of medical products, which will establish requirements on identifying medical products in order to ensure the reliability, comparability and automated data processing during the handling of medical products.
Ministry for Healthcare and Federal Antimonopoly Service have agreed upon determining the pharmaceuticals interchangeability
Drugs are supposed to be interchangeable if the quantitative and qualitative characteristics of the pharmaceutical substances used in their manufacturing, pharmaceutical forms, the composition of additives and their means of injection, are equivalent. The disclosure of information on the interchangeability of drugs in the state register and the use thereof is planned from 1 January 2019. Certain drugs (for example innovative ones) will however not be subject to these provisions.
Divergence arose over the deadline for protecting the results of the pre-clinical and clinical studies of the original pharmaceuticals. The parties agreed that on the expiry of four years since the registration, the registration certificate holder or its duly authorized representative is required to provide samples of a pharmaceutical for a fee to applicants for the state registration. The application for the state registration of a generic drug may be filed after the expiry of four years since the date of the state registration of the comparative drug in Russia, and in respect of a biologically analogous drug – after three years.
Ministry for Industry and Trade to vaidate the intended purpose of imported equipment for the medical industry
A public discussion in respect of drafting of the departmental Order “On Organizing Work at the Ministry for Industry and Trade of Russia on Validating the Intended Purpose of Imported Equipment for the Medical Industry” has been launched on the web portal of draft regulatory acts by the federal executive authorities.
The document aims to reduce the financial costs of enterprises in the medical industry during the procurement of state-of-the-art equipment that is not manufactured in Russia for new production facilities that comply with state-of-the-art requirements, the reconstruction and technical retooling of existing production facilities.
The document should enter into force in July 2014.
Ministry for Industry and Trade has developed the procedure for issuing a pharmaceutical certificate
Order No. 387 of the Ministry for Industry and Trade of Russia dated 11 March 2014 approves the procedure for organizing the work on issuance of the certificate of a pharmaceutical for medical use, and also the proforma of this certificate (see also KPMG Pharma Bulletin, Issue #2, 2014).
According to the Order, the Department for the Development of the Pharmaceutical and Medical Industry will review the completeness of submitted documents and the reliability of the information contained therein within five days. The decision on whether to issue a certificate will be adopted within 30 calendar days. The certificate is provided to the applicant within three working days upon its signing and registration.
From the perspective of drug manufacturers that have plants in Russia and supply their products to foreign markets, in January 2014 there was a risk of exports suspension. This was due to the fact that the state authority empowered for issuance of the pharmaceutical certificate was not defined by the Government by the start of 2014.
Expert Council for Contractual Relations is established
The Expert Council for Contractual Relations has been established at the Ministry for Economic Development. The main objectives of the Council will be to elaborate measures for development of the state procurement system, bona fide competition, increasing transparency and effectiveness of the budget expenditures.
The Council includes 15 experts, including members of non-governmental organizations (Chamber for Industry and Commerce, the Russian Union of Industrialists and Entrepreneurs (RSPP), Delovaya Rossia, Opora Rossii, the National Association of Procurement Institutes), representing small, medium and big businesses, representatives of anti-corruption organizations and civilian activists (Committee for Civil Initiatives, National Anti-Corruption Committee, Non-Profit Organization “Anti-Corruption Fund”, Autonomous Non-Profit Organization Center for Anti-Corruption Research and Initiatives), and representatives of higher educational institutions (Moscow State University, Higher School of Economics, the Russian Presidential Academy of the National Economy and Public Administration).
The first session of the Council, dedicated to amendments of the legislation aimed at improving contractual relations, will be held in April.