KPMG Pharma Bulletin Issue #5, 2017 (May)
KPMG Pharma Bulletin Issue #5, 2017 (May)
The Ministry of Healthcare has placed for public discussion the Draft Resolution of the Russian Government, which sets forth:
− the Rules for the state registration/re-registration of maximum ED selling prices;
− the Rules for keeping the state register of the maximum ED selling prices;
− the methodology for maximum ED selling prices calculation;
− the rules for re-registration of maximum ED selling prices in 2017 and 2018.
The re-registration of prices is to be performed by the Ministry of Healthcare and the Federal Anti-Trust Service.
KPMG Health & Pharma team’s publication on the new pricing methodology is coming soon.
The bill amending the Federal Law № 61-FZ of 12.04.2010 “On Circulation of Pharmaceuticals” is introduced to the State Duma.
It is proposed that submitting to the regulator the GMP certificate (issued by the authorized body), instead of the manufacturing license, should be sufficient for pharmaceuticals manufacturers to confirm the state registration of a drug.
The Ministry for Industry and Trade developed amendments to the Administrative Regulation on issuance of the resolution addressing the matters of state registration of the country of goods origin.
Such a resolution shall be enclosed to:
─ the application for state registration of the place of goods origin name; and
─ the application for granting exclusive rights for the name of the place of origin, already registered or subject to registration.
Should the amendments be approved, applicants would be able to file electronic requests for receiving the state service on issuance the above resolution via a web-portal without submitting any hard-copy documents.
The President of Russia signed the Federal Law # 83-ФЗ dd. 01.05.2017 “On Amendments to Articles 30 and 34 of the Federal Law “On Contractual System for Procurement of Goods, Works, Services for State and Municipal Needs”.
According to the Law, the payment shall be made by the state customer not later than 30 days upon signing the act of acceptance – under the general rule, and within 15 business days – under contracts with small enterprises and social entities.
The Government introduced to the State Duma the Draft Federal Law “On Adopting the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights”.
The Protocol empowers WTO members to issue compulsory licenses for manufacturing of generic drugs for export sales and, where required, to use the exemption from being held liable for such actions by other WTO members.
The enactment of the Protocol should enable local production of generics using international patents for the original drugs. In addition, in case of epidemic events, Russia will be able to use this mechanism to import expensive pharmaceuticals which are produced by WTO members under compulsory licenses.
The Protocol also entitles those WTO members which lack pharmaceuticals manufacturing facilities to request other WTO members to supply their locally manufactured pharmaceuticals in the required volumes.
The Draft Law “On Amendments to Certain Legislative Acts on Circulation of Biomedical Cellular Products”, which is introduced to the State Duma, provides for the following:
− including the wastes arising from biomedical cellular products (BMCP) circulation into the definition of “medical waste” set out by the Federal Law “On Fundamentals of Public Health Protection”, being subject to the same legal treatment and regulations;
− setting out requirements to licensing of BMCP manufacturing and to the state control over BMCP circulation;
− specifying the list of documents to be included into a BMCP registration dossier and the requisites of documents confirming payment of state duties for the associated expert examinations.
The Ministry of Healthcare has placed for public discussion the Draft Rules for selection of suppliers of expendable medical devices.
According to the Article 111 of the Federal Law #44-FZ “On Contractual System for Procurement of Goods, Works, Services for State and Municipal Needs”, the Government may specify additional terms of state procurement agreements.
Expendable medical devices shall be purchased by federal and regional medical institutions for delivering medical aid under state guarantees, whereas suppliers are to meet the following criteria:
− residence in Russia;
− local manufacturing;
− using for production the Russia-made innovative compositional formulation of PVC materials, developed under “Pharma 2020” program;
− have the valid certificate of compliance with the national manufacturing standards (ГОСТ Р ИСО 13485) as of the date of applying to a tender;
− have not less than 7 valid registration certificates, accompanied by CT-1 certificate;
− achieve sales turnover of at least RUB 700 million during the last three years, including revenues from sales of its own products and products manufactured by its Russian subsidiaries and affiliates.
The Draft Federal Law “On Delivering Medical Care, Social Services and Other Special Measures for Diabetic Patients” was introduced to the State Duma.
The draft governs arrangements in the area of legal, medical, social, economic and organizational/technical state guarantees for diabetic patients and sets out the list of the patients’ rights including, inter alia, availability of medical aid and including the right for free-of-charge pharmaceuticals and medical devices (self-control tools, insulin injection devices, skin-disinfection devices).
In addition, the draft stipulates introduction of a state register of diabetic patients, which is supposed to help analyze the causes of diabetes, morbidity dynamics, and take sufficient and effective measures for the comprehensive control over the disease.
The Government introduced to the State Duma the draft Federal Law “On Amendments to Certain Legislative Acts on Use of Information and Telecommunication Technologies and Introduction of Electronic Documents in Healthcare Area”.
The Draft enables medical aid delivery by using of tele-health technologies via consultations and councils of physicians, ensuring remote communication between healthcare professionals, between a physician and the patient, as well as remote monitoring of a patient’s health.
The Draft also envisages issuance of electronic prescriptions for pharmaceuticals and medical devices (including those containing drugs and psychotropic substances), which is supposed to allow optimizing and simplifying the medical paperwork and the process of obtaining pharmaceuticals by patients.
The Government approved the State Strategy on Fighting to the HIV Spreading in the Russian Federation till 2020 and for the future perspective, aimed at extending the HIV screening coverage, extending anti-retroviral therapy coverage, increasing the population’s awareness of HIV infection. The Prime Minister signed the corresponding Resolution #754-р on 20.04.2017.
The also provides for effective measures to reduce prices for anti-retroviral drugs, including:
− improving the mechanism of state regulation of prices for Essential Drugs;
− considering the possibility of priority state registration of anti-retroviral pharmaceuticals;
− working on options to reduce selling prices for contraceptives medical devices, including based on the analysis of the market competition.
The Prime Minister signed the Resolution # 550 dd. 10.05.2017, establishing the Rules for issuance of local product status confirmation for industrial products and criteria for such status.
The Resolution establishes the rules and criteria for confirming the “local manufacturer” status for industrial products made in Russia:
− an effective SPIC containing obligations for an investor or an engaged manufacturer with respect to gradual (phased) compliance with the local productions requirements;
− availability of the expert examination certificate issued by the Russian Chamber of Commerce and Industry, confirming the compliance with the established requirements,
− availability of certificate confirming Russia as the place of goods origin.
The previous Pharma Bulletin issues are accessible our site.
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