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KPMG Pharma bulletin, Issue #7, 2014 (July)
KPMG Pharma bulletin, Issue #7, 2014 (July)
Related content
In this issue:
Medical Devices
- Foreign manufacturers of medical devices will not be banned from participation in state tenders
- Ministry of Industry and Trade suggests prohibiting private trade of medical devices
- Draft Itemized Classifier of medical devices developed
- Work on draft Federal Law on circulation of medical devices resumed
- The Ministry of Healthcare adopted regulations on licensing of manufacturing and servicing of medical devices
Pharmaceuticals
- No possibility to re-apply for inclusion into Essential Drugs List in 2014
- List of OTC drugs allowed for sale in food retail chains is published
- Draft order regulating online trade of pharmaceuticals
- New list of drugs subject to item-quantifying accounting approved
- Ministry of Healthcare is to update the Essential Drugs List
- Maximal mark-ups on pharmaceuticals are set in Crimea
Healthcare and Medical Services
Medical Devices
Foreign manufacturers of medical devices will not be banned from participation in state tenders
The Ministry for Industry and Trade of Russia has revised the draft Resolution prohibiting the imported medical devices from participation in state procurement supply, by mitigating the wording. Instead of “prohibition”, the new document uses the term “restriction”. The purpose is to preserve the competition in the medical devices market, as well as to avoid possible difficulties with the circulation of medical devices.
The restriction applies only to those medical devices manufacturing of which corresponds to the following criteria:
- availability of competitive native manufacturers and sufficient level of internal competition;
- availability of manufacturing capacities ensuring meeting the healthcare needs;
- compliance of both the products and its manufacturing process with GOST ISO13485-2011 “Medical devices. Management quality systems. System requirements for the regulations purposes”.
As a result of the review of the proposals from domestic manufacturers, the List covering types of the medical devices subject to restriction was adjusted. In particular, perinatal and heavy x-ray machinery were excluded from the List. At the same time, the List was extended by inclusion of cooling medical equipment, ECG, diagnostic test-systems and reagents and some other consumables.
Ministry of Industry and Trade suggests prohibiting private trade of medical devices
The Ministry for Industry and Trade of Russia proposes to prohibit private individuals from selling medical devices. The draft Resolution changes the rules for trade of certain products, prohibiting the sale of medical devices out of stationary points-of-sale, in particular: from home, work or place of study, transport, in the streets and other places.
If adopted, the draft Resolution would preclude retail sale of medical devices out of stationary points-of-sale, thus decreasing the probability of a deceit or misleading of consumers by bad-faith suppliers.
Draft Itemized Classifier of medical devices developed
Following the Russian Government`s guidelines, the Federal Service on Surveillance in Healthcare (Roszdravnadzor) has developed an Itemized (Nomenclature) Classifier draft for medical devices.
The draft contains 20 696 types of medical devices and their descriptions in accordance with Article 38 of the Federal Law dd. 21 November 2011 N 323 “On Fundamentals of Public Healthcare Protection in Russia”.
In addition, the Ministry of Healthcare issued a draft Order “On Changes to the Order of the Ministry of Healthcare of the Russian Federation of 6 June 2012 N4-н “On Adoption of Itemized (Nomenclature) Classification for Medical Devices”.
The new classification is aimed at ensuring authenticity, comparability, automated information processing and data exchange in respect of medical devices circulation among the involved federal executive bodies, as well as other parties engaged therein. The new list has been composed taking into account the Global Medical Device Nomenclature (GMDN).
For the convenience of using of the classifier, Roszdravnadzor is developing an IT solution that would enable the search by various classification characteristics of medical devices.
Work on draft Federal Law on circulation of medical devices resumed
Work on the Draft Federal Law “On Circulation of Medical Devices” has been resumed by the Ministry of Healthcare. The law is supposed to cover the entire “life cycle” of medical devices, from the manufacturing to their recycling.
Up to now, more than 45 thousand units of medical devices are registered in Russia and approximately 20 thousand units are manufactured by Russian companies. The medical devices market capacity is estimated at approximately 200 billion rubles.
The Ministry of Healthcare adopted regulations on licensing of manufacturing and servicing of medical devices
The Administrative Regulation has been approved by the Federal Service on Surveillance in the Healthcare. It addresses the rendering of the state service on licensing the manufacturing and servicing of medical devices (with the exception of servicing for own needs of an entity or an entrepreneur).
The Regulation determines the timing and sequence of the administrative procedures in course of the state service rendering by the Federal Service on Surveillance in the Healthcare; in particular, according to the new regulation:
- The decision on granting (rejection) of a license should be taken within 45 business days from the date of receipt of the application and the documents (information),
- Decision on re-issuance (refusal in re-issuance) of a license due to the reason of an entity re-organization or the business name / address change should be taken within 10 business days; and in case of changing the address where the activity subject to licensing is performed – within 30 business days,
- The license should be issued (delivered) to the applicant within 3 working days from the day of signing and registering the license in the license register,
- Decision on license cancellation should be taken within 10 business days upon the application receipt,
- A duplicate / copy of a license should be delivered within 3 business days.
Pharmaceuticals
No possibility to re-apply for inclusion into Essential Drugs List in 2014
As of today, the Ministry of Healthcare received from parties engaged in circulation of drugs over 650 applications for inclusion or exclusion of pharmaceuticals into/from the EDL.
Preliminary, the submission procedure in 2014 has been prolonged until August 25. Earlier the submission date was to expire on July 1. However, this year there will be no chance for a repeated application in case of errors in the documents submitted.
It is planned that in 2015 applications for inclusion into the EDL would be accepted till March 1.
The draft Resolution “On Adoption of the Order for Creation of Pharmaceutical Lists Provided for by the Laws of Russia” has been submitted to the Government on July 1, 2014 and is expected be adopted shortly. The Resolution will govern the formation of all regulatory lists (registers) of pharmaceuticals in Russia, in particular:
- Essential Drugs List,
- Drugs for 7 Nosologies programme,
- Drugs for pharmaceutical aid to certain category of citizens,
- Minimal assortment of pharmaceuticals.
The renewed EDL would become the list covering all the major pharmaceuticals which the Russian citizens are entitled to receive within the state guarantees framework.
Formation of the above lists will be open to the general public to the maximal extent possible. The register of all the applications and the list of companies engaged in expert evaluation of the drugs subject to the inclusion into the lists are supposed to be published in web.
List of OTC drugs allowed for sale in food retail chains is published
On July 17, the Ministry of Healthcare presented to the Government the draft list of pharmaceuticals to be permitted for trade in food retail chains. The list was agreed upon with the two of the three responsible regulators – with the Federal Service on Surveillance for Consumer Rights and Human Well Being (Rospotrebnadzor) and the Ministry for Economic Development. The latter increased the number of drugs categories in the list up to 7. Also the Ministry for Economic Development tried to include into the list all the OTC drugs mentioned in the obsolete Order of the Ministry of Healthcare and Social Development #578, which was argued against by the Ministry of Healthcare.
While developing the draft list, the Ministry of Healthcare considered two main criteria:
- the drugs should require special storage conditions,
- the drugs should entail minimal risk of health damage even if used improperly.
Draft order regulating online trade of pharmaceuticals
The representatives of pharmaceutical business have developed a draft Order regarding the regulation of online trade of pharmaceuticals, which was submitted to the Ministry of Healthcare on July 28 for consideration.
The document was developed together with the Society of Professional Pharmaceutical Organizations, Russian Association of Pharmacy Chains and the Russian Association for Electronic Communications.
If adopted, the Order is supposed to ensure:
- legal formalization of the already established online market of pharmaceuticals,
- extension of the licensing requirements to this market,
- establishing strict requirements to companies engaged in drugs sale via internet.
New list of drugs subject to item-quantifying accounting approved
The Order of the Ministry of Finance № 183n dd. 22.04.2014 approved the list of pharmaceuticals item-quantifying accounting, which includes three categories:
- Pharmaceuticals (pharmaceutical substances) which contain narcotic drugs, psychotropic substances and their precursors (salts, isomers, stereoisomers) that are included in the indexes II, III, IV of the list of narcotic drugs, psychotropic substances and their precursors subject to the control in Russia in combination with a pharmacologically inactive substances as well as pharmaceuticals containing narcotic drugs, psychotropic substances and their precursors in combination with pharmacologically active substances (if included in the list as a separate item);
- Pharmaceuticals (pharmaceutical substances) containing superpotent and toxic substances (salts, isomers, esters and ethers, mixtures and solutions, regardless of their concentration), included into the list of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of Russia in combination with a pharmacologically inactive substances as well as pharmaceuticals containing potent and toxic substance in combination with pharmacologically active substances (if included in the list as a separate item);
- Combined pharmaceuticals containing small quantities of narcotic drugs, psychotropic substances and their precursors with pharmacologically active substances.
Ministry of Healthcare is to update the Essential Drugs List
In the near future the Ministry of Healthcare will revise the EDL. The new list will include pharmaceuticals that confirmed their high efficiency according to the evidence-based healthcare.
As per the Ministry, the EDL already includes more than 500 titles of the pharmaceuticals, which corresponds to more than 7,5 thousand brand names.
According to the strategy of the drug supply, a pilot project for implementation of new ED pricing control methods, based on reference prices, will be launched in 2015 in Russian regions.
Maximal mark-ups on pharmaceuticals are set in Crimea
Pursuant to the corresponding provision of the Russian law, the maximum wholesale and retail trade mark-ups for EDL products were established in the Republic of Crimea.
According to the Resolution, prices for such drugs will be governed by the authorities regardless of a pharmacy’s legal form. The maximum wholesale mark-up was set at 15%, where as the maximal retail mark-up cannot exceed 25%.
Healthcare and Medical Services
Federal Antimonopoly Service clarifies rules for advertising of medical services
On July 3, 2014 the Federal Law dd. 28.06.2014 № 190-FZ “On Introducing Amendments to Article 24 of the Federal Law "On Advertising" came into effect. It excludes from the regulation Part 8 of Article 24 of the Federal Law “On Advertising” which concerns the advertising of medical services.
Starting from June 30, 2014 the advertising of medical services is permitted through any means and in any form, if in compliance with Article 24 of the Federal Law “On Advertising” and the general requirements for advertising envisaged by the Federal Law "On Advertising".
The Federal Antimonopoly Service gives notice to its territorial bodies that they are not entitled to initiate proceedings on administrative offences for violation of Part 8 of Article 24 of the Federal Law “On Advertising” in respect of the medical services advertising. In view of the Federal Antimonopoly Service, according to Part 2 of Article 1.7 of the Code of Administrative Offences of Russia, the law has retro-active force in case if it moderates or cancels the responsibility for the administrative offence or otherwise improves the situation of person having committed such an offense.
In addition, with the account taken of Part 2 of Article 1.7 of the Code of Administrative Offences of Russia, should the administrative case be initiated with respect to advertising placement of healthcare services in places prohibited based on Part 8 of Article 24 of the Federal Law “On Advertising” and should the corresponding resolution be not yet released (i.e. the case is pending), processing of such a case should be terminated.
Draft law on an international medical cluster in Moscow submitted to the Parliament
The draft law on an international medical cluster, anticipated to be set up in Moscow, has been submitted to the State Duma.
According to the draft, the location and size of the cluster should be determined by the Moscow. The Cluster will provide for the special regulatory regime and simplified requirements for the resident companies. In particular, foreign approvals, permits and certificates of education will be recognized on par with Russian analogs. Participants may also be entitled to use medical devices registered in foreign jurisdictions. Russian labor quotas will not apply to foreign employees engaged in the Cluster.
Russian and foreign legal entities participating in the project will be granted the Cluster residence for up to 10 years. According to the draft, the Cluster will be governed by a management company – a Russian legal entity established by the Moscow Government.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
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