KPMG Pharma Bulletin Issue #9, 2018 (September)
KPMG Pharma Bulletin Issue #9, 2018 (September)
At the "BioTechMed" conference held during 9-11 September, the Unified National Serialization and Tracing system "Decent MARK" was presented. The deputy head of Roszdravravnadzor stated that no delays and postponements are expected with respect to the mandatory serialization of pharmaceuticals.
The drugs serialization is supposed not only to help clear the market of counterfeit products and increase the compliant manufacturers’ profits, but also provide more effective targeted assistance to consumers, and enable the business to precisely plan their shipments, using the analytical data on stocks available.
Starting from November 01, 2018, the Center of Advanced Technologies Development (CRPT) becomes the drug serialization system operator. An innovation introduced to the system is the use of cryptographic elements, which became mandatory for all serialized products under the Order of the Government of the Russian Federation # 791-R dd. 28.04.2018.
According to the Deputy Head of Roszdravravnadzor, the system’s ‘handover’ the Federal Tax Service to CRPT will be completed as per the approved roadmap without disruptions and ensuring most comfortable conditions for manufacturers.
The amendments to the Federal Law # 61-FZ dd. 12.04.2010 “On Circulation of Pharmaceuticals” regarding the pricing regulation for vital and essential drugs (ED) received a positive opinion on the regulatory impact analysis procedure (RIA) on July 17, 2017. However, the next stage – consideration by the Government – has not started yet.
According to the draft, in certain cases the registration certificate (marketing authorization) holder/owner will have to apply for re-registration of the registered maximum ex-factory price for an ED product downwards.
Further, the draft stipulates that upon the re-registration of the maximum ex-factory price the manufacturer may not deliver the drug at a price exceeding the registered one (including VAT).
The Russian Ministry for Industry and Trade has published the draft Order “On Approval of the Administrative Regulation on the Licensing Supervision over Production of Pharmaceuticals for Medical Use by the Russian Ministry for Industry and Trade”, with amendments introduced as per the Resolutions of the Russian Government # 676 dd. 13.06.2018 and # 702 dd. 20.06.2018.
In particular, production, storage and sale of the ethyl alcohol API (ethanol) are now classified as the activities constituting production of pharmaceuticals. Accordingly, the draft Regulation introduces licensing requirements for ethanol API manufacturers.
The public debates on the draft were completed on October 03, 2018.
According to the Order # 5539 dd. 07.08.2015, in scope of its activities of sample-based quality control, the Russian Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) shall collect and analyze the information submitted by manufacturers and importers with respect to batches (series) and lots of drugs entered into civil circulation in Russia.
In particular, the following data must be reported on the batches of pharmaceuticals produced in Russia:
- trade name;
- INN (group or chemical name);
- pharmaceutical form (indicating the finished dosage form, concentration, dispensing) and the quantity in the pack;
- manufacturer’s name;
- volume of the bacch released into civil circulation (the number of packs for finished dosage forms and the quantity of measurement units for APIs);
- legal name of the entity releasing the pharmaceuticals into civil circulation;
- address of the warehouse storing the batches upon conformity assessment of the pharmaceuticals with respect to the state registration requirements (permission for release);
- number and date of the conformity declaration acceptance, the certification body’s name, the name of the body that accepted the conformity declaration (for pharmaceuticals subject to conformity assessment).
The above data must be submitted within not more than 5 business days:
- upon confirming the compliance of the product batch with the state registration requirements (issuing the permission for release), or
- upon releasing the pharmaceuticals by the customs authority under certain customs procedure, or
- upon the date of importing the pharmaceuticals into Russia from the EAEU.
The data can be submitted in e-format (via the automated information system of Roszdravnadzor, AIS Roszdravnadzor), or in a hard copy. In case of electronic reporting, duplicating it in a hard copy is not required.
Failure to submit the data to Roszdravnadzor or deliberate submission of false information is an administrative offense penalized by an administrative fine of 10 – 15 kRUB (for a company’s management) or 30 – 70 kRUB (for a company).
Roszdravnadzor processes the data submitted, particularly, to identify pharmaceuticals lacking in public circulation.
The lack of data about the batches and lots of pharmaceuticals entered into the civil circulation in Russia could entail regulatory sanctions, up to revoking the state registration of the pharmaceutical.
The Russian Ministry of Healthcare has started developing the draft federal law aimed at improving the regulations on drug circulation, specifically, in part of observing patent rights.
In particular, the EEC Council Resolution # 78 dd. 03.11.2016 approved the “Rules for Registration and Expert Assessment of Pharmaceuticals”, according to which, information on existence of patent-protected IP rights to a drug, effective in the EAEU, shall be reported in course of the drug’s registration.
Hence, the Ministry proposes amending the Federal Law # 61-FZ dd. 12.04.2010 “On Circulation of Pharmaceuticals” by introducing the requirement to report:
- information on the existing protection of the IP rights to the drug being registered, and
- the confirmation that the drug’s registration does not violate any other party’s IP rights.
The purpose of the draft is to improve the legal and regulatory framework of drugs circulation and harmonization with the EEC regulations.
Under the Letter of the Russian Federal Anti-Trust Service # AC/70030/18 dd. 03.09.2018, the deadline for submitting the data on maintaining and/or changing the effective (set by manufacturers) wholesale and retail trade mark-ups, applied to the sale prices for ED products, are extended till November 12, 2018.
The prolongation is caused by technical difficulties related to upgrade of the NADB.JNVLP.APTEKA.2018 template of the Unified Information Analysis System of the Federal Tariff Service of Russia (the FGIS UIAS template).
The Letter notes that the FGIS UIAS template is used for planning calculation of the trade mark-ups to be set at the regional level. This planning mark-up value is supposed to indicate the objective level of a mark-up ensuring profitable sale of a pharmaceutical. The formula involves calculation of gross profits (GP) of a wholesaler (who can purchase drugs from both manufacturers as well as other wholesalers), which is computed based of the difference between the weighted average sales price of drugs and the weighted average manufacturer’s ex-factory price (according to the ED pricing protocol).
The updated template excludes from the calculation the negative GP values which arise in cases when the average sales price is lower than the average manufacturer’s ex-factory price (for wholesalers), or the average purchase price (for retailers). Thus, cases of deliberate loss-making sales of pharmaceuticals will not be accounted for and possible distortions of the objectively required mark-up level will be eliminated.
The Resolution of the EEC Council # 149 dd. 07.09.2018 “On the List of Stages (Steps) of Pharmaceuticals Manufacturing” stipulates the list of stages (steps) of drug production. It was developed to systematize the information about the degree (depth) of various production sites involvement into the manufacturing process and to summarize data on their production stages (steps).
The list is applied to form documents submitted by the pharmaceuticals circulation participants to the EAEU regulators. The use of the reference codes from the list is obligatory.
The Resolution comes into force on October 12, 2018.
The Resolution of the EEC Council dd. 07.09.2018 # 150 approves the Classifier of measuring dosage and concentration of API in pharmaceutical products. It will be used in course of the electronic communications between the EAEU member states’ regulators, including formation, maintaining and using of a unified electronic register of pharmaceuticals registered in the EAEU, as well as in course of preparing applications included into a registration dossier for pharmaceuticals registration and expert assessment purposes.
The Classifier is included into the EAEU system of unified regulatory and reference data sources. Its classification code shall be obligatory used while performing common EAEU processes in the sphere of pharmaceuticals circulation.
The Resolution comes into force on October 12, 2019.
The Resolution of the EEC Council dd. 07.09.2018 # 151 approved the Guidelines for Formation of the Regulatory Document on Pharmaceuticals Quality.
According to the Guidelines, the regulatory document is approved by the competent public authority of an EAEU member state in course of a drug registration and is to be used for control over the pharmaceutical quality in the EAEU during the post-registration period.
The document sets requirements to the quality control of a pharmaceutical based on the performed expert assessment and, in particular, contains specification and description of assessment/testing methods and the corresponding criteria of quality indicators acceptability.
The regulatory document is to be formed only for finished dosage forms and is not required for API.
Besides, Appendix 1 to the Guidelines contains requirements to preparing specifications of analytical methods and quality indicators acceptability criteria for API produced via chemical synthesis and the pharmaceuticals containing such APIs.
The Resolution comes into force on March 12, 2019.
The Federal Obligatory Medical Insurance Fund (FOMIF) in its Letter dd. 30.05.2018 # 6628/26-1/и clarified the matters of spending the funds received under OMI programs. Particularly, the following applies with respect to lease payments at the OMI expense:
- Under the base OMI program, tariffs for medical care covers, inter alia, costs for rental of property using, as well as for acquiring fixed assets (including equipment) with purchase value up to RUB 100K per unit;
- Should a lease contract provide for further buy-out of the leased asset by the lessee under a sale-and-purchase agreement, the acquisition cost should be posted to Article 310 “Increasing cost of fixed assets” of the KOSGU Classifier and can be financed at the expense of the OMI funding only if the buy-out price does not exceed RUB 100K.
It is additionally specified that monthly charges for repairs of common property in an apartment building owned by a medical provider under the operative administration title regime can be covered at the OMI expense only if these premises are used for delivering medical care.
The Russian Ministry of Healthcare prepared the draft Order “On Approval of Requirements to Organizing Internal Quality and Safety Control of Medical Care”.
According to the Federal law dd. 21.11.2011 # 323-FZ “On the Basics of Protection of Russian Citizens Healthcare”, the quality and safety control shall be conducted by authorities and organizations of state, municipal and private healthcare systems and includes, inter alia, monitoring the observance of:
- protection and guarantees of civil rights in the field of healthcare,
- rules for medical care delivery, clinical guidelines and medical care standards,
- rules for conducting medical examinations, medical inspections and medical certifications,
- restrictions applicable to healthcare professionals, heads of healthcare institutions in course of their professional activities,
- requirements to the formation and performance of medical commissions and their activities.
The control is to be performed by a medical commission, the department of quality and safety of medical activity and the head of the medical institution via:
- assessment of the quality and safety of the medical institution’s performance by a group of in-house and/or third-party experts,
- collection and analysis of performance quality indicators, as well as data on adverse events in course of medical care delivery.
Based on the results of the control activities, an integrated report shall be prepared at least annually, subject to approval by the head of the medical institution, containing the information on the quality and safety status of the medical care delivery and the measures undertaken further to the internal control results.
According to the Deputy Director of the Subdivision for Work Coordination in Area of Pharmaceuticals and Medical Devices Circulation of the EEC Department of Technical Regulation and Accreditation, development of the Unified Information System (UIS) enabling data exchange between EAEU member states is completed.
Though, the EEC has not yet announced the launch of a unified EAEU market and start of pharmaceuticals’ registration according to the EAEU rules.
The UIS was supposed to be launched yet in 2017, however significant difficulties arose while connecting the system’s national segments to the EEC segment. Currently, the system is operating in test mode and will undergo stress-testing (overload testing) during October. Afterwards it is supposed to go live.
On September 25, a new online tool was put into operation. It was developed by the WIPO and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and is supposed to assist procurement entities to analyze the global patent status of pharmaceuticals.
The Patent Information Initiative for Medicines (Pat-INFORMED) is free-access database where patent holders from any country publish information on patents for registered pharmaceuticals. Procurement companies can submit direct requests to patent owners via a platform linked to Pat-INFORMED.
At the moment, Pat-INFORMED accumulates information on over 14,000 patents, 600 patent families and 169 INN.
The Pat-INFORMED contains data on low-molecular pharmaceuticals intended for treatment of oncology diseases, hepatitis C, cardiovascular diseases, HIV, diabetes and pulmonology pathologies, as well as on pharmaceuticals of any other kinds included in the List of Essential Pharmaceuticals maintained by the WHO. In the second phase, this initiative will be extended to all kinds of drugs and could potentially cover complex pharmaceuticals as well.
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