KPMG Pharma Bulletin Issue #2, 2018 (February)
KPMG Pharma Bulletin Issue #2, 2018 (February)
The Ministry for Trade and Economic Development delivered a negative opinion on the proposed rules for the state registration / re-registration of maximum EDL prices.
According to the Ministry, the draft rules would significantly raise the costs for the business, which is likely to affect the end-consumer prices for pharmaceuticals.
Also, there is a risk that the responsible regulators will not be able to complete such a large-scale re-registration work by the deadlines set by the draft rules.
The Ministry highlighted that the proposed concept does not provide for the mechanism of calculating the minimal selling price which would account for the variety of pharmaceutical forms and dosages.
The Government of the Russian Federation approved the Rules for Providing Subsidies from the Federal Budget to Support Drugs Serialization Projects” by its Resolution # 189 of 23.02.2018.
The subsidies could be used to finance the following activities:
− re-tooling of the pharmaceuticals production, including purchases of equipment and engineering software;
− research and development works (in the amount not exceeding 10% of the project’s total costs);
− purchases of intangible assets used in the project (in the amount not exceeding 10% of the project’s total costs);
− engineering survey and project documentation design (in the amount not exceeding 5% of the project’s total costs);
− technological and pricing audit of the project (in the amount not exceeding 0.3% of the project’s total costs).
The Ministry of Health and Social Development issued the draft Order “On Approval of Drugs Prescription Rules, the Templates of Prescription Forms and the Rules for their Completion, Accounting and Storage”.
The draft Order specifies the requirements to issuance of drug prescriptions in electronic form using a qualified electronic signature of a healthcare professional.
In addition, the draft specifies the maximum permitted quantity of psychotropic and narcotic drugs to be provided under one prescription form and recommended quantities of certain specific drugs to be provided under one prescription form.
In its Letter # 418/25-5 of 14.02.2018, the Ministry of Healthcare clarified frequently asked questions in area of public procurement of pharmaceuticals, in particular:
− the rules for justifying the presentation of certain parameters of a pharmaceutical in the tender documentation;
− the mandatory obligation to use the approved template contract, with clarifications on its content (inclusion of certain provisions /sections / appendices);
− the mechanisms of calculating prices per unit and wholesale mark-ups.
Pursuant to the clarifications set out by the FAS in its Letter # РП/13254/18 of 28.02.2018, wholesale and retail companies have to re-valuate the EDL products purchased before 01.01.2018 at prices exceeding the maximum registered ex-factory ones.
The Letter also comments on the completion of the EDL pricing protocol in the above cases
The FAS submitted to the Government of the Russian Federation a draft law permitting the local re-production of analogues of foreign-made pharmaceuticals without the manufacturer’s consent in cases when the health за the population is at risk.
The draft provides for an opportunity to deprive pharmaceutical companies’ exclusive rights for production and sale of patented drugs, if they fail to deliver such drugs to Russia due to economic or political reasons.
According to the FAS, the bill would help avoid unjustified price inflation charged by companies dominating the market, and would preclude disruption of manufacturing or supply of essentially important drugs production in case of major threats to lives and health of the Russian citizens.
At the same time, the Ministry for Economic Development expressed a negative opinion on this draft. The Ministry concluded that the proposed solution is not sufficiently justified, and highlighted that some of the draft law’s provisions result in excessive obligations, prohibitions and restrictions for the business community.
The Ministry for Industry and Trade placed for public discussions a draft resolution expanding its authorities in the area of interacting with the EAEU authorized bodies responsible for pharmaceuticals circulation, with the Eurasian Economic Commission (EEC) and with its Expert Committee on Pharmaceuticals.
Additionally, the resolution proposes to extend the list of public services by adding the GMP auditing of the pharmaceuticals manufacturers operating in the EAEU.
The Ministry of Health approved the procedure for transferring biomedical cellular products (BMCP) samples for quality assessment. On 16.02.2018 the Russian Ministry of Justice registered the corresponding Order # 841n dd. 10.10.2017.
To carry out the quality assessment of a BMCP, the applicant shall submit to the expert institution BMCP samples and the declaration stating the name (INN, grouping or chemical) of the pharmaceutical being the ingredient of the BMCP along with the number and the date of the pharmaceutical’s registration certificate (marketing authorization) and the number of its regulatory documentation. The deadline for the BMCP samples and documents submission is 60 business days from the date of being informed by the federal expert institution that the corresponding Ministry of Healthcare’s notification was received.
In addition, the Order of the Ministry of Health # 694n dd. 29.09.2017 approves the procedure for professional assessment of the responsible person of the BMCP manufacturer, the requirements to such a person’s education and qualifications and his/her powers and authorities for BMCP quality assurance.
The professional assessment which is to be performed every five years includes the expert review of the report on the authorized employee’s professional activity, test examination on professional subject and an interview. To undergo the assessment, a professional must have a high-school degree in pharmaceutical, medical, biological or chemical sciences and at least 5 years of working experience in area of BMCP production and quality control.
The previous Pharma Bulletin issues are accessible our site.
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