On October 29, 2018, the Government of the Russian Federation approved the changes1 to the Rules for Producing the Lists of Medicines and Minimum range of medicines required for medical care that were adopted on 28 August 2014 (the "Revised Rules").
Thus, as from November 9, 2018, the RF Health Ministry committee is to follow the Revised Rules when producing the said lists.
Dentons Life Sciences practice would like to acquaint you with the main provisions of the Revised Rules, which are set forth below.
1. Criteria revised for producing the list of essential medicines
According to the Revised Rules, the list is produced with consideration for, among other things, clinical evaluation results on prevention, diagnostic, treatment and rehabilitation methods.
According to the provisions of the Federal Law on Fundamental Health Care Principles in the Russian Federation (No. 323-FZ of Nov. 21, 2011), clinical evaluation involves the practical application of developed but previously unapplied prevention, diagnostic, treatment and rehabilitation methods for delivering health care in order to substantiate their efficacy. There are certain features to health care that is delivered in the context of a clinical evaluation.
The Revised Rules also clarify the wording of the criterion on the use of a medicine for diagnostic, prevention, treatment and rehabilitation purposes when delivering health care in the event of illnesses and conditions, including the most prevalent ones in the distribution of disease in the Russian Federation (the reference to syndromes has been removed).
A listed medicine's therapeutic equivalence to medicines with a similar mechanism of pharmacological action has been removed from the list of mandatory criteria for a medicine to be included in the said list.
2. Grounds added for delisting medicines
Based on two new grounds, a medicine can be removed from the list of essential medicines, the list of high-cost medicines and the list of medicines for eligible beneficiaries and staple medicines, if:
- a chief external expert at the Health Ministry of Russia presents a research-based recommendation in relation thereto following the comprehensive assessment thereof;
- the manufacturer's maximum selling price for the medicine is not registered within six months after it is included in the list.
An alternative medicine being listed, the emergence of information about a medicine's toxicity or frequent undesirable side effects, discontinuation of use in the Russian Federation, revocation of the state registration, stoppage of production/deliveries of a medicine or its not being on the market in the Russian Federation for longer than one year – the grounds provided in the previous version of the rules will still be applicable.
3. Single-agent and combination medicines
The listing and minimum assortment of these medicines were formerly not expressly mentioned in the rules.
The Revised Rules now include a section 6(2), providing that single-agent medicines are to be included in these lists by default, and combination medicines are only to be listed when the results of a comprehensive assessment have demonstrated them to be use- and cost-beneficial compared with single-agent medicines. In case of such listing, all of the single-agent medicines registered in the Russian Federation that make up such combination are listed simultaneously.
4. Changes to the membership of the Health Ministry of Russia committee and meeting attendees
According to the Revised Rules, the Health Ministry of Russia committee no longer includes members from the RF Finance Ministry and the Federal Agency for Scientific Organizations, which owing to the dissolution of the latter has been replaced by the Science and Higher Education Ministry of Russia.
Previously, at the committee's initiative, representatives from other federal executive authorities, as well as nongovernmental organizations active in health care and pharmaceuticals and consumer protection in these industries, could be invited to a meeting.
Now the approach is for the prospective meeting attendees themselves to initiate the process; these include: a representative of a pharmaceutical entity and/or nongovernmental organization active in health care and pharmaceuticals and consumer protection in these industries, as well as representatives of other federal executive authorities. To do so, they have to file a respective written request with the committee at least five business days prior to the meeting date.
5. New procedure for entities to forward proposals for medicine listings and new rules for medicine assessments
According to the previous version of the rules, applicants forwarded their annual (no later than March 31) proposals for the listing of particular medicines to the Health Ministry of Russia by completing a special form in hard copy and electronically. With the Revised Rules taking effect, these proposals are now forwarded in electronic form only and no later than the first day of the first month of the quarter.
The 15-day period that had been allotted to the committee to review the set of documents received has been cut nearly in half – to seven business days.
That being said, if a submitted document's format technically prevents it from being opened, this could be grounds for the committee to reject the applicant's proposal; likewise if the applicant has resubmitted documents during a calendar year on which the committee has already issued a rejection in the current year or which have already undergone comprehensive evaluation (except for immediate amendments in accordance with RF Government instructions).
The report on the documentary review when a proposal is rejected is forwarded to the applicant electronically within up to three business days (formerly, seven days). A refined proposal with the faults eliminated may be resubmitted to the committee by the applicant within 10 business days.
Next, the committee forwards an applicant's accepted proposal to the federal state budgetary institution Health Care Quality Assessment and Control Center (abbreviated as FGBU TsEKKMP in Russian) and, as before, to the industry-specific state federal educational establishment and/or pharmaceutical research organization under the jurisdiction of the Health Ministry of Russia or the Science and Higher Education Ministry of Russia for comprehensive evaluation and production of the relevant report. Then, the set of documents together with this report is forwarded by the committee to a chief expert for the preparation of a research-based recommendation on listing the medicine. With regard to producing the list of required medicines, this set of documents is forwarded to at least two chief experts subject to their area of competence.
Committee meetings are now held before the 10th day of the second month of the quarter after that in which a proposal is submitted. Meanwhile, the committee may consider no more than 15 medicines at a single meeting.
The Revised Rules also include, among other things, new Appendixes 1–9:
- form of proposal for including a medicine in the lists of medications and required medicines;
- form of report on the documentary review of a proposal for inclusion (removal) of a medicine in (from) the lists of medications and required medicines;
- special requirements for the methodological quality of economic medicine evaluations and studies analyzing budgetary system impacts, which were not present previously;
- integrated comprehensive medicine rating scales;
- form of report on the analysis of information on a medicine's comparative clinical efficacy and safety and assessment of the economic consequences of its use;
- form of report on the analysis of the methodological quality of economic medicine evaluations and studies analyzing budget impacts on the budgetary system of the Russian Federation, and also studying additional consequences of the use of a medicine, and form of research-based recommendation for inclusion (removal, rejection) of a medicine in the lists of medications and required medicines.
The Revised Rules are an attempt to streamline the process of producing the lists of medications and required medicines, providing for shortened timeframes and creating a more transparent process for evaluating an applicant's proposals.
1. RF Government Resolution No. 1283 of Oct. 29, 2018, "On amending the Rules for Producing the Lists of Medicines and Minimum range of medicines required for medical care".
Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries. www.dentons.com.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.