The Russian Ministry of Health has approved the strategies for drug provision until 2025, aimed at improving the availability and access of drugs for the country's population.
IHS Global Insight perspective | |
Significance | In its order No 66, dated 13 February 2013, the Russian Ministry of Health approved the strategies for drug provision until 2025 and the plan for their implementation. |
Implications | The "tasks" for these strategies not only include the formation of registers of patients eligible for free or discounted drugs in an outpatient setting, but also the streamlining of pre-clinical, clinical, and production requirements, and the introduction of a system of reference pricing. |
Outlook | The strategies reflect the government's aim of improving access to drugs while maintaining a control over costs. |
The Russian Ministry of Health (MoH) has issued an order, No 66 from 13 February 2013, approving the strategies for drug provision until 2025, as well as the plan for the implementation for these strategies, reports Pharmvestnik.ru. The aim of the strategies is "increasing the availability of high-quality, effective and safe medicinal products in order to meet the needs of the population and the healthcare system through the development of a rational and balanced, with the available resources, system of drug supply for the population of the Russian Federation". The full order, in Russian, is available here.
The document lists five main "tasks" for the strategies:
- Task 1: "Ensuring the rational use of drugs for medical use". The measures for addressing this task include introducing updated clinical practice guidelines, implementing an "effective system of rational use of drugs on the basis of evidence-based medicine", forming registers of patients that would be eligible to receive medicines free or with a discount on an outpatient basis, and introducing a system for the electronic prescription of drugs.
- Task 2: "Improving the procedure of forming the list of drugs, the provision of which is to be carried out within the framework of the government's guarantees for free medical care to citizens, as well as within the provision of state social assistance in the form of a set of social services". This is to be carried out through improving the procedure for formulating the drugs lists, as well as the "provision of state social assistance in the form of a set of social services, according to their pharmaco-economic efficiency and clinical recommendations".
- Task 3: "Safety, efficacy, and quality of products for medicinal use". The measures here include improving the state control and permit system, as well as the monitoring of quality, efficacy, and safety of drugs; inspections of the production of medical immunobiological preparations, as well as their certification and monitoring of their side effects; streamlining the requirements in terms of preclinical and clinical research, production, storage, transportation of drugs etc; forming a list for interchangeable drugs for medical use; and optimising the procedure for the registration of orphan drugs.
- Task 4: "Improving state regulation of prices for drugs for medical use, the provision of which is to be carried out within the framework of the government's guarantees for free medical care to citizens, as well as within the provision of state social assistance in the form of a set of social services". In order to achieve these, the state regulation of prices for drugs is to be improved, in particular through the development of a system of reference prices.
- Task 5: Increasing the qualifications of medical and pharmaceutical workers.
Funding
The financing of the strategies is to come from funds allocated from the federal budget, regional budgets, and extra-budgetary funding. The funding for the third stage of the strategies is to be decided following the implementation of the first two stages.
Outlook and implications
The MoH had published the draft document for the strategies of drug provision until 2025 in November 2012 (see Russia: 2 November 2012: Russian MoH publishes strategies for drug provision implementation until 2025). The strategies are to be implemented in three stages (the timeframe for which has been changed slightly from the draft). The first phase, from 2013 to 2015, is aimed at implementing regulatory and organisational changes in order to ensure rational drug use and the optimisation of the system; the second phase is from 2015 to 2016, when the pilot projects are to be put into effect; and the third phase covers 2017–25, and would involve the implementation of the effective models of drug provision in the country. As per the draft, the strategies involved the introduction of three reimbursement models, with the List of Vital and Essential drugs (ZHNVLP) forming the base for the drug provision programme. It is therefore noteworthy that one of the tasks involves the implementation of a system of reference pricing, with the draft stipulating an "optimal methodology for reference prices" consisting of determining the median (reference) price and a "fixed step away from the upper and lower price niche (deciles)".
Thus, although the strategies aim at increasing access to drugs for the country's population, the introduction of reference pricing also points to the government's objective to control costs.
It is also important to note that the focus of one of the measures on orphan drugs also follows the MoH's proposal for an accelerated registration procedure for these drugs, potentially pointing to the government's aim of improving access to them (see Russia: 29 January 2013: Russian MoH publishes draft amendments to federal law "on drug circulation").