On 25.11.2013 Federal Law # 317-FZ was adopted, which introduced amendments to a number of legislative acts governing the healthcare and pharmaceutical activities. The following significant changes worth being highlighted:
According to the Ministry of Healthcare, the prices for drugs of Russian and foreign manufacture, and original drugs and their analogues from the Essential Drugs List should be registered under different rules. The Ministry of Healthcare has sent proposals for improving the methodology of Essential Drugs prices calculation to the Ministry for Economic Development.
The Ministry of Health is proposing to reduce the list of reference countries to 15. In each reference country, foreign pharmaceutical companies should obtain a confirmation of the declared price, or a documentary confirmation evidencing that the drug is not traded in the market.
Russian manufacturers of original pharmaceuticals with a complete production cycle are not required to provide a rationale for their prices; however, there should be a ceiling on how profitable a drug can be.
The Ministry of Health also proposes introducing a separate procedure for generic drugs prices formation.
Such concepts as biological drugs, bio-analog drugs, and interchangeable drugs have appeared in the Federal Law “On circulation of pharmaceuticals”. In addition, the Ministry plans to introduce an accelerated procedure for the state registration of medicines that treat rare (orphan) diseases, and an accelerated expert appraisal procedure for drugs used in pediatrics.
The basis for including a drug into the list is that the drug cannot be replaced with another on under an international non-proprietary name, or (in the absence of the INN) using a chemical or group name determined according to the efficacy and safety. Should the option for such a replacement exist, this shall be the reason for excluding a drug from the list.
The question of inclusion into / removal of a pharmaceutical from the list shall be considered and decided upon by the Government Public Healthcare Commission, at the request of individuals and legal entities.
A list of the basic drugs provides a framework for countries to develop their own domestic lists of basic pharmaceuticals (drugs of primary importance). With such a list, decision makers at the domestic level can reduce costs by identifying priority pharmaceuticals which are required to meet the health needs of their countries. The list can also play an important advocacy role: the inclusion of a drug in the list highlights its potential impact; removal can clearly signal that the drug is no longer appropriate.
It is planned for the Resolution to come into force in the first quarter of 2014.
During a meeting on 7 November 2013 of the Ministry of Healthcare working group and the Government Council of Experts on the Public Provision of medicines it was concluded that the status of the online retail trade of drugs has not been clearly defined. In this regard, it was decided to conduct an analysis of best global practices and the relevant Russian legal framework. On the basis of such analysis, proposals will be presented to improve the law.
To eliminate problems associated with the medical goods circulation, and to increase thus the competitiveness of the local manufacturing of medical goods, conference participants of the Union of Associations and Medical Industry Enterprises decided to summarize proposals made at the meeting in respect of improving the existing system of medical goods circulating and to submit them to the Russian Healthcare Ministry Coordination Council for discussion and for further introducing of amendments to respective laws.
The main issues discussed at the conference were "Legal framework supporting the medical goods circulation. Legal regulations. Law-enforcement practice. Government support for the medical industry. "
© 2020 KPMG. KPMG refers JSC “KPMG”, “KPMG Tax and Advisory” LLC, companies incorporated under the Laws of the Russian Federation, and KPMG Limited, a company incorporated under The Companies (Guernsey) Law, as amended in 2008.