New restrictions for interaction of pharmaceutical businesses with doctors
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:
1) Introducing the requirement for pharmaceutical companies to (a) post on their official websites and (b) report to the relevant federal executive body (Roszdravnadzor) the information about dates, locations, timing of scientific events which are aimed at raising the professional awareness of medical specialists or where the information about medical products is presented, as well as the data on the events’ participants, agenda and programs (Article 54, Clauses 2, 3);
2) Introducing, starting from 01.01.2014, administrative sanctions for companies for non-submission, late submission or deliberately unreliable submission of the said information, in the form of a fine in ranges of 10’000 – 15’000 Rubles (for the management) and 30’000 – 70’000 Rubles (for legal entities) (Article 39, Clause 11);
3) Extending the Federal Law # 61-FZ “On Circulation of Pharmaceuticals” by provisions similar to those contained in Article 74 of the Federal Law “On Basics of Public Healthcare in the Russian Federation”. In particular, pharmaceutical companies are prohibited from non-admitting to scientific events of other entities which manufacture or sell drugs with a similar curative mechanism, and from creating discriminatory conditions for any if the events’ participants (Article 54, Clause 1, Sub-clause 15);
4) Establishing administrative sanctions for healthcare professionals for the following violations (Article 39, Clause 4):
- failure by a medical / pharmaceutical professional to provide information about conflicts of interest to the management of their organization (a fine in range of 3’000 – 5’000 Rubles);
- failure by the head of a medical / pharmaceutical organization to notify or the late submission of a notification of a conflict of interest to an authorized federal executive body (a fine in range of 5’000 – 10000 Rubles);
- a repeated violation of the above offences (a fine in range of 10’000 – 20’000 Rubles, or disqualification for up to six months).
Health Ministry proposes reconsidering prices for vital and essential drugs
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.
Ministry of Healthcare tables amendments to the law “On circulation of pharmaceuticals”
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.
Rules approved to create list of drugs purchased under trade names
From 1 January 2014 rules will come into force for creating a list of drugs procured in accordance with their trade names.
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.
Procedure for creating a list of drugs to undergo public discussion
The Russian Government prepared the Resolution "On Approving the Procedure for Creating Lists of Drugs Prescribed Under Russian Law".
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.
Experts elaborate measures to regulate online trade of drugs
According to the Ministry of Healthcare, the online retail trade of drugs needs to be standardized and regulated in order to combat the proliferation of counterfeit and substandard products.
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.
Experts discussed the state regulation of the medical goods circulation
On 28 November 2013 the Russian Chamber of Commerce hosted a scientific conference on issues related to the state regulation of the circulation of medical products.
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. "