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15
April
2016

HIV drugs being prepared for expropriation

Yesterday, during a roundtable held at the Russian Union of Industrialists and Entrepreneurs, Timofey Nizhegorodtsev, Head of the Social Sphere and Trade Monitoring Department at FAS Russia, said that the introduction of compulsory licensing of drugs would give the government additional opportunities for providing drugs to the population in “extraordinary” circumstances. Such could be, as was previously stated by Minister of Health Veronika Skvortsova, the current situation with the rising incidence of HIV/AIDS.

Kommersant
18
March
2016

FAS has developed a draft bill on compulsory licensing

This federal agency has created a draft federal bill “On Amendments to the Federal Law – On Protection of Competition and Article 1362 of the Civil Code of the Russian Federation”. This document provides for compulsory licensing of certain goods.

Pharmaceutical Bulletin
15
March
2016

Bad compromise

The Competition Authority intends to be especially tough on persistent violators of the law, and actively cooperate with law enforcement authorities. At the same time, it will work on reaching peaceful agreements with companies voluntarily pleading guilty and prepared to change their behaviour in the market. However, experts warn that, despite all the external attractiveness of this idea, companies should seriously weigh the prospects of such peaceful agreements.

Pharmaceutical Bulletin
17
February
2016

Lawyer – for the client: clear and to the point

If you are a lawyer, then they judge you, in the first place, by your texts – at least, this is the argument of Brian Garner, head of the American company Law Prose. This scientist has devoted a great deal of work to the “ideal” legal prose. Although the requirements for it always depend on the company, the client and the set goals, Garner has created ​​a set of universal rules that can help improve any legal text. The editors of Pravo.ru chose nine key rules, and consulted with Russian specialists as to how best to implement them.
Pravo.ru
18
January
2016

No power

In 2016, during confirmation of pharmaceutical drug (LP) registration in Russia, foreign manufacturers may provide GMP certificates of conformity that were issued abroad. The act, which made the appropriate changes in Law 61-FZ, was signed by the Russian President at the end of 2015. The response to allegations made by lobbyists at the legislative level, was reflected in the postponement of inspections, recall foreign manufacturers: 01 January 2017 was set as the date of entry into force of Federal Law No. 429-FZ, the latest amendments to Law 61-FZ – recognizing the fact that Russian regulators were not ready to carry out inspections of foreign sites in 2016.

Pharmaceutical Bulletin
17
November
2015

Without discrimination

FAS explained the procedure for the formation of selling prices for Vital and Essential Drugs (VED), depending on the applicable taxation system.
Pharmaceutical Bulletin
13
October
2015

Meeting place cannot be changed

In early October, the public discussion on amendments to Administrative Offences Code ended. The draft bill provides for new types of offenses and penalties for medical and pharmaceutical workers. Finally this document has set penalties for doctors communicating with representatives of medical companies, although these fines amount to no more than 20,000 roubles. However, not all the penalties are so frivolous. For some other offences, Roszdravnadzor plans to levy fines of up to 5,000,000 roubles or suspend the activities of a company for three months.
Pharmaceutical Bulletin
22
September
2015

The difficulties of interpretation

In the order of the Ministry of Healthcare of Russia, which amends the procedure for the designation of drugs, experts have found an item that contradicts the INN norms for statement preparations. The ministry explained: the new position is correlated with the current system of statements and prescribing of drugs, and the updates apply only to the internal circulation of medicinal products in a hospital. FAS Russia intends to check the rate of dispensing of medicinal products in hospitals for the presence of anti-competitive provisions.
Pharmaceutical Bulletin
12
April
2016

Spy bridge

“FV” analysed the draft amendments to Law FZ-7 “On Non-Profit Organizations” within the sphere of clarifying the notion of “political activities”, and came up with a curious conclusion. If this law is adopted, joining the ranks of foreign agents, with a high degree of probability, will be the majority of charities and professional associations operating in the pharmaceutical industry. Moreover, these may not only be the companies, whose staff is composed of citizens of other countries, but also those whose members are traditionally domestic organizations, but with offshore charter capital.

Pharmaceutical Bulletin
18
March
2016

FAS will allow the court to sell a patent without the consent of the copyright owner

The Federal Antimonopoly Service has come up with a punishment for abusing the dominant position of rights holders. Using new amendments to the RF Civil Code, they propose to punish the forced transfer of a license to use an invention. The right to appeal to the court will be given only to the agency itself and the company that is ready to produce similar goods. The adoption of this bill will of course have an impact on the pharmaceuticals sector – what this impact will be, the lawyers are working on right now.

Pravo.ru
18
February
2016

Merry starts

Federal State Institution “State Institute of Drugs and Good Practices” officially started its work, at the request of foreign companies, on carrying out inspections

Pharmaceutical Bulletin
22
January
2016

The Law on PPP does not address the fundamental problem – long-term guarantees of return on investment

It is assumed that Federal Law No. 224, which entered into force on 01 January 2016, will create opportunities for the development of the institution of public-private partnerships in Russia. However, despite the fact that the list of objects, for which agreements on public-private partnerships or municipal-private partnerships could be concluded, includes health care facilities, the law does not define either the specifics of the healthcare objects, nor the practice of interaction between government and business, which has already been tried and tested at the regional level.

Medicinskiy vestnik (Medical bulletin)
23
December
2015

The “odd man out” resolution is working against Russian producers


The application of government decree number 1289 (“odd man out”) has caused serious problems for participants in the public procurement process. State customers require bidders, offering to supply Russian drugs, to have a certificate of origin of the product, but to date, the procedure for issuing such certificates has not been approved.
Pharmaceutical Bulletin
13
November
2015

Medications will become interchangeable

The Russian government approved the procedure for determining the interchangeability of drugs for medical use. The corresponding decree was signed by Prime Minister Dmitry Medvedev. Some industry representatives did not see in this document anything that the market had been expecting – a decision on interchangeability, and consider it just the next in a series of “guidelines”. However, the FAS has firmly stated that no other regulations on interchangeability are foreseen for the future.
Pharmaceutical Bulletin
29
September
2015

Grooming and paralleling

Prime Minister Dmitry Medvedev suggested, as one anti-crisis measure, the introduction of parallel imports in April. Since then, the development of this initiative, well, rather discussions about it, have been moved to the Eurasian Economic Commission (EEC) platform. By mid-September, on the eve of the next meeting of the EEC, appeared criteria for selecting the industries in which it would be possible to return to parallel imports. Ideal for the role of the “first victim” is the pharmaceutical industry, according to lawyers.

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