Press centre News

23
October
2017

Will SPIC's shield their parties from new price setting methods? It is an open-ended question

As the week draws to a close, an event occurred that the pharmaceutical industry had been waiting for in the course of more than one year. The Russian Ministry of Industry and Trade signed special investment contracts (SPIC's) with the Russian divisions of AstraZeneca and Sanofi. It should be that since the contracts are signed, this means that all issues have been resolved - but it meant nothing of the sort.
Сollective of authors, VEGAS LEX
Pharmaceutical Bulletin
11
May
2017

The Federation Antimonopoly Service named those pharmaceutical companies whose drugs occupy a dominant market position

The Federal Antimonopoly Service (FAS) named 16 medicinal products that occupy more than 50% of their respective product markets. This data was derived after analyzing the state of competition in the product markets for several medicinal products, and published on the official FAS web portal.
Pharmaceutical Bulletin
2
May
2017

Legal interpretations by the Federal Antimonopoly Service may be disputed through a special procedure

In March 2016, a special procedure came into effect for challenging an act containing interpretations of legislation and possessing normative properties. It is enshrined in Article 217.1 of the Russian Federation Code of Administrative Proceedings. However, practice applying the article is still not common.
Pharmaceutical Bulletin
26
April
2017

Salvation for advertisers

The number of offenses committed in the area of advertising OTC drugs has increased significantly recently. The Federal Antimonopoly Service (FAS) explains that they are concerned about the situation, and urge pharmaceutical companies to be more careful during their advertising activities. The pharmaceutical industry, in turn, fearing the initiation of more administrative liability cases, is requesting a clearer description of what they can and cannot do. However, the FAS is not agreeing to impose additional regulations.
Pharmaceutical Bulletin
6
April
2017

The Ministry of Finance drafted a bill about allowing insurance companies access to medically confidential information

The Ministry of Finance drafted amendments to the law entitled “On the organization of the insurance business in the Russian Federation”, and pursuant to them insurance companies are granted access to information about individuals that is covered by physician-patient privilege. About one year ago, there was a similar initiative that was not able to rise up to the level of interagency debate. This time, the Central Bank supports the amendments, and the Ministry of Finance has sent the draft to different agencies so that they can receive their comments before April 10th.
Medicinskiy vestnik (Medical bulletin)
7
February
2017

They are discussing the possibility of registering pharmaceutical drugs simultaneously with active pharmaceutical ingredients

A bill has been introduced in the State Duma that speeds up the process of registering medicines with the government. The bill provides for changes that present pharmaceutical companies with the opportunity to manufacture drugs from active ingredients whose master files are submitted during the pharmaceutical drug registration process. That means that generic drug manufacturers do not have to wait for around a year for active pharmaceutical ingredients to be registered, the way it was before. Market participants believe that, on the whole, the bill is good – but they have discovered legal and conceptual gaps in it.
Pharmaceutical Bulletin
14
December
2016

What will happen if we drop VED prices?

The government will drop its price controls on Russian vital and essential drugs (VED), priced under 50 roubles. What will happen if the government should allow pharmaceutical companies to raise prices of affordable medicines, included on the VED list? What is to be expected after the adoption of this law? Will this lead to increased prices for drugs of mass consumption? The Pharmaceutical Business Magazine discussed these issues with experts from the pharmaceutical market.
Pharmaceutical business
29
November
2016

Compulsory licensing of medicines need not involve the courts

The Federal Antimonopoly Service (FAS) has decided on a compulsory drug licensing mechanism – “in the interest of the life and health of citizens”. The FAS is proposing to give the government the authority to introduce compulsory licenses without court approval, upon the payment of compensation to the right holder. Earlier, FAS stated that compulsory licensing was necessary to fight HIV-infection.
Kommersant
9
June
2017

Experts suggest ways to improve the system to combat cartels

Medicinal products and medical equipment, according to the Federal Antimonopoly Service, occupy one of the top positions on the list of commodity markets that are most susceptible to cartel collusion. Recently, the antimonopoly authorities presented a system, one that possesses multiple parameters, for identifying cartels during electronic bidding. With the help of this program, it is possible to identify and prove, while located at a distance, the existence of cartels in electronic bidding in any region or industry. "FV" asked industry experts how to improve the fight against cartels.
Pharmaceutical Bulletin
11
May
2017

The FAS imposed fines on pharmaceutical companies for using the word “quickly” in advertising

After reviewing a number of cases involving administrative offenses, on May 4th the Federal Antimonopoly Service ordered that the companies Astellas Pharma Europe B.V, Sandoz CJSC, and Valeant LLC pay fines for inaccurately advertising medicinal products.
Pharmaceutical Bulletin
26
April
2017

Flexible body

In recent years, analysts have noted an increase in the scope of public procurement for cancer drugs. Another trend is an increase in the share of drugs purchased during government bids within the framework of Federal Law No. 223. Some experts suggest that this may be due to an intensification of activity by medical clinics’ medical commissions to justify their decisions to purchase specific medicinal products.
Pharmaceutical Bulletin
10
April
2017

Expert: the question of whether to make changes to the Drug Master File because of labeling that was applied is still up in the air

Participants in the drug labeling experiment are not changing the packaging layout, but are applying a two-dimensional bar code where there is free space on the end of the package.
Pharmaceutical Bulletin
17
March
2017

Work with concessions made easier for health facilities

The Russian government has approved a bill drawn up by the Ministry of Healthcare aimed at expanding the usage of concession agreements with regard to healthcare facilities. The draft law, which amends Sections 5 and 8 of the Federal Law "On Concession Agreements", will soon be put to the State Duma.
Medicinskiy vestnik (Medical bulletin)
31
January
2017

Putin instructed that prices be reviewed for essential medicines

The President instructed the government to review the prices for essential medicines, and to check all public procurement of medicinal products. The head of state demanded clarification on whether the cost of medicinal drugs has been inflated.
RBC
8
December
2016

Jewellery approach rather than industrial scale production

The rouble devaluation has exacerbated the problem of underutilization of pharmaceutical plants, which has emerged in Russia in recent years. New production plants began to pop up like mushrooms in the 2000s. Business people became especially active after the Pharma 2020 Programme was launched. They clearly understood the signals – the pharmaceutical market was growing at a rate of at least 10% annually, and the government intended to support this industry, and the currency fluctuations in 2008-2009 had shown how the pharmaceutical business was resistant to an economic crisis. And everything would have been good, were it not for two "buts". First, the devaluation of five years before was just a mere drill. Second, too many pharmaceutical plants had sprung up, and many of them started going idle.
Pharmaceutical Bulletin
21
November
2016

The Ministry of Health is proposing life sentences for attacks on doctors

The Ministry of Health has proposed to toughen punishment for those attacking doctors, and wants them to be sentenced from 12 years to life imprisonment for such offenses. This is the Ministry’s response to frequent cases of attacks perpetrated against health workers
RBC
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