Investors came across regional ins and outs in awarding special investment contracts
[PharmVestnik # 04, 07/02/2017, p. 1, cont’d p. 6]
Alcohol drug transfer into Rx category postponed
The market players concerned were eager to know the results of the Ministry of Health (MoH) meeting on alcohol drugs. Back in late 2016, Director of MoH Public Health and Communications Department Oleg Salagai stated that the ministry was to make a decision on the list of alcohol drugs to be dispensed upon prescription until the end of January 2017. However, no decision on that burning issue has been made so far. For a time being, the only tool for fighting the so-called “pharmacy alcohol abuse” will be limitation of the alcohol container volume.
[PharmVestnik # 04, 07/02/2017, p. 2]
MoH to develop an ideal government bidding price
In the end of 2016, the Russian MoH presented a design of a state drug purchasing information analysis system. This system will target two issues, namely purchase description and price. But after proposals on the system implementation mechanism were published, most executive authorities and market players were against such novelties. Major problems were associated with the reference pricing. The mechanism proposed may result in drug shortage.
[PharmVestnik # 04, 07/02/2017, p. 6]
Individual businesses not to “invite themselves along” government drug marking project
On February 1st, a drug marking pilot project was launched in Russia. Throughout the past year, relevant agencies were drafting the regulatory documentation, and the equipment required was installed on pharma companies’ production lines. There are other business entities as well that are interested in this project. However, experts believe that they will not be able to find their place in the new drug marking system managed in full by state agencies.
[PharmVestnik # 04, 07/02/2017, p. 7]
Concurrent drug and API registration under discussion
A draft law aimed at acceleration of state drug registration was introduced to the State Duma. This document amends the currently applicable regulations by providing to the manufacturers of an opportunity to produce drugs from the APIs dossiers for which are filed in the drug registration process. This means that generic manufacturers will no longer have to wait for above a year to have their APIs registered as before. Market players think this draft law to be good overall; however, they found certain legal and conceptual weaknesses in this document.
[PharmVestnik # 04, 07/02/2017, p. 8]
Telehealth law may be adopted this year
Presently, the State Duma reviews the telehealth draft law authored by the Internet Development Institute. Shortly, another telehealth project initially developed by the MoH and finalized by experts will be presented to the Duma. Thus, the deputies will have to decide which of the documents will make the basis for legislation given that both draft laws provide for revolutionary changes in the conservative Russian healthcare system. Vladimir GURDUS, a member of the Government Expert Council, speaks about the telehealth program chances to be launched this year.
[PharmVestnik # 04, 07/02/2017, p. 10]
Russian oncologists discussed a future national cancer program
The existing healthcare funding system will not be able to cover a national cancer program to the full extent, and early cancer diagnosis does not make sense so far, as just a small part of cancer patients has access to innovative drugs. On December 1st, 2016, oncologists discussed a draft national cancer program within the framework of the scientific and practical conference “Current issues of clinical oncology: 1st All-Russia meeting” at Blokhin Russian Cancer Research Center in Moscow.
[PharmVestnik # 04, 07/02/2017, p. 11]
Adoption of a web-based drug sales law postponed again
Web-based drug sales may not be legally permitted before October 2017, although earlier the relevant law adoption was expected in March at latest. Experts warn that the delay with the law adoption leaves all chances for unfair traders to sell drugs online without competition from reliable pharmacies capable of guaranteeing high-quality services.
[PharmVestnik # 04, 07/02/2017, p. 11]
Health economics may be drug efficacy evidence-based only
An individual health economic study may last from six months to more than a year. An analysis of 1,500 health economic studies in Russia showed that they were conducted by staff members of 63 universities; however, most studies were conducted in Moscow, St. Petersburg, Volgograd, and Nizhny Novgorod. Public health officials increasingly often resort to studies; in particular, federal drug lists take into account such studies. PharmVestnik interviewed Roza YAGUDINA, Head of Drug Coverage and Health Economics Management Department of Sechenov First Moscow State Medical University, on strategic approaches to health economics application.
[PharmVestnik # 04, 07/02/2017, p. 12]
Hi-tech medical device registration system to be simplified
The medical device registration system applicable in Russia is deterrent to the industry development. Experts arrived to such conclusion after they discussed measures aimed at improving the relevant system on January 31st in Moscow.
[PharmVestnik # 04, 07/02/2017, p. 13]
MoH is proposed to ban Ukrainian drugs
The bans on importing Georgian wine, Latvian sprats, and Holland tulips are still well-remembered; at the same time, a new sanction list candidate is already on its way. Sergey Zhigarev, Chairman of the State Duma Committee for Economic Policy, Industry, Innovative Development, and Entrepreneurship, approached the MoH with a proposal to ban in Russia the drugs manufactured in Ukraine.
[PharmVestnik # 04, 07/02/2017, p. 14]
What is barring Russian oncologists striving to conquer cancer?
Annually, 500 thousand new cancer cases are recorded in Russia, nearly half of these cases being advanced. Nearly 300 thousand cancer patients die in Russia every year, one third of them — on the year they were diagnosed. At the same time, oncologists note that both the world and Russian medicine have made huge advances in cancer treatment, both in terms of surgery and pharmacotherapy. A very high technology level provides for successful oncotomy of tumors that were considered unresectable just a few years ago. Up-to-date drugs, including those manufactured by Russian companies, provide for sustainable remission with minimum adverse effects. But only 2—5% of cancer patients in need of novel targeted medications have access to them. Due to a shortage of funding, approx. two thirds of cancer patients in Russia do not receive an adequate chemotherapy, and three fourths — an adequate radiation treatment. Overall, Russian oncology has a 10x funding gap. Such information was voiced by leading Russian oncologists at the press conference of the 10th forum “Movement Against Cancer. Oncology limitations”.
[PharmVestnik # 04, 07/02/2017, p. 15]
Vaccine manufacturer asks to change government procurement system
Combiotech approached the government with a proposal on changing the government procurement system as this private vaccine manufacturer was deprived of access to the only sales channel, namely a state order. According to the source of information close to Combiotech, such situation presents a threat not only for the above company but also for the country’s security in terms of bioimmunology as the government striving to cut costs in all ways possible has to purchase the cheapest low-quality APIs from foreign manufacturers. However, Natsimbio, an official state vaccine supplier, does not see any discrimination against the above private company as the former purchased large amounts of Combiotech’s products on a regular basis.
[PharmVestnik # 04, 07/02/2017, p. 16]
State Duma deputies ask to check the efficiency of hi-tech equipment use
Tatiana Solomatina, a member of the State Duma Committee for Public Health, sent to the MoH a request for information on the progress of the implementation of the healthcare modernization program in the Russian federal subjects as of 2016 in respect of expenditures associated with the acquisition of medical equipment as well as the use of such equipment. She declared that high-cost equipment in many regional hospitals was standing idle for years. According to the Federal Service for Surveillance in Healthcare and Social Development that monitors the equipment-related situation on an annual basis, the number of the equipment units standing idle decreased twofold in 2015. However, not all experts agree with the above figures.
[PharmVestnik # 04, 07/02/2017, p. 17]
Drug and supplement advertising market report, 2016
Nowadays, it is increasingly important to realize that the main thing is not so much to manufacture products as to sell them. When drugs and dietary supplements are superabound at pharmacies, brand awareness and loyalty cannot be overestimated. Therefore, adverts keep embossing the media.
[PharmVestnik # 04, 07/02/2017, p. 20]
Insulin state procurement report, 2016
Diabetes ranks third among causes of death, giving way only to cardiovascular diseases and neoplasms. It evolves as the most widespread noninfectious disease in the world resulting in numerous deaths, which means that diabetes control must be taken to the level of national programs. As insulin is a basic diabetes mellitus drug, it is important to review insulin state purchasing. The data was provided by IAS Zakupki (Information Analysis System “Procurement”).
[PharmVestnik # 04, 07/02/2017, p. 21]
Adopting best practices
Part 1. Clinical trials regulation in the EU until 2014
In 2014, the European Parliament and Council of Europe guideline regulating clinical trials in the EU was terminated. A directly applicable regulation was adopted, namely the Regulation on clinical trials of human drugs. The European legislative changes in the clinical trials area may affect the relevant environment in Russia.
[PharmVestnik # 04, 07/02/2017, p. 32]
