RFID chips all around
Ministry of Finance to label drugs for tracking
[PharmVestnik # 16, 04/05/2016, p. 1, cont’d p. 4]
State bidding system to be furnished with a three-stage structure of preferences
Creating additional preferences depending on the pharmaceutical manufacture localization “depth” is the Ministry of Industry and Trade next step after launching the “odd-man-out” mechanism. Presently, it goes about a three-stage structure to be implemented in the state bidding. The professional community has already started discussing this initiative authored by Natsimbio (National Immunobiological Company, JSC). Businesses approve of the initiative in itself, but it is unclear so far how to implement it while avoiding conflicts with other manufacturer support tools.
[PharmVestnik # 16, 04/05/2016, p. 2]
Eurasian Intergovernmental Council to assume new powers
In late April, the Russian Chamber of Commerce and Industry was the venue of just another discussion by state authorities and businesses on parallel imports and mandatory licensing. Apart from a routine debate typical for such meetings, a sensational statement was made. Executive Director of Pharmaceutical Innovations Associations Vadim Kukava informed the audience that the Eurasian Intergovernmental Council signed an order on preparing amendments to the Eurasian Economic Union Agreement that would empower the council to determine exemptions from the application of the principle of exhaustion of exclusive trademark rights.
[PharmVestnik # 16, 04/05/2016, p. 3]
Local medical device manufacturers urge to accelerate EEU common market launch
In the judgement of local medical device and equipment manufacturers, many items of the EEU Common Market Agreement are so attractive that the manufacturers cannot wait until they are given a thumbs-up. When speaking at an industry meeting, a representative of Zdravmedtekh Association proposed to incorporate individual items of this agreement into the national legislation already now without waiting for the common market to be launched. Quite naturally, this initiative was not discussed with all seriousness by the relevant ministries, but everybody approves of the emotional disposition of businesses. The professional community demonstrates a positive attitude to the common market, but, according to the Eurasian Economic Commission’s latest communication, there is no understanding so far of how long it may take to go through all approvals of the relevant documents.
[PharmVestnik # 16, 04/05/2016, p. 4]
Pharma market players to size up their counterparties more attentively
In 2015, which was the first year of recession, there were no large-scale bankruptcies, although there were some candidates. Nonetheless, the pharma market has thinned out as the stronger players have acquired the weaker ones. But this is just the beginning as not all of those still kicking are doing well. The issue of non-payments is being voiced increasingly often, and not only on part of pharmacy chains but also on part of distributors. Whereas before an advance payment was perceived in the pharma industry as something similar to punishment, now a partner asking for prepayment may become a trend-setter.
[PharmVestnik # 16, 04/05/2016, p. 9]
Foreign manufacturer site inspection opponents still have a card up their sleeves
The regulatory system evolution simultaneously with the pharma market development is an expected process. It shall not be considered an act of God preventing businesses from keeping on track. There is nothing worse than the situation when legislation is stagnating, as in the early 2000s. Therefore, if one analyzes the current pharma market environment and evaluates initiatives proposed by various ministries without being over-emotional, then one will be able to clearly see the vector aiming at creating a sustainable and workable regulatory system for this market. This is the viewpoint of NovaMedica Vice-President for Pharmaceutical Operations Mikhail GETMAN who was a recent guest of the Editorial Fireplace rubric.
[PharmVestnik # 16, 04/05/2016, p. 10]
MoH to get ready for state bidding reform
The late April saw an end of a public debate on the government draft regulation on centralization of purchasing diagnostic agents and drugs for the treatment of multiple drug resistant tuberculosis, HIV infection, and viral hepatitis. According to the document text, the Ministry of Health undertakes purchasing of all drugs required, including for healthcare institutions within jurisdiction of the Federal subjects. Besides, the ministry is ready to take charge of drug redistribution in case of their excess or shortage in specific regions.
[PharmVestnik # 16, 04/05/2016, p. 11]
A place for disputes
National Pharmaceutical Chamber convened its 1st congress
The mission of the National Pharmaceutical Chamber that held its 1st congress on April 22 in Moscow is to shape the industry, keep changing, and serve people. The congress’ agenda was intense: in just one day the delegates and participants were able to discuss the state policy in respect of the population drug coverage, issues and key trends of the pharmaceutical industry development as well as initiatives regarding improvement of the specialist training system and standardization of pharmaceutical activities. The congress resulted in adopting a resolution in which the chamber formulated a wide range of proposals that, if implemented, would shape the pharma industry’s future.
[PharmVestnik # 16, 04/05/2016, p. 12]
Money is not an issue
Denis Shvetsov on APIs, antibiotics, and investment
In early 2015, SIA International sold Biokhimik, an antibiotic manufacturer located in the town of Saransk, to API distributor NC Pharm. The latter attended to the new asset as appropriate, e.g., already in December 2015, Biokhimik was issued a GMP compliance statement. JSC Biokhimik CEO Denis SHVETSOV discusses difficulties that the new owners have to overcome as well as problems the Russian API manufacturers are faced with.
[PharmVestnik # 16, 04/05/2016, p. 14]
Cosmeceutical market report
Parapharmaceutical sales have been overall growing in Russia over the past few years. As a whole, sales of parapharmaceutical product categories (without dietary supplements) grew by 14% in value terms and 7% in real terms in 2012—2013. In 2014, the growth in this segment slowed down in the unfavorable economic environment to reach 8% in rubles and -3% in packs. In 2015, the recession trend intensified as consumers started saving on parapharmaceuticals.
[PharmVestnik # 16, 04/05/2016, pp. 18-19]
Drug launches in Russian pharma market, 2015
In 2015, some pharma companies declared launches of several drugs at once. Over the past few years, there was a trend to increasing an R&D cost share on the world pharma market. The Russian manufacturers strive to reinforce an innovative component in their competitive struggle as well.
[PharmVestnik # 16, 04/05/2016, pp. 20-21]
Fatal purchasing
Pharmacy heads believe that the transfer of state and municipal pharmacy chains to purchasing in line with the Federal Law No. 44-FZ “On contract system in the sphere of purchasing goods, works, and services for the state and municipal needs” dated 05.04.2013 will result in destruction of this segment. Prior to May 11, 2016, the relevant draft law initiated by the RF government is to undergo legal due diligence and public disputes. Pharmacy chains have already sent a letter stating their concerns to Anatoly Aksakov, State Duma Chairman for Economic Policy, Innovative Development, and Entrepreneurship.
[PharmVestnik # 16, 04/05/2016, p. 24]
South Russia’s regions demonstrate a high level of healthcare computerization
It was expected that from July 1, 2016, the Russians will be able to get e-prescriptions for sure. The project launch deadline has been shifted several times; however, it is obvious that only the residents of a limited number of regions will be able to use this service in some of the healthcare institutions in a couple of months, but not the way it was announced when the healthcare computerization program was launched. The situation is somewhat better in the south of Russia, but this situation is rather ambiguous.
[PharmVestnik # 16, 04/05/2016, p. 25]
TV instead of doctor
Tatiana SOLOMATINA, Chairwoman of the Healthcare Commission, Co-Chairperson of the Tomsk regional division of the All-Russia People’s Front, when speaking at the 50th meeting of the Legislative Duma of Tomsk region, urged her colleagues to support an appeal to the Russian State Duma for amendments to the Federal Law “On advertising” in respect of prohibition of drug advertising outside of specialized conferences and medical printed media. Ms. SOLOMATINA explained her position to PharmVestnik.
[PharmVestnik # 16, 04/05/2016, p. 25]
