Moscow trying to sell Stolichnye apteki pharmacy chain
[PharmVestnik # 24, 02/08/2016, p. 1, cont’d p. 2]
Ministry of Economic Development assesses state programs
The Russian Ministry of Economic Development presented to the government a consolidated report on the implementation and efficiency of the state programs as of 2015. The ministry’s analysis was based on annual reports of the relevant agencies as well as the funds allocation information provided by the Ministry of Finance. The Development of Pharmaceutical and Medical Industry for 2013—2030 program was evaluated among others. For some aspects, e.g. “the responsible agency’s efficiency”, the Ministry’s of Industry and Trade index was just 25%.
[PharmVestnik # 24, 02/08/2016, p. 3]
An efficiency mirror
Russia’s regions waiting for orphan disease patients drug coverage funding
The Federal register of rare disease patients includes about 15,000 subjects, of whom more than 7,000 are children. According to experts, since 2013, the drug coverage costs associated with this patient category increased by 6 bn RUB. Far from all regions obligated to allocate funding for drug procurement can carry the burden. At the moment, it is still unclear whether a tranche from the federal government may be expected. An opportunity of allocating extra-funds was discussed at a recent government meeting under a socioeconomic agenda. It is known that the discussion centered on 20 bn RUB, of which 8 bn RUB are allegedly to be allocated for regions in order to cover orphan disease patients drug coverage costs. However, no official order has been signed to this end so far. It was stated at a recent Expert Board meeting at the Federation Council that if the government ever learned how to cope with such challenges, then there would be a chance to make the entire healthcare system more efficient.
[PharmVestnik # 24, 02/08/2016, p. 4]
New drug coverage system for children with mucoviscidosis proves unpopular
Mucoviscidosis has the highest incidence rate among rare diseases, with 3,000 patients registered in Russia, about 400 – in Moscow; of them, approximately 250 are children. For a long time, this disorder was not discussed in public. The situation changed dramatically 4 years ago following unethical behavior of radio journalists discussing this issue that was highly publicized afterwards. Recently, another reason for debate evolved. Sharp criticism from patient associations was drawn by the recent changes to the drug coverage procedure in respect of patients with mucoviscidosis under 18 years residing in Moscow.
[PharmVestnik # 24, 02/08/2016, p. 5]
Who is to pay for drug localization?
Relevant ministries received official recommendations
The Russian government continues working on the pharma industry development and import substitution program. The Export Board under the State Duma’s Committee for Industry prepared recommendations for the Ministry of Health and Ministry of Industry and Trade in charge of the program implementation. Pharma companies already know part of these recommendations, while others have played out in fresh colors. Nonetheless, experts believe that it is impossible to implement some measures recommended as they are.
[PharmVestnik # 24, 02/08/2016, p. 6]
Ministry of Industry and Trade ready to determine drug manufacturing “depth”
On July 15, the Ministry of Justice filed the Ministry’s of Industry and Trade (Minpromtorg) order that approved the procedure of issuing a drug manufacturing process stage document to pharma companies. Now the industry players are waiting for Minpromtorg’s next step, namely a decision on the number of stages sufficient in order to treat a drug as local.
[PharmVestnik # 24, 02/08/2016, p. 7]
Foreign companies begin realizing that Russia is serious about GMP Inspectorate
Currently, the number of refusals to issue a Russian GMP certificate to foreign drug manufacturing sites exceeds the number of positive decisions. According to the Russian GMP Inspectorate officers, the main problem is the manufacturers’ formal approach to inspections. For some reason, they are sure that the relevant GMP certificates issued by other countries will be enough to successfully pass all checks by Russian inspectors. In fact, it turned out that far from all companies supplying their drugs to Russia are familiar with the local norms and regulations. The situation is changing mainly because the Inspectorate officials and relevant associations keep explaining the requirements applicable to foreign businesses pursuant to the Russian legislation.
[PharmVestnik # 24, 02/08/2016, p. 8]
Big Pharma injections
Alexander Kuzin on deals and manufacture
In late July, NovaMedica held a meeting of the bidding commission for a drug production facility construction in Kaluga region. Two hours before this event, NovaMedica Managing Director Alexander KUZIN gave an interview to PharmVestnik. He related, among other things, why the deal between an evolving Russian company and Pfizer was a win-win.
[PharmVestnik # 24, 02/08/2016, p. 10]
One for all
Proposal on merging all state bidding sites disapproved
The Russian Federal Antimonopoly Service (FAS) criticized the Ministry’s of Economic Development plan on creating a common state bidding site. Representatives of the existing sites fell in with the FAS and rejected the Ministry’s of Economic Development initiative threatening with creating a monopoly on the state bidding market.
[PharmVestnik # 24, 02/08/2016, p. 12]
Government bids for drugs: market report, H116
The government bidding for drugs attracts close attention of the regulators and public. This report is based on analytical data provided by IAS Zakupki.
[PharmVestnik # 24, 02/08/2016, pp. 14-15]
Granting life by killing
Antibiotics consumption in the Russian retail segment
Discovery of antibiotics in the 1930s and their wide application during the World War II resulted in a break-through in terms of managing infectious diseases that had caused disablement and even death before. One may assert that this factor, together with the economic growth in many countries, was the reason behind the population outbreak in the 20th century. Thus, in 1820, the world population was 1 bn; in 1930s before antibiotics were discovered, it was 2 bn; currently, it is about 7.2 bn people.
[PharmVestnik # 24, 02/08/2016, pp. 18-19]
Specialists ready to organize drug coverage of rare disease patients
Over the nine years of the Seven Diseases program operation, a few dozen hundreds of Gaucher disease patients came back to normal life. Representatives of physician and patient associations prepared an application to the Russian Ministry of Health regarding a set of measures to be taken on a regular basis in order to subsidize the deficit-ridden portion of the regional expenditure commitments. The MoH disagreed with their arguments.
[PharmVestnik # 24, 02/08/2016, p. 20]
Medical device assessment needs modernization
Medical device production and sales regulation is the most advanced niche in terms of the local and international regulatory and legal framework harmonization. At the same time, experts notes that there is still a lot of inconsistencies in the local legislative field. Deputy Director of the State Research Center of Applied Microbiology and Biotechnology Anatoly SHEPELIN, DSc (Biol.), briefed PharmVestnik on the harmonization process and issues that remain burning.
[PharmVestnik # 24, 02/08/2016, p. 21]
