Russia’s President signed a list of orders to regulate drug market
[PharmVestnik # 19, 07/06/2016, p. 1, cont’d 5]
A bottleneck
Starting from January 1, 2017, any foreign pharmaceutical manufacturer will be required to have a GMP certificate
A Russian GMP compliance certificate became the focus of special attention a few months ago. Notwithstanding the fact that all regulatory gaps have been bridged there are two opposite viewpoints at the Russian GMP Inspectorate in terms of the current regulation: the regulators do not see any problems and behave reassuringly, while the foreign manufacturers led by the AIPM are worried. PharmVestnik decided to make out who and when might need a Russian GMP compliance certificate.
[PharmVestnik # 19, 07/06/2016, p. 2]
FFOMS accuses Kirov region of trickery
According to experts, the results of the only pilot drug reimbursement project pursued by Kirov region are doubtful. The reimbursement project for cardiovascular disease patients launched in 2013 has demonstrated fantastic results: its economic effect at 90.5 mn RUB exceeded threefold the regional budgetary allocations for the program implementation. The only “but” is that the region cannot make use of this money as the money is “caught” somewhere in the healthcare system. In turn, analysts and the Federal Mandatory Medical Insurance Fund (FFOMS) assert that there are no millions of rubles freely available and that the Kirov regional government obviously magnify their pilot project’s efficiency.
[PharmVestnik # 19, 07/06/2016, p. 3]
Why Pharm-Sintez developed Copaxone and Velcade generics but failed to market them
In early May, R-Pharm announced that they registered the first in Russia Copaxone (glatiramer acetate) generic. However, another Russian manufacturer, F-Sintez, stated that their generic, Axoglatiran FS, might have been registered earlier if the timely registration had not been prevented by the officials’ procrastination. At the same time, Pharm-Sintez was the first in Russia to start developing a Copaxone generic. PharmVestnik asked Pharm-Sintez Chairwoman of the Board Anna NAZARENKO and CEO Milan YAROSHINSKY for comments.
[PharmVestnik # 19, 07/06/2016, p. 8]
36.6 Group closes Alliance Healthcare’s affiliates and warehouses but starts a new pharmaceutical partnership
In late May, Alliance Healthcare’s regional affiliates and warehouses stopped product shipments, which provided for a conclusion that 36.6 Group was not going to develop their wholesale business. However, according to the Group’s top management, this is not true. The thing is that the Group has chosen a non-standard approach to development. Besides, the Group has launched a new pharmaceutical partnership, which, among other things, will help developing logistics.
[PharmVestnik # 19, 07/06/2016, p. 9]
Parallel GMP worlds
Pharma business not ready for three simultaneous GMP inspection systems
Nearly half of the participants of Fleming Conference “Quality Assurance in Pharmaceutical Manufacturing” held on June 1 in Moscow gave the answer “Let’s wait and see” to the question about what the EEU market had in store for businesses. Pharma companies are not happy with the situation that may provide for the existence of three parallel approaches to manufacturing site GMP compliance inspection. Businesses are not going to oppose the implementation of tough regulations; however, they note the use of revolutionary, not evolutionary approaches when transferring to the GMP standards in Russia.
[PharmVestnik # 19, 07/06/2016, p. 10]
Both promising and interesting
By the Editorial Fireplace with Sergey Piven
According to SIA Internarional Ltd. President Sergey Piven, the company intends to make its way back to the TOP-3 distributors within the next three years. At the same time, SIA’s new management team does not plan to revive all achievements and undertakings of Igor Rudinsky, the company’s former owner. Thus, they are not interested in a vertically integrated business model.
[PharmVestnik # 19, 07/06/2016, p. 12]
Orphan disease treatment prospects remain dim
In Kazan, court proceedings are underway initiated by a cystinosis patient in respect of refusal to provide him with the required orphan drugs. A one-year treatment course costs 2-3 mn RUB. In 2015, the local ministry of health covered this patient with a 7,000 ruble-worth treatment and considered their obligations fulfilled. Such pieces of news are regularly coming from different Russian regions. The money allocated for covering patients with orphan drugs are running out; officials find a variety of ways to restrict purchasing high-cost drugs; and the patients bring such cases to court. One of the ways to resolve the problem is to manufacture orphan drugs locally. Will this idea be a success?
[PharmVestnik # 19, 07/06/2016, p. 13]
Flu drug and vaccine market report, 2014—2016
The topic of flu as well as its latest modifications has been increasingly the focus of attention from year to year, while at the same time demanding more funding, both from the state budgets and out-of-pocket by the population. There is a two-side approach to protection against this viral infection, i.e. vaccination and drugs to treat clinical manifestations of viral infections. This analytical report is based on IMS Health, IAS (Information and Analytical System) Purchasing, and EMISS (Common Inter-Agency Information and Statistics System) data.
[PharmVestnik # 19, 07/06/2016, pp. 14-15]
Russian pharmacy sector report, Q116
Most Russian pharma market reports prepared in 2015 ended with cautions forecasts for 2016. After the dramatic price changes, drug consumption reduction in real terms as well as regulatory collisions everybody was waiting for the year 2016 to bring in some clarity. This report based on IMS Health data shows whether the Russian pharma market development trends have evolved in a clearer way.
[PharmVestnik # 19, 07/06/2016, pp. 16-17]
Rating of Russian pharmaceutical distributors, Q116
In the beginning of this year, the central event was the rapidly closed deal that resulted in Alliance Healthcare becoming part of the actively growing Pharmacy Chain 36.6. Who acquired whom remains a philosophic question, but anyway such deals occur in Russia infrequently. For the first time since 2013, there is a change in the TOP-3 distributor ranking.
[PharmVestnik # 19, 07/06/2016, pp. 18-20]
API manufacture planned in Siberia
Pharmasintez considers an opportunity of constructing a large-scale API manufacturing facility in Irkutsk region. In this region, a company’s plant is already operating; the second facility is to be launched in 2017. The local government promised to consider co-funding of equipment purchases for the new project the fate of which would be determined next year.
[PharmVestnik # 19, 07/06/2016, p. 23]
Money unclaimed
Novosibirsk medical device and equipment manufacturers reluctant to seek Minpromtorg’s support
According to Vyacheslav Bratsev, Deputy Minister for Industry, Trade, and Entrepreneurship Development of Novosibirsk region, medical industry facilities used just one fourth of the funds allocated under the state support program in 2015. This information was voiced during the roundtable discussion “Medical industry development perspectives in Novosibirsk region” hosted by the Ministry of Industry and Trade (Minpromtorg).
[PharmVestnik # 19, 07/06/2016, p. 23]
Under the aegis of crisis
Dialog between Kazakhstan pharma business and regulators improves
The 23rd International Health Exhibition (KIHE-2016) closed in Almaty. It attracted participation of 200 companies from 19 countries (to compare: 300 companies representing 28 countries in 2015).
[PharmVestnik # 19, 07/06/2016, p. 24]
