Federal medical institutions cannot get payments for their services from insurers
[PharmVestnik # 7, 01/03/2016, p. 1, cont’d p. 3]
Localization of blood derived products requires access to APIs
Up to date, blood derived products were produced at blood transfusion stations and specialized clinics. Many things are lacking for a wide-scale production. E.g., there were no appropriate drug monographs before 2015. Currently, this issue has been taken care of. However, the most pressing problem is collecting blood plasma that is the API for this drug group. It will be premature to discuss localization of blood derived drug manufacture in Russia until a plasma collection process is established.
[PharmVestnik # 7, 01/03/2016, p. 2]
A competition patent
FAS plans amendments to patent legislation
Until mid-December 2015, Russia’s Federal Antimonopoly Service (FAS) had been collecting Pharma market players’ opinions on unreasonable issuance of patents. As a result, at the end of February, the FAS officials presented their proposals on amendments to be made to the patent legislation. Not all experts concur with the FAS’s vision of the issue.
[PharmVestnik # 7, 01/03/2016, p. 4]
FAS has questions regarding foreign manufacturer site inspection
The FAS sent a letter to the Russian Ministry of Justice requesting to cancel the registration of the order that had approved the fee calculation methods in respect of foreign manufacturer site inspection. The reason is that this document has not been reviewed by the FAS. The Ministry of Justice officials maintain that they have no competence to cancel order registration. Meanwhile, the Ministry of Industry and Trade keeps asserting that everything is ready for auditing foreign manufacturing sites.
[PharmVestnik # 7, 01/03/2016, p. 5]
Beneficial drug coverage still relevant
The topic of the Russian Association of Pharmaceutical Marketing meeting held on February 18 was “DLO (Drug reimbursement) / ONLS (Vital and essential drug coverage) / VZN (High-cost diseases): 2005—2015”. The industry experts gathered to sum up the interim results as well as highlight major achievements and problems to be further resolved in the beneficial drug coverage field.
[PharmVestnik # 7, 01/03/2016, pp. 6-7]
A patchwork quilt of legislation
Elena Maksimkina on responsibility and pharmaceutical business
In mid-February, the “Editorial Fireplace” rubric hosted Elena MAKSIMKINA, Director of the Department of Drug Provision and Regulation of Medical Device Circulation under Russia’s Ministry of Health. She shared information on the development of e-pharmacies in Russia as well as mentioned that the government has once again puzzled the MoH with the issue of drug sales at supermarkets.
[PharmVestnik # 7, 01/03/2016, p. 8]
Second this year mass influx of pharmacy customers expected in March
Successes of the Russian healthcare system go global. In mid-February, Ebola vaccines Gam-Evac and Gam-Evac Combi were presented in Geneva. The WHO noted that these developments were quite significant. Concurrently, studies were initiated in respect of Zika fever that spreads epidemically in South America. At that, MoH continues controlling the swine flu in Russia notwithstanding claims of “uncertain legal status” of trademarks recommended for flu therapy.
[PharmVestnik # 7, 01/03/2016, p. 9]
Between a rock and a hard place
Pharma market players claim that GMP regulations contradict prevailing legislation
Regulators ought to pay attention to non-conformity of specific GMP provisions to the requirements of other laws currently applicable in Russia. Pharmaceutical manufacturers were first faced with this situation when they started shifting to the international GMP standards on their own. In 2014, the national GMP standards became mandatory that most closely resembled the relevant international regulations. The issue of non-compliance of construction, fire, and sanitary regulations to the GMP has been “legitimated”. According to experts, it is the GMP that needs to be adjusted in order to do away with the discrepancies.
[PharmVestnik # 7, 01/03/2016, p. 9]
Russian Pharma market in figures: 2015 results
The diagrams present the market size (in value and real terms); the market structure spilt for Rx/OTC, VED-non-VED (in value and real terms); imported/local drugs (in value terms); out-of-pocket / hospital / reimbursement (including high-cost) drug sales; average drug price by sector; TOP10 corporations; TOP10 trademarks etc.
[PharmVestnik # 7, 01/03/2016, p. 13]
A crisis of relationships
Rating of Russian pharmacy chains, 2015
Some face a crisis as plummeting demand and decreasing margins. Others have to scrap business development programs and focus on tactics. Whereas for certain pharmaceutical retailers the hard times resulted, first of all, in a higher load on their legal units. The past year saw a significant growth in the number of debt recovery lawsuits where the claimants were drug distributors and manufacturers and the defendants were pharmacy chains.
[PharmVestnik # 7, 01/03/2016, pp. 14-17]
Analgesic prescription to cancer patients simplified
In Krasnoyarsk territory, patient-specific record-keeping in respect of narcotic drug prescription is being implemented. A Ministry of Health commission will check not only the fact of analgesic prescription but also the drug correspondence to each patient’s epicrisis and the stage-by-stage system of pain relief therapy prescription.
[PharmVestnik # 7, 01/03/2016, p. 20]
Going East
Russian facilities getting ready to exporting drugs to the South-East region
In mid-February, the residents of the Ural biopharmaceutical cluster discussed their joint strategies for 2016. They pointed out that expansion to foreign markets was their top priority, China, India, Iran, Egypt, and Australia being priority countries.
[PharmVestnik # 7, 01/03/2016, p. 21]
Not all oncologists share import substitution idea
Local drug manufacturers were able to take part in a competitive bidding for cancer drug procurement by St. Petersburg oncology dispensary in January only after they applied to the regional healthcare committee. The thing is that the bid data sheet provided for “exclusive” oxaliplatin and carboplatin dosages (150 mg and 600 mg, respectively) available only from a foreign company.
[PharmVestnik # 7, 01/03/2016, p. 21]
