// Regulatory & Legal
New pharmacy regulations established once again
The Russian MoH Order # 403n that came into force on September 22nd has alarmed the pharmacy community. Especially exciting was item 14 of the Drug Dispensing Regulations, in particular, those concerning alcohol-containing pharmaceuticals. The new regulations require that pharmacies keep for 3 months prescriptions for liquid drugs containing more than 15% of ethyl alcohol. Anxiety among retailers was caused by the fact that this document transferred Valocordin and Corvalol into prescription drug category. However, it turned out that the new regulations applied only to drugs with the Rx status specified in their PILs.
[PharmVestnik # 30, 26/09/2017, p. 1, cont’d p. 5]
// Drug Exports
Who and why needs drug export?
The Russian local pharma market has not been fully tapped so far, but by toughening price regulation the state pushes local manufacturers to export their products. Such opinion was voiced during the panel discussion on launching Russian drugs to foreign markets within the framework of the BioTechMed 2017 conference.
[PharmVestnik # 30, 26/09/2017, p. 2]
// GxP
Gelendzhik hosted Second All-Russia GMP Conference that attracted foreign participants
In 18 months of the Russian GMP Inspectorate operations, around 580 foreign site inspections were performed. This time was enough to form in foreign drug manufacturers an understanding that a Russian GMP certificate may be issued only following a thorough check for GMP compliance. Foreign companies began taking Russian inspector visits with more responsibility as a Russian GMP certificate became essential for companies willing to develop their business in Russia.
[PharmVestnik # 30, 26/09/2017, p. 4]
// Disease Management
Experts discussed ways to decrease death rate in cancer
On September 18th, within the framework of a regular meeting of the expert council for innovation economics in oncology held at Skolkovo School of Management in Moscow, experts representing core institutions and committees discussed pressing needs of Russian oncology. The officials and scientists could not have done without a bone of contention.
[PharmVestnik # 30, 26/09/2017, p. 6]
// Regulatory & Legal
BioTechMed 2017 forum participants discussed market access of new drugs
According to the Russian Ministry of Industry and Trade, more than 125 INNs on the VED list are of a biotech origin. Of them, around 100 INNs have been in a varying degree localized in Russia, and about 30 of them are manufactured in Russia starting from API synthesis. Since the beginning of this year, 18 new drugs received marketing authorizations; these drugs emerged due to the state support program for Russian manufacturers. The main issue now is how to launch them to the market.
[PharmVestnik # 30, 26/09/2017, p. 8]
// Pharma Manufacturing
Cancer drug manufacturers count on new preferences
The working group of the Drug and Medical Device Coordinating Council held a meeting at the Russian Union of Industrialists and Entrepreneurs. One of major issues was the current state and prospects of cancer drug manufacturing in Russia. The participants drafted a package of proposals aimed to increase Russia’s potential in this area as well as improve the efficiency of using government and private investment.
[PharmVestnik # 30, 26/09/2017, p. 9]
// R&D
Technology transfer blocks proprietary nuclear medicine R&D
When speaking about technology transfer, experts solely mean import of innovative technologies to Russia. So far, local companies have nothing to offer in terms of export when it comes to nuclear medicine. Certain businessmen believe that technology transfer boils down to the equipment assembly stage. This is enough to be considered a local manufacturer but is not enough to be on equal footing with the leading countries. Within the framework of the First National Import Substitution Forum experts stated that, regarding technology transfer, Russian partners should set tougher conditions and strive for deeper localization of foreign technologies or double down on R&D on their own.
[PharmVestnik # 30, 26/09/2017, p. 10]
// Pharma Distribution
Top player to survive through manufacture and distribution synergy
ROSTA, a TOP5 pharmaceutical distributor, has been under financial pressing for a year. Company’s owner David Panikashvili has been forced to sell the “soul” of his creation, i.e. the pharmacy business that gave a jump-start to his entire business in the 1980s. Despite the multibillion-ruble claims filed against the company, market players believe that ROSTA has formed an anticrisis roadmap and will be able to survive after transformation. At the same time, it will be difficult for the company to come back to pharmaceutical retail business.
[PharmVestnik # 30, 26/09/2017, p. 12]
// Vaccination
Scientists and officials discussed National Immunization Schedule extension prospects
It is a national security issue that a proprietary vaccine be produced based on a proprietary virus strain; therefore, immunobiological technology transfer is unfeasible. Vaccine R&D is currently in the focus of government attention, which became quite clear during a panel discussion on immunization within the framework of the Second BioTechMed Conference in Gelendzhik.
[PharmVestnik # 30, 26/09/2017, p. 13]
// Pharma Manufacturing
Expendables in biopharmaceutical manufacturing technologies to cut capital costs
The latest biopharma trend is the implementation of expendables at various technological process stages. Major expendables include cell bioreactors, liquid mixing systems, filtration systems, piping, and fittings. Basic materials to make such devices are plastic polymers.
[PharmVestnik # 30, 26/09/2017, p. 16]
// Insight
Pharmaceutical exports from Russia, January—July 2017
The formerly explosive growth of pharmaceutical exports from Russia has somewhat slowed down this year. It looks like the demand for traditional products weakens whereas new players ready to offer innovative products for foreign markets are just starting to file MA applications with foreign regulators.
[PharmVestnik # 30, 26/09/2017, p. 17]
// Insight
Government procurement of drugs, H117
Agency Headway reports on cost dynamics, government procurement trends, and split of funding by Russian regions based on biddings held from January 1st to June 30th, 2017.
[PharmVestnik # 30, 26/09/2017, p. 18]
// Insight
Cold drug sales (МАТ 07/2017)
According to AlphaRM, cold medications grow increasingly popular with pharmacy customers. Cold treatment becomes an increasingly complex and science-intensive process. Currently, two medications are often used to treat cold. The first agent based on sea water or substitutes cleans the nasal mucosa and prepares it for the application of the second agent used for treatment proper. Most often, vasoconstrictors are used as the second line agents along with medicinal products containing antibiotics, and those providing for nasal mucus dilution.
[PharmVestnik # 30, 26/09/2017, p. 20]
// Pharma Retailing
Claims on pharmacy chain exceeded 700M RUB
In September, creditors filed new claims on Klassika pharmacy chain (Chelyabinsk), its pharmacies having come under the control of Implozia chain. Experts think that suppliers have very few chances to recover the debts.
[PharmVestnik # 30, 26/09/2017, p. 22]
// Pharma Manufacturing
Antibiotic resistance management strategy gives an impetus to bacteriophage production
In October, the Russian national antibiotic resistance management strategy currently being reviewed by the government may be approved. The document provides for a wider use of bacteriophages as an alternative to antibiotics. This strategy, if approved, will give an impetus to Microgen, the only bacteriophage manufacturer in Russia.
[PharmVestnik # 30, 26/09/2017, p. 23]
// Pharma Manufacturing
Microreactor API synthesis established in St. Petersburg
Just three months after its official launch, the Regional Engineering Center for API Synthesis in St. Petersburg pursues three projects and is retrofitted with equipment. According to Center Director Elena Petrova, six microreactor units will provide for meeting the fine API demand of Russian pharmaceutical and cosmetic manufacturers.
[PharmVestnik # 30, 26/09/2017, p. 23]
// Medical Insurance
Mandatory medical insurance market grows ahead of inflation
In Q117, sales growth of mandatory medical insurance exceeded 10% (to compare: +7% in Q116). Market players forecast that such dynamics will persist as of the year end. Insurers note that major change is the quality of growth. The market growth is driven not only by inflation associated with medical services costs but also by extended service packages, and arrival of new customers.
[PharmVestnik # 30, 26/09/2017, p. 25]
// Health Providers
What drives private medicine growth?
Basically 50% of the Russian private clinics faced a customer flow reduction in 2016—2017. Nonetheless, their earnings grow, such growth being driven not only by the ascending medical service prices. Most market players expect further growth at a 5—10% rate annually. The point is that the development of private medicine is indirectly driven by the government actions in respect of free medical services.
[PharmVestnik # 30, 26/09/2017, p. 26]
// Health Providers
Clinics look for growth opportunities in economic turbulence
According to EY survey, in 2016—2017, private medical centers expanded their service ranges, and new clinics were opened. However, the crisis did produce an effect. Nearly 50% of the responders mentioned the growing price competition. At the same time, clinics try to avoid dumping.
[PharmVestnik # 30, 26/09/2017, p. 27]
// Patient Associations
Patient Advocacy League to share smart patient relationship policy for money
In September, the Patient Advocacy League announced the launch of the Loyalty to Patients certification program for health providers and pharmacies. The program participants will be obligated to comply with certain requirements in working with patients. The League is ready to help organize the work associated with smart customer relationships, and plans to monitor clinic and pharmacy compliance using a “mystery patient” tool. The program price ranges from 90,000 to 270,000 RUB.
[PharmVestnik # 30, 26/09/2017, p. 28]
