// GxP
AIPM pointed to biased attitude of Russian GMP Inspectorate to foreign manufacturers
At the annual conference “Drug and Medical Device Circulation’2017” in Moscow, delegates representing the Association of International Pharmaceutical Manufacturers (AIPM) declared that they were no longer ready to put up with the results of foreign manufacturing site audits performed by the Russian GMP Inspectorate. They gave reasons for their standing, too.
[PharmVestnik # 34, 24/10/2017, p. 1, cont’d p. 6]
// Regulatory & Legal
Overall drug marking to become reality in a year
A pilot project for drug marking and flow monitoring was launched in early 2017. To date, part of the project participants has successfully hooked up to the Marking Information System, and transmitted their drug data to the Master Database. The State Duma scheduled a review of the drug marking bill in the first reading for October 27. Pursuant to this bill, marking will be mandatory for all medicinal products from 2019. The Federal Service for Surveillance in Healthcare and Social Development officials assert that everything works out well. However, nobody knows how the overall system will operate when joined by hundreds of manufacturers and distributors as well as thousands of pharmacies.
[PharmVestnik # 34, 24/10/2017, p. 3]
// Regulatory & Legal
FAS attempts at sorting out generic price diminisher issue with pharma industry
In November, the Russian Ministry of Health is to finally present an approved VED pricing procedure. The Federal Antimonopoly Service (FAS) officials maintain that basically all differences have been settled with the MoH. They believe that the only thing that needs to be done is to agree upon generic and biosimilar price diminishers with manufacturers. However, industry players are sure that there are other pending issues, too.
[PharmVestnik # 34, 24/10/2017, p. 8]
// Pharma Manufacturing
Experts from different countries share best sterile manufacture practices
Pharmaceutical engineers from Europe and CIS attended GEP-Russia 2017 conference in Moscow to share best practices and discuss organizing of manufacturing sites to meet conservative regulatory requirements and at the same time not to lag behind the science and technological progress. Representatives of the Ministry of Industry and Trade as well as the State Institute of Medicinal Products and Good Practices attended the conference, too.
[PharmVestnik # 34, 24/10/2017, p. 11]
// Regulatory & Legal
What’s wrong with medical waste disposal laws?
Experts from the All-Russia People’s Front approached the Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor) with the initiative to legislatively restrict the use of hazardous chemical methods for medical waste decontamination. They also proposed legislating the priority of most effective and environmentally safe technologies in government procurement. PharmVestnik conducted a private poll to find out what lawyers and waste generating entities such as healthcare centers and pharmaceuticals thought about the issue.
[PharmVestnik # 34, 24/10/2017, p. 12]
// Regulatory & Legal
Rostec launches full-scale production of drug marking equipment
Tight timeline of pharma market players transfer to the drug marking system is beneficial for equipment manufacturers. The Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) officials do not deny that this may cause potential equipment price hikes. The equipment delivery time (6 to 7 months, on average) is also a problem. Rostec declared determination to solve two problems at one stroke, i.e. cut waiting time for the equipment, and come up with equipment cheaper than foreign analogs.
[PharmVestnik # 34, 24/10/2017, p. 13]
// Regulatory & Legal
Positive trends in Crimean drug coverage system
The 3rd annual forum “Crimean Healthcare’2017: Regulatory Issues and Development” in Alushta was attended by more than 250 participants. They discussed the state policy related to healthcare services and drug coverage of the Crimean, Sevastopol, and Southern Federal District population as well as pharma business regulation.
[PharmVestnik # 34, 24/10/2017, p. 13]
// Health Management
Scientists insist on molecular diagnostics in infection management
Antibiotic resistance increasingly often makes drug assignment a lottery even given correct diagnosing as over 100 years of antibiotic use, pathogens have accumulated scores of protective mutations. This results in life-threatening conditions for patients, wasted budget funds, and a new spiral of evolution for the surviving hazardous microorganisms. Scientists already can identify specific mutations in the causative agent’s genome. This is the only way to select a personal therapy excluding drugs inefficacious against the mutated strain. These topics were on the agenda of the Molecular Diagnostics Forum held within the framework of the 3rd Russian Laboratory Medicine Congress (12 October, Moscow).
[PharmVestnik # 34, 24/10/2017, p. 14]
// Regulatory & Legal
Ministry of Industry and Trade signed first special investment contracts
It took about 2 years to sign the first special investment contracts in pharma, whereas such contracts have already been made in other industries. Pharma market players waited for clear signals that the drugs they would manufacture in Russia would be in demand. Now, this issue has been basically settled.
[PharmVestnik # 34, 24/10/2017, p. 14]
// GxP
ISPE Eurasia sets up a discussion platform
On 17 October, the State Institute of Medicinal Products and Good Practices of the Ministry of Industry and Trade opened a Eurasian office of the International Society for Pharmaceutical Engineering (ISPE). The nonprofit organization deals with pharmaceutical engineering education by training staff to international standards. Among other ISPE key activities is conference management, manufacturing practice consulting, and provision of research materials on pharmaceutical facility design and operation.
[PharmVestnik # 34, 24/10/2017, p. 16]
// Regulatory & Legal
Experts call for joint efforts to harmonize EAEU legislation
The participants of the conference “Drug Market Launches in Russia and CIS” organized by Bravo Business Forums discussed transfer to a common EAEU pharmaceutical market. The speakers from Russia and Belarus demonstrated that there were still many inconsistencies and white spots in the EAEU legislation that required a special focus when harmonizing regulatory documents.
[PharmVestnik # 34, 24/10/2017, p. 18]
// Pharma Manufacturing
Staffing issues gain momentum from year to year
At the conference “Effective Pharmaceutical Manufacture: Regulatory Aspects and Advanced Technologies” organized by the State Institute of Medicinal Products and Good Practices, heads of the largest companies shared their best strategy formulation practices. Despite the shared views of production quality priorities, the speakers differed in their approaches to staffing issues and manufacturing division structure.
[PharmVestnik # 34, 24/10/2017, p. 19]
// Pharma Distribution
Is the distribution sector to hang on?
The distribution war outcome is seen with the naked eye, with the TOP3 pharma distributors accounting for 70% of the market. The competition has become customer-centric, with retailers that propose to limit the distributors’ functions to logistics snapping at the latter’s heels. The number of direct contracts with pharmaceutical manufacturers has been growing, and market players increasingly often suppose that distributors are out of place in the market. The recent Pharmacy Summit offered a special section to answer the question whether distributors were ready to lose their place in the sun.
[PharmVestnik # 34, 24/10/2017, p. 21]
// Insight
Antihypertensives sales in out-of-pocket segment as of August 2017
According to the Russian Ministry of Health, about 14M Russians are diagnosed with hypertension, which means that 1 in 9 Russian citizens has to take antihypertensives. According to QuintilesIMS, patients with hypertension spend on average about 4,000—5,000 RUB a year for appropriate treatment.
[PharmVestnik # 34, 24/10/2017, pp. 25-26]
