// Regulatory & Legal
Control of biomaterials distribution proposed in Russia
The events of the first weeks of this November have sent chills down spines of heads of diagnostic labs, clinical research organizations as well as transplant surgeons. All of them deal with human biomaterials that turned out to be collected all over Russia and exported abroad. President Putin disclosed this information speaking at the meeting of the presidential Human Rights Council on 30 October. He tried to water down the facts saying that there was nothing to be concerned about, but his words have set the wheels in motion. Experts proposed to give biomaterials samples the same status as to personal data, and implement government control of biomaterials distribution. It has nearly come to prohibiting biomaterials export, but everything has worked out.
[PharmVestnik # 38, 21/11/2017, p. 1, cont’d p. 3]
// Pharma Distribution
Shortage of drug storage equipment remains the main issue for distributors
Distributors remain the product distribution chain link the regulators make a lot of claims to. According to Roszdravnadzor (Federal Service for Surveillance in Healthcare and Social Development), overall one in three pharma market players violate the drug distribution laws. The problem is associated with the lack of a quality management system. Roszdravnadzor officials raised this point at the 3rd conference “Quality Standards of Pharmaceutical Logistics”.
[PharmVestnik # 38, 21/11/2017, p. 2]
// Regulatory & Legal
New investment contract models for pharma
The mechanism of preferences for pharma manufacturers in exchange for investing into manufacture localization is gaining ground. The first special investment contracts (SpICs) have just been inked when the regulators started working on their improvement. The regions work hard trying to keep up, and offer SpIC analogs of their own. Moscow has swung into action, too, with the first SpIC signed a month ago. However, it is unclear yet whether many market players will follow the pioneers.
[PharmVestnik # 38, 21/11/2017, p. 8]
// Regulatory & Legal
Federal Customs Service not equipped for drug marking
The State Duma approved in the first reading the amendments to Federal Law No. 61 “On Drug Circulation” that legislate as mandatory marking of all pharmaceuticals selling on the market staring from 1 January 2019. Businesses are getting ready lining up for appropriate equipment. However, the issue pertaining to customs logistics has not be resolved yet. Speaking at a recent industry conference, RNC Pharma Director for Development Nikolay Bespalov doubted that all customs stations would be adequately equipped at once to participate in the drug marking project. Consequently, certain companies will be putting at risk both their money and reputation. However, PharmVestnik interlocutors call such doubts “phantasies”
[PharmVestnik # 38, 21/11/2017, p. 9]
// Health IT
Roszdravnadzor director to implement digital health solutions
Roszdravnadzor (Federal Service for Surveillance in Healthcare and Social Development) does not only detect violations by healthcare providers but also strives to implement digital innovations across the board. To this end, Roszdravnadzor Director Mikhail Murashko is ready to set the agency’s regional representatives infecting all healthcare providers with the Big Data philosophy. Far from all participants of the National Medical Chamber Congress understood the wording or details of the novel technology, but “infecting” was majority voted. At the same time, experts had doubts in respect of philosophy’s “alchemy”, and pointed to weaknesses of the Patient Register’s common database.
[PharmVestnik # 38, 21/11/2017, p. 10]
// Monitoring – EAEU
Experts fear lest regulators are short of time to get prepared for medical device site inspections
The Eurasian Economic Committee’s Council adopted guidelines for the implementation, maintenance, and assessment of a quality management system for medical devices depending on potential risk of their use. The document was drafted in line with the EAEU’s agreement on common principles and regulations of medical device distribution. A year was allowed for medical manufacturers to smoothly shift to working in the new business and regulatory environment. However, some experts fear lest this time is not enough for regulators to be prepared.
[PharmVestnik # 38, 21/11/2017, p. 12]
// Monitoring – EAEU
Pharma community counts on advanced EAEU regulations
According to market analysts, drug R&D costs have been growing exponentially over the past few years, with the number of clinical trial permits, and marketing authorizations issued decreasing. This is a world trend, and different countries deal with it in different manners. Experts discussed clinical trial difficulties as well as trial procedure improvements at the 6th Adam Smith Institute forum “Clinical Trials in Russia” held on 14–15 November.
[PharmVestnik # 38, 21/11/2017, p. 12]
// Regulatory & Legal
Competitive bidding supports beneficiary drug coverage
Just before approval of St. Petersburg 2018 budget, it becomes increasingly clear that a drug procurement allocations growth will be primarily provided due to cost saving.
[PharmVestnik # 38, 21/11/2017, p. 13]
// Health Management
Estimating new cancer program costs
The National Cancer Strategy until 2030 has been approved by the MoH’s ad hoc commission, and is currently on the wait for being submitted for a government review. The program provisions and implementation were the focus of the agenda of the 21st Cancer Congress held in Moscow on 14–16 November. Experts considered approaches to estimating the program costs and fundraising to make cancer treatment affordable within the framework of the session hosted by the Health Research and Management Center of Moscow Skolkovo School of Management.
[PharmVestnik # 38, 21/11/2017, p. 14]
// Regulatory & Legal
Pharma manufacturers will have to work hard at personal data processing policy
According to the results of a scheduled onsite audit in September, Roscomnadzor (Federal Service for Supervision of Communications, Information Technology, and Mass Media) issued for Pfizer LLC an order requesting for corrective actions. The violations found concerned nonconformity of certain in-house documents with the regulations making the basis for personal data processing. This case sparked interest of the industry – and not for nothing. Lawyers believe there is plenty for pharma companies to think about.
[PharmVestnik # 38, 21/11/2017, p. 14]
// Regulatory & Legal
European pharma companies ignore Russian toxicity standards
While abnormal toxicity testing in animals has been ruled out in Europe, Russian regulators remain conservative sticking to animal tests. As in European countries, there is no regulations making animal tests mandatory, Russian regulators see European manufacturers ignoring this standard. The latter think it outdated, and work hard on alternative chemical techniques.
[PharmVestnik # 38, 21/11/2017, p. 15]
// Insight
ARVI and flu drug sales in out-of-pocket segment as of September 2017
This report is based on IQVIA data. Traditionally, cough and cold periods generate major ARVI and flu drug sales for pharmacies. Such periods, while guaranteeing good profits, give surprises, too, such as an unexpected success of newly-launched products, failure of well-established trademarks as well as other mainstream pharma trends. According to some studies, physicians prescribe up to 11 drugs to treat ARVI in a patient.
[PharmVestnik # 38, 21/11/2017, pp. 20-21]
// Insight
Out-of-pocket segment specifics in Russia’s traditional summer travel areas
This report is based on AlphaRM data. As a rule, summer sees a customer activity slowdown at pharmacies, which results in a lower drug turnover. However, the situation is not the same all over the country given Russia’s huge territory. In summer, traveler flows may explain reversed drug sales phases in certain regions.
[PharmVestnik # 38, 21/11/2017, pp. 22-23]
// Insight
Out-of-pocket segment report, Q317
According to DSM Group, in 2017, the drug sales growth in the out-of-pocket segment was driven by the population’s growing purchasing power as well as weather condition that promoted morbidity.
[PharmVestnik # 38, 21/11/2017, pp. 24-26]
// Monitoring – EAEU
Drug price control comparison in EAEU countries
On the emerging EAEU common drug market, it was decided to keep certain issues, including price controls, at a national legislation level. In the absence of common regulations, market players must take into account price regulation requirements established in each EAEU country. PwC Legal experts analyzed the regulatory environment of each of these counties to get a big picture.
[PharmVestnik # 38, 21/11/2017, p. 27]
// Pharma Retailing
Far from all pharmacies are ready to join information aggregation services
The number of pharmacy data aggregators has been growing fast. In this segment, as well as in pharma retailing, some try to attract customers by new opportunities while others seek to purchase readily available customer bases and develop them due to an identifiable brand. By joining data aggregation projects, pharmacies do boost their sales, but, at the same time, they make their price information available to competitors.
[PharmVestnik # 38, 21/11/2017, p. 28]
// R&D
Ural scientists synthesized a medicinal substance
Scientists of the Ural State Medical University completed Phase I clinical trials of a novel silicone gel-based sialadenitis drug. The gel was synthesized at the Organic Synthesis Institute of RAS Ural Branch. This project has already sparked interest of local pharmaceutical manufacturers.
[PharmVestnik # 38, 21/11/2017, p. 29]
