Russian regulators postpone harmonization of EAEU and national legislative requirements until 2020
[PharmVestnik # 39, 29/11/2016, p. 1, cont’d p. 2]
The start of a common drug market not determined
On November 16th, a package of documents required to launch a common drug market on the Eurasian Economic Union (EAEU) territory was signed. The market players and regulators are coming into a transition period when each of them must determine to what extent he will be ready to participate in the common market by 2025. The regulators will play the key role adapting the local legislative systems to the Union’s requirements. And while some countries are ready to leap into action, it is not all that simple for others.
[PharmVestnik # 39, 29/11/2016, p. 3]
Registration of drugs of foreign origin and GMP audits of manufacturing sites may be done simultaneously
Foreign manufacturers may breathe easily. After January 1st, 2017, their pharmaceutical products manufactured at the sites that have not undergone Russian GMP compliance audits will still be selling on the Russian market if the relevant amendments to the Federal law # FZ-61 “On drug circulation” announced at the regulation.gov.ru website are adopted. Pursuant to the draft law, if pharma companies need to amend their CTDs or undergo a registration confirmation procedure, it will be enough for them to commit in writing to receive a Russian GMP certificate within three years from the application filing date. The delay will be much shorter for newly registered drugs.
[PharmVestnik # 39, 29/11/2016, p. 3]
When ‘readily available’ is deceptive
In 2016, loans have not become easier available for pharma companies then before. The situation is much more complicated for pharmacy chains, their collective credit status having deteriorated against the background of numerous debt scandals. Nonetheless, there is a chance of receiving a loan, e.g. under programs targeting small businesses.
[PharmVestnik # 39, 29/11/2016, p. 4]
Russia to embrace with treatment 60% of HIV-infected by 2020
In October 2016, a state HIV infection control program was adopted. A year ago, the HIV issue was discussed at a special government meeting where Minister of Health Veronica Skvortsova voiced her concerns regarding a near epidemic. It seemed that the state would immediately rush to seek for funds required to take urgent measures. No extra-funding has been found, which does not mean at all that Russia may face a catastrophe associated with HIV infection.
[PharmVestnik # 39, 29/11/2016, p. 5]
EU experts told about how long it took to create a common medical device market
Drafting the documents that will determine the rules of the game for medical device manufacturers on the EAEU common market has been running smoothly without any sensational statements. Russian businesses declared more than once that they were looking forward to this market launch as the development of specific national regulatory acts relating to medical devices had been suspended until the EAEU legislation came into force. The EAEC representatives stated that the task of drafting the documents for the common medical device market was fulfilled. However, their European colleagues who have already made the same way in the EU suggest not to make hasty conclusions. In takes more than a year to make a code of laws relevant and applicable in practice.
[PharmVestnik # 39, 29/11/2016, p. 6]
Pharma market experts discussed future drug marking
The central event of the first day of the 18th International exhibition of the pharmaceutical manufacturing equipment, raw materials, and technologies (Pharmtech) in Moscow was the roundtable on the identification drug marking. On November 17th, a public discussion of the draft federal law “On identification marking of goods in the Russian Federation” completed on regulation.gov.ru website. This draft law establishes legal fundamentals of the government control over product circulation in Russia – from production to the end customer. The Ministry of Finance that has drafted the above law believes that it would provide for an efficient counterfeit control, and as far as the pharma market is concerned – for control of drug circulation violations. The amendments will refer to the Federal law # FZ-61 and the Administrative Offences Code of the Russian Federation. Pharmtech exhibition participants discussed future novelties.
[PharmVestnik # 39, 29/11/2016, p. 6]
Professionals interested in development
Pharmaceutical businesses and authorities discussed industry-specific problems at a regional venue
On November 24th, Ekaterinburg was the venue of the forum “Health Industry: Urals’2016” that brought together the Ural regional businesses and authorities. Representatives of the regional healthcare system, heads of drug manufacturing companies, distributors, and professional expert communities discussed regional specifics of drug coverage, strengthening the region’s role in the state funding program, current control and surveillance issues on the pharma market etc. The event was hosted by DSM Group and supported by Sverdlovsk regional MoH.
[PharmVestnik # 39, 29/11/2016, p. 8]
Children off-label
Refusal from clinical trials on children has adverse results
Pediatric clinical trials still make all process participants apprehensive. Pharmaceutical manufacturers avoid them because of high costs and long duration as well as tougher requirements to methods and ethical issues. The very fact of experimenting on children is repugnant for the society. Unfortunately, it looks like the fact that it is impossible to develop new efficacious drugs without clinical trials involving children is beyond the public understanding. The seriousness of this problem must not be underestimated.
[PharmVestnik # 39, 29/11/2016, p. 9]
Experts assessed efficacy and safety risks in clinical trials
The clinical trials legislation leaves the professional community asking a lot of questions. Within the framework of the All-Russia drug regulation conference “RegLek’2016”, experts of the Finished Drug Assessment and Control Center under the FSBI Scientific Center of Human Drug Assessment of the Russian MoH enlarged on what points need to be kept in mind when planning a clinical trials program and design.
[PharmVestnik # 39, 29/11/2016, p. 10]
Premium-segment pharmacy chain conquering the market
The economic recession has turned many pharmacy chains into discount stores. The sector players have dropped the prices fighting to get more customers. Nonetheless, a counter-trend is currently manifest: certain market players open new premium-class pharmacies. Experts agree that such pharmacies will find their customers even if the crisis persists and purchasing power does not increase. The thing is that the middle class is fed up with the discounters and is seeking a broad product range and high-quality services.
[PharmVestnik # 39, 29/11/2016, p. 12]
Reaching out to stars
Last week, a press conference devoted to the start of the 17th contest of the pharma industry professionals “Platinum Ounce’2016” was held in Moscow. Many journalists representing PharmVestnik weekly, website, and TV as well as their colleagues representing other media and pharmaceutical business “stars” were present. Besides the contest, the speakers discussed a general state of the market that has a long way to go to reach the “stars”.
[PharmVestnik # 39, 29/11/2016, p. 13]
Law and disorder
Internet services ready for distance drug selling legalization
The readiness of several large-scale web services to develop distance drug selling disturbed pharmacy market players. Online retailer Ozon and pharmacy chain 36.6 signed a partnership agreement. In its turn, Yandex.Market as a web aggregator focuses on accumulating many web pharmacies on its site. Representatives of business circles forecast an advent of large Internet players to the pharmacy market, that will grab part of the drug sales profits. However, the online drug sale control issue is still open as pharmacy businesses and web services have different views on control tools.
[PharmVestnik # 39, 29/11/2016, p. 15]
Dietary supplements sales at pharmacies, Q1-316
Dietary supplements account for 4% of total parapharmaceutical sales on the Russian market. Presently, more than 2,200 brand names manufactured by ~900 companies are selling in this segment.
[PharmVestnik # 39, 29/11/2016, pp. 18-19]
Import substitution in court
Local pharmaceutical companies initiate court proceedings twice as often as foreign players
From January 1st, 2016 to date, more than 150 lawsuits involving TOP25 drug market companies (distributors and manufacturers, both Russian and foreign) were considered at various courts of Moscow district. Russian pharma companies account for 65% of the lawsuits while foreign companies participate in 35% of the total number of cases.
[PharmVestnik # 39, 29/11/2016, p. 20]
Drug coverage to undergo ‘treatment’
In the context of the Russian MoH’s new statement on the development and implementation soon of insurance compensation for the drugs experts think over the current drug coverage situation and possible developments in this field.
[PharmVestnik # 39, 29/11/2016, p. 22]
