// Regulatory & Legal
Roszdravnadzor proposed effective dates for marking different drug groups
The State Duma starts reviewing amendments to the Federal Law No. 61 “On Drug Circulation” in respect of overall drug marking. The bill legislates marking as a mandatory drug circulation element from 1 January 2019 as well as specifies the government powers in this process. However, a major challenge for the authorities in charge is not so much the adoption of the law as surviving through 2018 when all market players will be hooked up to the marking system. Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) officials believe that this should be done stage by stage. Importantly, all government officials having to do with the marking system are sure that all relevant market players will be hooked up successfully in 2018. The latter are getting ready, but, for some reason, they are not so sure about that.
[PharmVestnik # 37, 14/11/2017, p. 1, cont’d p. 5]
// Regulatory & Legal
Drug pricing changes to be made within the framework of existing procedure
A new drug price registration procedure was to be adopted this autumn. However, protracted disputes between regulators and market players on the procedure details resulted in time extension. According to the latest comment by the Federal Antimonopoly Service (FAS), the situation is as follows: the new procedure proposed by the Ministry of Health has been ultimately ruled unworkable, while an updated version of the current system will come into effect in 2018. Head of FAS Social and Trade Control Department Timofey Nizhegorodtsev spoke about the proposed changes at a recent PBC Pharma Forum.
[PharmVestnik # 37, 14/11/2017, p. 2]
// Regulatory & Legal
Experts seek ways to implement online drug sales
It seems that even the most conservative market players have no doubts that an online drug sales law will be adopted soon. Therefore, the main questions now concern the final document’s contents overall, and provisions that require a special focus. This was on the agenda of the session on the future of digital pharmaceutics held within the framework of PBC Pharma Forum.
[PharmVestnik # 37, 14/11/2017, p. 4]
// Regulatory & Legal
Percentage of unapproved drugs being imported grows
The Ministry of Health is not ready to fund unapproved orphan drugs. As of 2017, they may make 1B RUB of the total drug procurement. In turn, certain regional officials solve the problem of funding such drugs by using the budgets allocated for covering the List 24 products, and the Audit Chamber charges them with inappropriate expenditures. Experts estimate that the percentage of unapproved orphan drugs will be trending up in value terms, while the government must decide whether to permit and control procurement of such drugs or leave a gap for corruption.
[PharmVestnik # 37, 14/11/2017, p. 6]
// Regulatory & Legal
Patient Advocacy League to draw WHO’s attention to unlawfulness of drug interchangeability concept in Russia
Russia’s Patient Advocacy League President Alexander Saversky drafted a letter to WHO Director General Dr Tedros Adhanom Ghebreyesus (available to PharmVestnik) stating that the implementation of new drug classification principles may trigger off major remaking of the pharmaceutical market that will cause deaths of many patients. Therefore, Mr. Saversky asks the WHO to interfere and recommend the Russian Federation to eliminate the mandatory procedure for establishing drug interchangeability as violating the general drug classification based on INNs accepted worldwide.
[PharmVestnik # 37, 14/11/2017, p. 8]
// Regulatory & Legal
MoH discussed public-private collaboration barriers
The first in Russia’s healthcare concessionary agreement was signed on 31 October at a regular meeting of Russian MoH’s Coordination Council for public-private collaboration. However, not in all regions investors are ready to buy into government-funded objects. The meeting participants discussed barriers to and prerequisites for creating public-private partnerships in healthcare.
[PharmVestnik # 37, 14/11/2017, p. 9]
// Regulatory & Legal
Telehealth service providers to face approval barriers
The protracted by-law adoption procedure may result in a situation where 99% of companies will be able to provide just information services instead of telehealth services throughout 2018. Only one provider that has been issued most of the appropriate approvals before the by-laws have been drafted may be an exception. On 30 October, the Ministry of Health used the state services website to initiate a discussion of by-laws version 2 pertaining to the Procedure for Arrangement and Provision of Telehealth Services. For the first time, a clause on mandatory approval of certain software types as medical devices was introduced. According to experts, even remote consultations made their way to the proposed list of services.
[PharmVestnik # 37, 14/11/2017, p. 15]
// Insight
Out-of-pocket drug market report, Q317
According to AlphaRM, analysis of quarter by quarter sales dynamics demonstrates a slight growth both in real and value terms year-on-year (y-on-y). If this trend prevails, Q4 may be promising. However, the difference that transpired in 2017 in terms of Q1-3 sales ratio prevents our forecast from being too optimistic. Typically, Q3 in the out-of-pocket segment shows higher results vs. both Q 1 and Q2, which is not the case this year. It is September that is to blame, with a sales growth less than 1% in value terms, and minus 2.2% in real terms y-on-y.
[PharmVestnik # 37, 14/11/2017, pp. 22-24]
// Regulatory & Legal
Some experts think drug marking unjustified
According to the Federal Service for Surveillance in Healthcare and Social Development, marking of all drugs released into civil commerce that will become mandatory starting from 1 January 2019 will yield dividends for the industry. Certain manufacturers disagree, of which they spoke at a special session of a recent Annual Investment Forum in St. Petersburg.
[PharmVestnik # 37, 14/11/2017, p. 26]
// Pharma Manufacturing
Sverdlovsk pharmaceutical manufacturers look for customers abroad
Medsintez factory (Novouralsk) that is a member of the Ural Biomedical Cluster filed MA applications for its insulin drugs in Pakistan and Yemen. According to cluster top managers, collaboration with Asian and African countries is part of the drug marketing strategy that Ural manufacturers implement to penetrate the world market.
[PharmVestnik # 37, 14/11/2017, p. 27]
// Pharma Manufacturing
A family business discloses its formula for success
In November 2017, Anapa Phytopharm, a production and sales company headquartered in Krasnodar territory, will celebrate its 25th anniversary. This multi-industry, closed-cycle holding company includes facilities engaged in medicinal herb growing and drug manufacturing from herbal raw materials and APIs. While some other market players tighten their belts preferring small pharmacy outlets, the company develops a chain of pharmacy hypermarkets.
[PharmVestnik # 37, 14/11/2017, p. 27]
