Current issue #11, 2017

Vice-Premier Arkady Dvorkovich: Preferences shall have a “shelf life”

The Russian Ministry of Industry and Trade (Minpromtorg) defined development priorities for this year. At a recent Minpromtorg Board meeting with participation of Premier Dmitry Medvedev, pharma was just touched upon, however the board members spoke well of this industry. The Premier was satisfied with the pharma development pace. He reiterated the government course for a reasonable import substitution through the existing system of subsidies and preferences. In turn, Vice-Premier delicately hinted that preferences were a fine point, and they’d better be considered temporary.

[PharmVestnik # 11, 04/04/2017, p. 1, cont’d p. 3]

Union of Pharma and Medical Associations and Enterprises to prove effectiveness of “odd-man-out” regulation

Following pharmaceutical manufacturers, medical industry players criticized Federal Antimonopoly Service Director Igor Artemyev’s proposal to substitute the “odd-man-out” approach to the state procurement with other types of price preferences. Businesses consider abusive practices in respect of the “odd-man-out” regulation (Resolution No. 102 “On restrictions and conditions for admission of specific types of medical devices of foreign origin for state and municipal procurement”) isolated occurrences, and are ready to prove that.

[PharmVestnik # 11, 04/04/2017, p. 3]

Experts seek for pricing policies advantageous for all market players

Many agencies seek to contribute to the drug price regulation, especially in respect of the government procurement. The Russian Ministry of Industry and Trade supports the three-stage bidding system; the Federal Antimonopoly Service monitors drug prices on the world scale; the Ministry of Finance supervises fiscal discipline; and the Ministry of Health works on an draft order that establishes the rules for calculating the maximum initial contract price taking into account the preceding purchase price compared with a reference price in the Information Analysis System (IAS) controlling the government drug procurement. Since March 1^st, the IAS has been running in a test mode.

[PharmVestnik # 11, 04/04/2017, p. 4]

Authorities and the public discussed ways for drug coverage of all in need

Transferring the drug coverage of orphan patients to the federal level; developing and implementing an all-embracing drug insurance mechanism; extending the high-cost disease list; and supplementing the VED list with up-to-date drugs were among the proposals voiced on March 23^rd during the roundtable discussion on subsidized drug coverage at the State Duma. Most initiatives require changes to the applicable legislation.

[PharmVestnik # 11, 04/04/2017, p. 5]

A state program to support APIs

Local API manufacture includes many aspects. Market players assert that support tools must embrace not only pharmaceutical manufacturers but also equipment vendors and chemical companies. Businesses wait for a set of measures – from tax preferences to appropriate regulation.

[PharmVestnik # 11, 04/04/2017, p. 6]

Participants of drug identification marking pilot project discussed progress

The drug identification marking project was launched in February. According to the Federal Service for Surveillance in Healthcare and Social Development that leads the pilot workgroup, the project includes more than 30 pharmaceutical manufacturers (both local and foreign), 7 distributors, more than 30 medical facilities, and 300 pharmacy chains. The experiment embraces 9 Russian regions.

[PharmVestnik # 11, 04/04/2017, p. 7]

Patent violence

Experts discussed patent holder problems

On March 28^th, Moscow hosted the International Pharmaceutics and Biotechnology Forum. The agenda included mandatory licensing, among other issues. Experts believe that the Federal Antimonopoly Service initiatives in this respect are deadly for patent holders as they provide for punishing the latter for any deeds. On the other hand, the current court practice is deadly as well as it is excessively protracted, and does not make it possible to punish all those violating the patent law.

[PharmVestnik # 11, 04/04/2017, p. 8]

Drug advertising restrictions may be biased

Pharmaceutical companies need to take a more careful approach to their drug advertisement content. In mid-March, the Federal Antimonopoly Service (FAS) posted on its website a digest of decisions charging three foreign manufacturers with inappropriate advertising of their medicinal products in Russia. In the FAS’ opinion, all of them have violated the law prohibiting any guarantees of beneficial effects of the medications being advertised.

[PharmVestnik # 11, 04/04/2017, p. 11]

Innovative drugs not to oust traditional therapies

A health economic approach is increasingly often used in drug coverage. In fact, health economics is a meeting point for pharma companies offering their products and public health officials managing budgets. Health economics is often perceived as a path to innovative drugs. However, its capabilities are much wider, as it provides for a rational distribution of the resources available using all treatment methods at hand. To this end, regional governments need to aim not at purchasing as many drugs as possible but at citizens’ survival. Practice demonstrates that this is already the case in many Russian regions.

[PharmVestnik # 11, 04/04/2017, p. 12]

Regulators and experts discussed GMP issues

Within the framework of the International Pharmaceutics and Biotechnology Forum on March 28^th, a session on the latest Russian GMP Inspectorate findings was held. The regulator news was not encouraging. So far, only one foreign pharmaceutical manufacturer is fully compliant with the Russian GMP standards, while the others may face sanctions, including those at the international level.

[PharmVestnik # 11, 04/04/2017, p. 13]

Analysts forecast an “interesting year” for pharma

The pharma industry slowly but surely overcomes the recession. Experts believe that the positive trends of the second half of 2016 will persist, and the market may grow by 10%% as of 2017. The pharmacy sector is still a major growth driver.

[PharmVestnik # 11, 04/04/2017, p. 14]

Russia’s Health Minister admits underfunding

Russia’s Minister of Health Veronica Skvortsova told President Vladimir Putin about the necessity to increase healthcare funding. “The implementation of new pilot projects will require additional funding”, she was quoted as saying. Previously, as a rule, the minister had not asked for money when Vladimir Putin inquired her about the healthcare funding level.

[PharmVestnik # 11, 04/04/2017, p. 16]

Out-of-pocket topical tissue regeneration enhancer segment, 2016

As of 2016, the out-of-pocket topical tissue regeneration enhancer segment totaled 5.93 bn RUB in value terms (+7% year-on-year), and 17.9 m packages in real terms (-5% year-on-year).

[PharmVestnik # 11, 04/04/2017, pp. 18-19]

Russian subsidized drug coverage segment, 2016

AlphaRM report demonstrates whether consumers and procurers succeeded in reaching a consensus in 2016.

[PharmVestnik # 11, 04/04/2017, pp. 22-24]