Current issue #31, 2015

No dialog ahead

Ministry of Health to be excluded from manufacturer consulting

In looks like the Ministry of Health, which, according to a number of experts, has sabotaged participation in consulting pharmaceutical manufacturers on issues related to preparation for drug registration, has achieved its goal. Public hearings on amendments to the Federal Law # 61 (On Drug Circulation) are underway, pursuant to which the ministry will no longer have to fulfill consulting functions. Most pharmaceutical companies are outraged by the regulator’s refusal to pursue the internationally accepted consulting practice as they foresee serious obstacles to the registration of new drugs associated with such refusal. However, there are those counting on the ministry’s help when passing through a complicated registration procedure.

[PharmVestnik # 31, 06/10/2015, p. 1, cont’d p. 3]

Those on top

Experts discuss a new draft VED list

In late September, an updated draft VED (Vital and Essential Drugs) list was posted on the Ministry’s of Health website. There are 46 new entries in the draft list, including three new dosage forms of the drugs already on the current list. Janssen Cilag’s telaprevir was substituted by simeprevir, which is a newer generation drug by the same company. All experts polled by PharmVestnik agree with such decision. However, there are certain points in the updated VED list that have raised questions and that provide for ambiguous interpretation.

[PharmVestnik # 31, 06/10/2015, p. 1, cont’d p. 2]

Budgetary “roulette”

When shifting to one-year budgeting, the state provided for drug supplier guarantees 

The recipients of taxpayer funds are allowed to make agreements with drug distributors providing payments after the year 2016. However, so narrow planning horizon, given the continuously shrinking budget allocations for healthcare, cannot fail to trigger market players’ concern, especially when it goes about manufacturers entrusted with a task of localizing their production facilities in Russia.

[PharmVestnik # 31, 06/10/2015, p. 3]

To hell with good intentions

Gilead’s antiviral agent may lose Russian market

Sofosbuvir, a non-interferon treatment for hepatitis C, is to be registered in Russia through the end of 2015. However, its analog is currently on sale in Russia. There are numerous online and offline commercials regarding this drug supplies from India. Gilead granted a permit to Indian manufacturers to produc...