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Current issue #31, 2015

Current issue #31, 2015

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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 produce this drug and sell it in specific markets, but Russia was not among the markets specified. 

[PharmVestnik # 31, 06/10/2015, p. 1, cont’d p. 4]

Error correction

Moscow City Health Department modified tuberculin purchasing conditions

Moscow City Health Department has finally tested the bottom in terms of purchase prices and found tuberculin supplier for Moscow in the person of Pharmstandard OJSC. It took a few months to choose a contractor. Tuberculin supply problems in children’s polyclinics were reported in summer. There might have been two causes of that, namely the department’s desire to get the drug at the lowest price possible and extremely narrow specifications. When both causes have been removed, the supplier has been finally determined. 

[PharmVestnik # 31, 06/10/2015, p. 5]

At the other side

Ex-Deputy Director General for Commerce of pharmacy chain Rigla Alexander KUZIN has changed his field of activities. He is currently assessing the market from a manufacturer’s perspective as RMI Partners Managing Director. In his interview to PharmVestnik reporter Polina Zvezdina, Mr. Kuzin explained whether NovaMedica, a RMI Partners’ project currently being developed, was a new Russian manufacturer, and how he was forming his new team.

[PharmVestnik # 31, 06/10/2015, p. 8]

Bidding for pilot projects

The Ministry of Health invited bidding for the right to sign a state contract for conducting a research titled “The development of implementation mechanisms for pilot projects aimed at modernization of the drug coverage system for eligible beneficiaries and introduction of rational pricing patterns including those based on reference pricing for human drugs”. The initial (maximum) contract price is 1,800 thousand rubles. As it follows from the invitation, any interested person may get an access to the bidding documents. 

The pilot project topic has been discussed for more than 2 years. It is well-known that the Russian Government Resolution No. 136-r dated 30.01.2015 specifies a list of criteria according to which the regions allowed to participate in the experiment shall be selected, the project implementation period being 2015—2016. A variety of experts and agencies have submitted their research results and developed patterns. That is why the very fact of inviting bidding in which anyone may participate puzzled the professional community believing that pilot projects would start some day. 

PharmVestnik reporter Oxana Baranova asked experts whether, in their opinion, the bidding would serve pinpointing optimum drug coverage patterns. 

[PharmVestnik # 31, 06/10/2015, p. 1, cont’d p. 9]

Crisis not to get in the way

Advertising activity of pharmaceutical companies, H115

The experts of the Russian Association of Communication Agencies evaluate the Russian advertising market as of H115 at 138 bn RUB (without VAT), 16% down year-on-year.

[PharmVestnik # 31, 06/10/2015, pp. 10-11]

Revaluation of values

Analysis of amendments to special-purpose medicinal product lists in 2015

The Ministry of Health Commission approved four lists of human medicinal products. On the whole, the revised lists have been significantly modified, some due to appreciable extension (VED and Essential Drug Reimbursement Sub-Program – ONLS), while others because of cuts (minimum drug range). PharmVestnik analyzed the most significant novelties in the lists.

[PharmVestnik # 31, 06/10/2015, p. 12]

Do not import or else you will be judged as you import

The law “On amendments to specific legislative acts of the Russian Federation in respect of countering the sales of faulty, counterfeit, poor-quality, and unregistered drugs and medical devices as well as faulty dietary supplements” that came in force on January 23, 2015, and caused a stir in the professional community at the time of approval keeps affording anxiety.

[PharmVestnik # 31, 06/10/2015, p. 13]

Pushing back private traders

Crimea-Pharmacia goes after sevenfold share growth in pharmaceutical retail turnover of the peninsula

In just one year of the existence of the state unitary enterprise Crimea-Pharmacia in the Republic of Crimea, it saw three CEOs. The Republic’s government was dissatisfied with basically everything they have done – have failed to perform the task set, remove social strain as well as make pharmaceuticals affordable and available. Now it looks like the main development diseases have been overcome. For the past 6 months, this state unitary enterprise has been headed by Vyacheslav DOBRETSOV who has an extensive management experience. PharmVestnik correspondent Ekaterina Pogontseva found out what he has managed to achieve so far and what is in store for him. 

[PharmVestnik # 31, 06/10/2015, p. 14]

Zero option substitution

On September 29, the All-Russia People’s Front project “Import substitution: citizen performance indicators” was launched in Vladivostok. One of its main topics was the development of the local pharmaceutical manufacturing. The hearings initiated in the most far-away Russian region will continue in 29 more regions and will come to a close in June 2016 in Moscow.

[PharmVestnik # 31, 06/10/2015, p. 15]

Within medium European limits

Statistical data is a basis for decision-making that has to do with dozens of millions of drug consumers, to say nothing about hundreds of thousands of pharmaceutical industry players. Therefore their accuracy is of prime importance. When executive authorities are the source of such data, and this data is made public by their heads or representatives, it should be perceived as official and reliable. But this is not always the case. 

[PharmVestnik # 31, 06/10/2015, p. 16]

 
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