Rules have been adopted to create a list of medicines to be purchased under their trade name

Pepeliaev Group advises that on 28 November 2013 the Russian Government approved, through Order No. 1086, Rules to create a list of medicines to be purchased under their trade name (the “Rules”). These Rules determine the procedure for medicines to be included in the relevant list (the “List”).

On 2 December 2013, the Order was published on the official web portal for legal information (http://www.pravo.gov.ru) and is to come into force in 7 days after its official publication. The Rules will come into force on 1 January 2014.

1. It is established that a medicine may be included in the List if such medicine cannot be replaced within the same international non-proprietary name (INN) of the medicine or, if there is no such name, within the chemical or generic name, and if the effectiveness and safety of such medicine suggest that it should be included. A medicine may be excluded from the List if it can be replaced.

2. Within the Governmental Healthcare Commission  (the “Governmental Commission”), a sub-commission for the circulation of medicines is created (the “Sub-commission”). The Sub-commission considers whether medicines may be included in (or excluded from) the List pursuant to applications from individuals and legal persons. Unfortunately, public representatives and business are at the moment prevented from discussing any issues concerning how the List is set up.  

3. Whether medicines may be included in (or excluded from) the List is considered on the basis of the following documents (information) which are available to the Russian Ministry of Healthcare (the “Healthcare Ministry”):

1)    reports regarding the testing results in relation to the bioequivalence or the therapeutic equivalence of medicines conducted in accordance with the clinical practice, or information that there are no such reports;

2)    the results of assessing the relationship between the expected benefit and the eventual risk of utilising a medicine;

3)    the results of monitoring of the safety of a medicine.

The applicant has the right to submit the above documents (information) at its own initiative, as well as other information obtained, among other things, based on international practices of utilising medicines (which are adopted by the World Health Organization, the European Medicines Agency and the US Food and Drug Administration), and the results of published scientific research.

3. The following procedure for creating the List is proposed:

1)    The applicant submits to the Healthcare Ministry an application in electronic form or in hard copy.

2)    The Healthcare Ministry, the Russian Ministry of Industry and Trade and the Russian Federal Antimonopoly Service jointly consider the application within a maximum of 30 days after receiving it. If the application cannot be considered within this period, it is extended by a maximum of 30 days, with the Healthcare Ministry informing the applicant of this in writing or in electronic form.

3)    Further to the joint consideration application, the Healthcare Ministry summarises the information received and submits to the Sub-commission a proposal for the medicines to be included in the List (or excluded from the List).

4)    If there are disagreements between the above executive bodies, the Healthcare Ministry submits its proposal together with the protocol of the consensus meeting and the remarks made by the relevant executive bodies.

5)    After the Sub-commission has reviewed the proposal, the Healthcare Ministry prepares the necessary materials to be submitted to the Commission.

6)    The Commission considers the proposal. After such review, the Healthcare Ministry:

•    sets up a draft List in which the medicines are included under their respective INN or, if there is no such name, under their chemical or generic name, together with their trade names and pharmaceutical form;

•    informs the applicant about the decision taken in relation to its application.
To think about, to do
In connection with the above new developments, we suggest that companies:

•    Analyse the current model of the company’s involvement in public procurement and assess whether medicines may be included in the List.

•    Assess competitors’ opportunities within an INN and make the corresponding adjustment to their own sales strategy in the public procurement market.