On the possibility of purchasing medicines by trade name for certain patients.

14.12.2011

Legal Update No. 298 

Goltsblat BLP can now advise that the Federal Anti-monopoly Service website has published an update to letter No. AK/34021 dated 06 September 2011 clarifying the provisions of the Federal Law, “On Placing Orders for Delivery of Goods, Works and Services for State and Municipal Needs”, regarding the application of the Federal Law, “On Circulation of Medicines”, when purchasing medicines for patients having contraindications to medication that has already been purchased via state programmes.

The Russian Anti-monopoly Service letter indicates that, if some patients have official contraindications (registered in their medical records, the historical profile of such an illness, medical opinion, etc.) to the use of medicines of a certain trade name having analogs in the context of the Federal Law “On Circulation of Medicines”, said trade name cannot be considered as interchangeable for such patients or having the same name as analogs thereof.

Medication that is not contraindicated for such patients should, therefore, be purchased.

In addition, the Russian Federal Anti-monopoly Service informs that trade documents for such purchases may include a reference to trade names without the words "or its equivalent", including when goods marked with other trade marks are incompatible.

On the basis of the above, the Russian Federal Anti-monopoly Service concluded that when medicines are purchased to support, in a centralised manner, high-cost disease types for patients suffering from adverse events and complications of injection of blood-coagulation factors, the customer can make a decision as to which medicine is to be purchased at its own discretion, on a case-by-case-basis, subject to relevant documents confirming the need and in quantities not exceeding such needs.

The Russian Federal Anti-monopoly Service letter also points out that if the patient's side effects and contraindications are not included in the medicine’s regulatory documents, a relevant investigation should be conducted and all subsequently discovered side effects and contraindications should be included in the regulatory documents.

When using the Russian Federal Anti-monopoly Service letter, it should be borne in mind that clarifications of the legislative provisions pertaining to order placement are provided by the Russian Federal Anti-monopoly Service in reply to the application by a particular person (a business entity, a territorial subdivision of the Russian Federal Anti-monopoly Service, a state authority, etc.), that the letter with relevant clarification is neither a regulatory nor individual legal act, that it does not predetermine the court's position on the issue it discusses and that the position of the Russian Federal Anti-monopoly Service on a certain aspect of application of the legislation on order placement might change soon.

For additional information, please contact:

to Nikolay Voznesenskiy
Head of Anti-monopoly Practice,
Goltsblat BLP,
T: +7 (495) 287 44 44,
E: info@gblplaw.com

to Nina Belozertseva
Head of Healthcare and Pharmaceuticals Practice,
Goltsblat BLP,
T: +7 (495) 287 44 44,
E: info@gblplaw.com

Contact details

For all issues related to publications, news and press releases, please contact:

Ksenia Soboleva

Head of PR and Communications

Subscription

If you would like to receive our legal alerts and updates highlighting current legal issues relevant to your areas of interest and providing expert commentary by our lawyers, please click on "Sign Up" and fill out the form.