The Ministry of Healthcare of the Russian Federation (the “Minzdrav”) has developed draft law aimed to improve regulation of drugs circulation, namely in respect of the determination of drugs interchangeability (the "Draft Law“)1.
The Draft Law is intended to amend the Federal Law dd 12 April 2010 No. 61-FZ “On Drug Circulation” in order to implement the provisions of Clause 3 of the Decision of the Council of the Eurasian Economic Commission dd 03 November 2016 “On Certain Issues related to Drug Circulation”, ratified by the Russian Federation.
The principal amendments contemplated by the Draft Law are as follows:
- The Draft Law amends the definition of reference drug and specifies, that bioequivalence or therapeutic equivalence, quality, efficiency and safety of the generic or bioanalogous (biosimilar) drug shall be assessed compared to the reference drug within the international non-proprietary, or grouping, or chemical name of the drug.
- The Draft Law specifies the procedures to determine the interchangeability of drugs for medical use and provides for the “therapeutic equivalence” parameter which shall be applicable to biological drugs.
- The Draft Law provides for the development of standard instructions for medical use of interchangeable drugs, as well as for formation and maintenance of the register of standard instructions for medical use of interchangeable drugs.
- Minzdrav shall be authorized to maintain the list of interchangeable drugs, as well as to post it on its official web-site on the Internet.
- The Draft Law establishes that conclusion on the interchangeability or non-interchangeability of a drug may be reviewed in case the documents contained in the registration dossier for a registered drug for medical use are amended and such alterations relate to the parameters determining its interchangeability.
According to the Draft Law the abovementioned amendments shall be effective from 1 January 2019.
As of the date of this publication the Draft Law is going through public discussions regarding its text and anti-corruption expertise.