The term "interchangeable medicine" was formally introduced to Federal Law No. 61-FZ on the Circulation of Medicines of April 12, 2010 (the "Law on the Circulation of Medicines") by amendments to it dated December 22, 2014, No. 429-FZ ("Amendment Law 429-FZ"). Thus, an interchangeable medicine is a medicine that has proven therapeutic equivalence or bioequivalence to a reference drug and that also has the quality and quantity of active ingredients, additives, dosage form and administration equivalent to the reference drug. The main stated objective of introducing this concept into the legislation was the need to protect competition during state procurement and to protect the interests of consumers by securing their ability to purchase medicines that are identical in terms of quality and effect but at advantageous prices. It remains unclear whether the RF Federal Antimonopoly Service will follow this definition of the interchangeability of medicines when etermining product market ranges of one medicine or another (in addition to performing market research using the current procedure), but the possibility is certainly likely.
The parameters for determining interchangeability of a medicine under examination and reference drugs are set forth in Article 27.1.1 of the Law on the Circulation of Medicines and include the equivalence of the qualitative and quantitative characteristics of pharmaceutical substances, dosage form, the equivalence or comparability of a medicine's additives, identical administration and usage, absence of clinically significant differences in a study of bioequivalence (or therapeutic equivalence, if applicable) and the manufacturer of the medicine in question complying with good manufacturing practice.
However, according to the same Article 27.1.1 of the Law on the Circulation of Medicines, the RF Government was to establish the procedure for determining interchangeability of medicines, based on the parameters listed above.
The RF Government adopted Resolution No. 1154 on the Procedure for Determining Interchangeability of Pharmaceuticals for Medical Use of October 28, 2015 (the "Resolution") approving the rules for determining the interchangeability of pharmaceuticals for medical use (the "Rules"). The Resolution entered into force on November 10, 2015.
The Rules state that the interchangeability of a pharmaceutical for medical use (the "medicine") is determined in the course of the process of its state registration, based on its comparison with a reference drug according to the above-mentioned parameters specified in the Law on the Circulation of Medicines. Interchangeability is determined when the commission of experts at the federal state expert agency (under the auspices of the RF Ministry of Health ("MoH")) performs an expert review of the medicine to verify the quality and/or risk to benefit ratio.
In many ways this wording repeats the rules contained in the Law on the Circulation of Medicines and in Federal Law No. 429-FZ on Amendments to the Federal Law on the Circulation of Medicines of December 22, 2014 (the "Amendment Law").
The Rules also contain some clarifications. For example, the interchangeability of a biosimilar drug with the reference drug is determined taking into account the data obtained from clinical trials that there are no clinically meaningful differences between the biosimilar drug and the reference drug in terms of safety, efficacy and immunogenicity. Also, the medicine's patient leaflet not having the indications for use stated in the leaflet of the reference drug and protected by a valid patent is not an obstacle to determining that a medicine is interchangeable with a reference drug.
According to Amendment Law 429-FZ, also cited by the Resolution, holders or owners of registration certificates for medicines that have already been registered may file applications to determine the interchangeability of medicines in the form of amending documents in the medicine's registration dossier by December 31, 2016. The process of determining interchangeability for such medicines will last until December 31, 2017 because information about interchangeability of medicines should be included in the state medicines register as of January 1, 2018. It is not permitted to use the results of the determination of interchangeability of medicines before that date.
The MoH is required to publish information about those registered medicines for which it has issued an assignment to experts to determine their interchangeability on its official website. The conclusion as to whether a medicine is interchangeable with a reference drug or not will be drawn up in the form of an annex to the expert commission report. However, the MoH has yet to approve the form of the report and, until that happens, one should suppose that such reports will not be issued.
It should be noted that according to Amendment Law 429-FZ, until January 1, 2016 the term "original medicine" (which, based on the comments of representatives of the competent authorities means the registered original medicine as defined in the version of the Law on the Circulation of Medicines that is no longer in force) will be considered the reference drug. Amendment Law 429-FZ does not specify which medicine will be indicated as the reference drug after its entry into effect. According to comments from the Director of the Department of Drug Supply and Regulation of the Circulation of Medical Devices of the Russian Ministry of Health Yelena Maksimkina, after January 1, 2016 not only the original medicine may be considered the reference drug, but also a generic or biosimilar drug that has a full dossier, including cases where the original medicine is not registered on the Russian market.
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