THE DRAFT LAW ON DRUG SUBSTITUTABILITY IS TO RESTRICT “CREATIVITY” OF SOME REGULATORS

In coming days, the parliament [State Duma] is going to consider the draft law on medicinal drugs substitutability ion the first reading. It is perhaps one of the most debated draft laws that generates hot arguments among the participants of the pharmaceutical market. The Forum on “Regulating healthcare: pressing issues if circulation and provision of drugs and medical products” at FAS Centre for Education and Methodology in Kazan also could not ignore it.

“In fact, the draft law approves what is already established in Russia and other countries at the level of regulator’s directives and guidelines, someway or other related to registration of generic drugs”,  started his speech Timophei Nizhegorodtsev, Head of FAS Department for Control over Social Sphere and Trade. “The objective of the draft law is to narrow the corridor of opportunities for unfair conduct of manufacturers and restrict “creativity” of some regulator’s experts”.

In the current version of the draft law, the Ministry of Healthcare defined substitutability based on the relevant parameters.

“One cannot simply say that capsule is not a tablet. It is necessary to prove through the appropriate expert examinations that capsules and tablets generate certain significant differences, which influence the therapeutic effect. If it is not confirmed, such drags are recognized equivalent”, explained Head of FAS Department.

The speaker informed that the draft law предполагает use the reference rule. It means that the Government should pass a Decree specifying a drug substitutability procedure and the rules for use of information about substitute drugs.

“The goal of the Decree is, on the one hand, to establish a common form for conclusions reached based on relevant expert examinations, standardize them”, clarifies Timophei Nizhegorodtsev. “On the other, we’d like to solve issues as to how medical doctors, pharmacists should act working with aggregated data on drug substitutes. Although ethical norms prohibit doctors to impose drugs, and pharmacists should, in their turn, offer a variety of inexpensive drugs, it does not work in Russia since the existing sanctions are not enough”.

One of the key objectives of the draft law is to level the requirements to the quality of registration dossiers for all medicinal drugs circulating on the market.

“According to the established practice, requirements to registration dossiers tightened gradually in Russia. And often it was related to local understanding that repeat clinical trials of drugs that were subjected to expert examination in other countries is necessary, rather than to international experience. Therefore, it is once again necessary to prove what is already proved”, described the speaker. “As a result of marketing activity of foreign pharmaceutical companies, however, both medical doctors and the population have developed unsubstantiated belief that efficacy, safety and quality of nearly all Russia-made drugs are “not proven”. To eliminate possibilities of such discrimination and abuse, we should level the “quality” of all registration dossiers all to meet the modern Russian standards.  I.e., a considerable portion of the draft law will focus on these norms and standards, related to analyzing registration dossiers, a transitional period and requirements to stretching out the quality of these registration dossiers to the modern standards in the absence of expert examinations on bio- equivalence or therapeutic equivalence”.

Head of FAS Department for Control over Social Sphere and Trade emphasized that manufacturers, who do not have the relevant expert examinations, will be obliged to perform them. If the required expert opinions are not presented within the period of transition, first circulation of such drugs will be suspended and then its registration will be abolished.

Other tasks to be solved by the draft law include eliminating the difference in descriptions of the same drugs and adjusting the conceptual framework to EAEU standards.

Timophei Nizhegorodtsev also outlined how substitutability will be determined for some group of drags and briefly talked about FAS control functions in the course of determining substitutability.

“Our control and supervision means not a repeat expert examination, but, first of all, correlating the conclusions, procedures and processes in the course of drug registration with the relevant requirements of the draft law and Governmental Decree that will specify the procedure”, summed up Timophei Nizhegorodtsev.