TIMOPHEI NIZHEGORODTSEV: IN RUSSIA REGULATORY SYSTEM OF REGISTERING MEDICINE IS OVERWHELMED WITH UNFAIR PRACTICES OF THE 1990’S
Head of FAS Department for Control over Social Sphere and Trade outlined the “difficulties” of defining substitutability and FAS point of view over the current problems in the sector
On 15 May 2019, Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev was a speaker at the 25th Russian Pharmaceutical Forum, where he presented the regulator’s position on substitutability of medicine.
Timophei Nizhegorodtsev started his speech, saying that “FAS counters unfair practices that emerged back in the 1990s and strongly influenced the regulatory system of registering medicine”.
Head of FAS Department for Control over Social Sphere and Trade reminded about the principles of medicine registration in Russia that are formalized in the law: reference medicine are equivalent to generics and vice versa.
“Thus, if a medicine is registered as a generic, it has already proved its equivalence – comparability, analogy – to a reference medicine, it means they are substitutes. Conversely, if equivalence to a reference medicine is not proven, it cannot be registered as a generic”, informed Timophei Nizhegorodtsev.
The speaker reported that in spite of the differences in dosage forms, generics have proved their equivalence to the referent medicine in the course of registration. In spite of the established medicine registration procedure in Russia, however, there are additional (other) varieties of generics. For instance, medicine are registered in comparison with non-reference medicine while there are reference ones, or have indications and contraindications different from the reference medicine, administration routes, etc.
In FAS opinion, generics registered in comparison with non-reference medicine although there are reference medicine, de jure cannot be generics while de facto confirmed their “generic nature” in clinical practice. In this context, the antimonopoly authority proposes to introduce a transitional period for manufacturers to submit the missing data, confirming the equivalence of such medicine to the relevant reference medicine.
If generics have other indications and contraindications from the reference medicine, all parameters of generics must be adjusted in line with the reference medicine. In-house clinical trails that determine such changes are an exception.
“Today the point is that we should clarify the law enabling to eliminate the problems in the work of the Ministry of Healthcare of the Russian Federation on medicine substitutability. Generics must be substitutes to the reference medicine. In principles, there are no problems at all to establish it within the registration dossier, commented Head of FAS Department for Control over Social Sphere and Trade.
Timophei Nizhegorodtsev explained the need to level the requirements to the quality of registration dossiers for all medicine circulated on the market, regardless of the requirements valid in a particular period when medicine were registered. This measure is necessary because absence of the equal set of expert examinations and studies in the registration dossier discriminates some manufacturers against others. It also creates conditions for unfair competition in the form of disseminating rumors on generic inefficiency as well as confirming equal quality for all generics and reference medicine circulating on the market.
To eliminate the issues of establishing substitutability and fully-fledged launch of medicine substitution programmes, medicine manufacturers must be obligated to conduct studies of bioequivalence or therapeutic equivalence (except special dosage forms); a requirement should be set to adjust indications and contraindications for use in line with the instructions for the reference medicine (except when in-house studies are performed); there should be a sufficient transition period; establish the circulation specifics of such medicine; suspend circulation and later abolish state registration of the registration dossier and indications for use are not adjusted in line with the modern regulatory requirements.
“Hopefully, the work will accelerate. We spent ten years to expose the issue, describe and discuss it; now, accelerated is achieved through digitalization. Under the orders of the president of Russia, efforts related to standardization, summarizing and describing medicine must be finalized within reasonable but shortest periods. In this connection, the draft laws and related decisions will be a priority. We expect that the work will be completed by 2021”, concluded Timophei Nizhegorodtsev.