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Are the amendments to Russia's drug circulation law on the way to becoming reality?

14 July 2014 Kavita Rainova

Early this month it was reported that the amendments to Russia's drug circulation law, Federal law FZ:61, were finally passed to the country's State Duma for consideration. While this does not necessarily signal that the amendments in this version will be approved, it is nevertheless the closest that the draft changes have gotten to "becoming reality". The news comes after months of discussions on the amendments. The draft has gone back and forth between the Ministry of Health and consultations leading to several versions being put forward in the time period.

So what exactly is the FZ:61?
The Federal law FZ:61 "On drug circulation" basically governs the process of registration of the drug in the country. The law covers, among others, clinical trials registration, documents and processes for the registration of drugs, and reporting of adverse events. The FZ:61 was put in place in 2010. However, the lack of clarity on certain texts of the law had lead for calls for the law to be reviewed.

What are the suggested amendments?
While there are many amendments proposed, some warrant special attention including the introduction of additional terminology in the legislation, accelerated registration process for certain drugs, and allowing generic/ biosimilar manufacturers to access the originator's data earlier.

The proposed amendments include the addition of definitions for terms such as biological drug, bioanalgues (biosimilars), and interchangeable drugs, which were previously not in the legislation. As it stands at the moment, interchangeable drugs are defined as "drugs that can be compared for their therapeutic equivalence or bioequivalence…". By specifying therapeutic equivalence, or bioequivalence, the government seems to be leaving the door open for biosimilars (or bioanalogues) to fall under the definition of interchangeable.

Accelerated registration process:
The measures include an accelerated registration process for first generic for paediatric use and orphan drugs. The accelerated registration process for these drugs will no doubt be welcomed by their manufacturers. However, the manufacturers of orphan drugs will benefit from the "doing away" with the need for conducting domestic clinical trials- a requirement that remains in place for other drugs.

Earlier access to originators data:
Last but by far not the least, the amendments propose allowing earlier access for generics and biosimilars' manufacturers to the orginator data- four years following the registration of the originator in the case of generics, and three years in the case of biosimilars. Since the proposal specifies that generics and bioanalogues manufacturers will not be allowed to use the results of pre-clinical and clinical trials used for the originator's registration for commercial purposes for six years without the consent of the originator's manufacturer, the six-year data-exclusivity period would technically remain in place. Nevertheless, the measure will enable the biosmilars/ generics manufacturers to conduct their biosimilarity/bioequivalence tests earlier, allowing them to bring their products to market sooner, once the data exclusivity expires.

What next?
That would depend on whether the amendments are passed in their current version and the State Duma is set to consider the amendments this autumn. If this were to happen, the draft specifies that the law is intended to be put in place from 1 January 2015. Whether this timeline is adhered to or is moved remains to be seen.

If the proposed amendments are not passed in the current version, with potentially more changes required, then the saga of introducing changes to the FZ:61 will continue. What seems to come through from some of the current proposes changes is a leaning towards more beneficial changes for generics/ biosimilars manufacturers.



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