On August 23, 2012, a six year regulatory data protection (RDP) came into effect in Russia coinciding with Russia’s accession to the World Trade Organization. The law regarding RDP can be found in Article 18.6 of the “Law on Circulation of Medicines.” The wording of Article 18.6 is somewhat awkward as shown in the below English translation which states:
“It is not permitted receipt, disclosure and use for commercial
purposes and for the purposes of state registration of medicines of the
information on the results of preclinical studies of medicines and
clinical studies of medicines provided by an applicant for registration
of a medicine without his agreement for 6 years from the date of state
registration of the medicine.
Non-observance of this prohibition established by this part will entail
liability in accordance with the legislation of the Russian Federation.
It is prohibited circulation of the medicines on the territory of the
Russian Federation that were registered in violation of this part.”
Although almost a year has passed since the RDP provision came into effect, it is too early to draw any conclusions as to whether or not RDP really works. Although it appears that during the last year no generic company has received marketing authorization during the six-year RDP period, a number of concerns still exist regarding the enforceability of Article 18.6.
A strong and enforceable RDP system must provide the following:
1. The RDP must be applied in connection with the granting of a marketing authorization for a generic medicine;
2. The RDP must provide for a ban on the granting of a marketing authorization for a generic medicine whose dossier contains reference to preclinical and clinical studies of an innovator medicine and the results of generic company’s bioequivalence studies; and
3. The RDP must be effective for six years from the date of the granting of the first marketing authorization of the innovator medicine.
Unfortunately, the current wording of Article 18.6 provides none of these requirements. Specifically, there is nothing in Article 18.6 that states that it applies with respect to generic drugs. Second, there is nothing in the Article that specifies that a ban on the granting of marketing authorization should be applied if a generic company’s dossier contains reference to the preclinical and clinical studies of the innovator medicine supported by the results of generic company’s bioequivalence studies. Finally, the Article simply does not specify that the six-year RDP period is effective as of the date of the granting of the first marketing authorization of the innovator medicine. In fact, it is unclear under the Article whether an innovator company would be the correct RDP holder.
The substantial loopholes in Article 18.6 will create serious problems for successful enforcement of RDP for an innovator company. Unless Article 18.6 is amended and/or the existing loopholes in the Ministry of Health’s administration regulations on granting marketing authorization are closed, there is a substantial risk that RDP may not be enforceable in Russia. Presently, we are not aware of any discussion regarding possible amendments to either Article 18.6 or the administration regulations. Therefore, innovator companies should be careful in relying on RDP in Russia when determining the date for loss of exclusivity for their branded medicines in Russia.