Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them.
The new regulation, which will bring the EAEU more in line with the EU rules on pharmacovigilance, is currently awaiting approval by the EAEU Council, according to the law firm Baker & McKenzie. Once it is in force, it will reform how the EAEU member states regulate drug safety monitoring, the firm said.
The regulation will, for example, require drug companies to appoint a qualified person for pharmacovigilance (“QPPV”) in one of the countries in which they operate within the EAEU to be responsible for all the other relevant EAEU countries, Baker & McKenzie explained. It will also make certain products subject to additional safety monitoring and will expect manufacturers to take a more active role in the area of pharmacovigilance, Evgeniya Shagarina and Julia Gillert, associates at Baker & McKenzie’s Moscow and London offices respectively, told Scrip Regulatory Affairs (“SRA”).
In Russia, for example, marketing authorisation (“MA”) holders currently have “a relatively ‘passive’ role in terms of pharmacovigilance,” Shagarina and Gillert said. “Their pharmacovigilance obligations are limited to reporting on certain events that have become known to the MA holder and submitting regular reports to the regulatory authorities.” “Once the new Regulation comes into effect, MA holders will assume an ‘active’ role in the pharmacovigilance area and thus will incur additional liabilities,” Shagarina and Gillert told SRA. “For example, they will have to proactively identify, validate and action product safety signals, submit additional safety information (obtained from international and national sources) to the regulatory authorities, [and] audit [pharmacovigilance] systems on a regular basis,” they explained.
“Further, once the regulatory authorities publish a list of pharmaceutical products subject to additional safety monitoring, the MA holders of such products would need to make amendments to the respective products’ directions for use in order to add a special mark and a note on additional monitoring.”
The new rules are not, however, expected to pose too much of a problem for multinational firms, and they might even alleviate a certain amount of regulatory burden for such companies.
“According to the comments of developers of the EAEU Regulation, the new Regulation is generally harmonised with the EU Guideline on Good Pharmacovigilance Practices, save for a few changes,” Shagarina and Gillert said.
“Since the new Regulation appears to be generally harmonised with the EU regulations, multinational companies should be able to apply their pharmacovigilance standards and procedures used in the EU to the EAEU market, subject to making only minor amendments to reflect the distinct local requirements,” they explained. “Previously Russian national legislation provided for different standards of reportable events, thus creating an additional burden for multinational companies.”
Appointing a QPPV
As for appointing a QPPV, Baker & McKenzie said that the QPPV should reside and work in one of the EAEU states. “The QPPV can provide services to more than one MA holder if he/she is capable of performing all pharmacovigilance obligations in this respect.” The QPPV would have to possess the necessary theoretical and practical knowledge to perform their pharmacovigilance duties and “be trained to use the pharmacovigilance system of the MA holder by the MA holder prior to his/her appointment to this role,” the firm noted. The QPPV should also have experience in the pharmacovigilance system management, performance of examinations or have access to such examinations in the fields of medicines, pharmaceutical sciences, epidemiology and biostatics.
To the best of Shagarina and Gillert’s knowledge, “the vast majority of multinational pharmaceutical companies operating in Russia already have an employee responsible for the pharmacovigilance reporting.” They believe, therefore, that once the new regulation comes into effect, “it is likely that such employees would already have the necessary knowledge and experience to be appointed as QPPVs for the EAEU market.”
They added that there is no specific deadline or transition period in the new regulation for the appointment of a QPPV. “Presumably a QPPV should be appointed immediately once the new Regulation comes into effect.”
“The new regulation does not establish any sanctions for the failure to appoint a QPPV,” the lawyers noted. “However, the respective sanctions may be established (if not established already) by the national legislation of the EAEU members. For example, in Russia at this stage only the failure to provide the necessary pharmacovigilance information to the regulatory authorities is subject to administrative and criminal liability, and there is no specific liability for non-appointment of a QPPV.”
It is still not clear exactly when the new pharmacovigilance regulation will come into force. It had originally been expected to kick in on 1 January 20161. “We are still waiting for the approval of the draft EAEU Pharmacovigilance Regulation by the EAEU Council, and the exact date of entry of the Regulation into force is not yet known,” Shagarina and Gillert told SRA.
The member states of the EAEU are Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.