12.10.2021 | News
Regulatory Sandbox goes official
  • An experimental legal regime, the first of its kind in Russia, designed for the effective use of anonymised health data and, in particular, conducting research of real-world clinical practice on the basis of such data, will be officially announced.
  • The experimental regime will remove legislative barriers to the processing of large sets of anonymised health data.
  • For more than a year, the BGP Litigation Life Sciences & Technology team has taken the lead in the discussions and approval of the experimental legal regime.

Introducing experimental legal regimes, no doubt, will boost the development of technology, and this is not confined to healthcare alone. Many sectors of the economy, from aviation to agriculture, will get an opportunity to make a technological breakthrough and get out of long-standing stagnation. I am convinced that in the next few years the work on this project, that our team performed in close cooperation with representatives of the state authorities, will bring such results as innovative, efficient, and safe solutions that will dramatically change lifestyles both in Russia and abroad,” says Alexander Panov, Partner, Head of the Life Sciences & Technology practice at BGP Litigation.

On 12 October 2021, at the International Congress “Digital Medicine and Information Technologies. Sechenov Digital Health Summit”, there will be an official announcement of the launch of the experimental legal regime for RWE research based on anonymised health data, developed by the BGP Litigation lawyers.

The experimental legal regimes announced at the International Congress will be among the first Russian precedents of establishing experimental regulations that have proliferated abroad in the “regulatory sandbox” format.

The experimental legal regime for RWE research was initiated by Data MATRIX, a leader in this area of Russia’s healthcare industry.

“The experimental legal regime for RWE research opens up great prospects for the use of the productive potential of data, and, most importantly, for the accumulation of large sets of verified data that allow for comparisons of efficiency and safety of drug treatments and innovative medical equipment,” says Alexey Loleit, Director for Strategy and Product Development at Data MATRIX. “RWE research (real-world data-based research) has proven its importance for pharmacology and medicine. And its role will only increase in the decade to come.”

“Experimental legal regimes are the best way to regulate innovations, as they allow the regulator and the industry to focus on special features of each area of technology, without trying to embrace the non-embraceable by introducing unified regulations in one law,” says Ivan Zaraiskii, Associate with the Life Sciences & Technology practice at BGP Litigation.

Previously, the BGP Litigation team took an active part in the development of a companion law that has already entered into force, allowing for the implementation of experimental legal regimes in several areas at once, including the processing of anonymised health data and the use of artificial intelligence in medicine.