OREANDA-NEWS. The plenary session of the PharmaStrategies-2015 conference focused on several key issues including a planned international pharmaceutical market information system for anti-monopoly regulators, changes in the federal law on circulation of medicines and the application of the law on public procurement contracts system.

The plenary meeting, Regulatory Challenges on the Pharmaceutical Market in 2015, took place as part of the PharmaStrategies-2015 summit on major issues for drafting pharmaceutical companies' strategies for 2015, organized with support of the VEGAS LEX law firm.

VEGAS LEX Managing Partner Alexander Sitnikov moderated the plenary meeting.

Timofei Nizhegorodtsev, head of the Federal Anti-monopoly Service Department for Control over Commerce and Social Sphere, who was specially invited to speak at the conference, presented the structure of a planned international pharmaceutical market information system (platform) for anti-monopoly regulators in various countries. The new system will enable them to quickly share information and exchange experience in the development of pharmaceutical market competition in their respective countries. It will also provide regulators with quick and convenient access to the pharmaceutical market regulatory updates, analytical reports and other materials.

"In his presentation Mr. Nizhegorodtsev also discussed the latest amendments to the Federal Law No. 61-FZ On Circulation of Medicines.* He said the draft has been submitted to the State Duma, and will soon be considered by the lawmakers. In his words, most of the controversy between the concerned parties has been resolved by now. "I think that by the second reading we will reach an agreement with the Healthcare Ministry on one of the remaining issues - registration and obtaining permits for clinical research," he said. "Once this happens, we can be certain that the resulting law will be even better than we expected. But even as it is, the amendments have greatly improved it."" Source: FarmatsevticheskyVestnik.

Deputy Head of the FAS Department for Control over State Procurement ArtyomLobov delivered a report on the application of Federal Law No. 44-FZ On the System of Public Procurement Contracts for Products, Work or Services for State and Municipal Needs**. He cited some examples of problems arising when applying this law in various industries, discussed the use of expert appraisal as part of the procurement process, explained whey extended deadlines for signing state contractsmake it impossible to meet government needs, and described the difficulty of estimating the contract value. In his words, the involvement of small enterprises in public procurement of pharmaceuticals creates one of the biggest problems, which can be solved by working out a system for taking such businesses into account, possibly through the Unified Information System (EIS).