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28
May
2015

VEGAS LEX on parallel imports regulation and planned mandatory pharmaceutical industry licensing

On May 28, 2015, Moscow hosted the Third International Forum Pharma and Biotech 2016: Problems of formation of EAEU market and the role of the cold chain* for representatives of major pharmaceutical companies and producers. A common Eurasian Economic Union (EAEU) market for pharmaceuticals and medical products will go on stream from January 1, 2016. A legal and regulatory framework for that common market is being developed right now.

Manager of VEGAS LEX Life Sciences Projects Maria Borzova delivered a report on Parallel imports and mandatory licensing in the pharmaceutical industry. She described various approaches to regulating parallel imports of pharmaceuticals that are used right now (including in the EU countries), and analyzed the recent initiatives aimed at legalizing parallel imports of pharmaceuticals (in Russia and at the EAEU level) in terms of their feasibility and consequences for the market. The expert spoke about the risks of legalizing parallel imports for the patients, manufacturers and the healthcare system as a whole; about the prospects and objective barriers for parallel imports in Russia and the EAEU space (also from the perspective of stimulating local manufacturing, protecting competition and price regulation).

The participants also discussed other issues such as the introduction of the GMP/GDP systems as foundations for the development of export potential, the possibilities of local manufacturing of medical products and access to the market for local manufacturers, the vaccines segment development, and cutting-edge technologies for maintaining the quality and safety of the cold chain.

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For more information on VEGAS LEX’s services for the pharmaceutical industry, please click here.

* The event was organized by the nonprofit partnership Cold Chains and Biotechnologies, and the company Komtekh-Consult.

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