Elena Arkhangelskaya at conference “Manufacture localization in pharma industry”

On June 15, Marriott Royal Aurora Moscow hosted a pharma localization conference sponsored by Vedomosti. Practice. The participants discussed a wide range of issues, including the development of local production capacities, state regulation, preferences, and intellectual property.

Petrovax Pharm President Elena Arkhangelskaya, together with Head of the Federal Service for Intellectual Property Grigory Ivliev, Patent and Lawyer’s Office Guardium Managing Partner Alexey Abramov, and Veropharm CEO Elena Bushberg, took part in the expert session on the development of innovative pharma manufacturing.

Session moderator Alexander Kuzin, NovaMedica CEO, asked the experts whether innovative manufacturing existed in this country, and if it was worthwhile developing it. Elena Arkhangelskaya remarked that since the time when the Federal Target Program «Pharma-2020» was adopted, all market played had done their utmost for the Russian pharma market stabilization and growth.

«Today, many foreign companies implement joint projects with Russian enterprises boasting a high level of technologies and production competencies. This is especially important for high-tech production,» emphasized Elena Arkhangelskaya.

Petrovax Pharm is an immunobiological industry pioneer. In 2004, it was among the first local companies to start cooperation with an international corporation, namely Solvay Pharma (presently an Abbott company), to launch an advanced influenza vaccine to the market. In 2008, it was the first local immunobiological company to launch a pharmaceutical manufacturing complex and a syringe filling line in compliance with the international GMP. Currently, the company is scaling up international cooperation. Elena Arkhangelskaya cited an example of a successful partnership with Boehringer Ingelheim on localization of innovative thrombolytics. «Contract manufacturing is key for the development of a state-of-the-art facility. It is a development system for all those involved in the process that provides for expertise upgrade, utilization of production capacities, better staff discipline, and new personnel training,» concluded the speaker.

There was an interesting discussion on intellectual property, difficulties, and long duration of the patenting process in Russia. The Federal Institute for Industrial Property, a body engaged in a wide range of activities preceding patenting, has been developing; presently in Russia, there are more than 500 thousand trademarks, and 300 thousand patents. The speakers noted the necessity of developing the patent protection market, and creating a unified register to include all patenting data.

«Intellectual property protection, and patent integrity maintenance indicate the level of market civilization,» said Elena Arkhangelskaya. «This issue, if unadjusted, creates additional risks for investors, these risks, in turn, destabilizing the market development. It is a thrilling and, at the same time, hard experience being a manufacturer with an original product portfolio. Our company holds more than 20 patents for molecules and manufacturing technologies. However, in today’s context, it is important not only to be able to manufacture innovative products but also to be able to protect one’s position in many ways, including patent protection.»

When asked what else was necessary for the pharma market, the speakers singled out stability, predictability, and creating favorable conditions for investment. Elena Arkhangelskaya called on the market players to actively discuss pharma market regulation issues. Petrovax Pharm president cited VED pricing to exemplify a special regulatory approach.⁠