Lex Russia – New Russian Pharma and Medical Device Legislation is a Reality

Lex Russia – New Russian Pharma and Medical Device Legislation is a Reality

Lex Russia – New Russian Pharma and Medical Device Legislation is a Reality

There is a change afoot in the Russian legislation concerning medical and pharmaceutical products. The much-anticipated new medical device legislation, which was expected at the beginning of 2012, has now been pushed out to around June this year. The new pharmaceutical regulation called ОБ ОБРАЩЕНИИ ЛЕКАРСТВЕННЫХ СРЕДСТВ (On the Circulation of Medicines) was introduced in 2010. It has caused a little confusion since then and led to subsequent updates.

One of the new regulation objectives was to help expand the local pharmaceutical industry, which requires foreign pharmaceutical companies to share their expertise and technologies with local businesses or face trade restrictions.

This has been set against the efforts to support local companies in line with the $4 billion Pharma 2020 Strategy, Russia’s health reform plan developed in 2010, which aims to increase the share of the domestic industry on the total pharmaceutical expenditure from the current 20% to a minimum of 50%.

In practice, there have been a few flaws. The new regulation, for instance, introduces the requirement to conduct clinical trials of new drugs in Russia prior to registration. International clinical trials would be accepted so long as Russian patients were among trial participants.

In the EU, in contrast, there is no requirement for the exact location of clinical trials. Not surprisingly, Russia’s requirement to conduct clinical trials on Russian patients has led to a general slowdown in the number of new drug registrations in Russia.

One thing to bear in mind is that Russia’s healthcare industry strategy concerns the medical device industry as much as it concerns pharma. Specifically, the Russian Federal Target Program (FTP) “PharmMed 2020” encompasses the Pharma 2020 as well as the MedProm 2020 strategies.

The latter has similar objectives as its Pharma equivalent – to promote the development of local production (Stage I - 2011-2017) and to support development of proprietary technologies in Russia (Stage II – 2015-2020).

The new up-coming legislation is expected to help realize that vision, and will have repercussions for every foreign medical device manufacturer marketing their products in Russia, or planning to do so.

Among others, the new regulation is expected to cover areas such as certification, medical device vigilance or clinical trial processes. Will it help or hinder access to foreign-made medical devices for Russia's healthcare and patients? We will find out soon.

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