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Russian healthcare reforms – the implications for pharma

Clinical trials, pharmaceutical manufacturing, medical devices and sales activities all face changes in the country

Pharmaceutical companies in Russia will soon face a number of important changes to their market environment, following the signing into law of the new healthcare bill.

In a live webinar on December 5, Russian experts Lucia Railean of Cegedim CIS and Vsevolod Tyupa of CMS Cameron McKenna, gave their views of the changes, focusing in particular on their regulatory and market access impact.

Tyupa outlined the regulatory implications of the law, including restrictions on interactions between pharmaceutical companies. He stressed that doctors were now prohibited from accepting visits, gifts or samples from pharmaceutical representatives, except in the cases of 'scientific activity', 'educational work', clinical trials or adverse events.

He explained that pharma companies could still set up seminars under the 'professional development' banner to meet doctors.

Pharmaceutical representatives can still meet doctors at public events and out of office hours, but they will no longer be able to see them at their offices during working hours.

Also, as 'scientific activity' was still permitted, doctors could be invited to speak at conferences, agree service agreements and then receive payments for their services. However, Tyupa added that doctors were concerned about the new rules and many did not understand the details, so it could be up to the industry to clarify the position.  

Under Russia's healthcare reform bill, the definition of medical devices has been broadened to include any software and disposable materials needed for medical use and the government now has greater control over their sale, in the form of inspections for compliance. In addition, all those selling such products must report any adverse events and side effects.

There are changes too for the companies running clinical trials in Russia. The remuneration paid to principal trial investigators will no longer be confidential, something Tyupa thought would be problematic for pharma, but which he said was a fact of life in Russia.

Considering localisation of pharma manufacturing from the legal angle, Tyupa thought there were several benefits to be enjoyed, including tax privileges for facilities set up in pharmaceutical clusters, the right to raise prices for drugs on the essential drugs list, plus the ability to sell goods bought by the government at full price without having to give an additional 15 per cent discount.

He also stressed that, although GMP rules were not obligatory in Russia at present, they will be mandatory from January 1, 2014 and companies should therefore ensure that they choose a Russian partner that complies with these standards.

Pharma market access in Russia

Cegedim CIS's Lucia Railean presentation described the complexities market access within the Russian healthcare system, with its parallel federal, regional and municipal budgets. 

The new law places increasing emphasis on regional decision-making and, with 83 regions to consider, Railean stressed the need to understand local processes and key stakeholders to help plan where attention should be focused for the best market access outcome for a particular drug.

Railean concurred with Tyupa regarding the growing importance of educational professional development meetings to influence stakeholders as part of any market access strategy planned from 2012.

She concluded that though there were budgetary limits on drugs at regional level at present, the trend was likely to shift towards greater state funding over the coming years. In 2012, standards of treatment would be updated and in 2013 patient registries would be established, followed by the 2014 launch of a pilot programme of regional reimbursement and then the actual launch in 2015.

The audio presentations on the regulatory and market access impact of the changes to Russia's healthcare system as well as their accompanying slides are available to view in the archived Russia – The Inside Story webinar.

8th December 2011

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