(WTO) will create Russia’s accession
to the World Trade Organization opportunities
to increase exports
of pharmaceutical products
and medical devices.
On 16
December 2011, WTO Members accepted the terms of the Russian Federation’s accession. Russia will
officially become a WTO Member 30
days following the ratification of its Protocol of Accession, which will take
place before 15 June 2012.
As part of its WTO accession
agreement, Russia has commitment to reduce and
“legally bind” import tariffs on pharmaceuticals and medical devices.
Russia must also follow WTO
rules on non-tariff barriers, particularly under the WTO Agreement on Technical Barriers to
Trade (TBT Agreement), and on the
protection of intellectual property, under the WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement).
Lower Import Tariffs
Russia’s tariffs on
pharmaceuticals will be significantly reduced and will be “bound” at a maximum
level of 6.5% by 2016, at the latest. Tariffs on medical devices will also be
reduced and bound at an average of 5%.
Non-Tariff Barriers
Quantitative restrictions on imports,
such as quotas, bans, permits, prior authorization requirements or other
requirements or restrictions that cannot be justified under WTO provisions will
be removed with Russia’s accession to the WTO.
Importers of pharmaceuticals
will no longer need specific import licenses.
However, foreign legal persons intending
to import pharmaceuticals, including veterinary drugs, into Russian territory will
be required to register and hold a license to engage in the production or
distribution of pharmaceuticals.
All technical regulations and
conformity assessment procedures will have to be developed and applied in
accordance with the relevant
WTO agreements and in particular
with the TBT Agreement.
Under the TBT Agreement, international
standards should be followed and Russia may only apply technical regulations to
the extent that they are not more trade restrictive than necessary to fulfill
legitimate objectives.
Protection of Intellectual Property
Upon accession, Russia must
protect intellectual property, including patents and trademarks, in accordance
with the TRIPS Agreement.
Furthermore, data protection
rules will enter into force to protect the data related to pre-clinical and
clinical trials of innovative drugs.
Price Control Rules
Russia will continue to apply
price controls on certain products and services, including medical goods, but
these controls must be applied in manner consistent with WTO standards.
Russia will not be entitled to
use price controls for the purposes of protecting domestic products or
services.
A comprehensive list of goods
and services subject to State price controls will be published in the
Rossiiyskaya Gazeta.
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