Alexander Yanev, Associate with Legal Alliance Company
On July 1, 2013 in Ukraine came into force a number of regulations, including the Law of Ukraine of 20.06.2013 No 353 -VII "On amendments to certain legislative acts of Ukraine on elimination of restrictions on economic activities" (hereinafter - "Law 353 -VII").
Law 353 -VII is a significant reduction in administrative burden on enterprenuers through introduced restrictions of intervention of the authorities in the economic activities of entrepreneurs. The purpose is achieved by introduction of the mechanism of confirmation by the administrative court of the lawfulness of measures imposed by controlling authority on enterprenuers.
The adoption of this document can be evaluated as a positive step towards minimization of a number of unlawful decisions of state authorities relating to the limitations on the entrepreneurs. However, the peculiarities of the pharmaceutical industry provides grounds for negative aspects of Law 353 -VII.
In particular, the order of the Ministry of Health of Ukraine of 22.11.2011 No 809 approves the Procedure of prohibition (temporary prohibition) and restoring of turnover of medicinal products in the territory of Ukraine (hereinafter - "Procedure"). The purpose of this Procedure, among other things, is to establish legal procedures of prohibition (temporary prohibition) of turnover of medicinal products in order to minimize the negative impact of not qualitive, counterfeit, unregistered medicinal products on life and health of patients.
Logically, the prohibition (temporary prohibition) of turnover of medicinal products requires prompt actions from both the State Service of Ukraine on Medicinal Products (hereinafter - "Derzhliksluzhba") and the operators of pharmaceutical market.
However , in accordance with the provisions of part 5 article 4 of the Law of Ukraine of 05.04.2007 No 877-V «On principles of state oversight ( control) in the sphere of economic activity " (including changes introduced by Law No 353 -VII) absolute or partial suspension of production (manufacturing) or sale of products and works, rendering of services may be allowed by the order of the administrative court adjudicated based on the consideration of a lawsuit of state controlling authority filed in order to impose necessary and relevant measures.
Thus, prohibition (temporary proibition) of turnover of medicinal products by Derzhliksluzhba is lawful only only after satisfaction by the competent administrative court of a respective lawsuit of Derzhliksluzhba . Certainly that under these circumstances “prompt“ prohibition of turnover of medicinal products must not be expected. Hence, the course of events could adversely affect the health of patients.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
