On June 8th a meeting of Pharmaceutical Committee of Ukrainian Bar Association took place in the format of a roundtable. The topic discussed was “The Law on Simplified Registration of Medicinal Products Registered in the Countries with Strict Regulatory Policy. Draft Resolution of the Cabinet of Ministers of Ukraine “On Reference Pricing of Medicinal Products”: annual reformation tradition”. Legal Alliance was represented by Partner Illya Kostinand AssociateNataliya Modlenko.
In accordance with the topic the event composed of 2 sessions:
1. The Law on Simplified Registration of Medicinal Products Registered in the Countries with Strict Regulatory Policy.
On May 31, 2016, Verkhovna Rada of Ukraine adopted as it is the Draft Law of Ukraine “On Amendments to Article 9 of the Law of Ukraine “On Medicinal Products” regarding the Simplification of State Registration of Medicinal Products” (Ref. № 4484).
The Law provides for the simplified state registration of medicinal products registered by competent authorities of the USA, Switzerland, Japan, Australia, Canada, and medicinal products registered by competent body of the EU under the centralized procedure. These medicinal products should be allowed for use on the territories of the abovementioned countries or the EU member-states.
2. Draft Resolution of the Cabinet of Ministers of Ukraine “On Reference Pricing of Medicinal Products”:annual reformation tradition.
On May 27th, 2016 the Ministry of Health published for public consideration the draft resolution, which provides for the reformation of the declaration system for medicinal products’ wholesale and retail prices. The document was drafted on order of the Government. Therefor, the CMU actions plan for the period by September 30th, 2016 it is scheduled to implement the new principles of pricing aimed at reducing the budget expenses at tenders up to 30%.
The planned concept involves different approaches to the development of wholesale and retail prices for original medicinal products (in accordance with minimal values in the reference countries) and for generic medicinal products (in accordance with the price for reference original or generic product).
The roundtable participants discussed the advantages and disadvantages of the developed pricing system, issues arising out of the implementation of this model, and came to the conclusion that despite the progressiveness of the abovementioned law novelties it is extremely important to develop the legal regulations system, and to make some efforts in order to turn “de jure” into “de facto”.
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.
