Compliance of pharmaceutical companies pricing practices with both regulatory and competition requirements became essential in the recent years in light of a number of regulatory developments, as well as practice of the competition authority of Ukraine heavily targeting pharma sector.
Fast-track regulatory procedures introduced in Ukraine allow applicants of medicines registered by strong regulatory authorities, as well as procured by international specialized organizations contracted by MoH (Crown Agents, UNDP and UNICEF), to promptly obtain registration. In some complex regulatory cases, the fast-track regulatory procedures remain the only viable option for putting/keeping products on the market.
The ongoing healthcare funding reform in Ukraine brings numerous novelties to pharma sector at many levels: market access and pricing, funding allocation, procurement and reimbursement of medicines.
Fast-track regulatory procedures introduced in Ukraine in the recent years allow applicants of medicines registered by strong regulatory authorities, as well as procured by international specialized organizations contracted by MoH (UNDP, UNICEF and Crown Agents), to promptly obtain registration. In some complex regulatory cases, the fast-track regulatory procedures remain the only viable option for putting/keeping products on the market.
Pricing for publicly procured and reimbursed medicines remains increasingly important. In the recent years, the Government introduced a number of new rules in the area and together with public payers continued pushing the medicines prices down. Ukraine still lacks managed entry agreements, direct pricing negotiations and confidential pricing mechanisms for innovative medicines, which makes pricing for such products traceable from international reference pricing perspective.
Supporting a health tech startup
March 27, 2019
Danevych.Law team (Artem Grudinin and Borys Danevych) supported pro-bono a local health and lifestyle start-up focused on social impact in settling an IP dispute. The Client’s IP rights were defended vis-a-vis a product developed by company commercializing health and lifestyle apps worldwide through Apple App Store. With the initial claim submitted to the Apple legal department, followed by good faith negotiations, which ended up in the settlement, within just one month 100% of disputable content was removed from the app. Terms of the settlement also covered compensation to the Client.
Advising on healthcare reform
March 26, 2019
Danevych.Law team advised a global top-10 pharma company on key developments of the healthcare funding reform, focusing on:
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