Deputies voted in favour of the draft laws No. 2538 “On Amendments to Some Legislative Acts of Ukraine to Improve the Affordability of Medicinal Products, Medical Devices and Other Goods Purchased by an Authorized Person for Healthcare Procurement” and No. 2539 “On Amendments to the Tax Code of Ukraine to Improve the Affordability of Medicinal Products, Medical Devices and Other Goods Purchased for State Budget Funds and to Create Conditions for Procurement in the Sphere of Healthcare”.
The first draft law proposes to transfer partially the public procurement of medicines to the centralized procurement organization of the Ministry of Health. In addition, the draft law provides for the elimination of the legal conflict that arose due to the adoption of the Law No. 114 “On Public Procurement”, which extended the possibility of medical procurement by Ukraine with the assistance of international organizations. This law amends another legislative act – Law of Ukraine No. 269-VIII.
The problem with these two acts is that the Act No. 114 will enter into force on April 19, 2020 and the Act No. 269-VIII will terminate on March 31, 2020. Thus, the international procurement is exempt from any regulation within 19 days.
The new draft law No. 2538, in its turn, should extend the possibility of public procurement through international procurement organizations until April 30, 2020, eliminating the gap between the validity periods of relevant legislative acts regulating the possibility of international procurement.
In addition, the draft law provides for the possibility to grant the right to mark and use instructions on the use of medicines and medical devices purchased through international organizations in their original language until March 31, 2022.
In addition, Draft Law No. 2538 proposes the introduction of simplified procedures for registration of medicines in Ukraine. They may refer to medicinal products already registered by the regulators of the European Union member countries, but such medicinal products will not be destined for the retail and wholesale markets, but only for public procurement through international organizations.
It is also proposed to introduce an accelerated medicine registration procedure regardless of the country of the medicine registration. The state registration will be carried out on the basis of consideration of the registration dossier within 30 days, such medicines can be sold to pharmacies and purchased for the funds of state and local budgets.
As for the draft law No. 2539, it is proposed to exempt from VAT the procurement of medical products. According to the initiators of the draft law, this approach should allow purchasing more goods without increasing the amount of funding for health care programs and should help stimulating supply growth by encouraging competition and reducing prices for medical products.