On 26 September 2018, the Cabinet of Ministers of Ukraine approved amendments to the Concept of Reforming Mechanisms for Public Procurement of Pharmaceuticals and Medical Devices ("Concept") approved by Resolution of the Cabinet of Ministers of Ukraine No. 582 dated 23 August 2017. The changes to the Concept became effective on 26 September 2018.
By way of background, the Concept provided for the establishment of a central procurement agency ("Agency"), which should be created by and be accountable to the MOH. Based on the Concept, the Agency should have been established in the second half of 2017. Considering that to date the Agency has not been established, the following changes to the Concept were introduced:
- The Agency should be established in 2018.
- The Agency will be provided with the function of strategic procurement while maintaining the centralized and local procurement frameworks focused on less critical procurement needs.
- Starting from 2018, the Agency should procure products for fulfilling the programs of the Global Fund to Fight AIDS, Tuberculosis and Malaria. The transitional period during which the Agency should procure medical products in parallel with specialized procurement agencies should last until 2021. Thus, it may be expected that the term of procurement by specialized procurement agencies (UNDP, UNICEF and Crown Agents) will be extended to 2021.
- Streamlining the public procurement reform with healthcare financing principles reform. In particular, the cost of certain pharmaceuticals, medical devices and other items of medical utility should be included into the cost of the medical service which will be guaranteed by the state. These services will be financed by the National Health Service, a newly created agency responsible for allocating funds for financing medical care (for more details about the National Health Service see our legal alert and May 2018 newsletter).
- Extension of the reimbursement program.
- Permitting the Agency to delegate the procurement function to the specialized procurement agencies.
- Amending legislation to allow direct participation of non-residents in procurement procedures.
- Use of framework agreements and e-procurement by the Agency.
- Amending legislation to allow group contracting, price negotiations with manufacturers, use of international trading platforms.
- Amending legislation to allow flexible settlement terms in relations with suppliers: advance payments, foreign currency payments etc.
- Simplification of the quality control for imported pharmaceuticals.
To implement these changes, the MOH, parliament, the Cabinet of Ministers of Ukraine and other government authorities will need to develop and approve a number of laws and bylaws.