In March 2017, Ukrainian Government approved the new National Essential Medicines List for Ukraine (the “NEML”), which is to become a single basis for the procurement and reimbursement of medicines in the public sector, as well as price controls.
While creation of a single up-to-date NEML was welcomed by the industry, its current version raises a number of concerns due to the following:
- with effect from July 1, 2017, the NEML shall on mandatory basis guide the public procurement of medicines in Ukraine. Though until 2019 this should not affect the purchases made by the Ministry of Health of Ukraine (the “MOH of Ukraine”) through international procurement agencies, regional and institutional procurements would still be captured;
- if not listed in the NEML, a medicinal product may be purchased by a public sector entity only if its need for drugs listed in the NEML has been fully satisfied. The procedure for calculation of such need has not been yet approved, though is available in draft form;
- the NEML contains a limited number of positions (INNs, dosage forms and strengths), as compared to the scope currently covered by public procurements in Ukraine;
- the NEML is substantially based on the WHO Model List of Essential Medicines and at this stage mostly includes basic drugs, in many instances omitting more sophisticated and innovative products, as well as products for treatment of orphan diseases.
The newly approved NEML has been subject to wide criticism from local industry associations and patient organizations. According to the MOH of Ukraine, the work on its further development and improvement is ongoing, including in terms of setting up a fast track procedure for listing of certain additional priority groups of medicines.
In the meanwhile, it is advisable for all interested pharmaceutical companies to check their Ukrainian portfolios against the NEML and assess its potential effect on their business, as well as possible mitigating strategies (filing applications for listing in the NEML etc.).