Association of international pharmaceutical manufacturers appealed to new Prime-Minister regarding the price decrease issue

AIPM Ukraine appealed to newly-appointed Prime-Minister, Mr Groysman within the discussion on measures to decrease prices on medical drugs.

It was mentioned that in its political approaches to pricing regulation Ukraine is very close to EU, implementing the principle “regulation for medical drugs, which are purchased for budget expenses”. But, as soon as state financing is very limited in comparison to other states, the implementation of other indirect mechanisms is desirable.

Economic and social challenges, Ukraine faced the recent years, and the full absence of social protection and compensation  mechanisms such as reimbursement, which guarantees the provision of at least minimum medical and medicines aid to citizens, caused the prioritization of the pricing issue up to date.

Measures, taken by the industry and the state before, was completely eliminated by the catastrophic devaluation (218% in comparison to 2103 year) and ungrounded steps on establishing 7% VAT and 5% import tax (canceled in 2016).

Association considers that the main barriers for normal pharmaceutical market functioning:

  • Tax burden for social group of commodities (among which are medicines);
  • Absence of reimbursement system;
  • Insufficient financing of medicines purchasing by health acre institution;
  • Bureaucratic/technical barriers at the stage of market access (conformity assessment procedures);
  • Bureaucratic barriers at the stage of import (simultaneous existence of import licensing and import quality control);

Association considers the next steps important to fulfil in order to normalize the market and get the decreased prices for medicines:

  • Cancel the 7% VAT rate in favor of 0% stake for medical drugs (including those for clinical trials);
  • Establishment of the reimbursement system (full or partial);
  • Implement the transparent system of monitoring the distribution of medicines, purchased for budget expenses, within the healthcare institution (open public register);
  • Accept the automatic approval of GMP PIC/S and the cancelation of conformity assessment procedure;
  • Cancelation of import licensing (minimum for the period of stabilization of situation with prices);

Amon the other important instruments Association mentioned that it is important to provide full information on equivalent generics (generic substitution) within pharmacy and establishment of the transparent register of level of therapeutic equivalence and effectiveness of registered medical drugs, making this information available for patients and pharmacists (with analogies to American OrangeBook).

At the conclusion, Association attracted the attention of the Prime-Minister to the developed Draft National Drugs Policy and importance to implement this document as a result of a long-term and complex work of international WHO experts, public organizations and business associations, which is aimed at the increase of availability of medical drugs and improvement of access of people in Ukraine to effective, safe and high quality medicines.