With this document, the Association of Representatives of International Pharmaceutical Manufacturers AIPM Ukraine expresses the vision of its member companies regarding the situation in the field of the introduction of state regulation of prices for medicinal products and reimbursement of their cost, determined by resolutions of the CMU No. 862 and 863 dated November 9, 2016.

The Association welcomes the decision of the Cabinet of Ministers of Ukraine to postpone the introduction of state regulation of drug prices until April 1, 2017 and to involve the professional community in the process of its further refinement.

As previously repeatedly emphasized, the mentioned legal acts contain a number of contradictions and conflicts in the regulation of this important issue and do not allow to achieve the goal of the Government of Ukraine to provide assistance to certain categories of patients, leaving them in the current version may lead to unforeseen consequences, due to imperfect regulation regarding prices, mark-ups on drugs, the cost of which will be reimbursed as part of the implementation of the project, and the lack of any certainty regarding drugs that, due to the price level, will not be included in the reimbursement system.

We emphasize once again that representatives of the pharmaceutical industry support the Government’s policy aimed at improving the access of Ukrainian citizens to high-quality and effective medicines, which is ensured by the introduction of a system of reimbursement (reimbursement) of the cost of medicines.

In the course of working out the changes to the specified normative acts, with the aim of balanced provision of the needs of socially vulnerable segments of the population and the requirements of the market economy, competition, it is necessary to take into account the principle proposals of the professional community, namely:

• Price referencing should be carried out by SKU (Stock Keeping Unit – identifier of the commodity item of the medicinal product by trade name, release form, dosage and package size). In the selected 5 reference countries for Ukraine, price referencing is carried out specifically by SKU, which ensures the pharmaceutical, biological and therapeutic equivalence of the referred drugs.
• In order to ensure healthy competition in the pharmaceutical market of Ukraine, state price regulation should be extended only to those medicinal products from List 21 of the INN that are purchased from the state budget and those that are voluntarily included in the reimbursement program by the manufacturer’s decision. All other medicines can be sold on the free market, even if their price exceeds the maximum retail price. Such an approach will allow to reduce the state’s expenditure on health care, will contribute to the reduction of prices and protect against a shortage of drugs on the market.
• State support in providing access to valuable medicinal products, which belong to the list of 21 INN and are extremely important for the lives of patients of Ukraine, by partially financing their purchase with the funds of the state budget, for example, reimbursement of the share within the limits of the maximum wholesale price, and covering the negative the difference in cost at the expense of the patients themselves (global practice with co-payment).

Considering the above, AIPM Ukraine emphasizes its readiness to participate in a professional dialogue that will ensure the resolution of problematic issues and prevent negative consequences for the pharmaceutical industry, patients and the state as a whole.