EBA Open Letter on elaborating mechanisms for pricing and reimbursement

09/ 02/ 2017

The business community is aware of the difficult situation with the provision of continuous supply of medicines that has developed in connection with the introduction in Ukraine of the mechanism of reference pricing for medicines from January 1, 2017, and the corresponding actions for its settlement. At present, less than two months remain for the development and approval of qualitative reference pricing and reimbursement mechanisms, so that their implementation has led to an increase in the economic availability of medicines for patients, provided that there is no risk of their physical availability. Developed and approved by April 1, 2017, the reimbursement mechanism should guarantee effective cost of funds in the amount of UAH 500 million allocated from the state budget, which should be sufficient before the end of the year to reimburse the cost of certain drugs to the population of Ukraine in three nosologies (cardiovascular diseases, diabetes mellitus Type II, bronchial asthma) according to the established list consisting of 21 INN (international non-proprietary name) (hereinafter - List of 21 INN). We believe that starting in Ukraine with new state price regulation and reimbursement of certain medicines, it is advisable to take into account the mechanisms and experience of their introduction in the EU countries, where the reimbursement of the cost of medicines to the population is standard for many years of practice. In particular, we believe that: The price list for medicinal products should be made according to the trade name, form of release, dosage and packaging size provided by the Stock Keeping Unit and introduced in the 5 selected reference countries for Ukraine. Voluntary participation of producers in the reimbursement program should be ensured. State regulation of prices should apply only to those medicines from the List of 21 INNs included in the reimbursement program by the manufacturers decision. It must be ensured that patients can obtain any medicines from the List of INNs, as well as at their own expense, if their value is not reimbursed by the state. Presence of free circulation medicinal products should be ensured, if their price exceeds the level of compensation. The business community emphasizes the necessity of developing qualitative reference pricing and reimbursement mechanisms with the involvement of the professional community on the platform of the Ministry of Health of Ukraine. In addition, we consider it necessary to amend the Resolution of the Cabinet of Ministers of Ukraine No. 862 and the Resolution of the Cabinet of Ministers of Ukraine On the Introduction of the Compensation for the Cost of Medicines No. 863 of November 9, 2016, which provide for the voluntary participation of market participants in reimbursement and the possibility of free circulation of medicinal products. Representatives of the Association Health Care hope that this important issue for Ukraine will be processed as soon as possible, so that by April 1, 2017, public authorities and market participants are convinced that there are no barriers to the introduction of reimbursement of outpatient drug consumption for patients and the negative consequences of their absence. on the shelves of pharmacies.

At present, less than two months remain for the development and approval of qualitative reference pricing and reimbursement mechanisms, so that their implementation has led to an increase in the economic availability of medicines for patients, provided that there is no risk of their physical availability. Developed and approved by April 1, 2017, the reimbursement mechanism should guarantee effective cost of funds in the amount of UAH 500 million allocated from the state budget, which should be sufficient before the end of the year to reimburse the cost of certain drugs to the population of Ukraine in three nosologies (cardiovascular diseases, diabetes mellitus Type II, bronchial asthma) according to the established list consisting of 21 INN (international non-proprietary name) (hereinafter – List of 21 INN).

We believe that starting in Ukraine with new state price regulation and reimbursement of certain medicines, it is advisable to take into account the mechanisms and experience of their introduction in the EU countries, where the reimbursement of the cost of medicines to the population is standard for many years of practice. In particular, we believe that:

The price list for medicinal products should be made according to the trade name, form of release, dosage and packaging size provided by the Stock Keeping Unit and introduced in the 5 selected reference countries for Ukraine.
Voluntary participation of producers in the reimbursement program should be ensured. State regulation of prices should apply only to those medicines from the List of 21 INNs included in the reimbursement program by the manufacturer’s decision.
It must be ensured that patients can obtain any medicines from the List of INNs, as well as at their own expense, if their value is not reimbursed by the state. Presence of free circulation medicinal products should be ensured, if their price exceeds the level of compensation.

The business community emphasizes the necessity of developing qualitative reference pricing and reimbursement mechanisms with the involvement of the professional community on the platform of the Ministry of Health of Ukraine. In addition, we consider it necessary to amend the Resolution of the Cabinet of Ministers of Ukraine No. 862 and the Resolution of the Cabinet of Ministers of Ukraine “On the Introduction of the Compensation for the Cost of Medicines” No. 863 of November 9, 2016, which provide for the voluntary participation of market participants in reimbursement and the possibility of free circulation of medicinal products.

Representatives of the Association Health Care hope that this important issue for Ukraine will be processed as soon as possible, so that by April 1, 2017, public authorities and market participants are convinced that there are no barriers to the introduction of reimbursement of outpatient drug consumption for patients and the negative consequences of their absence. on the shelves of pharmacies.