Health Care

08/ 10/ 2018

The example of a balanced approach to the amendments in the pharmaceutical sector

The European Business Association (Association) welcomes the amendments to the Article 9 Law of Ukraine ‘On Medicines’ [1] on access to the results of preclinical study and clinical trials of medical drugs, with the wording that does not put at risk the stability of the pharmaceutical market operation. Thanks to the Association’s Health Care Committee involvement in the amendments’ wording development the risks of the first wording adopted by the Verkhovna Rada of Ukraine, which could impact negatively the pharmaceutical market, were suppressed.

According to the published amendments, the results of preclinical study and clinical trials of medical drugs should be published via a relevant report developed by the Ministry of Health of Ukraine (hereinafter – the MOH). The Association hopes that the report form will be developed by the Ministry of Health with account of the best European practices. In particular, the EMA uses the European Public Assessment Report (EPAR) – a public report with consolidated medical drugs data that provides citizens with a general understanding based on data taken as a basis for medical drugs’ registration. The same rules of the report development and adoption are expedient to use for the report in Ukraine.

The previous wording of the Draft Law adopted in the first reading could lead to the disclosure of confidential information through possible manipulations with data, which were likely to lead to barriers for the medical drugs circulation in Ukraine, including innovative drugs. The Association’s experts were included to the membership of the Working Group at the Verkhovna Rada Committee on Health Care and provided their expertise for the development of a correct text for the Draft Law second reading.

The Association is thankful to the members of the Verkhovna Rada of Ukraine who participated in the Draft Law second reading development for a balanced approach to this issue, which is of utmost importance for the stable operation of the pharmaceutical market.

[1] Law of Ukraine №2519-VIII from September 4, 2018

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