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Business Does Not Support Draft Law #6535 on Amendments to the Law of Ukraine “On Medicines”

Business Does Not Support Draft Law #6535 on Amendments to the Law of Ukraine “On Medicines”

On January 20, 2022, the Draft Law of Ukraine #6535 "On Amendments to the Law of Ukraine "On Medicines" regarding the Holder of the Registration Certificate" (Draft Law) was registered on the official website of the Verkhovna Rada of Ukraine. Experts of the Chamber member companies do not support the Draft Law and have repeatedly drawn attention to the possible negative consequences of the proposed change, namely:

  1. The Draft Law contains provisions that can lead to a significant deficit of medicines and interruptions in their supply, which will have significant negative consequences for the citizens' health.
  2. The Draft Law does not contain a provision determining the payment/freeness of proposed changes for foreign manufacturers and holders of registration certificates for medicines. This may contain direct discriminatory features that distort competition and create additional financial and regulatory burdens for particular businesses.
  3. There is no objective need for the implementation of the proposed amendments, and there is no evidence of the need to implement them, as the current legislation provides for the relevant obligations to ensure pharmacovigilance and quality control of medicines by importers.
  4. The Draft Law proposes a temporary solution that does not comply with the provisions of the legislation, which are being updated and reflected in Draft Law #5547 “On Medicines”, and does not provide for the required transition period.
  5. The norms proposed by the Draft Law do not, in fact, ensure harmonization with the legal environment of the European Union (EU), as the relevant EU norms secure the recognition of registration of a marketing authorization holder in one of the countries without registration in each country. Also, these norms aim to simplify the administration and coordination of the work of the marketing authorization holder in all markets of EU member states. For Ukraine, such regulation is unreasonable and contains severe risks of creating an artificial barrier to access to medicines.

Given the abovementioned, the Chamber member companies call upon the Verkhovna Rada of Ukraine to withdraw the Draft Law from consideration and Cabinet of Ministers of Ukraine together with Parliament – to ensure consistency of legislative changes and to refrain from creating non-competitive advantages for certain entities on the pharmaceutical market.

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