EBA welcomes the adoption of the “Constitution for Pharma” – Draft Law No. 5547 on Medicinal Products
On July 28, 2022, the Verkhovna Rada of Ukraine adopted Draft Law No. 5547 “On Medicinal Products” in the second reading. For the pharmaceutical industry, it has significance comparable to the “Constitution” as the draft law regulates legal relations in the field of medicinal products and adapts Ukrainian legislation to the provisions and practices of the EU.
The document went through a tedious process of discussion and debates in the expert circle. Thus, 2 278 amendments were submitted to the second reading. The majority of them were prepared and elaborated by experts of the EBA Health Care Committee together with the VRU Committee on Public Health, Medical Assistance, and Medical Insurance.
Draft Law No. 5547 contains fundamental changes to the current provisions on the production and sales of medicinal products, as well as a number of novelties that will also require a significant further change in legal regulation at other levels, particularly in:
- adapting the legislation of Ukraine to the provisions and practices of the EU regulation on the registration, sales of medicinal products and their control;
- digitizing the industry – mandatory introduction of eCTD format that will meet the ICH standard;
- implementing the European medicines verification system – the most modern means of preventing falsification;
- significantly improving the regulatory environment for clinical trials in Ukraine;
- determining modern international requirements for bioequivalence – proving the effectiveness of generic medicines;
- establishing a new unified state regulatory body in healthcare;
- improving patients’ access to certain groups of medicines, etc.
An important aspect taken into account by the MPs is the provision of a sufficient transition period for the introduction of changes so that there is little risk of interruptions in the supply of medicines due to new regulations, particularly given the full-scale war waged by Russia against Ukraine.
Meanwhile, the EBA Health Care Committee experts consider that it is necessary to address the issues of exclusivity of the registration dossier (non-compliance with the terms defined by Directive 2001/83/EC) and the introduction of parallel import (there is only a similar mechanism that does not exist in the EU within the borders of one country and thus requires further legislative elaboration; avoidance of anti-counterfeiting requirements for parallel imported medicines – no verification requirements applied to them) that do not comply with EU regulation.
To ensure the comprehensiveness and effectiveness of the adopted Law, it is also necessary to modernize the provisions of criminal, administrative, and procedural legislation, which are primarily aimed at establishing the appropriate level of responsibility for violations and providing transparent legal tools to the controlling and law enforcement agencies. In this way, we can combat violations in healthcare, primarily regarding issues of falsification of medicinal products.
The European Business Association and the EBA Health Care Committee express their gratitude to the VRU Committee on Public Health, Medical Assistance, and Medical Insurance, to all MPs who participated in the development of Draft Law No. 5547 “On Medicinal Products”, as well as to all involved representatives of the pharmaceutical community. We hope that joint work for the benefit of patients in Ukraine and the establishment of a European regulatory environment for the Ukrainian pharmaceutical market will continue.