Harmonization of pharmaceutical legislation of the European Union and its member states in the context of legal liability: problematic aspects of the relationship and development prospects
The issue of legal liability in the pharmaceutical sector is one of the key topics of modern legal regulation of healthcare. In the countries of the European Union (EU), where the pharmaceutical industry has reached a high level of development, this issue is becoming particularly relevant. The ai...
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| Format: | Article |
| Language: | English |
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Zaporizhzhia State Medical and Pharmaceutical University
2025-03-01
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| Series: | Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki |
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| Online Access: | https://pharmed.zsmu.edu.ua/article/view/320860/314606 |
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| Summary: | The issue of legal liability in the pharmaceutical sector is one of the key topics of modern legal regulation of healthcare. In the countries of the European Union (EU), where the pharmaceutical industry has reached a high level of development, this issue is becoming particularly relevant.
The aim of the work is to establish the main problematic aspects of harmonizing EU pharmaceutical law with national sectoral legislation. To analyze examples of law enforcement and the experience of the EU.
Results. The insufficient level of legislative coherence is proven. The analysis showed that discrepancies between the national legislation of individual countries and European regulations create significant challenges in implementing uniform quality standards for medicines. This complicates the effective fight against drug falsification and ensuring transparency of the pharmaceutical market. The role of legal liability is emphasized. Legal liability in the pharmaceutical sector performs an important regulatory function, contributing to the protection of patients’ rights and ensuring justice in cases of violation of norms. However, the level of its implementation largely depends on the harmonization of the legislative framework and clear mechanisms for bringing it to justice. It has been confirmed that the harmonization of national legislation with European standards (in particular Directive 2011/62/EU and Regulation 2016/161) is a necessary condition for increasing the effectiveness of control over the circulation of medicinal products. The implementation of drug verification systems, mandatory labeling and digital tracking tools is of particular significance.
Conclusions. Harmonization of national and European legislation in the pharmaceutical sector is a key condition for ensuring effective control over the circulation of medicinal products and protecting patients’ rights. Strengthening legal responsibility, the implementation of digital tools and the harmonization of legal norms will contribute to the fight against the falsification of medicines and the creation of a transparent market. |
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| ISSN: | 2306-8094 2409-2932 |