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
DOI:
https://doi.org/10.14739/2409-2932.2025.1.320860Keywords:
pharmaceutical activity, criminal liability, pharmacists, European pharmacy legislation, pharmacists’ liabilityAbstract
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.
References
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance). Available from: https://health.ec.europa.eu/system/files/2016-11/reg_2004_726_en_0.pdf
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal L 2001;31167-128. Available from: http://data.europa.eu/eli/dir/2001/83/oj
Regulation EU No 536/2014 of the European Parliament and of The Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. April 16, 2014. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
Scheepers HP, Langedijk J, Neerup Handlos V, Walser S, Schutjens MH, Neef C. Legislation on the preparation of medicinal products in European pharmacies and the Council of Europe Resolution. Eur J Hosp Pharm. 2017;24(4):224-9. doi: https://doi.org/10.1136/ejhpharm-2016-001016
Zahnitok O, Kiurchev Y. Harmonizatsiia zakonodavstva Ukrainy yak umova chlenstva v YeS: prohres i perspektyvy [Harmonization of Ukrainian legislation as a condition for EU membership: progress and prospects]. Yurydychna hazeta. 2023 Dec 1 [cited 2025 Jan 8]. Ukrainian. Available from: https://yur-gazeta.com/publications/practice/inshe/garmonizaciya-zakonodavstva-ukrayini-yak-umova-chlenstva-v-es-progres-i-perspektivi.html
Grundgesetz für die Bundesrepublik Deutschland [Internet]. Deutscher Bundestag. 2010 [cited 2025 Jan 8]. Available from: https://www.bundestag.de/gg
Schmidt N, Schumann H. Alarming gaps in availability of innovative drugs across the EU [Internet]. Investigate Europe. [cited 2025 Jan 8]. Available from: https://www.investigate-europe.eu/posts/deadly-prices-gaps-in-availability-of-innovative-drugs-across-eu
A Critical Medicines Act to secure Europe’s pharmaceutical independence [Internet]. European Economic and Social Committee. 2023 [cited 2025 Jan 8]. Available from: https://www.eesc.europa.eu/en/news-media/news/critical-medicines-act-secure-europes-pharmaceutical-independence
Tang KW, Millar BC, Moore JE. Antimicrobial Resistance (AMR). Br J Biomed Sci. 2023;80:11387. doi: https://doi.org/10.3389/bjbs.2023.11387
O’Neill J. Antimicrobial resistance: tackling a crisis for the health and wealth of nations. 2014. Available from: https://amr-review.org/sites/default/files/AMR%20Review%20Paper%20-%20Tackling%20a%20crisis%20for%20the%20health%20and%20wealth%20of%20nations_1.pdf
Council of the European Union. Council recommendation on stepping up EU actions to combat antimicrobial resistance in a one health approach (2023). Available from: https://data.consilium.europa.eu/doc/document/ST-9581-2023-INIT/en/pdf
Anderson M, Panteli D, van Kessel R, Ljungqvist G, Colombo F, Mossialos E. Challenges and opportunities for incentivising antibiotic research and development in Europe. Lancet Reg Health Eur. 2023;33:100705. doi: https://doi.org/10.1016/j.lanepe.2023.100705
Dosi G, Palagi E, Roventini A, Russo E. Do patents really foster innovation in the pharmaceutical sector? Results from an evolutionary, agent-based model. J Econ Behav Organ. 2023;212:564-89. doi: https://doi.org/10.1016/j.jebo.2023.05.039
Pharmaceuticals: Commission refines intellectual property rules [Internet]. European Commission - European Commission. [cited 2025 Jan 2]. Available from: https://ec.europa.eu/commission/presscorner/detail/en/ip_18_3907
Lybecker KM, Watkins L. Liability risk in the pharmaceutical industry: Tort law in the US and UK. Soc Sci J. 2015;52(4):433-48. doi: https://doi.org/10.1016/j.soscij.2014.03.010
Di Giorgio D. Russo D. Medicrime vs Volcano: A practical case study of how the Council of Europe Convention could improve the fight against pharmaceutical crime. Council of Europe; 2020.
European Commission: Directorate-General for Health and Food Safety, Möller U, Maly S, Rennoch J, Berg M, Sinn A, Stroetmann K. Study on the transposition measures of Member States in relation to the pharmaceutical legislation (Art. 118a of Directive 2001/83/EC) : final report. Publications Office; 2017. Available from: https://data.europa.eu/doi/10.2875/41105
European Commission: Directorate-General for Health and Food Safety. Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : evaluation report. Publications Office of the European Union; 2023. Available from: https://data.europa.eu/doi/10.2875/62709
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