COVID-19, Geopolitics, and the Reform of European Pharmaceutical Law: Accelerating Enhanced Medicines Care for Europe?
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Abstract
Given the COVID-19 pandemic and intensified geopolitical disruptions, the European Commission, seeking to govern pharmaceutical supply, faced various problems from within and outside the European Union. The authority subsequently submitted far-reaching proposals to revise, amend, and repeal the European Union’s pharmaceutical law. It is against this backdrop that the article examines the different policy impacts on the new pharmaceutical legislation and makes a brief forecast about the extent to which the draft measures, should they come into force as proposed, will contribute to better medicines care in the future. In doing so, the analysis concludes that COVID-19 was a mere accelerator and not the original trigger of most legislative changes. Furthermore, the article argues that, although problems have been identified correctly, some of the approaches to solving them are entrenched in ineffective paths.
Keywords:
COVID-19, Geopolitics, European Pharmaceutical Law, Accelerating Enhanced Medicines Care for Europe
Article Details
How to Cite
PLANK, Kristine.
COVID-19, Geopolitics, and the Reform of European Pharmaceutical Law: Accelerating Enhanced Medicines Care for Europe?.
Medical Research Archives, [S.l.], v. 12, n. 1, jan. 2024.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/4915>. Date accessed: 15 may 2024.
doi: https://doi.org/10.18103/mra.v12i1.4915.
Section
Review Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
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33. Thym D, Bornemann J. Binnenmarktrechtliche Grundlagen des Infektions- und Gesundheitsschutzrechts. In Huster S, Kingreen T (eds.), Handbuch Infektionsschutzrecht, 65–90, paras 51ff. C.H. Beck, Munich; 2021.
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35. IQWiG. Comment by the Institute for Quality and Efficiency in Health Care of 7 June 2023 on the European Commission’s Proposal of 26 April 2023 on the Reform of the EU Pharmaceutical Legislation. Cologne; 7.6.2023.
36. Ruffert M. Art 288 AEUV. In: Calliess C, Ruffert M. EUV, AEUV Kommentar, 5. Auflage, München; 2016.
37. Schwarze J, Becker U, Pollak C. The implementation of Community law – Studies in the legislative and administrative policies of the European Community and its Member States, 67 ff. Nomos, Baden-Baden; 1994.
38. Schwarze J, Mellein C. Targeted review of EU pharmaceutical legislation – The Community Code on Medicinal Products needs to remain a Directive. EPLR. 2021; (1):4(16 ff.).
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41. Breyer F, Zweifel P, Kifmann M. Gesundheitsökonomik. 6th ed: 179-245. Springer, Berlin, Heidelberg; 2013.
42. EC. A European One Health action plan against antimicrobial resistance (AMR). Accessed October 31, 2023. https://health.ec.europa.eu/system/files/2020-01/amr_2017_action-plan_0.pdf
43. EC. Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach. 2023/C 2020/01. Luxemburg; 13. 6.2023.
44. Hosseini M, Baur M. Marktversagen bei der Arzneimittelversorgung am Beispiel von Antibiotika. Covid-19 wirft Schlaglicht auf das Problem – ist aber nicht dessen Ursache. In: Neustart der Industrie unter dem Einfluss von Covid-19: Wie bereit ist die globale Lieferkette? Accessed October 31, 2023. https://www.ifo.de/DocDL/sd-2020-05-goerg-moesle-etal-corona-globale-lieferketten.pdf
45. Bayerlein M. Offene strategische Autonomie der EU im Bereich Arzneimittel. SWP-Aktuell December 2022 (No. 75). DOI:10 .18449/2022A75.
46. EMA. PRIME: Analysis of the first 5 years’ experience. Updated April 5, 2022. Accessed October 31, 2023. https://www.ema.europa.eu/en/documents/report/prime-analysis-first-5-years-experience_en.pdf
47. Donati A. The conditional marketing authorisation of COVID-19 vaccines: A critical assessment under EU law. Eur J Health Law. 2022;29(1):33-52. DOI:10.1163/ 15718093-BJA10065.
48. Marinus R, Mofid S, Mpandzou M, Kühler TC. Rolling reviews during COVID-19: The European Union experience in a global context. Clin Ther. 2022; 44(3):352-363. DOI:10.1016/j.clinthera.2022.01.001.
49. Cowlishaw S, Handy E. EU Pharma Legislation Review Series: Temporary emergency marketing authorizations. Covington 3.5.2023. Accessed October 31, 2023. https://www.insideeulifesciences.com/2023/05/03/eu-pharma-legislation-review-series-temporary-emergency-marketing-authorizations/
50. EC. Decision of 16.9.2021 establishing the Health Emergency Preparedness and Response Authority. C(2021) 6712 final. Brussels; 16.9.2021.
51. EC. Communication on introducing HERA, the European Health Emergency Preparedness and Response Authority, the next steps towards completing the European Health Union. COM (2021) 576 final. Brussels; 16.9.2021.
52. European Parliament. Medikamentenengpässe in der EU: Ursachen und Lösungen. Accessed October 31, 2023. https://www.europarl.europa.eu/news/de/headlines/society/20200709STO83006/medikamentenengpasse-in-der-eu-ursachen-und-losungen
53. EC. Future-proofing pharmaceutical legislation – study on medicine shortages: final report (revised) 12.2021.
54. Joachimsen K. Worauf es jetzt ankommt. In: Neustart der Industrie unter dem Einfluss von Covid-19: Wie bereit ist die globale Lieferkette?. Accessed October 31, 2023. https://www.ifo.de/DocDL/sd-2020-05-goerg-moesle-etal-corona-globale-lieferketten.pdf
55. Hagemeyer-Witzleb TM. The international law of economic warfare. Cham; 2021.
56. PwC. 25th Annual global CEO survey: Reimagining the outcomes that matter. Accessed October 31, 2023. https://www.pwc.com/gx/en/ceo-survey/2022/main/content/downloads/25th_CEO_Survey.pdf
57. EC. Proposal for a Regulation establishing a framework for ensuring a secure and sustainable supply of critical raw materials. COM (2023) 160 final. Brussels; 16.3.2023.
58. EC. Guidance to Member States concerning foreign direct investment and free movement of capital from third countries, and the protection of Europe’s strategic assets. 2020/C 99 I/01.
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