Die Rolle des Staates bei der Entwicklung von Arzneimitteln und Impfstoffen

authored by: Anna-Lena Hollo
Abstract: Pharmaceutical research in Germany has, so far, been financed almost exclusively by private companies. Hitherto, the research-based pharmaceutical industry is one of the few sectors that has managed without any noteworthy government research subsidies. Entrepreneurial commitment is still one of the decisive factors for progress in medicine. Direct state subsidies have just played a subordinate role in the past. The fact that the Federal Ministry of Research is supporting the development of vaccines against the SARSCoV-2-virus with a total of 1.2 billion euros therefore appears even more extraordinary. But besides financial means, the German state is involved in many other ways in the development and approval of medicines and vaccines. The national legal requirements and regulations originate from the pen of the German legislators. At the same time, through various federal institutes and institutions, the German state is involved in the approval procedure, in the release process, in the distribution and in the monitoring of medicines and vaccines. However, the German government is not obliged to participate in the development of new medicines and vaccines in a certain way and to a certain extent. Rather, the type and scope are subject to its wide margin of appreciation which is only limited by the prohibition of insufficient actions. This leeway increasingly gets smaller, the more urgent, threatening and acute a health situation is for life and health of the citizens. In urgent cases as in a pandemic situation, the state’s duty to protect (Art. 2 § 2 Clause 1 of the German Basic Law) can then oblige the state to promote and to push the development of urgently needed medicines and vaccines, although the government remains free to choose the exact way how to fulfil this duty. It remains to be seen if, under the impact of the corona pandemic, the German government will continue to undertake greater (particularly financial) efforts to promote and push the development and the approval of new medicines and vaccines, or if this – what seems more likely – remains an exception for epidemic and pandemic situations.
Organisation(s): Chair in Public Law , specializing in the Law of State Transfer Systems
Type: Article
Journal: Die Verwaltung
Volume: 54
Pages: 375-409
No. of pages: 35
ISSN: 0042-4498
Publication date: 2021
Publication status: Published
ASJC Scopus subject areas: Law, Public Administration
Sustainable Development Goals: SDG 3 - Good Health and Well-being
Electronic version(s): https://doi.org/10.3790/verw.54.3.375 (Access: Closed)

BibTeX

@article{a7a2193831ce42bd83d7a93f2961d606,
title = "Die Rolle des Staates bei der Entwicklung von Arzneimitteln und Impfstoffen",
abstract = "Pharmaceutical research in Germany has, so far, been financed almost exclusively by private companies. Hitherto, the research-based pharmaceutical industry is one of the few sectors that has managed without any noteworthy government research subsidies. Entrepreneurial commitment is still one of the decisive factors for progress in medicine. Direct state subsidies have just played a subordinate role in the past. The fact that the Federal Ministry of Research is supporting the development of vaccines against the SARSCoV-2-virus with a total of 1.2 billion euros therefore appears even more extraordinary. But besides financial means, the German state is involved in many other ways in the development and approval of medicines and vaccines. The national legal requirements and regulations originate from the pen of the German legislators. At the same time, through various federal institutes and institutions, the German state is involved in the approval procedure, in the release process, in the distribution and in the monitoring of medicines and vaccines. However, the German government is not obliged to participate in the development of new medicines and vaccines in a certain way and to a certain extent. Rather, the type and scope are subject to its wide margin of appreciation which is only limited by the prohibition of insufficient actions. This leeway increasingly gets smaller, the more urgent, threatening and acute a health situation is for life and health of the citizens. In urgent cases as in a pandemic situation, the state{\textquoteright}s duty to protect (Art. 2 § 2 Clause 1 of the German Basic Law) can then oblige the state to promote and to push the development of urgently needed medicines and vaccines, although the government remains free to choose the exact way how to fulfil this duty. It remains to be seen if, under the impact of the corona pandemic, the German government will continue to undertake greater (particularly financial) efforts to promote and push the development and the approval of new medicines and vaccines, or if this – what seems more likely – remains an exception for epidemic and pandemic situations.",
author = "Anna-Lena Hollo",
note = "Funding Information: b) Beteiligung des Bundes an der Coalition for Epidemic Preparedness Innovations (CEPI). Au{\ss}erhalb des Zulassungsverfahrens beteiligt sich der Bund ferner finanziell an der Coalition for Epidemic Preparedness Innovations (CEPI). CEPI ist eine sog. Product Development Partnership106 (PDP), die unter anderem von Norwegen, Deutschland (namentlich dem BMBF), Japan, Kanada, Australien, der Bill & Melinda Gates Foundation und dem Wellcome Trust finanziert wird. Sie wurde 2017 eigens daf{\"u}r gegr{\"u}ndet, um Impfstoffprojekte gegen gr{\"o}{\ss}ere Epidemien oder Pandemien zu koordinie-ren, voranzutreiben und finanziell zu unterst{\"u}tzen.107 ",
year = "2021",
doi = "10.3790/verw.54.3.375",
language = "Deutsch",
volume = "54",
pages = "375--409",
journal = "Die Verwaltung",
issn = "0042-4498",
publisher = "Duncker und Humblot GmbH",
number = "3",
}