Covid-19: State Intervention In Times Of Vaccine Shortages

• Published date: 04 March 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent
• Law Firm: Morrison & Foerster LLP
• Author: Robert Grohmann

The European Union ("EU") and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain vaccine doses as the pharmaceutical industry slows down deliveries due to manufacturing issues. Yet, time is of the essence when it comes to vaccine rollouts, particularly amid a surge in cases due in part to the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19.

Against this backdrop, it comes as no surprise that certain political voices in Germany are calling for state intervention in the vaccine manufacturing process (see, i.e., the coverage by Central German Broadcasting, in German language). However, the idea that the state could take over production of highly complex vaccines or allow third parties to manufacture their competitors' proprietary pharmaceuticals faces factual and legal challenges.

In this article, we discuss whether German law provides the necessary means for state intervention in vaccine production and what stakeholders should bear in mind.

WHAT WOULD BE THE BASIS FOR STATE INTERVENTION IN GERMANY?

The German legislator amended the German Infection Protection Act (Infektionsschutzgesetz - "GIPA") at a very early stage of the pandemic, among other things to allow quicker decision‑making processes that will reduce requirements for participation of the German Federal Parliament (Bundestag). It thereby authorized the German Ministry of Health (Bundesministerium für Gesundheit - the "Ministry of Health") to autonomously¹ take "measures to ensure the supply of medicinal products, including vaccines," in an epidemic situation of national importance (sec. 5 (2) no. 4 GIPA).

The authorizations vested in the Ministry of Health are comprehensive. In the case that the German Federal Parliament declares an "epidemic situation of national importance," the Ministry of Health can issue statutory decrees, e.g., to:

• Allow exceptions from provisions of the German Medicines Act ("GMA") with respect to manufacturing labeling, approval, clinical testing, use, prescribing and dispensing, import and export, and transfer and liability;
• Order the securing and the use of vaccines; or
• Maintain, convert, open, or close production facilities or individual operating sites of enterprises producing the abovementioned products.

The aforementioned list in sec. 5 (2) no. 4 GIPA is exemplary and not exhaustive. Other measures are thinkable, too. In light of the extremely broad competences given to the Ministry of Health, such order could even encompass the manufacturing of vaccines by a new third‑party manufacturer to ensure continuous vaccine supply to the German population.

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