Simmons & Simmons LLP
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Healthcare & Life Sciences
Vaccinations represent a ray of hope in the fight against the COVID-19 pandemic. However, in recent months there have been several incident reports regarding vaccinations. These primarily concern cerebral venous thrombosis, which in some cases has caused serious health damage to patients or even death. Against this background, the question arises as to how the law responds to damage to patients caused by vaccinations.
Besides vaccination, one of the most important measures to counter the COVID-19 pandemic is to test people for the virus and order them to quarantine if necessary. While tests for specific diseases such as COVID-19 may normally be handled only by medical professionals, the legislature has amended the Ordinance Regulating the Dispensing of Medical Products to enable such tests to be dispensed by laypeople as well.
The Hamm Higher Regional Court recently found that fabric masks do not constitute medical devices, regardless of whether they are displayed alongside medical face masks or whether the public attributes to them a protective effect against COVID-19. The decision shows the importance of labelling, presentation and the placement of products on the market and highlights the pitfalls that lurk in this area.
The legislature recently acknowledged that digital innovation plays an important role in the health sector. The Act on Digital Supply (DVG) established numerous essential measures to facilitate the inclusion of digital innovation to standard care under the German statutory social health security system. One of the most important innovations that the DVG introduced is insured persons' entitlement to medical devices based on software and other digital technologies with a medical purpose (digital health apps).
A recent Munich Higher District Court case examined whether the advertising of digital medical consultations by Swiss-based doctors is admissible under the Law on Advertising in the Health Sector. The decision underlines the importance of a detailed case-by-case examination of advertising (for remote treatment). Such an examination must cover not only competition law aspects in general, but also medical aspects in particular, such as generally accepted professional standards.
Binding implications of notification under German Drug Act and qualification of preparation as presentation drugGermany | 07 October 2020
The Frankfurt am Main District Court recently examined whether a Federal Institute for Drugs and Medical Devices notification can establish whether a preparation is a medicinal product subject to authorisation. In principle, the courts are bound by the institute's assessment unless the notification is null and void. However, if a notification is redacted in such a way that its constituent elements are unknown, the court must decide whether the preparation is a functional medicinal product or a presentation drug.
Compulsory licensing under Infection Protection Act: effects on data exclusivity under pharmaceutical lawGermany | 01 July 2020
As part of its effort to secure potential COVID-19 treatments and vaccines, the government has introduced several amendments to the Infection Protection Act, most recently on 23 May 2020. One of the amendments addresses the compulsory licensing of patents to ensure the supply of pharmaceuticals, medical devices and products for disinfection and laboratory diagnostics.
Cannabis-containing finished medicinal products have been available on prescription in Germany for some time. In 2017 the amendment of various acts permitted the state-controlled cultivation of cannabis and allowed the production of cannabis-containing medicinal products in pharmacies. This article provides an overview of the legal framework applicable to cannabis products – especially cannabis-containing medicinal products – and the current discussions and developments relating thereto.
According to Section 24(1) of the German Patent Act, a compulsory licence can be granted to a patent infringer. Recent case law suggests that this possibility is becoming increasingly relevant. Further, in a recent originator-originator pharma case, the enforcement of a recall obligation was for the first time suspended for a certain period for public health reasons.
Two recent Federal Civil Court decisions strengthen the strict understanding of Section 7(1.1) of the Act on the Advertising of Medicinal Products, under which the granting of gifts constitutes a violation of German pricing regulations. These decisions also reiterate that the unequal treatment of national pharmacies is justified due to the particularities of the German pharmacy market and the minor impact that this has on German pharmacies.
To safeguard against potential liability claims under the EU Product Liability Directive, the EU Medical Device Regulation stipulates that medical device manufacturers must have measures in place to provide sufficient financial coverage. However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage.
The EU Medical Device Regulation (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. However, the MDR provides no definition of 'medical software' and limited rules on liability. Medical software liability under the existing regulatory framework requires that medical software be classified as a product; however, this classification is highly controversial and has been widely debated.