On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical DevicesMaximilian Aretz
Maximilian Aretz is an associate in Covington’s Frankfurt office and a member of our Food, Drug and Device Practice. He advises clients on regulatory and compliance matters.
His advisory work covers all aspects of pharmaceutical and medical device regulation, clinical trials, advertising and other regulatory aspects over the entire product lifecycle. In addition, he advises pharmaceutical companies on EU market access matters including the German AMNOG procedure. Furthermore, Maximilian provides legal advice on Freedom of Information Act (FOIA) cases, data protection laws and contractual matters. He represents clients before authorities and in court.
Maximilian received his law degree from the University of Marburg with a focus on medical and pharmaceutical law. He also obtained an LL.M. degree in Dispute Resolution from the University of Cape Town, South Africa.
He completed his legal clerkship at the Berlin Court of Appeals. During his clerkship, he has worked at the Berlin Public Prosecutor's Office and at the German federal health agency Robert Koch Institute.
Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations
Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German…
Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectationsGermany prepares new National Strategy for Gene and Cell Therapies
1. Background
Gene and cell therapies are on the rise. On June 12, 2024, the German Federal Government was handed the strategy paper for a National Strategy for Gene and Cell Therapies. The paper is intended to serve as a basis for policymaking to give Germany a leading…
Continue Reading Germany prepares new National Strategy for Gene and Cell TherapiesGermany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricing
In an earlier blog, we wrote that the German regulation of pharmaceutical pricing and reimbursement is one of the most complicated legal areas in the entire world of life sciences laws. With the new draft “Medical Research Act” (Medizinforschungsgesetz or MFG) that came out in…
Continue Reading Germany again to reform drug pricing and reimbursement laws – With “confidential reimbursements prices” that impede international reference pricingGermany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from…
Continue Reading Germany will revise laws for clinical trials with pharmaceuticals, medical devices and companion diagnostics – Overview of the “Medical Research Act”