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Maximilian 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.

Contact:Read more about Maximilian AretzEmail

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 post, we describe the specific new requirements for the processing of health and social data using cloud-computing. We will also discuss whether the new rules may impact medical research and other projects that utilize cloud-computing for processing health data.

1. Scope and Background of Sec. 393 SGB V

The new Section 393 SGB V (Social Security Code – Book V) has been enacted with the recent “Digital Act” (see our earlier blog on the Digital Act). The title of Section 393 SGB V is “Cloud-Use in the Healthcare System“. Hence, it aims to impose specific requirements for healthcare service providers, statutory health insurances and their contract data processors when they process health data and social data using cloud-computing services. According to the German legislator, the provision aims at enabling the secure use of cloud services as a “modern, generally widespread technology in the healthcare sector and to create minimum technical standards for the use of IT systems based on cloud-computing”.

The new requirements apply to data processing using cloud-computing irrespective of whether the cloud-computing is offered by an external vendor or utilizes a tool that the healthcare providers or health insurance has developed on their own.

The term “cloud-computing service” is defined in the law as “a digital service that enables on-demand management and comprehensive remote access to a scalable and elastic pool of shared computing resources, even if these resources are distributed across multiple locations” (Section 384 Sentence 1 No. 5 SGB V). This reflects the corresponding definition of cloud-computing in Article 6 (30) of the NIS2-Directive (EU) 2022/2555 on cybersecurity measures. Services that fall under this definition include, inter alia, Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS).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 Devices

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 Parliament has now accepted a modified version of that bill. The Medical Research Act mainly amends (1) national laws for clinical trials with drugs and medical devices, (2) rules for ATMPs (3) drug pricing and reimbursement laws (AMNOG) and (4) initiates a re-organization of the regulatory agencies and ethics committees.

In this blog, we take a closer look at the much-discussed changes in the German drug pricing and reimbursement area. We will focus on two key elements:

  • The controversial new feature of “confidential reimbursement prices”; and
  • The new link between drug pricing and local clinical trials which offers pricing incentives for companies that can show that a “relevant part”  of the clinical trials for a new medicine were conducted in Germany.

We had noted in an earlier blog that the German rules for pharmaceutical pricing and reimbursement are among the most complicated legal areas in the entire world of life sciences laws. With the now coming new laws, Germany adds some additional complexity to its system.

1. Background

The discussed changes to the German drug pricing and reimbursement laws are part of the German Government’s new National Pharma Strategy that aims to enhance Germany’s attractiveness as a place for pharmaceutical research, development, and manufacturing. The Government presented an underlying strategy paper in December 2023 and the Medical Research Act is the first legislative implementation step of that strategy. For an overview of this new National Pharma Strategy, we invite you to read our previous blog on this topic.

The Medical Research Act was first presented to stakeholders in late January 2024. For a comprehensive overview of this first draft, please see our earlier earlier blog. After an initial consultation, the Government revised the draft and initiated the legislative process at the end of May 2024. Overall, the Government has deployed an unusually fast pace and was successful with its plan to get the bill through Parliament before the summer break.Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

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 role in the field of gene and cell therapies (GCT) in Europe. The German Government recognizes that the age of GCT has started but that there are many legal, regulatory and practical shortcomings that impedes research and development of GCTs in Germany.

Back in the fall of 2022, the German Federal Ministry of Education and Research (BMBF) had commissioned the Berlin Institute of Health (BIH) to coordinate and moderate the development of a National Strategy for GCT. Eight working groups were created to develop the National GCT Strategy, with a total of about 150 experts from various stakeholder groups. The result of their work is a document divided into eight fields of action, in which various measures are proposed to achieve strategic goals in the field of GCT.

The National GCT Strategy is one of several highly targeted measures with which the German Government aims to make Germany more attractive as a location for pharmaceutical and healthcare innovation. Just six months ago, in December 2023, the Federal Ministry of Health (BMG) presented a strategy paper for the new National Pharma Strategy. We reported on this in detail in an earlier Covington blog.

Unlike the National Pharma Strategy, which was developed under the Social Democrat-led Federal Ministry of Health (BMG), the National Strategy for GCT is an initiative led by the Federal Ministry of Education and Research which is led by the liberal party FDP. The BMBF appears keen to play a leading role in the establishment of GCT in Germany. Industry stakeholders may welcome this as the BMBF is known to be a more industry-friendly part of the German Government than the BMG.

2.  The National Pharma Strategy as a possible role model

The example of the National Pharma Strategy and its rapid implementation already indicates what the next steps in the National GCT Strategy may be. Shortly after the National Pharma Strategy was agreed upon, the first draft of the “Medical Research Act” was presented on 26 January 2024 to implement key elements of the Pharma Strategy, including amendments in the areas of clinical trials, ATMPs and pharmaceutical pricing and reimbursement (AMNOG). We reported on this in two earlier blogs that discussed the proposed changes for clinical trials and drug pricing. The draft Medical Research Act is expected to come into force in the fall of 2024. Hence, the current German Government is keen to act fast to strengthen Germany as a place for pharmaceutical innovation and R&D.Continue Reading Germany prepares new National Strategy for Gene and Cell Therapies