Health Care &
Life Science

Luther stands for focused legal and tax advice in the entire Health Care & Life Science sector in Germany and Europe. This includes health care structures, inpatient and outpatient, regulatory issues, the safeguarding of complex research projects, up to and including transactions and litigation.

The highly regulated healthcare sector in Germany is constantly changing. Demographic developments are increasing the demand for medical services. Thanks to technological progress, pharmaceuticals medical devices research, production and therapy are linked with big data, gene sequencing, AI and biogenetics. Large technology companies and highly specialised start-ups have contributed to the fact that old structures in the health sector, biotechnology and chemistry have altered and now have to be redefined. Numerous challenges, therefore, that our clients are now facing.  

We can meet these challenges head on together with you and ensure that you are well advised in your competitive environment on all legal and tax issues relating to the healthcare and life science industry. Our experts are familiar with the structures within the healthcare market, know the regulatory conditions and understand the economic goals of our clients. This allows them to concentrate fully on their core business: be it patient care, research into new pharmaceuticals or the development of state-of-the-art medical technology.

Our range of advisory services:

Medical law for inpatient and outpatient service providers (acute, rehab)

For (dentists) doctors/medical-care centres

  • Professional law for the healthcare professions (doctors, dentists, etc.)
  • Panel doctor law/panel dentist law including remuneration law and licensing procedures
  • Opening a surgery and medical-care centre, developing medical-care centre group structures, advice on taking over a surgery
  • Law on medical services, including liability and accounting issues

For hospitals/clinics

  • Hospital planning law, administrative/court planning law proceedings
  • Hospital subsidization and hospital financing law
  • Public procurement procedures, advising construction projects for outpatient facilities
  • Law of hospital remuneration and accounting disputes
  • Employment law in hospitals, senior consultant service contracts
  • Approval issues for psychiatric and rehabilitation medical facilities (inpatient, outpatient)

For all service providers

  • Drafting and reviewing co-operation agreements between service providers
  • Employment law for service providers as well as the public sector
  • Company pension plans/law regarding Federal and State Government Employees Retirement Fund (VBL), supplementary pension fund (ZVK), church supplementary pension fund (KZVK)
  • Structural personnel measures, outsourcing, collective bargaining law
  • German pharmaceutical advertising law, German competition law, German copyright law
  • Data protection laws
  • Anti-corruption law, compliance advice
Old-age and nursing homes
  • Law regarding (inpatient/outpatient) care
  • Proceedings before arbitration boards according to the German Social Insurance Code XI (SGB XI)
  • Legal advice regarding setting up co-operations and management systems/interface consulting
  • Drafting contracts (transfer/release management; ordinance management)
  • Law regarding remuneration of care fees
  • Advice regarding real estate law (including construction/development, transactions)
M&A for investors/strategies
  • Advising complex, structured bidding procedures, company acquisitions and transactions
  • (Partial) privatisation, developing individual investment solutions
  • Restructuring, insolvency advice for service providers
  • Advice on transformation law (hive-downs, mergers), insourcing and outsourcing
  • Advice regarding creating a cooperation and holding (private, public as well as non-profit organisations)
  • Public procurement law (structuring public procurement processes, tenders, litigation), PPP projects
  • Subsidy law
  • European and German merger control in the hospital and insurance markets
  • Antitrust law advice regarding co-operations
  • Further developing university medicine, monitoring of legislative processes
  • Financing and reorganization-related advice
  • Tax law advice relating to transactions and co-operations
  • Non-profit law
Pharma, Biotech and Life Science
  • Pharmaceutical law (national, European)  
  • Approval of pharmaceuticals, clinical trials
  • Drafting pharmaceutical supply contracts
  • Legal advice during the market launch of new pharmaceuticals
  • Import and cultivation permits for medical cannabis
  • Pharmaceutical remuneration law (reimbursement)
  • Supplier and service contracts
  • Research funding and co-operation with national, European and international organisations
  • Joint ventures/co-operations
  • Pharmaceutical advertising law, competition law, copyright law
  • Protection of Intellectual Property
  • M&A
Medical technology

For manufacturers/importers

  • Advice on all regulatory aspects of medical device law (national and international)
  • Providing support when dealing with the competent authorities
  • Certification of medical devices, conformity assessment, risk classification, clinical trials
  • Launch market access of new medical devices
  • Support in dealing with Notified Bodies regarding the clinical verification of medical devices
  • Advising on product recall actions
  • Legal structuring of distribution channels in Germany and abroad
  • Reference against claims asserted against the manufacturer under manufacturer liability act
  • Law regarding remedies and aids (German Social Insurance Code V (SGB V)
  • Supplier and service contracts
  • Joint ventures/co-operations

For operators/users

  • Advice on legal obligations regarding the use and operation of medical technology
  • Providing legal advice and support in the procurement process of medical devices from the competitive bidding stage, through the dialogue phase, to the drafting of the contract and the selection procedure
  • Individual and innovative drafting of contracts for the procurement, management, maintenance and renewal of medical equipment
  • Advice on all aspects of liability law and on the enforcement and defence of liability claims
  • Comprehensive advice on employment law including advice on occupational safety, special safety regulations for employees dealing with medical technology and the implementation of training courses
Digital health

Digitisation in the healthcare sector opens up new opportunities for diagnostics and therapy, quality enhancement and the acceleration of research processes. Artificial intelligence as a key technology enables decision-making based on big data and can thus support physicians as a tool in everyday treatment as effectively as patients in self-monitoring of chronic diseases and researchers in identifying suitable targets as well as in the context of clinical trials.

More and more players in healthcare are therefore committing to digital health and want to drive digitisation supported by AI in their area of responsibility.

  • The German Hospital Future Act (Krankenhauszukunftsgesetz, KHZG) gives a boost to the digitisation of hospitals with a funding volume of EUR 4,3 billion.
  • Platform providers offer digital services such as making appointments in the practice or video consultations.
  • A growing number of patients are using health apps.
  • The German healthcare system has a unique selling point as it allows for the prescription and reimbursement of BfArm-listed Digital Health Applications (DiGAs).
  • Projects such as GAIA X and, in the future, the European Health Data Space, for which the EU Commission has presented a draft, are intended to optimise the use of data for new health solutions.

Nevertheless: There are numerous legal hurdles to overcome when introducing innovative digital solutions in the healthcare sector. In the highly regulated healthcare sector, some regulations are not compatible with digital requirements and would have to be dropped or, in some cases, replaced; liability law has to be observed; data protection and data security raise particular issues in the case of sensitive healthcare data.

Luther's experts accompany clients into the digital world with their expertise on the requirements according to the German Social Code (SGB V), medical device law and IT/data protection law.

  • Regulatory requirements for digital health applications (medical device law, SGB V, data protection law)
  • Cooperation agreements of medical device manufacturers with health insurance companies according to Sec. 68a SGB V
  • Market access and reimbursement for e-health apps and e-health platforms via pilot projects, innovation funds, selective contracts pursuant to Sec. 140a SGB V
  • Prescribability and reimbursement through listing as DiGA according to SGB V, new requirements for validation (proof of evidence)
  • Legal support for established service providers (pharmaceutical industry, medical devices/IVDs) in the digitisation of their products and business models, as well as data protection advice on the use of big data
  • Designing contracts with IT service providers and hyperscalers, cloud-based offerings and healthcare solutions in the metaverse
  • Joint ventures of medical service providers for innovative digital care
  • Funding programmes, KHZG: Application and implementation, procurement law
  • Establishment of competence centres, incubators and accelerators
  • Telemedicine centres

As a full-service law firm, Luther also offers legal advice to providers of digital health solutions in numerous other areas of law, such as competition law, compliance, intellectual property, public procurement law, commercial agreements, employment law and transactions.

>> Your contacts for Digital health

IT/IP, dispute resolution and public health law
  • Advice on patents and trademarks
  • Know-how protection and IP
  • Representation in arbitration and court proceedings and in dispute settlement negotiations
  • Preparing and supporting tender procedures both on the part of the tendering company and on the part of the bidders
Antitrust and merger control law in the health care and life science sector
  • Advice on all antitrust issues (prohibition of cartels and abuse of a dominant market position), e.g:
    • Co-operations with competitors (co-promotion / co-marketing, R&D co-operations, production agreements)
    • Information exchange / notification systems / market information systems
    • Measures to restrict parallel imports
    • Pricing and discounting
    • (Late) life cycle management
    • Distribution channels (direct-to-pharmacy, direct-to-hospital, exclusive distribution, cooperation with selected wholesalers)
  • Representation in antitrust investigations and proceedings by the European Commission, the German Federal Cartel Office and the state antitrust authorities
  • Antitrust compliance and internal investigations
  • German and EU merger control and coordination of merger control proceedings worldwide
  • German Foreign Direct Investment (FDI) law
  • EU state aid law (in particular FSR)

News

18.06.2024 Press Release
Pharmaceutical industry: Luther advises Lyomark Pharma on sale of Lyocontract GmbH to US PE investor
18.04.2024
Further partner addition: Luther strengthens its position with renowned healthcare expert
02.04.2024
Luther strengthens Health Care & Life Science practice with new partner
25.01.2024
Luther secures pioneering technology partnership for Braunschweig Hospital
18.01.2024
Clinic group expands presence locally and nationally: Johanniter successful with Luther on clinic acquisition in Westphalia

Key Contact >>

Key Contact

Dr Oliver Kairies

Partner

T +49 511 5458 17643

Prof. Dr Christian Burholt, LL.M.

Partner

T +49 30 52133 10589

Team Health Care & Life Science

Portrait Rechtsanwalt Hans-Christian Ackermann

Hans-Christian Ackermann
Partner
Dusseldorf

Volker von Alvensleben
Of Counsel
Hamburg

Caroline Ackermann
Counsel
Munich

Dr Marcus Backes
Partner
Hamburg

Dr Christoph von Burgsdorff, LL.M. (Essex)
Partner
Hamburg

Prof. Dr Christian Burholt, LL.M.
Partner
Berlin

Dr Arndt Begemann
Of Counsel
Essen

Anne Biebler
Senior Associate
Leipzig

Dr Robert Burkert
Senior Associate
Hamburg

Anna Büscher
Senior Associate
Dusseldorf

Charlotte Buck
Associate
Hanover

Dr Kuuya Josef Chibanguza, LL.B.
Partner
Hanover

Ann-Kristin Freiheit, Rechtsanwältin

Ann-Kristin Freiheit
Senior Associate
Dusseldorf

Dr Stefan Galla
Partner
Essen

Dr Thomas Gohrke
Partner
Hanover, Leipzig

Daniel Greger
Senior Associate
Hamburg

Dr Helmut Janssen, LL.M. (King's College London)
Partner
Brussels, Dusseldorf

Dr Jan-David Jäger
Senior Associate
Leipzig

Dr Oliver Kairies
Partner
Hanover

Dr Andreas Kloyer
Partner
Frankfurt a.M., London

Thomas Köhler
Partner
Frankfurt a.M.

Elisabeth Kohoutek
Partner
Frankfurt a.M.

Dr Thomas Kuhnle
Partner
Stuttgart, London

Oliver Köhler
Counsel
Frankfurt a.M.

Stefanie Kandzia, LL.M.
Senior Associate
Hamburg

Dr Lisa Kraayvanger
Associate
Hanover

Luisa Kramer
Associate
Hamburg

Dr.iur. Andreas Knaul, LL.M. diap (ENA)
--
Berlin

Achim Meier
Partner
Essen

Dr Cédric Müller, LL.M. (Bristol)
Partner
Essen

Sophia Meyer, Maître en Droit
Associate
Berlin

Dr Kay Oelschlägel
Partner
Hamburg

Tobias Osseforth, Mag. rer. publ.
Partner
Munich, Stuttgart

Theresa Oesch
Senior Associate
Leipzig

Dr Eckart Petzold
Partner
Dusseldorf

Dr Ulrich Philippi
Partner
Stuttgart

Robert Pacholski
Senior Associate
Leipzig

Frederike Peters
Senior Consultant
Berlin

Dr Stephan Rippert LL.M.
Partner
Munich

Jens Röhrbein
Partner
Hanover

Dr Eva Maria K. Rütz, LL.M.
Partner
Dusseldorf, Cologne

Rebecca Romig
Counsel
Frankfurt a.M.

Charlotte Riese
Senior Associate
Berlin

Manuel Rueß
Associate
Hamburg

Paul Schreiner
Partner
Cologne, Essen

Leif Dustin Schneider
Counsel
Ho Chi Minh City

Dr Daniel Schubmann
Counsel
Hanover

Dr Hendrik Bernd Sehy
Counsel
Hanover

Dr Aline Mück
Senior Associate
Cologne

Hannah-Laura Schütte
Senior Associate
Cologne, Stuttgart

Anja Schwarz, LL.M. (London)
Senior Associate
Cologne

Martina Steude, LL.M. (Cape Town)
Senior Associate
Hanover, Hamburg

Jan Spiering Rechtsanwalt

Jan Spiering, LL.M. Taxation
Associate
Hanover

Dr Johannes Teichmann
Partner
Frankfurt a.M.

Klaus Thönißen, LL.M. (San Francisco)
Partner
Essen

Denis Ullrich
Partner
Leipzig

Dr Andreas Vath
Partner
Munich

Guido Wenzel
Partner
Hamburg

Dr. Thomas Willaschek, Rechtsanwalt

Dr Thomas Willaschek
Partner
Berlin

Artur Winkler
Counsel
Hamburg

Dr Karina Wojtowicz
Senior Associate
Hanover

Frances Wolf
Senior Associate
Hanover

Wolffersdorff Anwalt

Clara von Wolffersdorff
Associate
Leipzig

Cornelia Yzer
Of Counsel
Berlin

Lara Zölck
Associate
Berlin

Referenzen

Land Schleswig-Holstein - Vorbereitung und Durchführung eines Markterkundungsverfahrens zur Zukunftssicherung des Universitätsklinikums Schleswig-Holstein
Universitätskliniken des Landes Baden-Württemberg - Kritische Würdigung und Erarbeitung von Vorschlägen zur Verbesserung des Universitätsmedizingesetzes Baden-Württemberg
Carl von Ossietzky Universität Oldenburg, Klinikum Oldenburg gGmbH, Pius-Hospital Oldenburg, Evangelisches Krankenhaus Oldenburg - Rechtliche und steuerliche Beratung bei der Gründung der „European Medical School Oldenburg - Groningen (EMS)", in Kooperation mit der Universität Groningen und dem Universitätsklinikum Groningen
Universitätsklinikum Freiburg / Herz-Zentrum Bad Krozingen - Konzeption und Begleitung der Umsetzung der Fusion der kardiologischen Bereiche
Universitätsklinikum Aachen / academisch ziekenhuis Maastricht - Erstellung einer Machbarkeitsstudie über die Errichtung eines Europäischen Universitätsklinikums sowie Umsetzung des Konzepts
Ministerium für Bildung, Wissenschaft und Kultur des Landes Mecklenburg-Vorpommern - Konzeption und Umsetzung eines „Integrationsmodells" (Fachbereich Medizin und Krankenversorgung werden zusammengelegt), Begleitung des Gesetzgebungsverfahrens
Universitätskliniken des Landes Baden-Württemberg - Erstellung eines Konzeptpapiers „Zukunftsfähige Trägermodelle" unter rechtlichen und steuerlichen Gesichtspunkten
Ministerium für Bildung, Wissenschaft, Jugend und Kultur des Landes Rheinland-Pfalz - Konzeption und Umsetzung eines „Integrationsmodells" (Fachbereich Medizin und Krankenversorgung werden zusammengelegt), Begleitung des Gesetzgebungsverfahrens
Universitätsklinikum Essen - Optimierung der Organisations- und Rechtsform des Universitätsklinikums Essen aus wirtschaftlicher, rechtlicher und steuerlicher Sicht
Land Hessen - (Teil-)Privatisierung der Universitätskliniken Gießen und Marburg
Klinikum Osnabrück GmbH und Stadt Osnabrück - Erwerb der Diakonie-Klinikum Osnabrücker Land gGmbH
Deutsche Kliniken Holding GmbH - Transaktionsberatung, Erwerb der Hochrhein-Eggberg-Klinik gGmbH und der Rehaklinik Sankt Marien gGmbH
Stadt Alfeld, Landkreis Hildesheim und Krankenhaus Alfeld GmbH - Veräußerung von Geschäftsanteilen des Krankenhauses Alfeld und Restrukturierung der Konzerngesellschaften
Landkreis Holzminden - Veräußerung der Beteiligung an der Krankenhaus Charlottenstift Stadtoldendorf GmbH nebst transaktionsbegleitender Restrukturierungsberatung
Kreis Bergstraße - Durchführung eines Markterkundungsverfahrens zur Zukunftssicherung des Kreiskrankenhauses Bergstraße
Hochtaunus-Kliniken GmbH - laufende rechtliche Beratung
AWO Krankenhausbetriebsgesellschaft mbH - Erwerb diverser (kommunaler) Krankenhäuser, z.B. Psychiatrisches Krankenhaus Halle (Saale), Stadtkrankenhaus Calbe; beabsichtigter Erwerb der Kreiskrankenhaus Belzig gGmbH; beabsichtigter Erwerb der psychiatrischen Fachpflege Schleswig GmbH und der Hesterberg & Stadtfeld GmbH
Bürgerhospital Frankfurt am Main und Clementine Kinderhospital - Fusion zweier Krankenhäuser
Sana Kliniken AG - Erwerb von Beteiligungen an kommunalen Krankenhäusern (z.B. Klinikum Hoyerswerda)
Klinikum Osnabrück GmbH - beabsichtigter Erwerb der Johanniter-Krankenhaus Bramsche GmbH