• Good to see what has allready been achieved. Better to know what still needs to be done.
  • Precision, perfect timing and an eyefor what matters.
  • Doing the right thing at the right time.That's what seperates the best from the rest.
  • Achieving your goalswith a reliable partnerby your side.

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 healthcare sector in Germany is highly regulated and in a state of constant change: Demographic developments are increasing the demand for medical services. Thanks to technological progress, pharmaceutical production, therapy and medical devices 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 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/panel (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 co-operation and holding (private, municipal, non-profit and church sponsors)
  • 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
  • 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
  • Approval of medical devices, conformity assessment, risk classification, clinical trials
  • Advice during the placing on the market and the market introduction 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
  • Advising on contract negotiations, contract initiation and contract negotiations, on concluding contracts and their implementation
  • Advising on defending against claims asserted against the manufacturer under manufacturer liability in the event of problems with the manufacturer's medical equipment
  • 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
  • Advising on all contractual aspects of the procurement of medical devices
  • 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

  • EU GDPR, German Federal Data Protection Act, sector-specific requirements for the protection of sensitive health data
  • Quality management and supplementing the "Internal Audit" guidelines
  • E-Health-Law
  • Big Data in clinical trials
  • Market entry and reimbursement, pilot projects and selective contracts, new validation requirements, evidence to support reimbursement in standard care, Digital Health Care Act
  • E-Health-Apps, E-Health-Platforms
  • Subsidy programmes, innovation funds
  • Selection and conclusion of contracts with specialised IT providers
  • Creating competence centres "Medicine 4.0", incubators and accelerators
  • Conception and implementation of partnerships ("joint ventures") with other medical service providers and IT providers
  • Innovative structuring of investment financing
  • Public procurement law for the integration of digital processes and products in clinics and surgeries; innovative contract design

 

IT/IP, dispute resolution and public health law

  • Advice on patent matters, trademark law problems
  • Know-how protection as well as all issues relating to industrial property protection
  • Advice on the competition law framework and compliance with antitrust regulations, comprehensive compliance advice
  • Representation in arbitration and court proceedings and in settlement negotiations, taking into account alternative dispute resolution options
  • Preparing and supporting award procedures both on the part of the tendering company and on the part of the bidders

Contact

Dr. Oliver Kairies, Partner
Phone +49 511 5458 17643
oliver.kairies@luther-lawfirm.com

Cornelia Yzer, Of Counsel
Phone +49 30 52133 21148
cornelia.yzer@luther-lawfirm.com

Denis Ullrich, Partner
Phone +49 341 5299 0
denis.ullrich@luther-lawfirm.com

Health Care & Life Science