Health Care & Life Science - Legal and Tax Advice | www.luther-lawfirm.com - Luther Lawfirm
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Health Care & Life Science
Legal and Tax Advice | www.luther-lawfirm.com
Health Care & Life Science
Luther stands for focused legal and tax advice in the entire Health Care & Life Science sec-
tor 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 con- We can meet these challenges head on together with you and
stantly changing. Demographic developments are increasing ensure that you are well advised in your competitive environ-
the demand for medical services. Thanks to technological ment on all legal and tax issues relating to the healthcare and
progress, pharmaceuticals medical devices research, produc- life science industry. Our experts are familiar with the struc-
tion and therapy are linked with big data, gene sequencing, AI tures within the healthcare market, know the regulatory condi-
and biogenetics. Large technology companies and highly spe- tions and understand the economic goals of our clients. This
cialised start-ups have contributed to the fact that old struc- allows them to concentrate fully on their core business: be it
tures in the health sector, biotechnology and chemistry have patient care, research into new pharmaceuticals or the devel-
altered and now have to be redefined. Numerous challenges, opment of state-of-the-art medical technology.
therefore, that our clients are now facing.
2 | Luther Rechtsanwaltsgesellschaft mbH
Our range of advisory services
Medical law for inpatient and outpatient German Social Insurance Code XI (SGB XI)
■ Legal advice regarding setting up cooperations and man-
service providers (acute, rehab)
agement systems/interface consulting
For dentists and doctors/medical-care centres ■ Drafting contracts (transfer/release management; ordi-
nance management)
■ Professional law for healthcare professions (doctors, den- ■ Law regarding remuneration of care fees
tists, etc.) ■ Advice regarding real estate law (including construction/
■ Panel doctor law/panel dentist law including remuneration development, transactions)
law and licensing procedures
■ Opening a surgery and medical-care centre, developing M&A for investors/strategies
medical-care centre group structures, advice on taking
over a surgery ■ Advising complex, structured bidding procedures, com-
■ Law on medical services, including liability and accounting pany acquisitions and transactions
issues ■ (Partial) privatisation, developing individual investment
solutions
For hospitals/clinics ■ Restructuring, insolvency advice for service providers
■ Advice on transformation law (hive-downs, mergers),
■ Hospital planning law, administrative/court planning law insourcing and outsourcing
proceedings ■ Advice regarding creating a cooperation and holding (pri-
■ Hospital subsidisation and hospital financing law vate, public as well as non-profit organisations)
■ Public procurement procedures, advising construction proj- ■ Public procurement law (structuring public procurement
ects for outpatient facilities processes, tenders, litigation), PPP projects
■ Law regarding hospital remuneration and accounting dis- ■ State aid law
putes ■ European and German merger control in the hospital and
■ Employment law in hospitals, senior consultant service insurance markets
contracts ■ Antitrust law advice regarding cooperations
■ Approval issues for psychiatric and rehabilitation medical ■ Further developing university medicine, monitoring of legis-
facilities (inpatient, outpatient) lative processes
■ Financing and reorganisation-related advice
For all service providers ■ Tax law advice relating to transactions and cooperations
■ Non-profit law
■ Drafting and reviewing cooperation agreements between
service providers Pharma, biotech and life science
■ Employment law for service providers as well as the public
sector ■ Pharmaceutical law (national, European)
■ Company pension plans/law regarding Federal and State ■ Approval of pharmaceuticals, clinical trials
Government Employees Retirement Fund (VBL), law ■ Market access and reimbursement
regarding supplementary pension funds (ZVK), law regard- ■ Drafting pharmaceutical supply contracts
ing church supplementary pension funds (KZVK) ■ Import and cultivation permits for medical cannabis
■ Structural personnel measures, outsourcing, collective bar- ■ Supplier and service contracts
gaining law ■ Research funding and cooperation with national, European
■ Data protection law and international organisations
■ Anti-corruption law, compliance advice ■ Joint ventures/cooperations
■ Protection of Intellectual Property
Old-age and nursing homes ■ M&A
■ Pharmaceutical advertising law, competition law, copyright law
■ Law regarding (inpatient/outpatient) care
■ Proceedings before arbitration boards according to the
Luther Rechtsanwaltsgesellschaft mbH | 3
Medical technology selective contracts, new validation requirements, Digital
Health Service Act
For manufacturers/importers ■ E-Health-Apps, E-Health-Platforms
■ Subsidy programmes, innovation funds
■ Advice on all regulatory aspects of medical device law ■ Contracts with specialised IT providers
(national and international) ■ Creating competence centres “Medicine 4.0”, incubators
■ Providing support when dealing with the competent author- and accelerators
ities ■ Conception and implementation of partnerships (“joint ven-
■ Certification of medical devices, conformity assessment, tures”) with medical service providers and IT providers
risk classification, clinical trials and support when dealing ■ Innovative structuring of investment financing
with Notified Bodies ■ Public procurement law for the integration of digital pro-
■ Launch and market access of new medical devices cesses and products in clinics and surgeries; innovative
■ Advising on product recall actions contract design
■ Legal structuring of distribution channels in Germany and
abroad IT/IP, Dispute Resolution and Public Health
■ Defence against claims asserted against the manufacturer
law
under the manufacturer’s liability act
■ German Social Insurance Code V (SGB V) ■ Advice on patents and trademarks
■ Supplier and service contracts ■ Know-how protection and IP
■ Joint ventures/cooperations ■ Advice on the competition law framework and compliance
with antitrust regulations, comprehensive compliance
For operators/users advice
■ Representation in arbitration and court proceedings and in
■ Advice on legal obligations regarding the use and opera- dispute settlement negotiations
tion of medical technology ■ Preparing and supporting tender procedures both on the
■ Providing legal advice and support in the procurement pro- part of the tendering company and on the part of the bidders
cess 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 pro-
curement, management, maintenance and renewal of
medical equipment
■ Advice on all aspects of liability law and on the enforce-
ment 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 “Internal Audit” guidelines
■ E-Health-law
■ Big Data in clinical trials
■ Market access and reimbursement, pilot projects and
4 | Luther Rechtsanwaltsgesellschaft mbH
Your contacts
Cornelia Yzer
Lawyer, Of Counsel, Former member of the Berlin Senate
Berlin
T +49 30 52133 21148
cornelia.yzer@luther-lawfirm.com
Cornelia Yzer has worked in an executive function at Bayer AG, as Chief Managing
Director of the German Association of Research-based Pharmaceutical Companies
(vfa) (1997-2012), Member of the German Parliament (1990-1998), Parliamentary
State Secretary at the Federal Ministry for Education, Science, Research and Tech-
nology, Senator for Business, Research and Technology of the State of Berlin,
Chairwoman of the Administrative Board of of Investitionsbank Berlin, Member of
the Strategic Advisory Board of Medidata Inc., New York (SA), Member of the Euro-
pean Advisory Board of the medical products manufacturer Guidant, chairwoman of
the Board of Trustees of major research institutions (German Cancer Research Cen-
tre (DKFZ), Max Delbrück Centre for Molecular Medicine (MDC) and member of the
board of the European Federation of Pharmaceutical Industries and Associations
(EFPIA) and the International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA).
Cornelia Yzer studied law and business at the Universities of Bochum and Münster
(both Germany). She was admitted to the Bar in 1990.
Areas of practice
Cornelia Yzer advises domestic and foreign companies on mergers and acquisitions
and on regulatory issues, making them benefit from her many years of experience in
industry and in government positions. A particular industry focus of Cornelia Yzer
are the life science and digital economy sectors. At Luther Rechtsanwalts-
gesellschaft, Cornelia Yzer is the coordinator of the Health Care & Life Science
sector and the Digital Health working group.
Furthermore, Cornelia Yzer advises her clients on all aspects of research funding.
Luther Rechtsanwaltsgesellschaft mbH | 5
Your contacts
Dr Oliver Kairies
Lawyer, Partner
Hanover
T +49 511 5458 17643
oliver.kairies@luther-lawfirm.com
After finishing his vocational training in banking, Dr Oliver Kairies studied law in
Hanover, which included training posts in Frankfurt, Stuttgart, Hamburg, Munich and
London. He received his doctorate in 2001 and was admitted to the Bar the same
year. He has been at Luther (or its respective predecessor) since 2001 and joined
the partnership in 2008.
Areas of practice
Oliver Kairies specialises in assisting and coordinating innovative and complex pro-
cedures to form alliances in the health care sector as well as implementing and
coordinating competitive tendering procedures, privatisations, and restructuring
projects. A further focus of his advisory services is the support of German and inter-
national operators and investors in M&A transactions as well as the structuring and
design of medical care centre structures and advice on buy & build procedures.
Within the scope of insolvency proceedings in the health care sector, Dr Oliver
Kairies and his team take care of investor processes that are carried out regularly
and the support of the proceedings under regulatory aspects. In addition, Dr Kairies
is the coordinator of the Health Care & Life Science Industry Group at Luther.
6 | Luther Rechtsanwaltsgesellschaft mbH
Your contacts
Denis Ullrich
Lawyer, Partner
Leipzig
T +49 341 5299 0
denis.ullrich@luther-lawfirm.com
Denis Ullrich studied law with a major in economics at the University of Bayreuth
(Germany). He joined Luther in 2005.
Areas of practice
Denis Ullrich specialises in advising on the sale and acquisition of companies and
shares in companies (M&A), the incorporation of companies and the reorganisation
of companies and groups. His work also includes restructuring and crisis transac-
tions. His clients include medium-sized companies, international groups and
strategic investors from various industries as well as private equity companies and
entrepreneurs within the framework of succession planning. Furthermore, Denis
Ullrich advises shareholders, management board members, managing directors,
supervisory board and advisory board members on all matters pertaining to corpo-
rate law.
A further focus of Denis Ullrich’s consulting activities lies in the area of pharmaceu-
ticals and biotechnology. Here he advises clients in the context of transactions,
cooperations and joint ventures as well as on complex contractual arrangements
and regulatory aspects.
Denis Ullrich is the coordinator of the Health Care & Life Science sector at Luther.
Luther Rechtsanwaltsgesellschaft mbH | 7
Hits the mark. Luther.
Luther Rechtsanwaltsgesellschaft mbH is one of the leading corporate law firms in Germany. With some 420 lawyers and tax
advisors, we can advise you in all fields of German and international corporate law. In addition to having offices in every eco-
nomic centre throughout Germany, we are also present in ten locations abroad: in Brussels, London and Luxembourg in Europe,
and in Bangkok, Delhi-Gurugram, Jakarta, Kuala Lumpur, Shanghai, Singapore and Yangon in Asia.
Our advisory services are tailored to our clients’ corporate goals. We take a creative, dedicated approach to achieving the best
possible economic outcome for each of our clients.
The name “Luther” stands for expertise and commitment. With a passion for our profession, we dedicate all our efforts to solving
your issues, always providing the best possible solution for our clients. Not too much and not too little – we always hit the mark.
We know how crucial it is to use resources efficiently and to plan ahead. We always have an eye on the economic impact of our
advice. This is true in the case of strategic consulting as well as in legal disputes.
We have complex projects on our agenda every day. At Luther, experienced and highly specialised advisors cooperate closely
in order to offer our clients the best possible service. Thanks to our fast and efficient communication, permanent availability and
flexibility, we are there for you whenever you need us.
Luther won the JUVE Award ‘Law Firm of the Year 2019’.
About us
Lawyers and Locations Long-standing Offices in international
tax advisors connections to commercial financial centres and
law firms worldwide investment locations
420 20
8 | Luther Rechtsanwaltsgesellschaft mbH
Our locations
We have a global outlook, with offices in ten key economic and financial centres in Europe and Asia. We also maintain close
relationships with leading corporate law firms worldwide. This way, we ensure a seamless service for our clients throughout their
demanding international projects.
In continental Europe, Luther is part of a group of independent law firms, each one a leader in its own country, that have been
cooperating regularly on international mandates for many years.
Our partner firms are based in Africa, Australia and New Zealand, Europe, Israel, Japan and Korea, the Middle East, Russia and
the CIS, South and Central America, the US and Canada.
Luther locations
Best friends Our locations
Bangkok Jakarta
Berlin Kuala Lumpur
Brussels Leipzig
Cologne London
Delhi-Gurugram Luxembourg
Dusseldorf Munich
Essen Shanghai
Frankfurt a.M. Singapore
Hamburg Stuttgart
Hanover Yangon
Luther Rechtsanwaltsgesellschaft mbH | 9
Our industries
Our lawyers and tax advisors focus on Energy
advising clients from five industries. Hits
the mark.
Conventional or renewable energies: We work efficiently and
sustainably.
Health Care & Information Tech &
Life Science Telecommunications
With our expertise, we have our finger on the pulse of time. We connect today with tomorrow.
Mobility & Real Estate &
Logistics Infrastructure
We understand what gets you moving and can set you on the We lay the foundation for you to build on.
right course.
10 | Luther Rechtsanwaltsgesellschaft mbHOur practice areas
Antitrust Law Capital Markets & Commercial & Complex Disputes
Banking Distribution Law,
Product Liability/
Product Compliance
Compliance & Corporate/M&A Data Protection Law Employment Law
Internal Investigations
Energy Law Environment & Financial Services IP & Copyright Law
Planning Law,
Regulatory
IT Law Insurance Law International Notarial Services
Trade Law
Public Public Subsidies/ Real Estate Restructuring &
Procurement Law State Aid Law Insolvency
State, Administration, Tax Law White-Collar Crime &
Public Undertakings Tax Offences
Luther Rechtsanwaltsgesellschaft mbH | 11Luther.Digital
The digital revolution is well under way. In a highly competitive market where new business models are always being
developed and existing processes are continually being challenged, multinational groups, well-established medium-
sized businesses and small start-ups are all looking for the best possible ways to position themselves in this environ-
ment. In order to do this, they do not just call existing business models into question, but also create completely new,
innovative forms of cooperation. This revolution is being driven by numerous recent technological developments,
such as cloud computing, digital platforms, Big Data and artificial intelligence, the Internet of Things and blockchain
technology.
Protecting Intellectual Artificial Intelligence &
Luther.Digital supports and advises comprehensively on Property Big Data
all legal areas relating to digital business models, agile
architectures and technical levers as well as the neces-
sary transformation processes in the company. From the
realignment of value chains to commercial and distribu-
tion law aspects, employment law, IT and data protection
topics up to and including digital compliance and anti-
trust law. Digital Infrastructure Digital Value
Chains
Luther.Digital supports you in all the phases of upcoming
transformation projects – from strategic dialogue to
LegalTech solutions and the subsequent change process.
Blockchain & FinTech Data Protection & Future Work Legal Operations
Compliance
Digital Legal Services Digital Media & Gaming Platforms & Start-ups &
Communities Venture Capital
12 | Luther Rechtsanwaltsgesellschaft mbHOur awards
JUVE
In the 2020/2021 JUVE Guide to Commercial Law Firms, 45 lawyers from Luther were recommended, and
nine of these were also listed as “leading advisors”. The legal publisher JUVE published rankings for a total
of 28 areas of law. In 2019, Luther was named “Law Firm of the Year 2019” by JUVE and, in addition, was
nominated for the JUVE awards “Law Firm of the Year for Mergers & Acquisitions” and “Law Firm of the
Year for Dispute Resolution”. In the past, Luther has already won “Law Firm of the Year 2017 for Environ-
mental and Regulatory Law”, “Law Firm of the Year 2015 for Distribution/Trade/Logistics”, “Law Firm of the
Year 2014” in the categories of “Energy Law”, “Regulated Industries” and “Private Sector Building Law”
(Germany), and in 2011 “Law Firm of the Year for Distribution Systems”.
The Legal 500
“The Legal 500 Deutschland 2020” recommends 68 lawyers from Luther, six of whom are recognised as
leading. A total of 26 areas of law were ranked. 52 lawyers were named in Legal 500 in 2019, five of them
winning awards.
Chambers
In 2020 Luther received awards from Chambers in Germany in twelve practice areas: Commercial Contracts
(band 2), Corporate/M&A: Mid-Market (band 2), Dispute Resolution (band 5), Employment (band 3), Energy
(band 3), Projects: Construction (band 4), Public Law (band 4), Public Law: Planning and Environment (band
3), Public Law: Public Procurement/PPP (band 4), TMT: Information Technology (band 4), as well as in Lux-
embourg in Corporate/M&A (band 4) and Dispute Resolution (band 3). In addition, 18 partners were ranked
by Chambers Europe in 2020, six of whom were also included in the rankings in Chambers Global.
Kanzleimonitor
Luther is one of the ten most frequently recommended law firms in Germany according to the German survey
of law firms “Kanzleimonitor 2020/2021”. Luther ranks 6th in terms of its range of legal services, with 22
(out of 32) areas of laws. Luther achieved top 5 rankings in employment law (2nd place), corporate law
(3rd place) and energy law (4th place). A total of 13 Luther lawyers were recommended by in-house lawyers.
“Best Lawyers in Germany 2021”
For the year 2021, 81 of Luther’s partners have been recommended as “Best Lawyers in Germany 2021”,
an award presented by the US publisher “Best Lawyers” in cooperation with the German Handelsblatt.
Dr Martin Fleckenstein has been awarded “Lawyer of the Year” in “Land Use and Zoning Law”.
WHO’S WHO LEGAL
Twelve of Luther’s partners are listed in WHO’S WHO LEGAL in 2020, two of whom were recognised as
Thought Leaders and one as a Future Leader.
Global Arbitration Review
In 2019, the English legal journal “Global Arbitration Review included Luther for the eighth time in a row in
its “GAR 100”, a list of law firms specialising in arbitration law assessed by the journal throughout the world.
Luther Rechtsanwaltsgesellschaft mbH | 13Luther Rechtsanwaltsgesellschaft mbH
Anna-Schneider-Steig 22
50678 Cologne, Germany
Telephone +49 221 9937 0
Telefax +49 221 9937 110
contact@luther-lawfirm.com
For reasons of better legibility, the simultaneous use of gender-specific language
forms is dispensed with. Corresponding terms apply in principle to all genders in the
sense of equal treatment. The abbreviated form of language has editorial reasons and
does not imply any valuation.
Release: November 2020
14 | Luther Rechtsanwaltsgesellschaft mbHBangkok, Berlin, Brussels, Cologne, Delhi-Gurugram, Dusseldorf, Essen,
Frankfurt a.M., Hamburg, Hanover, Kuala Lumpur, Jakarta, Leipzig, London,
Luxembourg, Munich, Shanghai, Singapore, Stuttgart, Yangon
You can find further information at:
www.luther-lawfirm.com
www.luther-services.com
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