slide kit outsourced general counsel-april 2015
TRANSCRIPT
Outsourced General Counsel----------
An innovative approach of the legal function for
innovative companies involved in life sciences
• Innovative companies involved in life sciences have their own expertise and development path;
• Some of them face the difficulties proper to start-up companies, related to their creation and development;
• They face in the same time the intricacies of the pharmaceutical and medical regulations applying to their activities at any level;
• Life sciences industries need informed counsels.
Life sciences industries need tailored legal services
Outsourced general counsel Innovative
approach of the legal function
3Life sciences companies face
various kinds of legal challenges
Usual management of the legal topics
4
Your company
Has no legal department so
Has a legal department
which is
Understaffed and
overwhelmed so
Not to be enlarged for
costs matters so
You refer to external law
firms but
Costs and delays are
unpredictable
You refer to your auditors but
Legal advice is not the core business
of your auditors so
Your legal needs are unmet so
You may be at risk
Life sciences companies face various kinds of legal
challenges
Outsourced general counsel Innovative
approach of the legal function
Life sciences companies face various kinds of legal
challenges
Life sciences industries face multiple challenges
5
As companiesChallenges: corporate law, contract
law, management of the relationship with multiple
service providers (head-hunters, software developers,
consultants, etc), employment law, data privacy
Opportunities: development of distribution networks, multiple partnerships and subsidiaries, collection and treatment of big
data, marketing 2 and 3.0, recruitment of new collaborators
As Life Sciences industries
Challenges: clinical trials, marketing authorisations,
reimbursement prices, parallel imports, generics and
biosimilars, adverse events
Opportunities: progresses of biology and genomics, orphan treatments and personalised
therapies, new technologies for medical devices, booming of biomaterials and 3D-printing
For their usual management and growth, these companies need to have partners providing them back-
office legal services.Outsourced general counsel Innovative
approach of the legal function
Outsourced legal counsel: tailored legal services
Within a company, the general counsel is both a body guard and a Swiss army
knife
7
PROTECTING
PREVENTING
SWISS ARMY KN IFE SOLVINGCOOPERATING
BODY
GUARD
Profile of a general counsel
Outsourced general counsel Innovative
approach of the legal function
• The general counsel is a problem solver, cooperating with all the departments of the company;
• The general counsel participates to the risk prevention and protects both the company and its managers;
• The general counsel is listening to his/her colleagues; as a consequence, he/she is curious of them, their jobs, their challenges;
• The general counsel knows how to manage information, what to keep for himself/herself, what to share with whom within his/her environment, how, and when;
• The general counsel is responsive.
What are the qualities of a general counsel?
Profile of a general counsel 8
Outsourced general counsel Innovative
approach of the legal function
• Life sciences companies should be assisted by legal advisors who:– Understand what their own expertise and development
path are; – Can take on the legal intricacies these companies are
facing;– Can put at their disposal a validated experience already
acquired in the life sciences industry;– Can free these companies, their managers and their
employees from the burden of legal matters; and – Allow them to focus on their core business.
• This is what Labeolegal provides to these companies, offering them services as outsourced general counsel.
Labeolegal: tailored services for life sciences industries
Need of dedicated services for life sciences companies 9
Outsourced general counsel Innovative
approach of the legal function
3 – The outsourced legal counsel is a solution to the
legal challenges faced by the life science industries
• These services are an innovative way to provide legal services, for both growing and well-established businesses;
• These services are conceived for the companies who have the need for regular, on-going legal support;
• These services are conceived for the companies who do not consider to recruit a full-time in-house lawyer.
Outsourced legal counsel: tailored legal
services
What are Labeolegal outsourced general counsel services?
11Outsourced general counsel Innovative
approach of the legal function
Who is an outsourced general counsel?
Outsourced legal counsel: tailored legal
services
12
In-house counsel
External lawyer
Attorney-at-law Possibly Yes Yes
Confidentiality duty by status No Yes Yes
Experience as an in-house counsel Yes Yes No
Experience in the life sciences industries Possibly Yes Possibly
Employee Yes No No
Consultant No Yes Yes
Full-time dedication to the client’s needs (i.e. 40h/week)
Yes No No
Part-time dedication to the client’s needs Possibly Yes No
Dedication to the client’s needs on a per-hour basis
No Yes Yes
Work within the client’s premises Yes Yes No
Phone/email address provided by the client Yes Yes No
Daily visibility on the legal needs of the client Yes Yes No
Direct capability to anticipate the client’s legal needs
Yes Yes NoOutsourced general counsel Innovative
approach of the legal function
• The Labeolegal services are a perfect solution for companies, letting them optimise their costs and their organisations;
• Labeolegal provides them with a regular legal service at a measured cost;
• Labeolegal provides them with all the benefits of an in-house counsel coupled with all the flexibility of a consultant.
Advantages for your organization
Outsourced legal counsel: tailored legal
services13
Outsourced general counsel Innovative
approach of the legal function
• The company keeps its relationship with its usual external advisors, referring to them on the topics where these law firms can provide their most accurate skills and expertise;
• The company avoids referring to these law firms for day-to-day legal services, where the expertise of these law firms can be over-dimensioned;
• It brings an optimisation of the legal costs.
Optimised use of the external law firms
Outsourced legal counsel: tailored legal
services14
Outsourced general counsel Innovative
approach of the legal function
• The Labeolegal outsourced general counsel solution provides all the advantages of having an in-house lawyer, without the inconvenient of having a full-time employee.
• Like an in-house counsel, the Labeolegal outsourced general counsel is a key-element for the company’s growth:– He is a regular interlocutor of the managing team.– He gets an intimate knowledge of the company’s
legal needs and challenges.– He solves problems internally.– He anticipates on the future challenges of the
company.
Benefits of the outsourced general counsel
Outsourced legal counsel: tailored legal
services15
Outsourced general counsel Innovative
approach of the legal function
Outsourced general counsel specific
services
Scope of activities of the outsourced general counsel
17
Corporate law
Contract law
Employ-ment law
Marketing
Regulato-ry affairs
Data privacy
Market access/reimburse-
ment
Pre-litigation
and dispute
resolution
Outsourced general counsel Innovative
approach of the legal function
Corporate law
18
Creation of entities, in
Switzerland and other countries
Shareholders agreements
Legal book-keeping
Merger & acquisitions
Leases
Distribution agreements
Consulting agreements
Intra-group agreements
Licenses
Contract law
Outsourced general counsel specific
services
Outsourced general counsel Innovative
approach of the legal function
Employment law Marketing
19
Employment agreements
Agreements with
headhunters
Disciplinary law
Prevention of permanent
establishment risk
Review of marketing
documentation
Compliance with medicines
regulations
Compliance with
advertising regulations
Prevention of inappropriate advertising or branding risks
Outsourced general counsel specific
services
Outsourced general counsel Innovative
approach of the legal function
Regulatory
20
Relationship with physicians
Relationship with patient
associations
Legal support for clinical trials
Implementqtion of the EFPIA regulations
Grants and sponsorships
Identification of the collectible
data
Declaration and authorisation procedures
Data transfer EU-CH/ROW
Safe Harbor
Implementation of the new EU
regulation
Outsourced general counsel specific
services
Data privacy
Outsourced general counsel Innovative
approach of the legal function
Market access/reimburs
ements
21
Assistance of the company in its
relationship with MoH and medicine
agencies
Assistance of the company in its
relationship with Welfare states and
insurance companies
Negotiations with insurance
companies
Identification of local partners
Prevention of
conflicts
Termination of
agreements
Termination of
employees
Relationship with damage
insurances
Interface with external
law firms
Arbitrations, settlements
and ADR
Pre-litigation and dispute
resolutions
Outsourced general counsel specific
services
Outsourced general counsel Innovative
approach of the legal function
Full panel of services
Providing legal advice and outsourced general counsel services, Labeolegal brings its clients with strategic support in:
• Legal support for EU and Swiss pharmaceutical regulatory procedures;
• Legal support for implantation in Switzerland and in the EU;• Company officer;• Data privacy officer;• Drawing up of contracts and legal documents;• IP coordination;• EMEA coordination.
22Dedicated services for life
sciences companiesOutsourced general counsel Innovative
approach of the legal function
Labeolegal is led by Olivier Guillotin
• Olivier Guillotin is a lawyer, holding the French advocate proficiency certificate, alumnus from and former teacher at the Paris Institute of Political Studies (Sciences Po).
• He has practised during the last fifteen years as an
advocate and as a legal counsel. As a legal counsel, he has successfully created and managed for seven years the European legal department of a start-up, converted shortly into a major biotech company. He has been a key player of its growth, monitoring the legal aspects of its development in almost thirty countries in Europe, Russia, Turkey and Middle East.
• He has built on this fruitful experience to develop a broad international approach, an in-depth knowledge of the European and various national regulations applying to the life sciences industry, and a strategic vision of the legal function within the global activity of a company.
• Olivier Guillotin works in French, English and Spanish. Olivier Guillotin –
Experienced as a lawyer and as an in-house counsel
23Outsourced general counsel Innovative
approach of the legal function
LABEOLEGAL – LIFE SCIENCES EXPERIENCE – LEGAL EXPERTISE
LIFE SCIENCES
INDUSTRIES NEED
TAILORED SERVICES
LIFE SCIENCES
INDUSTRIES NEED
INFORMED ADVISORS
THE OUTSOURCED
GENERAL COUNSEL
SERVICE IS MADE FOR THE
COMPANIES WHO NEED ON-GOING LEGAL SUPPORT
LABEOLEGAL SUPPLIES YOU
WITH AN OUTSOURCED
GENERAL COUNSEL WHO
IS EXPERIENCED IN THE LIFE SCIENCES INDUSTRYDedicated services for life
sciences companies 24Outsourced general counsel Innovative
approach of the legal function
CONTACTS
Avenue du Léman 19, 1005 Lausanne, Switzerland
Tel: + 41 (0) 21 558 58 70Mob: + 41 (0) 79 102 22 20
Skype: labeolegal-og
www.labeolegal.ch
LIFE SCIENCES EXPERIENCE LEGAL EXPERTISE