2021 LS&HC Horizons - Flipbook - Page 61
Life Sciences and Health Care Horizons 2021
61
Launching first pharma product in Europe and early pitfalls
A pharmaceutical company planning to launch
its first product in the EU needs to plan ahead to
anticipate issues, such as applying for marketing
authorization, setting up its first subsidiary, supply
chain planning, and market access. In the EU,
orphan drug manufacturers often engage even
earlier in disease awareness activities and in finding
patients. Depending on the launch sequence in
the respective countries (e.g., often Germany is
the first launch market), besides EU laws, local
laws and industry rules must be respected – with
many of them presenting early pitfalls. Based on
recent issues we have observed with our clients, we
recommend that pharma companies planning their
first product launch in the EU:
• Ensure compliance with clinical trials and
related data privacy obligations.
• Avoid entering the realm of pre-market
promotion or direct-to-consumer advertising
due to the very narrow definition of disease
awareness in national laws.
and third party logistic (3PL) service
providers. This is particularly important
following Brexit. Check license requirements
such as manufacturing/ import authorization
(MIA), wholesale distribution license, and
local requirements (e.g., exploitant in France).
• Be careful of involvement in named patient
imports into the EU as these are regulated
locally and may be prohibited or restricted.
• Set up inter-company agreements and
demarcation of responsibilities, including
medical, regulatory and legal review of
communication, early pharmacovigilance,
early product quality reviews (PQRs), etc.
• Ensure compliant governance of local
subsidiaries, tax/finance agreements, and
mandatory local requirements under local
laws (e.g., minimum responsibilities of local
managers)
• Develop a basic compliance structure
and Standard Operating Procedures
(SOPs) regarding engagement with public
officials (like HCPs and market access
representatives) as well as third parties, such
as reimbursement advisors and
patient advocacy groups (PAGs). Look
out for contradictory local laws on fair market
value (FMV) rates, contracting, mandatory
transparency.
Jörg Schickert
Partner, Munich
joerg.schickert@hoganlovells.com
Arne Thiermann
Partner, Hamburg
arne.thiermann@hoganlovells.com
• Decide how best to comply with privacy
obligations related to interactions with HCPs
and PAG representatives.
• Prepare a legal review of your supply chain,
especially when significant outsourcing is
involved, including outsourcing to importers
Elisabethann Wright
Partner, Brussels
ea.wright@hoganlovells.com
Ranked Band 1
for Life Sciences – Europe-wide
Chambers Europe-wide, 2020
