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T H E P R I M E R U S P A R A D I G M | C e l e b r a t i n g 2 5 y e a r s w i t h t h e w o r l d ' s f i n e s t l a w f i r m s
New Rules for Europe's Medical
Technology Companies in their Interaction
with Healthcare Professionals
In December 2015, MedTech Europe,
1
the principal association in Europe
representing the medical devices industry,
adopted a new Code of Ethical Business
Practice (the "Revised MedTech Code"),
with the objective of regulating all
aspects of the interaction between the
medical device industry and healthcare
professionals, in order to reinforce ethical
standards.
MedTech Europe calculates that it
represents over 25,000 European medical
technology companies. MedTech Europe's
guidelines and rules are followed by
members and non-members alike.
The Revised MedTech Code is meant
to set minimum standards across the
MedTech Europe geographic area, but
not to supersede any national laws or
regulations or any professional association
or company codes of ethics that provide
for more strict requirements.
2
Principal Changes Brought
About by the Revised MedTech
Code
As of January 1, 2017, more stringent
rules apply to the relationship between
medical technology companies and
healthcare professionals. These rules
include:
·
the phasing out of direct sponsorship
of healthcare professionals throughout
2017;
·
more strict requirements for the
giving of educational grants: they
must be publicly disclosed, can only
be provided to a legal entity (which
will then select the individuals
receiving them), and must be the
result of a grant request followed by
an independent and objective process
within the company giving the grant;
·
more stringent ethical standards to
all aspects of medical conferences:
strictly scientific/medical program,
appropriate location and venue, no
entertainment, reasonable hospitality,
and no spouses or guests; and
·
a conference vetting system that will
review the compliance of third-party
educational conferences with the
Revised MedTech Code, and will
decide whether it is appropriate for
members to financially support these
events through educational grants,
promotional activity or satellite
symposia.
Starting on January 1, 2018, medical
technology companies will no longer
be able to directly invite healthcare
professionals and pay for their expenses
for attending third-party organized
medical conferences as attendees or
listeners.
A third-party organized medical
conference must be interpreted broadly
to include any educational, scientific or
medical conference organized by national,
regional or specialty associations,
societies, hospitals, professional
conference organizers, patient
organizations or accredited medical
education providers.
Support to healthcare professionals
directly from medical technology
companies will continue to be permitted
only if healthcare professionals are
(1) hired to speak at satellite symposiums
under consultancy agreements, or
(2) invited to attend third-party organized
procedure training.
Medical technology companies
will only be able to sponsor healthcare
professionals attending medical
conferences as mere attendees or
listeners through a more strict system
of educational grants paid to hospitals,
scientific societies and other healthcare
organizations, who will then choose which
healthcare professionals can benefit from
such grants and attend conferences.
Europe, Middle East & Africa ­ Spain
Mercedes Tort specializes in commercial,
contractual, corporate law and mergers and
acquisitions. She represents Spanish and
international clients doing business in Spain and
abroad. Clients include companies in the medical,
real estate and consumer goods areas. She has
worked in Spain, the United States and Chile.
1961 Abogados y Economistas
Mestre Nicolau 19
2ª planta
Barcelona, Spain 08021
+34 93 366 39 90 Phone
mtort@1961bcn.com
1961bcn.com
Mercedes Tort