Netherlands compliance update presented at the MedTech Europe Compliance Network meeting in Brussels on 13 January 2015

1. COMPLIANCE
NETWORK
DUTCH UPDATE
MedTech Europe
13 January 2015
Erik Vollebregt
www.axonlawyers.com

2. What’s going on in NL?
• GMH developments – mutuality now accomplished
• Enforcement developments
• Transparency / Sunshine
• Permanent fillers

3. HCP interaction enforcement by
CA IGZ
• While waiting for Brussel, NL wants to do something in terms of HCP
interaction enforcement
• Change in Act on Medical Devices under construction
• Analogous to provisions on hospitality in Medicinal Products Act,
supplemented by self regulatory standards
• Amendment was to be tabled in 2014 (didn’t happen); entry into force
expected by 1-1-2016
• Unclear if and how the enforcement competence will apply to
different product groups and risk classes – Minister says amendment
will be analogous to “medicinal products logic”
• In the mean time: update of GMH code

4. HCP interactions maximum
amounts
• New maximum hourly rates effective as of 1 January 2015

5. HCP maximum travel costs
Travel costs not more than national civil servants regulations:

6. Transparency / Sunshine – where?
• Minister wants public transparency of
HCP – industry relations
• To be implemented in self-regulation
like with medicinal products
• Entry into force as of 1 January
2015
• Infrastructure: Transparantieregister
Zorg
• Prohibition on contract clauses
that impede publication of HCP
interactions
• Standard clauses for
agreements re transparency
and

7. Transparency / Sunshine – what?
• Certain interactions to be reported as a pilot
• Consultantcy / sponsoring of projects / activities (> € 500 total value)
• Between physicians in the BIG register as cardiology or ortopedic
and manufacturer of certain implants
• ICDs
• pacemakers
• stents
• hip and knee replacements

8. Prohibition on permanent fillers
• Prohibition on permanent fillers as of 1 January 2015 for other
purposes than reconstructive

9. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
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