Presentation of 15 January 2014 at Eucomed Compliance Committee Meeting in Brussels

1. COMPLIANCE
NETWORK
DUTCH UPDATE
MedTech Europe
15 January 2014
Erik Vollebregt
www.axonlawyers.com

2. What’s going on in NL?
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GMH developments – mutuality
Dutch lobby for HCP interaction provisions in MDR and IVDR proposal
Enforcement developments
Transparency / Sunshine

3. GMH – Mututality
• Problem of “HCP shouldn’t ask what industry is not allowed to offer”
• As of 1 January 2014 hospitals and doctors associations have agreed to
comply with GMH code
• NVZ & NFU
• KNMG and Orde van Medisch Specialisten
• Not all HCPs bound yet though
• Nurses (V&VN)
• Institution for long-term care (Actiz)
• Minister want to involve healthcare insurance funds as well because of
their role in the purchase of medical devices

4. Dutch lobby MDR and IVDR
• Dutch Minister of Health unhappy with enforcement tools re HCP
interaction
• IGZ (competent authority) should be able to enforce in addition to self
regulation
• Dillema: national or EU solution?
• Dutch have put it on the agenda for MDR and IVDR revision and will
keep pushing the point
• Late in the legislative process and so far difficult to see if there is any
traction – may however pop up post elections if MDR and IVDR do
not complete pre-elections

5. HCP interaction enforcement by
CA IGZ
• While waiting for Brussels, 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 to be tabled in 2014; entry into force expected by 1-12016
• 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”

6. Generally: CA enforcement up and
experimental
• Visible increase in CA enforcement in NL
• “new” sectors
• As of 1-1-2014 IGZ actively enforces in medical software field on
medical device law
• Joint Immediate Action Plan gone wild
• IGZ has adopted policy to enforce against authorised
representatives as if they are manufacturer for manufacturer
infringements
• IGZ has adopted policy to redo Ethical Committee approvals for
clinical investigations based on manufacturer’s notification duty

7. Transparency / Sunshine
• Minister wants public transparency of
HCP – industry relations
• To be implemented in self-regulation
like with medicinal products
• Entry into force 2015
• GMH body to present proposal
shortly
• Transparency to be limited only to
“interactions relevant to the patient”
• Example given by Minister
“gloves: no, pacemakers and
hip replacements: yes. Implants
should always be covered.
Scope of products flexible.”
• Infrastructure: Transparantieregister
Zorg

8. 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
READ MY BLOG:
http://medicaldeviceslegal.com
www.axonlawyers.com

9. Legal stuff
• The information in this presentation is provided for information purposes only.
• The information is not exhaustive. While every endeavor is made to ensure
that the information is correct at the time of publication, the legal position may
change as a result of matters including new legislative developments, new
case law, local implementation variations or other developments.
• The information does not take into account the specifics of any person's
position and may be wholly inappropriate for your particular circumstances.
• The information is not intended to be legal advice, cannot be relied on as
legal advice and should not be a substitute for legal advice.