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Presentation of 15 January 2014 at Eucomed Compliance Committee Meeting in Brussels
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COMPLIANCE NETWORKDUTCH UPDATE
MedTech Europe15 January 2014
Erik Vollebregtwww.axonlawyers.com
What’s going on in NL?
• GMH developments – mutuality• Dutch lobby for HCP interaction provisions in MDR and IVDR proposal• Enforcement developments• Transparency / Sunshine
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
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
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 1-1-
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”
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
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
www.axonlawyers.com
THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E [email protected] @meddevlegalB http://medicaldeviceslegal.com
READ MY BLOG:http://medicaldeviceslegal.com
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.