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

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THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E erik.vollebregt@axonlawyers.com @meddevlegalB http://medicaldeviceslegal.com

READ MY BLOG:http://medicaldeviceslegal.com

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