Intended for healthcare professionals

Editor's Choice

Why aren’t medical devices regulated like drugs?

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5032 (Published 29 November 2018) Cite this as: BMJ 2018;363:k5032

Letter to the Editor. Re: Why aren’t medical devices regulated like drugs?

The principle of non maleficence is at the origin of clinical medicine since Hippocrates: first do no harm (primum non nocere). This principle was revisited with the concept of quaternary prevention(1) a core value of the Wonca, the World Organization of Family Doctors. This principle can be extended to all Health Care Professionals (HCPs). There is also a socio-political dimension of this principle(2) : for this reason HCPs are engaged together with Patients’ Associations to improve European regulations on Health Technologies at the level of European Commission Health Technology Assessment Network(3) and at the European Network for Health Technology Assessment (EUnetHTA(4)). We welcome your editorial and hope it will contribute to improved safety and transparency. In a public health approach, safety necessitates better evidence before the introduction of a device into the market, better follow-up of side effects in a centralised manner, in relation to drug-device combinations, or companion diagnostics, and device entry procedures that would encompass involvement of the European Medicines Agency (EMA). We consider that transparency is important for informed decision making for both patients and doctors. For this reason, diminishing transparency to protect commercial secrets and to avoid scaring the public is an untenable argument.

For the EC - HTA network stakeholder pool :
Health care professionals - HCP :
European Union of General Practitioners, Family Physicians, UEMO, Daniel Widmer
European Public Health association, EUPHA, Carlo Favaretti
European Forum for Primary Care, EFPC, Elena Petelos
European Hospital and Healthcare Federation, Hope, Pascal Garel
European Society of Cardiology, ESC, Piotr Szymanski
European Association of Hospital Pharmacists, EAHP, Petr Horàk
Standing Committee of European Doctors, CPME, Frank Ulrich Montgomery
European Society for Medical Oncology, ESMO, Josep Tabernero
Patients/Consumers :
European Patients Forum, EPF, Katie Gallagher
European Cancer Patient Coalition, ECPC, Kathi Apostolidis
Rare Diseases Europe, EURORDIS, François Houÿez

References.

1 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept: Quaternary prevention aims to protect patients from medical harm. European Journal of General Practice. 2018 Jan;24(1):106–11.

2 Jamoulle M, Roland M, Bae J-M, Heleno B, Visentin G, Gusso GDF, et al. Ethical, pedagogical, socio-political and anthropological implications of quaternary prevention. Revista Brasileira de Medicina de Família e Comunidade. 2018 Oct 10;13(40):1–14.
3 EC - HTA network stakeholder pool. List of participants. https://ec.europa.eu/health/sites/health/files/technology_assessment/doc...
4 EUnetHTA. https://www.eunethta.eu

Competing interests: All associations mentioned are members of the European Commission Health Technologies Assessment Network Stakeholder pool.

07 March 2019
Daniel C. Widmer
General Practitioner, Vice-President UEMO
Carlo Favaretti (EUPHA), Elena Petelos (EFPC), Pascal Garel (Hope), Piotr Szymanski (ESC), Petr Horàk (EAHP), Frank Ulrich Montgomery (CPME), Josep Tabernero (ESMO), Katie Gallagher (EPF), Kathi Apostolidis (ECPC), François Houÿez (EURORDIS)
European Union of General Practitioners/Family Physicians, UEMO
UEMO, European Union of General Practitioners/Family Physicians, Head Office, rue des Deux-Eglises 37-39, 1000 Brussels - Belgium