The CNER in Luxembourg operates according to the rules established by the ICH, the Grand-ducal Regulation of 30 May 2005, the law on hospitals of 18 March 2018 and in compliance with the Declaration of Helsinki. The CNER was founded on 17 July 2000 by ministerial decree.
The CNER, as a national body, gives a single opinion for Luxembourg.
The CNER therefore operates within the following international and national regulatory frameworks:
1. General legal framework:
A) 4th APRIL 1997 "OVIEDO" CONVENTION (Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine)
This international European convention was signed on 4 April 1997 in Oviedo (Spain) and entered into force on 1 December 1999.
In the biomedical field, it is the only binding international legal instrument for the protection of human rights. It sets out the fundamental ethical principles for biomedical research.
See in particular the additional protocol concerning biomedical research
The Declaration of Helsinki is a set of ethical principles concerning human experimentation, originally developed in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the international benchmark for the ethics of human research.
In Luxembourg, this Directive is transposed into national law by the Grand-ducal Regulation of 30 May 2005 on the application of good clinical practice in the conduct of clinical trials on medicinal products for human use. It is repealed by the "Clinical Trials" Regulation EU 536/2014.
D) "CLINICAL TRIALS" REGULATION (EU) No 536/2014
It repeals the "Clinical Trials" Directive of 2001. From the entry into force of this European regulation, the CTIS (Clinical Trials Information System) portal set up by the European Medicines Agency (EMA) becomes the single portal for the submission of interventional clinical trials with investigational medicinal products.
E) "MEDICAL DEVICE" REGULATION (EU) No 2017/745
This Regulation on medical devices amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC. A single submission portal for clinical trials with medical devices is provided for in this Regulation.
F) RULES ON GOOD CLINICAL PRACTICE ESTABLISHED BY THE ICH
The National Research Ethics Committee is organised and works according to the rules established by the ICH concerning good clinical practice.
See in particular the following guideline: Guideline for good clinical practice E6(R2).
G) COMMISSION DIRECTIVE 2005/28/EC OF 8 April 2005
laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
H) GENERAL DATA PROTECTION REGULATION (EU) 2016/679
2. Luxembourg legal framework:
A) 8th MARCH 2018 LAW ON HOSPITALS (Loi du 8 mars 2018 relative aux établissements hospitaliers et à la planification hospitalière)
See in particular Article 27 relative to health-related research:
- Article 27 : "Aucun essai, étude ou expérimentation clinique ne peut être pratiqué sur l'être humain en vue du développement des connaissances biologiques ou médicales sans autorisation préalable du ministre, les avis de la Direction de la Santé et du Comité national d'éthique de recherche ayant été demandés au préalable."
B) GRAND-DUCAL REGULATION OF 26 JUNE 2019 ON THE ORGANISATION AND FUNCTIONING OF THE NATIONAL RESEARCH ETHICS COMMITTEE (Règlement grand-ducal du 26 juin 2019 relatif à l'organisation et au fonctionnement du Comité national d'éthique de recherche)
C) GRAND-DUCAL REGULATION OF 30 MAY 2005 ON THE APPLICATION OF GOOD CLINICAL PRACTICE IN THE CONDUCT OF CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE (Règlement grand-ducal du 30 mai 2005 relatif à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain)
D) GRAND-DUCAL REGULATION OF 10 JANUARY 2007 AMENDING FOR THE PURPOSE OF TRANSPOSING DIRECTIVE 2005/28/EC OF 8 APRIL 2005 LAYING DOWN PRINCIPLES AND DETAILED GUIDELINES FOR GOOD CLINICAL PRACTICE AS REGARDS INVESTIGATIONAL MEDICINAL PRODUCTS FOR HUMAN USE, AS WELL AS THE REQUIREMENTS FOR AUTHORISATION OF THE MANUFACTURE OR IMPORTATION OF SUCH PRODUCTS (Règlement grand-ducal du 10 janvier 2007 modifiant aux fins de transposition de la directive 2005/28/CE du 8 avril 2005 fixant des principes et des lignes directrices détaillées relatifs à l’application de bonnes pratiques cliniques en ce qui concerne les médicaments expérimentaux à usage humain, ainsi que les exigences pour l’octroi de l’autorisation de fabriquer ou d’importer ces médicaments)
E) 13th March 2013 MEDICAL DEONTOLOGY
See in particular Chapter V on human experimentation and its articles 69, 70, 71 and 72.
- Article 72 : "Le protocole de tout essai hospitalier et extrahospitalier doit avoir été dûment autorisé. L'essai ne peut commencer qu'après délivrance d'un avis favorable du comité d'éthique de recherche et après approbation explicite ou implicite du ministre, conformément aux dispositions légales et réglementaires applicables en la matière."
F) LAW OF 1 AUGUST 2018 ON THE ORGANISATION OF THE NATIONAL COMMISSION FOR DATA PROTECTION AND IMPLEMENTATION OF REGULATION (EU) 2016/679 (Loi du 1er août 2018 portant organisation de la Commission nationale pour la protection des données et mise en oeuvre du règlement (UE) 2016/679)
- see Articles 63 to 65 in particular