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. 2016 Nov;5(4):244–254. doi: 10.5582/irdr.2016.01054

Table 3. Compassionate use programs in Western European countries (Ref. 12,31,39–46).

Items Austria Belgium Luxembourg Netherlands
Authority involved Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) Federal Agency for Medicines and Health Products (FAMHP) Direction de la Santé Villa Louvigny Division de la Pharmacie et des Medicaments Medicines Evaluation Board
Laws and regulations 8a Austrian Medicinal Products Act (AMG)

  • Belgian law 1 May 2006 Art.6 quater point 2 (modifications ofmodifications of the loi du 25 mars 1964 sur les médicaments)

  • Articles 106 and 107 in the Royal Decree executive measures of the Law 1 May 2006 (However, The Royal Decree of 25 April 2014 amending the Royal Decree of 14 December 2006 on medicinal products for human and veterinary use was published and is effective since July 2014)

 Regulations specifically for CUP are absent. Further information unavailable At national level, the legal requirements are implemented in the Medicines Act in Article 40 paragraph 3 (f) and the Ministerial Regulations Article 3.18
Overview CUP in Austria covers:

  • Medicinal products developed biotechnologically

  • Veterinary products

  • Unauthorized medicinal products for human use with a new active substance, for which the therapeutic indication is the treatment acquired immune deficiency syndrome, viral diseases, cancer, neurodegenerative disorder, diabetes, auto-immune diseases and other immune dysfunctions

  • Medicinal products designated as orphan medicinal products

 CUP permits use of medicinal products unauthorized in Belgium, to patients with a chronically or seriously debilitating or life threatening disease, and who cannot be treated satisfactorily by an authorized medicinal product.

  • No CUP

  • All medicinal products require a prior authorization “Autorisation de Mise sur le Marché” - article 22 (1) of the “Code de la sécurité sociale”. The only exception is the EMA authorization valid in all the member states

 If there is no registered alternative available and new drugs for multiple patients (cohort) is deemed necessary before a marketing authorization, a CUP is applicable. NPP also exists.