Wet tot wijziging van de wet van 25 maart 1964 op de geneesmiddelen wat de programma's voor gebruik in schrijnende gevallen en medische noodgevallen betreft, de 22 novembre 2020
Artikel 1. Deze wet regelt een aangelegenheid als bedoeld in artikel 74 van de Grondwet.
Art. 2. In art. 6quater, § 1, eerste lid, van de wet van 25 maart 1964 op de geneesmiddelen, hersteld bij de wet van 1 mei 2006 en laatstelijk gewijzigd bij de wet van 17 juli 2015, worden de volgende wijzigingen aangebracht:
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de bepaling onder 2° wordt vervangen als volgt:
"De Koning kan tevens regels vastleggen inzake het beschikbaar stellen van geneesmiddelen voor menselijk gebruik voor gebruik in schrijnende gevallen.
Onder "schrijnende gevallen" wordt verstaan het beschikbaar stellen, om redenen van medeleven, van een geneesmiddel dat tot een in artikel 3, leden 1 en 2, van Verordening (EG) Nr. 726/2004, genoemde categorie behoort en aan een groep patiënten die lijden aan een chronische ziekte, een ziekte die de gezondheid sterk ondermijnt of levensbedreigend wordt geacht en die niet op bevredi-gende wijze kan worden behandeld met een vergund geneesmiddel, dat in de handel is en terugbetaald wordt.
Voor het betrokken geneesmiddel moet overeenkomstig artikel 6 van dezelfde Verordening een aanvraag voor een vergunning voor het in de handel brengen zijn ingediend of moeten de klinische proeven nog gaande zijn.";
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de bepaling onder 3°, tweede lid, eerste volzin, wordt aangevuld met de woorden "en terugbetaald wordt".
Handtekening
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