Policy implications and ethical considerations 219 IV ♠ Harmonization of expanded access pathways We first will focus specifically on expanded access in the Netherlands, where two expanded access pathways exist already, as one can read in the Prelude.8 Recently, a third non-legislated pathway was proposed and implemented. This pathway is named the ‘DRUG Access Protocol’ – which intends to unify data collection primarily for authorized, yet not reimbursed oncology medicine.9 Although this is in various ways an innovative pathway, it further complicates the access routes in the Netherlands, which we discussed with the authors in the following article.
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