Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy. In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the so-called 648 List after the product has obtained a marketing authorization, at least until the company starts to commercialize it in Italy. The latter normally presupposes that the product is classified as subject to reimbursement.
Access to Medicines Not Authorized in Italy
There are de facto two regimes allowing patients to access investigational medicines (i.e., medicines that are not yet authorized in Italy). The first, applied in most cases, is the compassionate use regime. The second, used in more exceptional cases, is the so-called 648 regime. The two regimes may not be applied simultaneously.
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