Patient groups warn new criteria could further slow access to rare disease and orphan therapies already reaching Greece years after EU approval
The Greek parliament approved new legislation on 15 May extending the controversial “5/11” reimbursement criterion to medicines entering the country through the IFET emergency and early-access mechanism. The new law prompted warnings from patients and industry representatives over further delays in access to innovative therapies.
Under Article 12 of the health ministry’s Innovation Fund bill, medicines seeking access through the Electronic Pre-Approval System (ΣΗΠ), used primarily for therapies imported through the Institute of Pharmaceutical Research and Technology, will now generally need to be reimbursed in at least five (or four in some cases) out of 11 reference countries.
The legislation also changes the composition of those reference countries, replacing Germany, Austria and Italy with Poland, Slovenia and the Czech Republic. According to the government, the aim is to align the basket more closely with those of countries whose GDPs are closer to Greece’s.
“This regulation introduces an especially strict access filter,” Vaso Vakouftsi, president of the Hellenic Society of People with Crohn’s Disease and Ulcerative Colitis, told Euractiv.
