Source: European Parliament
Question for written answer E-001881/2025
to the Commission
Rule 144
Stefano Cavedagna (ECR), Ruggero Razza (ECR), Carlo Ciccioli (ECR), Michele Picaro (ECR)
On 30 August 2024, the European Commission removed the marketing authorisation for the drug Ocaliva (obeticholic acid), used to treat primary biliary cholangitis, a rare, chronic and progressive liver disease.
As a result of this decision, Advanz Pharma Specialty Medicine Italia voluntarily withdrew the drug from sale in Italy and it was taken off the list maintained under Law No 648/96 of drugs paid for by the national health service.
Ocaliva was the only approved second-line treatment for patients who do not respond to or cannot tolerate ursodeoxycholic acid treatment, and its withdrawal has left many patients without any viable treatment options.
Although the European Medicines Agency has suggested compassionate use or programmes for designated patients, access to such measures remains fragmented at European level, giving rise to inequalities in access to treatment.
Can the Commission therefore say:
- 1.Whether, in view of the provisions of EU law, it believes measures such as the purchase of Ocaliva from abroad should be taken to enable Italian patients to continue their treatment?
- 2.How it intends to ensure continuity of treatment for patients without any valid therapeutic alternatives, even given the emergence of new drugs?
Submitted: 12.5.2025