Patients who still need a medicine after taking part in a clinical trial must continue receiving it free from the trial’s sponsor, under rules published today.
The protection applies when the investigator considers continued treatment indispensable and no alternative offers comparable safety and effectiveness.
The ministerial order, signed by Secretary of State for Health Ana Povo, sets out how an obligation established in March’s clinical trials law will operate.
Normally, sponsors remain responsible until the medicine is commercially available and accessible through Portugal’s national health service, the SNS.
Their obligation can end once public funding is approved. It can also end if the regulator’s decision deadline expires, provided an exceptional access authorisation covering the patient has been granted.
But if public funding is refused — or the sponsor never applies — the sponsor must continue supplying the treatment free while the clinical conditions remain met.
The ministerial order also states that the costs arising from this free supply may not be charged to any public funding contract that may be concluded.
In effect, this is a move to protect patients from losing access to essential treatment once their participation in a drug trial ends, while preventing pharmaceutical companies from passing the costs of their free-supply obligations onto the State.
Source material: Lusa
Natasha Donn
Journalist for the Portugal Resident.