Portugal

There is no legal requirement or any formal recommendation.

There is no health authority requirement.

As per PT-CRIN information any Portuguese citizen can participate in cross border trials without any prior permission, upon his/her own decision and taking full responsibility of any costs.

There is no Portuguese ethics committee requirement for Portuguese patients who want to participate in a clinical trial abroad to be considered. Patients can decide on their own.

Any Portuguese citizen can participate in cross border trials without any prior permission, upon his/her own decision and taking full responsibility of any costs.

Coverage of trial costs that occur when the patient is back home

Any health problems occurring in Portugal after a clinical trial in another country will be treated under the Portuguese national health system.

There is no legal requirement.

There is no specific health authority requirement. Any EU-citizen or any citizen from another country can participate in trials taking place in Portugal without any authorization.

However, it would be very difficult for an investigator in Portugal to enroll a patient living in another country in a clinical trial, especially in a hospital from the National Health Service.

There are expectations from the Central Ethics Committee (CEIC):

• The CEIC must be informed that patients from another country may participate in the planned clinical trial
• Patient-facing materials should be available in the language the patient is fluent in
• The patient information sheet should mention that the participants who have personal insurance should check if participating in clinical trials will imply any changes in the insurance policy conditions, regardless of whether the trial is taking place in Portugal or in any other country

Coverage of trial costs abroad that are not covered by the Trial’s Sponsor

If there is a healthcare need, this will be provided by the national healthcare system. However, costs such as travel and accommodation will not be covered and have to be paid by the patient or trial sponsor.

Coverage of trial costs that occur when the patient is back home

Any health problems occurring in Portugal after a clinical trial in another country will be treated under the Portuguese national health system.

The eHealth Digital Service Infrastructure (eHDSI) is an infrastructure ensuring the continuity of care for European citizens while they are travelling abroad in the EU. This gives EU countries the possibility to exchange health data in a secure, efficient and interoperable way.