France

There is no legal requirement. 

There is no legal requirement. 

There are legal requirements:

1° or 2° of Article L.1121-1 of the Public Health Code.

• EU patients: must be insured under a scheme of a Member State covered by the above regulations (otherwise they cannot benefit from the services provided by French health insurance and cannot therefore take part in such research). The social security organisation will cover the costs incurred during the research (form E112).
• EEA-Swiss: Patients must be covered by a scheme from another EU-EEA-Swiss member state falling within the scope of regulations (EEC) no. 1408 /71 and 574/72 for coordination of social security systems.
• Non-EU participants: Non-EU residents can participate in trials in France if they are: 

• entitled to the benefit of a bilateral social security agreement concluded between his country and France providing for the payment of benefits in kind from the French health insurance (and the trial operates according to this agreement), and 
• are insured under a scheme of another Member State of the EU-EEA-Switzerland. 

According to Article L. 1124-1 IV of the French health public code "These clinical trial according to 2.2 of the CTR) are prohibited on a person who is not affiliated to a social security system or who is a beneficiary of such a system" (ie this reference to a social security system not only refers to a French social security system).

The ECs require that:

• All social security schemes are valid: general scheme, agricultural scheme, self-employed scheme, various special schemes, as well as universal medical coverage (CMU), state medical aid (AME), and recognized foreign schemes In France.
• Affiliation to a social security scheme or the benefit of such a scheme must be explicitly included in the inclusion/non-inclusion criteria of any biomedical research protocol.
• This is documented in the patient information sheet and consent form; it is the attestation of the person taking part in the research which demonstrates the investigator's compliance with this legal provision.

Anecdotally, a contract was signed with a liability insurance company that also covered clinical trial-related damage that occurred to patients from abroad who are not covered by the national health care system in the country where the site was located.

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

As only patients with health insurance scheme from their own country accepted by France are allowed to join a clinical trial in France, it is the decision of the patients’ home country insurance scheme whether additional costs are covered or not.

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.