EU-X-CT - Borders Should no Longer be Barriers

Country Analysis

Are there specific legal requirements in France for a patient living in France who wants to participate in a clinical trial in another country?

Are there specific legal requirements in France if an investigator wants to enroll a foreign patient in a clinical trial?

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

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.

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).

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).

Are there national health authority requirements in France for a patient living in France who wants to participate in a clinical trial in another country?

No data.

Are there specific national health authority requirements in France if an investigator in France wants to enroll a patient living in another country in a clinical trial?

No data.

Are there specific ethics committee requirements in France for a patient living in France who wants to participate in a clinical trial in another country?

No data.

Are there specific ethics committee requirements in France if an investigator in France wants to enroll a patient living in another country in a clinical trial?

Yes. Link

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.

Are there national health insurance rules or experiences in France concerning coverage of any additional costs for a patient living in France when participating in a trial in another country?

See EC requirements, above.

Are there national health insurance rules or experiences in France concerning coverage of follow-on healthcare costs occurring after a patient has returned from participating in a clinical trial in another country?

See EC requirements, above.

Are there national rules or experiences in France concerning additional costs (not covered by the trial sponsor) if an investigator wants to enroll a patient living in another country?

No data.

10.

Are there requirements for clinical trial liability insurance in France to cover the costs of trial associated damages occurring in the participating patient's home country?

Limited data. 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.

11.

Are there any additional liability insurance requirements to join an ongoing trial in France from another country?

No data.

12.

From where do patients in France get information on clinical trials taking place in another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 179

13.

Did patients living in France get enrolled in a clinical trial in another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 183

14.

Did patients living in France experience challenges with getting their trial medication when they returned to their country of residence?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 187

15.

Did patients living in France experience challenges with continuation of their medical care after returning to their country of residence?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 191

16.

Did patients living in France experience challenges with coverage of their basic healthcare costs like hospital stay, baseline diagnostics or treatments, etc. when joining a clinical trial in another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 195

17.

Are there clinical investigators in France that accept trial participation of patients from another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 199

18.

Is there experience with transfer of medical information when a patient living in France wants to join a clinical trial in another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 203

19.

Are there clinical investigators in France who have experience with enrolling patients from another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 207

20.

Do treating physicians in France inform patients about the option to participate in a clinical trial in another country?

Deprecated: htmlspecialchars_decode(): Passing null to parameter 1 (string) of type string is deprecated in /data/sites/web/eu-x-cteu/www/bo/country-analysis.php on line 211