Patients are free to participate in clinical trials performed outside of Germany. No German specific requirements in the other country for such cases.
There is no specific legislation for this case. The German Arzneimittelgesetz (relevant legislation in Germany) does not say anything on this topic. In fact, generation of data by a German treating physician for a site in another country does not make this treating physician a German site according to German legislation because this situation is not articulated in the German legislation.
There are no health insurance rules in Germany to cover costs of trial participation abroad, also due to the fact that there are over 50 health insurance companies that have no agreement on this topic. In practice health insurances in Germany mostly cover costs of their patients in emergency cases or if the costs are planned healthcare expenses agreed beforehand. Coverage of clinical trial costs has to be agreed on an individual basis beforehand with the individual health insurance company.
There are no rules covering this, however follow-on costs that are standard of care will be covered by the patients’ health insurance in Germany. Coverage of any other costs should be clarified with the health insurance company.
There are no specific legal requirements. Investigators are only checking if the patient can read / understand German or at least understand English. He checks if the patient can provide informed consent and whether the patient really understands what the study involves - including the risks and the obligations for the visits and the need for study documentation. Investigators can consult with their responsible Ethics committee. The investigator has to ensure that the costs for standard of care used in the trial (and not part of the study medication) will be covered either by the patient themselves or by the patients insurance.
There is no law explicitly forbidding patients from another country to join a trial in in Germany therefore in principle it is possible as long as ethical and regulatory standards are fulfilled.
There are German Ethics Committee requirements.
It is possible to enroll a patient from another country at a site in Germany as long as the site can guarantee that the patient understands the information on the trial and has a translator or a family member (who speaks both languages) to accompany them to the site visits. The Ethics Committee wants to be notified about these patients but are not required to give official approval.
Ethics Committee should be informed and approve if international patients are planned to be included in trial.
Different patient languages need to be considered (translator might be required during patient visits). This is not explicitly stated. According to the AKEK (Working Group of Ethics Committees) recommendation the sponsor is responsible for ensuring that communication throughout the study is ensured (see text below).
ICFs and other patient-facing materials (depending on the involved EC) might need translation to the patients mother tongue depending on the patients language skills. This is now also clarified by this AKEK guidance:
Recommendation from EC working group (AKEK):
Wording in guidance document (official version):
English translation (unofficial translation):
If different languages (not German) are being used to inform patients the respective documentation needs to be submitted to EC (required documentation depended on involved EC, from Certificates of translation up to submission of all translated documents incl. translation of insurance documents).
This is now also clarified by the AKEK recommendation and not different for different ECs anymore: PIS/ICF and all patient-relevant documents need to be translated and the translation submitted to the EC relevant for the respective trial (thus NOT the local EC for trials under CTR and MDR).
Travel insurance should cover international travel in such cases. Availability of a travel insurance is mandatory in Germany for all participants on request of the ethics committee. Such travel insurance usually does not specifically speak about travel from another country and ethics committees are not looking for that information (yet).
Travel arrangements are usually organized by a 3rd party vendor (to ensure data protection) as a commercial sponsor usually covers travel costs. This is not an ethics committee requirement but more daily practice. In academic trials this is organized by the site staff.
Respective documentation should be submitted to EC (documentation required depended on involved EC, from Certificates of translation up to submission of all translated documents incl. translation of insurance documents).
Costs must be covered by the health insurance of the patient or privately by the patient.
Patients not included in the German healthcare system through the mandatory healthcare insurance may be required to provide a deposit payment upfront at the site.