Belgium

Country Analysis

1.
Are there specific legal requirements in Belgium for a patient living in Belgium who wants to participate in a clinical trial in another country?

I am not aware of (or I don't know)

2.
Are there specific legal requirements in Belgium if an investigator wants to enroll a foreign patient in a clinical trial?

I am not aware of (or I don't know)

3.
Are there national health authority requirements in Belgium for a patient living in Belgium who wants to participate in a clinical trial in another country?

I am not aware of (or I don't know)

4.
Are there specific national health authority requirements in Belgium if an investigator in Belgium wants to enroll a patient living in another country in a clinical trial?

No (it is not forbidden)

5.
Are there specific ethics committee requirements in Belgium for a patient living in Belgium who wants to participate in a clinical trial in another country?

N/A

6.
Are there specific ethics committee requirements in Belgium if an investigator in Belgium wants to enroll a patient living in another country in a clinical trial?

N/A

7.
Are there national health insurance rules or experiences in Belgium concerning coverage of any additional costs for a patient living in Belgium when participating in a trial in another country?

No rules as such

But from experience: Patients enrolled into trial in another EU country had a lot of difficulty obtaining an S2 form, and even then only part of the medical costs were covered. Travel, lodging etc, were not covered

8.
Are there national health insurance rules or experiences in Belgium concerning coverage of follow-on healthcare costs occurring after a patient has returned from participating in a clinical trial in another country?

There is no structure/procedure to follow, and all sick funds determine on a case by case basis what they cover. Also, many countries/hospitals exclude patients from other countries

9.
Are there national rules or experiences in Belgium concerning additional costs (not covered by the trial sponsor) if an investigator wants to enroll a patient living in another country?

There is no structure/procedure to follow, and all sick funds determine on a case by case basis what they cover. Also, many countries/hospitals exclude patients from other countries

10.
Are there requirements for clinical trial liability insurance in Belgium to cover the costs of trial associated damages occurring in the participating patient's home country?

N/A

11.
Are there any additional liability insurance requirements to join an ongoing trial in Belgium from another country?

As an EC, we have a number of concerns, including (if applicable):

· The Load of Frequent Displacement

· Possibility of on-site clinical follow-up, and differences with care here

· Possible suction effect and problems afterwards with possible UC and possible reimbursement afterwards (possibly in Belgium and not in country of origin)

· Financial tax

· Practical organization here (To what extent should one take into account people who have to come from so far?)

· The sponsors knowledge of the identity of the trial participant in such a case

12.
From where do patients in Belgium get information on clinical trials taking place in another country?
13.
Did patients living in Belgium get enrolled in a clinical trial in another country?
14.
Did patients living in Belgium experience challenges with getting their trial medication when they returned to their country of residence?
15.
Did patients living in Belgium experience challenges with continuation of their medical care after returning to their country of residence?
16.
Did patients living in Belgium 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?
17.
Are there clinical investigators in Belgium that accept trial participation of patients from another country?
18.
Is there experience with transfer of medical information when a patient living in Belgium wants to join a clinical trial in another country?
19.
Are there clinical investigators in Belgium who have experience with enrolling patients from another country?
20.
Do treating physicians in Belgium inform patients about the option to participate in a clinical trial in another country?