Table 3 Compassionate use programmes in the Netherlands, Turkey and the United States.

From: Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries

 

The Netherlands

Turkey

United States

Phase of clinical study

Post phase III

Post phase II

Post phase III

Number of patients

Group of patients

Group of patients

Group of patients (intermediate-size groups or widespread use)

Financing

Pharmaceutical companyIX

State

Pharmaceutical company, health insurer, patient

Uptake

29 programmes 2010–2020X

42 programmes 2006–2011XI

20–40 programmes per yearXII

Oversight

Medicines Evaluation Board (CBG)

Medicines and Medical Devices Agency (Ministry of Health)

Food and Drug Administration (FDA)

Evaluation by Ethics Review Committee

Not applicable

Not applicable

Necessary

  1. IXTheoretically, pharmaceutical companies are allowed to charge for compassionate use, but in practice this rarely happens and is not viewed as acceptable. Another possibility is hospitals or insurers paying for these drugs, which does not happen often, either. X(CBG, 2021), XI(Vural et al., 2012), XII(FDA, 2020).
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