5. EU Expanded access (programmes) (Clinical trials)

The recommendation of the EMA is for EU countries to include within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment:

“Sometimes patients can enter ‘expanded access programmes’. A company that makes a promising medicine may choose to run one of these programmes to allow early access to their medicine and to widen its use to patients who can benefit from it. For example, patients who have been treated with the medicine during a clinical trial and wish to continue treatment may be able to do so via an expanded access programme. These programmes are often authorised by national authorities in the same way as clinical trials, and patients are followed in the same way as patients in a clinical trial”.

When the company wants to implement extended access with the primary motive of providing continued access and not data collection, EAPs offer an efficient and a cost-effective option.