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What is an Early Access Program?

An Early Access Program (EAP) gives access to innovative therapies that are not available in the country of treatment.

EAPs are known by differing names depending on the regulatory jurisdiction. These include Expanded Access, Early Access, Compassionate Use and Named Patient Programs.

These solutions are all used when there’s significant unmet clinical need, when all other alternatives are exhausted, or when there’s no suitable treatment alternative.

Physicians want to do the best for their patients and often ask for access to innovative new therapies.

There are 2 main types of programs

Individual Patient Programs

Physicians take responsibility for treating an individual patient with a medicine unlicensed in the treatment country. In some regulatory jurisdictions, this may require permission from the competent authority and, if so, this is granted for the individual patient.

Group or Cohort Programs

A central protocol is approved by the relevant competent authority for a defined group of patients. This may be patients with a specific diagnosis, disease state, or patient profile.

Who initiates

Entry criteria set by


Restricted to protocol use

Physician re-imbursement

Can therapies be charged for


Individual or Named Patient Programs


Physician/ Regulator

(company may choose to supply only for certain pts)

In many countries Regulator may give permission

Physician/ Institution

In some countries

nATU – France

Single patient IND – USA

Group or Cohort Programs

Pharma/ Biotech or Group of Physicians

Pharma/ Biotech or Group of Physicians

Physician/ Pharma/ Biotech

cATU – France EAMS – UK Treatment IND – USA

For a country-by-country analysis of which program is right for you, please get in contact.

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