compassionate use programme
Medicinal products that have not been registered may be
prescribed in highly exceptional cases.
There are two possibilities:
- The provision of a medicinal product on the basis of a
physician’s statement (named patient). ‘Named patient’ is
prescribed to an individual patient and falls under the
jurisdiction of the Health Care Inspectorate (see www.igz.nl for more
information);
- If the case involves a severe condition for which no
alternative medicinal product is marketed and the as-yet
unauthorised medicinal product will be registered (given a
marketing authorisation) in the near future, the medicinal product
manufacturer can submit a request to the MEB to come under
consideration for the ‘compassionate use programme’.
The compassionate use programme concerns a specific situation in
which the MEB considers the availability of new medicinal products
for multiple patients (cohort) to be necessary prior to the
awarding of the definitive marketing authorisation.
The legal context
The Regulation 726/2004/EC gives
the outline of the European framework, however as a result of
the transnational character of such programmes the assignment of
compassionate use programmes falls under national jurisdiction.
Thus the national competent authority should award permission
for the availability of the medicinal product without market
authorisation.
At the national level, the legal conditions have been included
in the Medicines Act and the MEB has the authority to approve a
compassionate use programme.