| Medicines in Europe Forum leaflets |
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| Why must there be a European regulatory framework
to guarantee "compassionate use" of medicines in terminally
ill patients? |
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| Leaflet
N°8 |
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| 09 September
2002 |
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Medicines in Europe Forum has proposed an amendment to the proposed
Regulation aiming to strengthen the framework of compassionate
use through incentive, constraints and recommendations that
will allow exceptional access to new medicines sufficiently
early and commensurate to the needs of those patients who are
terminally ill.
French
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 We
call "terminal illness" the situation where patients suffer
from serious illness for which there is no possibility of treatment.
This could mean that the medicines available to a seriously ill patient
are not effective, that the patient cannot follow a course of treatment
because of serious adverse effects or patients who have an illness,
for which no treatment is available.
For
these people whose life is threatened in the short term by a lack
of treatment, the only hope is to have access, as soon as possible,
to new medicines being developed or close to being authorised whenever
they are sufficiently promising. This is justification for resorting
to compassionate use.
The
early use of these medicines is not without risk: undesirable effects
are not completely known and their frequency is poorly evaluated.
But for terminally ill patients, more so than for others, it is the
balance between potential benefits and the risks of the treatment
that must be taken into account, not just the isolated risks.
In
France, the medical products agency has shown that compassionate use
of new anti HIV drugs, (delivered through Temporary Authorised Use
or ATU) has saved lives before being granted marketing authorisation.
But
the European regulatory framework on this subject is at the moment
insufficient: the compassionate use of some medicines to combat situations
of terminal illness is often restrictive and tardy. Let us take for
example the T-20, a medicine developed by the firm Roche representing
some hope for those terminally ill with AIDS. In spite of the great
need, Roche chose to allow compassionate use at a very late date and
then limited its use to only 450 patients throughout the world, when
thousands more still need the medicine as a matter of urgency. Those
patients unable to enter into the clinical trials are still waiting
for this medicine even though no medical reason has been given to
justify the restriction of access to T-20.
At
the moment, compassionate use programmes depend solely on the good
will of pharmaceutical companies. Health authorities have not taken
the necessary steps to get drug companies to facilitate access of
medicines that could be the answer to public health emergencies.
The
proposed mechanism for compassionate access, as described in Article
73 of the European Regulation, does not provide for constraint or
incentive towards the firms. Therefore it will not allow a better
response to the needs of the patients who do not have access to medicines,
until these firms find it to their own interest. |
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