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KCE Reports 133 Special Solidarity Fund 79
7.3.2.3 Foreign drugs
The new regulation facilitates the access to drugs that are not authorized (yet) in Spain
and that are commercialized in other foreign countries in cases where the use of these
drugs is essential for the medical treatment of a patient with a serious disease. This
creates the possibility of authorizing the import as well as prescribing and administrating
them in Spain, whenever the drugs are legally authorized in other countries. Such
authorization is given when using these drugs is essential for the prevention, the
diagnosis or the treatment of concrete pathologies and where there does not exist a
suitable alternative for the treatment of the patient that has been authorized for use in
Spain. Again the procedure foresees as well an individual authorization for one patient
as well as a non individualized authorization for a specific (homogeneous) group of
patients. The AEMPS can issue protocols in which the use of the drug is conditioned.
7.3.3 Overall situation for drugs and medical devices used in the specialized
care
As explained previously for drugs that are used at specialized care level (used in NHS
hospital care and prescribed by a medical specialist) there is no cost for the patient.
Costs of drugs in hospitals are financed in the hospital budget. The hospital budgets
resort under the competence of the Autonomous Communities and determined by the
Regional Health Services.
If the use of the drug is authorized by the AEMPS, the drug can be used at hospital level.
This counts for all medication authorized by the AEMPS, as well as medication that is
part of the ‘cartera de servicios’ as for drugs authorized in special situations and orphan
drugs. One could conclude that this would mean all authorized medication is covered
by the NHS.
One big restriction on the availability and the use of drugs that are not integrated in the
‘cartera de servicios’ of the NHS or the Regional Health Service is that the hospital will
decide on provision of the drug within the hospital. Since these drugs have to be
covered by the hospitals budget, the hospitals decide on the use of them. In practice
hospitals have a Pharmacy and Therapeutics Committee (on drugs) (Comisión de
farmacia y terapéutica) as well as on medical devices (Comisión de evaluación de
técnicas sanitarias). These committees decide on the use and the conditions for using
the drugs and the medical techniques and devices. In some autonomous communities
such committees are organized at regional level, preventing differences within the
different hospitals of the region. Such for example is the case for the region of
Andalusia.
This situation leads to differences in drug provision between the regions (and in some
regions between hospitals of the same region) and does not match with equity. The fact
the management of the hospital has a great impact, on availability of drugs for serious
diseases, is the reason why the Spanish Organisation of Rare Diseases asked to change
the actual regulation eliminating the decision at hospital level and enhancing the position
of the prescribing medical specialist. 43