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200 Special Solidarity Fund KCE Reports 133
9.16.2.5 Medication
For medication (drugs and other sanitarian products) a specific portfolio of products has
been foreseen for the NHS. (Cartera de servicios comunes de prestación farmacéutica)
It contains the pharmaceutical drugs and other products and sets the conditions on
which patients receive them appropriated to their clinical needs, in measured doses
according to their individual requirements, during the appropriate time and at the
lowest possible cost to themselves and the community. The provision of drugs and
products is regulated by the Law 29/2006 of 26 July, on guarantees and rational use of
medicines and medical devices and other applicable provisions. 51
The ‘cartera de servicios de prestación farmacéutica’ differentiates the medication for
patients that are treated in the specialized care (hospital care) and those that are not
(primary care).
For patients outside the hospital care, the ‘cartera’ comprehends the prescription and
the provision of drugs within the NHS. Products have to be authorized and registered
by the Agencia Española de Medicamentos y Productos Sanitarios or have to meet EU
regulation on autorisation and control of medical drugs for human use. These drugs and
care products are distributed through local pharmacies.
For the drugs delivered at hospital care level the ‘cartera de servicios communes de
atención especializada ’ contains the pharmaceutical products to be used and financed
by the NHS. Of course this portfolio (cartera) can also be expanded by the regional
health authorities. It sets the indications and the administration of medication parenteral
or enteral nutrition, cures, consumables and other health products. This ‘cartera’ also
contains the implants and medical devices used at hospital level.
9.16.2.6 Acceptance of drugs in the NHS system
The decisions to integrate new medication in the NHS (minimum to be guaranteed for
all citizens) are taken by the Ministry of Health in accordance with the orientations of
the ‘Consejo Interterritorial del Sistema Nacional de Salud’.
New drugs are to be approved and registered by the AEMPS (Agencia Española de
Medicamentos y Productos Sanitarios). Once they are, the Ministry of Health and
Consumer Affairs will decide by a reasoned decision, prior to placing the drug on the
market, to include or not the drug in the National Health System. In case of inclusion it
will also decide on the conditions of this inclusion. Price setting is done by a specific
committee, the ‘Comisión Interministerial de Precios de los Medicamentos’.
The AEMPS has different functions related to the drug policy. The AEMPS holds the
competences to:
• Grant marketing authorization for pharmaceuticals and other medicines
for human use manufactured industrially, as well as to review and make
appropriate adjustments in the existing market.
• Participate in the planning and evaluation of medicinal products for human
use that are accepted by the EU through the European Agency for the
Evaluation of Medicinal Products.
• Evaluate and authorize trials and products under clinical investigation.
• Authorize pharmaceutical drugs for human use.
• Plan, assess and develop the Spanish pharmaco vigilance system.
• Develop inspection activity and drug control state competition.
• Manage the Royal Spanish Pharmacopoeia.
• Instruct the procedures associated with drug-related offenses as
appropriate to the General State Administration.
• Take responsibility for narcotic drugs and psychotropic prescribed by
regulation.