The applicant's subsidy application (appropriate data sheet with supplements) is passed to the Pharmaceutical Division of the National Health Insurance Fund within the framework laid down by law. The law differentiates between two types of procedure.

Primary state administration procedure >>

Simplified procedure:

Registered pharmaceutical agent included earlier which has
    new packaging
    new potency
    identical route of administration of new form of drug
    new combination
    new generic
    second brand
Inclusion of new nutrition or registered Galen's drug compound

Regular procedure

new route of administration of new form of drug
new indication
new agent
new combination
price increase

In that case when the Pharmaceutical Division classifies the application in the simplified procedure, after a short process of preliminary opinion it is taken before the Health Technology Assessment Committee. Decision is made by the director of the National Health Insurance Fund's Pharmaceutical Division based on the Health Technology Assessment Committee's recommendation.

In that case when the application is classified in the regular procedure, then the National Health Insurance Fund's Transparency Division transfers the complete documentation to the Technology Assessment Office of the National Institute for Strategic Health Research for a critical technology assessment. The task of the National Institute for Strategic Health Research is the critical evaluation of the documentation found in international literature and in the application with reference to both clinical and economic parameters, with special regard to health economic analyses.

Debates on the applications - taking account of the assessment of the National Institute for Strategic Health Research, the preliminary opinion of the Pharmaceutical Division and the opinion of medical professional colleges - take place also before the Health Technology Assessment Committee

After the decisions of the committee all final recommendations are made in the National Health Insurance Fund's Pharmaceutical Division that are then disseminated in the form of legislation by the minister of health in agreement with the minister of finance.

Following the decision of the first instance, decision is made in a legal redress by the chairman of Health Insurance Supervisory Authority.

Basic principles of inclusion and financing of pharmaceuticals

professional foundation (evidence-based decision-making),
consideration of budget frameworks (consideration of the operative budget frameworks of the Health Insurance Fund),
transparency (89/105/EEC transparency directive),
predictability (traceable scheduling of decision-making ),
publicity (accessibility of data by stakeholders),
transparency of interest relations
enforcement of equity (equality of access),
needs-based approach (consideration of the clinical needs of specific patient groups),
cost-efficiency