Pharmacy preparation reimbursement

Medicines are made available as authorised medicines, pharmacy preparations, or investigational medicinal products. For many diseases active substances are available, and yet groups of neglected patients or special patient groups will not receive the medicines they need. If a patient needs a medicine, which is not on the national market, it may be imported from abroad or prepared in a pharmacy. The complicated rules, which are nationally determined, for reimbursement (in some Countries) and Iraig procedures render importation a laborious way to make medicines available for the patient To be reimbursed some Countries require that medicines are to be shown to be efficacious, appropriate and economic. 

Medicines are available for patients as authorised medicines or as pharmacy preparations (unlicensed medicines). Market logic ensures that only medicines with sufficient return on investment will be marketed. However, health care logic requires pharmacists to provide their patients with necessary medicines. There are regulations that cover medicines for clinical research, marketing authorisation and import, as well as traffic between European countries (parallel imports). If medicines are not available as authorised medicines, various options such as compassionate use or parallel trial programme can be considered. The authorisation of medicines for orphan diseases is promoted by the orphan dmg regulations. The system of reimbursement will be discussed briefly due to its special situation at the interface of both public health and social insurances. 

The costs of materials, duration of preparation, quality control, investment in premises, training, quality assurance et cetera determine the basic cost of pharmacy preparation. As with the reimbursement of licensed medicines there is a distinction between in-patient and out-patient supply. Pharmacy preparations used in hospitals could be considered to be part of the reimbursement for the therapy as a whole. Anyhow, the hospital pharmacist normally has to find his payment within the hospital organisation. In community pharmacy most pharmacy preparations are reimbursed by the health insurer, according to the Tax price with a surcharge according to the performance cost system. Reimbursement for... 

Unlicensed medicines are medicines, including pharmacy preparation, that don t have a Marketing Authorisation. Patients who suffer firom a disease, for which no licensed medicinal product is available, may exceptionally get unlicensed medicines from a manufacturer. This happens on the legal basis of a compassionate use program either on a named patient basis or to cohorts of patients. This regulation applies to patients with a chronically or seriously debilitating disease or whose disease is considered to be life threatening. Reimbursement has to be clarified firom case to case (see Sect. 3.3.2 Reimbursement). 

A medicine is available when imported from another cormtry, but will not be reimbursed in that situation. A pharmacy preparation may (temporarily) solve the problem. 

From those medicines prepared in one of a selection of European hospital pharmacies, half to three-quarters are available in the market in another EU country, North America or Australia [80]. Although the European legislation has been aimed at decreasing trade barriers since 2001, the purchase of medicines from other countries is an5 thing but simple. A patient is allowed to travel abroad and buy an authorised medicine for personal use and import it into Europe, however, a pharmacist can only import a medicinal product if he has a wholesale import authorisation. The complicated rules for reimbursement (in some Countries) and the amount of time the whole process takes, renders import a laborious way to make medicines available for the patient. 

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