message in brief from 17.02.2010

Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed draws attention to particularities in the use of unauthorised medicinal products, especially with unauthorised radiopharmaceuticals.

Radiopharmaceuticals are considered medicinal products/specialities and are therefore subject to the Medicines Act (AMG). Marking kits, generators and radioactive precursors used for the production of radiopharmaceuticals are also classified as medicinal products.

The Medicinal Products Act and the associated Medicinal Products Ordinance 2009 provide for certain exemption provisions that are intended to take account of the specifics of radiopharmaceuticals (e.g. their half-life). In nuclear medicine practice, however, certain requirements must be observed. In the production and distribution of such preparations, therefore, not only the requirements of pharmaceutical law but also those of the Radiation Protection Act must be taken into account.

In the following, the specifics of the pharmaceutical law aspects may be discussed.

Production / manufacturing

In principle, the production / manufacturing of radiopharmaceuticals can be carried out either in a company with a corresponding licence according to § 63 AMG, in a suitable (institutional) pharmacy or by nuclear medicine institutions or laboratories that manufacture radioactive medicinal products exclusively for the purpose of direct application to patients. So-called "magisterial preparations" on the prescription of the attending physician for a specific patient (colloquially also referred to as "clinic requirements") are by definition tied to manufacture exclusively in pharmacies.

Placing on the market

In principle, medicinal products that are dispensed in Austria require a marketing authorisation. Radiopharmaceuticals requiring a marketing authorisation, which are neither covered by a marketing authorisation nor by a so-called "notice of reduced quantities" according to § 7 Abs 8 AMG, can only be dispensed within the framework of the exemption provision of § 8 Abs 1 Z 2 AMG. This provision states that if a physician, dentist or veterinarian authorised to practise independently in Austria certifies that the proprietary medicinal product is urgently needed to avert a threat to life or serious damage to health and that this success cannot be expected to be achieved with an authorised and available proprietary medicinal product according to the state of scientific knowledge, the proprietary medicinal product prescribed does not require a marketing authorisation.

Dispensing

Section 57 of the AMG regulates the dispensing of medicinal products; in para 3 it is stated that these may only be dispensed by the manufacturer, distributor or wholesaler to holders of a licence for the handling of radioactive substances pursuant to the Radiation Protection Act. Use of unauthorised medicinal products The authorisation process for a medicinal product is time-consuming and costly. Especially in research-oriented areas such as oncology, medical knowledge often precedes drug approval.

When using medicinal products in the non-approved area, there is an increased obligation to inform patients as well as liability issues for the treating physicians.

Section 49 (1) of the Medical Act states that a doctor is obliged [...] to safeguard the well-being of the sick and the protection of the healthy in accordance with medical science and experience and in compliance with existing regulations and professional quality standards. If a physician uses a drug outside of the approved indication or uses an unapproved drug, the physician's liability insurance will also examine whether less risky alternatives would have been available in the event of a claim.

This raises the question of whether the doctor has negligently (and thus culpably) breached his duty of care. This is to be emphasized in particular if approved drugs would have been available in an indication. Since subsequently no intended use of the respective preparation used can be inferred, the producer/manufacturer may not be held liable.

Attention should also be paid to the related medical duty to inform (e.g. § 8 Abs 3 KAKuG ), because the legality of the treatment depends on the effective consent of the patient. Otherwise, a punishable unauthorised medical treatment within the meaning of Section 110 of the Criminal Code may exist.