Austria Further Member State to Combat Medicine Shortages
On 18 October 2019, Austria notified to the European Commission (the “Commission”) a series of proposed measures to tackle medicine shortages (see, attached notification). The notification, based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, should allow the Commission and other Member States to offer their view on the compatibility of the proposed measures with EU pharmaceutical law and with the rules governing the free movement of goods. Only a few days earlier, the Czech Republic took a similar step (see, Van Bael & Bellis Life Sciences Newsflash, 15 October 2019). Many more Member States have taken action in this area or are contemplating doing so.
Austria seeks to adopt the following measures to ensure the availability of prescription-only medicines:
- Obligation for the marketing authorisation holder to notify immediately any limitations on the distribution of a prescription proprietary medicinal product in Austria.
- Publication of notified proprietary medicinal products on the website of the Federal Office for Safety in Healthcare (Bundesamt für Sicherheit im Gesundheitswesen).
- Obligation of notification resting on the Federal Office for Safety in Healthcare if the marketing authorisation holder does not observe its notification obligation or if for other reasons the supply does not adequately cover patient needs.
- Introduction of possibility to ban exports to another EEA Member State.