Czech Republic Latest Member State to Tackle Medicine Shortages

• 15/10/2019
• Articles

At the beginning of October 2019, the Czech Republic 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 free movement of goods principle.
 
The Czech Republic contemplates adopting the following measures to ensure that reimbursed medicines remain available to patients: 

• the possibility to import medicines subject to shortages, even if the formal requirements for importing are not satisfied and as long as the quality and safety of the medicines are not compromised;
• new authorisation requirements for the export of predefined medicines whose export restrictions are justified;
• the establishment of an emergency medicine ordering system that benefits pharmacies; and
• the possibility to change temporarily the maximum price and the reimbursement basis of a medicine that is in short supply.

The move is part of a wider trend that sees Member States try and respond to medicine shortages.