On 26 May the EU Commission disclosed it called on Portugal & Slovakia to change current conditions on wholesalers for the export of medicines. It views them as unjustified obstacles to free movement of goods & may start legal action if changes are not made by end August 2016. More details below.
The issue is, national authorities are adopting different approaches to manage shortages, contain expenditure on medicines and support supply chain security. To comply with EU law, their restrictions must be clear, transparent and objective. This test can be complex to justify when authorities require data & information from wholesalers.
In France a new law requires holders of marketing authorizations to work with wholesalers & pharmacists to provide plans to the French Agency ANSM on how to manage shortages of medicines of major therapeutic interest & vaccines. If more information is requested about exports, could this be too restrictive ?
In Germany a proposed law, likely enacted by December 2016, seeks to remove current mandatory substitution of medicines with cheaper imported packs. The pharmacists association counter-proposes using a pricing reference system, as in their view, importing medicines does not lead to major savings for health insurers & parallel trade leads to supply chain & counterfeit risks. What controls will Bfarm consider to prevent shortages in Germany ahead of changes ? IMS recently estimated about 50% of medicines sold in Germany (15% in UK) were exported from other EU countries.
In Portugal, wholesalers must now notify their intention to export medicines considered “at risk of shortage” & to provide further details. In Slovakia, wholesalers must wait 30 days after their notification, before they can export. Both the need for further detail & a duration of 30 days are considered by the EU Commission to be excessive..
In Greece, a criminal investigation is still being run into shortages. Current controls on exports have not been challenged.