A position paper published by Medicines for Europe is the response of the generics and biosimilars industry association to the stockpiling of various types of medicines that several European countries have put in place as a tool against drug shortages. According to the industry representative, warehousing mandates initiated by countries such as France, Germany, the Czech Republic, Austria, Greece, Denmark and Poland could actually worsen the shortage problem by undermining European solidarity mechanisms. According to the note, a six-month national stockpile of antibiotics in Germany would correspond to a quarter of the quantities for the entire EU. Such a six-month stockpile, moreover, could cover the combined supply of eleven small EU countries, the manufacturers’ association adds. There would, the note also points out, also be a problem with the affordability of many low-cost generics, due to the additional costs of stockpile management and the increased risk of unnecessary stock depreciation. Dynamics that, according to Medicines for Europe, could further strengthen the consolidation of the generics market in the hands of fewer and fewer companies. National stockpiles, moreover, could create a false sense of security about the actual ability to mitigate a serious shortage.
Alternative solutions
In its position paper, Medicines for Europe supports the EU strategic stockpile initiative announced by the European Health Emergency and Response Authority (HERA) and proposes some actions that could be included in it.
In particular, it would be necessary according to the industry representative for the EU Commission to strictly monitor national requirements in order to prevent disproportionate and excessive stockpiling actions by individual countries. The voluntary European solidarity mechanism should also allow manufacturers to reallocate stocks from one country to another efficiently in the event of a shortage. An objective that Medicines for Europe believes requires greater transparency of the EU market, together with greater use of the real-time data on demand and supply contained within the European Medicines Verification System (EMVS). As far as European strategic reserves, co-financed by the EU and Member States, are concerned, these should be agreed with manufacturing companies on the basis of stock rotation, so as to reduce wasteful cancellations and greatly reduce costs for taxpayers. These reserves should also be targeted, proportionate and transparent.
Medicines for Europe would also welcome some regulatory changes, such as the electronic package leaflet or the digitisation of the network of regulatory bodies, which could better support agile supply chain management. Finally, for the trade association, it would also be necessary to include security of supply in market policies, as well as in future EU guidelines on the procurement of medicines and the adjustment of reference pricing policies. This would, in fact, encourage companies to invest more in production and diversification activities.