Action on shortages must be transparent
Today the UK Government announced that new restrictions limiting parallel export of medicines to the EU would apply with immediate effect. The European Association of Euro-Pharmaceutical Companies (EAEPC) agrees that parallel exports should never be the cause of shortages of medicines anywhere in the EU. To this end, placing temporary, transparent, and objective restrictions based on already EU-defined criteria where genuine shortages occur can be helpful. However, the UK Government have failed in several aspects to deliver on several of these parameters.
“While we do not want worsen or prolong any shortages, and therefore accept that temporary, transparent, and objective restrictions might apply, we object to the complete failure on the UK Government to be transparent on their decision,” says Kasper Ernest, Secretary-General of EAEPC.
“Many of the products on the UK list have not been exported, and therefore most obviously we cannot be the cause of the shortage. We are therefore awaiting to see which sanctions the UK Government will place on manufacturers for failing to meet their legal supply obligations,” continues Kasper Ernest.
Over the last years, shortages have increased all over Europe due to a complete failure from the manufacturing industry to deliver enough medicines to European patients.
“Parallel exports come from all over the EU, and parallel imports also go all over the EU. In fact, the UK is net parallel importer. Every day we alleviate shortages in the UK with our imports. If anyone thinks that parallel export is a root cause for shortages, we have clear evidence to refute that, says Kasper Ernest”
“We are tired of being the scapegoat of big pharma when they fail or chose not to deliver for commercial reasons, it’s time for the EU and Member States to act” continue Kasper Ernest.
Time for sanctions
The EAEPC welcomes the efforts made in the Netherlands and France to tackle the real root causes of shortages, well known to be manufacturing disruptions, quality issues, and lack of commercial interest in the EU market due to a general lower price level compared to e.g. the US.
“Only by forcing the industry to improve their practices and sanction them when failing to do so, can the real reasons for the shortages be addressed, says Kasper Ernest.
The EAEPC also welcome the efforts done by the EMA/HMA Task Force to improve the monitoring and reporting of shortages which will create more transparency on the situation.
“Transparency can no longer be voluntary. Reporting must be mandatory for the industry, and it is time for Europe to discuss sanctions when manufacturers fail to deliver medicines to EU citizens,” says Kasper Ernest.
The EAEPC has seen an increasing demand from authorities all over Europe asking its members to parallel import due to severe shortages from manufacturers.
“Our main mission is to create price competition on medicines vis-à-vis pharmaceuticals extracting enormous profits from health systems all over the EU, however, more and more patients and authorities turn to us for help to alleviate shortages by parallel importing medicines.”
For more information, please contact Kasper Ernest, Secretary-General at ke@eaepc.org or by mobile on +32491255611
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