The European Commission on Tuesday launched some short-term measures to prevent medicine shortages this winter and the next as a stop-gap while a proposed pharmaceutical rules overhaul is hashed out by the EU’s key legislative arms.
After the COVID-19 pandemic and ensuing medicine shortages due to supply chain bottlenecks, the Commission proposed the first major reform of its pharmaceutical regulations in April and hopes to forge a closer health union.
A key short-term move is the set up of a voluntary mechanism between member states to fill medicine gaps across the block this winter.
“The scheme allows Member States to flag needs for a given medicine in critical shortage at national level to other Member States, so that they can indicate the availability of stock that could be redistributed,” a statement said.
Further, the Commission is looking to set up a joint buying scheme for antibiotics and medicines for certain respiratory illnesses ahead of winter 2024-2025, it said.
The EU’s European Medicines Agency (EMA), together with member states, is also slowly narrowing down a list of critical medicines after calls from member states – including Belgium, France, Spain and Germany – to improve security of supply and come up with a Critical Medicines Act. The list will be finalised by the year-end.
Once the medicine list is finalised, which currently has between 100-350 being debated, each one will go through a vulnerability assessment to see what is required and then dialogue with the industry on to ramp up output. Any measures taken on the list will be done by April next year.
Over the last decades, the EU has become heavily reliant on India and China for generic medicines and key ingredients after production was off-shored due to high levels of pollution in the bloc.
The EU will set up a Critical Medicines Alliance in early 2024, an embryonic version of a Critical Medicines Act, to develop coordination between the Commission, industry, civil society and national authorities on a short list of medications.
The EU aims to reshore some production, broaden its sources of key ingredients, coordinate stockpiling as well as set up some pre-reserved production capacity in case of an emergency, such as during the COVID-19 pandemic.
(Reporting by Julia Payne; editing by David Evans)
