Out-Law News 3 min. read
31 Oct 2023, 3:12 pm
A widespread shortage of some antibiotics impacted many EU countries last winter. It prompted a majority of EU member states – including Germany, France, Spain, and the Netherlands – to call on the EU to take “more drastic steps to improve the security of medicines supply” earlier this year.
In response, the Commission has now published a communication (19-page / 513KB PDF) detailing immediate actions, and further initiatives it will pursue in the short, medium, and long-term, to address the issue.
One of the medium- to long-term projects is to explore the need for a new Critical Medicines Act, an initiative the EU countries called for in their ‘non-paper’. They said at the time the legislation could support “the European green, digital manufacturing of key medicines, APIs [Active Pharmaceutical Ingredients] and intermediate ingredients for which the EU is entirely dependent on one country or a limited number of manufacturers”.
The Commission said: “Strengthening the EU’s security of medicines supply may require new legislation. A legislative initiative for an EU ‘Critical Medicines Act’ would require thorough preparation, including the assessment of economic dimensions. The Commission will, to that end, launch a dedicated, preparatory study by the end of 2023, paving the way for an impact assessment.”
Under existing EU law, holders of a marketing authorisation for a medicinal product and the distributors of those products in the EU have a duty, “within the limits of their responsibilities, [to] ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the member state in question are covered”.
However, according to the Commission, the existence of that duty “has not prevented shortages arising due to unforeseen events outside of the control of the companies”. It cited manufacturing issues and natural disasters as examples.
The Commission said that the Covid-19 pandemic and Russia’s war in Ukraine has “exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised”. It has further highlighted the “delocalisation of the manufacturing of Active Pharmaceutical Ingredients (API) to a limited number of locations outside the EU” as having “accentuated concerns about security of supply inside the EU”.
In the EU, responsibility for organising national health systems rests with each individual EU country, but there has been “improved” EU-level coordination in respect of addressing critical shortages in recent years, the Commission said, citing forums that encourage better dialogue with industry, stockpiling projects, and the joint procurement of medicines – including during the Covid-19 pandemic – as among existing efforts to support EU member states in addressing the risk of shortages.
Legislative intervention to address the risk of medicines shortages is already envisaged as part of a package of proposed reforms to the EU’s general pharmaceutical laws that the Commission set out earlier this year. The measures proposed include a new European alert system to identify shortages earlier, new obligations on companies to develop shortage prevention plans, and the coordinated management of shortages by the European Medicines Agency (EMA).
However, in its communication paper, the Commission acknowledged that “a new approach is needed to better tackle medicines shortages” and reflected on the political consensus built across EU member states for greater action in this area.
Immediate action that has been taken includes the establishment of a new voluntary solidarity mechanism (5-page / 218KB PDF), which a steering group within the EMA will facilitate. The mechanism enables individual EU member states to request assistance in obtaining medicine stocks during critical shortages.
Member states can only turn to the mechanism after they have “exhausted other possibilities”, the EMA said. A range of conditions need to be met – including that the EMA has already been notified of the critical shortage; that there are no or insufficient therapeutic alternatives available in the country; that the country has no more than one month’s worth of stock of the medicines left; and that the importation of foreign stock or other short-term measures do not provide a solution in a timely manner or in sufficient quantities to address the shortage.
Other short-term actions have been set out by the Commission. It intends to establish an initial list of ‘critical medicines’ before the end of 2023 and develop EU guidance on procurement by early 2024. That guidance, the Commission said, will be focused on “procurement practices that can make a direct contribution to security of supply and availability through effectively integrating supply security as an award criterion, whilst having regard to the EU’s international commitments”.
The Commission also said it would work with regulators and member states to ensure existing “regulatory flexibilities” are used to prevent critical shortages, where appropriate. Those flexibilities, it said, might include “measures to facilitate the quick authorisation and roll-out of alternatives; the upscaling of production or approval of alternative suppliers of raw materials or finished products; temporarily extending shelf-life; or measures to facilitate redistribution between member states”. A joint action plan to further promote effective use of regulatory flexibilities is to be developed in 2024.
Other related projects expected next year include the development of a common strategic approach to medicines stockpiling, which the Commission said it will establish in conjunction with member states by June 2024, and the establishment of a new “matchmaking platform” to support supply and demand forecasting in the second quarter of next year. The Commission said the platform will enable “economic operators and developers … to flag their capabilities and collaboration needs”.
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