EU-Commission is addressing medicine shortages in the EU
Resilient and secure supply of medicinal products through European and international coordination.
CC – 11/2023
On 24 October, the European Commission presented
a comprehensive
package of measures to eliminate and prevent supply shortages of critical
medicines within the European Union (EU). In view of recent shortages,
particularly that of supply-critical antibiotics, the communication aims to
make the supply of medicines in the EU more resilient in both normal as well as
crisis times. According to the European Commission, a new approach to tackling
the shortage of medicines within the EU is urgently needed. Some existing
problems are being addressed as part of the pharmaceutical
reform that was published in April. However, there is an urgent need to
implement some of the pharmaceutical reform's proposed elements more quickly in
the short term. The legislative process up to the adoption of new regulations
and their subsequent implementation could take years - one cannot wait that
long.
In its communication, the European
Commission has outlined short- and long-term measures to eliminate bottlenecks
and improve the supply reliability of medicines. In principle, it calls for a
comprehensive and coordinated approach involving national authorities,
industry, civil society representatives and EU agencies at national, EU and
global levels, focussing on preventing or mitigating critical supply shortages,
especially with regard to key medicines.
Short-term measures
- The European Commission has
complied with the request from EU member states for a voluntary European
solidarity mechanism for medicinal products (see News
06/2023). The mode of action introduced in October will ensure that a
member state must notify other member states of its need for a particular
medicinal product. They can respond by redistributing medicines from their
available stocks.
- A Union list of critical
medicinal products must also be prepared by the end of 2023. This list will be
used to analyse the supply chains of selected medicinal products until April
2024 in order to derive further follow-up measures.
- EU member states will also
benefit from the flexibility of the regulations. They should make use of
exemptions to ensure that medicinal products reach patients in good time, e.g.
by extending the shelf life or by speeding up the authorisation of alternative
medicinal products. There will be a joint action in 2024 to promote the
effective utilisation of this leeway.
- How medicinal products are
procured will also taken into consideration. The European Commission intends to
publish a revised EU guideline for procuring medicinal products to improve
supply reliability by the beginning of 2024. Mutual EU procurement of
antibiotics and medicinal products for combating respiratory viruses will also
be examined.
Long-term measures
In addition to their short-term measures,
the European Commission is also proposing structural long-term measures to
strengthen the supply reliability of medicinal products.
This is why the European Commission plans
to form an Alliance for Critical Medicines by the beginning of 2024 to promote
cooperation between national authorities, industry, civil society and EU
agencies. According to the European Commission, the alliance is intended to
supplement the European Health Union as an industrial policy pillar. It will
also focus on diversifying supply chains, promoting and modernising the
production of critical medicines and active ingredients, diversify global supply
chains through strategic partnerships and coordinate public procurement
practices and stockpiling at EU level.
The work of this alliance could be an
important step towards a "Critical Medicine Act". Many EU member
states have also called for such measures. This is why the European Commission intends
to commission a preparatory study by the end of 2023 to pave the way for an
impact assessment.
International cooperation will also be
important in addition to European cooperation. A network of international
partners and strategic partnerships with third countries will be established
for the production of key medicinal products, taking into consideration both
local demand and needs at both EU and global levels.
Parallels to the pharmaceutical reform
It makes sense that the European Commission
wants to strengthen the supply reliability medicinal products within the EU
through this package of measures. Some measures, such as the list of critical
medicines, the EU solidarity mechanism or the review of mutual procurement of
supply-critical medicines, are well-known political demands. it will be
challenging to initiate - and legitimise - measures in addition to the regular
negotiations about pharmaceutical reform. One must be particularly vigilant
with statements such as "more flexibility, e.g. through measures that
enable rapid authorisation of medicinal products and the introduction of
alternatives". DSV's point of view is that there must be no loss of
quality in drug authorisations. In order to improve availability and supply
reliability, marketing authorisation holders must be held more accountable in
the future and EU-wide monitoring must be expanded, e.g. with regard to the
further use of safety features for medicinal products. DSV has set
out these and many other demands in its
position paper covering pharmaceutical reform.