Page 175 - CW E-Magazine (4-6-2024)

Special Report

mulation and clinical drug-product manu- tive substances of medicines considered Given the global nature of the supply
facturing and will be completed in 2026. critical for healthcare systems across the chain, these new partnerships could
EU/European Economic Area, for which bring the diversifi cation of the sup-
Vetter, a CDMO of aseptic fi lling and continuity of supply is a priority and for ply chain of critical medicines. The
packaging, is investing EUR 230-mn which shortages should be avoided. The European Chemical Industry Council
($252-mn) in a new production build- list contains active substances of innova- (Cefi c), which represents EU chemical
ing, which is currently under construc- tor and generic drugs covering a wide manufacturers, is a member of the Criti-
tion at its global corporate headquarters range of therapeutic areas and includes cal Medicines Alliances, and through
site in Ravensburg, Germany. vaccines and medicines for rare diseases. its sector group, the European Fine
It refl ects the outcome of a review of 600 Chemicals Group (EFCG), supports
Small-molecule drugs active substances taken from six national potential policy moves to advance fi ne
A key issue potentially impacting lists of critical medicines. The goal is chemical manufacturing in the EU.
fi ne chemical producers and CDMOs in update that list on an annual basis.
the Europe Union (EU) relates to policy “The more dependent Europe is on
moves to increase manufacturing in the The European Commission carried other regions, the more vulnerable its
EU and reduce dependence on other out an analysis of supply-chain vulner- people are on products as fundamental
countries for active pharmaceutical in- abilities for a fi rst tranche of 11 critical as medicines,” said Maggie Saykali,
gredients (APIs) and related inputs for medicines on the Union list, set to be Director, Specialty Chemicals, Cefi c, in an
critical medicines. In April 2024, the published in April 2024. The outcome April 24, 2024, statement in commenting
European Commission launched the of this work will inform the scope of the on the launch of the Critical Medicines
Critical Medicines Alliance. First an- mandate of the Critical Medicines Alli- Alliance. “Through our Sector Group,
nounced by the European Commission ance. In addition, the European Com- we represent around 350 API and fi ne
in October 2023, the Alliance will focus mission will proceed with evaluating chemical sites in Europe, and we can
on industrial policy and complements the remaining medicines in the Union provide important insights on the key
the reform of the EU’s pharmaceutical list. It will then recommend priority value chain players, capacities in Europe,
legislation as proposed by the European actions for the near future and propose technologies involved in the manufactur-
Commission. Set up as a consultative new tools to address the challenges it ing process, among others. Our goal is to
mechanism to policy-makers, the Al- has identifi ed. In particular, the recom- strengthen Europe’s strategic autonomy
liance seeks to work to enhance secu- mendations will focus on mitigating and re-establish Europe as a major player
rity of supply, strengthen availability structural risks, reinforcing supply by in API manufacturing.”
of medicines, and reduce EU supply- making demand more predictable, en-
chain dependencies. The recommenda- couraging diversifi cation, and boosting Cefi c’s EFCG issued a set of recom-
tions made by the Alliance will serve as manufacturing in the EU. mendations last November, which
a basis for a multi-year strategic plan included fostering supportive legisla-
containing milestones and correspond- Those efforts will also be part of tive policies for EU API manufactu-
ing deadlines for their implementation. discussions in the Alliance, which rers that emphasized sustainable growth
will help the European Commission to and reshoring initiatives while investing
Key factors being analysed include identify what it terms as “pipeline in- in innovation and shifting procurement
an over-dependency on a limited number vestment projects,” which could bene- focus on supply security and social-en-
of external suppliers, limited diversifi - fi t from EU and national funding to vironmental standards. In making those
cation possibilities, and limited produc- strengthen manufacturing in the EU. recommendations, EFCG pointed to the
tion capacities. This will build on the The Alliance will also look at how mar- continued decline of European-based API
European Commission’s vulnerability ket incentives, such as capacity reser- production with respect to the supply of
analysis of supply-chain bottlenecks of vation contracts and joint procurement, critical medicines. From a global produc-
critical medicines on the Union list of can be used to enhance security of sup- tion share of 53% in 2000, the EU’s share
critical medicines. The Union list of ply of critical medicines. In addition, of API production in 2020 fell to 25% due
critical medicines, which was published the Alliance is taking a holistic view to increased competition from lower-cost
by the European Medicines Agency last of the supply chain, and its members countries and EU pricing and procure-
December, refers to a list of critical medi- will seek to identify new synergies to ment policies not favourable to EU-based
cines for the EU/European Economic work with each other more effectively, domestic manufacturing, according to
Area, which contains more than 200 ac- including creating new partnerships. information from EFCG.

Chemical Weekly June 4, 2024 175

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