LSHC Horizons Brochure 2024 - Flipbook - Page 10
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | ESG and Supply Chain
EU supply chain issues for medicinal products:
Important recent developments
Supply chain structures of import and
distribution of medicinal products in the
EU should be carefully set up, taking into
account logistics, but also regulatory, customs
requirements as well as tax considerations.
An important recent development is that, in a
different context, the Court of Justice of the EU
(CJEU, 47/22, 21 September 2023) made clear
that a wholesaler in the EU may not obtain
medicinal products from others than holders of
an EU wholesale license. Further, the European
Commission (Commission)’s proposal of
reform to the EU’s pharmaceutical legislation
published in April 2023 (Pharmaceutical
Law Package) explicitly included fiscal
transactions in the definition of wholesale
activities. This amendment seeks to make clear
that entities which merely fiscally purchase
products, even without touching them, are
wholesalers. Thus, wholesalers engaged in (tax
driven) fiscal transactions would be subject
to good distribution practice (GDP) laws. As
a consequence, they would need to obtain
the products solely from entities which hold
an EU wholesale or manufacturing license.
Purchasing products from entities outside of
the EU would no longer be possible. Fiscally
importing products would arguably then
require holding the manufacturing license
under the proposed amendment. However,
in several jurisdictions it is currently not
even clear whether a manufacturing license
could be granted by local authorities for such
mere wholesale activity. We are seeing many
countries now becoming less flexible in regards
to tax-optimized supply chain planning.
Dr. Jörg Schickert
Partner
Munich
In addition to structuring questions around
import and distribution, supply chains of
medicines are under scrutiny of the EU
authorities. For example, the above-noted
Pharmaceutical Law Package proposals include
strengthened requirements for marketing
authorization holders with respect to supply
shortages, including an obligation to have
in place a shortage prevention plan. These
proposals followed the Commission’s October
2022 publication of its main findings from
a Structured Dialogue on the security of
medicines supply, which addressed global
supply chain vulnerabilities and risks of
shortages. Topics raised included identifying
critical medicines, increasing manufacturing
capacity in the EU, optimizing regulatory
environment, promoting green and digital
innovation in manufacturing and global
cooperation.
Medicines shortages are also on the radar of
the authorities in several EU Member States
as well as of the European Medicines Agency
(EMA). The EMA published key principles and
examples of good practices to support patients
and health care professionals in preventing and
managing shortages of medicines. Structuring
supply chains and combatting medicines
shortages will remain key areas for companies
and regulators in the EU in 2024.
Hein van den Bos
Partner
Amsterdam
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