After several delays, the European Commission presented its
revision of the EU's general pharmaceutical legislation on 26 April. The aim is
to create a single market for medicines that will make affordable, accessible
and innovative medicines available to all citizens. On the other hand, this
should enhance the innovative strength and competitive position of the European
pharmaceutical industry. A new directive and a new regulation will replace the
existing pharmaceutical framework. This reform is the first major overhaul of pharmaceutical
legislation in more than 20 years and it is one of the EU’s most important
health dossiers to be submitted during this legislative period.
Five main objectives
The European Commission is pursuing five main
objectives with this reform: creating equal access to medicines, promoting
innovation when manufacturing medicines, ensuring supply reliability,
strengthening environmental sustainability and combating antimicrobial
The package: Directive, regulation and proposal for council recommendations
The proposed regulation that will establish EU procedures for authorising and supervising
medicinal products for human use and establishing the EMA (European Medicines
Agency) also contains specific provisions for medicinal products authorised at
EU level, such as orphan medicine ("Orphans") and antibiotics.
Regulations will be defined for the coordinated handling of critical
bottlenecks. EMA governance will also be regulated. The proposed directive about establishing an EU code relating to medicinal products for
human use will include all of the regulations that cover authorising,
supervising, labelling and legally protecting all medicinal products authorised
at EU and national levels. The package is supplemented by a proposal for a council
recommendation that will
intensify EU measures for combating antimicrobial resistance under the “One
Health” approach (see News 05/2023).
Differentiated incentive system
A major innovation in the extensive legislative texts is the
introduction of a differentiated incentive system for pharmaceutical companies.
The regulatory protection periods will be linked to conditions: market launch
in all 27 EU member states, meeting unmet medical needs, conducting comparative
clinical trials and the inclusion of new therapeutic indications to an
authorised medicinal product. All-in-all this proposal provides for shortening
the data protection period of a medicinal product by two years to allow earlier
market launches of more affordable generic medicinal products and biosimilars.
This is to be welcomed. Nevertheless, one cannot speak of a general shortening
of the protection periods, because if a medicinal product meets all of the
conditions, the protection period could be a maximum of 12 years, instead of
today’s 11 years. The standard market exclusivity for orphan medicinal products
will be shortened by one year from the previous 10 to 9 years. However
protection periods of a maximum of 13 years instead of today’s 10 years can
also be granted if additional conditions are also met.
Combating medicinal product shortages
In order to combat medicinal product shortages the EC wants to make
it obligatory for companies to report potential shortages earlier, to build up
emergency stocks and to draw up plans to prevent shortages of their medicinal
products. For example, it is also intended that a company wishing to
permanently withdraw its marketing authorisation for a critical medicinal
product must first offer a third party the opportunity to market this medicinal
product on reasonable terms before it does so. A publicly accessible EU list of
critical medicines will also be created for which stricter requirements, such
as stockpiling obligations, might apply in emergency situations.
Stricter environmental testing
There are stricter regulations for the environmental testing of
medicinal products. They will be extended to all products that are already on
the market that are potentially harmful to the environment as well as any
medicinal products that were approved before 2005. The EMA can refuse marketing
authorisation for medicinal products if a manufacturer fails to provide
sufficient information about the possible environmental risks of its medicinal
There should be more transparency with regard to
how public funds become part of R&D costs. Authorisation holders will be
required to report on a public website any direct financial support they have
received from any government agencies or publicly funded organisations for
medicinal product R&D. This is helpful for the national price reimbursement
Vouchers as an incentive
However, the transferable market exclusivity vouchers, i.e. the
so-called vouchers, are also meaningful proposed measures for combating
antimicrobial resistance. These vouchers are intended to provide incentives for
developing innovative antimicrobial agents. Up to 10 transferable data exclusivity
vouchers can be used or sold over a 15-year period, which will provide an
additional year of data protection. DSV spoke out against this costly
instrument in their statement.
The legislative proposals will now be discussed in the European
Parliament and the Council. Tiemo Wölken (S&D/DE) will report on the
Regulation and Pernille Weiss (EPP/DEN) will report on the Directive in the
European Parliament. Long deliberations are expected as pharmaceutical
legislation is not only highly complex and many interests come together here.
DSV will actively contribute in the sense of a high-quality, needs-based and
affordable supply of medicinal products for the insured (see Pharmaceutical strategy Opinion).