Amendment to the pharmaceutcal legislation – insights into a complex proposal
Working drafts provide first insights
CC – 02/2023
With the proposal on the amendment to the
pharmaceutical legislation, which is to be presented on 29 March, the
European Commission aims to secure or improve access, availability and
affordability of pharmaceutial products. According to the European Commission, the
aim is to create a balanced and competitive system that keeps pharmaceutial products affordable for healthcare systems while promoting innovation.
Draft versions of the amendment pharmaceutical legislation
About two months prior to the official
publication, working drafts and accompanying documents have been made public.
They have not been officially published by the European Commission as internal
consultations are still ongoing. Therefore, the contents are still subject to
change until the official release. Nevertheless, one gets a first glimpse of
Two new laws on medicinal products - one regulation and one directive
The amendment is intended to pass two new
laws on pharmaceutical products. On the one hand, the directive establishing a Union
code on medicinal products for human use is being entirely redrafted. Secondly,
the five existing regulations - laying down Union procedures for the
authorisation and supervision of medicinal products for human use and
establishing a European Medicines Agency, as well as on advanced therapies,
clinical trials, medicinal products for paediatric use, orphan drugs - are to
be merged into one legislative text.
Shortening market exclusivity
to the initial considerations of the European Commission, the market
exclusivity of pharmaceutical products is to be shortened, or at least made subject
to conditions in specific cases. When medicines are launched in all 27 EU
Member States, meet unmet medical needs (UMN) or undergo rigorous clinical trials
with comparator therapies, there are additional periods of market exclusivity.
The term of patent on orphan drugs - i.e. pharmaceutical products for rare diseases
- is also to be shortened to 9 years, unless specific conditions are met.
order to avoid shortages in pharmaceuticals, their manufacturers are to draw
up a "shortage prevention plan". In the event of an imminent
interruption of supply, they should inform the EU Member States as soon as
possible, but at least six months in advance. In addition, there is to be a
list of medicinal products that are critical for the supply. Reporting and
information obligations of Member States and manufacturers are to be linked to
the listed pharmaceutical products in order to make bottlenecks transparent and
allow countermeasures to be taken. In addition, as a lesson learned from the
COVID-19 pandemic, the European Commission is planning a regulation to suspend
patent protection in the event of a public health emergency.
In order to provide incentives in the
production of antibiotics, the European Commission plans to introduce
transferable exclusivity vouchers (also called vouchers or TEE - Transferable
Exclusivity Extension). The voucher is intended to extend the term of patent on
a pharmaceutical product by one year and the developer of the new antibiotic can
apply it once to a pharmaceutical product of its choice that has a central marketing
authorisation. It should also be possible to sell the voucher to another
addition to these measures, the European Commission is planning, among other
things, new regulations in the areas of package inserts, packaging, research
transparency, reorganisation of the European Medicines Agency (EMA). The German
Social Insurance (DSV) had already positioned itself in its feedback on the amendment
to the legislation on medicinal products and the pharmaceutical
strategy. The official proposal of the European Commission is now eagerly
awaited at the end of March.