Saatja: "Toma Mikalauskaite" <
[email protected]>
Saaja: "SM Info", "Agne Nettan-Sepp Brüsselis"
Teema: ECL position on incentives for drug development in EU pharmaceutical legislation
Kuupäev: 2024-06-06 12:52
Dear Ms Sikkut and Ms Nettan-Sepp,
The ongoing revision of the European pharmaceutical legislation is a
long-awaited opportunity to make the pharmaceutical system patient-centred
and fit for purpose by addressing unmet medical needs and ensuring
availability and timely access to safe, effective, and affordable medicines
for all patients in need.
As you continue to negotiate on the regulatory data protection periods in
Article 81 of the proposed pharmaceutical Directive, we call on you to
support compromise text suggested by the Belgian Presidency of the Council
of the EU, as reported in media, which is in line with the European
Commission’s proposal.
The redesign of the regulatory protection system from ‘one size fits all’ to
a modulated one addresses the issue of unmet medical need and promotes
development of better medicines by incentivising use of comparative clinical
trials or rewarding drugs that have additional therapeutic indications.
Moreover, it improves unequal patient access to treatments across the EU by
incentivising the EU-wide market launch of innovative medicines.
Finally, the basic regulatory data protection period of 6 years would allow
cheaper generic and biosimilar medicinal products to enter the market faster
and therefore substantially improve affordability.
According to a recent study
<https://www.bmj.com/content/384/bmj-2023-077391> , which analysed EMA
approved oncology drugs during the period of 1995 – 2020, 41% had a negative
or non-quantifiable added benefit. Moreover, median time to offset median
R&D costs is 3 years, and 91% drugs recovered these costs within 8 years.
As most oncology medicines recover R&D costs within a few years despite
providing little added benefit, the co-legislators need to promote
development of the most effective ones for patients with the greatest needs
and equitable access across Europe.
Thank you for taking our views into account.
I am available should you require additional information.
Best wishes,
Toma
Toma Mikalauskaitė
Senior Policy Officer
Association of European Cancer Leagues (ECL)
Chaussée de Louvain / Leuvensesteenweg 479 (central office)
Brussels | 1030 | Belgium
+32 (0) 2 256 2000 (main office)
Rue de l’Industrie 10 (EU district office)
Brussels | 1000 | Belgium
<mailto:
[email protected]>
[email protected] | <http://www.cancer.eu/>
www.cancer.eu
<https://www.cancer.eu/ecl-manifesto-2024/>