Subject: ECL position on incentives for drug development in EU pharmaceutical legislation
From: "Toma Mikalauskaite" <[email-masked]>
To: "SM Info",Agne Nettan-Sepp Brüsselis
Date: Thu, 6 Jun 2024 15:52:02 +0300

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)

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Brussels | 1030 | Belgium

+32 (0) 2 256 2000 (main office)

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