Pöördumine

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, 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

[email protected] | www.cancer.eu