EU-HTA: A topic at the world`s largest Biotech Convention

At Bio Convention 2023 the main focus of the participation of the IGES Group was on the harmonisation of the assessment of the benefits of new therapies that is already underway on the EU level. Fabian Berkemeier, Managing Director, Pharmaceutical Industry at IGES Institute, spoke about this at two central events during the world's largest biotechnology convention. Several details of the new procedure have still to be clarified.

Berlin, 06. June 2023 (IGES Institute) – The harmonisation of the Health Technology Assessment (HTA) in Europe is one of the most far-reaching changes in EU pharmaceutical legislation since the introduction of the centralized marketing authorisation about two decades ago. It envisages the progressive introduction of a joint clinical assessment of new medicines on the European level from 2025 starting with oncology products and advanced therapy medicinal products (ATMP).

The challenge facing developers of innovative therapies is to set up clinical trials already now that meet the requirements of the new procedure, too. The tight procedural deadlines will also necessitate prudent planning.

Fabian Berkemeier, Director, Pharmaceutical Industry at IGES Institute, commented on this during a panel discussion: "Pharmaceutical companies have to get to grips with the new procedure today. New structures and processes are needed for the new procedure, and companies should align the clinical development of their products with the new requirements if they want to be successful in the EU in the future." Other participants included representatives from the European pharmaceutical association EUCOPE, the European biotechnology association EuropaBio, the US Biotechnology Innovation Organization (BIO) and company representatives.

IGES Group has been in attendance and has made contributions at this international specialist event since 2016. In 2023 it was held in Boston. IGES was also a co-exhibitor on the joint German joint stand. EU-HTA and joint clinical assessments have been important topics in the past and will continue to be so in the future.

IGES supports developers and manufacturers of medical innovations in the development of market access strategies and operational market launches in Europe. Companies from the IGES Group, such as IGES Institut GmbH and HealthEcon AG, also participate as EU-HTA stakeholders in the public consultations of EUnetHTA 21.