2nd Joint Meeting on ‘Innovations in Healthcare’

How can methodological and scientific advice to manufacturers of medicinal products be further optimised at European level in order to generate more relevant scientific evidence before and after the authorisation of a product? This question will be addressed at the 2nd Joint Meeting ‘Innovations in Healthcare’ (INNO Meeting) at the beginning of October. The virtual symposium is being organised by the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG). The INNO Meeting will take place between 1-2 October 2020 and is part of the German Federal Ministry of Health’s associated programme under the German EU Council Presidency 2020.

Participating organisations include the Scientific Advice Working Party (SAWP), the EU Innovation Network (EU-IN), the Clinical Trials Facilita-tion and Coordination Group (CTFG), the European Network for Health Technology Assessment (EUnetHTA), the Innovation Task Force (ITF) and the SME Office of the European Medicines Agency (EMA). The guiding concept of the event is to collect relevant data that can be used for both marketing authorisation and HTA assessment through efficient cooperation between European marketing authorisation authorities and HTA organisations when advising the industry. The main topics include how to work with innovations, such as advanced therapy medicinal products (ATMPs), and the collection of registry data and their applicability in Europe.

‘I am very pleased that the G-BA and IQWiG will be jointly hosting and supporting the second INNO Meeting. In recent years, there has been a trend towards authorising new medicinal products faster than ever, sometimes on the basis of data that is still inconclusive. This means that timely cooperation between the European regulatory authorities and HTA organisations in providing scientific advice to the pharmaceutical industry is vital. The common goal should be to generate meaningful data via clinical trials for both authorisation and HTA evaluation’, said Professor Josef Hecken, impartial Chair of the G-BA and Chair of the Subcommittee on Pharmaceuticals.

‘All study data must meet the requirements for evaluating new drugs of the respective Member States of the European Union. Scientific issues, such as clinical trial requirements, methodology, endpoints or surrogate parameters, should be addressed as uniformly as possible according to the standards of evidence-based medicine’, added IQWiG Director Pro-fessor Dr. Jürgen Windeler. ‘It is essential to have an exchange of infor-mation between the European partners.’

The most important outcomes of this invitation-only event will be an-nounced in a press release shortly afterwards. Comprehensive documen-tation of the outcomes will then be posted later on the G-BA website.

Background

Both the G-BA and IQWiG are partner organisations in the European Network for Health Technology Assessment (EUnetHTA). Since 2007, IQWiG has been the Lead Partner of EUnetHTA’s JA3 Work Package 6 – Quality Management, Scientific Guidance and Tools; as such, it is largely responsible for developing the quality framework of EUnetHTA products. The Federal Joint Committee has been Co-Lead Partner of EUnetHTA’s JA3 Work Package 5A – Early Dialogues since 2016; thus playing a major role in jointly advising the industry on trial design by HTA organisa-tions at European level, together with the additional participation of the European Medicines Agency (EMA).

The 1st Joint INNO Meeting took place in Helsinki in 2019 under the Finn-ish Presidency of the EU Council. It was agreed to continue this exchange once a year under the aegis of the rotating EU Council Presidency.