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Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

AGES

Die Agentur für Gesundheit und Ernährungssicherheit(AGES) unterstützt das Bundesministerium für Gesundheit (BMSGPK) und das Bundesministerium für Landwirtschaft, Regionen und Tourismus (BML) und die ihr zugeordneten Bundesämter (Bundesamt für Ernährungssicherheit - BAES; Bundesamt für Sicherheit im Gesundheitswesen - BASG; Bundesamt für Verbrauchergesundheit - BAVG) in Fragen der Öffentlichen Gesundheit, Tiergesundheit, Lebensmittelsicherheit, Strahlenschutz Arzneimittelsicherheit, Ernährungssicherung und des VerbraucherInnenschutzes fachlich und unabhängig mit wissenschaftlichen Expertisen.

Lobbying Activity

Response to Biotech Act

10 Jun 2025

The Austrian Agency for Health and Food Safety GmbH / Medical Market Suveillance (AGES MEA) within its remit of medicinal products and medical devices supports this legislative initiative intended to facilitate bringing innovative biotech products from lab to market. We consider this comprehensive perspective as an opportunity to address interfaces between legislations that currently pose significant challenges as innovative therapeutic approaches and product developments increasingly fall in the scope of more than one legislation. In particular, this concerns the interfaces between the medicines, medical devices, GMO and SOHO legislations. The arising complexities cause challenges for regulators in oversight, assessment and advice. The Pharma Revision envisages a sandbox concept for medicinal products, but there is a need for a sandbox concept beyond the definition of medicinal products. In addition, the status of xenogeneic organs needs to be clarified as they are currently not explicitly covered by European legislation. In the wording of the legislative text, emphasis should be placed on the consistency between recitals and body text. The text should reflect a distinct EU strategy for public health that includes targets and priorities, specifically when requirements of equal legislative impact meet. These guiding principles could subsequently aid and accelerate decision making in previously unencountered situations in the context of innovation. Realistic resources to organisations responsible for operative tasks need to be ensured, particularly in situations where acceleration of procedures increases pressure on regulatory agencies. Where increased flexibility is envisaged, the consequences need to be thoroughly understood and accepted, particularly in terms of potential risk and required resources. It is a consideration to establish a steering group tasked with the strategic implementation of the Biotech Act with competence on operative issues. Communication of the strategy in lay language could foster public acceptance. Divergence of member states is stated as an issue for development. There is a need to identify the source of these differences, e.g. whether they arise from the (national) legislative framework, different scientific positions or other, as this critically impacts on improvement strategies required. Harmonisation needs to be supported and demanded. Current legal requirements should be considered from their practical feasibility for certain products/in certain situations and flexibility legally anchored. Examples include labelling requirements for frozen investigational medicinal products and the legally required import testing even for cell based/low volume ATMPs at Marketing authorization. The Biotech Act could also be the vehicle to introduce flexibility for appropriately validated digital solutions for labelling, patient information and trial management. The possibility of acceleration of approval processes significantly depends on the maturity of dossiers submitted and their compliance with regulatory requirements. Engagement of authorities and their review team(s) as early as possible and throughout the entire clinical development phase would be helpful and reduce time-consuming errors in development programs.
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