Pharma Deutschland e.V.

We welcome the European Commissions initiative to revise the EU Public Procurement Directives. In our statement, we focus on the Directive on Public Procurement (2024/24/EU), assessing it considering the specific requirements of the pharmaceutical industry. As public-law entities, statutory health insurance funds are subject to EU public procurement law.

Pharma Deutschland welcomes the European Commissions initiative to simplify the EU regulatory framework for medical devices and to enhance the competitiveness of the European medical device sector within the internal market and at global level.

Pharma Deutschland e.V. welcomes the European Commissions initiative to simplify EU rules for medical devices and to strengthen the competitiveness of the European medical device sector both within the internal market and globally. We particularly support the objective to foster innovation and reduce dependencies.

Pharma Deutschland represents the interests of the pharmaceutical industry of Germany with around 400 member companies - in including international corporations as well as small and medium-sized enterprises (SMEs) and mid-sized companies.

The BAH welcomes the EU Commission’s aim to act against green washing and to strengthen consumer rights through better protection against unfair practices. This overarching goal is in the interest of both consumers and companies. At this point, it should be explicitly emphasised that it is not about misleading and untruthful statements.

Filed in German · English published by the European Commission

Pharma Deutschland welcomes the European Commission's proposal for a European Biotech Act as an important step towards strengthening Europe's competitiveness, resilience and innovation capacity in biotechnology and biomanufacturing. The proposal addresses several key barriers to innovation by promoting faster clinical development, regulatory cooperation, digitalisation and strategic investment.

Pharma Deutschland welcomes the European Commissions intention to present a comprehensive Biotech Act in 2026. The sector is indeed fast-moving, research-intensive, and capital-demanding. A modern legislative framework is therefore urgently needed to improve translational capacity, reduce regulatory fragmentation, and facilitate market and global access for biotech products.

Pharma Deutschland welcomes the European Commission's initiative, which aims to ensure uniform application of the requirements set out in Annex VII of the MDR and IVDR. In support of this initiative, Pharma Deutschland wishes to draw attention to certain aspects of the draft implementing regulation that merit further examination and potential revision.

Pharma Deutschamd generally welcomes the ABS system and is aware of the need to respect and comply with ABS requirements. Preventing future cases of biopiracy is an important goal, and this is explicitly supported by the industry. The introduction of the EU regulation aims to create uniform and harmonised processes in Europe, which we expressly welcome.

Pharma Deutschland welcomes the establishment of common rules governing the creation, development, implementation, operation and supervision of AI regulatory sandboxes. We particularly support the objectives of these sandboxes, namely to enhance legal certainty for innovators, facilitate regulatory compliance with Regulation (EU) 2024/1689, promote responsible innovation and competitiveness, and accelerate the…