Pharma Deutschland e.V.

Pharma Deutschland welcomes the European Commissions initiative to make the application of the PPWR more practical through delegated acts and to simplify existing implementation requirements. Since many member companies operate across Europe, a harmonized application of the requirements across member states is of particular importance.

Pharma Deutschland welcomes the European Commissions initiative to adopt a set of measures aimed at quickly reducing the burden on businesses in the fields of data legislation, cybersecurity incident reporting, and the Artificial Intelligence Act. Pharma Deutschland calls for avoiding double regulation and ensuring that all EU rules on cybersecurity and data are harmonized.

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.

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.

The German Medicines Manufacturers’ Association (BAH) fully shares the goals of the legislative package for the reform of the EU pharmaceutical legislation, ensuring that patients all across the EU have timely and equitable access to safe, effective, and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive to manufacturing and continuous innovation.

Filed in German · English published by the European Commission

The German Medicines Manufacturers’ Association (BAH) fully shares the goals of the legislative package for the reform of the EU pharmaceutical legislation, ensuring that patients all across the EU have timely and equitable access to safe, effective, and affordable medicines, through better competition, a more efficient regulatory system and a framework conducive to manufacturing and continuous innovation.

Filed in German · English published by the European Commission

The BAH supports the objective of strengthening the European Health Union and the Pharmaceutical Strategy to make the pharmaceutical system more patient-centred, future-proof and crisis-proof. Unmet Medical Need • Unmet medical need definition: It makes sense to define unmet needs or gaps in health care. The well-known definition under Article 4 (2) of Regulation (EC) No 507/2006 is very broad.

Filed in German · English published by the European Commission

The Bundesverband der Arzneimittel-Manufacturers e.V. (BAH) is the largest trade association in the pharmaceutical industry in Germany. He represents the interests of some 400 member companies, which employ around 80 000 employees in Germany. The BAH’s tasks cover both prescription-only and non-prescription medicines, as well as material medical devices and digital health applications.

Filed in German · English published by the European Commission

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.

The Bundesverband der Arzneimittel-Manufacturers e.V. (BAH) represents the interests of the pharmaceutical and medical devices industry both at federal and regional level vis-à-vis health policy, authorities and institutions. With around 400 member companies, it is the largest association in the pharmaceutical and medical devices sector.

Filed in German · English published by the European Commission

The BAH welcomes the European Commission’s initiative on European Health Dataspace (EHDs) and has the following expectations and requirements: 1. The Commission should collect the status quo in order to obtain a concrete overview of the individual countries and of the main obstacles to a common data space in order to target the legal framework in the most targeted and efficient way.

Filed in German · English published by the European Commission

BAH, BPI, ProGenerika and vfa represent the interests of the German pharmaceutical and medical device industry vis-à-vis public health policy, authorities and institutions. Political advocacy and support for members cover the areas of prescription and non-prescription medicines, as well as medical devices such as medical apps and digital health applications.

Filed in German · English published by the European Commission

The Bundesverband der Arzneimittel-Manufacturers e.V. (BAH) represents the interests of the pharmaceutical and medical devices industry both at federal and Land level vis-à-vis the policy, authorities and institutions in the health sector. With around 400 member companies, he is the largest member association in the field of pharmaceuticals and medical devices.

Filed in German · English published by the European Commission

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.

In general, BAH welcomes the transfer of coordinating, advisory and supporting tasks to the EU or the EMA respectively in certain defined (crisis) situations, particularly in connection with combating shortages. In order to secure production and supply, unilateral national measures such as restrictions on the free movement of goods, export bans or similar measures must be avoided.

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…