Brilitas Pharmaceuticals EU OÜ
Brilitas EU
- Serving as an authorized representative for medical and pharmaceutical enterprises, advocating for the collective interests of patients across EU member states, and of EU and non-EU manufacturers, and championing the propagation of EU culture and policies across the globe.
ID: 413055049244-08
Lobbying Activity
Response to Review of the Digital Markets Act
26 Aug 2025
As a regulatory operating across the European Union, Brilitas EU supports the EUs commitment to protecting consumers and ensuring transparency in the digital marketplace through the Digital Services Act (DSA) and Digital Markets Act (DMA). However, we would like to bring to the Commissions attention several systemic issues observed in the online marketing of pharmaceuticals, medical devices, cosmetics, and food supplements, which we believe fall within the broader public safety and digital compliance objectives of the Acts. Our regulatory team has continuously observed a surge in disinformation, exaggerated health claims, and misleading promotional content, particularly on: E-commerce platforms, Social media advertising, Direct-to-consumer websites targeting EU citizens. Based on our compliance audits and client dossiers, we believe the underlying drivers of this situation include: - Fast-track registration schemes that prioritize speed over scientific substantiation, particularly in borderline products (e.g., cosmetics with therapeutic claims, IVD devices lacking performance evidence) - Inadequate or missing risk assessments in technical documentation - Use of template-based or superficial documents to obtain CE marking or CPNP upload - Lack of Good Manufacturing Practice (GMP) audits or due diligence on OEM/ODM partners - RP (Responsible Person) or EU Authorised Representatives who do not fulfil active surveillance or compliance duties. These gaps are often exploited in the digital space, where products that should not have passed regulatory scrutiny are promoted aggressively with no meaningful oversight. We believe that this shall have a negative impact on public health and fair competition. Consumers are exposed to untested, unverified, or non-compliant health products. Trust in the CE mark and EU regulatory symbols is being eroded. Compliant SMEs and ethical manufacturers are being undercut by non-compliant competitors. Platforms hosting such products often claim immunity under intermediary liability or algorithmic neutrality. For proposed solutions, please kindly find the attached. We believe that effective implementation of the Digital Services Act and Digital Markets Act should be aligned with evidence-based product registration, GMP standards, and active regulatory surveillance, especially in health-related sectors where consumer trust and public safety are at stake.
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