Johnson & Johnson

Fostering regulatory coherence and legal certainty is essential to safeguard high standards of healthcare quality and patient safety, while enabling innovation in the medical sector. We welcome the establishment of a single-entry point for cybersecurity incident reporting via ENISA: incidents with patient safety implications that qualify as MDR vigilance events should continue to be reported through established…

As one of the worlds leading scientific innovation companies, Johnson & Johnson views the AI Omnibus as a critical opportunity to preserve and reinforce recent regulatory improvements, while ensuring that the EUs AI framework delivers regulatory coherence and legal certainty. This is essential to safeguard high standards of healthcare quality and patient safety, while enabling innovation in the medical sector.

Free and effective data use is crucial for Europes digital economy, healthcare, and research, but inconsistent national rules and outdated laws create barriers and increase compliance costs for cross-border solutions. Data availability underpins AI and innovation, but overly complex or fragmented rules risk can discourage data sharing and reuse.

J&J welcomes the MDR and IVDR revision proposal as a long awaited and targeted response to concerns raised by a broad range of stakeholders, including patients, healthcare providers, Notified Bodies and the MedTech industry. The proposed revision is an important contribution to Europes broader competitiveness and innovation agenda.

The EU’s general pharmaceutical legislation has provided strong foundations for pharmaceutical innovation and medicines development, helping to tackle some of the leading causes of disease and life-threatening illnesses.

Johnson & Johnson welcomes the opportunity to build a trustworthy and innovative ecosystem for artificial intelligence (AI), where the AI Act (AIA) plays a critical role in combination with the existing regulatory framework.

The EU Biotech Act should outline how to ensure coherence and interplay across different (non)legislative frameworks impacting companies to avoid duplication or inconsistencies. The cumulative impact of overlapping or complex requirements in CT, health data and environmental management can hinder innovation.

Johnson & Johnson welcomes the European Commissions initiative to revise the EU Cybersecurity Act in response to the evolving threat landscape and the growing importance of cybersecurity for critical sectors, including healthcare and medical technologies.

Johnson & Johnson welcomes the EU Commission Regulation on a European Health Data Space (EHDS) intended as a patient- and consumer-centric data ecosystem based on the full respect of ethics, privacy and security principles.

1)Data governance, access, sharing, use and re-use The EHDS should build on F.A.I.R. (findable, accessible, interoperable, reusable) data principles to ensure maximum value and trust from the data collected. Given the specificities of the health sector, J&J welcomes the intent to complement the Data Governance Act proposal by establishing sectoral bodies, namely national digital health bodies and sectoral bodies…

Insights derived from data have the potential to make healthcare systems more sustainable, supporting the daily life of patients as well as decision-makers faced with the challenge of assessing different technologies and treatments in the context of fixed budgets.

As one of the largest scientific innovation companies in the world, Johnson & Johnson views quantum technologies as a transformative enabler for the future of health and scientific discovery. Quantum capabilities have the potential to redefine how we compute biology, accelerate drug discovery and diagnostics, scale secure data analysis, and unlock new solutions for patients, providers, and health systems globally.

The Orphan and Paediatric Regulations have spearheaded a wave of innovations in underserved areas. They have undeniably delivered on their objectives considering the marginal economic case for developing most of these medicines; but more must be done. We welcome the opportunity to discuss how to improve them so they better address unmet needs, unintended effects and are more future proof.

Intellectual property (IP) protections provide a vital framework to help enable the continuous investment in cutting-edge research and development of innovative and life-changing treatments and cures, including in times of a health crisis. IP encourages the disclosure of information and data that promotes competition, as well as collaboration and knowledge-sharing.

The COVID-19 pandemic has clearly shown that there are opportunities to further strengthen and improve the EU health security framework to be ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the EU’s goal to equip ECDC with a stronger mandate in epidemiological surveillance, preparedness and response planning, reporting and auditing.

The COVID-19 pandemic has clearly shown that there are opportunities to further strengthen and improve the EU health security framework to be ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the EU’s goal to equip the EMA with a stronger mandate.

The COVID-19 pandemic has clearly shown opportunities for a strengthened and improved EU health security framework, ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the Commission’s proposal for a Regulation on serious cross-border health threats, providing a stronger and more comprehensive legal framework allowing the Union to react rapidly and trigger the implementation of…