Changes from report parliamentary committee draft to plenary report

Added89. Recognises that while AI systems and computing can significantly accelerate research and lead to new innovations –enabling better computational designs of biological systems and faster methods to design DNA and genomes of organisms –they can also lower the barrier to biological threats; calls, therefore, for a robust governance framework to address these threats;

Added90. Stresses the importance for Member States to update their national action plans on rare diseases, in cooperation with the Commission, academic institutions and relevant stakeholders from the biotech sector; emphasises that the drafting of these plans should be aligned with best practices exchanged among Member States and encourages these to be discussed within the Commission’s expert groups;

Added91. Highlights the de-funding and staff reductions at the Food and Drug Administration (FDA) in the United States, which undermine its role as the leading global medicines regulator, and which are likely to degrade EU patient access to innovative medicines and hinder global access to vaccines; underlines, in this regard, the urgent need to ensure that the EMA becomes the world-leading medicines regulator;

Added92. Stresses the urgent need to strengthen the capacity and resourcing of the EU regulatory network for medicines, including agencies such as the EMA and the Heads of Medicines Agencies (HMA), to ensure the timely and efficient evaluation of innovative therapies and to ensure that the EU is seen as the most attractive region globally to launch new medical products;

Added93. Stresses that appropriate funding and in-house expertise for the EMA and HMA is fundamental both for the development of new vaccines and novel antimicrobials and for EU preparedness for health emergencies, including viral threats and AMR; underlines that the EMA should be appropriately resourced to enable it to proactively offer scientific advice and provide innovative biotech companies, including SMEs and developers of novel antimicrobials, with clarity on the regulatory path to market and time to market;

Added94. Recalls the ongoing backlog of GMP inspections due to the COVID-19 pandemic, which must be urgently addressed; stresses that mutual recognition agreements with non-EU regulators, such as the US FDA, are important to resolve this backlog; underlines that the EU’s backlog of inspections now risks growing given the latest decisions of the US administration to defund the FDA and to prioritise domestic GMP inspections; stresses, in this regard, the EU’s vulnerability in its ability to inspect manufacturing facilities, which is a major challenge to increasing biotech manufacturing capacity and therefore EU competitiveness and strategic autonomy in public health; calls, in this regard, for the conclusion of additional mutual recognition agreements with like-minded partner countries;

Added95. Stresses the need to urgently restore close collaboration between the EMA and the UK Medicines and Healthcare products Regulatory Agency in order to strengthen innovation in biotech and life sciences across all of Europe, including but not limited to the EU;

Added96. Calls for better coordination between key agencies and regulators, including the EMA, the European Centre for Disease Prevention and Control, the Commission’s Directorate-General for Health and Food Safety and the Health Emergency Preparedness and Response Authority; calls, furthermore, for work to be carried out to ensure that the EU is seen as the best place in the world to invest in life sciences and biotechnology R&D, manufacturing and clinical trials;

Added97. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.