The European Federation of Pharmaceutical Industries and Associations (EFPIA) has confirmed its position on the use of AI in the lifecycle of a medicinal product. This follows the European Medicines Agency (EMA) adopting a reflection paper on the use of AI and machine learning in drug development in October 2024. EFPIA’s position paper sets out a broad acceptance of the EMA reflection paper and outlines six key recommendations intended to realise the potential of AI in medicine development. It confirms that EFPIA supports a risk-based approach to the regulation of AI systems, where the level of regulatory oversight is proportionate to the risk associated with the intended use of the AI system. Additionally, it advocates for a harmonised regulatory framework for AI in the medicinal product lifecycle across the EU to ensure a consistent and predictable regulatory environment.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a statement outlining a set of key proposed recommendations designed to boost EU competitiveness in the pharmaceutical sector. EFPIA’s statement notes that investment in EU pharmaceutical research and development has not kept pace with global shifts. The proposals coincide with high-level European discussions on economic competitiveness and cover several key areas:

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report assessing the economic and societal contribution of industry-sponsored clinical trials in Europe, estimating that 35,000 additional Europeans could gain access to clinical trials if new EU targets aimed at attracting research are met. According to the report, achieving the 11% increase in trial activity target set by the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) would generate an additional €4bn annually for EU healthcare systems and the wider economy, create 18,000 jobs and prevent three million sick days each year, equating to around 500 additional multinational trials over five years and increasing annual trial numbers from 900 to 1,000. The report estimates that industry-sponsored clinical trials currently generate €35.7bn per year across the European Economic Area (EEA), comprising €21.7bn from clinical trial activity, €3.6bn in research and development spillovers and €10.4bn in productivity gains linked to the prevention of 26.9 million sick days annually. The analysis also examines two more ambitious scenarios, finding that a 25% increase in trial activity would deliver an additional €8.9bn in gross value added (GVA) and 79,000 more trial places, while a 50% increase would unlock up to €17.9bn in additional GVA and 158,000 additional places. The report notes that Europe’s share of global industry-sponsored clinical trials declined from 22% in 2013 to 12% in 2023, despite an overall rise in global trial numbers during the same period. The Association of the British Pharmaceutical Industry (ABPI) states that the findings align with its previous UK analysis, which found that industry clinical trials contributed £7.4bn to the UK economy in 2022, including £1.2bn in revenue for the NHS and that restoring activity to 2017 levels would generate an additional £3bn and support 26,000 jobs.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report it commissioned by Lygature outlining its findings on the impact of disclosure activities. The report's research was aimed at understanding the perceived value for public health of various disclosure activities as well as developing an approach to quantify the use and value of disclosure. The report outlines a synopsis of major mandatory and voluntary disclosure types supported by the pharmaceutical industry. Furthermore, it reveals gaps in understanding the broader public health impact of these activities. While some voluntary disclosure websites report metrics indicating added value, these are largely output-related and may not fully capture the public health impact. It is suggested in the report that a more comprehensive approach to measurement is warranted. For mandatory disclosure venues, no systematic reporting of indicators measuring potential public health impact was found.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has has published research by Charles River Associates that compares the EU's attractiveness for pharmaceutical investment with that of the US, China, the UK and Switzerland. The report analysed 20 indicators spanning regulatory frameworks, innovation systems and commercial environments. In 2024, the average EU regulatory approval timeline was 430 days, compared with 356 days in the US. In addition, the EU’s share of global clinical trials declined from 22% in 2013 to 12% in 2023. The research estimates that closing these competitiveness gaps could generate an additional €105 billion R&D investment over the next 10 years.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a statement on the signature of the EU-Mexico Modernised Global Agreement and Interim Trade Agreement. EFPIA noted the inclusion of commitments on regulatory data protection and supplementary protection in the intellectual property (IP) chapter, stating that these provisions distinguish the agreement from other EU trade agreements. The agreement also covers public procurement market access and alignment with international regulatory standards and best practices. EFPIA called for the agreement to enter into force promptly and for both the EU and Mexico to effectively implement the IP provisions to ensure that research-based pharmaceutical companies benefit from them.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published three reports, on 12 June 2024, displaying the disparities in the amount of time it takes for European patients to access new medicines, with the average time for patient access being 531 days, across the region. The EFPIA highlights the necessity for medicines to reach citizens regardless of where they live in Europe, and is both a shared goal and a shared responsibility. The Charles River Associates (CRA) report explores the multifactorial reasons for unavailability and delays, and emphasises that even before a medicine is approved in Europe, slow regulatory processes can lengthen the time it takes for new medicines to get to patients. The European Access Hurdles Portal provides further detailed insights into the reasons behind the delays to patients getting access to medicines, and also highlights issues in all the different categories of root causes. Whereas the Patient W.A.I.T. Indicator reports on the time taken from EU marketing authorisation to the reimbursement of medicines in Member States, the portal allows the EFPIA to analyse the timings of different steps in this process.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has recommended the creation of a new Office of European Life Sciences and Competitiveness strategy to accelerate the EU’s position in the life sciences industry. Other recommendations include developing a globally competitive location for manufacturing new technologies through investments into research and innovation and investing in health.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its 2025 Scorecard for drinks and meals, setting out national monetary thresholds for pharmaceutical companies providing food and beverages to healthcare professionals, healthcare organisations and patient organisation representatives. The thresholds, required under Article 10.05 of the EFPIA Code, follow the Host Country Principle where limits are set by national member associations through their respective codes.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released its call for a Competitiveness Strategy for European Life Sciences. The Call includes five pillars to help Europe take an efficient strategy to its life sciences ecosystem—the creation of an EU Office for Life Sciences and a dedicated Competitiveness strategy for European Life Sciences; a European eco-system; establish a globally competitive location for developing and manufacturing new technologies; invest in health; and secure Europe’s place as a strong global biopharma player. EU Government officials have also officially adopted the Strategic Agenda 2024–29, which highlights Europe’s priorities for the next EU mandate following the EFPIA's Call. The Call shares the same objectives of the Strategic Agenda to minimise regulatory burden, get investments and boost the EU's 'attractiveness' to launch medicines. The EFPIA will collaborate and discuss its vision with EU institutions to ensure a healthier, more competitive and resilient Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released a statement outlining its initiatives to reduce its environmental impacts with the aim of addressing climate change and building a resilient health system. The EFPIA is committing to set carbon reduction targets, invest in renewable electricity and clean technology solutions, advance circularity throughout its operations and value chains to improve resource efficiency and collaborate with stakeholders to share knowledge and address concerns associated with Pharmaceuticals in the Environment.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report on the use of Artificial Intelligence (AI) across the medicines lifecycle, highlighting governance challenges and the policy actions needed to ensure responsible innovation. The report calls for regulators to clarify how AI-related exemptions under the EU AI Act apply in practice, adopt adaptive guidance through living Q&A documents and increase transparency by sharing concrete AI use cases, and governance approaches. It also recommends establishing structured engagement pathways, similar to initiatives led by the Food and Drug Administration (FDA), as well as integrating AI oversight into established frameworks such as good clinical practice (GCP), good manufacturing practice (GMP) and good pharmacovigilance practice (GVP). The report further encourages greater international harmonisation between the European Medicines Agency (EMA), FDA and the International Council for Harmonisation (ICH). Additional priorities include developing domain-specific guidance for areas such as pharmacovigilance and generative AI and providing clearer rules on licensing and text or data mining rights for safety reporting.