On 16 September 2026, the European Medicines Agency (EMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) will hold their ninth annual bilateral meeting — a high-level strategic dialogue covering the most pressing regulatory, access, and legislative challenges facing the European pharmaceutical sector. The EMA-EFPIA bilateral meeting agenda reflects a sector under acute pressure, with five substantive items spanning patient access data, a sweeping regulatory transformation proposal, pharmaceutical legislation implementation, and upcoming EU legislation. The meeting takes place at EMA headquarters (room 0A) and via Teams, chaired by Juan Garcia Burgos, Head of Public and Stakeholder Engagement.

Pipeline Trends and the EFPIA W.A.I.T. Indicator: A Deepening Access Crisis

The meeting opens with EFPIA presenting its most current pipeline and access data, drawing on the 2025 W.A.I.T. Indicator survey covering 168 medicines centrally authorised between 2021 and 2024. The data tells a consistently deteriorating story. As previously reported, quantifying EU medicine access challenges has become increasingly urgent — only 46% of centrally approved medicines were available to patients across the EU27 in 2024, down from 48% in 2019, while the public reimbursement rate collapsed from 42% to 29% over the same period.

Mean time to availability from EMA approval rose to 578 days in 2024, up from 531 days in 2023. For oncology medicines it stands at 586 days; for orphan medicines, 611 days. Country-level inequality remains extreme — Germany’s mean access time of 128 days stands against Portugal’s 840 days, a more than seven-fold gap between the fastest and slowest EU member states.

On the competitive pipeline front, EFPIA’s Industry in Figures data frames the challenge starkly. Europe now originates only 16 new molecular entities per year, versus China’s 46 and the USA’s 28. US pharmaceutical R&D spend at $114.6 billion in 2024 dwarfs Europe’s €56.3 billion. Sales of new medicines launched between 2020 and 2024 went 74% to the USA and only 15.6% to Europe’s top five markets. Proposed 15% US tariffs on pharmaceutical products — applied to an export base of €120 billion from the EU to the US in 2024 — represent an estimated €18 billion cost to the industry and add further urgency to the competitiveness argument.

EMA’s counter-narrative is robust. The EU medicines regulation achievements of 2025 included a record 104 medicines recommended for authorisation, 41 biosimilar approvals, and 16 orphan medicines. The tension in the room is that authorisation and access are two different things — and the gap between them continues to widen.

EFPIA OneVision: A Proposal to Redesign European Regulation

The most technically detailed agenda item is EFPIA’s OneVision proposal, released in November 2025, which calls for a root-and-branch redesign of the EU regulatory framework built around four interconnected pillars.

The first pillar — One Evidence Lifecycle — calls for replacing the current milestone-based, siloed evidence model with a continuous, connected data ecosystem where regulatory, HTA, and real-world evidence are progressively built, shared, and reused across a product’s entire lifecycle. This connects directly to EMA’s DARWIN EU real-world evidence network, now covering 188 million patients across 16 countries with over 100 studies and 32 data partners.

The second pillar — One Process — proposes eight specific shifts: a single entry point, a lifecycle regulatory steward per product, iterative scientific advice replacing milestone-based consultations, an EU Priority Designation framework for transformative innovations, integrated clinical research and regulatory assessment, modernised manufacturing oversight, proportionality in post-authorisation variations, and adaptive risk minimisation informed by real-world evidence.

The third and fourth pillars — One System and One Governance — call for cloud-based regulatory platforms enabling real-time collaboration, a single EU portal for all submissions, and a redefined EMA mandate as central strategic orchestrator. The governance pillar is the most politically sensitive, touching directly on the balance of power between EMA and national competent authorities within the network.

EMA’s response is likely to be supportive on digitalization and process streamlining, while remaining cautious on governance expansion. Companies seeking to demonstrate the value of their innovations through robust evidence strategies benefit from health economics and outcomes research frameworks that align with both regulatory and HTA expectations — precisely the kind of integrated evidence approach that OneVision envisions.

New Pharmaceutical Legislation: From Political Agreement to Implementation

Political agreement on the revised EU Pharmaceutical Legislation was reached in December 2025. As reported at the time, the provisional agreement on EU pharmaceutical reform preserved the baseline regulatory data protection period at eight years plus one year market protection — a significant EFPIA win against the Commission’s original proposal to reduce it to six years. Key provisions include twelve-month extensions for unmet needs or multi-member state trials, a maximum cap of eleven years for orphan or breakthrough products, a novel antimicrobial resistance delinked payment structure, and a Transferable Data Exclusivity Voucher for AMR capped at €490 million in annual EU sales.

The meeting’s implementation discussion is now forward-looking. With the legislation formally agreed, the delegated acts, implementing measures, and EMA scientific guidelines that give it practical effect are being drafted. EFPIA’s focus areas are predictable: the practical criteria for demonstrating EU-wide availability that unlock additional data protection years; transitional arrangements for products already in development pipelines; how the new AMR incentive framework is operationalised; and how EMA’s procedural processes adapt to the new authorisation pathways.

The broader transformation of EU pharmaceutical legislation and EMA’s strategic role within it has been extensively analysed, with the legislative architecture now set but the practical implementation details — which will determine the real-world impact on investment, innovation, and access — still being shaped.

The EU Biotech Act: Timelines, IP Protections, and Competitiveness

The final substantive agenda item covers upcoming legislation, with the EU Biotech Act at the forefront. EFPIA has called on the European Commission to be significantly more ambitious on clinical trial approval timelines. The Act currently proposes reducing multinational trial approval from 106 days to 75 days standard — or 47 days if no further questions arise. EFPIA benchmarks this against the global competitive norm: the UK’s MHRA and China’s NMPA both operate approximately 30-day reviews for innovative drugs under certain conditions.

As covered in the analysis of enhancing European biotech competitiveness through regulatory reforms, the Act also proposes a 12-month Supplementary Protection Certificate extension for biotech-derived products and advanced therapies. EFPIA’s position is that this should be extended to cover all innovative medicines, with clear and predictable eligibility criteria. Where companies succeed in demonstrating the value of these innovations across European markets, robust global market access strategies become essential to translating regulatory approval into patient reach.

The Critical Medicines Act — requiring data sharing on emergency reserves, lowering joint procurement thresholds, and mandating supply resilience over price in tender evaluation — is a further piece of upcoming legislation likely to surface in this discussion, given that 80% of EU active pharmaceutical ingredient imports come from just five countries and 45% from China alone.

The Overarching Narrative

Every agenda item at the ninth EMA-EFPIA bilateral meeting connects to a single overarching argument: Europe is losing ground as a destination for pharmaceutical investment, innovation, and clinical research, and the window to reverse this trajectory is narrowing. The W.A.I.T. data documents the patient access gap with precision. The pipeline and investment data documents competitive decline. EFPIA’s legislative positions — on the Pharmaceutical Legislation, the Biotech Act, the Critical Medicines Act, and the OneVision regulatory transformation agenda — form a coherent, data-backed programme to arrest and reverse that decline.

At this bilateral meeting, EFPIA is likely seeking three things from EMA: operational alignment on the OneVision direction; constructive participation in shaping the implementing measures for the new Pharmaceutical Legislation; and EMA’s scientific voice in support of more ambitious timelines and protections in the Biotech Act. The meeting is structured as a dialogue, not a negotiation — but the positions taken on 16 September 2026 will directly influence the technical implementation decisions that determine whether Europe’s pharmaceutical landscape strengthens or continues to erode.

Frequently Asked Questions

What is the EFPIA W.A.I.T. Indicator and what does it measure?

The EFPIA Patients W.A.I.T. Indicator is an annual survey tracking the availability of and time to access innovative medicines across European countries following EMA marketing authorisation. It measures the percentage of centrally authorised medicines available to patients, the reimbursement rate, and the average time from EMA approval to patient access in each country. The 2024 survey covering 173 medicines found that only 46% were available across the EU27, with a mean wait time of 578 days.

What is the EFPIA OneVision proposal?

OneVision is EFPIA’s November 2025 proposal to transform the EU regulatory framework through four pillars: a connected evidence lifecycle replacing siloed milestone-based assessment; streamlined processes including a single entry point and lifecycle regulatory steward; a unified digital system with a single EU submission portal; and a redefined EMA governance mandate as central orchestrator of the European regulatory network.

How does the new EU Pharmaceutical Legislation affect data protection for medicines?

The revised EU Pharmaceutical Legislation agreed in December 2025 maintains the baseline regulatory data protection period at eight years plus one year market protection, with extensions of up to twelve additional months available for medicines addressing unmet needs or developed across all EU member states. The total maximum is eleven years for orphan or breakthrough products. This was a significant change from the European Commission’s original 2023 proposal, which would have reduced the baseline from eight to six years.