Euro Roundup: ‘Slow and complex’ drug regulatory framework blamed for EU’s emerging competitive gap

A report ordered by the European Commission has found a “slow and complex” regulatory framework is contributing to the emergence of a competitive gap between the EU and other parts of the world.

Mario Draghi, the former European Central Bank chief and Italian prime minister, wrote the report at the request of the Commission to understand the challenges faced by 10 industries. The section on pharma provides data on the size and geostrategic importance of the industry, discusses Europe’s strengths in trade, manufacturing and science, and identifies an emerging competitiveness gap.

Draghi found the EU is falling behind in markets such as biologicals and cell and gene therapies. From 2012 to 2022, EU-based companies lost five percentage points of market share in the biologics space, while their US counterparts added seven percentage points.

The report identifies the EU regulatory framework as one of four main causes of the competitive gap. The median approval time in 2022 was longer in the EU, 430 days, than in Switzerland, Japan, the US, Australia and Canada. Switzerland was the only other country to take longer than 351 days.

“Industry stakeholders report that compared to the US Food and Drug Administration, the EMA offers less opportunities for direct, structured interaction on scientific advice,” Draghi wrote. “Moreover, the need to interact with multiple EMA committees renders the EU framework complex. Complexities also arise from the links between general pharmaceutical legislation and other pieces of EU legislation.”

Draghi identified the reimbursement process as another problem, noting that there are 27 different national pricing and reimbursement procedures and “a considerable share of products is eventually only launched in a limited number of markets.” The report contrasts the EU unfavorably to the US, “where by and large Medicare (the largest public payer for medicines) covers FDA-approved medicines.”

The report identified lesser and fragmented public R&D investment in the EU, lesser private R&D investment in the EU and a weaker supporting environment, and the complex emergence of a European Health Data Space (EHDS) as the other three key problems.

On the EHDS, Draghi said “there is significant untapped potential to leverage health data in the EU, as demonstrated by the considerable possibilities to access and link datasets in healthcare relative to the US.” GDPR allows the processing of health data but uptake of the options has been uneven, Draghi said, resulting in “the ineffective secondary use of health data.” EHDS is intended to improve the situation.

“To optimize its implementation, it is key to make short-term resources available for the introduction of EU requirements and standards in electronic health records at the national level,” the report said. “This is important notably to enable the cross-border provision of healthcare and patient rights to access their health data in a structured interoperable format.”

Draghi also called for changes that streamline the set-up and management of multi-country trials in the EU. Specifically, the report calls for “rules to address challenges for studies which combine medicines with medical devices and the application of AI,” new coordination mechanisms for facilitating clinical trial initiations and model templates for activities such as interactions between sponsors and sites.

Trade group EFPIA welcomed the report, voicing support for the “holistic view” it takes of the industry and saying it makes “a number of pragmatic recommendations which could help support and incentivise companies working in the region.” The report lacks a medical device section but touches on the sector. MedTech Europe responded with a call for “structural reform” of the device regulatory system.

Draghi Report, EFPIA Statement, More

MHRA publishes guidance on applying for UK Early Access to Medicines Scheme

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on applying for the UK Early Access to Medicines Scheme (EAMS).

MHRA has rewritten an existing document, which walks through each step from applying for a Promising Innovative Medicine (PIM) designation to postmarketing and has published a new overview of the EAMS. The rewritten document lists three criteria for PIM designation and explains when and how to apply for the status before covering the process for requesting an EAMS scientific opinion.

The final section addresses the postmarketing authorization and winding-down period. Winding down is “when an EAMS scientific opinion continues to have effect in specified circumstances or for specified purposes (or both) following the grant of a marketing authorization,” MHRA said. Access to the EAMS medicine for existing and new patients may be considered for up to one year after authorization.

The separate, shorter EAMS overview describes the scheme at a high level, lists the associated fees and dates for submission, and links out to other documents related to the program. There is typically one EAMS filing date a month.

MHRA Guidance, More

EMA seeks feedback on regulation of coprocessed excipients in solid dosage forms

The European Medicines Agency (EMA) is holding a consultation into its position on coprocessed excipients used in solid oral dosage forms.

EMA defines coprocessed excipients as two or more excipients that are processed together, for example through spray drying. The process can provide benefits such as improved functionality, EMA said, but also introduces risks compared to individual excipients. The risks relate to issues such as quality control, formulation development and stability.

The agency has set out its views on coprocessed excipients in a question-and-answer document. EMA’s answers cover using a risk-based approach to categorize co-processed excipients in finished products and the regulatory dossier requirements for the ingredients. An annex lists the risk factors that companies should consider, as well as the impact they can have on the finished product.

EMA is accepting feedback on the draft until 31 December.

EMA Q&A

EMA working parties share goals, plans for guidelines in 2025 to 2027 working plans

EMA working parties for oncology, hematology, and rheumatology and immunology have published their plans for 2025 to 2027, providing an overview of their goals and guideline work for the coming years.

The oncology group is leading work to release two concept papers for consultation in the fourth quarter of 2024. One paper will cover the clinical evaluation of anticancer drugs. The second paper will focus on studies of therapeutic radiopharmaceuticals. The working group plans to start revising the anticancer study guideline and creating a draft reflection paper on treatment optimization next year.

At the hematology group, the near-term focus is on finalizing a guideline on the clinical investigation of human normal immunoglobulin following public consultation in the third quarter of 2025. The group is also aiming to release guidelines on the clinical requirements for sickle cell disease and beta thalassemia for consultation by the end of 2025.

The rheumatology and immunology working plan is a draft for public consultation. The working group is currently working to create or update eight documents, including guidelines on psoriatic arthritis and cystic fibrosis. Work on guidelines for pediatric ulcerative colitis and Crohn’s disease treatments is also due to start this year. The plan for 2026 and 2027 includes idiopathic pulmonary fibrosis guidance.

Oncology, Hematology, Rheumatology and Immunology

Other news:

EMA has recommended steps to mitigate the risks of the century-old painkiller metamizole. The actions are intended to raise awareness of the potential for patients to experience a sudden decrease in a type of white blood cell. EMA Notice

Euro Roundup: ‘Slow and complex’ drug regulatory framework blamed for EU’s emerging competitive gap

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