Euro Roundup: HTA body publishes guiding principles on data transparency, updates JCA answers
A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.
The Coordination Group on Health Technology Assessment (HTACG), which comprises representatives of national HTA authorities, published the principles as part of its work to support the implementation of the legislation. Under HTAR, companies must file data and other evidence for joint clinical assessments (JCAs) and joint scientific consultations. The process necessitates the sharing of confidential information.
Legal interpretations of “commercially confidential information” vary across the EU, leading HTACG to set out how it defines the term in the JCA framework. In principle, trade secrets, structures and chemical analytics, and a company’s development plans are commercially confidential information, HTACG said.
Clinical trial methodologies and results, plus any information that is already in the public domain, are not classed as commercially confidential under the HTACG principles. HTACG also views “evidence synthesis approaches taken including discussions on uncertainties in the results and the underlying information and data used, excluding personal data” as not commercially confidential.
The principles address who can see commercially confidential information submitted by companies. JCA subgroup members must accept confidentiality stipulations. Other people within an organization that is involved in a JCA process can view the dossier, provided they “are bound by the professional secrecy obligations and have ‘need-to-know’ to access that information,” HTACG said.
HTACG published the principles alongside an update to a question-and-answer document about JCAs. Compared to the document published in November, the updated Q&A features seven new questions. The questions cover topics including how to present results in the dossier, whether there is a minimum number of patients needed for subgroup analyses, and literature reviews to identify prognostic factors.
EFPIA sees ‘concerning’ signs MFN pricing may be limiting EU access to new drugs
EFPIA has detected a “concerning” trend in the data on European Medicines Agency (EMA) approvals that suggests most favored nation pricing (MFN) may be constraining access to new drugs.
The Trump administration’s MFN proposals tie US medicine prices to the rates charged in certain reference countries. Currently, the list prices of prescription drugs are typically higher in the US than in the European Union. MFN could force companies to accept lower prices in the US, raise prices in Europe, delay entry to Europe to secure a period of premium US pricing, or skip overseas launches altogether.
Multiple companies have publicly discussed how MFN is shaping their ex-US plans, including by driving them to delay European launches. The latest edition of EFPIA’s WAIT Indicator, the trade group’s look at drug access across the EU, quantifies the reports that companies are deferring global product rollouts.
To assess the impact of MFN, EFPIA tracked the percentage of FDA-approved medicines authorized by EMA. The 12-month rolling average was above 60% in January 2024. The percentage trended downward slowly, with occasional increases, over the next 18 months. Starting in October, “there is an apparent acceleration in the trend,” EFPIA said, with the percentage falling sharply through the cutoff in February.
The trend is not statistically significant and is based on regulatory approvals, rather than submissions. As such, EFPIA said “we need to be cautious of any impact at this stage.” The limitations of the data mean it is “too early to determine the full effect of this policy,” the trade group said, but “the trend is concerning and should be monitored closely.”
EFPIA tracked a larger and longer-term decline in drugs approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). In April 2025, MHRA had a higher 12-month rolling average than EMA. By November, MHRA’s rolling average had slumped to a similar level to agencies in Canada, China, Japan, and Switzerland. UK trade group ABPI said many points in the approval process limit access.
Drugmakers have ideas for how to address the trends. EFPIA argued that MFN makes it particularly important to advance certain proposals. Accelerating EMA approvals and creating an efficient system of European assessments of relative efficacy at the time of launch are even more important goals in the context of MFN, the trade group said.
Other actions could improve monitoring of MFN’s impact. EFPIA has created a portal where marketing authorization holders can provide information on the timing and processing of pricing and reimbursement applications in Europe. The portal will include explanations for why a company has yet to file in a particular market, information that could show the impact of MFN on drug launches in the EU.
In 2022, EFPIA members committed to file for pricing and reimbursement in all EU countries within two years of EMA approval. The sample size is limited, but EFPIA said the data show an early increase in the speed of filings after the commitment. Yet progress stalled in recent updates, and EFPIA warned that MFN’s impact on the timing of EU launches may complicate efforts to analyze the effect of the commitment.
Press Release, EFPIA Report, ABPI Statement
MHRA updates information on RWE scientific dialogs after relaunching program
MHRA has revised its information on real-world evidence (RWE) scientific dialogs after relaunching the service with the National Institute for Health and Care Excellence (NICE).
The UK medicines agency piloted its RWE service last year to assess whether early, structured regulatory engagement could support better evidence generation. The goal was to support collaboration between regulators and applicants to enable decision-making by MHRA and NICE. Outcomes included evidence of the value of early dialog and the identification of a need for clearer regulatory expectations.
Building on the pilot, MHRA will hold ongoing workshops to discuss RWE topics and continue to explore the integration of real-world evidence advice into its existing services. The updated guidance describes the current service offer, including by providing clearer information on the scope, purpose, and eligibility of the new MHRA-NICE scientific dialog initiative.
MHRA has revised the expression of interest process, setting out how applicants can apply and what to expect at each stage, and provided clearer expectations on the type of questions suitable for discussion. The agency implemented the changes to support the transition from a pilot to an established service, for example by providing greater clarity and consistency for stakeholders engaging with the program.
Team-NB reports all notified bodies are available for assessments, for now
All notified bodies have capacity to assess medtech products, but that may change as the end of the regulatory transition period approaches, a survey found.
Team-NB, a notified body association, discussed capacity after assessing the results of an annual survey of its 41 designated members. Notified body employment fell for the first time in more than 10 years. The number of internal employees working on conformity assessments dipped 8% and the number of subcontractors dropped 21%.
“These figures confirm that notified bodies had more than enough resources to meet market needs. Now they have too many resources,” Team-NB said. “Technical resources are overstaffed due to the suspension of manufacturers’ applications and the postponement of ongoing procedures.”
The survey showed a slowdown in notified bodies’ receipt of applications and issuance of certificates in 2025. The slowdown applied to both medical devices and in vitro diagnostics. While the sector currently has excess capacity, Team-NB said “this may change as outstanding applications are received closer to the end of the transition period.”
