Euro Roundup: Commission seeks feedback on procedural rules for joint scientific consultations
The European Commission has posted a draft implementing regulation that sets out detailed procedural rules for joint scientific consultations under the Health Technology Assessment Regulation (HTAR).As part of HTAR implementation, the Commission must create and maintain an IT platform that health technology developers can use to request joint scientific consultation. After receiving a request, which should include the dossier of information, data, analyses and other evidence, European authorities may arrange for joint scientific consultations to take place in parallel to scientific advice from the European Medicines Agency (EMA).
The draft implementing regulation fleshes out the process, providing details about submitting requests, selecting and consulting stakeholders, and exchanging information with EMA.
The coordination group will have at least two request periods each year and share the dates by the end of November of the preceding year. During a request period, applicants can file using the IT platform. The draft describes the actions authorities will take in response to requests, covering the notification of EMA, the selection of people with expertise in the disease, and the formation of confidentiality agreements.
Applicants will receive a deadline for submitting a briefing package. The assessor or co-assessor will ask for package amendments if they identify a need for “further specifications or clarifications or additional information, data, analyses or other evidence” or conclude a question is outside of the scope of the joint scientific consultation process.
Individual experts will receive the final briefing package 30 days after its submission or, in the case of parallel EMA processes, 30 days after the application is validated. Additional rules apply if the consultation occurs in parallel to the EMA scientific advice process. Applicants need to submit the briefing packages for joint consultation and scientific advice at the same time.
After assessing the briefing package, HTA authorities will send a list of questions to cover at the meeting and, if necessary, questions to answer in writing before the meeting. Written responses, plus materials or presentations, must be submitted at least 10 days before the meeting. The meeting will generate a joint scientific consultation outcome document.
The Commission is accepting feedback on the draft until 29 October. The publication of the draft text coincided with an update to the rolling plan the Commission maintains to track the implementation of HTAR.
EU Consultation, Press Release, Rolling Plan
As Class D oversight moves to EURLs, Team-NB discusses impact on conformity assessment
The notified body trade group Team-NB has set out what the transition of oversight for Class D in vitro diagnostics (IVD) to European Reference Laboratories (EURLs) will mean in practice.
Under the IVD Regulation, EURLs are involved in performance verification and the release of individual batches for Class D diagnostics. While authorities are yet to designate EURLs for some types of IVDs, laboratories for tests for hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses that cause life-threatening diseases are in place.
“For Class D devices with certificates issued or applications received by a Notified Body before 1 October 2024, performance verification activities will need to be conducted before recertification,” Team-NB said. “For applications received after 1 October 2024, performance verification activities will be part of the initial conformity assessment of the Class D device before the Notified Bodies issue the certificate.”
Team-NB said batch verification activities for Class D devices should begin as soon as possible after 1 October or once the device is certified. The trade group said its members have collaborated with EURLs for several months to ensure a smooth transition. The work has included “significant efforts” to standardize Class D oversight and documents used for batch release and performance verification.
Notified bodies can continue their current batch-release process if problems such as logistical issues, verification or validation of equipment and training of staff prevent EURLs from carrying out tests. The fallback option could prevent shortages in the lag between the official end of the transition and the date on which testing of a specific device by an EURL can start.
Press Release
EMA finalizes guideline on the quality of locally applied, locally acting cutaneous products
EMA has finalized its guideline on the quality and equivalence of locally applied, locally acting cutaneous products more than five years after closing the consultation period.
The agency collected comments on the draft from December 2018 to June 2019. In feedback published by EMA this week, EFPIA called the guidance “important” and said it was “broadly in agreement with the guidance.” The trade group noted areas where the draft overlapped with other guidelines and called for changes to minimize the risk of conflicting frameworks.
This week, EMA shared the changes it has made in response to feedback from EFPIA and other groups. The agency removed references to topical products from the title and body of the document, resulting in the deletion of large sections of the introduction to the guideline.
The section on therapeutic equivalence has also undergone significant changes. The final guideline adds details of a stepwise approach to the demonstration of therapeutic equivalence. EMA also added a third pharmaceutical equivalence acceptance criteria that covers physicochemical and structural characterization.
Reflecting EFPIA’s concerns about overlapping documents, EMA has deleted text about products that contain flammable materials or accelerants. The agency also clarified the scope of the text in response to feedback, explaining that the guideline is “applicable to certain cases of demonstration of therapeutic equivalence of a new cutaneous medicinal product with an existing cutaneous medicinal product.”
EMA Guideline
ABPI urges UK government to act as NICE opts against changing how it values medicines
The UK government it must free the National Institute for Health and Care Excellence (NICE) to unlock access to medicines for severe conditions, according to ABPI.
The intervention followed a meeting of the NICE board. where the board opted against changing how it values medicines for severe health conditions. ABPI said that it believes the method is causing patients who would have gained access to medicines under a previous system to miss out on new treatments. The issue, as ABPI sees things, is that NICE is constrained by the government.
“NICE’s hands have been tied by having previously been instructed to ensure that any change to its methods did not result in higher costs overall,” Paul Catchpole, director of value and access policy for ABPI, said in a statement. Catchpole said the combination of the constraint and “other strong spending controls on the medicines budget agreed with the industry” means patients inevitably miss out.
The NICE board committed to researching how the public wants medicines for severe conditions to be valued. Catchpole welcomed the plan but, with NICE setting a two-year timeline for the research urged the organization to be more ambitious about how quickly it completes the work.
Press Release
Other news:
EFPIA has outlined its position on the European Health Data Space (EHDS) Regulation’s proposed opt-out mechanism. The trade group, which warned about the risks of allowing patients to opt out throughout the EHDS drafting process, stressed the importance of avoiding fragmentation and bias, limiting the mechanism to personal data, and creating a centralized system for opting out. EFPIA Notice
