Euro Roundup: Industry groups sound alarm on EMA’s proposed scientific advice fees

EFPIA has voiced support for the European Commission’s proposed reforms of the rules on regulatory fees and charges. However, while the trade group is aligned with the Commission on most key points, it raised fears that changes to the remuneration for scientific advice may have unintended consequences.
 
In December, the Commission set out plans to simplify the legislation governing the fees the European Medicines Agency (EMA) charges drug and medical device companies its services. The plan is intended to align fees and costs, fairly distribute fees and national competent authority remuneration, and strike a balance between a cost-based approach and simplification.
 
The objectives of the update are well aligned with EFPIA’s views, and the group hailed the favored proposal as “the best balance of simplification and proportionality,” according to a statement. The trade group said plans to expand the annual maintenance fee to cover minor variations will “significantly reduce the administrative burden” for companies and EMA while supporting “the appropriate level of regulatory oversight.”
 
However, EFPIA identified a potential problem with the proposal for the remuneration for scientific advice. An annex to the proposal sets remuneration rates for scientific advice coordinators involved in requests related to clinical development, bioequivalence studies, and various other topics. EFPIA is concerned that “remuneration could function as an unintentional deterrent” for national competent authorities (NCA) contributions and slow development of expertise in some agencies.
 
“This comes at the same time as companies are experiencing delays in [scientific advice] procedures. As such, we strongly urge the EC to confirm that the fee and remuneration genuinely reflect the actual costs for NCA participation,” EFPIA wrote. “EFPIA believes the system should be fair and proportionate to the service and resources provided to encourage NCA participation in procedures.”
 
The group wants the cost-based approach to “include indicators of timelines achieved and should be closely monitored and transparently shared,” and for the fees to be “drafted in a way that allows EMA to charge for the full range of scientific advice.”
 
Teva Pharmaceutical picked up on the same theme in its feedback. “We would like to emphasize that the reduction of fees should neither impact the quality nor limit the capacity to perform this advice. For some time now, the industry has been experiencing delays in access to scientific advice as well as a reduction in the extent of the answers to their questions,” the drugmaker wrote. “We would also like to see a clarification on whether the follow-up scientific advice is free of charge or if it will be considered as a new scientific advice charged as an initial one.”
 
Teva is “very concerned by the overly, unjustified high increase in the annual pharmacovigilance fees,” which it thinks will “disproportionately impact generic medicines producers.” The company told the Commission the reason “for such a large increase is not clear, therefore a clear breakdown of the costs should be provided, with a justification of what exactly is going to be additionally funded by this annual fee.”
 
EFPIA Statement, Consultation Response, Teva Feedback
 
UK government frames regulation as a ‘fundamental part’ of realizing its medtech strategy
 
The government has published an inaugural medical technology strategy designed to make the UK a more attractive market by “improving access, shaping our own regulatory framework, leading in research and development and maintaining a strong international market presence.”
 
Regulation is at the heart of the strategy. Since leaving the European Union, the UK has created new medical device regulations to replace the CE mark with the UKCA mark and strengthen the powers of the Medicines and Healthcare products Regulatory Agency (MHRA) to protect patients. Now, officials have released a broader strategy for the industry and articulated the role regulation plays in the plans.
 
“Work is already underway to maximize opportunities in the current landscape, such as new regulatory powers post-EU exit. The regulatory space has clear ownership, with work well underway to maximize opportunities in the current landscape. However, we do recognise that regulation is a fundamental part of realizing our ambitions, so we will work closely with our regulators to ensure that our priorities are supported by the appropriate regulations and guidance.” the government wrote.
 
The medtech policy paper identifies work towards the new UK Medical Devices Regulatory Framework as an existing initiative that “could be further strengthened” through additional government support.
 
Elsewhere, the government lists “regulatory enhancements that can facilitate a proactive approach to supply resilience” as one of the ways to achieve resilience and continuity of supply, one of four priorities in the paper. Officials also see a role for regulatory policy in achieving innovative and dynamic markets their second priority. The government wants regulatory activity to reflect work to provide the industry with “a coordinated national signal on detailed priorities for innovation.”
 
Medtech Strategy
 
MedTech Europe welcomes EU cybersecurity proposals, praises exclusion of MDR/IVDR devices
 
MedTech Europe has published favorable feedback on the EU’s proposed Cyber Resilience Act (CRA), praising the “clear and comprehensive demarcation” between the new policy and medtech regulations.
 
Last year, the European Commission began gathering feedback on plans to create common cybersecurity rules for digital products and ancillary services. As with the separate artificial intelligence proposals, the development of a cross-industry policy raised concerns that CRA would duplicate the requirements set out in the medtech regulations and thereby burden the industry.
 
MedTech Europe commended the Commission on avoiding that problem, stating it supports the fact that products with digital components that are covered by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are outside of the scope of CRA.
 
“The MDR/IVDR’s state-of-the-art safety and security requirements and associated risk assessments, detailed by the MDCG guidance, already meet the CRA’s objectives,” the trade group wrote. “The inclusion of MDR/IVDR-regulated devices in scope of the CRA, would result in a regulatory overlap, potentially giving rise to legal uncertainty and conflicting requirements.”
 
MedTech Europe identified the interplay between CRA and the European Health Data Space as “crucial for manufacturers navigating an already complex regulatory environment.” The trade group wants the Commission to give additional consideration to a wide range of hardware and software “that either support MDR/IVDR-regulated devices or are themselves health IT solutions and health apps.” MedTech Europe highlighted the regulation of software-enabled medical technologies as a concern.
 
Press Release, Consultation Response
 
Other news:
 
EMA has adopted the International Conference on Harmonisation (ICH) updated guideline on quality risk management. ICH updated the Q9 guideline to address the subjectivity of risk assessments, issues with managing supply chain risk, understanding of formality in quality risk management and the clarity of its advice on risk-based decision making. The text will take effect in the EU in July. ICH Q9
 
MHRA has published principles for responding to emerging COVID-19 variants of concern. The guidance provides an approach for understanding the impact of new variants on antiviral drugs and monoclonal antibodies used in the treatment of COVID-19. MHRA has proposed methodologies for in vitro and in vivo testing of the therapies. MHRA Guidance