Euro Roundup: European Commission moves to simplify EMA fee legislation

The European Commission is planning to update and simplify the legislation on fees charged to drug and medical device companies, aiming to ensure that fees better reflect the underlying costs of the work done and coordinated by the European Medicines Agency (EMA).
 
In 2019, the Commission ran a consultation on plans to change the fee legislation that drew responses from organizations including EMA. The consultation and broader review of the current legislation found an array of problems with the existing system, including misalignment of fees with the underlying costs of the work, rigidity that makes it hard to keep pace with innovation and complexity that creates unnecessary burdens. The Commission found the issues are a challenge to EMA’s financial sustainability.
 
The Commission identified four potential ways to reform the system, ranging from only making changes to resolve problems created by the Veterinary Medicinal Products Regulation though to the introduction of a cost-based fee system for all activities and the significant simplification of the fee structure.
 
Officials identified the second most significant overhaul of the system, which uses a cost-based principle and partial simplification of the fee system structure, as the most efficient option. The preferred option is one of two choices that the Commission envisions placing “a slightly reduced administrative burden” on companies that pay for EMA services. Officials also expect the option to make fees more predictable.
 
The proposal features “an effective and proportionate monitoring and evaluation framework.” According to the Commission, the framework will “support future changes in the EMA fee system by providing a factual basis for adjustment of fees and remuneration.” Flexibility of the fee system could be achieved by delegating powers to the Commission to adjust the fee system, based on the monitoring data.
 
Commission Notice
 
EMA task force warns anti-SARS-CoV-2 antibodies unlikely to work against new COVID strains
 
EMA’s Emergency Task Force (ETF) has warned that monoclonal antibodies currently authorized for use in the treatment of COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2.
 
Four anti-SARS-CoV-2 monoclonal antibodies—AstraZeneca’s Evusheld, Celltrion Healthcare’s Regkirona, Roche’s Ronapreve and GSK’s Xevudy—are authorized for use in the EU. EMA has shared advice on the use of a fifth antibody combination—bamlanivimab and etesevimab—but Eli Lilly pulled its submission late last year after concluding it was unable to meet a request from the regulator.
 
Because the antibodies were developed in response to the ancestral strain of SARS-CoV-2, their efficacy has been affected by the rise of variants with different spike proteins, potentially rendering the monoclonal antibodies ineffective. According to EMA, recent laboratory studies show that the drugs do not significantly neutralize BQ.1 and BQ.1.1, the Omicron subvariants that are expected to become dominant in the EU in the coming weeks. The European Centre for Disease Prevention and Control expects the two subvariants to account for more than 80% of cases in the EU by January. The rise of the subvariants is probably driven by immune escape.
 
EMA is unsure how the reduced neutralizing activity seen in the lab will affect real-world efficacy, but it is advising healthcare professionals to consider alternative treatments. The agency named antiviral drugs such as Pfizer’s Paxlovid and Gilead Sciences’ Veklury as authorized therapies that are expected to retain their activity against the emerging strains.
 
EMA Notice
 
MDCG creates templates to support IVDR performance study procedures until EUDAMED arrives
 
The Medical Device Coordination Group (MDCG) has published a series of application and notification documents to support In Vitro Diagnostic Regulation (IVDR) performance study procedures. Performance studies are one of the ways companies can show they meet the clinical requirements of IVDR.
 
MDCG, which assists the European Commission with the implementation of MDR and IVDR, created the documents to compensate for the absence of the European database on medical devices (EUDAMED). Once the EUDAMED module for performance studies is fully functional, sponsors will use the database to inform the member states in which they are running a study of their plans.
 
For now, sponsors can use the MDCG templates. The group has shared templates for a range of activities related to performance studies, including applications and the addition of sites, performance devices and comparator devices. In a separate but related update, MDCG released a template for the substantial modification of performance studies.
 
The use of the templates by competent authorities and sponsors is “encouraged,” MDCG said, but “it is important to check with the individual Member State in which the performance study is planned to be conducted for any specific national requirements.” MDCG envisages the templates being withdrawn after the EUDAMED performance study module goes live.
 
MDCG Guidance, More
 
In feedback to EMA, Merck pushes back against ‘mildly offensive’ terminology in ICH guideline
 
Merck & Co. has called for the removal of terms from an International Council for Harmonisation (ICH) draft because they “are outdated and mildly offensive given the current state of the world.”
 
Responding to EMA’s request for feedback on an ICH guideline on drug interactions, a representative of Merck, which is known as MSD outside the U.S. and Canada, proposed a change in the language used to describe the drugs involved in pharmacokinetic interactions.
 
“Throughout the document the role of the drugs involved in drug interactions are referred to as ‘victim’ and ‘perpetrator.’ These terms are outdated and mildly offensive given the current state of the world,” Merck wrote. “This guidance could help usher in a better way to talk about [drug-drug interaction] instead of unnecessarily reminding those involved of either perpetrators or victims.”
 
The ICH draft uses victim to describe when other drugs affect an investigational product and perpetrator to describe an investigational drug that interacts with concomitant drugs. Merck told EMA that the text should use object instead of victim and precipitant instead of perpetrator.
 
Industry Feedback
 
Swissmedic gets government backing for 2023-2026 strategy to support innovation, digitalization
 
The Swiss Agency for Therapeutic Products (Swissmedic) has secured approval for its 2023 to 2026 strategic goals from the executive body of the federal government.
 
Swissmedic’s goals state that it “must constantly renew and expand its competencies so that it can keep pace with the many developments in its operating environment.” Over the period covered by the strategy, the regulatory agency envisages “new technologies” further increasing “the effectiveness and efficiency of market surveillance of medicinal products and medical devices.”
 
The strategy calls for Swissmedic to “actively support” development of innovative therapeutic products, thereby promoting rapid access to novel therapies. National and international cooperation and communication with the public also remain on the agenda.
 
Swissmedic Notice
 
Other news:
 
The Committee on the Environment, Public Health and Food Safety has warned EMA is under “significant pressure” in its review of the agency’s budget for 2021. ENVI Opinion