Euro Roundup: Politicians call for urgent fix to property problems that are using up EMA resources

A European Parliament committee has called for urgent action to find “a long-term political resolution” to the subletting of EMA’s former offices in London. The committee said the current situation requires the European Medicines Agency (EMA) “to divert significant resources from its public health activities.”

Before the Brexit vote, EMA agreed to lease property in London until 2039. The subsequent UK vote to leave the European Union left EMA needing to find a new home and find a solution for the £500 million ($634 million) lease on its old office. After a court ruled against its attempt to cancel the lease, EMA struck a deal to sublet the office to WeWork in 2019.

WeWork filed for bankruptcy in November and, according to reports in publications including Politico, has stopped paying rent to EMA. The agency reportedly asked the European Union for almost €4 million to cover costs this quarter and said covering rent and bills will cost around €30 million a year without a sublet agreement. The estimated outstanding rent, charges and insurance was €366 million at the end of 2022.

Commenting on EMA’s budget, the Committee on the Environment, Public Health and Food Safety called for the European Commission to “secure a long-term political resolution of this issue and to allow the agency to fully focus its efforts on its public health mission.” Without a political resolution, EMA may face the distraction of finding a tenant at a time when vacancies in the London office market are at a 30-year high. In September, analysts said the market was in a “rental recession.”

The Parliament committee also used the budget opinion to warn that “inadequate resources for the EMA may undermine the ability of the agency to deliver on its mission.” Committee members want the Commission and Council “to allocate adequate EU funding to ensure the agency has enough resources to carry out all of its activities on the wide range of regulatory mechanisms.”

ENVI Opinion

EMA seeks feedback on plans to update hepatitis B clinical trial guidance

EMA has published a draft concept paper on plans to revise its guideline on the clinical evaluation of treatments for hepatitis B. The agency is seeking feedback on the need to update the guidance in light of international conferences to discuss the endpoints in hepatitis B trials.

Since EMA published the current guideline in 2006, companies have sought scientific advice on “new products and treatment strategies aimed at achieving functional cure, including finite and combination treatment regimens,” the agency wrote. The field has also worked on antiviral and immunomodulatory treatments with different mechanisms of action than nucleos(t)ide analogue or peg-interferon alfa24 2a.

The current guideline covers clinical study designs and endpoints that are relevant to those traditional classes of hepatitis B drugs. EMA sees a need to adapt its advice to the capsid assembly modulators, silencing RNAs and antisense oligonucleotides, nucleic acid polymers and immunomodulatory therapies like Toll-like receptor agonists, checkpoint inhibitors and monoclonal antibodies that companies have begun to test in hepatitis B patients. The goals of hepatitis B trials have changed, too.

“Since adoption of the current guideline, undetectable HBV DNA, and a combined endpoint of sustained suppression of HBV DNA and sustained HBsAg loss have been accepted as surrogate markers for efficacy in studies evaluating chronic suppressive and finite therapies, respectively. Therefore, the acceptable and recommended primary endpoints for clinical trials have changed,” EMA wrote.

EMA plans to update its guidance to support trials of potential functional cures, including by proposing new endpoints and discussing the efficacy and safety implications of stopping suppressive nucleos(t)ide analogue treatments. The agency is seeking feedback on the draft concept paper until the end of April and aims to finalize the document in May.

Draft Paper

Swissmedic sets deadlines for assessing cancer risk of nitrosamine impurities

The Swiss Agency for Therapeutic Products (Swissmedic) has set deadlines for assessing the risks posed by nitrosamine drug substance-related impurities (NDSRIs).

There is no specific experimental data on NDSRIs to show whether they cause cancer. The Carcinogenic Potency Categorization Approach (CPCA) allows risks to be identified through a structural comparison with nitrosamines with known carcinogenic potential. Swissmedic is prioritizing the highest CPCA risk categories.

The agency gave marketing authorization holders until the end of January to identify preparations with the potential to form NDSRIs in CPCA categories 1 and 2. Companies with products in those categories must analyze their preparations “using validated and sufficiently sensitive methods” and send Swissmedic the results by the end of September.

Swissmedic Notice

EU, US trade groups push for single development program for complex generics

Trade groups representing off-patent drugmakers in the EU and US have called for a regulatory framework that enables a single development program for complex generic medicines.

In a joint statement, Medicines for Europe and its US counterpart the Association for Accessible Medicines said “the current regulatory practice entails the unnecessary repetition of the same or very similar clinical studies across regions, using local comparator products in each case.” The requirements are “resource-consuming” and “scientifically unethical,” because they necessitate “superfluous” human testing.

The trade groups said a single development program would “avoid study duplications, cut development program inefficiencies and better respond to patient needs,” adding that there is no legal barrier to the approach in the EU or US.

Joint Statement

EFPIA calls for compromise as European Health Data Space talks enter final stages

EFPIA is calling for a compromise on the European Health Data Space (EHDS) to balance “the desired improvement of data sharing mechanisms with the preservation of a competitive European innovation ecosystem.”

With discussions between EU bodies advancing, the pharma trade group has set out recommendations on how the framework can foster innovation, ensure the representativeness of data and provide a “global ecosystem for medical research.” The recommendations cover long-standing points of contention such as the introduction of an opt-out mechanism.

“The inclusion of an opt-out and even in some cases opt-in mechanism may jeopardize the development of future innovations by reducing the overall amount of data in the EHDS,” EFPIA wrote. If lawmakers want to insert “a general opt-out right,” EFPIA believes it should cover a limited set of data categories.

EFPIA Statement

MDCG shares device-specific vigilance guidance to harmonize adverse event reporting

The Medical Device Coordination Group (MDCG) has published a set of Device Specific Vigilance Guidance (DSVG) documents to harmonize the reporting of events linked to certain types of technology.

MDCG has created DSVG for cardiac ablation, coronary stents, cardiac implantable electronic devices and breast implants. Each document features examples of the types of device-related problems that should be reported as individual serious incidents, included in Periodic Summary Reports or reported at the time the trend is identified.

For example, the guidance on coronary stents and associated delivery systems states that cardiogenic shock should be reported as an individual serious incident, but infections only need reporting when a trend is identified.

MDCG Guidance

Other News:

A European Commission analysis of the use of EU antitrust and merger rules has found “active enforcement ... continues to play an important role in delivering European patients' access to a wider choice of affordable and innovative medicines.” Press Release

Euro Roundup: Politicians call for urgent fix to property problems that are using up EMA resources

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