Euro Roundup: EU court dismisses industry’s call to annul wastewater treatment directive

A European Union court has dismissed multiple requests to annul the Urban Wastewater Treatment Directive (UWWTD) because they failed to meet the legal requirements to challenge the law.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a group of generic drugmakers including Teva and Viatris, and Cosmetics Europe separately filed to have UWWTD annulled. For the court to consider the cases, the groups needed to show the act is “of direct and individual concern” to them. Each applicant failed to meet that requirement, the court ruled, leading to the dismissal of the cases.

The generic drugmakers told the court they would bear between 57% and 62% of total fees under the law, despite their products making up 17% of the value of the pharmaceutical market. Imposing the fees would undermine the business model and, ultimately, the security of generic drug supply, the companies argued. However, the court said the “mere fact” a company may lose even a major source of income is not enough to establish that the law applies to them individually.

EFPIA argued that the innovative pharmaceutical companies it represents belong to a closed group. Yet the court said that “the applicant merely asserts the existence of that subgroup without adducing any evidence that would make it possible to identify the companies which are part of it, to assess its standing to bring proceedings, or to demonstrate that the applicant represents its specific interests.”

Although the court dismissed the cases, EFPIA and Medicines for Europe, a trade group representing off-patent drugmakers, both identified encouraging points for their causes in the rulings and vowed to keep challenging the directive.

Medicines for Europe said the court dismissed the cases on a “mere procedural matter” and took “a very conservative approach” to determining whether the legal challenges were admissible. The trade group said the ruling is not a judgment on whether the directive violates EU law and threatens secure medicine supply.

EFPIA said it will continue to challenge the directive. The trade group said the Irish Pharmaceutical Healthcare Association (IPHA) is progressing its case in the High Court in Ireland. IPHA is seeking a referral to the Court of Justice of the European Union (CJEU) for a preliminary ruling on the validity of the UWWTD.

EFPIA Ruling, Accord Ruling, EFPIA Notice, More

UK shares guidance on seeking integrated scientific advice from MHRA and NICE

The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) have shared guidance on their integrated scientific advice (ISA) service.

MHRA and NICE decisions determine whether patients can access medicines in the UK, with the former authorizing drugs and the latter assessing whether they meet the criteria for use by the public health service. Seeking to minimize the lag between approval and access, the organizations adopted a joint scientific advice service. ISA replaces the old service.

“It’s designed to support earlier patient access to medicines by helping companies adhere to aligned pathway timelines,” MHRA and NICE said. “By clarifying regulatory and HTA evidence requirements early in the development process, companies can optimize clinical development plans and reduce the risk of unforeseen delays.”

The organizations have published guidance describing the scope of ISA, how to access the service, the timeline for receiving advice, fees, and how to prepare for meetings. Indicative timings show applicants could receive a final report from the ISA team 70 days after determining that they are eligible for the service. Applicants have an option to ask for clarifications after receiving the final report.

MHRA and NICE shared the high-level guidance alongside documents addressing specific aspects of the process in more detail. One document lists good questions for ISA, plus good questions with a bias to the expertise of MHRA or NICE. Another document explains how to get the most from meetings by creating a presentation that supports effective discussions.

MHRA Guidance, More

MHRA pauses planned pediatric puberty suppressant trial over concerns for subjects

MHRA has paused preliminary work on a clinical trial of puberty suppressants for children and young people with gender incongruence.

The UK regulator wrote to the study sponsor, King’s College London, to raise concerns regarding the trial. MHRA wants to discuss the inclusion of a minimum age for participating in the trial because of the “potentially significant and, as yet, unquantified risk of long-term biological harms.” At the very least, MHRA wants to set 14 years as the initial lower limit of eligibility. Subsequent trials could lower the limit.

MHRA also identified a need to change the safety monitoring and withdrawal criteria. The agency has proposed strengthening the requirements about treatment discontinuation in the event of bone scan findings, persistent vaginal bleeding, and cognitive effects. MHRA wants the sponsor to get independent advice on what changes in neuroimaging would necessitate withdrawal over cognitive effect concerns.

“Discussions between the MHRA and King’s College London will begin this week to address these new concerns,” politician Wes Streeting said. “I have always been clear about the red lines regarding this trial and the prescription of puberty blockers – the safety and wellbeing of the children and young people and always being led by the expert clinical evidence.”

MHRA Letter, Streeting Statement

Swissmedic prepares to start testing machine-to-machine medical device registration

The Swiss Agency for Therapeutic Products (Swissmedic) has published technical documentation for machine-to-machine (M2M) registration of medical devices in its swissdamed database.

Swissdamed is the Swiss equivalent of Eudamed, an EU database that allows companies to register their medical devices manually, by uploading an XML file, or through automated M2M connections. Setting up M2M connections is more challenging than using the other routes, but the model is more efficient in the long term for companies with large portfolios.

Swissmedic has published M2M documents for swissdamed to enable companies to start preparing to connect their systems to the database. The regulator said it plans to start allowing companies to test their M2M connections in its playground environment at the end of March. Companies should use the test environment to ensure accuracy and prevent costly corrections to registrations, Swissmedic said.

The agency plans to make M2M available in the swissdamed production environment before the device registration obligation enters into force. Swissmedic said it may change the specifications before rolling out the production environment.

Swissmedic Notice

MHRA finds falsified Mounjaro pens, raids sites in illegal weight loss drug investigation

MHRA has found a falsified version of Eli Lilly’s Mounjaro KwikPen for sale at an online pharmacy in the UK.

The agency identified five affected pens, all of which had a faulty mechanism. MHRA said the pens likely contain tirzepatide, the GLP-1/GIP receptor agonist in legitimate Mounjaro, but the pens are not safe to use. In all but one case the dose knob came off while in use, MHRA said. The agency has asked people with the affected products to quarantine the stock.

Separately, MHRA said it has disrupted a facility suspected to be involved in the manufacture of illegal weight loss medicines. The agency seized almost 2,000 doses of unauthorized weight loss medicines awaiting dispatch to customers. An image shared by MHRA shows a package labeled retatrutide, which is an unapproved triple agonist in development at Lilly.

MHRA Notice, More

Euro Roundup: EU court dismisses industry’s call to annul wastewater treatment directive

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