Euro Roundup: Council’s adoption of wastewater rules triggers backlash from pharma industry

The European Council has adopted rules on the treatment of urban wastewater, advancing legislation that pharma groups have said will have a “negative impact on patient access” and “generate a tsunami” of drug shortages.

The Council's formal adoption marks the final step in the legislative procedure. The pharma industry pushed back against aspects of the legislation throughout the procedure but ultimately failed to secure its desired changes. The directive will now be signed and published, triggering a 31-month transition period to allow countries to adapt national legislation to account for the new rules.

Pharma trade groups responded to the Council's adoption of the legislation with more warnings about the rules' potential impact. Medicines for Europe, a group representing off-patent drugmakers, issued a particularly strongly worded statement.

Like their branded counterparts represented by EFPIA, off-patent drugmakers have criticized the decision to make the cosmetic and pharma industries pay for additional treatment to remove micropollutants. Medicines for Europe said the extra costs would threaten the drug supply.

“If implemented in the current form, the direct economic impact of the directive will lead to massive shortages of essential and critical medicines in Europe due to lack of economic viability,” Medicines for Europe said.

Because the profit margins on generic medicines are relatively small, off-patent drugmakers are more vulnerable to changes that increase costs than their branded counterparts. Medicines for Europe quoted estimates that put the system's annual costs at €5 billion ($5.4 billion) to €11 billion ($11.8 billion).

The Council said pharmaceutical and cosmetic producers would need to contribute at least 80% of the additional treatment costs, based on the premise that those industries are the primary source of micropollutants in urban wastewater. EFPIA criticized the decision to target the two industries, calling it arbitrary and arguing that it failed to incentivize greener product development for all polluters.

EFPIA is continuing to argue against the rules because the implementation of the legislation will inform its impact. The trade group said European countries had raised concerns about only two sectors being picked to finance the costs and the unintended impact on medicine availability and affordability. EFPIA also noted calls for the European Commission to perform an urgent impact assessment.

The group wants to collaborate with national policymakers to ensure “the directive is implemented in a fair, predictable, and non-discriminatory manner while ensuring access to medicinal products.” EFPIA hopes “all sectors that contribute to micro-pollutants in the water will be considered” when the rules are implemented nationally.

Council Notice, EFPIA Statement, Medicines for Europe Statement

MHRA details plans to relaunch Innovative Licensing and Access Pathway in 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a statement about its intent to open the relaunched Innovative Licensing and Access Pathway (ILAP) for applications in March.

Working with the National Institute for Health and Care Excellence, MHRA developed and launched the original pathway in 2021 to accelerate time to the UK market for innovative medicines. Successful ILAP applicants received Innovation Passports. MHRA and other agencies developed roadmaps for regulatory and development milestones for candidates with the passports.

MHRA has highlighted the program's successes, claiming it received an “unprecedented number of applications” and awarded 166 Innovation Passports. However, the UK life sciences sector has evolved, MHRA said, and new regulatory initiatives, such as the international recognition procedure, are in place.

The changes have prompted MHRA to reconsider and relaunch ILAP. Criticisms of the first version of the pathway included claims that the offer was not clear enough, the entry criteria were overly permissive, and a lack of direct NHS involvement to support the timely adoption of ILAP products. MHRA said it heard the permissive entry criteria made the pathway unsustainable.

MHRA highlighted key improvements in the relaunched ILAP. The pathway will provide a better-quality bespoke service through more selective entry, MHRA said, and simpler roadmaps and predictable timelines that enable developers to plan more effectively. The new entry criteria focus the pathway on candidates that “provide a step-change in care while also addressing unmet needs in the NHS.”

The voice of the NHS, the UK health service, has been built into the new pathway. MHRA said, “The NHS will be involved as a core partner and will bring a focus on operational planning and system preparedness for the introduction of innovative new medicines into the NHS for the benefit of patients.”

Other improvements include prioritized scheduling of the ILAP Joint Scientific Advice, the ILAP Access Forums, MHRA scientific advice and pre-submission meetings and access to Clinical Practice Research Datalink. MHRA is expanding the scope of the pathway to cover drug-device combinations. The pathway will focus on candidates who have yet to start confirmatory trials to maximize the impact of ILAP.

MHRA plans to provide more information in January and start accepting applications in March. The agency will stop accepting applications under the first version of ILAP in November “to allow system partners and medicine developers to transition to the new pathway.”

MHRA Statement

EMA Vaccine Working Party lists guidance development activities for next year

A European Medicines Agency (EMA) working party has outlined the vaccine regulatory documents it will work on for the remainder of this year and into 2025.

The Vaccine Working Party shared details of its activities in its three-year rolling work plan. This year, the group aims to finalize an addendum to its guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals. EMA closed a consultation on a draft version of the addendum in late October.

The working party plans to finalize the addendum while revising its interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union. The current version of the guidance took effect in 2014. Since then, EMA has identified a need to revise the document to improve the quality and quantity of the data collected for regulatory appraisal. Work on the revisions will continue in 2025.

The plan for 2025 also includes developing a concept paper on developing vaccines against orthopoxviruses. The concept paper will be a step toward guidance that “provides clear directions to developers and informs on the requirements for the development of vaccines also with novel platforms,” the working party said.

Work Plan

Türkiye becomes full member of official medicines control laboratories network

A department of the Turkish Medicines and Medical Devices Agency has become a full member of a network of official medicines control laboratories (OMCLs) that conduct quality control testing for national competent authorities.

The department has become the first Turkish lab to become a full member of the General European OMCL Network (GEON). The European Directorate for the Quality of Medicines & HealthCare (EDQM) coordinates GEON to facilitate communication and knowledge-sharing, harmonize standards and testing methodologies and pool resources across 68 laboratories from 42 countries.

Türkiye acceded to the Convention on the Elaboration of a European Pharmacopoeia in 1993 and formally requested GEON membership in 2022. The country became a full member in August but EDQM only publicized the news this week.

EDQM Statement

Euro Roundup: Council’s adoption of wastewater rules triggers backlash from pharma industry

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