Euro Roundup: MHRA clarifies interim approach for UK-wide approvals

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has set out how it will handle UK-wide approvals through to when it changes its relationship to the European Union at the start of 2025.

Under the Windsor Agreement, MHRA will regain responsibility for authorizing medicines in Northern Ireland, reversing a change implemented as part of the Brexit deal. The new agreement means that, from 1 January 2025, MHRA will authorize new medicines for the UK market and require them to carry a “clearly legible” label that states “UK only.” Medicines sold in Northern Ireland will not display the safety features required under the EU Falsified Medicines Directive.

According to a 9 June communication, MHRA will allow manufacturers to supply medicines in legacy EU packaging until the end of 2024; previously, the regulator required Great Britain-compliant packaging for medicines sold in England, Scotland and Wales by the end of 2023. Legacy EU packs that are already on the market at the start of 2025 can remain until they expire.

All suppliers and distributors need to prepare to use different packaging for the UK and EU markets beginning in 2025. MHRA will share “comprehensive guidance” on its requirements for products sold in Northern Ireland “in due course.” Formal guidance covering labeling requirements and authorizations from MHRA is on the regulatory roadmap.

MHRA also released guidance explains a “bridging mechanism” that the government is creating to avoid the possibility that patients in Northern Ireland will be unable to access new medicines that are available in the rest of the UK.

The mechanism applies to companies that expect MHRA to authorize their products before they receive a decision from the EU. In that situation, MHRA is asking manufacturers to notify it so it can make use of the bridging mechanism. The mechanism allows MHRA to issue authorizations that are valid in Northern Ireland for up to six months. The temporary authorization will allow patients in Northern Ireland to get medicines at the same time as the rest of the UK while they wait for a drug to be approved in the EU.

If a product is yet to get EU approval at the end of the bridging period, the manufacturer will need to stop selling it in Northern Ireland. Products already on the market can continue to be used, and it may be possible for the company to continue supplying the medicine through the existing Northern Ireland MHRA Authorised Route.

Press Release, MHRA Guidance, More

MedTech Europe warns AI Act requirements may conflict with medtech regulations

MedTech Europe has joined with other healthcare stakeholders to warn that the EU’s AI Act may impose “conflicting requirements” because AI-enabled medical devices and in vitro diagnostics (IVDs) are already subject to sector-specific artificial intelligence regulations.

In the joint statement, MedTech Europe argues that the AI Act “must align with all relevant horizontal and sectoral European laws and concepts.” The statement names the Medical Devices Regulation (MDR) and IVD Regulation (IVDR), plus current and forthcoming pan-industry requirements such as the General Data Protection Regulation and Cyber Resilience Act, as examples of potential areas of overlap.

AI-enabled devices and diagnostics “are already regulated under MDR/IVDR as Medical Device Software, while in many respects, AI goes unregulated elsewhere,” the authors state, adding that “in this specific case, conflicting requirements may be imposed if the AI Act were to come into force as proposed by the European Commission.”

There are signs that lawmakers have recognized the problem. The European Parliament’s position aims to remove the conflicting requirements, according to the joint statement, by “deeming obligations relating to high-risk AI systems as fulfilled if they are already addressed by sectoral legislation.”

MedTech Europe and the other signatories of the statement welcomed the Parliament’s position but called for lawmakers to make an additional reference to notified bodies “as this would further integrate the requirements laid down by sectoral legislation.”

“If not adequately addressed during the trilogue negotiation, the AI Act may risk creating two-track systems, one applicable to the AI component of a device, and the other to the MD or IVD component of a device. This could create legal uncertainty and obstacles in delivering the ethical, safe and effective devices that this Act intends to support,” the healthcare stakeholders wrote.

Press Release, Joint Statement

Off-patent drugmakers call for ‘significant improvement’ to SPC manufacturing waiver

Medicines for Europe has found “ample consensus” that the Supplementary Protection Certificate (SPC) manufacturing waiver needs “significant improvement in several aspects in order to be able to produce the results it is intended for.”

The trade group, which represents manufacturers of generics and biosimilars, made the statement in its review of the first year of the waiver. The EU introduced a waiver for the SPC, a mechanism for extending the market protection of patented medicines, in July 2022 to address unintended consequences that the trade group said disadvantaged manufacturers based in the EU.

To understand the effects of the waiver, Medicines for Europe surveyed its members earlier this year. More than half of the 13 responding companies have used the waiver and uptake “seems to be gradually growing.” Respondents said the waiver has had a significant impact on their business.

However, the respondents have only located production of half of their products in the EU since the SPC waiver was adopted. “The main reason for opting for a non-EU supply were the complexities embedded in the legislation which cause legal uncertainty, unnecessary disclosure of confidential information, unnecessary limitations and the risk of frivolous/abusive litigation,” the trade group wrote.

Medicines for Europe is calling for lawmakers to “remove existing discriminations against EU based pharmaceutical manufacturers.” Specifically, the trade group wants to restrict the information that is published as part of the SPC waiver notification process and eliminate “unnecessary ‘due diligence requirements.’ ”

Press Release, Industry Report

UK shares Biological Security Strategy, makes shaping regulations an indicator of success

A government policy paper on biological security has called for the UK to “shape regulations and standards” internationally to support resilience “to a spectrum of biological threats.”

The policy paper marks the first time the UK has published a Biological Security Strategy since COVID-19. In the document, the government sets out how it aims to increase the resilience of the UK to biological threats by 2030. Several aspects of the policy cover the limitations of current regulations and plans to improve the situation.

One goal is to make “the UK a world leader in responsible innovation by 2030, shaping international norms and standards.” Influencing the World Trade Organization’s regulations and standards is part of the plan.

The policy paper also identifies areas in which regulations held back the response to COVID-19, noting that “a lack of clear specifications, and insufficient global regulatory harmonization” initially hindered the work of companies developing tests for SARS-CoV-2.

Security Strategy

Euro Roundup: MHRA clarifies interim approach for UK-wide approvals

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