Kevin McKenna

The Medicines and Healthcare products Regulatory Agency (MHRA) greatly welcomed the £10 million of funding announced by HM Treasury in March 2023, which has enabled the MHRA to make progress on the Innovative Licensing and Access Pathway (ILAP).

The ILAP harnesses the collective expertise of the regulatory and health technology assessment systems and National Health Service bodies, with the aim of supporting medicines from an early stage through to patient access more quickly. Since its launch in 2021, 166 Innovation Passports have been awarded.

The United Kingdom’s life sciences ecosystem within which the ILAP sits has evolved, with new regulatory initiatives such as the international recognition procedure. On Wednesday 6 November 2024, the ILAP partner organisations published a statement of policy intent on the relaunch of the ILAP. The new ILAP will continue to target timely patient benefit, take forward lessons learnt from the ILAP to date, and respond to the needs of our fast-paced life sciences sector by providing a more compelling offer of support to the medicine developer. The new ILAP will open to applications in March 2025, with full details of the pathway to be published in January 2025.

The new building safety regime puts in place more stringent oversight for the safety of high-rise residential buildings, with clearer accountability backed by stronger enforcement and sanctions to deter and rectify non-compliance.

The new regulatory requirements also require all people responsible for higher-risk buildings to capture and report certain fire and structural safety issues (mandatory safety occurrences) to the Building Safety Regulator.

There is a pathway to fixing unsafe cladding in all 11 metres+ residential buildings in England through developer, social housing provider and government funded remediation programmes.

Any contribution required from qualifying leaseholders for non-cladding defects and interim measures is firmly capped and spread over 10 years, with costs already paid out since 28 June 2017 counting towards the cap. If remediation costs exceed the cap, building owners must make up the difference. This means that, for the majority of qualifying leaseholders, the maximum amount that can be charged for non-cladding remediation and interim measures is £15,000 in Greater London (or £10,000 elsewhere in England).

All leaseholders, including those who hold a non-qualifying lease, benefit from qualifying lease status for their principal residence on 14 February 2022 if it is in a relevant building above 11 metres or five storeys. Non-qualifying leaseholders cannot be required to pay more than they would have done in the absence of the leaseholder protections, i.e., they cannot be required to pay for others’ share of remediation costs.

The Building Safety Act enables provides a route for building owners to pursue remediation contribution orders against developers and contractors – and their associated companies – for funds they have spent or will spend remediating their buildings for relevant defects.