Healthcare’s Premier Industry Advisor

The European Union (EU) has undertaken several reforms in the life sciences sector, such as in pharmaceuticals, clinical trials, Artificial Intelligence (AI), and digital health. To guide the EU on a path towards a more competitive environment in the healthcare and life sciences sectors, the European Commission (EC) published a new competitive strategy in September 2024, and its findings will steer the EC’s work to improve its attractiveness to this industry. In the first of a two-part series, Marwood analyses how these recommendations may develop over the medium-term and assesses the impact they may have on the EU’s pharmaceutical and clinical trials sectors.

Following the two-year anniversary of the signing of the Inflation Reduction Act (IRA), Marwood takes a closer look at the state of clinical trials. In this piece, Marwood analyzes the IRA’s potential impact on clinical trial starts for industry-sponsored mid-(Phase II) and late-stage (Phase III) trials. Additionally, Marwood examines Phase I trial starts, which is likely more closely linked to early-stage biopharma companies. Marwood notes that for early stage companies the current challenging capital market environment may also be an influence on clinical trial activity.

Skilled home healthcare is a growing area of interest as the industry experiences strong tailwinds driven by an aging US demographic. Home health has always appealed to patients and providers as it allows patients to remain in their preferred setting and reduces costs for providers. The increase in the US population that typically receives home healthcare creates an opportunity and challenges, such as staff shortages, that must be addressed to serve this growing market. In this piece, Marwood explores the outlook for the skilled home healthcare market, including growth drivers and ways in which providers are navigating through potential challenges to prepare for the increasing market demand.

Following The Labour Party’s election win on 04 July 2024, Marwood takes a closer look at how the change in Government may impact the volume of National Health Service (NHS) outsourcing to the Independent Sector (IS). In this piece, Marwood examines Labour’s 2024 manifesto pledges around reducing wait times for elective care in the context of the current economic and social climate, as well as historic precedence. On the one hand, Labour campaigned hard on saving our NHS, implying a negative impact on the IS, and on the other they promised reductions in waiting times and lists for elective care. In this piece Marwood weighs these seemingly conflicting policies and examines the net potential impact of this change on NHS outsourcing of elective activity to the IS.

On May 6, 2024, the Food and Drug Administration (FDA) issued a landmark Final Rule clarifying that in vitro diagnostics (IVDs) marketed as laboratory developed tests (LDTs) under the Clinical Laboratory Improvements Amendment (CLIA) are now explicitly designated medical devices with the accompanying regulatory requirements. Although the FDA did carve out certain exceptions subject to their enforcement discretion including, most notably, grandfathering exceptions for certain quality system and FDA submission requirements, this decision will still be costly and burdensome for the IVD space as a whole. However, for those LDT diamonds in the rough with superior clinical validation, this Final Rule could instead present a significant market access opportunity if developers are quick to adapt.