Pricing and Reimbursement

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Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health digest. This digest covers key virtual and digital health regulatory and public policy developments during August 2026 from the EU and UK.

The more significant developments this month have been in the data protection space. Notably, Uber was fined almost €825 million following a finding that they breached the general prohibition on fully automated decision-making in the General Data Protection Regulation (GDPR). This decision serves as an important reminder for the need for meaningful human review in the Life Sciences industry as companies increasingly rely on AI-assisted decision-making, for example in screening candidates for eligibility to take part in clinical trials.

Further, the European Data Protection Board (EDPB) has written to the European Commission to request that the commission “closely assess” the recent U.S. Supreme Court decision of Trump v. Slaughter and its impact on the EU-U.S. Data Privacy Framework (DPF) adequacy decision. The EDBP has raised that this decision, which holds that the statutory protection against removal of Federal Trade Commissioners are unconstitutional, may affect the validity of the DPF decision.

Other developments include that the International Medical Device Regulators Forum (IMDRF) has published technical guidance regarding Predetermined Change of Control Plans (PCCP) for medical device software. This guidance intends to foster regulatory harmonization by identifying the essential principles for developing PCCP. 

Continue Reading Virtual and Digital Health Digest – September 2026

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health digest. This digest covers key virtual and digital health regulatory and public policy developments during June and early July 2026 from the United Kingdom and European Union.

AI continues to be at the top of the agenda for regulators in Europe. The European Commission (EC) has been focused on preparing for the majority of the provisions in the AI Act to come into force this August. Among those provisions are the transparency requirements, and to assist organizations with compliance, the EC has published a voluntary Code of Practice on the marking and labeling of AI-generated content. Further, a Scientific Panel and an Advisory Forum have been appointed to advise the EC’s AI Office and national competent authorities on implementation and enforcement of the AI Act.

In the UK, we are seeing a continued commitment to regulating AI through guidance and codes of practice, as well as the provision of regulatory support through sandbox programs. The Information Commissioner’s Office (ICO), the data protection regulator, has published its plan for upcoming work in relation to AI, which sets out various plans for guidance and codes of practice. The Medicines and Healthcare products Regulatory Agency (MHRA) continues its focus on regulatory sandboxes and recently reported the outcome of the second phase of the AI Airlock. It has also announced further AI sandboxes in order to accelerate the development of medicines and to allow innovators to test AI tools that have the potential to predict how medicines behave in the body, and another, which will be London-focused.

The key legislative development this month is that the EU Council has adopted its position on the first part of the Biotech Act, which, together with the European Commission’s draft, will form the basis of the trilogue discussions between the European Union (EU) institutions, hopefully leading to agreement on a finalized text. 

Continue Reading Virtual and Digital Health Digest – July 2026

The UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded “newer” prescription-only medicines to the NHS at 16.5% for 2026, a significant reduction on the current rate of 24.3%. The DHSC published the proposals in a consultation, which is open for comment until 21 April 2026.

The Statutory Scheme applies by default to suppliers of branded prescription-only medicines to the NHS who have not elected to be members of the equivalent voluntary scheme for controlling NHS expenditure on branded medicines, currently the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).

Continue Reading UK government sets out 2026 branded medicines Statutory Scheme repayment rate

The UK and US governments have announced that they have reached an agreement on pharmaceutical pricing and tariffs. Under the arrangement, the tariffs charged by the US government on imports of pharmaceutical products from the UK will remain at zero for three years, in exchange for the UK agreeing to pay higher amounts for innovative medicines and reducing the rebates payable by pharmaceutical companies on newer branded medicines.

The changes to UK pricing of medicines have been welcomed by industry, which has criticised the UK environment for supply of and access to medicines.

Continue Reading US-UK Pharmaceutical Pricing Deal: UK agrees increase in amounts it can pay for innovative medicines and reduction of rebate rates

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.

Continue Reading MHRA and NICE launch aligned approvals pathway

The Association of the British Pharmaceutical Industry (ABPI) and the Department of Health and Social Care (DHSC) have confirmed that they have ended negotiations on  amendments to the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The breakdown of the talks between the government and the ABPI mean that the pharmaceutical industry will continue to pay annual rebates on sales calculated by the current mechanism under VPAG, which produced a repayment rate of 22.9% on “newer” medicines for 2025.

Continue Reading UK government and pharmaceutical industry fail to reach agreement on amendments to medicines pricing scheme

The Association of the British Pharmaceutical Industry (ABPI) has published a report (the Report) setting out its members’ concerns regarding the operation of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).

VPAG is an agreement between the Department of Health and Social Care (DHSC), NHS England and ABPI, which came into effect on 1 January 2024.  It is the latest in a series of voluntary schemes, intended to manage NHS expenditure on branded health service medicines and operates by controlling prices, limiting profits and, importantly, by imposing a requirement for scheme members to make repayments to Government, reflecting NHS expenditure on medicines in excess of permitted growth and calculated as a percentage of eligible sales.  A key driver for changes introduced in VPAG was recognition that the level of repayments under the previous scheme had become unsustainably high (21.2% in 2023).  Therefore, while industry accepted what is described in the Report as an “exceptionally tough deal” this was in the expectation that the new scheme would, over time, bring repayment rates for newer medicines down to below 10%, consistent with the position up until 2021. However, while the repayment rate for newer medicines was set at 15.1% in the first year of VPAG, the rate for 2025 is 22.9% (with an additional 0.6% payable under an investment programme). The Report describes rates of this magnitude as “unsustainable”.

The Report analyses the reasons that repayment rates for newer medicines have ended up so much higher than predicted under VPAG, and calls for the Government to work with industry on its proposed solutions. It also sets out the consequences of requiring industry to pay such high repayments rates, including worse access to medicines for UK patients and lower investment by industry in the UK.

Continue Reading ABPI calls for changes to “unsustainable” medicines pricing scheme

On February 24, 2025, new rules came into force in the UK transforming the public procurement landscape. The new regime aims to provide a simplified and flexible framework for contracting authorities when conducting procurement processes, including the purchase of medicinal products by the National Health Service (NHS).

Under the new Act, a number of elements of the procurement processes have changed, and we set out the background in our previous post. For tenderers, the changes are mainly procedural, including the framework for the tender process and the timelines, rather than fundamental changes to how the procurement will operate. Nevertheless, it is important to take note of the new procedures. We set out some of the key aspects in our Advisory.

Continue Reading UK Public Procurement Landscape Transformed: What Does It Mean for Medicines?

Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.

Of note, health authorities in the EU continue to develop methods to assess and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.

It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.   

Wishing you the best for the new year! 
The Arnold & Porter Team 

Continue Reading Virtual and Digital Health Digest – December 2024

This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.

Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government recently published the new medical devices post-market surveillance rules, which could be in place by summer 2025. Further, the Medicines and Healthcare products Regulatory Agency’s (MHRA) priorities until spring 2025 are focused on the draft pre-market rules for devices, the in vitro diagnostics (IVD) roadmap, and guidance on AI development and deployment. In the EU, industry should watch the potential upcoming reform of the Medical Devices and In-Vitro Medical Devices Regulations, with increasingly urgent calls for reform from key stakeholders gaining traction with the institutions.

Continue Reading Virtual and Digital Health Digest – November 2024