This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.

You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.Continue Reading Virtual and Digital Health Digest, May 2024

The EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282), which entered into force in January 2022, will start to apply from January 2025 for oncology medicines, advanced therapy medicinal products and medical devices (the HTA Regulation will apply to orphan medicines from 13 January 2028, and all centrally authorised medicines from 13 January 2030).

The HTA Regulation aims to accelerate access to innovative health technologies. Currently, new technologies undergo national-level assessments to evaluate their costs effectiveness, and have to meet national pricing and reimbursement (P&R) requirements to determine if they will be made available on the national healthcare system. This is a costly process, both in economic, and time and resource terms.

The HTA Regulation seeks to increase cooperation across Europe, to ensure the efficient use of resources and strengthen the quality of HTAs. At the heart of the HTA Regulation lies the introduction of EU-level joint clinical assessments (JCAs), which are collaborative assessments, including resources and expertise from different EU Member States. With relevant data only needing to be submitted once within the EU, JCAs will minimize duplication and alleviate the workload for companies and authorities. Under the HTA Regulation, HTA bodies in the Member States are expected to consider the JCA reports in their decision-making processes, but the ultimate decision on whether a particular product will be available and reimbursed on the national healthcare system will remain the competence of the national authority.

Ahead of its introduction, several measures are being introduced, as set out in the Implementation Rolling Plan published by the Commission. These include a number of implementing acts,  IT projects and EU support such as capacity building, training and awareness raising. As part of this, in the past few weeks, the Commission has published information on the evaluation of parameters used in JCA dossiers and a draft Implementing Regulation on JCAs.Continue Reading Preparing for the implementation of the EU Health Technology Assessment Regulation

The revised transparency rules governing the transparency of information submitted to the Clinical Trial Information System (CTIS), as adopted by the European Medicines Agency (EMA) on 5 October 2023, will come into effect on 18 June 2024, thesame day thenew CTIS portal will launch. The CTIS, established under the Clinical Trials Regulation (EU) No 536/2014 (CTR), aims at facilitating the information exchange on trials in the European Union (EU). It operates on the principle of public disclosure, with the exception of information relating to personal data and Commercially Confidential Information (CCI).

Preparation is crucial for sponsors conducting clinical trials in the EU as they may need to adapt ongoing trial documentation and future submissions. Our blog post sets out the key changes and provides tips for preparation.Continue Reading Getting Ready for the Upcoming Revised EMA CTIS Transparency Rules

This digest covers key virtual and digital health regulatory and public policy developments during March.

You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product liability regime, including that software and artificial intelligence (AI) technologies will now fall within the scope of a product. On March 13, 2024, the EP formally adopted the Artificial Intelligence Act, meaning the legislative process for the world’s first binding law on AI is nearing its conclusion. Finally, on March 15, 2024, the Council of the European Union and the EP reached a provisional agreement on the European Health Data Space (EHDS), which aims to improve access to health data electronically across the EU. Each of these important legislative provisions should shortly be finalized and will then become law in the EU.Continue Reading Virtual and Digital Health Digest, April 2024

On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.

The Communication, while directed towards the broader biotech sector, refers to the aim to have a resilient EU biotech ecosystem to safeguard the supply of innovative and generic medicines. It recognizes the significance of vaccine and mRNA technology research for cancer, cardiovascular infectious, and rare diseases, as well as the role of AI in personalized healthcare and diagnostics, including generative AI for medicines discovery and complex genetic diseases.

At the same time, it acknowledges the challenges found in the biotech sector in the EU due to complex regulatory obstacles both nationally and at EU level; or the uncertainty over the return of their investments. Continue Reading Commission Communication on biotechnology and biomanufacturing

On 12 March, the European Commission adopted a proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.Continue Reading European Commission proposal to amend the Variation Regulation for Medicines

This digest covers key virtual and digital health regulatory and public policy developments during February 2024.

Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating AI, while leaving regulatory authorities, like the Medicines and Healthcare products Regulatory Agency (MHRA), discretion over how the principles apply in their respective sectors. A central governmental function will coordinate regulation across sectors and encourage collaboration. The government’s aim with this approach is to enable the UK to remain flexible to address the changing AI landscape, while being robust enough to address key concerns. This is in sharp contrast to the position in the EU, where the EU AI Act is reaching the conclusion of the legislative process.Continue Reading Virtual and Digital Health Digest, March 2024

On 15 March 2024, the European Parliament and the Council of the European Union (EU legislators) reached a provisional agreement on the text of the Regulation creating a European Health Data Space (EHDS).

Please note that the text of the agreement has not yet been officially published. This blog is solely based on the press releases that have been published by each of the institutions on their websites (available here, here and here) and has been updated considering some additional indications as to the content of the agreed text.Continue Reading EU legislators reach provisional agreement on the European Health Data Space

On 1 February 2024, the Danish Data Protection Agency announced that it reported the private hospital HP Gildhøj Privathospital ApS’s (Capio A/S) to the Danish police and recommended imposing a fine of not less than DKK 1,500,000 (over 200.000 euros). In their investigation, the Danish Data Protection Agency found that the hospital had failed to effectively supervise the data processors they used for the processing of large amounts of patients’ sensitive  personal data.Continue Reading Proposed fine against Danish hospital for failure to supervise data processors