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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 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 international and European self-regulatory bodies for the research-based pharmaceutical industry (IFPMA, International Federation of Pharmaceutical Manufacturers and Associations and EFPIA, European Federation of Pharmaceutical Industries and Associations) yesterday published a Note for Guidance to assist member companies with their use of social media and digital channels.

In the EU and UK, direct to consumer (DTC) promotion of prescription only medicines (POMs) is prohibited. Given the reach of social media, the Guidance correctly identifies the highest risk for companies as unauthorised promotion of POMs to the public. In addition, it notes that information shared through digital channels that can be accessed globally generates risk and uncertainty for industry. These risks, combined with the difficulty of controlling the content and audience of posts (both geographically and due to the prevalent use of social media by employees and affiliated third parties), have resulted in many companies being found in breach of self-regulatory codes.

The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code. IFPMA and EFPIA intend the Guidance to act as an “evolving resource”. This is welcome; uses of social media are continually expanding and it has been difficult for industry to apply pre-social media legislation and guidance to the modern world. It would be helpful if local self-regulatory authorities provide their own (or update previous) guidance in line with the new Guidance to ensure it is appropriately implemented within the national Codes.Continue Reading ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry

In September 2021, we posted about the European Commission’s implementation of its new pharmaceutical strategy (which was also discussed in more detail in our posts on the strategy, proposed amendments to orphan and paediatric legislation and the industry response). Readers will be aware that the focus of the Strategy is on the availability, accessibility and affordability of medicinal products, based on the view that current incentive models do not provide an adequate solution for unmet medical needs or appropriately incentivise investment in innovation. As part of its work on the revision of the EU pharmaceutical legislation, the European Commission launched a public consultation to seek views on the current framework and on some of the proposals for changes in order to support the European Commission’s impact assessment for the revision of the legislation.

Following this consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published an article entitled “Back Innovation, Boost Access” with its response to the EU pharmaceutical strategy consultations and some of the concerns raised by the Commission. This expresses EFPIA’s position that innovation is only meaningful if patients have access to it, but highlights that access is not always in the control of the pharmaceutical companies. It also describes the current status of access to medicines in the EU Member States, some of the reasons for the delays to access and EFPIA’s proposals to improve patient access to innovative medicines.Continue Reading EFPIA’s Response to EU Pharmaceutical Strategy Consultations

We discussed in previous posts the Commission’s announcement at the end of 2020 of its new pharmaceutical strategy for the EU. One topic identified as in need of revision was the unmet medical needs in areas currently not within the scope of the legislation governing rare diseases and paediatric medicines.  We have previously discussed recent consultations and stakeholder engagements by the Commission to explore possible changes to the legislative regime in these areas, including the possibility of reducing the ten-year market exclusivity period for orphan medicines and changing the criteria for determining the rarity of a disease.

Following the responses to these consultations, in May 2021, the Commission launched its latest public Consultation on the proposed revisions to the legislation.  The Commission’s statement accompanying the launch asserts that its evaluation “revealed shortcomings in the current system concerning in particular the development of medicines in areas of high unmet need for patients and their accessibility to all EU patients across the Member States.” Industry bodies representing the innovative pharmaceutical industry have now published their responses to the Consultation, as summarised below.
Continue Reading Industry’s response to the Commission’s proposed amendments to the EU orphan and paediatric legislation