On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.

The Industrial Strategy will be informed by the new Industrial Strategy Advisory Council, which is to be chaired by Clare Barclay, CEO of Microsoft UK. The green paper explains that the Advisory Council will be led by evidence and “empowered to advise, make recommendations, and monitor Industrial Strategy policy”. The creation of the Advisory Council is intended to prevent frequent policy changes and ensure “stability and long-termism” and the government has committed to making it a permanent and independent statutory body.

This green paper comes less than a week after the UK Government announced the launch of the Regulatory Innovation Office noting that more plans for boosting growth were to be expected.Continue Reading UK government launches new Industrial Strategy and Advisory Council to boost economic growth

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

Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life cycle. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for its AI Airlock, a regulatory sandbox for AI as Medical Devices. And over 100 companies have signed up to join the EU AI Pact, a voluntary initiative to encourage companies to comply with the AI Act before the statutory deadlines. These guidance documents and initiatives provide companies with much greater clarity on how the authorities will regulate the use of AI in health care.Continue Reading Virtual and Digital Health Digest – October 2024

This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.

There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN pathway. This opinion suggests that while PECAN provides a more streamlined process by not requiring formal clinical trials, the regulator still expects robust data to show that the digital therapeutic is worthy of reimbursement. In the UK, the National Institute for Health and Care Excellence has published a position paper that highlights the risks of using AI for generating and reporting evidence for health technology assessments. It sets out that the use of AI in this context should be limited to situations where the value of doing so can be clearly demonstrated, and sets out guidance for companies on how to present such data and to justify the use of AI. Health technology assessment seems to be an area where AI has more readily been accepted, and industry will welcome guidance on the parameters around such use.Continue Reading Virtual and Digital Health Digest – September 2024

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union.

Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy agenda. Of particular importance to the life sciences sector are the Product Safety and Metrology Bill and the Digital Information and Smart Data Bill. Although the scope and content of each bill is currently unknown, they could impact medical devices and innovative scientific research. Further, there was no artificial intelligence bill in the agenda, although the government will “seek to establish the appropriate legislation” in the future.Continue Reading Virtual and Digital Health Digest – August 2024

This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union.

While it has been a relatively quiet month in the EU given elections in the European Parliament and in the UK (as well as other countries across the EU), agencies across the globe have published important guidance on machine-learning enabled medical devices. This includes the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guiding principles on transparency, published together with the U.S. Food and Drug Administration (FDA) and Health Canada, and the International Medical Device Regulators Forum (IMDRF) consultation on its guiding principles on good machine learning practice (which itself follows similar guidance from MHRA, FDA, and Health Canada in 2021). This demonstrates the increased importance of international standards in this area and the need for coordination between regulatory authorities to standardize guidance for these products.Continue Reading Virtual and Digital Health Digest – July 2024

Answers to Some Common Questions

After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.Continue Reading Demystifying the UPC and the Unitary Patent

The Unified Patent Court (UPC) and the unitary patent system are expected to commence on 1 June 2023. Until early December 2022, the UPC was advocating 1 April 2023 as the date of entry into force of the Agreement on a Unified Patent Court (UPCA) with the Sunrise Period commencing on 1 January 2023. The two-month postponement has been implemented to allow users to prepare for “strong authentication” required to access the court’s Case Management System and to sign documents.  In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.
Continue Reading Demystifying the UPC and the Unitary Patent – answers to some common questions

The use of artificial intelligence (AI) and machine learning is growing at a significant pace and  spreading across many industry sectors, including healthcare. With the rapid development of AI technology which has the potential to revolutionise many aspects of our lives, including in providing and receiving healthcare services, the concept of “creations of the mind” is no longer limited to creations by a human being. These technological developments mean that the legal framework governing intellectual property (IP) rights such as patents and copyright, which protect “creations of the mind”, may need to be adjusted to address the changes and impacts brought about by the use of AI.

In line with the UK government’s ambition for the UK to be a leader in AI and to better understand the implications AI might have for IP policy, as well as the impact IP might have for AI in the short to medium term, the UK IPO conducted a public consultation at the end of 2020. The aim of the consultation was to seek responses on a range of questions relating to AI and IP rights. The UK IPO received 92 responses from a wide range of stakeholders, including IP rights holders, producers of AI technology and academia. The government’s response to the call for views on AI and IP was published in March 2021, under which reforms to patent and copyright law and policy were discussed.

In this blog, we summarise the UK government’s conclusions from the consultation before considering the potential impact to digital health applications and companies.Continue Reading AI and IP: Implications for digital health from possible reforms to UK IP law

As the end of the transition period draws near and new laws and regulations are set to come into effect at 11.00pm UK time on Implementation Period Completion Day (31 December 2020)[1], it is important to appreciate the impact of the changes to businesses navigate through a post-Brexit era. Once the UK is no longer part of the European single market, what will it mean for parallel trade and exhaustion of intellectual property (IP) rights when goods are exported out of the UK into the EU and vice versa.
Continue Reading End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients