On 21 October 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK will be the first country in the world to introduce a tailored framework for the manufacture of innovative medicines at or close to the location where a patient receives care.

A new statutory instrument was laid before the UK parliament to amend the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004, to provide a new regulatory framework to support the manufacture and supply of these innovative products. This includes:

  1. products with a very short shelf life and highly personalised medicines that mean they have to be manufactured close to the place where they are administered; known as Point of Care, or POC, products. This often applies to advanced therapy medicinal products (ATMPs), but could also be technologies such as 3D printing.
  2. products that are manufactured in a self-contained modular unit, to enable deployment from that site to other locations; known as Module Manufacture, or MM, products.

This new framework follows a consultation in 2021, discussed in a previous blog post. The consultation received overwhelming support, and 91% of responders agreed with the need for a new regulatory framework. At present, there is no specific framework that covers decentralised manufacturing of medicines in the UK, but as products become more innovative, and more personalised to the patient, the need for change has increased. At present, any on-site manufacturing has to rely on the hospital having obtained the necessary licences and having put in place the required quality, safety and traceability standards under the general framework. This leads to practical – and contractual – difficulties between the company and hospital sites.

The new framework seeks to provide the necessary regulatory oversight to ensure that POC and MM products have appropriate quality, safety, and efficacy attributes, whilst allowing increasing numbers of patients to benefit from these innovative products. According to the MHRA, the proposed regulation ensures that POC and MM products can be more easily made in or near a hospital setting and can get to the patients who need them safely and more quickly.

Continue Reading UK to implement novel framework for point of care manufacture of medicinal products

On October 10, 2024, the National Medical Products Administration in China released the Draft Rule on Rewarding Internal Whistleblowers for Reporting on the Quality and Safety Issues of Drugs and Medical Devices (the Draft Rule) for public comment, due by November 9, 2024. The Draft Rule marks a milestone in the development of China’s regulatory system for pharmaceuticals and medical devices and, like the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks recently published by the State Administration for Market Regulation, reflects Chinese regulators’ increasing use of best practices from other jurisdictions as well as their continued focus on the healthcare sector. Once effective, the Draft Rule may lead to more enforcement actions by Chinese authorities.

Pharmaceutical and medical device companies operating in China should continue to monitor the development of the Draft Rule, and may wish to take this opportunity to review their internal quality and safety systems as well as their internal reporting systems for their China operations. If you have any questions about the above topics, please feel free to contact the authors of this Advisory or other members of Arnold & Porter’s Life Sciences & Healthcare Regulatory or White Collar teams.

Read our Advisory for more information on the Draft Rule’s background and applications, as well as the channels for reporting issues, methods for handling reports, rewards for whistleblowers, and the confidentiality and anti-retaliation provisions set forth in the draft.

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

On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices in the EU, to ensure higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector. However, it is also acknowledges that significant challenges have been encountered in implementing the MDR and the IVDR. These include delays, shortages, and difficulties in navigating the regulatory procedures. The particular impact on small and medium sized enterprises (SME) and on patient care are highlighted.

The lack of harmonised procedures for Notified Bodies, and the lack of harmonised interpretation of the MDR and IVDR between Notified Bodies, is also noted, and the fact that this leads to unpredictable timelines for certification and market access.

The Parliament resolution therefore seeks to address some of these difficulties.

Continue Reading European Parliament resolution on need to revise the Medical Devices Regulation

On October 11, 2024, the Chinese State Administration for Market Regulation (SAMR, 国家市场监督管理总局) issued the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Draft Guidelines, 医药企业防范商业贿赂风险合规指引). These Draft Guidelines were published for public comment, due by Sunday, October 20, 2024. While China’s public comment system is still developing, the Draft Guidelines provide valuable insight into regulators’ views and expectations. We have prepared informal translations of the Draft Guidelines and their related Drafting Statement which provides additional background.

We believe these Draft Guidelines, once effective, will play a vital role in the development of compliance programs for China’s healthcare companies. For questions on this or any other subject, please reach out to the authors or any of their colleagues in Arnold & Porter’s White Collar Defense & Investigations practice group.

Read our Advisory for an overview of the Draft Guidelines, including informal English translations of the Draft Guidelines and their related Drafting Statement, which provides additional background.

On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.

The RIO, established within the Department of Science, Innovation and Technology, will seek to reshape regulatory landscapes by working with existing regulators to accelerate approvals, bring regulations up to date and facilitate inter-regulator collaboration. The creation of the RIO is a key manifesto commitment, as part of the government’s wider mission to kickstart economic growth, aiming to provide regulatory certainty and reduce unnecessary delays.

Continue Reading UK government launches new Regulatory Innovation Office to reduce red tape

Earlier this week, the EMA published its Reflection paper on the use of AI in the medicinal product life cycle. As set out in our previous blog post, the EMA’s draft reflection paper was published for consultation in July 2023, and following many months of review of the feedback collected from the relevant stakeholders, the Paper has now been published.  The Paper reflects the views of the EMA on the use of AI from drug discovery and non-clinical development, to clinical trials, manufacturing and post-authorisation. The Paper recognises the utility of AI in digital transformation and notes new risks that need to be mitigated to ensure patient safety and data integrity.

Continue Reading EMA adopts reflection paper on the use of Artificial Intelligence (AI)

On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) published an updated Code of Practice for the pharmaceutical industry. Following an extensive consultation with over 3,000 comments, ABPI has announced that the new “orange” 2024 Code amends the previous 2021 Code in three key areas: the PMCPA constitution and procedure; the provision of prescribing information; and certain elements of the Code moving from guidance to mandatory requirements. However, there are also interesting amendments to the requirement to maintain high standards and obligation to seek a lawful basis for disclosure of transfers of value to an individual.

ABPI has said that the new Code seeks to “raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be resolved quicker”.

Continue Reading A New 2024 Code for the British Pharmaceutical Industry  – “The Future is Orange”

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