On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction with six other government agencies. The Draft Management Measures were issued for public comment, with a deadline of December 13, 2024.

Although the Draft Management Measures’ title references medical representatives, i.e., sales representatives, their content is much broader, providing substantive requirements for and restrictions on the conduct of Marketing Authorization Holders (MAHs), healthcare institutions, and healthcare providers (HCPs). Once effective, the Draft Management Measures will replace the previous Administrative Measures for Management of Record-Filing for Medical Representatives (Trial Version) (the Record-Filing Measures, 医药代表备案管理办法(试行), which have been in effect since December 1, 2020. The Draft Management Measures are consistent with recent regulations issued for and enforcement trends in China’s healthcare industry, including the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks released on October 11, 2024.

Read our Advisory for an overview of the Draft Management Measures, including new requirements, prohibitions, and enforcement measures.

In our blog post from May this year, we set out what you need to know about the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).

Following that publication, two cases challenging the FDA’s authority to regulate LDTs were filed.

With a second Trump administration coming in January, we felt an update on the current state of the litigation opposing the LDT rule would be of interest. In our recent Advisory, we briefly summarize the current state of the two consolidated cases against FDA and end with some thoughts on where the new administration’s policy prerogatives may lead us as we seemingly enter yet another chapter in the long history of FDA’s attempts to fully regulate LDTs as medical devices.

Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence medicines across the whole of the UK.  The changes to the UK licensing regime will have knock-on effects on the Supplementary Protection Certificate (SPC) framework. To accommodate for this, The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (the Windsor Framework SPC Regulations) were laid before Parliament on 31 October 2024 to come into force on 1 January 2025. This will amend the existing assimilated Regulation (EC) No 469/2009 as it applies in the UK.

Although the UK SPC application process will eventually be simplified, the Windsor Framework SPC Regulations insert new definitions and additional provisions, as well as an Annex setting out transitional arrangements to address issues relating to territorial scope, validity, duration, expiry and paediatric extensions.

Continue Reading Windsor Agreement changes to UK Assimilated SPC Regulation

The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’).

This new reporting obligation is set out in the newly introduced Articles 10a in both the IVDR and the MDR, as amended by Regulation (EU) 2024/1860. This obligation will start to apply on 10 January 2025.

Our blog focuses on the key requirements applying to manufacturers, and how these align with  the European Medicines Agency’s (‘EMA’) role to monitor medical device shortages.

Continue Reading Medical devices: European Commission issues Q&A on the obligation to notify supply interruptions and discontinuations

Do discount campaigns on prescription-only medicines (POMs) run by mail order pharmacies lure patients into consuming medicinal products?

Advocate General Szpunar has opined that they do not. The opinion comes in the latest of a stream of cases on advertising practices involving DocMorris (Case C-517/23), a Dutch mail-order pharmacy that supplies medicines to end customers in Germany. The AG concluded that the discount campaigns regarding POMs do not fall within the definition of “advertising of medicinal products” (Article 86(1) Directive 2001/83) as the discount is implemented at the point of purchase of the POM.  The decision of which product to prescribe has already been taken by a doctor and all the patient is left to do is choose the dispensing pharmacy. As such, the purpose of the discount campaign is not to encourage patients to purchase medicinal products. Rather, it is simply to attract them to a specific pharmacy.

Continue Reading When discount campaigns regarding prescription only medicines do not fall within the definition of advertising in the EU

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

The European Union has for the first time introduced measures to facilitate the development of medical devices for rare conditions, and has recently published the Medical Devices Coordination Guidance on the clinical evaluation of orphan devices (the MDCG Guidance). Key aspects of the document include defining “orphan devices” and guidance on their clinical evaluation, including when it may be justified to certify a product with limitations in the pre-market clinical data.

The MDCG Guidance also envisages further assistance to manufacturers of orphan devices and their Notified Bodies through the provision of scientific advice by expert panels. To help implement the new guidance, the European Medicines Agency (EMA) is operating a pilot programme to provide scientific advice for manufacturers of orphan devices. The pilot programme is intended to operate until the end of this year, with the intention that scientific advice from expert panels will subsequently be rolled out on a wider basis.

Continue Reading EU looks to facilitate development of “orphan” medical devices

The current version of the Innovative Licensing and Access Pathway (ILAP) was first launched by the UK government in January 2021, shortly after the Brexit transition period came to an end. Its aim was to be a new, accelerated route to bring innovative medicines to the UK market, through facilitating a streamlined and efficient collaboration between developers, regulators, the UK Health Technology Assessment (HTA) bodies and the NHS, and facilitating enhanced patient access to medicines.

While ILAP has received an unprecedented number of applicants, with 166 Innovation Passports having been awarded since its launch, there have also been criticisms, including delays in considering applications and limited coordination with the NHS and HTA bodies, which slows the adoption of ILAP products. The Medicines and Healthcare products Regulatory Authority (MHRA) is therefore relaunching a renewed version of the scheme to “refine and refresh” the process.

It is hoped that the improvements will make for a quicker and more effective path for transformative medicines to be adopted into the UK market, reducing time to patient access and making the UK a more desirable market to launch innovative products.

Continue Reading The UK Innovative Licensing and Access Pathway (ILAP) to enter a new era

A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain, improve marketing and sales strategies, and more.

However, as with any disruptive innovation, risks need to be managed. The report also highlights looming governance and compliance needs as companies seek to mitigate the risks associated with AI technologies, particularly in areas like data privacy, cybersecurity, and intellectual property.

The Arnold & Porter report found that AI use is still in its early stages for many in the life sciences industry, with around 75% of respondents beginning implementation less than two years ago. Despite this, 86% of companies currently integrating AI plan to fully deploy these tools within the next two years, reflecting a significant acceleration in AI adoption.

Continue Reading The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk

On 21 October 2024, the UK Government laid before Parliament the draft statutory instrument setting out proposed new post-market surveillance (PMS) requirements for medical devices in Great Britain (the PMS SI). The PMS SI will significantly enhance the PMS requirements for manufacturers of medical devices placed on the market or put into service in Great Britain. 

PMS comprises the post-market monitoring and evaluation of the safety and performance of a medical device. Currently, the medical devices legislation applicable in Great Britain contains limited, high-level requirements for a device manufacturer to operate a PMS system as part of its Quality Management System (QMS). Much of the detail on how a manufacturer should operate its PMS system, including incident reporting, is set out in guidance, primarily EU MedDev guidance 2.12/1 rev 8 and related guidance published under the old EU Directives (upon which the Great Britain medical devices regulatory framework  is based). The PMS SI will introduce much more detailed obligations into UK legislation, with a view to creating greater consistency and making enforcement easier. The amendments contained in the PMS SI will bring PMS requirements in Great Britain broadly into alignment with those in the EU Medical Device Directive 2017/745 (the MDR) and the EU In Vitro Diagnostic Medical Devices Directive 2017/746 (the IVDR) (which apply in Northern Ireland).

Notably, the new PMS requirements will apply to all medical devices placed on the market in Great Britain (subject to limited exceptions), including devices CE marked under the EU regimes and made available in Great Britain under transitional arrangements.

Continue Reading UK Government Publishes Draft Regulations on Medical Devices Post-Market Surveillance