The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.

Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software.  Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.

The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023.  This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized.  The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.

All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).

Consultation Summary

 The MHRA’s overarching objectives are to develop a regime for medical devices that enables:

  • Improved patient and public safety;
  • Greater transparency of regulatory decision making and medical device information;
  • Close alignment with international best practice, and;
  • More flexible, responsive and proportionate regulation of medical devices.” (emphasis added)

The Consultation sets out a proposal for a future UK-wide regime to regulate medical devices, which would run in parallel to existing or future EU rules.  However, the consultation acknowledges that the MHRA seeks “…greater alignment with … international regimes rather than bringing in higher regulatory burdens.”

 The Consultation sets out four “significant areas” that the new regime will focus on, namely:

  • creating new access pathways to support innovations
  • a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices
  • reforming IVD regulation
  • becoming a sustainability pioneer – through safe reuse and remanufacture

The MHRA has further split these areas into 15 Chapters, which cover: (1) the scope of the regulation; (2) classification; (3) economic operators; (4) registration and UDI; (5) approved bodies; (6) conformity assessments; (7) clinical investigations/performance studies; (8) post-market surveillance, vigilance and market surveillance; (9) in vitro diagnostic medical devices; (10) software medical devices; (11) implantable devices; (12) other product specific changes; (13) environmental sustainability and public health impacts; (14) routes to market; and (15) transitional arrangements.

For each of these chapters, the Consultation indicates how the MHRA proposes to update the UK regulatory framework in line with the overarching objectives detailed above.  Many of the principles appear to align with those in the EU Medical Devices Regulation 2017/745 (“MDR”) and EU IVD Medical Devices Regulation (EU) 2017/746 (“IVDR”), which is not surprising given the UK was a key player in the development of the MDR and IVDR.  It is clear, however, that the UK intends for broader alignment with international standards (e.g. the IMDRF) rather than simply aligning with the EU regulatory framework.

Impact on Software and AI

 The MHRA acknowledges that software and AI are developing fast and play an “increasingly prominent role within health systems” and that UK device regulation needs to be updated to both protect patient safety and also keep up with technological advances.

Chapter 10 of the Consultation sets out proposed changes for “Software as a Medical Device (SaMD), including AI as a medical device (AIaMD).”  The Consultation provides a detailed overview of changes, including defining software, introducing requirements for persons selling SaMD via electronic means, adopting the IMDRF Risk Categorization for SaMD and defining specific requirements for AIaMD (amongst others).

Separately, the MHRA published details of an extensive work programme to inform regulatory changes for software and AI devices.  These aim to ensure that:

  1. The requirements for software and AI as a medical device provide a high degree of assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public
  2. That the requirements are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards
  3. That friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence and NHSX to align, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK.” (emphasis added)

The programme includes 11 work packages over two workstreams. The work packages relate to: (1) qualification; (2) classification; (3) pre-market; (4) post-market; (5) cyber secure medical devices; (6) innovative access; (7) SaMD airlock; (8) mobile health and apps; (9) AI rigour; (10) AI interpretability; and (11) AI adaptivity.

The MHRA plans to deliver these work packages between autumn 2021 and summer 2023.  It is anticipated that much of the reform from the work packages will be in the form of clarificatory guidance, standards, or processes rather than secondary legislation. Any legislative change proposed by any work package for software/AI will build upon wider reforms to medical device regulation being consulted upon as a part of the Consultation.

Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports from Westminster bodies have proposed a new regulatory regime for so-called “nutraceuticals” (products that are part drug, part nutritional) to encourage investment.

Taskforce on Innovation, Growth and Regulatory Reform Report

On 16 June 2021, the UK’s Taskforce on Innovation, Growth and Regulatory Reform (“TIGRR”) published a report setting out their vision for the UK’s approach to regulation post-Brexit. In this report, TIGRR makes 120 recommendations covering three broad areas: a new UK regulatory framework based on core principles of UK law; specific regulatory reforms in high-growth sectors; and proposals for how these regulatory reforms could be delivered. The report focusses heavily on principles that the UK should adopt post-Brexit. The overarching theme of these ambitions is removing unnecessary regulatory burdens, boosting innovation and the UK’s long-term competitiveness, and a departure away from the EU model of regulation.

As part of the UK Government’s renewed scrutiny of current regulations, TIGRR’s report explores new possibilities for food and drug regulation post-Brexit. One of the report’s recommendations is to introduce a separate regulatory regime for nutraceuticals. TIGRR explains that a new pathway is necessary to fill the gap between food and pharmaceutical regulation and to help the fast-growing sector “realise its potential.” In particular, they propose fixing the current lack of a clear regulatory framework for assessing, verifying and authorizing medicinal claims for nutraceuticals.

All Party Parliamentary Group on Access to Medicines and Medical Devices Report

In July 2021, the growing need for separate nutraceutical regulation was highlighted again by the Parliamentary Group on Access to Medicines and Medical Devices. In a report, the group summarizes and comments on stakeholder views on potential improvements to the MHRA. Stakeholders proposed a licensing process review and a clearer regulatory framework for “nutri-foods.” The Parliamentary Group appears to agree, citing the similar calls made by TIGRR and the current backlog of borderline products for review, which it says stifles innovation.

Conclusion

These reports are significant as, beyond nutraceuticals, they more generally signal a departure away from the EU model of regulation for medicines, medical devices and borderline substances. The proposals also include adaptive approaches to medicines regulation and the use of artificial intelligence in healthcare. Industry should keep abreast of these developments and the opportunities they present, in particular for regulator, policy and corporate investments.

Covington lawyers have a well-established nutraceutical practice in the UK (e.g., R (otao Blue Bio) v MHRA) and the EU, having represented clients before the English courts and the European courts on borderline matters, and working with the appropriate regulators to agree appropriate branding and ingredients.

On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.

I. EU

On 18 May 2021, the Commission Working Group on Food Additives discussed EFSA’s revised assessment and its follow-up.  According to a report on the meeting by the Dutch delegation, all Member States indicated they could support a ban on E171. An official from the European Commission has confirmed that the Commission foresees a transitional period to give operators time to phase out the use of this additive in food and replace it where needed. However, reportedly, the Commission wishes for this transition period to be as short as possible. The Member States will provide feedback on this as soon as possible. As a reference, France suggested that a transition period of 8 months was applied without any problems with the French (national) E 171 ban in 2019/2020. The Commission expects to table a proposal by the end of July to be voted on at the Plants, Animals, Food and Feed Standing Committee meeting on Toxicology & Novel Food (SCoPAFF Tox & NF) scheduled for 28 September 2021.  If adopted, the proposal could enter into application at the beginning of 2022.

Titanium dioxide is also permitted as a coloring agent in other products, such as pharmaceuticals, animal feed, food contact materials and care products. The relevant agencies have been informed and will consider for themselves whether the EFSA opinion has consequences for the use of titanium dioxide in their area. For its part, EFSA also concluded on 16 June 2021 that titanium dioxide can no longer be considered safe to use in animal feed.

II. The Netherlands

It is currently unlikely that the Netherlands will impose a national prohibition on the use of titanium dioxide as a food additive.  In the Dutch minutes for the Commission Working Group on Additives on 8 February 2021, the Netherlands reportedly indicated that European legislation exists for a reason and that national bans are undesirable. The National Institute for Public Health and the Environment (“RIVM”) webpage on E171 confirms that any decision on banning titanium dioxide is to be taken at EU-level.

III. Germany

Similarly, there are no developments in Germany that suggest it will adopt a national E171 ban.

The Federal Minister for Food and Agriculture and the Federal Institute for Risk Assessment have both issued press releases on titanium dioxide on 6 May 2021.  Both of them refer to actions to be taken at EU level. Federal Minister Klöckner stated in her press release that she has asked the Commission to take action. The Federal Institute for Risk Assessment also issued a press release stating that it has reached comparable conclusions to the EFSA.  It subsequently updated its Q&A on the additive and indicated it expects action at the EU level.

The emphasis on EU-level action suggests that an initiative at the national level is rather unlikely.

IV. UK

The UK is still considering its stance on the additive, suggesting no immediate national ban is to be expected, but further action cannot be ruled out.

Following the publication of the EFSA opinion, a spokesman for the UK Food Standards Agency (‘’FSA’’) said its independent scientific advisory committees would scrutinize EFSA’s revised assessment alongside existing evidence. This review would inform next steps and future policy.

The FSA also discussed the issue during its board meeting on 26 May 2021, where it concluded it would “put the EFSA opinion through the risk analysis process” and that “devolved administrations have been informed and we are considering implications for Northern Ireland.”

Conclusion

In short, an EU-wide ban on the use of titanium dioxide could be put to a SCoPAFF Tox & NF vote in September 2021 and come into effect by January 2022 with a relatively short transition period of 6 to 9 months. We await the outcome of the UK FSA scrutiny of the EFSA assessment and expect no further national action in the Netherlands and Germany.

 

 

 

 

 

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Continue Reading New Early Access and Off-Label Use Rules in France

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The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space: Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics

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On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”).  One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework.  However, the inverse is also true.  Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin. Continue Reading Brazil Ratifies the Nagoya Protocol

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Continue Reading EU Adopts Export Authorization Scheme for COVID-19 Vaccines and their Active Substances