Life Sciences in Scotland: Flourishing Innovation Between Industry, Academia, and Government

In 2017, Life Sciences in Scotland published its Strategy for Scotland 2025 Vision “to make Scotland the location of choice for Life Sciences businesses, researchers, healthcare professionals, and investors while increasing Life Sciences contribution to Scotland’s economic growth.” Almost six years on, the life sciences sector has reportedly seen around 7% growth year on year, with Life Sciences Scotland confirming that the sector is well on its way to meeting its target of contributing GBP8 billion to the Scottish economy by 2025. Echoing its commitment to the sector in its Innovation Strategy for 2023 to 2033, the Scottish government set out its aspiration for Scotland to be “one of the most innovative small nations in the world.”

Examples of collaborative innovation in Scotland’s life sciences sector are not hard to find. InnoScot Health works with the NHS, academia, the industry, and others to “inspire, accelerate, and commercialise impactful healthcare innovation.” They have formed seven spin-out companies and have brought a range of medical devices, products, and technologies to market. One such company, Aurum Biosciences, was awarded an Innovation Passport in February 2023 for its stroke technology which has the potential to offer “the first major enhancement in the management of acute stroke patients in more than two decades.”

Another example is digital healthcare company PneumoWave. In January 2023, it secured GBP5.2 million of funding from the Scottish National Investment Bank to continue trials of its remote patient monitoring technology designed to identify potentially fatal respiratory changes.

iCAIRD (The Industrial Centre for Artificial Intelligence Research in Digital Diagnostics) established a world-class centre of excellence in Scotland focusing on the application of AI to the field of digital diagnostics including radiology and digital pathology. iCAIRD is a pan-Scotland collaboration of 15 partners, funded by Innovate UK.

These examples clearly illustrate that the sector is continuing to grow in Scotland despite the impact of Brexit, the COVID-19 pandemic, and the current economic climate.

The content of this article includes:

• the continuing impact of Brexit on the regulation of medical devices in the UK;
• medical product liability; and
• a summary of the Scottish government’s scheme on funding transvaginal mesh revision surgery.

Brexit and the regulation of medical devices in the UK

The regulation of medical products following Brexit is extremely complex and undoubtedly presents significant challenges for the life sciences market.

How are medical devices regulated in Scotland?

As health is a reserved matter, the regulation of medical devices in Scotland is legislated for by Westminster. The manufacturing and marketing of medical devices in Scotland is regulated by the Medical Devices Regulations 2002 (the “Regulations”).

The Regulations give effect in the UK to EU Directives on the regulation of medical devices and were made and updated using delegated powers provided in Section 2(2) of the European Communities Act 1972. However, following 1 January 2021, any EU Directives not yet having taken effect could no longer be automatically implemented in the UK by way of Section 2(2). As a result, even minor amendments to the Regulations would require primary legislation.

To address that issue, the UK government enacted the Medicines and Medical Devices Act 2021 (the “Act”), which received Royal assent on 11 February 2021. It proved to be a controversial Bill, designed to allow the amendment of retained EU law post-Brexit as it relates to the regulation of medicines and medical products, but without the need for primary legislation to do so. It applies equally in Scotland as it does in England and Wales.

Part 4 relates to medical devices, in terms of which the Secretary of State is empowered to make regulations amending or supplementing the Medical Devices Regulations 2002. The Secretary of State’s overarching objective must be safeguarding public health and must have regard to the following:

• the safety of medical devices;
• the availability of medical devices; and
• the likelihood of the UK being seen as a favourable place in which to:
1. carry out research relating to medical devices;
2. develop medical devices; or
3. manufacture or supply medical devices.

Importantly, where regulations may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if they consider that the benefits of doing so outweigh the risks.

The UK government put forward proposed changes to the regulations. The changes are extensive and include:

• extending the definition of medical devices;
• changing the categorisation of certain devices;
• introducing additional clinical evaluation; and
• strengthening post-market surveillance requirements.

The Medical and Healthcare products Regulatory Agency (MHRA) is responsible for the governance of healthcare products in the UK. The MHRA consulted on the UK government’s proposed changes in 2021. On 26 June 2022, the UK government published its response to the consultation, indicating that aspects of the future regulatory framework will align with the EU MDR. The response bases the future medical device regulatory framework around five pillars:

• strengthening the MHRA’s powers to act to ensure patient safety;
• making the UK a focus for innovation – the best place to develop and introduce innovative medical devices;
• addressing health inequalities and mitigating biases throughout medical device product life cycles;
• proportionate regulation to support businesses through access routes that build on synergies with EU and global standards; and
• setting world-leading standards – building the UK Conformity Assessed (UKCA) mark as a global exemplar.

In 2022, the MHRA also announced the Software and AI as a Medical Device Change Programme, a programme to ensure the regulatory requirements for software and AI are clear and patients are protected. It is anticipated that this programme will build upon the wider reforms proposed by the UK government.

In terms of timescales, the UK government intends to introduce legislation later this year that will bring into force strengthened post-market surveillance requirements. These requirements are expected to apply from mid-2024. The remaining core aspects of its updated regime for the regulation of medical devices is expected to apply from 1 July 2025.

Placing a medical device on the UK market – what you need to know

The MHRA has produced helpful guidance on the rules that currently govern medical device regulation in the UK, and is an essential read for anyone looking to submit a new product to the UK market post-Brexit.

Since 1 January 2021, any manufacturer wishing to enter a medical device on the UK market must register with the MHRA. If the manufacturer is not established in the UK, it is required to appoint a UK Responsible Person to register and act on their behalf.

The CE mark

Manufacturers must comply with product marking and conformity assessment requirements in order to place medical devices on the UK market. The UK government has amended the Medical Device Regulations 2002 to extend the period in which CE-marked medical devices will be accepted on the UK market. Depending on the product and its certification, CE-marked devices could be accepted on the UK market as late as June 2030.

After the applicable period has ended, products will require the new “UKCA mark” before they can be placed on the UK market.

Medical product liability in Scotland

Procedure

It will surprise many who practise in England and Wales that, until 31 July 2020, Scotland had no dedicated procedure for class actions or group litigation. Whilst it was within the power of any judge to issue a Practice Direction to regulate the conduct of such cases, it was very rare for one case to be selected as a lead case that would decide all of the relevant issues in related matters. This occasionally led to pursuers taking another bite of the cherry, picking another case when the first was unsuccessful.

On 31 July 2020 the relevant provisions of the Civil Litigation (Expenses and Group Proceedings) (Scotland) Act 2018 (the “2018 Act”) came into force. At the same time, the Act of Sederunt (Rules of the Court of Session 1994 Amendment) (Group Proceedings) 2020 codified the procedure to deal with group proceedings in the Court of Session. Like a group litigation order (GLO) in England and Wales it is an opt-in procedure, in that a representative is authorised by the Court and each pursuer must actively apply to that representative to join the proceedings.

Section 20 of the 2018 Act provides that the Court may grant permission for group proceedings if the following conditions are met:

• all of the claims made in the proceedings raise issues (whether of fact or law) which are the same as, similar to, or related to each other; and
• the representative party has made all reasonable efforts to identify and notify all potential members of the group about the proceedings.

Once established as a group procedure, any court rulings on common issues are binding on all members of the group. Procedurally, the focus will be on judicial case management and a preliminary hearing will be fixed once defences have been lodged at court. Strict court directions are not a prominent feature of litigation in Scotland, other than in the Commercial Court. As the new rules give judges wide powers to make orders that will proactively manage the litigation, it is hoped that judges will make the most of the new procedure to drive group proceedings forward efficiently.

There are currently three sets of group proceedings being heard by the Court of Session in Edinburgh, with a handful of associated procedural decisions having been reported. Only time will prove its effectiveness, both procedurally and in terms of cost. It is, however, a welcome addition to the Court of Session rules, and its potential impact on product liability claims in this sector is easy to see.

The law

Liability for defective medical products continues to be governed by the Consumer Protection Act 1987 (CPA), the implementing legislation which transposed the EU Product Liability Directive 85/374/EEC (PLD) into UK law. While cases are also capable of being brought under the common law of negligence, the majority of claims are made under the CPA.

Under the CPA, a product will be defective if the safety of the product is not such as persons generally are entitled to expect. “Safety” includes safety with respect to products comprised in that product, and where there is a risk of damage to property or personal injury and death (see Section 3 of the CPA).

The Court of Session recently had cause to examine the way in which Section 3 of the CPA should be interpreted in the context of prosthetic hips. In Hastings v Finsbury Orthopaedics and Stryker (UK) Limited [2019] CSOH 96, the pursuer alleged that his metal-on-metal (MoM) total hip replacement was a defective product in terms of Section 3 of the CPA. The case was the first of its kind in Scotland following the landmark decision of Andrews J in Gee v DePuy International Limited [2018] EWHC 1208 QB in which the court concluded that a different type of MoM total hip replacement was not defective.

At proof in the Outer House of the Court of Session, the parties agreed the terms of the principal question for the court’s determination (see paragraph 89 of the opinion). In summary, the court was to consider whether the propensity of a MoM hip to shed metal debris and the risk of an adverse reaction necessitating early revision rendered the product less safe within the meaning of the CPA, taking account of all the circumstances.

The question was answered in two stages, firstly by establishing what people generally are entitled to expect, and secondly whether the product had failed that expectation.

Upon consideration of extensive expert evidence, the court concluded that the pursuer had failed to establish that the product was defective under the Act. The court addressed the interpretation of “defect” within the meaning of Section 3 of the CPA in the context of a new product designed to improve on the previous generation of products. The decision is closely aligned with that of Andrews J in Gee and Hickinbottom J in Wilkes v DePuy International Limited [2016] EWHC 3096, upon whose judgments Lord Tyre relied and commented in his opinion.

The pursuer was unsuccessful in his appeal to the Inner House of the Court of Session, and so took it further to the Supreme Court of the UK where his appeal was unanimously dismissed by the judgment dated 29 June 2022. As a result, the case now stands as firm and final UK authority on the interpretation and application of the CPA.

While the decisions in Wilkes and Gee and Hastings are fact specific and focussed on, and restricted to, the particular products that were the subject of the litigation, the following principles summarise the judicial approach as it stands in Scotland.

• The effective protection of consumers is a key objective of the CPA, but it is not the “main or overriding” objective. It has equal status with other objectives and its interpretation should not favour the protection of consumers over any of the other objectives set out in the legislation.
• Under the CPA, liability for a defective product is strict, but a pursuer has to prove the existence of a defect and causation. It needs to be approached on the basis of the entitled expectation of the public at large, at the time when the product is used.
• A lack of safety is the hallmark of whether a product is defective under the CPA. The CPA requires a flexible approach and the court should have regard to all relevant circumstances impacting upon the assessment of the safety of a product. Relevant circumstances may include:
1. the ease and extent to which a risk can be eliminated or mitigated;
2. whether a product is within the producer’s specification; or
3. compliance with relevant standards.

• In the case of a medical or medicinal product, there cannot be an expectation that the product is risk free. The court must balance the potential benefits of a product against risk when assessing the appropriate level of safety.

These principles were also largely affirmed by the Supreme Court in Hastings, in which it was held that expressions of professional concern in the surgical community regarding MoM prostheses generally did not help to establish that the specific product was defective, given that revision rates for the MoM class of prostheses varied from product to product. In addition, it held that:

• the Lord Ordinary was entitled to find that the product had been withdrawn from the market on commercial considerations; and
• product safety alerts and notices issued by a regulator and/or manufacturer cannot of themselves be determinative of product defect where, as was the case here, it was found that the statistics on which the alert/notices were based were unreliable.

Transvaginal mesh

In 2014 the use of transvaginal mesh in Scotland was suspended after it emerged some women had allegedly suffered painful side effects. It was the subject of an independent review at the request of the Cabinet Secretary for Health and Wellbeing, the final report of which was published in 2017. In 2018, use of the mesh was halted in Scotland. Since then, a number of claims have been lodged with the Scottish courts.

In 2020, the Scottish government awarded a GBP1.3 million contract to NHS Greater Glasgow and Clyde for a national removal service in Scotland. In addition, the Scottish government awarded contracts in 2021 to Spire Healthcare in Bristol and the Mercy Hospital in Missouri America, to carry out mesh removal with the NHS.

The Mesh Reimbursement Scheme came into force on 6 June 2022. The scheme accepts applications for reimbursement of the cost of private mesh removal surgery and other associated costs, including travel. The scheme will continue to accept applications until 6 December 2023.

Looking forward

Recent projects and collaborations indicate that the life sciences sector in Scotland is not slowing down. The continued development of AI for use in the healthcare sector will no doubt raise novel points in the courts in relation to product liability, as well as questioning appropriate human interpretation and use of AI technology.

The Scottish courts have already seen high-profile product liability cases, such as those discussed above. The introduction of group proceedings, combined with the comparatively lower costs of litigating in the Scottish courts, may make Scotland an attractive forum for raising such claims going forward.

The MHRA’s consultation on the proposed reform to the regulation of medical products highlights the important balance between opportunity and innovation on the one hand, and patient safety and regulation on the other. The challenge going forward will likely be creating a regulatory framework that strikes the correct balance – and which can evolve as quickly as the technological advances in this sector.