Life Sciences in Scotland: A Space of Opportunity and Risk

The most recent available statistics continue to reflect the Scottish government’s commitment to life sciences, including medical devices and consumer health products, in Scotland. In March 2015, Scotland’s Economic Strategy identified life sciences as a strength area for which it committed a continued focus for growth. 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.”

The newly created Scottish Investment Bank provides further support for such projects in Scotland. For example, in November 2020 it was announced that Clear Surgical, the first client of the new Medical Device Manufacturing Centre at Heriot Watt University had secured investment from the Scottish Investment Bank as well as Scottish Health Innovations and existing shareholders. Their product, the OpLight is attached to existing surgical devices such as surgical retractors, and directs light into the surgical cavity to eliminate the possibility of shadowing.

According to the Growth Sector Briefing – Life Sciences: Office of the Chief Economic Adviser, 10 June 2022, by the first quarter of 2022, the latest GDP data showed output in this sector increasing by 2.9% compared with 1.0% across the economy as a whole. That is an 11.7% year on year increase, with more than 40,000 employees across the sector.

The sector is clearly continuing to grow despite the unprecedented challenges owing not only to the general uncertainties presented by the COVID-19 pandemic, but also the impact of Brexit.

This article examines (i) the impact of Brexit on the regulation of medical devices in the UK, (ii) medical product liability, and (iii) summarises the Scottish government’s recently announced position 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?

Since 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 to 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.
• 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.

A “medical device” includes medical devices to which the Regulations apply and devices to which the EU Medical Devices Regulations (“EU MDR”) apply.

The Medical and Healthcare products Regulatory Agency (MHRA) is responsible for the governance of healthcare products in the UK. It has produced helpful guidance on the rules governing medical device regulation in the UK, pre and post-Brexit and is an essential read for anyone looking to submit a new product to the UK market post-Brexit. Between September and November 2021, the MHRA consulted on proposed changes to the UK’s existing regulatory framework governing medical devices. On 26 June 2022, the UK government published its response to the consultation on the future of medical devices regulation in the UK, 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 lifecycles.
• Proportionate regulation to support businesses through access routes that build on synergies with EU and global standards.
• Setting world-leading standards: building the UK Conformity Assessed (UKCA) mark as a global exemplar.

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

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.

There are different requirements and grace periods for registration depending on the type of product as follows:

• from 1 May 2021 – Class III medical devices, Class IIb implantables, all active implantable medical devices and List A IVDs;
• from 1 September 2021 – all other Class IIb medical devices, as well as all class IIa medical devices and list B and self-test IVDs; and

• from 1 January 2022 – Class I devices, custom-made devices and general IVDs that are not already required to register with the MHRA under existing rules.

The CE mark

From 1 July 2023, the CE mark will no longer be recognised in Great Britain (including Scotland). Instead, there is now a “UKCA mark”, and from 1 July 2023 UKCA will be compulsory for all devices entering the UK market and any such devices will require to carry the UKCA label.

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 having another bite at 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 ruling 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.

The group procedure is very new, with only one reported application so far, and only time will prove its effectiveness. 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 United Kingdom where his appeal was unanimously dismissed by 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 Hastings, the Supreme Court 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
• that 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, on 23 June 2021, the Scottish government introduced the Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Bill to establish a scheme to reimburse those who have paid privately to undergo mesh removal surgery, estimated to cost approximately GBP16,000–23,000 per case.

A procurement process permitted qualified surgeons outside the NHS to bid to perform the surgery, and on 12 July 2021 the Scottish government announced that contracts had been awarded to Spire Healthcare in Bristol and the Mercy Hospital in Missouri America to carry out mesh removal. Travel and surgery costs to either clinic will be covered for any women who would prefer to be treated outside Scotland.

Looking Forward

It is undoubtedly a very exciting time for medical devices and consumer health products in Scotland. The Scottish government’s commitment to this sector promises real opportunity to 2025 and beyond. While the impact of Brexit will have caused some administrative headaches, the sector shows no signs of slowing down.

With high-profile product liability cases such as those discussed above, however, there is undoubtedly scope for an increase in class litigation when products are deemed by some to be defective. While Hastings in particular highlights the difficulties that pursuers will face under the CPA, it might also be seen as a blueprint or roadmap for the right case. Now that the Scottish courts have the procedure to deal with group litigation, they may see an increase in product liability litigation in the life sciences sector.