While economic output in Scotland decreased by 1.9% as a whole in the first quarter of 2021 and by 5.4% compared to the same quarter of last year, the same cannot be said of the life sciences sector, which has seen increases of 3.8% and 9.1% respectively. The sector employs 40,000 people in businesses and other organisations (see Growth Sector Briefing - Life Sciences, 30 June 2021).
These statistics 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.
The sector should have confidence in its continued economic growth. However, it has also had to endure unprecedented challenges owing not only to the general uncertainties presented by the COVID-19 pandemic, but also the impact of Brexit.
This article examines the impact of Brexit on the regulation of medical devices in the UK, medical product liability, and 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?
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.
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 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, which is an essential read for anyone looking to submit a new product to the UK market post-Brexit.
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.
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 UK Conformity Assessed (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
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:
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, 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.
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 (the 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 are generally 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  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 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 andHickinbottom JinWilkes v DePuy International Limited  EWHC 3096, upon whose judgments Lord Tyre relied and commented in his opinion.
The pursuer appealed to the Inner House of the Court of Session, where he was unsuccessful. As a result, the case now stands as firm Scottish authority on the interpretation and application of the CPA.
While the decisions in Wilkes, Gee and Hastings are 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.
Neither Gee nor Wilkes resulted in any appeal to a higher court. However, in Hastings the Court of Session has granted the pursuer permission to appeal to the UK Supreme Court. If the pursuer does proceed with this appeal, it will allow the issues decided in Wilkes, Gee and Hastings to be considered by the Supreme Court Justices. Whatever the outcome, the appeal is certain to be a very significant decision for consumers and manufacturers alike.
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, whose final report 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 between around 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.
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 current authority stresses the high onus on any such pursuers, now that the Scottish courts have the procedure to deal with it, we can expect an increase in product liability litigation in the life sciences sector.