The UK is one of the largest markets for medical technology in Europe, bringing together clinicians, engineers and scientists as they design and manufacture novel solutions for patients. The NHS, serving more than 60 million patients, is MedTech's largest customer.
Our market-leading health and life sciences practices, combined with our full service corporate offering, provide us with a unique understanding of the MedTech market. We use this expertise to advise medical device manufacturers, pharmaceutical companies, providers and funders of medical technology, trade associations and intermediaries in this sector. We combine our knowledge of working with the NHS and our experience of acting for many of the UK's leading life sciences companies to help clients develop their business throughout the entire lifecycle of their products.
What we are known for
We are ranked as a tier 1 firm in Health by both Legal 500 and Chambers, the legal profession’s leading directories. We advise on strategic issues affecting the sector and have advised on all major NHS re-organisations.
Our product liability department is also top ranked, providing specialist advice to the life sciences industry on all aspects of regulatory, liability and product safety issues and have assisted clients with their products' approval, safety monitoring and compliance issues. We have defended the majority of significant pharmaceutical/medical product liability cases in the UK over the last four decades, including the Opren, Whooping Cough Vaccine, Benzodiazepine, HIV Haemophilia, Oral Contraceptive, MMR and the Hepatitis C litigations.
What we do
We work with MedTech clients from the early stages of development, as well as with established providers. We connect our MedTech clients with our own broad networks in the sector, including with investors. We support our clients with input from our employment, real estate, corporate, commercial regulatory and intellectual property specialists, as required. We also offer bespoke governance advice on compliance issues.
How we can help
The MedTech industry presents a myriad of challenges, which we can help you to navigate in the following areas:
- Market insight – advising MedTech providers or investors on the route to market and the legal framework around how the NHS buys MedTech, including the impact of the NHS Five Year Forward View.
- Regulatory - clarity on the regulatory safety and compliance issues to navigate as a MedTech provider or investor.
- Contracts - protecting and challenging IP legal needs as well as advising on manufacturing and distribution agreements, sale of goods and services and international trade.
- IP and Brand management – building IP management into the foundations of the business and ensuring maximum benefit.
- Governance Advisory Practice – our team of chartered secretaries are highly experienced in carrying out governance reviews and advising on effective governance solutions for highly regulated organisations.
- Corporate - successfully managing M&A, JVs, spinouts, fundraising and the associated tax and employment considerations for transactional work.
- Litigation - leading clinical trials and product liability team managing and protecting you from disputes.
- Procurement challenges – advising MedTech providers on procurement disputes.
- Competition - experts in the application of competition law, including EU and EEA procedures.
We have an extensive track record advising MedTech clients, highlights include:
- Contaminated blood litigation - acting for the National Blood service and all NHS Trusts, on the instruction of the National Health Service Litigation Authority, in the HIV Haemophilia and Hepatitis C litigations.
- Northwick Park - acting for clinical trial insurers in respect of claims and issues arising from the phase 1 trial of monoclonal antibody TGN1412.
- MMR Vaccine Litigation - acting for GlaxoSmithKline in the successful defence of the group litigation.
- Oral Contraceptive Litigation - acting for Akzo Nobel in the third generation oral contraceptive causation trial.
- Fresenius Kabi - advising a clinical nutrition manufacturer on a successful challenge to a multi-trust procurement exercise.
- NHS England - acting for NHS England in the Lyrica patent dispute involving Warner-Lambert and Actavis.
- Seroquel Litigation - acting for a UK captive of AstraZeneca seeking $900M recoveries from reinsurers in respect of the costs of defending the US Seroquel product liability group action involving 30,000 plaintiffs.
- NHS Consortia - advice to a regional NHS purchasing consortium on a CMA investigation into pharmaceutical supplies;
- Joint Clinical Trials Office - advised the Office, based at Guys and St Thomas NHS Foundation Trust, in relation to a proposed NHS/Industry/University Model Collaborative Commercial Clinical Research Agreement.
- PIP breast implants - advising two private healthcare organisations in the defence of the group litigation involving allegedly defective PIP silicone implants.
- Metal on metal implants - advising private hospitals on claims arising out of the use of these hip implants.
- Advising manufacturers regarding advertising, product information, packaging, safety, recall, liaising with regulatory authorities and managing customer communications.