The lawyer's role in the future of UK clinical research - What would Lord O'Shaughnessy say?
Following last year's review from Lord O'Shaughnessy on the UK commercial clinical trial landscape, all of us (including lawyers) need to reflect on how to solve the issues flagged in the report.
It has been a while since the UK Government asked Lord O'Shaughnessy to provide a report on the UK commercial clinical trial landscape. The review was about solving challenges and unlocking opportunities, and the report was published in May 2022.
The recommendations were intended to further the objectives and 10-year vision of the Government's March 2021 'Saving and improving lives' policy paper. Lord O'Shaughnessy celebrated the great history of UK clinical trials and the stock of leading universities, as well as the formidable asset in the NHS.
However, the report explained that, in the competitive world of clinical trials, countries like Spain and Australia are popular initiating locations and Poland is doing well with recruitment numbers. In other words, we in the UK risk falling behind, with implications for patient access to innovative medicines, healthcare outcomes in general, and inward investment. In summary, the report warns that the UK needs to step things up or the taxpayer will need to step in where innovative businesses otherwise could have led the way.
Lord O'Shaughnessy's 27 recommendations were all accepted in principle by the Government. And it is expected that the government will publish a comprehensive response to the report this Autumn, including an action plan and an update on the efforts made so far. That will be an important milestone and everyone in the sector, including lawyers, should review it carefully.
In the meantime, here are a few ways by which lawyers can help:
Enable accountability
Lawyers can advise on forming obligations appropriately with the important national objectives in mind and expressing them clearly. And if obligations are not met, lawyers can get involved in enforcement.
Make life for regulators easier
Lawyers can help clients understand approval requirements and check that client submissions meet legal and regulatory requirements.
Review contracts like they are non-negotiable
Lawyers could advise on the use of nationally approved contract templates, summarising risks rather than jumping straight to redlining (sometimes changes will be necessary and reasonable, but a first suggestion could involve the client escalating issues to the government/regulator/industry level).
Advice on standard templates can be recycled for future use (with a health warning, of course, about differing context). And lawyers should avoid tinkering where a national approach to costing and contracting is being used, unless requested to do so.
Help make transparency the norm
Clients may be concerned about the protection of commercial secrets. This is a valid and important concern, but it is possible to engage in transparency initiatives without sacrificing commercial advantages. Lawyers can help find the line between transparency and protecting commercial secrets.
Help clients get documents ready for decentralised trials
A decentralised approach to clinical trials is a relatively new way of working and requires some detailed thinking about privacy and consent. Lawyers can help get your recruitment and consent documents in order.
Update contracts to deal with concepts in the report
Consider asking lawyers to add new provisions into contracts to reflect the points raised in the report, such as provisions designed to tackle health equality and diversity issues relating to clinical trials.
Get ready for innovation in the form of apps and software services
Lawyers can review and draft development, collaboration, software-as-a-service, licence, reseller and end user terms covering any health technology innovation you can think of. Particularly in relation to the main target customers/patients, this work should be considered strategic in nature since contract elements can influence business models and marketing strategies.
Advise on appropriate incentives and marketing
Ultimately, the Lord O'Shaughnessy message is that the UK needs more people to take part in commercial clinical trials. Whether incentives are offered to healthcare professionals or patients, lawyers should ask about the flow of funds and other rewards and can advise on what is lawful. In the same way, lawyers can advise on ways to keep advertising and promotion campaigns on the right side of the law.
Help with data privacy compliance
Lawyers can help answer questions concerning direct contact with patients about participation in research or using existing data collected during clinical care for research. They can also help clarify the distinction between medical consent and data privacy consent and assess additional considerations related to genomic sequencing identified in the report.
Access Secure Data Environments (SDEs) safely
NHS Research SDEs are likely to be an integral part of the future of clinical research in the UK and organisations need to understand the risks and terms of operating and engaging with them. As SDEs are developing their access terms, businesses have questions about commercialising the output of research.
Identify regulated medical devices and help with regulatory compliance
Much of the report looks to the digital future of health and research. If health technology has a medical purpose (and sometimes even if it doesn't), it might be a regulated medical device. Lawyers can help make that assessment, which is best done early.