LIFE SCIENCES: An Introduction to UK-wide

Life sciences transactions: a review 

Mark Anderson, Lisa Allebone, Stephen Brett, Paul Maclennan and AnnMarie Humphries, Anderson Law LLP

The relationship between life sciences lawyers and life sciences organisations could best be described as symbiotic. Both are part of a thriving ecosystem. The UK has some of the best pharmaceutical and medical device companies, biotech companies, research organisations and service providers in the world. The NHS provides a ready source of trial subjects and population data.

The UK is also home to some of the best lawyers and patent attorneys practising in the life sciences field. UK lawyers have long been trusted to conduct and coordinate international transactions, IP filing and litigation, due to their extensive sector expertise.

Brexit 

Many practitioners had concerns about the likely effect of Brexit on the UK life sciences sector. One obvious example was the decision by the UK government not to participate in the Unified Patent Convention (UPC). UK life sciences lawyers and judges had led the efforts to reach international agreement on the UPC, and the UK government had leased rooms in central London for a UPC life sciences medical devices court. But it was not to be.

Following Brexit, the UK is consulting on whether to deviate from the EU regulatory regime in areas such as medical devices and data protection. Life sciences is an international business, and many UK organisations will continue to ensure that they comply with EU rules as well as those in the UK.

Covid-19 

The UK life sciences sector’s expertise was highlighted by its responses to the Covid-19 pandemic. New products and services have been developed, made or licensed in the UK for use internationally, in fields as diverse as vaccines, testing apps and ventilators. In our experience, there has been a huge amount of related research in universities, for example, on how patients react to treatments, and on how the virus is transmitted in public places.

Much of this work requires support from transactional lawyers, who are asked to draft and negotiate research funding and collaboration agreements, licence agreements and supply agreements, as well as ancillary documents such as data processing agreements and material transfer agreements. Several of the law firms recommended in Life Sciences: Transactional, UK-wide have been involved in Covid-related work.

UK government policy 

The UK government has recently produced several policy documents that may affect the sector, including its UK Life Sciences Vision and its UK Innovation Strategy. It is clear that the government considers life sciences and innovation to be important to Britain’s commercial and political future. The inspiring example of the Oxford/AstraZeneca Covid vaccine has brought this area into sharp political focus.

Other developments 

The Covid pandemic may affect how the life sciences sector operates in the future. For example, existing products may be more actively researched with a view to repurposing them. Existing wisdom on development and approval procedures and timescales may be revisited, in light of the rapid deployment of Covid vaccines.

The types of life sciences product and service that are encountered change over time. Areas such as medical devices (including apps), personalised medicine, and the use of 'big data' and artificial intelligence, are increasing. Other areas may be on the decline. For the transactional lawyer, these changes are not as significant as they might be for patent attorneys or litigators. Contract structures can be adapted to new technologies. The skill set required of good transactional life sciences lawyers is extensive, but they generally don’t need the same degree of specialist scientific knowledge that might be required to draft a patent application or interview an expert witness in litigation.

An area of law that has become more prominent in recent years is the regulation of personal data, particularly since the introduction of the EU GDPR, and (following Brexit) its UK equivalent. Some life sciences lawyers have become adept in dealing with the complex data protection issues that can arise in life sciences transactions. Even though the law is supposed to be identical across Europe, in practice there have been national variations in the practical application of EU laws, such as on whether a CRO is treated as a controller.

Funding  

Life sciences research and development (R&D) requires ongoing funding, which comes from various sources. Typically, biotech companies depend on investor support, while universities may be reliant on a mixture of private and public research funding. Some funding comes from major pharmaceutical companies.

The Covid-19 pandemic doesn’t seem to have stopped life sciences R&D from being funded, although some of the public funding has, understandably, been diverted into Covid-related projects. In common with other UK life sciences lawyers, we have been very busy dealing with funding and associated agreements over the last 18 months. It will be interesting to see whether and how the pattern of public funding changes, when the current pandemic subsides.

Finding good life sciences lawyers 

It can be difficult for clients to find lawyers who are experienced in this sector, particularly if the task requires advice from more than one jurisdiction. In some jurisdictions, life sciences transactions would be regarded as a very specialist subject, with no more than a handful of lawyers having substantial experience in the field.

If I am the CEO of a small biotech company and I need a lawyer in mid-sized country X who is a transactional IP lawyer (rather than an IP litigator or patent attorney), who really understands life sciences, and who is not based in a major (and likely expensive) international firm, where do I look? The task may be to review a hospital’s clinical trial agreement, which is stated to be made under the laws of country X.

Guides such as Chambers are a good starting point. Seasoned UK life sciences lawyers often have experience of working with suitable lawyers in other countries. Or the client’s CRO or regulatory adviser may be able to help.

Conclusions  

The UK continues to be an attractive place to do life sciences business, whether in the form of research, commercialisation, or obtaining professional services such as lawyers. We may have lost some of the 'gateway to Europe' appeal that we had when the UK was a member of the EU. But the UK government’s policy is to support the sector, as an important part of the UK economy. It now seems clear that the sector will thrive despite the loss of EU membership.