The evolving field of genomics continues to play an increasingly important role in healthcare and drug discovery, with new initiatives such as the 100 000 Genomes Project. Here, CMS discuss navigating some of the legal hurdles of such ‘big data’ projects in order to reap the rewards of genomic medicine.

The importance of genomics

At the end of 2014 the National Information Board set out its Framework of Action, containing commitments for the NHS to investigate how it can best use genomic datasets. Genomics is the study of all the genetic information in an individual. It plays an increasingly important role in ascertaining why certain people get some diseases, what drugs work best for them and identifying new therapeutic targets. Improved technologies mean that an entire human genome can now be sequenced for $1,000, as opposed to $95 million in 2001. The preventative and personalised role genomics can play cannot be underestimated, both for patients and for the Life Sciences industry as a whole.

Genomics England (a wholly-owned subsidiary of the Department of Health) aims to sequence 100,000 genomes from NHS patients with cancer, rare inherited disorders and infectious diseases. This new initiative is bringing together funders, academics, NHS clinicians and commercial partners with the aim of delivering healthcare benefits to patients. The challenge is legally and ethically managing a ‘big data’ project, which encapsulates arguably the most sensitive personal data each individual has. Equally, competing intellectual property interests must be carefully managed.

Data protection

The Data Protection Working Party has advised that under current European Data Protection legislation genetic data should be treated as ‘sensitive personal data’ and the new draft European Data Protection Regulation makes this explicitly clear. The current exemption for processing when necessary for medical purposes is unlikely to apply to all uses of genomic data, and questions have been raised as to whether an individual’s whole genome can be truly anonymised. This places huge importance on obtaining explicit consent and ensuring that it covers all potential uses of the genetic material, some of which may not be known at the time of consent. Data-access agreements will need to be robust to ensure public confidence and compliance with legislation.

Intellectual property

Ensuring public confidence that commercialisation will bring benefits to the NHS is one reason behind Genomics England’s centralised ownership model, in which it will own not only genome sequence data but also any new intellectual property generated from the data. It will be interesting to see how the competing intellectual property interests of the various parties are reconciled, especially once commercial partners enter the arena. Genomics England has stated it will license this intellectual property back to third parties on ‘favourable terms’, but just how favourable those terms are, and more importantly who they are favourable towards, remains to be seen. Given the size of the public investment in gathering this generic data, it is to be hoped that the intellectual property terms will not prove to be a barrier to encouraging patient benefit.

Conclusion

Alongside data protection and intellectual property, complex issues include secure data storage for the anticipated 30,000 petabytes of data generated, competing interests regarding publication of results, concerns over use of genomic information by insurance companies and employers, and compliance with regulatory and ethical requirements. However, the potential benefits to all parties from genomic medicine mean that overcoming any possible legal hurdles should be well worth it.

Authors: Sarah Hanson, Partner, IP & Commercial; Hannah Curtis, Senior Associate, IP & Commercial; Emily Bradley, Lawyer, IP & Commercial of CMS Cameron McKenna LLP