Guest Blog |Is now the time for genomic medicine?

This article was co-authored by Cliodhna McDonough, Life Sciences Director and Eleanor Mac Intyre Associate at Fieldfisher.

The Covid-19 pandemic has permanently altered the world; for the life sciences sector it has opened the doors of opportunity very wide. Over the last year, the sector has seen record levels of attention, investment and support from regulators. The world is invested in the innovation that our sector is able to bring to revolutionise healthcare – so is now the time for genomic medicine to shine?

To put it simply genomic medicine is using a person's genetic variants to decide what type of treatments would work best. This treatment is also called personalised or precision medicine. Genomic medicine is fundamentally altering the way scientists understand disease and revolutionising healthcare. It provides a detailed understanding of what causes illness and infectious disease, and is underpinning the development of new interventions. Experts are so invested in the future of these medicines that it was identified as a top 10 digital healthcare technologies in an independent report commissioned by the UK Government in 2019 .[1]

Furthermore, back in September 2020, the UK government published Genome UK: The Future of Healthcare, this document stated the ambition of "creating the most advanced genomic healthcare system in the world". In May 2021, this strategy was complemented with an implementation plan which involved the creation of Genomics Workforce Steering Group to support the execution of personalised medicine throughout the NHS.

Challenges

There are a number legal and ethical challenges when it comes to genomic medicines, however, we're going to focus on the regulatory obligations, which like with getting most new medicines to market is not straightforward.

The majority of genetic testing relating to health is conducted in hospitals, often in UK NHS Genetics Clinics or Genomic Centres. However, an increasing number of private companies are now offering direct-to-consumer genetic testing ("DTC-GT") services whereby companies are selling online DTC services directly to UK consumers or selling diagnostic kits through pharmacy retail chains.

A challenge for the effective regulation of DTC-GT is that these tests are mostly sold through the internet and hence where different jurisdictions begin or end is difficult to clearly delineate. If a genetic testing company operates in, and from, the UK, it would have to comply with a wide range of legislation such as for example data privacy, unfair commercial practices and consumer protection laws.

Furthermore, genetic medical diagnostic tests are classified as an in-vitro diagnostic (IVD) medical device and a manufacturer of an IVD medical device must ensure to meet relevant regulatory requirements prior to placing a product onto the market.

Another issue is concerns over misleading advertising and marketing claims over the accuracy and interpretation of a DNA test product. These concerns have come to the attention of the Advertising Standards Authority (ASA), who even ruled against misleading promotion in the case of Trisomy.

However, with the above regulatory bottlenecks and the latest challenge to genomic medicine and concerns about NHS data sharing to private companies, while it's looking positive that the UK will continue to be global leaders in personalised medicines there will be more battles on the way.