Biolawgy

What makes Biolawgy different?

Biolawgy is a boutique life consultancy that advises on life science regulations and the laws that underpin them.  It's what we do all day, every day, and we don’t do anything else:  Biolawgy does not purport to be a “full service” life science practice.  We only undertake life science work that involves regulation or governance.  That focus is to your benefit.  And as a consultancy, we can offer far more strategic and policy advice than a law firm.

Shoes not boxes

Life science technologies comprise one of the most economically active areas of the modern economy, so it’s no surprise that a great many commercial law firms claim expertise in life science law.  However, many adopt the “shoe box” approach: advise on boxes of shoes, and you’re a shoe lawyer.  If the boxes contain life science stuff, you’re a life science lawyer.  Box lawyers may be excellent.  Proficiency in areas such as corporate or commercial deals, distribution agreements or patent licensing may be impressive and, in many cases, entirely appropriate.  But life sciences are not just economically hot: the sector is one of the most sternly regulated on the planet.  So hoping for the best and going easy on the regulatory due diligence is unlikely to be a good commercial option.  Even the best commercial lawyer is unlikely to be able to advise on the regulation of, say, continuous glucose monitoring, the use of genomic data to validate polygenic risk scores, the marketing of healthcare products, AI or ML-implemented medical devices, research on material from tissue banks, organoids or reproductive tissue, precision breeding, mRNA vaccines or CRISPR-implemented medicinal products, or whether an instrument is being used for “research us only” or is a regulated medical device or IVD.  Very few practices that have dedicated regulatory lawyers.  That’s our own pedigree, and we’re very happy to recommend them for particular areas, not only in the UK and Europe, but internationally. Like Biolawgy, they deal with shoes, not boxes.  Biolawgy deals with life science regulation exclusively.

Working with a boutique

There are clerical advantages to engaging a law firm that can provide expertise in life science regulation as an adjunct to areas such as tax, employment, and commercial services.  However, full-service law firms require considerable overhead costs, such as those for IT and marketing departments and (largely empty) City offices, all of which must be borne by client fees.  A boutique can provide at least the same level of expertise without requiring you to pay the rent. 

Being a boutique also removes the in-house bias that is inherent in a full-service practice. Instead of being inward looking, a boutique such as Biolawgy looks outward.  This puts you at the centre of your network of legal advisors and consultants; not the senior partner at Bloggs & Co.  Biolawgy works collaboratively with other advisors, big and small, to help you to optimise your business.  Our network of leading life science regulatory lawyers and consultants provides expert advice on EU and UK life science regulation, to help you solve the most complex regulatory challenges effectively and strategically.  If we can’t advise you, we’ll suggest someone who can. For example, because we have long experience of life science practice that is not regulatory (e.g. commercial and corporate matters, patents and copyright) we can suggest other practices to undertake those areas.  We may be retained to work alongside your existing lawyers or consultants to advise on specific matters or, for example, on aspects of transactions as they arise.  Law firms may also retain our services.

Working with a boutique such as Biolawgy is refreshingly flexible approach, enabling in-house counsel to decide exactly who is going to advise on particular areas.

Why science matters

Biolawgy really is a life science practice.  To our knowledge no other UK based practice is so involved in basic science.  Even bona fide regulatory practices steer away from science except in the shoe box sense; for example, advising on clinical trials, ethical approval, the use of research data or the distribution of human cells for research purposes.  There is a simple reason for this avoidance: there is no money in basic research.

We think that being involved in the practice and governance of basic research justifies its unprofitability.  Although our involvement brings a fluency in certain areas that you simply won’t get at most practices, that is not our motivation. As members of both the scientific and legal communities, we feel a strong duty to contribute our expertise to the development of responsible regulatory and governance frameworks to facilitate scientific research.