By Robert Hewitt, MB BS, PhD, Biosample Hub
More often than not, there needs to be a key event (or series of events) to shine a light on a situation so that we can see that we are facing a crisis. As Business365 readers will be aware, there are times when a situation is screaming for urgent action, but we fail to see it. The field of medical research has its share of such crises, and here are two examples: one that has resulted in some positive changes, and one needing greater attention.
The field of biobanking has been shaped by a number of crises. One of the most noteworthy was the UK organ retention scandal of 1999 (Bauchner & Vinci, 2001). The problem came to light because a bereaved mother investigating the death of her child, demanded a copy of her medical records. Here she found a letter revealing the fact her child’s heart had been removed at autopsy and retained without permission (The Guardian, 2003).
From the public inquiry that followed, it emerged that it was common practice in many hospitals for pathologists performing autopsies on infants to retain whole organs like the brain and heart for education and research purposes, without having the informed consent of the parents. When this information was publicised in the news media, parents who had already suffered a bereavement came to learn that their child’s organs had been retained without their knowledge. This resulted in a huge public outcry; it became obvious that major cultural change was necessary.
The report of the Royal Liverpool Children’s inquiry, published in January 2001, made many recommendations including amendment of national law to clarify the fact that informed consent is required for organ retention at autopsy. In response to these and other recommendations, the Human Tissue Act of 2004 came into force. In addition, a regulatory body called the Human Tissue Authority (HTA) was set up in 2005. Its aim is to ensure that organisations follow legal requirements and so it promotes understanding of these requirements through codes of practice and other guidance.
Biotech companies play a vital role in medical research. But three years ago, the annual report of a UK agency called Medicines Discovery Catapult (MDC) came up with a disturbing finding: 80% of small to medium sized biotechs found accessing samples from the National Health Service unexpectedly difficult with the result that 75% imported samples from abroad (SODN, 2018).
We need to recognise this as a crisis.
The UK has over 150 hospital-associated biobanks so there is no shortage of samples. The problem here is quite simply a failure to share samples with biotech companies. This is partly because public sector biobanks are established by hospitals and universities to support research in academic centres rather than industry. This is not just a UK issue, it is global.
It is well-known that biotech companies around the world rely mainly on commercial tissue brokers to obtain clinical samples. Commercial brokers serve a valuable purpose in that they provide biotech companies with vital clinical samples for their research. However, in general brokers have the disadvantage that for business reasons they will not reveal the source of their samples, because to do so would risk circumvention and loss of income. This obviously means that their clients will tend to lack reliable provenance information on the samples they receive. This poses a serious problem for manufacturers of medical devices who must use samples with reliable provenance information to validate their devices in order to be compliant with the new European IVDR regulations.
There seem to be two main ways in which we can respond to this sharing crisis, and both require cultural change.
The first is that we embrace the commercialisation of biosample procurement. This would mean that hospitals in Western Europe put aside ethical concerns and supply samples to commercial brokers, who in turn provide samples to biotech companies. This would reduce the need for brokers to source samples from other less developed parts of the world.
The second is that public sector biobanks, or rather their management committees, accept it as their responsibility to share samples with biotech companies. This would be the ideal, because biotech companies must have access to high quality samples with reliable provenance information.
The good news is that once a crisis is recognized, it can be a powerful accelerator of change. We can see this in changes in attitudes to video conferencing, online education and working from home brought about by the pandemic. We had all the tools for years, we just needed a push to see the value in them. The trick with all crises is recognising the push.
ABOUT THE AUTHOR
Robert Hewitt, MB BS, PhD, is the founder of Biosample Hub, a new platform that connects Biotech companies looking for samples, with Biobanks that have ethically sourced samples available.