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Biobanking: preserving a precious resource or bio-harvesting for commercial gain?

Product safety and consumer law solicitor, Stuart Warmington, discusses biobanking and the questions that have arisen regarding whether patients have any legal right of ownership over samples taken from their bodies.  

Stuart is a solicitor in the product safety and consumer law team where he focuses on health related claims on behalf of injured clients.
There have long been concerns surrounding clinical research that is conducted in the developing world. Whilst some of this work has produced important progress and been carried out to high ethical standards, too many stories have emerged over the years that suggest there has been the potential for participants to be unfairly exploited.

Criticisms of ‘outsourced’ clinical trials include the extent to which providing payment or free healthcare in return for participation is an unfair incentive in less developed countries. There is also concern about how far properly informed consent can be obtained in areas where access to education is limited, or where regulatory oversight is less stringent. There may simply be more opportunity to conduct research away from proper scrutiny. 

Furthermore, a fundamental ethical consideration when carrying out clinical research in developing nations is the extent to which the participants stand to benefit from any resulting treatment advancements that are made with their contribution. If health insurance (or state healthcare) is not readily available to them, will they ever be able to access the treatments that they help develop?

Recently, a report was published in the Daily Telegraph that illustrates many of the above issues, and also fundamentally questions where the rights of a research participant start and end. 

The West Africa Ebola crisis between 2014 and 2016 was the largest outbreak of Ebola since the disease was discovered in 1976, and constituted a massive health emergency. By the time the ‘Public Health Emergency of International Concern’ was lifted in March 2016, the World Health Organisation (WHO) estimated that over 28,000 people had been infected, and over 11,000 had died as a result (although some believe this to be an underestimate). 

In the course of combatting the disease, as many as 269,000 specimens were collected from those infected by Ebola, or those who were at risk of infection. Primarily, these were blood samples but it is thought that samples of other bodily fluids and even human tissue were also collected. Some of the diagnostic testing conducted in Sierra Leone was carried out in Public Health England (PHE) led laboratories.

As the epidemic passed, it was clear that a significant number of potentially hazardous biospecimens remained – often in storage facilities that were not sufficiently secure to protect the wider public. The World Health Organisation (and others) also appreciated that the samples were a “precious and non-renewable resource”. WHO meetings were held in Geneva and Sierra Leone in May and August 2015 where in the course of the discussions the “countries intensely affected by [Ebola]…indicated that this opportunity should be used to build scientific, administrative, and technological capacities in the region”.

Despite this call from the affected nations, it has transpired that many of samples collected at the PHE-led laboratories have since been, “transferred to PHE laboratories in the UK for curation by PHE”. In total, some 9,955 samples have been brought to the UK, of which 1,108 are positive for Ebola. 

The process of curating biological samples for research purposes is known as biobanking. PHE states that, “The Ministry of Health and Sanitation in Sierra Leone (MOHS) have retained ownership of the data and materials, and have agreed to work with PHE and other collaborators to develop and conduct a series of research projects that will inform future public health strategy relating to Ebola”. Guidelines produced by PHE confirm that, “Researchers from the UK and overseas, from academia, government other research organisations and commercial companies can submit proposals to the Biobank to access and use the samples” .  

Controversially, however, the guidelines also state that, “In any event prior to any commercial exploitation of such inventions, the researcher agrees to enter into good faith negotiations with PHE and MOHS to negotiate terms that reflect the technical contribution of the materials”.

Although the Sierra Leonean Government states that it has retained ownership of the samples, and will be part of any commercial negotiations surrounding them, this does not appear to provide any guarantee that any proceeds will filter back down to directly benefit the communities that suffered most during the epidemic and provided the samples. It also seems clear that commercial companies (including pharmaceutical companies) can apply for access to the samples, potentially standing to make huge profits from any successful research. As an indication of the incentives involved, vials containing 0.5ml samples of the Ebola virus are currently being advertised by a separate institution in Hamburg with a price tag of €3,637.38. As noted by the journalist Emmanuel Freudenthal, “That is 170 times the price of gold” .

At its most extreme, some may argue that biobanking can amount to little more than biological ‘asset stripping’. 

One question that arises is whether the patients have any legal rights of ownership in the samples taken from their bodies? This is far from straightforward. Clearly, as noted above the Sierra Leonean government considers (presumably under the law of Sierra Leone) that the samples are state property. In the UK, there is a common law maxim that, “there is no property in a dead body or its parts”1.In R v Kelly , however, the Court of Appeal held that property rights can be gained if it has, “acquired different attributes by virtue of the application of skill, such as dissection or preservation techniques…”2 and it might be argued that this suggests a biobank gains ownership rights when preserving the samples in its facility. The Kelly case did not, however, concern samples taken from a living body. 

In the US, there was an attempt in 19883 by a John Moore to pursue a civil claim arising from the conversion (i.e. civil theft) of his spleen that was removed during surgery to treat his cancer. His doctor went on to use the tissue, without Mr Moore’s consent, to develop and patent a cell-line that was ultimately sold for $15m. The Court held that Mr Moore had no property rights in his spleen, and that (with somewhat unattractive terminology) to find otherwise would, “hinder research by restricting access to the necessary raw materials”. It is worth noting, however, that the Court did accept that there might have been a valid claim for breach of fiduciary duty, and also that Shaun Pattison, Professor of Medical Law and Ethics at Durham University has also suggested that, “It maybe that the conversion-property approach might have fared better before the English Courts”4.

A further issue to consider is the extent to which the Human Tissue Act (HTA) 2004 might be relevant to the Ebola biobanking scenario. This Act was introduced following the Alder Hey organ scandal, where it was found that – among other things – children’s organs had been retained without consent. While tissue specimens are obviously covered by the Act, it is clear that blood samples also fall within the definition of “relevant material” for purposes of the Act5. The HTA 2004 essentially makes it an offence to retain human material for research without “appropriate consent". Crucially, however, this does not apply to imported material (on the basis that consent should have been gained by the exporter) , and there is also an exception where consent is not required in circumstances where the researcher cannot identify the donor and the project has been ethically approved . 

Finally another area of law to look at might be data protection. Although the PHE Guidelines referred to above assert that, “PHE is committed to the fair and lawful processing of personal data in accordance with the GDPR” , the Telegraph reports that it spoke to two dozen Ebola survivors from Sierra Leone, Guinea and Liberia and none were aware that their blood might be being used for research, and did not believe they had consented to this. However, the GDPR also allows personal data to be lawfully processed in certain circumstances without consent if it can be shown that there is a “legitimate interest” in doing so. 

As illustrated above, this is an incredibly complex situation. It is important to bear in mind that there are persuasive arguments to support the steps that have been taken. Clearly, it was vital that potentially dangerous biological specimens were secured in appropriate laboratories, and that the samples be preserved to help try and prevent a similar epidemic occurring in future. And, if a new treatment is discovered, the ‘donor’ communities may well also benefit from the therapy. 

Equally, many may feel a sense of moral unease at what has been done, and it is a conclusion that is reinforced where it appears that business and academia in this country and abroad may stand to gain hugely. It is far from clear that the communities that suffered most under the epidemic will benefit in kind. There should also be consideration given to the local scientists, clinicians and technicians who collected Ebola samples at significant personal risk, without opportunity to learn from their work in their own country. 

As can be the case, however, the law may not offer a legal remedy to a moral injury. 

1 p. 485, Medical Law and Ethics, 5th Edition (2017), S. D. Pattinson
[1999] Q.B. 621
Moore v Regents of the Universtiy of California (1990) 51 Cal. 3d 120
p. 487, Medical Law and Ethics, 5th Edition (2017), S. D. Pattinson
§53, Human Tissue Act 2004: “In this Act, “relevant material” means material…which consists of or includes human cells”. 

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