Tissue samples: A need to protect owners’ rights

A public consultation on the Human Biomedical Research Bill is ongoing online until Dec 18. To be enacted next year, the new law will, among other things, establish a regulatory framework for how human tissue will be sourced for and used in research.

Scientific discoveries come from studying cancer tissue, blood and so on, but patients who supply them have no say in how their tissue samples are used and no share in the ensuing profits, if any.

Currently, if there are leftovers, tissue samples collected in the course of diagnostic or therapeutic procedures may be used for research without requiring specific consent from the patient.

The Bill will, however, require researchers to obtain specific informed consent. This means they will have to tell patients what research is planned for their tissue samples. This is a laudable move that accords respect to the patient’s autonomy to decide, based on his moral convictions, whether he wants his tissue sample used in a specific kind of research.

A second issue is that researchers currently procure tissue without disclosing that it may have commercial value down the line. Sadly, the Bill brushes this aside in proposing to “protect patient welfare” by prohibiting “the commercial trading of human tissue”.

It mandates that human tissue used in biomedical research be “obtained only through altruistic donations”. Infractions attract fines of up to $100,000 and/or jail time of up to 10 years.

Conversely, researchers and firms may freely exploit their market value by using these tissue samples in potentially lucrative research. So it will be enshrined in law that it is unacceptable for the person providing tissue to make any money from it.

But researchers, their employers and commercial entities (Big Pharma) may benefit financially from any product that might be derived from these tissue samples. That is, when the research enterprise takes possession of my tissue samples as a gift, they become its property. This provision seems to have been drafted to avoid the kind of legal disputes seen overseas where patients sue doctors and researchers who benefit commercially from their tissue samples.

The landmark case was a controversial 1990 state-level decision called Moore v Regents of the University of California. In 1976, doctors treated Mr John Moore for hairy cell leukaemia. But they continued to subject him to unnecessary procedures over the next seven years to extract his tissue to make a blockbuster product without telling him so. Widely used in research, the “Mo” cell line derived from his tissue has raked in billions of dollars for its makers.

The case was not appealed any higher as it was settled for an undisclosed sum after the court ruled controversially that Mr Moore no longer owned the tissue removed from his body. It did rule that his consent for the commercialisation of his tissue should have been obtained first.

But how could it be that I don’t own my tissue after its removal from me? If I lose a toe in a freak accident, I have the right to ask doctors to re-attach it as it is mine.

You might argue that we only own body parts that can be re-attached, but you would be resorting to legal gymnastics to draw up various rules just to argue that my tissue is not mine.

Better to accept that tissue samples taken from me are physical assets that did belong to me in the first place. There is no reason why the researcher should own them just because he took them from me. They did not materialise out of thin air: They came from me, so I was the initial owner.

My tissue forms the first link in a chain of events that involves research adding value to it, so that, eventually, a private firm can make billions from them.

Save for those tissue samples, the process that leads to such profits can’t even begin. So they clearly have a market value from the get-go.

One might argue that recognising property rights may endanger the poor, who might be tempted into selling their tissue samples for money, thus endangering their health. But, first, removing tissue, unlike organs, is usually not life-threatening.

Second, if protecting the poor were the real aim, then compelling everyone to donate altruistically is not only a blunt but also paternalistic instrument to wield. The Bill would then be saying I don’t own my removed tissue because I must be protected from parties who will exploit me by offering to buy it. But it is fine that these parties go on to profit handsomely from those tissue samples they take from me for free.

If protecting the poor were the real aim, the Bill should just forbid the selling of tissue when it harms one’s health, or permit only tissue removed in medical treatment to be sold.

Finally, you might also object that the commodification in allowing human tissue to be sold is an insult to human dignity. That is, people might come to be seen as merely the sum of their parts, each with a specific dollar value.

All this might be true if there were actual bedside bargaining over tissue prices, which would also bog down research badly.

But this won’t happen if the law establishes, as a neutral third party, a tribunal that sets fair compensation and applies it to individual cases that it adjudicates.

While researchers would be free to use the tissue once there is informed consent, firms would be able to use them only if they agree to pay tissue providers reasonable royalties as set by the tribunal when it ascertains, at a later date, that the tissue samples indeed proved commercially profitable.

In fact, similar compensation schedules already exist for the loss of body parts in, say, death and disability insurance. Even as early as the seventh century, Anglo-Saxon laws had laid down specific financial compensation for personal injury to various body parts. This well-established, collective process for determining the value of body parts can easily be extended to tissue, so no bedside bargaining would be needed.

Such an arrangement would, in fact, encourage people to give consent for research on their tissue.

Our commitment to business friendliness and bioscience research must not blind us to the inequity and unfairness of legislating away a patient’s ownership rights in his own tissue samples, which could be a lucrative proposition.

Source: The Straits Times
Published: 05 Dec 2014

Tags: featured

Category: Community, Features