Do we need a law to help people try experimental drugs?

People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments. juicyrai/Flickr, CC BY-NC-ND

People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments, but they face the risk of exploitation. Is the law the best avenue to ensure that they are protected while medical innovation is encouraged?

Protection of vulnerable people is a thread running through many laws, in Australia and elsewhere. In medical law, for instance, children and people with impaired decision-making capacity warrant special attention.

But what of the ordinary person diagnosed with a life-threatening disease? Such people are vulnerable to harm and potential exploitation when they seek access to innovative, experimental or unproven treatments that depart from the existing range of accepted medicine.

Choice in medical decision making

Personal autonomy is a well-entrenched guiding principle in medical decision making in Australia. An adult with the capacity to make decisions may refuse medical intervention if they wish, even if that treatment could preserve their life and be seen by doctors as being in their best interests.

A recent NSW case, for instance, required the courts to comment on the request by a young man, who had suffered quadriplegia since age seven, that his life-sustaining mechanical ventilation stop on his 28th birthday. The court confirmed doctors would be acting lawfully if they did so.

Conversely, courts rarely compel doctors to provide treatment requested by a patient if that treatment is futile, or hopeless.

But what does hopeless mean in this context? To a dying person, a remote chance may be infinitely preferable to no chance at all.

Consider someone suffering from a rare and probably fatal neurological disorder who wants stem cell treatment. Apart from one or two exceptions, such treatments are currently unproven. Even if this person asks for early access to experimental treatment, it’s likely their [doctor will be cautious](http://es](https://www.mja.com.au/insight/2014/13/james-best-peddlixample.com/).

A medical professional may be concerned the treatment would do more harm than good by raising false hopes, or exposing patients to side effects. They may fear the impact of the person being diverted from partly beneficial conventional treatment or palliative care, or financial costs they would incur. Doctors may also worry about being sued if some of these risks eventuate.

Cases like these give rise to the question of whether the law strikes the right balance between encouraging medical innovation, promoting patient autonomy and protecting vulnerable people against harm and potential exploitation by maverick health-care providers.

UK attempts at legalisation

While not currently on the Australian law reform agenda, encouraging medical innovation has been the subject of wide public debate in England. It’s driven by the sad personal story of a man with a role in political life and a strong background in advertising.

Lord Maurice Saatchi lost his wife Josephine Hart to primary peritoneal cancer. Writing in the Daily Mail newspaper in late 2012, he wrote of his intention to introduce a Medical Innovation Bill, saying:

The aim, in practical terms, is to change the way we treat patients, many of them terminally ill. The Bill’s ultimate goal is to help find a cure for cancer.

The core of the suggested law reform is a provision that would not consider a doctor as being negligent if he or she departs from the existing range of accepted treatments, provided the decision follows an accountable, transparent process that considers all relevant matters.

The proposed Medical Innovation Bill has been through two drafts and a third may soon follow. The revisions all seek to give doctors more clarity and confidence if they wish to innovate.

The challenge of balance

Drafting the proposed law is difficult because of fears the reform will have the unintended consequence of protecting maverick, perhaps even exploitative, health providers who offer false hope to vulnerable patients as their lives draw to a close.

Many, including some doctors groups, particularly the British Medical Association, and insurers, have questioned whether the bill is needed at all.

But the strong public response in support of the bill suggests the promotion of medical research and responsible innovation by treating doctors has widespread support. Perhaps the focus of the debate should shift to identifying and addressing practical barriers to medical innovation, such as adequate funding of medical research, rather than suspected but unlikely legal barriers.

Resources might be allocated to educating the public and assisting medical practitioners along the pathways to innovative practice, including participation in clinical trials (even trials involving only one person where this is clinically relevant and in the best interest of that patient) and existing ethical, legal and regulatory frameworks concerning medical research and innovation.

One example of this approach is the recent publication by the National Health and Medical Research Council (NHMRC) that provides practitioners with information to help them discuss stem cell treatments with patients.

In Australia, as in England, changing the law of medical negligence is probably not the best way to promote responsible medical innovation, even if the aim is to help people diagnosed with a life-threatening disease.

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