Regulatory loophole closes

Despite Australia’s reliable and robust regulatory environment addressing drugs and medical technologies in market, unproven and expensive stem cell therapies have been able to expand and flourish across our nation because of a significant oversight ambiguity.

But the loophole is now about to close, with the Therapeutic Goods Regulator (TGA) announcing in late September that it will have greater regulatory oversight of the manufacturing and clinical use of autologous cells and tissues of this area, effective from early 2018.  For many patient advocates, healthcare practitioners and scientists, this announcement has been long overdue.

So-called autologous stem cell therapies, marketed as ‘using the patient’s own cells’, have exploited the regulatory loophole with hundreds, possibly thousands of patients in Australia experimenting with the technology.

Many scientists and clinicians who have followed the implementation of these unproven therapies have raised concerns over the years, often in the strongest of languages, calling on the national regulator to step in to protect patients from coming to harm and to ensure genuine efforts to translate promising stem cell research into clinical trials to prove safety and efficacy are not stymied.

Commenting on the announced change that will take effect in early 2018, Program Leader of Stem Cells Australia Professor Melissa Little said, “We are very pleased to see these changes announced. This will bring our industry in line with regulations in place in many international jurisdictions and safeguard the vulnerable patient groups from unproven and potentially unsafe practices”.

Historically the use of the patient’s own cells had been seen as a medical practice and not regulated by the TGA. However, many practitioners and scientists are convinced that some cell therapies on offer in Australia by some clinics place patients at considerable risk and warrants safeguards to protect patients from coming to harm.

It’s important to recognise that not all autologous stem cell therapies are being labelled ‘bad science’ in this dialogue. There are some highly effective autologous treatments available in Australia that have deep and thorough files of clinical trial data and has been developed via rigorous and repeatable experiments and good manufacturing practice (GMP) standards.

The organisations that offer autologous cell therapies which are already compliant with the proposed regulatory oversight will have no concerns about the new regulations about to be imposed.

For years, the hope and promise of cell therapies has sustained many patients and their carers through extraordinary suffering and uncertainty. The desperation many feel when current treatments fail to relieve pain, the effects of progressive disease or impact of serious injuries drives many towards alternative solutions, even if they are experimental or unproven. Many patients are confused as to what a clinical trial is and how to tell if a therapy merely is ‘experimental’ or a part of a duly registered trial.

The introduction of tighter oversight is not expected to disadvantage those cell therapies in registered clinical trials or already in compliance with proposed regulations. The regulations will instead serve to reduce the uncertainty for patients, in being able to trust the Australian healthcare system to deliver proven therapies and to minimise risks involved in accessing emerging treatments.

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