Recent weeks have again demonstrated problems with Australia’s regulation of medical devices. Those problems involve pelvic mesh, implants affecting an unknown number of Australian women and claimed to have caused serious harm. They also involve the security of wireless pacemakers, with speculation about ‘assassination by pacemaker’ or other implanted devices. They follow litigation in Australia and overseas about defective breast implants and joint implants.
An effective response to those problems will reduce unnecessary suffering, litigation and a burden on the national economy rather than just the taxpayer. That response is achievable: the problems are not unfixable. It requires a restructuring of the medical devices regulator – the Therapeutic Goods Administration (TGA) – for enhanced performance and meaningful accountability. It requires a comprehensive national register of all devices, along with timely information sharing about device failures. It also requires meaningful disclosure by health practitioners, service providers and manufacturers about conflicts of interest. Changes to the Australian regime should be welcomed by everyone with a professional interest in public health and anyone who is a potential recipient of a medical device or a taxpayer.
Some problems are avoidable
Public health involves minimisation of risk — reducing the severity and incidence of harms — rather than the elimination of risk. Some harms are foreseeable and can be prevented through action by practitioners, regulators, manufacturers and an informed public.
The pelvic implants disaster has demonstrated, yet again, the need for a comprehensive national register of all implantable devices.
Unfortunately recent months have demonstrated that some risks have not been effectively managed. The harms have involved incapacitation of patients, avoidable pain and other suffering, costs to the taxpayer (through for example remedial surgery) and a loss of national productivity (with patients and carers being off work because of injury). Irrespective of pain that can never be adequately measured, the economic impact of defective joint, breast and pelvic implants is in the billions of dollars. It dwarfs the cost of running the TGA, where Australia has been what used to be damned as ‘penny wise, pound foolish’.
The pelvic implants disaster has demonstrated, yet again, the need for a comprehensive national register of all implantable devices. Data in that register can be managed to both protect patient privacy and enable forensic analysis to identify problems with particular products or types of implants. The cost of an integrated register, building on current partial registers, will be lower than the funds expended in inquiries mentioned below. It can be funded by manufacturers. Those manufacturers and some practitioners may complain that registration – and being accountable through public scrutiny – is unduly onerous. Such a complaint is disingenous; enterprises that wish to gain revenue from the Australian market and gain international legitimacy through operation in that market should expect to pay a small amount for the privilege.
Sunlight is the best disinfectant
Medicine advances by learning from mistakes. We need however to be able to quickly identify those mistakes and place them in context. That requires disclosure by regulators, who cannot be too close to the entities they regulate (ie must be wary of ‘regulatory capture’), and by health practitioners, service providers (which may have different priorities and ethical frameworks to the professionals that they employ) and manufacturers.
One disturbing aspect of recent problems with implants is the very belated disclosure that the WA branch of the Australian Medical Association had a direct commercial interest in the product that was being used in that state. Irrespective of concerns about potential conflicts of interest for a gatekeeper, we should expect full disclosure of the pecuniary interests of practitioners and other parties. That disclosure is not contrary to privacy or other law. It is consistent with a commitment by practitioners to avoid paternalism, ie to enable patients to make informed decisions. It is also consistent with the ongoing movement to disclosure by practitioners and pharmaceutical companies, encouraged by the Australian Competition and Consumer Commission in endorsing the Medicines Australia Code, for public disclosure of benefits provided to practitioners for prescribing a specific drug. It should be required by law and can indeed be given effect through changes to both the Health Practitioner Regulation National Law and the Australian Consumer Law.
Anticipation, not Reaction
The TGA is a troubled part of the national Health Department, having been criticised in a succession of specialist investigations and parliamentary inquiries since the Pan Pharmaceuticals debacle that saw the Commonwealth government pay $50 million damages a decade ago. We might wonder whether the TGA, facing such scrutiny, has become both inward-looking and more than a little gun-shy. That wariness about a timely and robust engagement with both the businesses that it is responsible for regulating and with consumers who might be adversely affected through inadequate regulation is disquieting.
On that basis the TGA needs to be a discrete government agency, separate from the Health Department, reporting directly to the national parliament and funded on a needs rather than an operational costs recovery basis.
Effective regulation means that the TGA must be less complacent about relying on information from overseas counterparts, such as that in India, where there are admitted problems with corruption and capability in supervising production. The TGA has to be prepared to act quickly to avert harms, rather than respond slowly after harms have received an embarrassing degree of publicity. It also needs to engage with consumers, avoiding perceptions that it has been captured by the entities it is meant to regulate. Those entities provide its funding.
On that basis the TGA needs to be a discrete government agency, separate from the Health Department, reporting directly to the national parliament and funded on a needs rather than an operational costs recovery basis. It needs both the funding and expertise to do its job well, including expertise about devices that are part of the emerging Internet of Things rather than traditional stents and joints. It needs to be fearless, rather than worrying about what the Health Minister and head of the Health Department will say if it brings bad news or asks for more funds. Its mission is ultimately the protection of Australian consumers rather than cost recovery or support for manufacturers who are typically based offshore with low tax liability.