By Jyoti Haikerwal
Patents protect our intellectual property, but who is going to protect our health?
Patents in the medical field are very common in Australia and around the world. Patent protection has been awarded over many things – surgical and medical equipment as well as pharmaceuticals (i.e. medicines). However, patents can be awarded, not just over ‘things’ but a ‘method’ of doing something, and this is an area which still remains unresolved even after a series of High Court of Australia decisions.
Should patents be awarded over medical, diagnostic or surgical techniques (MDST), that is, over the very way surgeons and doctors practise their medicine?
In Australia, section 18 of the Patents Act 1990 – as interpreted by the courts – sets out what can be patented and what cannot. Medical methods already seem patent-eligible. In 2013, the High Court considered in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (Apotex) that section 18 of the Patents Act 1990 (Cth) could be interpreted to allow a patent over a method of applying a treatment cream for psoriasis, and therefore established the prospect of MDST patents. Note, this patent was over the method of applying to cream to treat a medical condition – not a patent over the medicinal cream itself.
But what is wrong with having MDST patent protection?
The right to health is a fundamental human right. Australia is party to a number of international human rights treaties that define and encompass the right to health. However, as with all human rights in Australia, there is no nationwide law enshrining that right. Even in the ACT and Victoria, which have their own Charters of Human Rights, the right to health is not specifically protected.
The right to health has been defined by the UN Committee on Economic Social and Cultural Rights as the right to be able to access the ‘highest attainable health’, rather than the right to be healthy. The right to health encompasses an entitlement that each human being has access to a health care system that exhibits equality and affordability in the standard of care to be delivered.
Despite the lack of a national Charter of Human Rights, it may be argued that the right to health in Australia is manifested in Medicare’s principles which promote access to the health care system free of charge for those in medical need and equitable access to clinical services. Currently Medicare provides universal access to free health, via public hospitals, and subsidised medicines and outpatient services via the Pharmaceutical Benefits Scheme (PBS) and the Medical Benefits Scheme.
The potential danger of patents (which are in reality monopolies) to the right to health can be seen in their impact on the PBS. The PBS is described as a scheme which ‘ensures timely access to medicines that Australians need, at a cost individuals and the community can afford.’
However, because of the costs patent-holders can charge for their medicines, adding new medicines to the PBS increases the cost of the PBS: meaning either the community has to pay more, or that fewer new drugs are listed (and, even if listed, only available for a small number of people who might benefit from the drug). This is an example of patents limiting patient access to the healthcare system.
Because MDST cover not just treatments but ways of achieving, delivering and/or performing a treatment, were they patented, not only would they affect us as users of the healthcare system, but they would also affect our medical practitioners. Not all doctors could afford to buy a licence to perform the necessary diagnosis to tell you what was wrong with you; not all surgeons would be able to buy the necessary licence to then treat you.
Unable to afford consultations
MDST patents would mean that you as a patient might be unable to afford consultations with the necessary practitioners (i.e. those who hold the right licences). Even if you could, you might not be able to seek a second medical opinion – perhaps because, as with gene patents, only one company would hold the diagnostic patent.
The hardest hit would likely be those living in the regions, with rural community medical centres unlikely to have sufficient funds to purchase patent licences. If access to patents meant the ability to practice up to date medicine, MDST patents could encourage doctors to move away from rural areas to practice in places, such as cities, where advanced techniques and access to specialist programs were available.
Patenting MDST would limit clinician freedom and restrict the growth of the medical profession. Right now, in Australia, medicine is a profession that is about knowledge sharing and wanting to help better people’s lives.
The modern Hippocratic Oath even includes the phrase ‘gladly share such knowledge as is mine with those who are to follow’ and AMA Code of Ethics (which practitioners rely on) highlights that there is a duty to pass on knowledge to colleagues and keep their skills up to date.
With Australia being a signatory to the Doha agreement, which encourages States to use intellectual property ‘flexibilities to protect the public health”, it is confusing why Australian law is progressing towards limiting our right to health by suggesting MDSTs can be patentable.
Parliament could easily amend section 18 of the Patents Act to exclude MDST – as has happened in many countries.
Australia needs to reassess which is more important to Australians: protection over intellectual property, or protection of the right of Australians to access affordable and universal health.
Australians need to advocate for their human rights and realise that their right to health may be impacted if judicial interpretations of section 18 of the Patents Act keep progressing as they have been.
We the Australian people are responsible for being acutely aware of, and actively protecting, our right to health, because at the moment the courts, the parliament and the government are not providing that security for us.
– Jyoti Haikerwal is a Law student at ANU, who in July 2017 completed an internship with Civil Liberties Australia in which she analysed the situation in relation to legal developments in the fields of gene technology and practices, and patents and their interaction with people’s lives, insurance needs and superannuation.