In this edition: organ harvesting research, vaping warning, pharmaceutical advertising, nuclear equipment failure, legalising cannabis and secure dementia units.
The latest insights from our Health Law team:
Research retracted following suspected organ harvesting
Vaping warning from Australian Government
Wrongful pharmaceutical advertising leads to $12,600 fine
Health reacts to nuclear close down
ACT to legalise cannabis
Anita Courtney and Melanie Tan have been published in LASA's Spring issue of Fusion
Learn more about Russell Kennedy's expertise in the Health sector here.
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Amidst intense scrutiny of Chinese transplant practices from international transplant communities, PLOS ONE Journal and Transplantation Journal have collectively retracted 19 articles that have failed to adequately evidence the origins of their organ data.
Both Journals make plain that the internationally recognised ethical standard to evidence the voluntary, informed consent of an organ donor is necessary to ensure that organs have not been procured from “vulnerable populations”, including executed prisoners.
Transplantation Journal states:
"A minimum requirement for all authors in all countries is to consider the origin of the transplanted organs described in their article and that the necessary ethical boundaries and approvals for research are in place and transparent.”
Both Journals will not publish any article that fails to meet this minimum requirement.
To read Transplantation’s retraction statement, click here.
To read PLOS ONE’s retraction statement, click here.
Australia’s Federal, State and Territory governments have responded to emerging international evidence of a possible link between the use of e-cigarettes (commonly known as ‘vaping’) and lung disease.
In a joint statement, Australia’s Chief Medical Officer and all the State and Territory Chief Health Officers have urged a precautionary approach to the marketing and use of e-cigarettes and recommended that e-cigarette users with unexplained respiratory symptoms seek medical advice (Statement). The statement comes as deaths related to vaping are being recorded in the United States of America.
There is growing evidence implicating e-cigarettes in a range of harms to individual and population health. E-cigarettes are relatively new products and the long-term safety and health effects associated with their use and exposure to second-hand vapour are unknown. International evidence is emerging of a possible link between the use of e-cigarettes and lung disease. This includes severe lung disease requiring intensive care support and, as at 11 September 2019, at least six fatalities being linked with vaping in the United States.
The Statement urges clinicians to ask individuals presenting with respiratory symptoms of unclear cause whether they use e-cigarettes. If e-cigarette product use is suspected as a possible cause of a patient’s lung symptoms or disease, the patient should be advised to cease their use of e-cigarettes.
Read the Statement here.
PharmaCare’s “Sambucol Cold & Flu Kids Liquid” was removed from the Australian Register of Therapeutic Goods (Register) in June 2019 after the Therapeutic Goods Administration (TGA) found that the scientific evidence used to support the medicine’s inclusion on the Register was lacking.
Despite this, PharmaCare continued to advertise the product on its website.
This resulted in the TGA issuing a $12,600 fine to the Australian pharmaceutical company for advertising a therapeutic good after it had been cancelled from the Register. Once goods are cancelled from the Register, they can no longer be advertised in Australia.
Recent amendments to the Therapeutic Goods Advertising Code (No.2) 2018 (Code) came into effect on 30 July 2019. This penalty imposed on PharmaCare serves as a reminder to pharmaceutical companies to ensure that they are complying with the updated Code and other relevant legislation when advertising their products to the community.
The Department of Health says that it is “working proactively to find solutions and support patients following an unexpected shortage of nuclear medicine scans in hospitals and medical centres."
The scarcity is as a result of “an equipment failure” at the Australian Nuclear Science and Technology Organisation (ANSTO) facility in New South Wales, impacting the production of nuclear medicine molybdenum-99 (Mo-99). This means that supplies of radioisotope Technetium-99m (Tc-99m) which is the decay product of Mo-99, are limited.
Tc-99m is used mainly for selective imaging of organs and soft tissues such as the lungs, bone, brain, liver and kidneys, enabling an effective diagnosis.
In a media release, Minister for Health Greg Hunt said that his “key focus is ensuring the continuation of diagnostic procedures, and any impact on services, especially for patients living with cancer, is minimised.”
“My Department is working closely with the state and territory health departments to minimise the impact of the shortage” and alternative diagnostic methods are being explored, the Minister said.
Temporary provisions under the Medicare Benefits Schedule (MBS) have been included to allow patients access to relevant PET services (PET means Positron Emission Tomography, a nuclear medicine functional imaging technique) and ensure continuity of care. Prioritisation of Tc-99m is being given to the most urgent cases and the ANTSO is working to ensure that supply is distributed equitably to patients around the country.
An ANSTO spokesperson said that ANSTO is working to address the equipment issue impacting on the production of nuclear medicine and “has four teams working in parallel to progress options to rectify the issue, and a fifth in daily contact with international partners to source medicine from overseas.”
You can read the Minister for Health’s media release here and the ANTSO’s statement here.
The Legislative Assembly of the Australian Capital Territory has passed a bill which permits the possession of cannabis and cultivation of cannabis plants for personal use from 31 January 2020. Persons over the age of 18 are permitted to possess up to 50g and grow 2 plants, with a maximum limit of 4 plants per household.
The Drugs of Dependence (Personal Cannabis Use) Amendment Bill 2018 is a private members bill. It amends the Drugs of Dependence Act 1989 and the Criminal Code 2002 (ACT). The original Bill was amended by the Government, in particular to imbed principles of harm minimisation, which is endorsed by the Federal Government, and in accordance with the national and ACT Government Drug Strategy.
It will be an offence under the new laws to use cannabis in public places, or to knowingly or intentionally use cannabis in such a way as to expose it to a person under 18 years old. Notably, these actions are still offences under Commonwealth laws. Police will still have power under Commonwealth criminal legislation to arrest people for the same actions. It is uncertain how the federal government and police will manage the conflicting legislation.
You can view the bill here.
Principal Anita Courtney and Senior Associate Melanie Tan have had an article published in LASA's Spring issue of Fusion, titled: 'Secure Dementia Units'.
This article provides key recommendations regarding the new obligations under the Quality of Care Amendment (Minimising the Use of Restraints) Principles 2019, which commenced on 1 July.
You can read more about their article, titled 'Secure Dementia Units', here.
Learn more about Russell Kennedy's expertise in the Health sector here.
If you'd like to stay up to date with Russell Kennedy's insights, please sign up here.