The latest insights from our Health Law team.
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Changes to the therapeutic goods advertising framework commence
Following the Therapeutic Goods Administration’s (“TGA”) Review of Medicines and Medical Devices Regulation a range of changes to the regulatory framework will be made between 2018 and 2020, with the first changes commencing last month.
The changes mainly relate to the four following areas:
- increased penalties for non-compliant advertising from March 2018;
- amended Therapeutic Goods Advertising Code from 1 July 2018;
- a streamlined complaints handling system from 1 July 2018; and
- abolishing the requirement for certain advertisements to be pre-approved from 1 July 2020.
The March 2018 changes amend the Therapeutic Goods Act 1989 by amending existing criminal offence sanctions and penalties, as well as introducing new sanctions and penalties, for example, civil penalties and infringement notices.
The broadened penalties and sanctions are intended to complement the TGA’s education and compliance program to achieve advertising compliance.
Read more about the current and future changes here.
Medical practitioner convicted of fraud has registration suspended by VCAT
The Victorian Civil and Administrative Tribunal ("VCAT") determined Dr Pralay Mazumdar, a specialist psychiatrist, engaged in professional misconduct and unprofessional conduct in November 2017.
Dr Mazumdar pleaded guilty and was convicted in December 2014 for fraudulently obtaining payments and knowingly providing false and misleading information following an investigation by the Victorian WorkCover Authority ("VWA").
Dr Mazumdar's conduct involved systematic overcharging of the VWA by fraudulently obtaining payments on 114 occasions over an 18-month period, the total amount involved was $44,539.
On 11 December 2014, Dr Mazumdar was sentenced to a suspended six-month jail term and fined $5000. On appeal, the suspended sentence was set aside and a two-year Community Corrections Order for two years, including 350 hours of community service, was imposed instead.
VCAT has approved the Medical Board of Australia’s ("Board") recommendation to reprimand and suspend Dr Mazumdar for six months from 1 January 2018. Conditions were also imposed on his registration, including to:
- undertake education about billing practices and professional behaviour, during the suspension period,
- attend mentoring, following his return to practice, and
- submit to audits of his practice, to focus on billing practices, following his return to practice.
VCAT's finding of professional misconduct related to Dr Mazumdar’s criminal convictions, and its finding of unprofessional conduct related to his failure to advise the Board that his clinical privileges at the clinic where he worked had been suspended, as is required under the Health Practitioner Regulation National Law.
Read the Medical Board’s media release here.
Call for changes to mandatory reporting for treating practitioners
United General Practice Australia ("UGPA"), is seeking changes to mandatory reporting requirements for treating practitioners. The current requirement are seen to increase the risk that health practitioners will not seek independent medical assessment, advice and treatment to address a physical or psychological medical condition that they may be personally experiencing.
UGPA believes that mandatory reporting laws should be in line with the recommendations made by the Medical Council of New South Wales and the model already adopted by Western Australia.
The changes sought would remove the mandatory reporting requirement and thereby encourage health practitioners to seek treatment from their colleagues and only require reporting where they see a genuine risk to the public, as already is the practice.
Read more here.
Palaszczuk Governments acts on discrimination
The Palaszczuk Government in Queensland has committed to changing the Births, Deaths and Marriages Registration Act 2003so that people who undergo gender reassignment will not have to divorce their partner.
Section 22 of the Act currently states “The reassignment of a person’s sex after sexual reassignment surgery may be noted in the person’s entry in the register of births or adopted children register only if the person is not married” [emphasis added]. Queensland Attorney-General Yvette D’Ath introduced the Births, Deaths and Marriages Registration Amendment Bill 2018 into Parliament on 7 March 2018. It will be amended to remove the requirement that a person not be married.
Further, as at 9 December 2018, the exemption in the Sex Discrimination Act from anti-discrimination law in relation to a refusal to alter a person’s sex on an official record because the person is married where it is in accordance with state and territory laws will be repealed.
Some members of the community have held this requirement as a choice between their identity and their marriage. With same-sex marriage being legalised in December 2017, this move has come to reflect both the legal and social landscape of Australia.
Read the Bill’s explanatory memorandum here.
Victoria’s new information sharing scheme aimed at reducing family violence
A new information sharing scheme in Victoria will come into effect this month to address the concerns raised by the 2016 Royal Commission into Family Violence. The Family Violence Protection Amendment (Information Sharing) Act 2017 is aimed at minimising the legislative barriers that have prevented the timely sharing of information in cases of family violence.
The previous requirement that a threat be ‘imminent’ as well as ‘serious’ before information could be shared or released set a higher threshold that was difficult for practitioners to interpret. The new scheme is designed to operate within the existing privacy obligations, however sets a lower threshold for the disclosure of confidential information for the purpose of family violence assessment and protection.
The HCC and the Office for the Victorian Information Commissioner have released an information sheet to assist organisations that handle personal and health information, which can be viewed here.