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Insights

Health Bulletin

Russell Kennedy Health Insights 11 February 2019

The latest insights from our Health Law team.

In this edition:

Learn more about Russell Kennedy's expertise in the Health sector here.

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South Australian man convicted of 11 charges relating to counterfeit and unapproved medicines

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In early January 2019, a South Australian man pleaded guilty to 11 criminal charges under the Therapeutic Goods Act 1989 (Cth) relating to illegal acts involving counterfeit therapeutic goods. The Adelaide Magistrates’ Court convicted the man of all charges including:

  • dealing with counterfeit therapeutic goods in Australia;
  • using a therapeutic good in reliance of advertising that causes harm or injury to a person;
  • supplying therapeutic goods in Australia not included on the Australian Register of Therapeutic Goods (ARTG); and
  • importing therapeutic goods not included on the ARTG for use in humans.

The man was sentenced to five months’ imprisonment, which was suspended upon the man entering into a two year good behaviour bond.

In a media release discussing the case, the Therapeutic Goods Administration (TGA) reminded the public of the seriousness of offences involving counterfeit therapeutic goods and the harm that can be caused by selling fake medicines. The TGA has powers to investigate and take strong action against individuals dealing with fake medicines.

The TGA also warned that to avoid counterfeit medicines, consumers should only buy therapeutic goods from reputable sellers such as pharmacies and supermarkets. Online marketplaces continue to present a risk to consumers as, in many cases, there is no way to establish the safety, quality and efficacy of the medicines sold. More guidance and information can be found on the TGA buying medicines and medical devices online  web page.

Voluntary Assisted Dying Statewide Pharmacy Service FAQs

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In January 2019, the Victorian government announced that the pharmacy service at The Alfred hospital will be the sole service for dispensing voluntary assisted dying medication when the scheme takes effect on 19 June 2019. The voluntary assisted dying medicine will be funded by the Victorian government and patients will not be required to be out-of-pocket to access the medication.

The pharmacy service at The Alfred will be responsible for importing, storing, preparing and dispensing the medication across the State, including delivering medication to those who are too unwell to travel. The Alfred will also provide phone support and advice to co-ordinating medical practitioners about the prescription of voluntary assisted dying medication.

The Victorian government has released the Voluntary Assisted Dying Statewide Pharmacy Service FAQs to provide further information for the health sector as to how the pharmacy system will operate.

Read the media release here and access the FAQs here.

Healthcare facility concedes privacy breach after specialist sends medical report to wrong GP

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In NSW, the Health Privacy Principles (HPPs) contained within the Health Records and Information Privacy Act 2002 (HRIP Act) protect individuals in NSW in relation to the collection, storage, use and disclosure of their health information by NSW public sector agencies and health service providers. The NSW Civil and Administrative Tribunal (Tribunal) has recently considered whether there was a breach of HPPs as a result of the disclosure of personal information to a general practitioner not involved in the care of the patient due to a computing error.

In DKV v Southern NSW Local Health District [2019] NSWCATAD 12, the applicant scheduled an urgent appointment with a specialist at the respondent’s public healthcare facility. On the same day as scheduling the appointment, the applicant also sought treatment from a general practitioner (GP 1). The applicant saw GP 1, who was a visiting medical officer, because the applicant’s usual treating GP (GP 2), was not available.

The following week when the applicant attended a specialist appointment, the specialist prepared a report addressed to the applicant’s GP. Due to a computing error, the program auto-populated the GP’s names in the report template to be both GP 1 and GP 2, and the report was faxed to each accordingly. Upset that GP 1 received the report, the applicant complained in writing directly to the respondent and also lodged an application at the Tribunal for review.

The respondent conducted a comprehensive internal review and conceded breach of the HPPs when it erroneously sent the report to GP 1 and when it failed to inform the applicant about the purpose for collecting the health information and to whom it might be disclosed.

The Tribunal closely considered whether the respondent had breached HPP 9 in relation to the relevance and accuracy of the health information, and whether there had been an additional breach of HPP 11 by sending the report to the treating GP. Ultimately the Tribunal found there had been no breach of HPP 9 and HPP 11, except as conceded by the respondent.

Read the decision in full here.

QCAT finds anaesthetist did not make false statements about methyl-amphetamine use

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On 21 December 2018, the Queensland Civil and Administrative Tribunal released findings in relation to disciplinary proceedings against an anaesthetist (Dr Euston) who was charged and convicted of supplying methyl-amphetamines and possessing dangerous drugs in breach of the Drugs Misuse Act 1986. The Tribunal was required to determine the factual disputes prior to the parties providing evidence and submissions in relation to any sanction being imposed.

On 19 October 2013, Queensland Police Service members carried out a search of Dr Euston’s home locating drugs and other items. Previously, he had denied suppling methyl-amphetamines or possessing dangerous drugs. He was later convicted on his own plea of guilty to various criminal charges relating to the unlawful supply and possession of a dangerous drug.

AHPRA placed a condition, to which Dr Euston voluntarily submitted, on Dr Euston’s registration requiring him to attend for drug testing. Results of urine and hair samples suggested the presence of methyl-amphetamine in his body but Dr Euston denied ever using methyl-amphetamines.

Dr Euston deposed that in the six months prior to the testing he had taken Selegiline, a medication that metabolises to methyl-amphetamine and has been implicated in false positive hair tests in the past. He argued the quantity of methyl-amphetamine found was also significantly below international guidelines required to indicate methyl-amphetamine use.

The Tribunal accepted Dr Euston’s evidence as to his use of Selegiline and as a result did not accept that the positive hair test result was evidence of his methyl-amphetamine use. The Tribunal therefore found that Dr Euston was a truthful witness and the concerns regarding his false evidence and statutory declaration were unfounded.

Read the full decision here.