In this edition: TGA provisionally approves Pfizer COVID-19 vaccine, Medical Research Future Fund, Health Care Complaints Commission v Russ.
The latest insights from our Health Law team:
TGA provisionally approves Pfizer COVID-19 vaccine
Medical Research Future Fund – Consultations for roadmaps and implementation plans
Health Care Complaints Commission v Russ [2021] NSWCATOD 5
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TGA provisionally approves Pfizer COVID-19 vaccine
Pfizer Australia Pty Ltd has been granted provisional approval by the Therapeutic Goods Administration (TGA) for COMIRNATY, its COVID-19 vaccine. As a result, the vaccine is now included in the Australian Register of Therapeutic Goods for active immunisation to prevent COVID-19 in individuals 16 years or older. Provisional approval includes a six step process which a sponsor (usually a pharmaceutical company) must adhere to, as follows:
- Pre-application
- Application
- Evaluation
- Decision
- Registration
- Monitoring
Provisional registration continues for an initial period of two years, with the option to then apply for up to two further periods of two years. After the provisional registration is completed, the vaccine will transition to full registration.
The provisional approval of the Pfizer vaccine means that the vaccine meets the TGA’s efficacy, safety and quality requirements and as a result, can be legally supplied in Australia, subject to certain conditions. Pfizer is required to continually inform the TGA as to the long term efficacy and safety of the vaccine, as determined from ongoing clinical trials and market assessment.
Following provisional approval, COVID-19 vaccine batches must be dispatched by the manufacturer, received at the Australian border and checked by the TGA, following which it will be allocated and distributed to vaccination sites. At the vaccination sites, the vaccines will be administered by health care professionals. Vaccinations will commence in February 2021 to high priority recipients including vulnerable Australians, aged care/disability workers, frontline healthcare workers and quarantine and border workers.
You can read the TGA’s media release here. For more information on the vaccine approval process administered by the TGA, click here. The Australian Government’s National Rollout Strategy is available here.
Medical Research Future Fund – Consultations for roadmaps and implementation plans
The Medical Research Future Fund has opened consultations to develop a roadmap and implementation plan for cardiovascular health, traumatic brain injury, genomics and stem cell therapies.
Expert Advisory Panels were appointed for each of the above research investment streams, to provide their advice on the priorities for these areas. They are tasked with developing a roadmap and implementation plan to achieve the mission statements set out for each area in the 2019-20 budget. The implementation plans will be used to assist the government to design and implement investment via grant opportunities.
An initial consultation opened mid-2020, and the second round will close on 23 April 2021. You can contribute to the cardiovascular health, traumatic brain injury, genomics and stem cell therapies consultations at the links provided.
Health Care Complaints Commission v Russ [2021] NSWCATOD 5
A nurse convicted of drug related offences was recently successful in opposing an order sought by the Health Care Complaints Commission (HCCC) to have her registration as a nurse cancelled. In April 2019, the nurse was arrested as part of the NSW Police Force’s Strike Force Cyril, which targeted the supply of cocaine within the Coffs Harbour area. She was convicted, appealed, and was subsequently discharged under a conditional release order on the basis that her offending was at the low range and that she was a “very low risk of reoffending”. Since her arrest, the nurse had not worked as a nurse.
The New South Wales Civil and Administrative Tribunal (the Tribunal) were tasked with determining whether the circumstances of the offence for which the nurse was convicted render her “unfit in the public interest to practise the … profession” of nursing and if so, whether the power to cancel her registration should be exercised.
The Tribunal considered a range of evidence tendered by the nurse and the HCCC and made the following observations in respect of whether the nurse was unfit in the public interest to practice her profession:
- The objective seriousness of the nurse’s offending fell at the low end of the scale;
- There was no evidence that the nurse’s involvement in the illegal drug activities had affected her professional competence as a nurse. Rather, colleagues spoke highly of the nurse; and
- The nurse had entered a very early plea of guilty and had accepted her legal punishment. Her remorse was assessed by the courts and others as genuine.
Ultimately, the Tribunal considered it more appropriate to reprimand the nurse. In reaching this conclusion, it observed that the nurse had a very low risk of reoffending. The Tribunal was satisfied that the nurse had rehabilitated.
The issue of a reprimand was entered on the public record of the nurse’s registration.You can read the full decision here.
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