We Asked, You Said, We Did

Below are some of the issues we have recently consulted on and their outcomes.

We asked

Public consultation on the Delegate’s interim decision on nicotine scheduling was held between 23 September and 12 November. The interim decision and public consultation relate to a delegate-initiated proposal referred to the June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25).

You said

We received 2385 submissions in response to the public consultation, including seven submissions that were received offline. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback that we received.

We did

The Delegate considered all submissions prior to making the final decision on nicotine scheduling. The final decision was published on 21 December 2020 on the TGA website.

We asked

We asked for your feedback on the new ARPANSA Standard for Limiting Exposure to Radiofrequency Fields – 100 KHz to 300 GHz (RPS S-1) because we want to make sure that the standard is fit for purpose and provides clear guidance to industries and regulators to ensure the safety of Australian workers and the general public including people of all ages and health status.

You said

We received 61 submissions from a range of stakeholders, including health authorities, scientists, academic bodies and members of the general public. There were a range of technical comments, questions, and suggestions, as well as comments from members of the public expressing concern about the certainty of the science underpinning the exposure limits.

We did

We have reviewed all submissions and made some amendments, primarily to clarify technical aspects of the Standard. The revised Standard and our responses to individual consultation comments will now undergo formal approvals prior to publication.  

The new Standard will be published on the ARPANSA website in the first quarter of 2021.

We asked

Public consultation on the Delegate’s interim decisions, in relation to scheduling proposals referred to the June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), was held between 9 September 2020 and 13 October 2020.

You said

We received 41 submissions in response to the consultation. Respondents provided feedback on the proposed changes to the Poisons Standard. We appreciate all of the feedback we received.

We did

The Delegate considered all submissions in making the final decision on these proposals.

Final decisions regarding oxymetazoline, eletriptan, clotrimazole, sildenafil, ibuprofen and cumyl-pegaclone were published on 25 November 2020.

The final decision for cannabidiol (private application and delegate initiated) was published on 15 December 2020.

We asked

We asked for feedback on our draft Therapeutic Goods Order 106 – Standard for Serialisation and Data Matrix Codes (TGO 106) because we want to make sure the standard is fit for purpose and provides clarity for early adopters of medicine serialisation and data matrix codes on medicines supplied in Australia.

You said

We received 43 submissions in response to the consultation. Respondents provided a range of suggestions to improve the new Order and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. We appreciate all the feedback we received.

We did

We did

We considered all feedback received and made changes to the standard and guidance. We implemented the updated standard in March 2021. For more information, see new standard for serialisation and data matrix codes on medicines.

Changes we made in consideration of feedback included:

  • Extending the delayed commencement period to allow sufficient time for medicine manufacturers and sponsors already serialising medicines or using data matrix codes to comply with the standard. The standard now commences on 1 January 2023.
  • Reducing requirements to allow sponsors to use data matrix codes to identify medicines without a serial number where serialisation is not required. Medicines that are not serialised will not need to include additional data elements in a data matrix. These changes help to maintain benefits for scanning in health care settings where appropriate technology exists and assist those gradually implementing data matrix codes.
  • Restructuring the standard to streamline and clarify requirements for medicines that are serialised versus medicines that are not serialised but have a data matrix code that contains a GS1 Global Trade Item Number (GTIN).
  • Updating the guidance to clarify requirements for the primary pack and the information that needs to be included in a data matrix code. Primary pack is different to primary packaging, as explained in the guidance and new medicine packaging definitions for sponsors webpage.

We asked

For views and input across all sectors of the Australian community about a Lung Cancer Screening enquiry to investigate the feasibility of a national lung cancer screening program for people at high risk of lung cancer.

 

You said

That many factors should be considered across many sectors of the Australian community and the health system.  Public consultation submissions and input from stakeholders were detailed. Thank you for this feedback.

 

We did

We considered all feedback and engaged a consultant to analyse and summarise consultation outcomes for consideration by the Minister for Health. The Lung Cancer Screening enquiry report will be submitted to the Minister for Health in October 2020.

We asked

Between November 2019 and February 2020, the national obesity strategy Working Group asked for feedback on a proposed framework and ideas to be included in a national obesity strategy.

You said

Across the country, 604 Australians engaged in community events. In addition, 1,038 short-form and 342 long-form surveys were completed, and 35 stand-alone submissions were received. Some further targeted consultation was also progressed with three priority groups (people with disability, young people, older people).

Respondents proposed a range of ideas and suggestions for what could be included in a national obesity strategy, with most highly supportive of a comprehensive strategy. The feedback received is appreciated.

We did

Consultants have reviewed and analysed all the feedback received in the national public consultation and prepared consultation reports, which have been considered by the national obesity strategy Working Group.  Work has also continued on further refining the strategy. 

We asked

For written feedback, based on the Terms of Reference, for the independent review of nursing education - Educating the Nurse of the Future - by 30 June 2019.

You said

We received 83 written submissions and these have now been published (scroll down to view).

We did

Professor Steven Schwartz AM has now submitted the final report to Minister Hunt following completion of the Review. The report will be considered by government and a plan for public release will be developed. There is no fixed date for the release of the report available at this time.

We asked

For feedback on our tobacco control legislation to make sure that it is effective and fit for purpose.

You said

Improvements could be made. Public consultation submissions and input from stakeholder workshops were detailed. Thank you for this feedback.

We did

We considered all feedback and engaged a consultant to analyse and summarise consultation outcomes for Australian Government consideration (scroll down for the consultation summary). This feedback is being used to progress this legislative review.

We asked

In December 2018, we asked for feedback based on the Terms of Reference for the Review of the Quality Use of Medicines Program’s delivery by the National Prescribing Service (NPS MedicineWise).

You said

54 external submissions were received and 26 external interviews were conducted. Submissions were detailed and highlighted the requirement for greater transparency, accountability and efficiency in the delivery of quality use of medicines programs. Thank you for this feedback.

We did

Emeritus Professor Lloyd Sansom AO conducted the Review and a final report has been accepted by Minister Hunt. The public report and the Government’s response to the Review recommendations can be found at

https://www1.health.gov.au/internet/main/publishing.nsf/Content/qum-nps-review

 We are working with NPS MedicineWise to implement the Review’s recommendations.  

We asked

We asked for feedback, supported by, evidence on draft food category definitions and reformulation targets for sodium, sugars and saturated fat.

You said

Submissions were detailed and included specific points for clarification, as well as suggestions for amending targets, and identifying potential risks and challenges associated with a nutrient reformulation program. Thankyou for this feedback.

We did

The Reformulation Working Group (RWG) is currently considering all submissions and a report summarising these and the RWG's recommendations is being prepared. Work is continuing on summary reports for sugars and saturated fat targets.  Further targeted consultation on categories in which a significant change is proposed will be undertaken.

 The RWG will finalise the reformulation targets in two stages –

Stage 1 - A recommendation about food categories with only a sodium target.

Stage 2 - Consideration of targets for saturated fats, sugars, or sodium plus sugars/ saturated fat.

Keep an eye on the Healthy Food Partnership website for updates.