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Consultation: Evaluating the feasibility of a new-to-market risk communication scheme for therapeutic goods

13 May 2013

This consultation closed on 13 June 2013

The TGA sought comments from interested parties on the feasibility of implementing a scheme to publicly indicate which therapeutic products are newly marketed (known as a 'new-to-market risk communication scheme').

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on 13 May 2013.

Interested parties responded by close of business 13 June 2013.

Feedback will be released following consideration of submissions (see 'What will happen').

About the consultation

The TGA is evaluating the feasibility of implementing a new-to-market risk communication scheme in Australia. A new-to-market risk communication scheme is intended to signal to people using therapeutic products that a particular product is new, or newly available for a particular use.

The purpose of this consultation is to seek views from interested parties on the value, feasibility, design and impacts of a new-to-market risk communication scheme.

The TGA will also hold consultation workshops in May with peak bodies representing consumers, health professionals, the therapeutic products industry and providers of therapeutic product information. Workshop outcomes will be published on the TGA website.

Background

In 2010, the TGA undertook a review of the way it communicates its regulatory processes and decisions, with the aim of improving its transparency. One of the recommendations of the review was that the TGA undertake a feasibility study of a new-to-market risk communication scheme for therapeutic goods. The panel who conducted the review noted that there appeared to be a lack of public awareness of the uncertainties about the safety profiles of medicines early in their lifecycles, and felt that a risk communication scheme for new products could help to encourage public understanding of safety profiles.

Submissions

See: Submissions received

Submissions may address any issues relating to a new-to-market risk communication scheme. In particular, the TGA invites comment about:

  • whether or not you support the idea of a new-to-market risk communication scheme,
  • the potential value and uses of a new-to-market risk communication scheme,
  • how a new-to-market risk communication scheme might best be designed, promoted and evaluated, and
  • how a new-to-market risk communication scheme will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Organisations represented at the stakeholder workshops are not expected to also provide a written submission.

What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA website.

Content of submissions will inform the further development of a model for a new-to-market risk communication scheme and the evaluation of its feasibility, including impacts on the regulated industry.

The TGA's evaluation report will be provided to Government by June 2014.

If you would like to be kept informed on TGA reform consultation activities, please subscribe to the TGA-UPDATE email list.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Any questions relating to the consultation should be directed to complianceconsultation@tga.gov.au, or by telephone to 02 6232 8660.

If you would like to be kept informed about TGA activities, please subscribe to one of the TGA's email lists.