Tony Zappia (Makin, Australian Labor Party, Shadow Assistant Minister for Medicare) Share this | Hansard source

For the benefit of anyone who has just tuned in and is listening, the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 is legislation which provides for mandatory reporting of medicines that might be in short supply or be discontinued. It's a measure that has been brought in because the current way of dealing with matters, which is basically a voluntary reporting system, has proved to be unsatisfactory.

The new mandatory scheme will apply to both medicine shortages and any decisions to permanently discontinue supply of a currently available medicine. The bill does include civil penalties for non-compliance with the scheme; however, I understand the intent is more so to educate suppliers in doing the right thing. If there are to be any penalties applied, the focus will be on those suppliers who have a history of non-compliance. Again, I think the intent here is not necessarily to go out there and make things difficult for the suppliers but rather for them to take the responsible action and provide information to the health department where a medicine is going to be discontinued or where it's likely to be in short supply.

The new scheme will mainly apply to prescription medicines; however, there is the capacity for the Minister for Health to include other medicines that are registered in the Australian Register of Therapeutic Goods if the minister is satisfied that their inclusion would be in the interests of public health. In either case, it will be a reportable medicine, for which the sponsor would be required to notify the secretary of any shortage or permanent discontinuation of their product. For a shortage of critical impact, the intent is that as soon as possible, but no later than two working days after the supplier knows about the possible shortage, they have to provide advice to the department. For any other shortage, it's within 10 working days after they know or ought to have reasonably known of the shortage. For a discontinuation of critical impact, it's at least 12 months before the discontinuation would occur or, if this is not possible, as soon as practicable after the sponsor's decision. For any other discontinuation, it's at least six months before the discontinuation would occur or, if this is not possible, again, as soon as practicable after the decision to discontinue.

A medicine is considered to be in shortage if its supply in Australia will not or will not likely meet the demand for it at any time in the next six months for all the patients in Australia who will take it or who may need to take it. A shortage only applies at a national level, so instances of unavailability or short supply that occur at a particular location within Australia would not necessarily be considered shortages under the bill. In relation to the reporting of shortages within the stated time frames, the requirement to do so would only apply after the sponsor has considered all of the information that it needs to take into account for the purpose of identifying if its medicine will or will likely be in shortage.

A shortage or a decision to permanently discontinue a reportable medicine would be of critical impact, meaning that the shorter notification time frame would apply where either the reportable medicine is included in the medicines watch list—a legislative instrument that is prepared, signalling that the minister is satisfied that a shortage or permanent discontinuation of that product could cause significant morbidity or death for patients in Australia—or there are no other registered medicines that could reasonably be used as a substitute for the medicine, or, if there are, it is not likely that there would be enough of such substitutes to meet the demand for them as a result of the reportable medicines shortage or discontinuation.

The bill also makes a number of unrelated miscellaneous amendments to the act, mainly aimed at reducing inefficiencies in the regulation of therapeutic goods for industry and the Therapeutic Goods Administration. These include allowing standards to adopt other documents as enforced from time to time. Standards for therapeutic goods sometimes rely on Australian or international standards, which are specified in documents issued by the standards organisation. The bill provides the capacity to use the current version of the standard instead of the present situation whereby only a specific version of the document is specified, which may later be superseded.

The Special Access Scheme is also a matter that is covered by those amendments, and the intent is to streamline health practitioner notifications under the Special Access Scheme. This scheme follows a pathway for patients to access therapeutic goods that are not on the Australian Register of Therapeutic Goods and aren't exempt from being on the register. The bill will allow notification, as required by the TGA, to be submitted by another health practitioner on behalf of the treating practitioner rather than the current situation in which the notice can be submitted only by the treating practitioner. That will make the system much more flexible—and, quite frankly, it's a commonsense change to the regulations.

With respect to variations to the medicines register through notification, again, a medicine on the Australian Register of Therapeutic Goods can have its entry changed at the request of the sponsor in certain circumstances without the need for preapproval. Some of these variations are very minor but would nonetheless result in the creation of a separate entry on the register. Creation of that new entry would also require a new application for marketing approval. The bill allows these types of variations to be made, avoiding the need for additional marketing approval applications—another commonsense provision, because presently if a minor amendment or a minor change is made to a medicine that is listed then it may warrant a full application process, which, quite frankly, in most cases is simply unjustified. Again, for the suppliers, that's going to streamline the process and make the medicine available much more quickly, and it will obviously cut back on some red tape and costs.

Finally, the bill will also remove the requirement for a particular type of application relating to therapeutic goods advertisements to be signed and allows these applications to be submitted online again, which is common practice across most areas of government these days, where online applications and the use of online systems is slowly taking over the use of hard copies. In closing, Labor believes that the need for a mandatory reporting scheme for medicine shortages is in the public interest, and Labor will be supporting this legislation.

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