Option 3 (c) $1.1 $1.1 Total by Sector $ $ $ $ Cost offset ($million) Business Community Organisations Individuals Total by Source Electronic Submission of Data Dossiers OBPR ref: 14783 $-3 $ $ $-3 Are all new costs offset?  yes, costs are offset  no, costs are not offset  deregulatory, no offsets required
Table 6: Summary and Response to 2014 public consultation Issue Comment Response from TGA Policy options Option 3 (regulatory option) was the predominant choice amongst stakeholders. There was a clear message that the RIS and the draft TGO 79 both required revision and then further amendment and consultation prior to any implementation. Option 2 (guidance) was not preferred on the basis of potential lack of compliance, while Option 1 (status quo) was seen as not addressing the issues which are overall well recognised and understood by stakeholders. Industry preference was for a 4-year implementation (or longer) while health professionals and consumer representation preferred the 2-year implementation option. The RIS and draft TGO 79 have been revised. While a 2-year transition period would be optimal for objectives of the review including quick uptake and benefits to be realised, the cost to implement is too high. A 4-year transition period more closely aligns with typical business as usual activities for the therapeutic goods industry. A 4-year transition period has been chosen to minimise costs and align with IHIN transition period. During IHIN consultation, some stakeholders indicated that a shorter transition period could lead to a disruption in the supply chain for products that have a short shelf life and potentially result in medicine shortages and risks to public health. If there are specific safety issues with particular types of goods, these can be dealt with through, for example, amendments to the Required Advisory Statement for Medicine Labels for medicines or through of registration or listing.
RIS: evidence to support new requirements While the RIS identified specific concerns with current labelling practices, a number of respondents from both the health professions and industry considered that it did not provide a good level of evidence that the proposed actions would deliver the overall desired level of improvement in public health and safety. Comments particularly applied to low risk, non-prescription products. The comments also drew on the lack of good base level data and the absence of an evaluation plan. Evidence from literature has been relied upon to support objectives of the labelling review, where available. Literature in Australia on the true extent of the problem attributed solely to labelling and packaging is limited. Therefore, much of the evidence outlined in the RIS comes from overseas. RIS: risk based approach (proportionate response) Feedback noted that the draft TGO 79 presented a ‘one size fits all’ approach and did not adequately differentiate requirements on the basis of the risk. Many respondents identified problem products, such as those containing paracetamol and ibuprofen, and considered that their risks should be directly addressed, rather than imposing requirements on all medicines in a particular category. Implementing a risk-based approach would be too difficult to define in a labelling Order. Specific issues of this nature would not be dealt with through a labelling Order update. For example, for a particular active ingredient, issues of this nature can be addressed by applying specific or listing to particular classes of goods. Consideration is being given to issues raised on a basis. For example the split between prescription and non-prescription medicines has led to greater differentiation between the types of goods (low risk vs higher risk registered goods). This can be seen through exemption for medicine information panel (now called the display of ‘critical health information’) for low risk products.
Options for identification of declarable substances on labels of prescription and related medicines Many industry stakeholders raised issues with the inclusion of a leaflet inserted into the primary pack to disclose schedule 1 declarable excipients, citing unacceptable costs for sponsors when the information is already included in the consumer medicine information (CMI). Some speciality health groups also provided feedback on specific schedule 1 excipients (gluten, lactose), for example, the inconsistency between schedule 1 and Australian Food Standards Code. A full review of schedule 1 declarable excipients is beyond the scope of this labelling review. However, to align with Food Standards Australia New Zealand, a gluten declaration has been prescribed where gluten is present in a concentration of 20 parts per million or more. A number of issues have been taken into account including difficulties in including the CMI in the pack; concerns about the ability to fit all required information on medicine labels; the need for consumers to have consistent access to important safety information; the levels of risk associated with different excipients and dosage forms; the merits of determining threshold levels for excipient concentrations; and the possibility of greater harm resulting from medicines not being taken because of a perceived risk from exposure to certain excipients. Considering declarable excipients in schedule 1 may pose considerable safety risks to consumers, the prescription medicines Order has been amended to allow a choice of declaring the schedule 1 excipients through: declaration [of the specific excipients] on the label; or identified by a statement that directs consumers to the CMI. The point that identifies the declarable excipients is a ‘flag’ that alerts consumers and initiates a conversation with healthcare practitioners on appropriate medication. It does not necessarily preclude use of the medicine.
Labels of registered medicines must provide information in a consistent order and manner. Concern regarding no definition of ‘MIP’. Request for clarity on the degree of flexibility allowed, especially inclusion of ‘other information’. TGO 92 has been amended to reflect a move away from prescriptive ‘box/panel presentation.’ Reference is now made to ‘critical health information (CHI)’ rather than a ‘panel’. CHI has been defined in section 6. Medicine Information Panel (MIP) requirements for medicines Note: now Display of critical health information Industry stakeholders requested further exemptions for certain lozenges, antacids, some hand sanitisers. Extend exemptions to all hand sanitisers and also toothpastes. Requests for exemptions for anti-acne, anti-fungal, corn and callus removers not accepted (for safety reasons). Criteria for exemptions was combination of pack size (overdose risk), low risk actives and intended use (no 'course of treatment', occasional relief/symptomatic relief. Medicine name to be on at least 3 sides of a carton Removal of this requirement from TGO 92 has raised concerns with some stakeholders. Maintained. Reiterating the same information on multiple sides of the carton would clutter important health information on medicines. Small containers The majority of industry submissions detailed concerns about the requirements for small containers (defined as 25mL or less) relating to font sizes, existing information requirements and impact on package size especially re the proposed MIP. A number of respondents proposed a redefinition of ‘small container’, even up to 100mL. Exemption for small containers has been included where multiple actives can be on the same line and smaller minimum text size used for active ingredients on labels of small containers that do not have outer packaging.
The 4-year transition period is also being aligned, as closely as possible, to the work. The transition period for the IHIN reform commenced in April 2016. Executing both reforms in parallel will ensure that costs to industry are minimised. This aligns with feedback received from industry during recent consultation activities undertaken.