We believe that there are a number of changes that can be implemented to improve the efficiency and flexibility of the scheduling arrangements while maintaining their effectiveness. These include the following:
(a) Where a scheduling change is proposed for a substance to allow its use in the chemicals sector, only the Advisory Committee on Chemical Scheduling (ACCS) should meet to consider the proposal, not the joint committee of ACCS and the Advisory Committee on Medicine Scheduling (ACMS). We believe this would improve efficiency by ensuring that only the relevant advisory committee with specific expertise and focus considers the issue at hand.
An example of this is the consideration of tranexamic acid by the ACMS/ACCS joint committee. The proposal to exclude tranexamic acid derivatives for cosmetic use did not impact on the medicinal use of the substance. However, the joint committee deliberated on the pros and cons of the cosmetic use of the substance which we believe is an inefficiency. Accord notes that industry was happy with the final decision – we simply note that it is an inefficient practice to involve the medicines advisory committee when the proposal had no bearing on medicinal use.
Another example, although perhaps less clear cut, is the consideration of scheduling hydrogen peroxide/carbamide peroxide by the ACMS/ACCS joint committee. While the proposal by the applicant was rather confusing, it was clear that the proposal only related to the teeth whitening application. As teeth whitening is a cosmetic procedure, only the ACCS was needed to consider the application. While we concede that the applicant initially wanted medicine scheduling for this substance and the input from the ACMS that teeth whitening procedure which is purely cosmetic and should not be scheduled as a medicine is helpful, this could have occurred prior to the meetings. We also note that the applicant then amended the submission and did not seek a specific medicines scheduling, which should have put the consideration into the ACCS agenda, rather than to the joint committee.
We also note that sodium lauryl sulphate was considered by the joint committee, although the consideration of its uses was clearly cosmetic/industrial and agvet chemical. We believe this may have led to a more conservative and unnecessarily restrictive decision, which has negatively impacted on our Members. More information is provided under responses to question 4.
(b) Implement an administrative decision process for excluding scheduled chemicals where they are inadvertently captured. We propose an application using a simple application form and a decision by the Delegate of the Secretary of Department of Health and Ageing (the Delegate). We believe that this would improve the flexibility and efficiency of the scheduling process.
Accord has noted a number of cases where chemicals that are freely available for use in industrial sector or in cosmetics have been caught up inadvertently in Schedule 4, prescription only medicines. Previously we had advocated separation of the committees and decision-making process, as well as the Poisons Standard itself to solve the problem. However, noting that the latter would require significant changes to State and Territory legislation, we believe that a simpler decision-making process to exclude substances inadvertently captured by scheduling decisions could also provide an acceptable and efficient outcome.
Tranexamic acid is one such example. Derivatives of tranexamic acid are used as cosmetic ingredients globally, including in economies with equivalent consumer health and safety focus to Australia, such as the EU and the USA. It is our understanding that when tranexamic acid was scheduled as Schedule 4 without exemptions, the cosmetic use of the substance was never considered. We also note that the cosmetic use of the substance has no similarity to the use of the substance as a medicine. In this case, we believe that the inadvertent consequences could have been raised using a simple form noting the use of the substance in cosmetics, and the cosmetic use of the substance could have been excluded from scheduling by the Delegate, after considering similar uses globally. Instead, a full application including toxicity information had to be lodged for consideration by the advisory committees before the final decision could be reached. This is a costly exercise which put the onus on industry to prove that the substance shouldn’t be regulated, when the regulation of the substance for cosmetic use was purely an administrative error.
Another more interesting example is the use of hydroquinone monomethyl ether (also known as MEHQ, mequinol, 4-methoxyphenol and p-hydroxyanisole) in gel nail polishes. This is a new, novel and minor use and we are seeing this technology in Australia being currently marketed by companies that are not Accord Members. MEHQ is being used in the nail polish as a polymerisation inhibitor. Currently the methyl ether of hydroquinones are capture in Schedule 4 monobenzone entry. The entry reads:
MONOBENZONE and other alkyl ethers of hydroquinone for human therapeutic use or cosmetic use.
Clearly nail polishes are cosmetics. However, it is our understanding that the cosmetic use that was considered was not as polymerisation inhibitors in nail polishes, but rather skin whitening applications. It can be easily established that the use of the MEHQ as a polymerisation inhibitor, which is used in ppm quantities in the formulation and binds to the polymer as they form on the nail, carries a much lower risk than as a skin lightening agent. However, in order for this to be considered, a full rescheduling application apparently must be made, which is onerous and again unnecessary.
Further we note that while some of the State Health Departments are aware of this non-compliance by companies marketing these products, these products continue to be used in nail salons and sold to consumers through retail outlets. We understand that this is a low priority for compliance officers as these products do not pose a public health risk. However, we are concerned that this creates a situation where being compliant with existing legal requirements is seen as anticompetitive for compliant companies, and creates a view within the non-compliant companies that legal compliance is a “nicety” rather than a necessity.