About you
1. What is your name?
Name
Ann McCormack
3. If you are responding on behalf of an organisation, what is its name?
Organisation
Endocrine Society of Australia
Proposal 1 - Prioritising evaluation of important generic medicines
5. Do you think that prioritising TGA’s evaluation of first and second generic versions of innovator medicines will assist in preventing medicine shortages? Why? (please use the textbox provided for your response)
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Yes
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No
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Not sure
7. Do you think that prioritising TGA’s evaluation of new generic versions of ‘sole source’ medicines will assist in preventing medicine shortages? Why? (please use the textbox provided for your response)
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Please provide your comments in the textbox below
In the field of endocrinology there are some "sole source" medications that have been affected by supply issues particularly over the past year.
Proposal 2 – Mitigating the effects of a medicine shortage
11. Do you think that waiving or reducing application and/or evaluation fees for new generic versions of medicines known to be often in shortage or limited supply in Australia will assist in preventing future shortages? Please tell us the reasons for your answer in the textbox provided.
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Yes
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No
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Not sure
13. Do you have any suggestions on which criteria could be used to identify medicines eligible for a fee waiver or reduction?
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Rare diseases with sole source, often long-off patent drugs, or rare disease with limited other therapeutic options. An example for the endocrine world would be management of Cushing's disease. Currently only off-label use drugs are available, so no TGA approved drugs for Cushing's disease in Australia. There are a couple of drugs in the pipeline overseasRedacted text which for commercial reasons would be difficult to bring to Australia in terms of registration costs, but there are very few options otherwise.
Proposal 3 – Improving reliability of supply for known shortages
14. Would implementation of a new TGA process that provided faster evaluation times and lower fees encourage you to make an application to register one of the medicines that are subject to longstanding section 19A approvals?
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As a health care professional I can't answer yes to this but I imagine it would be a good option and attractive to potential sponsors.
16. Do you think introduction of the proposed process will assist in supporting a more reliable supply of overseas-registered medicines currently imported under section 19A?
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Yes
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No
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Proposal 4 – Managing alternative supply if medicines are discontinued
18. Would introduction of a new annual charge waiver encourage you to retain your ARTG entry, if it was eligible? Please use the textbox provided for a detailed response
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Yes
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No
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Not applicable
19. Do you think introduction of a new annual charge waiver will assist in supporting a more reliable supply of overseas-registered medicines imported into Australia as substitutes when the Australian medicine is in longstanding or repeated shortage? Please use the textbox provided for a detailed response.
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Yes
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No
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Not sure
20. Do you see any risks associated with introduction of a new annual charge waiver for medicines where there is a lack of therapeutic alternatives on the ARTG? Please use the textbox provided for a detailed response.
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Yes
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No
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Not sure
22. Do you have any other suggestions on ways to prevent, mitigate or manage medicine shortages in Australia?
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There is a need for better communication between pharmacists/doctors and TGA about medicine shortages. We get sent a weekly list of medication shortages/discontinuation that are frequently outdated and not relevant, or simply inaccurate. We believe the monitoring and communication system needs to be much improved.