Paul01 Posted January 10 Share Posted January 10 1 minute ago, Davo said: Technically the Therapeutic Goods Act allows it because it has provisions to allow the Health Minister to make certain therapeutic products exempt from registration in a public health emergency. They did it back in March to allow unregistered face masks into Australia to top up the national stockpile. Within the Act, Face masks fall under Devices, not medicines. There are significant difference between devices and medicines in the regulatory area. Also, Masks fall under the lowest risk category for a device. a vaccine falls into a high risk medicinal area. wendybr 1 Link to post
Davo Posted January 10 Share Posted January 10 10 hours ago, Paul01 said: Within the Act, Face masks fall under Devices, not medicines. There are significant difference between devices and medicines in the regulatory area. Also, Masks fall under the lowest risk category for a device. a vaccine falls into a high risk medicinal area. I work in devices so I may be wrong here as I don't have the experience with medicines, but my understanding is that the exemption because of emergency applies to "therapeutic goods" generally and doesn't specify only devices. While the risks are significantly higher I believe it's still within the minister's power to exempt medicines in the event of a national emergency. wendybr and Paul01 2 Link to post
Midfielder Posted January 10 Share Posted January 10 Let's be thankful we don't live in Europe or America both north and south. The national effort and response to one locally acquired UK case in QLD was amazing. There is only a handful of countries in our position. wendybr and Paul01 2 Link to post
Paul01 Posted January 11 Share Posted January 11 2 hours ago, Davo said: I work in devices so I may be wrong here as I don't have the experience with medicines, but my understanding is that the exemption because of emergency applies to "therapeutic goods" generally and doesn't specify only devices. While the risks are significantly higher I believe it's still within the minister's power to exempt medicines in the event of a national emergency. I have not looked at the TGA Act for a while. It was certainly the case about 5 years ago that there was no emergency power for the minister or the delegates for medicines. That may have been amended. I think the TGA are waiting for EMA approval of Oxford vaccine. Link to post
Davo Posted January 11 Share Posted January 11 33 minutes ago, Paul01 said: I have not looked at the TGA Act for a while. It was certainly the case about 5 years ago that there was no emergency power for the minister or the delegates for medicines. That may have been amended. I think the TGA are waiting for EMA approval of Oxford vaccine. For the record I actually agree with the current approach to go through the full approval process rather than rush it through. We have no Covid patients in ICU and have had only two deaths in the last few months. There's no need to take the risk of rushing it through and it looks like we're on track to be the first country to grant general approval for a Covid vaccine. Everyone else so far has used emergency exemptions. Paul01 and Edinburgh 2 Link to post
Midfielder Posted January 11 Share Posted January 11 In population Australia comes in at 54 In Cases per million Australia comes in at 162 In total cases we come in at 100 and look like moving further down . In deaths per million we come in at 132 Mobile testing and contract tracing is arguably the best in the world, the NSW team which most have copied The outbreaks in Australia have essentially been because our quarantine safeguards have been found lacking in various ways and we have over time identified these and have taken action to ensure as best as possible these don't happen in the future. By any measure Australian governments collectively and most oppositions have co-operated and taken expert advise resulting in according to recent polls a considerable increase in trust in our politicians . With all of the above taken into account, when a state has one case or a small number of cases ... the border closures concern me... being fair if a major outbreak occurs then fine... however I do wonder aloud if its not over reacting a mate told me of a mate of his who lives in Orange NSW and had travelled to Perth to see his brother and had been in Perth for 2 days prior to the last Norther Beaches outbreak and was contacted and sent to isolation. QLD had one case and locked down for three days. Everything is relative, and in many ways its popular across te broad spread of the community... but I wonder aloud if say a 3 day lock down occurs should public servants and people on pensions not get paid or get half pay for those days ... because that's what happens to the arts and tourism The economic consequences are almost zero for 70 % of the population... but 30 % of the population it varying degrees of hardship... My guess is if we said public servants will get half pay in lock downs then they would need a major outbreak to be set up... and as for the states shutting borders and each other out... Its all in the telling I guess.... but for me if a state government is incapable of using contract tracing and other methods i.e. masks, social distance etc to handle say a hand full of cases then me thinks we should start to make everyone pay the same price ... and not just heap it all on the arts and tourism ... Link to post
Ossified Posted January 12 Share Posted January 12 NSW Fail to meet own testing targets - Media silent. NSW Exporting Covid to other States - Media silent. NSW Gets annoyed with other States - Media join in. Carns, sonar, EmMac and 3 others 3 3 Link to post
Paul01 Posted Friday at 08:17 PM Share Posted Friday at 08:17 PM This article tells me that the federal politicians are telling the scientists how to manage quarantine. Same as Trump failed to tell the U.S. people that Covid-19 is spread through aerosols generated by people. We have a f***wit of a PM Experts call on Federal Government to acknowledge possible airborne transmission of COVID-19 in hotel quarantine http://www.abc.net.au/news/2021-01-16/hotel-quarantine-gap-prevent-airborne-spread-of-covid-19/13057644 Link to post
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