Australian Medicines Regulator Relaxes Standards After Political Pressure

Australians might be concerned to know that the regulatory body which upholds safety measures for medicines can be pressured by politicians to relax its standards.

According to Therapeutic Goods Administration (TGA) guidelines that have been in place for many years, incentives must not be offered to the Australian public to encourage vaccination.

Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG), p.23

The reasoning behind these rules is that medical choices must be made through a process of free and informed consent. Providing incentives for vaccination, or any other type of medical treatment, interferes with a patient’s free agency.

The same TGA rules prohibit “scare tactics” that warn people of harmful effects resulting from choosing not to have a vaccine.

In July 2021, a pub in Melbourne started offering free beer to patrons who had received a Covid vaccine. However, the TGA responded by sending the pub a cease-and-desist order, in line with its existing rules.

Prime Minister Scott Morrison promptly intervened, backing the pub’s offer of beer as a reward for vaccination. According to Morrison, Health Minister Greg Hunt would have “a chat” with the TGA to “get it sorted”.

Following this political intervention, the TGA relented. A special authorisation was issued to change the rules so that alcohol could be given as a reward.

It should be noted that as recently as June 2021, the TGA released a statement that made clear that alcohol and tobacco must not be offered as incentives for vaccination against Covid.

Since July, several other policy adjustments have been made by the TGA, relaxing further rules around the promotion and advertisement of Covid vaccines. The most recent of these special “permissions” was issued on September 23.

The September 23 change allows rewards (including alcohol) to be granted to people who are partially vaccinated against Covid. The previous rule had restricted rewards to those who are fully vaccinated.

Before rule change:

Repealed: Therapeutic Goods (Restricted Representations – COVID-19 Vaccines) Permission (No. 3) 2021

After rule change:

This latest change in TGA rules happened immediately after the NRL was sanctioned by the TGA for giving away 3,000 free tickets to Queenslanders who had been vaccinated, including some who had not yet received a “full” course of two vaccines.

As Morrison and Hunt had done in July, Queensland Premier Annastacia Palaszczuk and Health Minister Yvette D’Ath exerted pressure on the TGA to change the rules.

According to the ABC, D’Ath complained in a snap press conference on September 23 that the TGA’s action against the NRL was “bureaucracy gone mad”.

Within hours, the TGA had complied with D’Ath’s wishes and the free ticket giveaway went ahead.

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