Craig Kelly (Hughes, Independent) Share this | Hansard source

by leave—I move amendments (1) and (2) together:

(1) Schedule 1, item 3, page 4 (after line 6), after the paragraph beginning "Subdivision E" in section 153ZQA, insert:

• Subdivision EA provides that goods are not RCEP originating goods if safety approval of the goods has been sought but has not been obtained or has been refused.

(2) Schedule 1, item 3, page 13 (after line 20), after Subdivision E, insert:

Subdivision EA — Safety

153ZQIA Safety

Goods are not RCEP originating goods under this Division if:

(a) the producer or importer of the goods, or an entity related to the producer or importer of the goods, has applied for approval of the goods under a safety law of:

(i) if the goods were wholly obtained or produced in a Party—that Party; or

(ii) otherwise—the Party in which the goods were produced; and

(b) that approval has not yet been granted or has been refused.

I will quickly go through them. This particular bill gives special preference to goods that are of RCE, which is the agreement of the partners origin. If a good is made in that country, it gets special treatment. However, the purpose of this amendment is based upon safety. It seeks to exclude goods from that provision—exclude them from giving those preferences—if:

(a) the producer or importer of the goods, or an entity related to the producer or importer of the goods, has applied for approval of the goods under a safety law of:

  (i) if the goods were wholly obtained or produced in a Party—that Party; or

  (ii) otherwise—the Party in which the goods were produced; and

(b) that approval has not yet been granted or has been refused.

If goods are made in foreign country, and in that foreign country they attempted to obtain some safety or regulatory approval and it is not given in that country—if the regulatory authorities in the country of manufacture say, 'That good is not yet approved' or 'We do not think it's safe to be distributed in this country,' they cannot export that to Australia and expect to get these preferential tariff arrangements.

Now, some may think that would never happen. It would never happen if goods were imported into Australia for use in Australia, and yet in the country of manufacture, the country of origin, the regulators have said: 'Hang on a minute. We're not going to grant this particular good safety approval, because we have concerns about that particular good.'

Let me give you an exact example of why this bill is needed and an exact example of why this is something that would be caught by this amendment. I quote directly from the Wall Street Journal on 15 October 2021. The headline says 'FDA delays Moderna COVID vaccine for adolescents to review rare myocarditis side effect'. It says:

Agency holds off decision on expanding use of shot to 12-to-17-year-olds while it looks into risk of rare heart condition

The article goes on:

The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.'s Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.

So, in the USA, their regulators, the FDA, the Food and Drug Administration, have not approved Moderna vaccines for 12- to 17-year-old children because they are not sure. They are applying the precautionary principle, and yet that good, which is manufactured in the USA, is exported to Australia. And what have we done? I'll quote directly from a release by the minister of health on 5 September. It says:

TGA approves Moderna vaccine for 12 to 17-year-olds. Australia's medicines regulator, the Therapeutic Goods Administration, has provisionally approved the use of the Moderna (Spikevax) COVID-19 vaccine for adolescents aged 12 to 17 years.

This enables this vaccine to be injected into Australian children. We have regulators in the USA that say that this good is not fit for 12- to 17-year-olds in America, where it is manufactured. But it's being exported to Australia where our regulators say, 'Maybe it's okay, don't worry and just shoot this stuff up into kids.'

Do parents around the nation know this? Is any media outlet in the country reporting that this substance is being injected into Australian teenagers? It's made in America, but the American say, 'This is not safe for American teenage kids.' How many children in Australia are we putting at risk because of this madness? What is the TGA doing by approving something to be injected into Australian children, when it cannot be injected into American children? It's a good that is made in the USA. (Time expired)

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