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Direction about advertisements: Mr David Leyonhjelm

Direction under Section 42DV

8 February 2021

THERAPEUTIC GOODS ACT 1989


DIRECTION UNDER SECTION 42DV

ISSUED TO: Mr David Leyonhjelm

ON: 5 February 2021

ABOUT: Advertising of Ivermectin on Twitter

BY: Nicole McLay
Assistant Secretary
Regulatory Compliance
Therapeutic Goods Administration (Delegate of the Secretary of the Australian Department of Health)


Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

Contact Officer Name:
[REDACTED]

Contact Officer Telephone:
[REDACTED]

Contact Officer Email:
[REDACTED]


DIRECTION ABOUT AN ADVERTISMENT

Made Under Section 42DV of the Therapeutic Goods Act 1989

TO: David Leyonhjelm
[REDACTED]

Email: [REDACTED]

I, Nicole McLay, delegate of the Secretary of the Australian Department of Health (the Secretary) in the Therapeutic Goods Administration (TGA), being satisfied, for the reasons set out in Attachment A, that there has been a contravention of the Therapeutic Goods Act 1989 (the TG Act) in relation to the advertising of medicines containing, as an active ingredient, Ivermectin:

DIRECT you, as the person apparently responsible for that advertising or for causing the advertising of the therapeutic goods, to:

  1. Cease all advertising of therapeutic goods containing the active ingredient ivermectin, including but not limited to advertising on your profile on the Twitter website at the Uniform Resource Locator [REDACTED].
  2. Cease making claims or representations in advertisements for any therapeutic goods that those goods have any effect on COVID-19 (including that said therapeutic goods are capable of preventing, treating or alleviating COVID-19).

CONDITIONS

under subsection 42DV(3) of the TG Act

This Direction is subject to the following conditions that you must:

  1. complete each action you are directed to carry out, including as required by these conditions, by 12 noon on Saturday, 6 February 2021;
  2. cease, permanently, all advertising referred to at paragraphs 1 and 2 above; and
  3. email evidence of your compliance with this Direction to the email address listed on the first page of this Direction by 12 noon on Saturday, 6 February 2021.

OTHER INFORMATION

Important information about the reasons for making this Direction and its effect is set out in Attachment A. The possible consequences of failing to comply with this Direction are explained in Attachment B.

The sections of the TG Act relevant to the making of this Direction are set out in Attachment C.

This is an initial decision and is reviewable. Your review rights are set out in Attachment D.

Please note, under subsection 42DV(6) of the TG Act, the TGA will publish this Direction on its website. Publication is planned to occur on or before Monday, 8 February 2021.

DATED: 5 February 2021

Signed electronically

Nicole McLay
Assistant Secretary
Regulatory Compliance
Therapeutic Goods Administration
Delegate of the Secretary
Australian Department of Health

Material findings of fact

I make the following material findings of fact.

Background

  1. At 4:26pm on 2 February 2021, you made a post on the 'Twitter' social media platform in the following terms, accompanied by an image of '[REDACTED]', being a medicine for use in horses containing ivermectin as an active ingredient (Initial Advertisement):

    In several countries, ivermectin is being used to treat Covid. For those who want some, this horse product is probably the most economical source. Enough to treat the street too.

  2. A copy of the Initial Advertisement is provided at Attachment E.
  3. The TGA was alerted to the Initial Advertisement, and commenced an investigation on or about 3 February 2021. The TGA investigation concluded that the Initial Advertisement contravened subsection 42DLB(1) of the TG Act, in circumstances where it:
    1. promoted medicines containing ivermectin, and [REDACTED] specifically, for the treatment of COVID-19 in humans, and consequently constituted advertising within the meaning of section 3 of the TG Act;
    2. referred to a substance, being ivermectin, that is included in Schedule 4 to the current Poisons Standard as made under section 52D of the TG Act (with the result that subsection 42DLB(4) of the TG Act applied to the advertisement); and
    3. contained a restricted representation, being a reference to a disease (COVID-19) that is a serious form of a disease within the meaning of section 28 of the Therapeutic Goods Advertising Code (the Code) (with the result that subsection 42DLB(7) of the TG Act applied to the advertisement).
  4. At 4:25pm on 4 February 2021, I sent you a letter outlining the reasons why I considered that the Initial Advertisement was contrary to the TG Act. That letter relevantly noted that:
    1. the TGA has powers to direct advertisers to remove non-compliant advertising under section 42DV of the TG Act; and
    2. failure to take down the Initial Advertisement may result in the TGA taking enforcement action against you, including by issuing a direction under section 42DV of the TG Act requiring the Initial Advertisement to be removed.
  5. On 5 February 2021, [REDACTED], Director, Advertising Compliance and Investigations (ACIS) and [REDACTED], Assistant Director, ACIS made a telephone call to you. In that telephone call, it was noted that the TGA had sent a letter to you requesting that you immediately remove the Initial Advertisement from Twitter. At your request, the letter of 4 February 2021 was re-sent to you at 2:43pm on 5 February 2021.
  6. After receipt of the further letter, you did not remove the Initial Advertisement. Instead, at 4:03pm on 5 February 2021, you posted a further tweet (Further Advertisement). The Further Advertisement, a copy of which is provided at Attachment E, quoted the Initial Advertisement in full with the accompanying image of [REDACTED], and added the following additional text:
    The TGA (following a complaint from some snivelling toad) has written to say I'm promoting human use of an animal product. Promoting? Which part of "for those who want some" did they miss? Also, every horse owner in the country knows this.

Reasons for decision

  1. My reasons for making the Direction and associated conditions are set out below.
Power to issue Direction
  1. Subsection 42DV(1) of the TG Act provides that if, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of the TG Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods to do certain specified acts. Those specified acts include ceasing the advertisement in question, and ceasing making a particular claim or representation made by the advertisement.
Ivermectin (and [REDACTED] as promoted in the Initial Advertisement) is a therapeutic good
  1. The Initial Advertisement clearly represents ivermectin (in general) and [REDACTED] (specifically) to be for therapeutic use, being the treatment of COVID-19. I am therefore satisfied that ivermectin and [REDACTED], as promoted in the Initial Advertisement, are therapeutic goods within the meaning of subsection 3(1) of the TG Act as goods 'represented in any way to be… for therapeutic use'.
The Initial Advertisement is an advertisement within the meaning of the TG Act
  1. Subsection 3(1) of the TG Act provides that 'advertise', in relation to therapeutic goods, 'includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods'. I am satisfied that the Initial Advertisement was intended to promote the use or supply of medicines containing ivermectin and of [REDACTED] specifically, insofar as it:
    1. referred to ivermectin as being a suitable treatment for COVID-19 (a disease in humans);
    2. indicated that persons who were interested in using ivermectin for that purpose may want to acquire [REDACTED], which was represented to be 'probably the most economical source'; and
    3. further represented that a container of [REDACTED] would provide enough medicine to treat multiple persons (i.e., '[e]nough to treat the street').
Ivermectin and [REDACTED], as promoted in the Initial Advertisement, are for use in humans
  1. Section 42AB of the TG Act provides that the advertising prohibitions in Part 5-1 of the TG Act do not apply to advertisements 'in respect of goods that are not for use in humans'. I am satisfied, having regard to the Initial Advertisement, that ivermectin and [REDACTED], as depicted in that advertisement, are for use in humans.
  2. In this respect, I note that subsection 3(2) of the TG Act provides that therapeutic goods 'are taken to be for use in humans if they are not solely for use in animals'. The Initial Advertisement plainly claims that [REDACTED] and ivermectin have a therapeutic effect against COVID-19 in humans (in addition to the uses for which those goods are indicated in animals). As a consequence, I am satisfied that the Initial Advertisement is subject to Part 5-1 of the TG Act.
The Initial Advertisement contravened subsection 42DLB(1) of the TG Act
  1. Subsection 42DLB(1) of the TG Act, being a civil penalty provision in Part 5-1 of the TG Act, provides that a person contravenes the subsection if:
    1. the person:
      1. advertises, by any means, therapeutic goods; or
      2. causes the advertising, by any means, of therapeutic goods; and
    2. subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.
  2. Contraventions of subsection 42DLB(1) of the TG Act may result in the imposition by a court of civil penalties of up to 5,000 penalty units for an individual. Noting that the current value of a penalty unit is $222, this amounts to a maximum penalty of $1.11 million.
  3. For the reasons set out above, I am satisfied that you, by posting the Initial Advertisement (and retweeting it in the Further Advertisement) advertised therapeutic goods. I am further satisfied that subsections 42DLB(4) and (7) of the TG Act apply to those advertisements.
  4. Subsection 42DLB(4) applies to an advertisement if it contains a restricted representation, and neither an approval under section 42DF of the TG Act nor a permission under section 42DK of the TG Act is in force in relation to that restricted representation.
  5. Section 42DD of the TG Act relevantly provides that a representation in an advertisement about therapeutic goods that refers to a form of a disease identified in the Code as a serious form of a disease is a restricted representation. Section 28 of the Code provides that a form of a disease is a serious form if 'it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management'.
  6. COVID-19 requires diagnosis and treatment by a suitably qualified medical professional. Consequently, I am satisfied that the references to COVID-19 in the Initial and Further Advertisements were restricted representations within the meaning of the TG Act, and that subsection 42DLB(4) of the TG Act applies to those advertisements.
  7. I am further satisfied that no permission was in force under section 42DK of the TG Act, and that no approval was in force under section 42DF of the TG Act, in relation to those restricted representations.
  8. Subsection 42DLB(7) of the TG Act applies to an advertisement if it, relevantly, refers to substances, or goods containing substances, included in Schedule 4 to the current Poisons Standard, other than a reference required by a government or government authority.
  9. I am satisfied that ivermectin is included in Schedule 4 to the current Poisons Standard as a prescription-only medicine. I am further satisfied that the reference to ivermectin (and [REDACTED], as a good containing ivermectin) in the Initial and Further Advertisements was not required by a government or government authority. Consequently, I am satisfied that subsection 42DLB(4) of the TG Act applies to those advertisements.
Conclusion
  1. Having regard to the above, I am satisfied that the Initial Advertisement and Further Advertisement contravened subsection 42DLB(1) of the TG Act, and that you are the person apparently responsible for advertising ivermectin and [REDACTED] in those advertisements.
  2. I am also satisfied that the Further Advertisement contravened subsection 42DL(2) of the TG Act, being a criminal offence provision which is in substantially the same terms as subsection 42DLB(1). That offence provision carries a penalty of imprisonment for up to 12 months and a fine of up to 1,000 penalty units ($222,000).
  3. In this respect, I find that it is clear that your actions in posting the Further Advertisement were intentional, and occurred in circumstances where you knew that, or were reckless as to, the application of subsections 42DL(4) and (10) of the TG Act to those advertisements, having received my letter to that effect earlier on 5 February 2021.
  4. I have further concluded, having regard to the background to this matter as set out at paragraphs 1 to 6 above, that it is necessary and appropriate to direct you to cease advertising medicines containing ivermectin. I am further satisfied that it is necessary and appropriate to further direct you to cease making claims or representations in any advertisement for a therapeutic good concerning any effect on COVID-19.
  5. In that respect, I note that the COVID-19 pandemic is a global health emergency that is causing significant concern in the Australian community. It is of significant importance to public health that persons comply with the TG Act in advertising therapeutic goods relating to COVID-19, given the threat to public health that misinformation presents in the current environment.
  6. Your advertising further presents a specific risk to members of the public, insofar as it may encourage them to obtain and take ivermectin as a treatment or prophylaxis for COVID-19 rather than obtaining and following the advice of appropriately qualified medical practitioners.
  7. I therefore make the Direction set out above together with the associated conditions. Noting the public health issues arising from advertising of this kind, I have decided to allow you until 12 noon on 6 February 2021 to comply with this Direction.
  8. Failure to comply by that time will lead to further action by the TGA, which may include the commencement of proceedings seeking pecuniary penalties for contraventions of section 42DLB of the TG Act (as noted above), and section 42DX of the TG Act, in relation to your failure to comply with this Direction. The TGA further reserves its rights, if it becomes necessary to do so, to seek urgent interim injunctions to secure the removal of the Initial and Further Advertisements from Twitter.

EFFECT OF NOT COMPLYING WITH THIS/THESE DIRECTIONS

Contravening a direction or a condition of a direction made under subsections 42DV(1) or (2) of the TG Act, is a criminal offence under section 42DW of the TG Act, and may give rise to civil penalties under section 42DX, which could lead to court action against you.

The TGA could also issue you an infringement notice as an alternative to these actions.

In conjunction with pursuing civil or criminal sanctions, the TGA may also seek an injunction from a Federal Court to immediately cease your advertising.

The TGA can also alert the public to its concerns about particular therapeutic goods advertising through the use of public warning notices (section 42DY).

Please Note:

Subsection 42DV(6) states

As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.

Therapeutic Goods Act 1989

Part 5-1 - Advertising and generic information

Division 6 - Directions about advertisements or generic information

42DV Directions about advertisements or generic information

Advertisements
  1. If, in relation to the advertising of therapeutic goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the therapeutic goods, or for causing the advertising of the therapeutic goods, to do one or more of the following:
    1. cease the advertisement;
    2. make a retraction;
    3. make a correction;
    4. recover any advertisement that is still in circulation;
    5. destroy the advertisement;
    6. cease making a particular claim or representation made by the advertisement.
Generic information
  1. If, in relation to the dissemination of generic information about therapeutic goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following:
    1. withdraw the generic information;
    2. make a retraction;
    3. make a correction;
    4. recover any generic information that is still in circulation;
    5. destroy the generic information;
    6. cease making a particular claim or representation made by the generic information.
Conditions
  1. A direction under subsection (1) or (2) may be subject to conditions specified in the direction.
  2. Without limiting subsection (3), the conditions may relate to one or more of the following:
    1. the period for doing a thing the subject of the direction;
    2. in relation to the making of a retraction or correction, either or both of the following:
      1. the form and manner of the retraction or correction;
      2. the period for which the retraction or correction must be made publicly available;
    3. the reporting to the Secretary of compliance with the direction.
Direction not a legislative instrument
  1. A direction under subsection (1) or (2) is not a legislative instrument.
Publication
  1. As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website.
42DW Offences - contravening direction under section 42DV
  1. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2) in relation to therapeutic goods; and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction; and
    4. either:
      1. the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
      2. the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and
    5. the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention.
    Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
  2. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction.
    Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
  3. A person commits an offence if:
    1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
    2. the person does an act or omits to do an act; and
    3. the act or omission contravenes the direction or a condition of the direction.
    Penalty: 100 penalty units.
  4. An offence against subsection (3) is an offence of strict liability.
42DX Civil penalty for contravening direction under section 42DV

A person contravenes this section if:

  1. the Secretary has given a direction to the person under subsection 42DV(1) or (2); and
  2. the person does an act or omits to do an act; and
  3. the act or omission contravenes the direction or a condition of the direction.

Maximum civil penalty:

  1. for an individual - 5,000 penalty units; and
  2. for a body corporate - 50,000 penalty units.

Request for reconsideration of an initial decision

This decision is a reviewable initial decision under section 60 of the TG Act. Under section 60, a person whose interests are affected by a 'reviewable' initial decision, can seek reconsideration of the initial decision.

As this document constitutes written notice of the making of an initial decision being given by the Secretary, a request for reconsideration of this initial decision must be given to the Minister within 90 days and be accompanied by any information that you wish to have considered. A request for reconsideration given to the Minister outside the statutory 90 day reconsideration period cannot be accepted.

The Minister may either personally undertake a request for reconsideration of an initial decision or delegate to an officer of the Department with the appropriate delegation.

Under section 60(3A) of the TG Act, the Minister (or the Minister's delegate) is not able to consider any information provided after the notification is made of a request for reconsideration of an initial decision unless the information is provided in response to a request from the Minister (or the Minister's delegate), or it is information that indicates that the quality, safety or efficacy of the relevant therapeutic goods is unacceptable.

Guidelines for requesting reconsideration of an initial decision

A request for reconsideration should be made in writing, signed and dated by the person requesting reconsideration, should be titled "<insert person/company name> - Request for Reconsideration Under Section 60 of the Therapeutic Goods Act 1989" and should include the following:

  • a copy of the initial decision notification letter (or other evidence of notification);
  • identify, and describe with as much specificity as possible, which component(s) of the initial decision should be reconsidered and set out the reasons why reconsideration is requested;
  • any information/documentation in support of the request, clearly labelled to correspond with (any or each of) the reasons why reconsideration is requested; and
  • an email address nominated for the purposes of receiving correspondence in relation to the request for reconsideration.

ll requests for reconsideration should be given to the Minister by email:

Email: 'minister.hunt.DLO@health.gov.au' and copied to 'decision.review@health.gov.au'

Requests for reconsideration that include dossiers (or similar bulk material) that cannot easily be attached to the request given first by email, may then be submitted on a USB drive or CD sent by express post or registered mail to:

Mail:

Minister for Health
Suite M1 40
c/- Parliament House
CANBERRA ACT 2600

If upon reconsideration by the Minister (or the Minister's delegate), you are dissatisfied with that decision, you can apply to the Administrative Appeals Tribunal (AAT) for a review of that decision (see the Administrative Appeals Tribunal Act 1975 (AAT Act)).

NOTE: This initial decision remains in effect unless and until it is revoked or revoked and substituted by the Minister (or the Minister's delegate) as a result of a request for reconsideration under section 60 of the TG Act OR is set aside, varied or remitted by the AAT or is otherwise overturned or stayed.

Advertisements attached to the complaint

Initial Advertisement
Initial Advertisement

Further Advertisement
Further Advertisement