Australian government seeks to bolster powers under therapeutic goods legislation
In December 2013, the Minister for Health introduced the Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013 (the Bill) into Parliament. The bill was listed for debate in Parliament on 11 February 2014.
If the bill is passed in its present form, the key changes to the Therapeutic Goods Act 1989 (Cth) (the Act) will be:
- the introduction of new criminal offences and civil penalties;
- the granting of increased power to the Secretary to cancel or suspend a registration or listing;
- the granting of power to the Minister to exempt certain goods from the operation of the Act;
- changes to publication requirements for regulatory decisions.
New criminal offences and civil penalties
Requests to vary the register
Section 9D of the Act permits a person to request the Secretary vary the information on the Australian Register of Therapeutic Goods (the Register). This information can relate to a variety of matters, including safety issues such as adding a warning or precaution to a product information sheet or relate to the provision of pre-clinical or bioequivalence data relevant to the safety, efficacy or quality of the good. The Bill creates criminal offences and civil penalties for supplying false or misleading information in such a request.
The Bill has tiered levels of criminal liability each of which must be proved to the criminal standard of beyond reasonable doubt:
- where the statement provided is false or misleading in a material particular and has or will result in harm or injury to a person the court can impose a maximum penalty of 5 years imprisonment or a fine of $AUD680 000 (4000 penalty units) or both. This offence requires fault;
- where the statement provided is false or misleading in a material particular and the use of the goods would be likely to result in harm or injury to a person, the offence is one of strict liability and a penalty of up to $AUD 340 000 (2000 penalty units) can be imposed. This offence has a lower penalty and no custodial sentence to balance the fact that there is no fault element;
- where the statement is false or misleading in a material particular but does not cause damage the court can impose a maximum penalty of 12 months imprisonment or a fine of $AUD170 000 (1000 penalty units) fine or both.
Additionally, the Bill introduces a maximum civil penalty of $AUD850 000 (5000 penalty units) for individuals and $AUD8 500 000 (50 000 penalty units) for a body corporate for making a statement that is false or misleading in a material particular in connection with a request under section 9D. This must be proved to the civil standard of the balance of probabilities.
Information requested by the Secretary
Section 31 of the Act provides the Secretary with the power to request a wide range of information from persons who are applicants for registration or have registered therapeutic goods. This includes information about the formulation, composition, quality, presentation, safety, efficacy and history of the goods. Currently, criminal liability applies under section 31 to a sponsor of a section 26A good (complementary medicine) who provides false or misleading information in response to a section 31 notice.
Section 31AAA contains the civil penalty provision for the same conduct. The Bill expands these liabilities to any person issued with a section 31 notice.
Accordingly it is critical to provide up to date and accurate information in all dealings with the Therapeutic Goods Administration (TGA) and the Secretary.
Secretary’s powers to cancel a registration or listing
The Bill spells out the responsibility of sponsors to comply with the Therapeutic Goods Advertising Code (the Code). Currently, compliance with the advertising requirements in Part 5.1 of the Act and under the Regulations is a condition of inclusion on the Register and non-compliance can result in removal of the good from the Register. Although Part 5.1 of the Act makes reference to the Code, the Bill clarifies that compliance requires conformity with the Code and amends section 30(2) of the Act to make it clear that non compliance with the Code is a ground for cancelling registrations or listings of medicines.
Failure to respond to a section 31 notice
The Bill gives the Secretary power to cancel a registration or listing if a person fails to comply with a section 31 notice to provide information or documents within 14 days of the end of the notice period. For example, the Secretary may cancel a registration or listing 14 days after the expiration of the 28 day notice period.
Registered goods are assessed by the TGA for quality, safety and efficacy. All prescription medications and most over the counter medicines are registered goods. Listed goods are assessed by the TGA for quality and safety but not for efficacy. Most complementary medicines and some over the counter medicines are listed.
If the presentation of the registered good is not acceptable, or the presentation of a listed good is unacceptable, the Secretary will have the power to cancel the registration or listing. The way goods are presented for supply includes matters relating to the name, labelling and packaging and any advertising or other informational material associated with the goods.
Subsection 3(5) of the Act provides that presentation will be unacceptable if it is capable of being misleading or confusing as to the content or proper use or identification of the goods. This includes:
- if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or
- if the name applied to the goods is the same as the name applied to other therapeutic goods which contain additional or different therapeutically active ingredients; or
- if the label of the goods does not declare the presence of a therapeutically active ingredient; or
- if the label of the goods does not contain an advisory statement when it is required to do so; or
- if the form of the presentation may lead to unsafe use of the goods.
For registered goods, the ‘not acceptable’ standard is a higher one and encompasses a range of factors that go beyond the definition of unacceptable. The explanatory memorandum to the Bill indicates that this may include matters such as the content of consumer medicine information for the goods.
Exempting certain goods from the Act
The Act has a broad definition of therapeutic goods being ‘goods that are represented in any way to be, or that are, whether because of the way in which they are presented or for any other reason, likely to be taken to be for therapeutic use.’ Therapeutic use relevantly includes use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons.
The Bill introduces section 7AA, which empowers the Minister to deem specific goods excluded for the purposes of the Act and to deem goods, when used, advertised or presented for supply in a certain way specified in the determination excluded from the Act. Currently the Minister is only able to exempt goods from discrete parts of the Act.
This new section addresses the concern that the breadth of the definition of ‘therapeutic goods’ captures clothing, jewellery and bedding which make therapeutic claims but for which public health is not an issue, such as ‘power band’ bracelets and mattresses which contain bacteria designed to reduce the effects of dust mites. The view in the explanatory memorandum to the Bill is that any issues concerning these products are better dealt with under consumer protection legislation.
In making a determination under section 7AA the Minister must have regard to:
(a) whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;
(b) whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods;
(c) whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory regime.
These factors should ensure that section 7AA is not used as a means for genuine therapeutic goods to avoid the scope of the Act.
Changes to Publication Requirements
The Bill requires the Secretary to publish a notice setting out the particulars of any cancellation made under section 30 of the Act of any registered or listed goods.
At present, the Secretary must publish information on regulatory decisions in the government Gazette. The Bill gives the Secretary the option to publish this information either in the government Gazette or on the TGA website. There are some particulars such as emergency exemptions which must still be published in the Gazette.
The Bill also contains amendments which:
- give power to the Secretary to remove products from the Register that are not or are no longer a therapeutic good, as distinct from the Secretary’s current powers to cancel products from the Register;
- clarify the Secretary’s current power to approve product information for medicines accepted for registration;
- modify the definition of kit to include any unit with one therapeutic good or more; and
- support the transition process for the reclassification of hip, knee and shoulder implants.