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Regulation impact statement: General requirements for labels for medicines

Version 3.0, July 2016

10 August 2016

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Implementation and review

Should the proposal to update TGO 69 be accepted, TGOs 91 and 92 will be finalised and a decision on their adoption as Ministerial Standards made by the delegate of the Minister (under the provisions of section 10 of the Act). Once the decision is made, the documents and associated Explanatory Statements will be registered on the Federal Register of Legislation (FRL). As TGO 91 and 92 are legislative instruments, they are both subject to disallowance by the Federal Parliament.

Prior to registration, key stakeholders will be notified and information made available on the TGA website. The draft guidance document that has been prepared to assist industry in applying the new requirements will also be published.

As the existing labelling Order, TGO 69, is due to 'sunset' on 1 October 2017 it will need to be re-made. Sunsetting is the process by which legislative instruments undergo automatic repeal after 10 years following their registration. Remaking TGO 69 ensures that medicine sponsors have the choice of complying with either the current requirements or TGO 91 /92 (as relevant) over the 4-year transition period.

Once the new standards are registered, a mechanism for their review and variation exists under section 10 of the Act.

Risks

Undue delay of implementation of new labelling requirements would result in a misalignment with the IHIN implementation and potential increase in label update costs. This risk has been raised as a concern by industry stakeholders.

If the draft TGOs 91 and 92 are not adopted, TGO 69 will still need to be remade as all stakeholders agree that mandatory labelling requirements are necessary for medicines supplied in Australia. However it is also widely accepted that TGO 69 does not reflect current best practice for quality use of medicines.

In addition, the lengthy consultation on revised labelling requirements has raised stakeholder expectations which would need to be managed in the event of the current requirements being maintained.

There is also the risk of implementing TGO 91 and 92 with unintended consequences, such as stakeholders finding ambiguity or contradiction within the relatively complex framework. While consideration has been given to these issues and relevant technical and legal expertise engaged in drafting the Orders, it is not until the new requirements are implemented that this can be fully identified. If these situations arise, consultation with affected stakeholders would be conducted and either the existing mechanism for review and variation to the Orders would be utilised or the guidance document updated.

It is possible that the new Orders have been drafted in ignorance of a specific stakeholder need due to lack of involvement in the consultation - that is, requirements for a particular type of medicine may not have been incorporated. This risk is slight given the extensive consultation process and in fact reflects an existing situation; that is, TGO 69 cannot be applied to some medicines already on the market. These medicines are appropriately regulated by the Secretary of the Department of Health granting consent for their supply under the provisions of sections 14 and 14A of the Act. This mechanism is still available post-implementation of the new TGOs 91 and 92 and could be utilised until the Orders were updated as needed.

There is also a risk of dissatisfaction from consumer and healthcare groups that the requirements in TGO 91 and 92 do not go far enough in meeting their objectives. The balancing of stakeholders views between improving safety outcomes on the one hand, and economic viability and international harmonisation on the other, required careful consideration. It is therefore likely that consumer and healthcare groups will be dissatisfied that many of the issues raised throughout the consultations have not been reflected adequately in legislation (e.g. active ingredient name above trade name, expiry/batch colour contrast requirements). The creation of specific best practice principles may be an appropriate way to address some of these issues once the new labelling Orders have been implemented.

Review and post-implementation activities

It is intended that TGO 91 and 92 will be reviewed on a regular basis. Many issues raised by stakeholders in previous consultations were considered out of scope for the current medicine labelling reform, but may be considered for future updates (e.g., a review of Schedule 1 substances which was raised by some consumer groups). It is envisaged that the splitting of TGO 69 into separate Orders for prescription and non-prescription medicines will help ensure that future updates are more targeted and streamlined. Each review will involve further consultation. A regular ongoing process of review will assist in maintaining currency of the Orders.

Communication and education

An education strategy for industry, healthcare professionals and consumers will help raise awareness of the key medicine labelling changes.

We will work closely with consumer, healthcare professional and industry peak bodies to develop and disseminate information about the changes. These organisations have existing resources and networks that extend beyond those currently available to TGA.

Targeted communication

TGA will work with consumer and healthcare professional organisations to develop communication and education strategies. The overall intention of the new Orders is to improve access to information for consumers and healthcare professionals; however it is anticipated that explanation on why information is now being presented a certain way, and why not all labels will be compliant immediately, will be needed. We will work closely with these stakeholders to address their communication needs.

For industry stakeholders, it is anticipated that education sessions on how to use and interpret the new Orders may be required. We will be working closely with these stakeholders to identify and respond to their needs.

A range of education materials will be developed through different media to meet the needs of different stakeholders. These may include targeted mail-outs to sponsors, information that healthcare professionals can pass on to consumers, and presentations at professional seminars or conferences. A consumer education video can also be created for GP waiting rooms.

TGA will also create a dedicated page on the TGA website that will be a central source of information on the new Orders and contain a copy of useful communication and education materials. All education materials will provide links back to this central webpage.

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