Communication and stakeholder engagement

Communication about the regulation of therapeutic goods needs to be timely, targeted to the intended audience and enable informed decision making. Immediate focus areas involve creating better information that is easily understood by consumers; therapeutic goods information that can be received and shared by health professionals; and information that will provide greater certainty on regulatory arrangements for the therapeutic goods industry.

On 21 December 2012, the TGA external communication and education framework: Priorities and projects 2013-2015 (the Communications Framework) was released publicly. The Communications Framework describes the TGA's approach to improving communications and stakeholder engagement activities over the coming three years.

We will be focusing strongly on increasing stakeholder participation in the regulatory system, and reaching a wider audience, through well-developed and effective relationships with information partners, and high level participation and engagement in face-to-face fora.

The TGA Internet sites (including www.tga.gov.au and www.ebs.tga.gov.au) will continue to be a primary source of information about the TGA; however our ongoing review and refinement process will ensure that we maintain a well-functioning and user-friendly online presence that contains a thorough suite of information, resulting in a reduction in the number of individual inquiries received by the TGA.

During 2013, there will be an increased focus on communication and stakeholder engagement, particularly with consumers. Major activities will include:

• Creating and testing new communication and educational materials that are audience centred. The clarity (audience-focus), timeliness and dissemination of materials will be improved. Part of this work will involve continuing to work with information partners on the dissemination of educational materials and safety related information.
• Finalising and releasing TGA Consultation Principles to ensure that our approach to consultation activities is consistent, well-coordinated, transparent and timely.
• A review of the Public Contact Team model to determine if stakeholder needs are being met. The Public Contact Team was introduced in 2012 as a pilot program to improve the efficiency, consistency and quality of the way that the thousands of general inquiries the TGA receives (by phone, email and fax) each year are handled.
• Developing a plan for improving the TGA website (www.tga.gov.au) in accordance with the TGA Communications and Education Framework.
• Developing specific key performance indicators for communication and stakeholder engagement activities to ensure that the desired outcomes associated with these activities are being achieved.

Complementary medicines

Reforms to complementary medicines regulation seek to improve community confidence in the safety and quality of these medicines and strengthen the integrity and transparency of the regulatory framework for complementary medicines. The TGA has progressed work on a series of reforms to complementary medicines to achieve this including:

• ensuring that the TGA effectively informs the community about the pre- and post market roles that the TGA performs
• clarifying requirements for sponsors of complementary medicines, particularly in regard to evidence requirements and allowable indications
• improving the Australian community's understanding of the TGA's regulatory processes and decisions for complementary medicines
• strengthening the integrity and transparency of the regulatory framework for complementary medicines
• enhancing the complementary medicine regulatory framework to ensure that it remains adaptable to community and industry expectations
• implementing reforms to labelling and packaging of medicines, including complementary medicines.

The reforms will initially focus on implementing the recommendations of the Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines ('the ANAO Report') through the following projects:

1. Key regulatory guidance materials. Clearer documentation of Evidence Requirements provides sponsors with information on regulatory requirements and guidance on the evidence they are required to hold to support indications made for listed complementary medicines. There have now been two rounds of public consultation, and a final document will be developed and published before June 2013.
2. Standard or 'coded' indications. This will involve review of the free text field in the Electronic Listing Facility to limit the use of inappropriate claims and indications, and improve the integrity of the self-assessment process for listing complementary medicines on the Australian Register of Therapeutic Goods (ARTG). Public consultation on a guidance framework and draft list of standard indications allowed to be used in listed complementary medicines will be completed in March 2013.
3. Publishing outcomes of listing compliance reviews. The TGA will continue to make information available in a timely manner to the Australian public, for each listed complementary medicine, stating whether it has been subject to post-market review by the TGA, when it was reviewed, and the outcome of that review.
4. Developing risk profiles. To improve compliance with the regulatory framework, the TGA will use information from compliance reviews to develop risk profiles of sponsors and characteristics of medicines to inform the targeted compliance review program.
5. Investigation processes for advertising breaches. The TGA has a standard procedure for investigations of advertising breaches in place. A workflow system for complaints, to facilitate reporting to the TGA Executive, is to be designed. Regular reporting on progress with investigations and trends in non-compliance will be developed and implemented.

The Evidence Requirements and Coded Indications consultations are required to inform Regulatory Impact Statements (RIS), and lead to the development of legislative amendments.

Medical devices

This set of regulatory reforms seeks to improve community confidence in the safety and quality of medical devices and strengthen the integrity and transparency of the device regulatory framework to ensure that devices available to the public are of acceptable quality and safety, and perform as intended. Government-agreed recommendations from the Health Technology Assessment (HTA) Review and Senate inquiries outlined in the Blueprint recommendations will be implemented. Proposed regulatory reforms seek appropriate levels of scrutiny of devices prior to their supply in Australia. This needs to be balanced with the desirability of implementing internationally aligned regulatory requirements for pre-market assessment, post-market vigilance, market surveillance and audits, and product testing.

Hip, knee and shoulder joint implants (total and partial) were reclassified on 1 July 2012 from Class IIb (medium-high risk medical devices) to Class III (high risk medical devices), increasing regulatory oversight to better assure the products’ safety, quality and performance. Regulatory change to the Therapeutic Goods (Medical Devices) Regulations 2002 includes a two year transition period from 1 July 2012 to 30 June 2014 for devices already in the ARTG. A key element in the transition period is the assessment of the available post-market data prior to approval of existing devices as a Class III medical device. Communication with industry is ongoing to address emerging issues for sponsors and the TGA, and to ensure that the goals of the reform are achieved.

A consultation paper 'Changes to premarket assessment requirements of medical devices' was publicly released in January 2013. The proposed regulatory changes are intended to ensure that implanted and long term surgically invasive medical devices receive a greater degree of scrutiny by the TGA than is currently the case, prior to market approval. Options for defining the roles of third party conformity assessment bodies are included in the consultation paper. The TGA will use the stakeholder feedback from the consultation process to inform the development of a Regulatory Impact Statement, prior to seeking regulatory changes.

Advertising of therapeutic products

The advertising of therapeutic goods to consumers and health professionals is currently controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant industry associations.

The object of potential reforms to advertising is to improve the level of compliance and timeliness of decision-making in a resource effective manner. The outcome of increased compliance will be greater certainty that consumers are protected from untruthful, deceptive and misleading advertisements and will give greater confidence that the regulatory system is providing protection to the health of consumers.

Advertising to consumers is currently permitted for the majority of therapeutic goods available for general retail sale, while advertising of Prescription-Only and certain Pharmacist-Only (Schedule 3) medicines is prohibited.

Reviews and feedback from public consultations and media coverage have highlighted the ongoing concern that the advertising regulatory framework for therapeutic goods does not provide adequate protection for consumers for a number of reasons. These include views that the current framework is overly complicated, ineffective, and inefficient, lacks transparency, and is difficult and costly to administer. In addition, there has been consistent feedback from consumer groups, supported by some media reports that resolution of advertising complaints is too slow, and that damage from misleading or inaccurate advertising may already have been done by the time the advertiser may be forced to withdraw materials.

In May 2012 an Advertising Options Paper, Advertising regulatory framework - Options for reform was published on the TGA website. The paper examined the complexity and limitations of the current framework. The Advertising Options Paper outlined several broad opportunities for change to the framework for the regulation of the advertising of therapeutic goods and described possible options for improvements.

The TGA has developed a refined set options for reforming the advertising regulatory framework based on those that were broadly outlined in the May 2012 Advertising Options Paper. The reforms mainly deal with the pre-approvals process, complaint handling procedures and aligning the sanctions and penalties with other parts of current legislation.

Subject to agreement by Government, in 2013 the TGA will use the information received from the earlier consultation process to inform a consultation Regulatory Impact Statement, setting out options for reform of the advertising framework.

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