TGA reforms: A blueprint for TGA's future

25 September 2014

The 'blueprint'

On 8 December 2011 TGA reforms: a blueprint for TGA's future was released. The Blueprint aims to improve the Australian community's understanding of the TGA's regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.

The blueprint was released in response to several major reviews of therapeutic goods regulation that were undertaken in 2010 and 2011. These reviews include

Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future

In July 2012 the TGA released its plan for delivering the blueprint. Implementing the Blueprint reforms will require the TGA to:

  • deliver outcomes that respond to the Government’s Blueprint recommendations
  • achieve operational reforms needed to deliver benefits from those recommendations; and
  • ensure that concurrent reform activities underway at the TGA in addition to the Blueprint reforms (ANZTPA and other activities) are achieved in a coordinated way.

Reform in each of these areas will be achieved incrementally over four years, in three phases. The priorities are:

  • better managing our communication;
  • better managing our practice; and
  • mature and sustainable performance.

Further information is available in the document, Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future.

To assist in the delivery of this program of work the TGA has developed the 'Program Implementation Guide for TGA Staff'. It will provide a single integrated view of the activities and control measures necessary to achieve the objectives of the program. The Guide also provides a baseline for the measurement and tracking of project progress, and the control of changes to the project.

Introduction

The Therapeutic Goods Administration (TGA) was established to safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods. It does this through the application of the Therapeutic Goods Act 1989 (the Act). The TGA is part of the Commonwealth Department of Health.

The TGA applies risk-based regulatory processes to therapeutic goods before they are marketed and monitors products once they are on the market. Additionally, it assesses the suitability of medicines and medical devices for export from Australia.

It also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.

The TGA works with consumers, health professionals, industry and its international counterparts in order to effectively regulate increasingly complex medicines and medical devices resulting from rapid scientific and medical developments.

In order to ensure that the TGA continues to fulfil its public health role and is able to meet community expectations within a complex therapeutics regulatory environment, several major reviews have been undertaken across various therapeutic regulatory areas. These have included:

  • the review to improve transparency of the Therapeutic Goods Administration;
  • the Working Group on Promotion of Therapeutic Products;
  • public consultations on the regulatory framework for advertising therapeutic goods;
  • the Auditor-General's report on Therapeutic Goods Regulation: Complementary Medicines;
  • an informal working group examining the regulation of complementary medicines and reasons for low compliance rates;
  • public consultations on the medical devices regulatory framework; and
  • the Health Technology Assessment Review.

In response to the various reviews, this work was drawn together into a comprehensive package of reforms to be progressed in stages. The reforms will enhance the TGA's current processes to ensure that the regulatory framework within which it operates remains able to adapt with flexibility to new scientific developments and emerging community expectations. They will improve the Australian community's understanding of the TGA's regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.

These reforms will also ensure that the TGA is better aligned to the central principles of the National Medicines Policy, by effectively implementing plans to inform the community of its role in providing timely access to the therapeutic goods that Australians need, and that they meet appropriate standards of quality, safety and efficacy.

These reforms are grouped under the following themes to ensure monitoring progress and achievements can be effectively undertaken:

  • communications and stakeholder engagement;
  • advertising of therapeutic products;
  • complementary medicines;
  • medical devices; and
  • promotion of therapeutic products.

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Communication and stakeholder engagement

Current arrangements for communication and stakeholder engagement

The TGA has a number of mechanisms in place to provide information on the regulation of therapeutic goods to consumers, health professionals and industry.

The Australian Register of Therapeutic Goods (ARTG) includes details of all therapeutic goods authorised by the TGA for use in Australia. This online database is accessible through the TGA website.

The TGA website has specific information portals for consumers, health practitioners and the therapeutic goods industry. This website provides a wide range of information about the role of the TGA, its regulatory processes and decisions.

Publications available from this site include Australian Public Assessment Reports (AusPAR) for prescription medicines. An AusPAR provides information about the evaluation of a prescription medicine, and the considerations that have led the TGA to approve or not approve an application to bring it to market.

Communication with stakeholders is currently undertaken by the TGA through a range of committees dedicated to specific areas of regulation, with membership drawn mainly from subject matter experts (health practitioners and researchers), consumers, and in some cases, therapeutic goods industry association representatives.

The TGA also conducts regular consultations on options to change existing regulation and procedures in response to emerging community and industry concerns, and in response to medical and technological advances.

Issues

In recent years there has been a growing awareness that:

  • the TGA's role as a regulator is not well known or understood by the Australian community;
  • the information provided by the TGA has been primarily directed to the therapeutic goods industry, rather than being targeted to assist consumers in their healthcare decision making;
  • there is a need to bolster confidence in the TGA as the regulator through proactive and targeted communication with all stakeholders, and consumers in particular, about its role and regulatory decisions; and
  • the community increasingly expects access to detailed information about the work of the TGA and in particular, about its evaluation of therapeutic goods.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Communication and stakeholder engagement.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

Advertising of therapeutic products to the general public

Current regulatory arrangements for advertising therapeutic goods

The advertising of therapeutic goods to consumers and health practitioners is controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant therapeutic goods industry associations. Advertising to consumers is permitted for the majority of medical devices and medicines available for over the counter sale, while advertising prescription-only and certain pharmacist-only medicines to the general public is prohibited.

Advertisements for therapeutic goods in Australia are subject to the requirements of the Act and Regulations, the Competition and Consumer Act 2010 and other relevant laws. Advertisements directed to consumers must also comply with the Therapeutic Goods Advertising Code with certain advertisements directed at consumers requiring approval prior to broadcast or publication.

The responsible use of advertising provides one mechanism to enhance the health outcomes of Australians.

Issues

Current calls for a more robust and effective system for the regulation of therapeutics advertising that ensures consumer confidence, and provides a level playing field for industry, have been noted.

The regulatory framework for advertising therapeutic goods has been the subject of a number of reviews over the past decade. The current framework has more recently been the subject of public criticism around misleading advertising of therapeutic goods and the potential consequential risks to public health. This criticism has focused mainly on the scope of the pre-approval process, the timeliness of the complaints handling process and that the available sanctions and penalties do not provide sufficient deterrence.

In June 2010, the TGA released a consultation paper seeking feedback on options to enhance the operation and effectiveness of the therapeutic goods advertising regulatory scheme.

Criticisms of therapeutic goods advertising included:

  • concerns about unfounded efficacy claims used in advertisements. The current pre-approval system is limited in its ability to prevent consumers from being exposed to advertisements for therapeutic goods that contain misleading claims related to the treatment of serious medical conditions, because only a sub-set of products are covered and only a sub-set of advertising media is covered by the current arrangements;
  • a lack of clarity about complaints processes. Consumers view the advertising complaints system as cumbersome and slow, with multiple processing pathways, procedures and resolution bodies depending on the nature of the complaint; the type of therapeutic good; the advertising media involved; and the target audience for the advertisement; and
  • a lack of incentive to comply with regulatory requirements. The currently available sanctions and penalties that can be imposed as a consequence of non-compliance with advertising requirements have been criticised for not providing a sufficient deterrent. These sanctions and enforcement strategies involve significantly lower pecuniary penalties compared to other comparative breaches of the Act.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Advertising of therapeutic products to the general public.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

Complementary medicines

Current arrangements for complementary medicines regulation and listing

The TGA has a two-tiered regulatory framework for complementary medicines, based on risk. Low risk medicines containing pre-approved low risk ingredients with demonstrated safety and quality are listed on the ARTG. Evidence for efficacy for listed complementary medicines is not evaluated prior to entry, although sponsors are required to hold evidence to support their claims.

The TGA currently undertakes post-listing reviews of the evidence for a proportion of products listed each year through a targeted and random audit system. Higher risk complementary medicines must be registered on the ARTG, which involves individually evaluating the quality, safety and effectiveness of the product.

Applications for listed medicines are submitted through the TGA's Electronic Listing Facility. The Facility can detect and refuse to validate applications that are non-compliant with some, but not all, requirements. Following payment and subsequent inclusion of the listing on the ARTG, the medicine is eligible to be supplied into the Australian market.

Sponsors must, at the time of listing, certify that the medicine meets a range of requirements including the general requirements for the labelling of the product under the Act.

Issues

The Auditor-General's report into complementary medicines regulation highlighted:

  • a poor rate of compliance with the regulatory requirements;
  • a lack of incentives for sponsors to comply with the legislation;
  • a lack of clarity and understanding of the regulatory requirements; and
  • community concern that the labels of complementary medicines fail to inform consumers that listed medicines have not been assessed against efficacy criteria.

The flow-on effect of non-compliance with the regulations is a reduction in community confidence in the existing regulatory framework and the TGA's oversight of therapeutic goods more generally.

Further, the lack of understanding within the community of the TGA's regulatory role in this area has led to misconceptions around the level of regulatory rigour that complementary medicine products undergo. There has been reported confusion surrounding the 'AUST L' number, which must be printed on the label of listed complementary medicines to demonstrate that they have been listed on the ARTG.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Complementary medicines.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

Medical devices

Current regulatory arrangements of medical devices

The TGA regulates the quality, safety and performance of medical devices supplied in Australia, using a regulatory framework which allows inclusion of medical devices in the ARTG. The fundamental components of the framework set out requirements for safety and performance of a medical device and a classification system based on the risk the device presents to the patient, the user and the environment.

Medical devices are classified according to the intended purpose of the medical device and the degree of risk involved for the patient and user. The device classifications are determined through the Therapeutic Goods (Medical Devices) Regulations 2002, and take into account factors such as the degree of invasiveness in the human body, the duration and location of use and whether the device relies on a source of energy. The level of pre-market assessment of medical devices is commensurate with the risk classification. The lowest risk devices (Class I) including things like tongue depressors and bandages can be automatically included in the ARTG based on declarations given by the sponsor. The level of evidence required for higher risk devices increases with increasing risk classification.

The regulatory framework for medical devices includes provision for post-market monitoring by the TGA including checking evidence, conducting periodic inspections of a manufacturer's quality management systems and technical documentation (including documentation held by a sponsor), and imposing specific requirements for manufacturers and sponsors to report, within specified timeframes, adverse incidents involving their medical devices.

In addition to this, the TGA receives expert orthopaedic input on hip, knee and shoulder arthroplasty devices through the independent expert advisory committee, the Orthopaedic Expert Working Group (OEWG).

The National Joint Replacement Registry (NJRR), created through an arrangement with the Commonwealth Department of Health, also provides post-market surveillance on joint replacement procedures carried out across Australia to ensure ongoing safety and efficacy of the medical devices implanted.

The Registry contains the most complete set of data relating to hip and knee replacement in Australia. The data is used to inform surgeons, other health care professionals, government bodies, including the TGA, orthopaedic device companies and the community.

Issues

The current entry of products onto the ARTG allows for several devices from one sponsor to be included under a single device description. These individual devices may not appear distinctly on the ARTG. This makes it difficult to identify if a particular device is in fact listed on the ARTG or not, and makes it difficult to identify the products in the event of a recall of the device.

There have also been community concerns that have arisen with some joint replacement implants. This has led to calls to increase the pre-market scrutiny of these and other high risk prostheses.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Medical devices.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

Promotion of therapeutic products

Current arrangements for the promotion of therapeutic products

The professional relationship between health care practitioners and therapeutic goods companies is governed by industry and professional codes of conduct, not by government regulation.

A number of therapeutic goods industry associations have codes of conduct/practice which include guidelines on ethical and responsible business practices.

Issues

From time to time, examples are highlighted of industry offering inducements to health professionals to promote products. This has the potential to influence clinical decisions on grounds other than the best interests of the patient. Strong and enforceable industry codes of conduct are effective in limiting unethical behaviour, but there needs to be consistency across industry codes in terms of their requirements, application, enforcement and penalties. Concerns have also been raised that non-members of industry associations may not be bound by industry codes.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program.

Responsibility for delivering the 18 recommendations relating to the promotion of therapeutic goods lies with the Best Practice Regulation and De-regulation Division of the Department of Health.

Resourcing

The proposed reforms are fundamental to the appropriate operation of the regulatory frameworks that allow therapeutic goods to be supplied in the Australian marketplace and directly relate to that regulatory activity.

As has been the case since 1998, the full cost of regulating therapeutic goods continues to be met by cost recovery from the regulated industry. This operates effectively under the Act through annual negotiations with relevant industry sectors.

In order to deliver the fundamental reforms, a modest increase in the TGA's fees and charges was introduced from 1 July 2012.

Reforms relating to the promotion of therapeutic goods sit outside the TGA and thus resourcing of that project will not be sought through cost recovery.

Implementation and governance of reforms

Plans for implementing the reform initiatives are outlined in the document Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future.

In addition to the usual governance processes applying to the TGA in its role as part of the Commonwealth Department of Health, the Secretary of the Department of Health has established a high level steering committee to oversight all aspects of the implementation of these reforms. Progress on the reforms will also be reported to the Australian Therapeutic Goods Advisory Council.

Appendix 1: Correlation of recommendations

Recommendations relating to: Recommendation Government response
Communication and stakeholder engagement

Transparency Review - Rec 1

The TGA establish an Australian Therapeutic Goods Advisory Council, with membership representative of major stakeholder groups, to enable more effective stakeholder input into future directions and program implementation. The Council will have an oversight role in the implementation, ongoing monitoring, and evaluation of the recommendations of this review.

Agreed

Transparency Review – Rec 2

The TGA define, adopt and publish consultation principles to guide regulatory transparency and accountability.

Agreed

Transparency Review - Rec 3

The TGA develop and implement a comprehensive communication strategy to inform and educate. A dedicated communications team should be established within TGA to implement that strategy.

Agreed

Transparency Review - Rec 4

The TGA work transparently with other key providers of information to enhance the information available to the public (community and stakeholders), consistent with the principles of the quality use of medicines.

Agreed

Transparency Review - Rec 5

The TGA develop a plan to ensure information on the key public access portal, the TGA website, is current, accurate, relevant, timely and up to date, and meets the needs of its audiences.

Agreed

Transparency Review - Rec 6

The TGA provide user-friendly information on the risk based framework under which it operates, including detailed explanations of how this operates for different classes of therapeutic goods. As a priority, the differences between registered and listed therapeutic goods, and their processes of evaluation, should be explained.

Agreed

Transparency Review - Rec 7

The TGA implement mechanisms to educate and inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.

Agreed

Transparency Review - Rec 8

The TGA provide clear information on the role of its statutory advisory committees, and adopt a consistent and transparent approach to the publication of information from those committees.

Agreed

Transparency Review - Rec 9

The TGA improve access and quality of information on the processes for regulation of advertising of therapeutic goods, including the complaint process and the outcomes of complaints.

Agreed

Transparency Review - Rec 10

The TGA, in conjunction with key stakeholders, develop and publish agreed Key Performance Indicators to provide quantitative and qualitative information on the TGA's organisational effectiveness and operational efficiency. This may be achieved in conjunction with the proposed Australian Therapeutic Goods Advisory Council.

Agreed

Transparency Review - Rec 11

The TGA develop and publish a policy on the disclosure of commercially confidential information, noting significant issues for each therapeutic product type. The policy should take into account the practices followed by comparable international regulators.

Agreed

Transparency Review - Rec 12

The TGA explore mechanisms for providing explanations on its various regulatory processes, and the TGA adopt publication principles on the outcomes of application assessments using as an exemplar the Australian Public Assessment Reports (AusPAR).

In-principle agreement with consultation to be undertaken with stakeholders to further develop options for consideration by the TGA.

Transparency Review - Rec 13

The TGA assess and report on the feasibility of developing an on-line system for the submission and tracking of all applications for assessment, which enables the sponsor to ascertain the progress of an application.

Agreed with consultation to be undertaken with stakeholders to further develop options for consideration by the TGA.

Transparency Review - Rec 14

The TGA work with stakeholders to improve labelling and packaging requirements to educate and assist consumers and health practitioners to make informed decisions about the quality use of therapeutic goods.

The Government considers that there is capacity to improve labelling and packaging requirements and will further develop options in consultation with stakeholders.

Transparency Review - Rec15

The TGA conduct, and report on, a feasibility study into the development of an early post-marketing risk communication scheme for therapeutic goods, with consideration of international models.

Agreed

Transparency Review - Rec 16

The TGA actively promote the distribution of therapeutic goods safety information, and examine mechanisms for improving the timely communication of alerts and recalls, to health practitioners and to consumers.

Agreed

Transparency Review - Rec 17

The TGA explore mechanisms to maintain the currency of Consumer Medicines Information and Approved Product Information.

In-principle agreement with further consultation to be undertaken with stakeholders and development of options for consideration by the TGA.

Transparency Review - Rec 18

The TGA progressively develop and implement a system to publish the outcomes of investigations and compliance actions taken.

Agreed

Transparency Review - Rec 19

The TGA more effectively facilitate the recognition and reporting of adverse events by health practitioners and consumers, and promote the adverse event reporting system.

Agreed

Transparency Review - Rec 20

The TGA make its Adverse Events Database available to, and searchable by, the public in a manner that supports the quality use of therapeutic goods.

Agreed

Transparency Review - Rec 21

The TGA work with State and Territory governments, stakeholders, and other relevant agencies, to improve the visible management of adverse event reporting in support of consumer safety and consistent with the findings of the Horvath Review into Immunisation.

Agreed
Complementary medicines The Auditor-General's report was tabled in Parliament on 30 August 2011

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Rec 1

To achieve timely completion of key guidance material for complementary medicines, the ANAO recommends that DoHA:

(a) provides a target date for the completion and publication of each key guidance document; and

Agreed

(b) provides regular progress reports on the development of key guidance documents on the TGA website, to keep industry, health professionals and consumers informed.

Agreed

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Rec 2

To improve the integrity of the self-assessment process for listing complementary medicines on the Australian Register of Therapeutic Goods (ARTG), the ANAO recommends that DoHA seeks to finalise work on the 'coded indications' project so as to limit the use of inappropriate claims and indications on the ARTG.

Agreed

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Rec 3

The ANAO recommends that the TGA makes 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.

Agreed

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Rec 4

To improve compliance with the regulatory framework, the ANAO recommends that the TGA:

(a) use its random sampling review of listed medicines to develop risk profiles of sponsors and the most significant characteristics of medicines; and

Agreed

(b) use the profiles to inform its program of post-market reviews.

Agreed

Auditor-General's Report on Therapeutic Goods Regulation: Complementary Medicines - Rec 5

The ANAO recommends that the TGA adopt a standard operating procedure for completing investigations of advertising breaches. In developing the procedure TGA should incorporate:

(a) appropriate timeframes for completing the investigations of advertising breaches; and

Agreed

(b) the provision of regular reports to the TGA executive on progress with investigations and trends in non-compliance.

Agreed

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 1

Provide increased information:

(a) on product labels regarding regulatory assessment undertaken by TGA of complementary medicines; and

The Government considers that improvements in this area could increase public awareness of the regulation of complementary medicines and will work with stakeholders to develop options for consideration by Government.

(b) on TGA website regarding regulatory assessment undertaken by TGA of complementary medicines.

Agreed

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 2a

Modify Electronic Listing Facility system, to:

(a) include restriction or elimination of access by sponsors to 'free text'.

Agreed

(b) Provide guidance and cautionary notes for sponsors using the Electronic Listing Facility, regarding the consequences of misleading and unsubstantiated claims.

Agreed

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 3

Update 'Guidelines for levels and kinds of evidence' and include 'Guidelines for levels and kinds of evidence' in regulation.

In-principle agreement with further consultation to be undertaken with stakeholders.

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 4

Review current 'coded indications' project based on the document 'Guidelines for levels and kinds of evidence' and either restrict or eliminate access by sponsors to 'free text' in the Electronic Listing Facility.

Agreed

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 5

Apply, enforce and publicise sanctions and penalties, including for advertising breaches, including recalling products from the market that are removed from the ARTG as a result of regulatory action, where circumstances warrant.

Agreed

Informal Working Group Examining Complementary Medicines Regulation and Reasons for Low Compliance Rates - Rec 6

Enhance sanctions and penalties for repeated breaches of non-compliance (as well as strengthening sanctions and penalties for advertising).

Noted with further consultation with stakeholders to consider appropriate sanctions and penalties.
Medical devices

Medical Device Reforms – Proposal 1

Reclassification of joint replacement implants.

Agreed

Medical Device Reforms – Proposals 2A

Use of third party assessment bodies for Australian manufacturers.

Noted. Linked to further recommendations in Senate Community Affairs References Committee inquiry into 'The regulatory standards for the approval of medical devices in Australia'.

Medical Device Reforms – Proposal 2B

Increasing pre-market scrutiny for implantable medical devices.

Noted. Linked to further recommendation in Senate Community Affairs References Committee inquiry into 'The regulatory standards for the approval of medical devices in Australia'.

Medical Device Reforms – Proposals 2C

Recognition of third party assessment bodies.

Noted. Linked to further recommendation in Senate Community Affairs References Committee inquiry into 'The regulatory standards for the approval of medical devices in Australia'.

Medical Device Reforms – Proposal 3(i)

Amend the way in which a kind of medical device is included in the ARTG.

The Government will look at options to improve the way medical devices are included on the ARTG in consultation with stakeholders.

Medical Device Reforms – Proposal 3(ii)

Enhance the ability to identify devices that have been approved by the TGA for supply in Australia by having the ARTG identifier on the label.

Not agreed. Proposal not supported as other reforms will achieve this objective.

Medical Device Reforms – Proposal 4

Publication of device product information on the TGA website.

The Government will look at options for publication on the TGA website in consultation with stakeholders.
Advertising of therapeutic products

Advertising consultation – Rec 1

Publish the report on advertising reform on the website, once finalised.

Agreed

Advertising consultation – Rec 2

Reforms to advertising framework.

The TGA will further consult with stakeholders on appropriate reforms to the advertising framework.

Advertising consultation – Rec 2a.

Modify pre-approvals process to include medical devices and pay TV (advertising claims about the efficacy of a product to be assessed by the TGA).

In-principle agreement with further consultation to be undertaken with stakeholders and development of options for consideration by Government.

Advertising consultation – Rec 2b.

Establish a single entry point for all complaints, with some handled by TGA (complaints about the efficacy of a product to be assessed by the TGA).

Agreed

Advertising consultation – Rec 2c.

Develop a more effective approach to sanctions and penalties (including use of the infringement notice provisions).

The Government will look at options to introduce more effective approaches to sanctions and penalties in consultation with stakeholders.
Promotion of therapeutic products

Working Group on Promotion of Therapeutic Products - Rec 1

The artificial difference in the Position Paper between 'high risk' and 'low risk' products be set aside, with application of a sector specific industry code to be determined by coverage of the relevant therapeutic sector to a specific product.

Supported

Working Group on Promotion of Therapeutic Products - Rec 2

Consistency of therapeutic sector industry codes of practice be facilitated by each therapeutic industry association, incorporating in its code the high level principles, operational coverage areas and governance provisions developed by the working group.

Supported

Working Group on Promotion of Therapeutic Products - Rec 3

Each industry association must determine the steps required to be taken to implement the working group's recommendation 2, and the time by which these steps will be completed. Each industry association will advise the Government of the anticipated completion date for implementation.

Supported

Noting that industry associations have indicated that the target timeline for completion of code revisions is 2014.

Working Group on Promotion of Therapeutic Products - Rec 4

Information on therapeutic industry codes be made available to the public via the internet, with access to the complaints processes and links to each of the applicable codes. The industry associations will work with the Government to identify the most appropriate vehicle to make the information available.

Noted

Improves access to information responds to consumer concerns and will strengthen self-regulation.

Working Group on Promotion of Therapeutic Products - Rec 5

TGA include on its application forms (whether electronic or paper) a requirement for an applicant to nominate the relevant code of practice to which it will subscribe, as a condition of registration/listing on the ARTG.

Not supported as currently proposed.

Departs from self-regulatory model.

The Government's preference is to maintain the current self-regulatory focus.

If after industry codes have been updated, further encouragement is required for non-members to nominate a code, the Government will consider further legislative measures including the TGA seeking this information

Working Group on Promotion of Therapeutic Products - Rec 6

TGA provide on the ARTG public summary for each product, information on the nomination of an industry code, in a searchable format.

Noted

Cannot be implemented separately to Recommendation 5.

Working Group on Promotion of Therapeutic Products - Rec 7

Industry associations work with TGA to develop a process for notification to an association when an applicant nominates that association's code of practice.

Not supported as currently proposed.

Departs from self-regulatory model as TGA is co-opted as an intermediary between industry associations and product sponsors.

Working Group on Promotion of Therapeutic Products - Rec 8

Industry associations develop comprehensive training programs on the codes to ensure that non-members (as well as members) are educated on the requirements of the relevant code.

Supported

Working Group on Promotion of Therapeutic Products - Rec 9

The effectiveness of voluntary registration be evaluated annually and that consideration be given to mandatory nomination of a code if voluntary registration proves ineffective to achieve the Government's objectives.

Noted

Evaluation prior to 2014 may be premature given industry's advice on when their codes may be revised and operational.

Further work with industry associations will be required to identify the most appropriate evaluation methodology.

Working Group on Promotion of Therapeutic Products - Rec 10

AHPRA and AHMAC be encouraged to advocate changes to health professional codes to more closely reflect the mutuality of obligations between industry and healthcare professionals, to ensure ethical promotion of therapeutic products.

The Government will refer this matter to AHPRA and National Boards.

Working Group on Promotion of Therapeutic Products - Rec 11

The healthcare professional colleges and associations actively pursue alignment of their professional codes and/or guidelines to be consistent with the principles and areas of operational coverage.

The Government will refer this matter to National Boards and professional colleges.

Working Group on Promotion of Therapeutic Products - Rec 12

Education on relationships with the therapeutic industry be included in the training of healthcare professional students, in addition to education on the healthcare professional codes and guidelines.

The Government will refer this matter to healthcare professional associations and/or education bodies.

Working Group on Promotion of Therapeutic Products - Rec 13

An educative complaints portal be established as a mechanism to assist channelling complaints to the appropriate industry association. The industry associations will work with the Government to identify the most appropriate vehicle for this purpose.

Noted

Strengthens access to information, communication and universal adherence to consistent industry-wide codes.

Further work by industry associations will be required to identify options, expectations regarding lines of responsibility and mechanisms for effective implementation.

Working Group on Promotion of Therapeutic Products - Rec 14

Each industry association provides on its website, a link to the complaints mechanism for each other therapeutic industry sector.

Supported

Working Group on Promotion of Therapeutic Products - Rec 15

The industry associations actively engage in the education on and dissemination of the outcomes of the deliberations of the working group, with assistance from the Government as appropriate.

Noted

Further work by industry will be required to identify the need and scope for Government assistance and the capacity to fulfil within existing resources.

Working Group on Promotion of Therapeutic Products - Rec 16

The establishment of a process to evaluate, on an ongoing basis, the implementation of the recommendations of the working group.

Noted

Further work by industry will be required to identify mechanisms for evaluation.

Working Group on Promotion of Therapeutic Products - Rec 17

The Government form a permanent advisory group, similar in composition to the working group, with responsibility for the oversight of implementation of the working group's recommendations, and with a mandate to regularly report to Government on the effectiveness of the implementation against the evaluation criteria set out above.

Noted

Proposal for continuing involvement of government departs from a self-regulatory approach.

Further work will be required to identify an appropriate role, membership and source of resourcing of such a group.

Working Group on Promotion of Therapeutic Products - Rec 18

The Government review the National Medicines Policy (NMP) and consider replicating its policy coverage through the development of analogous policies for other therapeutic product sectors.

Not supported as currently proposed.

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