Presentation: A spotlight on other reforms from the medicines and medical devices regulation review
•Download as PPTX, PDF•
2 likes•655 views
An overview of advertising reforms and changes to penalties and sanctions arising from the Review of Medicines and Medical Devices Regulation.
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Presentation: A spotlight on other reforms from the medicines and medical devices regulation review
Similar to Presentation: A spotlight on other reforms from the medicines and medical devices regulation review (20)
More from TGA Australia
More from TGA Australia (20)
Recently uploaded
Recently uploaded (20)
Presentation: A spotlight on other reforms from the medicines and medical devices regulation review
- 1. A spotlight on other reforms from the medicines and medical devices regulation review Advertising and sanctions and penalties Leanne McCauley Director, Advertising Compliance Unit Regulatory Practice, Education & Compliance Branch Regulatory Practice and Support Division, TGA 2017 ARCS Annual Conference August 2017
- 2. Medicines and Medical Devices Review (MMDR) Stage Two Report (Released July 2015) TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 1
- 3. Review recommendations 52 to 58 cover advertising: • Advertising of therapeutic products to the public continues to be regulated by the TGA under a legislative framework which includes an advertising code (rec 52) • Public advertising for prescription medicines continues to be prohibited. The restriction on the advertising of most pharmacist only medicines should be retained while a review of the Schedule 3 Advertising Guidelines is undertaken (rec 53) • Requirements for advertising therapeutic products to the public are made consistent for all medicines and medical devices where appropriate (rec 54) TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 2
- 4. Review recommendations 52 to 58 cover advertising: • Vetting and pre-approval of advertising is stopped (rec 55) once other recommended consumer protections are implemented, including: – strengthened investigation and enforcement powers (rec 57) and – an improved complaints management process • Current mechanisms for managing complaints are disbanded and a new mechanism is established with a single agency responsible to receive and manage complaints (rec 56) • A formal sponsor education program to assist with compliant advertising is implemented (rec 58) TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 3
- 5. Australian Government Response to the Review Released on 15 September 2016 • Removal of pre-approval requirements could help reduce unnecessary complexity for sponsors and advertisers, and is consistent with the Government’s commitment to minimising unnecessary regulatory burden. • Broadening enforcement powers will benefit consumers by appropriate compliance with advertising regulatory requirements, and deter inappropriate and misleading advertising of products. • The Department of Health will consult with stakeholders on the appropriate design of the new complaints-management process. • Developing education programs to assist sponsors and advertisers in understanding their obligations will be particularly important once the reforms to the advertising regulatory framework are in place (particularly the removal of pre-approval requirements). TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 4
- 6. Public consultation on advertising framework 9 Nov - 21 Dec 2016 TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 5
- 7. Stakeholder responses to the consultation • 59 submissions received – mixed views • Almost unanimous agreement for single complaints handling agency • ACCC, AHPRA, the majority of healthcare professional bodies and many industry associations and companies indicated preference for TGA managing complaints • Some stakeholders supported an independent non-Government Authority being responsible for managing all advertising complaints • A smaller number of stakeholders favoured self regulation or regulation by the ACCC • Submissions not marked as confidential are now available on the TGA website TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 6
- 8. Handling of advertising complaints Government announcement - 10 July 2017 • The TGA will take on the role of the single body responsible for handling advertising complaints from 1 July 2018. • The TGA will develop and implement new arrangements to simplify and improve the handling of complaints about the advertising of medicines and medical devices to the public. • This reform will be externally reviewed after three years to confirm that it is delivering the intended benefits and meeting community expectations. TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 7
- 9. Public consultation on sanctions & penalties 1 May - 29 May 2017 TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 8
- 10. What amendments were proposed in the consultation • Trigger the Regulatory Powers (Standard Provisions) Act 2014 (RPSPA) in relation to monitoring, investigation, infringement notices, and injunctions • Modify RPSPA powers to maintain existing monitoring and sampling powers • Maintain the current power to enter any premises without warrant and seize goods to avoid imminent risk of death or serious injury or illness (s. 46B) • Introduce substantiation notices and public warning notices for suspected contraventions of the advertising provisions • Standardised strict liability offences • Reduce penalties for strict liability offences to achieve a workable infringement notice scheme • Remove the ‘harm’ element from strict liability offences, and • Strengthen existing aggravated criminal offences TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 9
- 11. Stakeholder responses to the consultation • 9 submissions received: – 6 from peak industry bodies and – 3 from sponsors of complementary medicines • Most peak industry bodies broadly supported enhancing sanctions & penalties • One peak industry body and two individual sponsors were either not supportive or were cautiously supportive about incorporating the RPSPA provisions TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 10
- 12. Next steps • The TGA will continue to focus its attention on the successful implementation of the Review recommendations for advertising and sanctions and penalties. • A consultation on the Therapeutic Goods Advertising Code is anticipated to commence in August 2017. • Implementation of a sponsor education program – early 2018 • The TGA is working towards implementing all of the discussed recommendations implemented by 1 July 2018 – subject to legislation. • Further information will be provided on the TGA website as it becomes available. TGA’s new arrangements for handling complaints and the results of our public consultation on sanctions and penalties 11
Editor's Notes
- I’m here today to update you on the reforms to the therapeutic goods advertising framework that have arisen from the Expert Panel Review of Medicines and Medical Devices Regulation.
- The independent review of medicines and medical devices regulation was announced on 24 October 2014. The Review examined Australia's medicines and medical devices regulatory framework and processes with a view to identifying: areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods. The Review was conducted in 2015 by a panel of three independent experts: Emeritus Professor Lloyd Sansom AO, Mr Will Delaat , AM and Professor John Horvath AO. The Report of Stage one of the Review was released in June 2015 and covered recommendations on the regulatory frameworks for medicines and medical devices. The second report (Stage two ) was released on 31 July 2015 and addressed the regulatory frameworks for complementary medicines and the advertising of therapeutic goods
- Recommendation 52 The Panel considered that, given the limits on pre-market assessment for low-risk products, controls on advertising under the legislative framework for therapeutic products provide an important assurance that consumers have access to accurate information in making health care choices. The Panel also noted that the use of a regulatory underpinning for advertising controls is consistent with the approach taken in other comparable countries such as the UK, Canada and the US (even if administered in a variety of ways). The Panel noted that while stakeholders had expressed a range of views about the features, processes and administration of the advertising framework for therapeutic products, the embedding of controls on advertising and compliance in legislation is widely supported. Recommendation 53 The Panel accepts the view widely expressed by consumers, health professionals and industry, that allowing direct-to-consumer advertising of prescription medicines is not in the public interest. As such, they recommended no changes be made to the prohibition on advertising prescription medicines to the public. My colleague, Mark, will speak more of the review currently underway in to the advertising of Schedule 3 medicines. Recommendation 54 The Review Panel noted that there are a number of inconsistencies in the current advertising framework between the requirements for medicines and those for medical devices and considered that these inconsistencies should be addressed whereever possible. This includes the requirements for advertising pre-approval.
- Recommendation 55 The Panel recommended that the whole process of vetting and pre-approval of the advertising of therapeutic products to the public is stopped in favour of a more self-regulatory regime, subject to the implementation of other recommendations that would provide additional consumer protections and confidence. Recommendation 56 The Panel recommended that the current mechanisms for managing complaints are disbanded and a new mechanism is established consistent with best practice principles for complaint handling. In establishing the new complaints management mechanism, a single agency should be responsible to receive and manage complaints on the advertising of therapeutic products to the public. The Government should consider the following options: Establishing the function within the [TGA] or other existing Commonwealth agency and ensuring appropriate resourcing for the function; or Calling for tenders from external organisations to undertake the function. Recommendation 57 The Panel recommended that consideration be given to whether the current range of investigation and enforcement powers should be broadened. Recommendation 58 The Panel recommended that the TGA facilitates the development of a formal sponsor education program to provide industry and industry associations with appropriate information and tools to assist them in achieving compliance with advertising requirements under the regulatory framework
- Following extensive consultation with stakeholders including consumers, healthcare professionals and industry, the Government, for the most part, supported the recommendations of the Review of Medicines and Medical Devices Regulation. Of the Review's 58 recommendations, 56 were supported by the Government. The majority of these recommendations were supported in full, while for some, the Government supported the intention of the recommendation but proposed to implement them in a different manner to that suggested by the Review. In relation to advertising the Commonwealth accepted Recommendation 52 to 58 noting that: stakeholders strongly supported continuing to regulate advertising of therapeutic goods to the public within the therapeutic goods regulatory framework the issue of advertising of Schedule 3 (Pharmacist only) medicinal substances will be considered as part of a review of the Scheduling Policy Framework (Recommendations Eleven and Twelve). increasing consistency of approach could help reduce complexity for advertisers, however the differences between medicines and medical devices means that consistency may not be appropriate in particular the acceptance of Recommendations Fifty-Seven (enforcement powers) and Fifty-Eight (sponsor education) is critical for managing potential concerns by consumers and healthcare professionals in accepting this recommendation, removal of pre-approval requirements could help reduce unnecessary complexity for sponsors and advertisers, and is consistent with the Government’s commitment to minimising unnecessary regulatory burden. A single agency approach to complaints management has the potential to reduce complexity and encourage greater consistency in decision-making, benefiting consumers. To progress this recommendation, the Department of Health will consult with stakeholders on the appropriate design of the new complaints-management process. broadening enforcement powers will benefit consumers by appropriate compliance with advertising regulatory requirements, and deter inappropriate and misleading advertising of products. developing sponsor education programs to assist sponsors and advertisers in understanding their obligations will be particularly important once the reforms to the advertising regulatory framework are in place (particularly implementation of Recommendation-Fifty-Five).
- The Government had agreed to simplify the processes by which the advertising of therapeutic goods to the public is regulated. This includes the process for managing complaints about therapeutic goods advertisements directed to the public. The purpose of the consultation was to provide an opportunity for interested parties to provide their views on the appropriate body or bodies for the handling of complaints under the design of a new centralised advertising complaints management-process and other recommended reforms to the advertising regulatory framework. That is, the preferred design of the new advertising complaints handling process and whether it should be performed by the TGA, another Commonwealth agency or outsourced to an external service provider.
- As expected stakeholder views were mixed on who should handle complaints about advertisements directed to the public but they were almost unanimous in their agreement that there should be a single agency to undertake this function ACCC, AHPRA, the majority of healthcare professional bodies and many industry associations and companies indicated preference for TGA managing complaints, on the basis that it would be wasteful to build the technical medical, scientific and legal capacity in a second organisation and that it would streamline compliance and enforcement powers. Some stakeholders supported an independent non-Government Authority being responsible for managing all advertising complaints. All submissions that were not marked as confidential are now available in PDF format on the TGA website
- Stakeholders have identified that the advertising arrangements needed to be improved and simplified. The decision to consolidate all complaints about the advertising of therapeutic goods to the public within the TGA will address many of the criticisms made about the current disjointed arrangements. The current complaints handling arrangements are complex for consumers and businesses to navigate and often do not deliver timely or consistent decisions. Complaints can currently be considered by the Complaints Resolution Panel, multiple industry associations and the TGA depending on the type of product and the medium in which the advertisement appeared. The effective handling of complaints is essential in enabling the advertising of therapeutic goods to comply with legislative requirements, be socially responsible and assist in delivering good health outcomes. A timely response to advertising complaints benefits the Australian community by helping consumers to avoid both wasting money on therapeutic goods that will not help them and, more importantly, not seeking medical attention when they really should. The simplified and improved advertising complaints arrangements will benefit advertisers, health professionals and consumers by providing, through the TGA, a single body for lodging, handling and reporting on the final outcome of their complaint and will help deliver consistent decision-making, compliance and enforcement outcomes.
- To seek stakeholder’s views on proposed legislative reforms to ensure the Act provides for an effective layered approach to compliance and enforcement. The proposed amendments will provide us with an expanded suite of possible regulatory actions to address the severity of a compliance breach. The ultimate objective is to ensure that regulatory actions are proportionate with the risk that the therapeutic goods pose and to address any potential health and safety issues to the Australian public. Some of the proposed amendments directly relate to the Government’s response to the Expert Panel’s Review such as the introduction of substantiation notices and public warnings in relation to advertising non-compliance. Other amendments from the Review will enhance sanctions and penalties and introduce the ability to seek an injunction to rapidly address serious cases of noncompliant advertising of therapeutic goods. Other proposed amendments intend to give further clarification to the 2006 amendments with changes to strict liability offences and the infringement notice regime that are consistent with contemporary Government policy. All these measures will align the Act with regulatory provisions comparable to other Commonwealth regulators ensuring that we will have the right tools to effectively address noncompliance with appropriate and effective risk-based graduated responses in a timely manner.
- The proposed enhanced enforcement powers are consistent with those previously put forward in a Consultation Regulation Impact Statement (RIS) on the Advertising Regulatory Framework that was released by the TGA in 2013, and in further stakeholder consultation undertaken directly resulting from the Government’s response to the MMDR Review in late 2016. Some of the proposed amendments directly relate to the Government’s response to the Review such as the introduction of substantiation notices and public warnings in relation to advertising non-compliance. Other amendments from the Review will enhance sanctions and penalties and introduce the ability to seek an injunction to rapidly address serious cases of non-compliant advertising of therapeutic goods. Other proposed amendments intend to give clarification to the 2006 amendments with changes to strict liability offences and the infringement notice regime consistent with contemporary Government policy. These measures will align the Act with comparable Commonwealth regulators ensuring the TGA will have the right tools to effectively address non-compliance with appropriate and effective risk-based graduated responses in a timely manner. Proposed amendments to the Therapeutic Goods Act 1989 (will provide for a more effective approach to enforcement by tailoring regulatory action to the severity of the compliance breach, consistent with whole of government policy. The proposed amendments will: • Trigger the Regulatory Powers (Standard Provisions) Act 2014 (RPSPA) in relation to monitoring, investigation, infringement notices, and injunctions; • Modify RPSPA powers to maintain monitoring powers in premises occupied by TGA regulated entities and maintain existing sampling powers during compliance monitoring; • Maintain the current power to enter any premises without warrant and seize goods to avoid imminent risk of death or serious injury or illness (s. 46B); • Introduce substantiation notices and public warning notices for suspected contraventions of the advertising provisions in the Act; • Standardised strict liability offences in the Act, reduce penalties for strict liability offences to achieve a workable infringement notice scheme; • Remove the ‘harm’ element from strict liability offences in the Act; and • Strengthen existing aggravated criminal offences in the Act.
- The consultation paper gained some media attention, and remained open for comments until 29 May 2017. The three respondents that did not embrace incorporating the RPSPA provisions were of the view that penalties in the Act should not exceed those available to the Australian Competition and Consumer Commission (ACCC), or that non-compliance with advertising should be a matter for the ACCC. TGA notes in response that: • The ACCC has advised that it considers TGA, as a specialist safety regulator, to be best placed to manage therapeutic goods advertising complaints, due to TGA’s specialist technical expertise and broader regulatory role; • Stakeholders were not yet aware of the Government’s position that TGA is to be the single advertising complaints handling body as this has not been publicly announced; at the time • The penalties proposed for advertising non-compliance will equal those already in the Act for contraventions of other regulatory requirements; • The current ACL review has recommended much higher maximum penalties for consumer law breaches • Some industry concerns were based on misunderstandings, such as that TGA retains money from fines levied under the Act (in fact these monies are paid into Consolidated Revenue).
- The implementation of the advertising review recommendations require changes to the TG Act and Regulations. As such, implementation is dependent on the successful passage of Act changes through Parliament and the approval of new regulations. A revised and more objective Code will be needed to support the enhanced sanctions and penalties. The current Code is largely principles based and a number of stakeholders (in response to the consultation) indicated that it needed to be updated to make it more objective. Clearer requirements will make it easier for advertisers to ensure that their content complies with the requirements. Watch the TGA website for news of a consultation on issues with, and possible changes, to the Code.