A spotlight on other reforms from the medicines and medical devices - - PowerPoint PPT Presentation

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

Medicines and Medical Devices Review (MMDR) Stage Two Report (Released July 2015)

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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)

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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)

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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).

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Public consultation on advertising framework 9 Nov - 21 Dec 2016

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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

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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.

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Public consultation on sanctions & penalties 1 May - 29 May 2017

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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
• f 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

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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
• r were cautiously supportive about incorporating the RPSPA provisions

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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.

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