Dental Regulation Projects — Promotion of therapeutic goods 

The Australian Dental Industry Association (ADIA) has been working with the Australian Government to review options to improve the framework for the promotion of therapeutic goods, including dental product.    On 30 June 2010, the Government released a Position Paper on Promotion of Therapeutic Goods which proposed strengthening self-regulation and called on the therapeutic goods industry to develop common high-level principles as the basis for strengthening and aligning its codes of conduct.

ADIA was invited by the Parliamentary Secretary for Health and Ageing to nominate a representative to a working group established to develop a framework of high level principles, in consultation with healthcare professional and consumer representatives, to support consistent ethical standards.  In March 2011, the working group completed its deliberations and presented its report to the Australian Government which, in turn, published its response in December 2011.

Key documents —
    Australian Government Position Paper — Promotion of therapeutic goods [PDF]
    Australian Government Policy Response — Promotion of therapeutic goods [PDF]
    ADIA Media Release — Promotion of therapeutic goods [PDF]

ADIA has maintained a policy position that allows the Australian Government to achive the desired policy objectives while at the same time freeing the dental industry from an unnecessary regulatory burden.

The impact of the proposed framework drafted by the working group would have required ADIA to amend its code of conduct to more closely resemble the codes already in place across the therapeutic goods sector, such as medicines. In this environment, the various rewards / privileges programs offered by ADIA members would have had to have been severely curtailed as would other marketing and promotional tools, such as free gifts to clients.  However, as a result of ADIA's policy advocacy at a departmental and parliamentary level, the dental industry secured several important outcomes including the ability to identify what product types may / may not be incorporated in the new arrangements and also retain a commitment to the self-regulatory model (as opposed to government regulation, the Australian Government's other option).  Further, the Australian Government's policy response accepts that the dental industry will need a long transition period to adopt the new arrangements given that cultural change is required.

Australian Government's Policy Response —

In announcing its response, the Australian Government restated its preference to maintain an emphasis on self-regulation and strongly supports industry’s initiative to harmonise their codes of conduct to incorporate the working group’s high level principles. The inclusion of these high-level principles into industry specific codes of conduct is a continuing process and the Australian Government will consider the feasibility of establishing a committee to evaluate the work of industry bodies.  Further changes will be considered if it is found that there is a need to provide greater encouragement to non-members of industry associations to nominate and sign up to an appropriate industry code, including the Therapeutic Goods Administration (TGA) seeking notification of a sponsor’s nominated code of conduct at the point of including a product on the ARTG.  The following list some of the Australian Government's key decisions.

Policy Outcome:  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.

Policy Outcome:  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.

Policy Outcome:  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.

Policy Outcome:  The Australian Healthcare Practitioner Regulation Agency (AHPRA) and Australian Health Ministers Advisory Council (AHMAC) be encouraged to advocate changes to health professional codes, including those for dentists and allied oral healthcare professionals, to more closely reflect the mutuality of obligations between industry and healthcare professionals, to ensure ethical promotion of therapeutic products.

Policy Outcome:  The healthcare professional colleges and associations, including the Australian Dental Association (ADA) and allied professional groups within the dental and oral healthcare sector, actively pursue alignment of their professional codes and / or guidelines to be consistent with the principles and areas of operational coverage.

Policy Outcome:  Education on relationships with the therapeutic industry be included in the training of healthcare professional students, including dentists and allied oral healthcare professionals, in addition to education on the healthcare professional codes and guidelines.

Policy Outcome:  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.

ADIA supports these policy outcomes and has given in-principle support to the revision of the ADIA Code of Practice to reflect the high-level principles which will be common across the Australian healthcare sector.  One option under consideration is the adoption, either whole or in-part, of the joint Medical Technology Association of Australia (MTAA) / Medical Technology Association of New Zealand (MTANZ) code of practice in order to achieve the Australian Government's long-term objective of harmonised codes across the entire therapeutic products industry.

As the implementation of the policy progresses, ADIA is working to ensure that the arrangements are transparent, readily understood by key stakeholders and maintain an even playing field. ADIA has been a strong advocate for a policy that recognises that therapeutic goods differ in nature and that it may not be practical, indeed desirable, for all therapeutic goods to be grouped together for purposes under the code. ADIA’s position is that the high-level principles should directly address practices that potentially could have an impact on patient outcomes.

Given the shared interests that the dental industry and dental professionals have on this issue, ADIA has written to the ADA highlighting the issues and, in so doing, has proposed a joint working group to look at how changes to the promotion of therapeutic goods may impact on the relationship between a the dental industry and dental profession.

ADIA’s work in this area is being undertaken by the ADIA-DRC Dental Regulation Committee.

To keep up to date with changes on this issue follow ADIA on Twitter @AusDental or contact the ADIA National Office via email at dental.regulation@adia.org.au or by telephone on 1300 943 094 (internationally on +61 2 9319 5631).