Regulatory reform for therapeutic goods

The Government’s response to a series of recent reviews of the regulatory framework for therapeutic goods will deliver some much-needed reform, but many of the key changes that have been called for by industry, health professionals and consumers have either not been accepted by Government, or will be delayed by further consultation and regulatory reviews, says the Consumers Health Forum.

In December 2011, TGA Reforms: A blueprint for the TGA’s future (the Blueprint) was released, which provides the Government’s response to recent reviews of the transparency of the Therapeutic Goods Administration (TGA), complementary medicines regulation, advertising arrangements for therapeutic goods, medical device regulation and promotion of therapeutic goods to health professionals.

The Government’s positive response to some of the recommendations from these reviews – particularly around medical device regulation and consumer communication – is welcomed by consumers,’ said the CEO of the Consumers Health Forum of Australia (CHF), Carol Bennett.

‘We’re pleased to see that the Government has accepted some key recommendations – even if some areas of reform, including advertising of therapeutic goods and labelling of complementary medicines, will be subject to even more consultation before any changes can take place. Consumers must be key stakeholders in these consultations and in the implementation of the reforms,’ Ms Bennett added.

CHF is particularly disappointed that the Government has chosen to undertake further consultation on complementary medicines labelling, when it is clear that consumers should be informed these products are not tested by Australian authorities.

CHF is also disappointed that the Government has not supported a core recommendation of a Working Group (comprising industry, health professional and consumer representatives) to require that all sponsors listing products on the Australian Register of Therapeutic Goods must comply with an industry code of conduct. This is one of a number of recommendations from the Working Group that have not been supported by Government.

More recently, the CHF has restated its concerns in its submission to the Senate Community Affairs Committee (the Committee) Inquiry into the role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prosthese (PIP) breast implants (the Inquiry).

CHF’s submission makes six recommendations:

  1. CHF recommends that the Committee calls for the TGA to maintain a proactive public presence on safety issues of priority to consumers.
  2. CHF recommends that the Committee calls for the TGA to further improve transparency by sharing information about what is unknown, as well as what is known, and providing the public with information on timeframes for the gathering of evidence.
  3. CHF recommends that the Committee critically reviews the Government’s response to recent regulatory reforms, as outlined in TGA reforms: A blueprint for TGA’s future.
  4. CHF recommends that the Committee calls for the urgent implementation of the recommendations of the TGA Transparency Review, particularly those that relate to post-market surveillance and the management of adverse events.
  5. CHF recommends that the Committee calls for the urgent implementation of reforms to the medical devices regulatory framework.
  6. CHF recommends that the Committee calls for the urgent implementation of recommendations 13, 14 and 15 of the HTA Review, noting that this was also a recommendation of the Committee’s 2011 inquiry into the regulatory standards for medical devices.

Read the full CHF submission