The 29 page response - titled TGA Reforms: A Blueprint for the TGA's Future [PDF] - follows seven formal reviews and consultations -
• the Auditor-General's report on Therapeutic Goods Regulation: Complementary Medicines noted hereImportantly, the response does not address the Regulatory standards for the approval of medical devices in Australia report by the Senate Community Affairs Reference Committee (tabled 22 November 2011). A response to that document is scheduled for the first half of 2012.
• the review to improve the transparency of the Therapeutic Goods Administration
• public consultations on the regulatory framework for advertising therapeutic goods
• an informal working group examining the regulation of complementary medicines and reasons for low compliance rates
• public consultations on the medical devices regulatory framework
• the Working Group on Promotion of Therapeutic Products
• the Health Technology Assessment Review.
Promotion of the response is traditional, with the TGA for example stating that -
The Government's response takes into account submissions made by stakeholders, and draws this work together into a comprehensive package of reforms that will be progressed in stages.The response states that -
The reforms will enhance the regulatory framework, ensuring that it remains adaptable to new scientific developments and emerging community expectations.
They will also 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 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.The response explains that "The reviews were undertaken as part of the commitment to open government". Regrettably, there needs to be more than openness. Despite the invocation of the seven reviews/consultations the response is a tacit admission that the regulatory cupboard is bare. We need to do more to address systemic problems in health administration.
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.
The TGA remains an inward-looking organisation that faces substantive questions about its procedures, recruitment (and consequent expertise) and commitment to a timely, informed and sustained engagement with health problems. It should be of fundamental concern that the ACCC rather than TGA addressed concerns regarding notorious scammer Peter Foster. Handling of hip implants and other devices should also be of major concern, given the impact on individuals and on the overall community through litigation, insurance costs, productivity and pain.
The critique by Ken Harvey of La Trobe University is cogent and commended. The TGA may well endorse the response through its statement that -
The reforms will enhance the regulatory framework, ensuring that it remains adaptable to new scientific developments and emerging community expectations.As things stand the TGA has committed to a public outreach campaign but trust will remain in doubt until more meaningful changes are made at the agency and legislative levels.
They will also 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.
