Consultation on regulatory reforms for therapeutic goods

Overview

The TGA has recently completed stakeholder consultations on a number of regulatory reforms proposed for each therapeutic product sector. The consultations were not intended to re-open discussion on issues already considered and agreed as part of the reforms to be adopted when establishing the joint Australia New Zealand therapeutic products regulatory scheme but to provide an opportunity for discussion of how these reforms are to be implemented in the Australian context.

Four consultation sessions were held at Parliament House, Canberra on the dates below:

All sessions were very well attended. The active involvement of participants contributed to the success of each session.

Introduction by the Parliamentary Secretary to the Minister for Health and Ageing

Each session was opened by Senator the Hon Jan McLucas, Parliamentary Secretary to the Minister for Health and Ageing, who outlined the Government's plans for reform in therapeutic goods regulation.

The Parliamentary Secretary emphasised the importance the Government places on reducing the burden of inappropriate, ineffective or unnecessary regulation while still achieving the objectives set out in the Therapeutic Goods Act (1989) (TG Act) of ensuring the:

• safety
• quality
• efficacy and
• timely availability

of medicines and medical devices to the people of Australia.

She then outlined the Government's broad areas of reform for therapeutic goods which includes:

• Legislative amendments deferred in anticipation of the joint regulatory scheme with New Zealand
• Opportunities for reducing regulatory burden
• Increasing the transparency and availability of consumer information
• Enhancements to post-market monitoring, and
• Future directions for reform.

The consultations did not cover reforms to regulation of the advertising of therapeutic goods or the scheduling of medicines and poisons.

Discussion of key reform areas

Following a presentation by a senior TGA executive, participants were able to ask questions and seek clarification on the issues raised.

Discussion was facilitated by Dr Rohan Hammett, TGA's National Manager, on the key areas of reform for each of the product sectors. He outlined for participants the way ahead to progress these reforms. Legislative changes in general have to pass a clearance process and be included in the Government's drafting priorities, to be assured of consideration at a particular sitting of Parliament. Practically this means that while some changes to the TG Act have already been tentatively scheduled for consideration in the spring 2008 sittings, others may be delayed depending on Government priorities. The TGA is working to have the remaining legislative changes ready for introduction into the Parliament by mid to late 2009.

The reforms common across all product sectors include:

• Low Volume/Low Value Exemptions (LVLV)
• Default standards
• Export scheme (medicines)
• Product licences
• Infringement notices
• GMP fees and charges
• Improved access to information
• Improved arrangements for statutory committees
• Pharmacovigilance framework and establishment of the "Medicines Safety Committee"
• "Fit and proper person"
• Suspension from Register
• GMP sampling provisions
• Good distribution practice
• Clinical trials

Further information on the discussion of these and the sector specific reforms can be found at:

• Reforms common to all product sectors
  <http://www.tga.gov.au/regreform/common.htm>
• Prescription medicines (discussion summary & presentation)
  <http://www.tga.gov.au/regreform/pm.htm>
• Complementary medicines (discussion summary & presentation)
  <http://www.tga.gov.au/regreform/cm.htm>
• Over-the-counter medicines (discussion summary & presentation)
  <http://www.tga.gov.au/regreform/otc.htm>
• Medical devices (discussion summary & presentation)
  <http://www.tga.gov.au/regreform/md.htm>

The discussion summaries should be read in conjunction with the corresponding presentation.

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