Review of medicines and medical devices regulation commences with forum

A forum was held last week as the first step in the recently announced independent review of medicines and medical devices regulation. Attendees were advised that the review will commence with a discussion paper, which is expected to be launched by the end of the week, and the opening of the call for submissions.

The contents of the discussion paper are being developed from previous consultation submissions, including the Commission of Audit, and have five key themes:

• Duplication of regulatory processes
• Flexibility of regulatory frameworks (including cost recovery)
• Regulation requirements and risk
•  Regulatory process requirements
• Complexity of the regulatory framework

The review was announced following the October launch of the federal government’s ‘Industry Innovation and Competitiveness Agenda’ (IICA).

To reduce duplicative domestic regulation, the government said it will adopt the principle that if a system, service or product has been approved under a trusted international standard or risk assessment, then Australian regulators should not impose any additional requirements, unless there is a good and demonstrable reason to do so. This will reduce costs and delays for businesses, increase the supply of products into the Australian market and allow regulatory authorities to focus on higher priorities.

The IICA said as a first step, the government will enable Australian manufacturers of medical devices to register routine medical devices using conformity assessment certification from European notified bodies.

The review will examine the Therapeutic Goods Administration’s (TGA) regulatory framework and processes with a view to identifying:

• areas of unnecessary, duplicative or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia;
• opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

The scope of the review is set out in the Terms of Reference. The review has specific exclusions, such as reimbursement, ethics approvals for clinical trials and the level of fees charged by the TGA.

The review will be led by a panel of three experts:

• Emeritus Professor Lloyd Sansom AO (chair) is a distinguished educator, researcher and policy adviser who has sat on numerous government and industry advisory groups. Professor Sansom played a major role in the development of Australia’s National Medicines Policy and was Chair of the Pharmaceutical Benefits Advisory Committee between 2001 and 2012.
• Professor John Horvath AO was the Australian Government Chief Medical Officer from 2003 to 2009. He continues to advise the Department of Health as principal medical consultant and is on numerous health-related boards and committees, including the Prosthesis List Advisory Committee, which he chairs.
• Will Delaat AM has over 40 years’ experience in the pharmaceuticals industry in a range of roles. He was Managing Director of Merck, Sharp & Dohme (Australia/NZ) for 11 years to 2008 and the Independent Chairman of Medicines Australia until December 2011. Delaat is currently on the boards of a number of pharmaceutical companies including Pharmaxis and EnGeneIC.

The review panel will be consulting with health professionals, industry, consumers and other stakeholders to explore ways in which the government can reduce the regulatory burden in the regulation of medicines and medical devices administered by the TGA. The panel is due to report to the federal government by the end of March 2015.

More information on the review can be found here.