PERTH, Australia – Industry stakeholders in Australia welcomed the Senate passage of the drug and device reforms contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 last week.
Approved by Australia's House of Representatives on March 27, the bill will now go to the Attorney General to be signed off as law. The bill is the first of three expected to make it through Parliament that will overhaul the nation's drug and device regulations.
The government has committed to implementing the reforms in a staged approach over the next two years, with a second bill covering further reforms expected to be introduced later this year.
Overall, the reforms stress a systems-based approach that focuses on long-term sustainable goals to both increase access to therapies and remove unnecessary regulatory burdens for industry. Among the reforms are new pathways that allow for earlier access to drugs and devices. (See BioWorld Today, Sept. 20, 2016.)
Bringing products more quickly onto the Australian market will be achieved, in part, by greater use of approvals by comparable overseas regulators like the U.S. FDA and the EMA. Under the current regulatory structure, Australian patients have to wait up to 15 months longer than the U.S. and Europe to access breakthrough medicines.
The move also brings Australia in line with other international regulators.
Regulatory reforms were especially needed since plans to form a joint "Australia New Zealand Therapeutic Products Agency" fell apart almost a decade ago. When those negotiations were put on hold, the Australian government agreed to introduce reforms to the TGA.
To make that happen, the government commissioned an independent review panel in October 2014 to examine Australia's drug and device regulatory framework to identify areas that were duplicative or ineffective, and to look for opportunities to position Australia to be more globally competitive.
Numerous industry consultations were held over the last two years, and the government signed off on the majority of the 58 recommendations made by the review panel.
Health Minister Greg Hunt told the Senate Standing Committee on Community Affairs that the bill would support the implementation of eight key recommendations of the Expert Review of Medicines and Medical Devices Regulation.
"These recommendations aim in particular to enable faster access to important new medicines and medical devices for Australian patients, as well as to streamline administration and reduce regulatory burden in several areas," Hunt said.
Some of those streamlined processes would replace the need for pre-approval with notifications for some variations to products that do not affect product safety and would lower costs to industry and, potentially, consumers through decreased TGA fees, he said.
AusBiotech said in its comments to the Senate committee that the reforms are expected to provide industry with annual savings of around A$75 million (US$57 million) by reducing unnecessary red tape and regulation on the drug and device industries. The association that represents biotechnology companies in Australia said it has been pushing for those reforms for more than a decade.
"Priority review of medicines that offer substantial benefits over existing therapies or which address high unmet clinical needs for Australian patients will reduce registration working days by almost half," the association said in its submission. It also stressed that more efficient Special Access Schemes for patients would also mean a "life-saving difference."
The bill also enhances patient safety by collecting more postmarketing safety and efficacy data from sponsors to provide more information about new medicines approved under an expedited pathway.
AusBiotech CEO Glenn Cross told BioWorld Asia that the association is "strongly supportive of the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, which will help reduce costs and administrative burden for industry, while ensuring safety and quality for patients."
Medical Technology Association of Australia (MTTA) CEO Ian Burgess said the association welcomed the passage of the new bill, particularly "the decision for greater use of overseas assessment to fast-track access to innovative and life-saving products, without compromising the integrity and safety of medical devices in Australia."
MTTA member companies are mostly small-to-medium sized companies that "complain about the avoidable red-tape, [and] this bill will go to streamlining the regulatory burden," he added.
The Australian Dental Association (ADIA) also praised the bill and the anticipated reduction in bureaucratic red tape. "ADIA has been a strong proponent for these reforms that will reduce the costs associated with conformity assessment," said ADIA CEO Troy Williams.
"This is a significant reform that's long overdue and we congratulate the commitment of the Australian Government to making the changes necessary to reduce the complexity of obtaining market approval for new and innovative patient diagnostic and treatment options," Williams said.
Seeking comment on expedited pathways
The TGA is working on the next rollout of reforms that outline two separate expedited pathways.
The provisional approval pathway would allow sponsors to seek a time-limited provisional registration of certain medicines that don't meet full clinical data requirements, where the potential benefit of earlier availability outweighs the risk that additional data are still required.
The priority review pathway would involve faster assessment of certain prescription medicines that meet the TGA's full data requirements, with a target time frame of 150 working days for an approval decision. The provisional approval pathway, meanwhile, would be supported by broader reforms to develop more comprehensive postmarket monitoring for drugs and devices.
"The objective of the provisional approval pathway is to allow certain promising new medicines to reach patients with unmet clinical needs earlier than might otherwise be the case, while ensuring appropriate measures are in place to manage the risks inherent in the fact that additional data are still required," the draft guidance says. The pathway could allow medicines to reach Australian patients up to two years earlier than under the current framework.
The provisional approval pathway would involve four separate phases: A designation process where sponsors would apply for the expedited pathway; a premarket registration process whereby sponsors would submit a registration application and supporting dossier; a postmarket requirement in the provisional registration period; and a lapsing or transition to full registration. The TGA said it might allow rolling submissions that would be decided on a case-by-case basis. (See BioWorld Today, May 3, 2017.)