UPDATED GENE TECHNOLOGY REGULATIONS

Australia’s regulations on gene technology are being updated to clarify the regulatory status of new genome editing techniques.

 

Minister for Regional Services, Senator Bridget McKenzie, today announced on behalf of the Legislative and Governance Forum on Gene Technology that amendments had been made to the Gene Technology Regulations to make the legal position of genome editing clearer.

 

Following extensive consultation, this approval was made through the Forum, which is chaired by Minister McKenzie.

 

“Rapid technological developments in recent years have led to uncertainty about which techniques are considered gene technology in Australia”

 

The amendments mean that SDN-1 techniques that pose no different risks, and cannot be distinguished from conventional methods, do not require unnecessary regulation.

 

“Clarifying the regulations will allow health and medical researchers to be confident that they are meeting regulatory requirements, so they can proceed with their research,” Minister McKenzie said. 

 

“The amendments will make it quicker and easier for medical researchers to do early proof of concept work and progress to clinical trials with patients. This includes working to identify genes involved in diseases.  

 

For example, cancer patients will benefit greatly from  Car-T Cell therapy where patient’s cells are extracted, reengineered in a purpose built facility and injected back into the patents body to attack and kill cancer cells. 

 

The changes complement the Prime Minister’s recent announcement to provide $105M co-investment from the Commonwealth to establish the Peter Mac Centre of excellence in Cellular Immunotherapy. The new centre will provide CAR-T cell therapy which boosts the body’s own immune system to fight cancer. The investment will support a new manufacturing facility specifically for cell therapies.

 

“The Liberal and Nationals Government stands with every Australian that is fighting cancer and through the responsible management of our economy, we have been able to deliver record funding to Medicare,” Minister McKenzie said.

 

“Our commitment includes a focus on cancer research through the $20 billion Medical Research Future Fund.

 

“We are serious about helping Australians tackle the insidious disease of cancer.”

 

Australia’s gene technology regulatory scheme is recognised as one of the best in the world, using the latest scientific evidence to inform decisions. The Regulator is an independent statutory office holder responsible for administering the Gene Technology Act 2000 (the Act) and corresponding state and territory laws.

 

The regulatory system is open and transparent. Public consultations and publication of information on the OGTR website are a required part of applications for approval of gene technology.

 

Further information is available on the Office of the Gene Technology Regulator website:

 

 

ENDS