TUNNEL down deep enough into the 2016-17 Budget papers and a couple of health care nuggets emerge, buried under the increases to the tobacco excise, the Health Care Homes trial and the Healthier Medicare package.
One such shiny morsel is the $20.4 million to be poured into improving the regulation of therapeutic goods in Australia, which will be spent via the Therapeutic Goods Administration (TGA) from 2016–2017 to 2019–2020.
The measure is a response to the Sansom review (Expert panel review of medicines and medical devices regulation) which reported to the government back in July 2015 with a list of 58 recommendations.
MJA InSight understands that the Minister for Health, Sussan Ley, will make a formal response to the Sansom review in the near future, but for now, stakeholders in the health sector must make do with the few details in the Budget papers.
The $20.4 million for regulatory reform will mean that new cancer drugs will enter the market sooner “through new provisional approvals and making greater use of overseas assessments”. New medicines and devices will be approved faster in “certain circumstances” based on criteria “to be developed in consultation with consumers, health professionals and industry”. Advertising regulations will be standardised across medicines and devices, with the TGA powers strengthened.
Other measures include:
- Assessment times will be reduced by up to 3 months through the use of work carried out by comparable overseas regulators.
- There will be greater focus on post-market reporting, including enhanced electronic reporting and a risk communication strategy.
- Commercial bodies approved by the TGA will be allowed to undertake medical device assessments.
- A catalogue for approved ingredients and permitted indications will be established for use by sponsors and others.
- Sponsors will be able to add medicines and medical devices to the Australian Register of Therapeutic Goods through new approval pathways. The scheduling policy framework will be reviewed in consultation with state and territory governments.
- The government will reduce the number of statutory advisory committees that provide independent expert advice to the TGA from 11 to seven. The new committees will advise on medical, chemical and scientific matters, market approval of new therapeutic goods and product safety issues.
- Appointment of new membership and expert advisors will be made with consideration to requirements for technical expertise and stakeholder representation.
- Pre-approval will be introduced under the Special Access Scheme (Category B) for low-risk products such as those that have specific and well-established patterns of use for patients with a non-terminal condition.
- Changes to design and information technology systems will be drawn from reserves in the TGA Special Account. An increase in TGA fees and charges will not be required.
Professor Ken Harvey, Adjunct Associate Professor in the School of Public Health and Preventive Medicine at Monash University, told MJA InSight that “the devil will be in the details”.
There was no question that “problems of regulatory non-compliance of listed medicines continue”, he said.
In the complementary medicines category, the TGA undertook post-marketing compliance reviews for 330 listed products between January 2015 and February 2016, Professor Harvey said in a personal communication.
Of those products, 208 were picked at random for review and 66% of them were non-compliant; of the remaining 122, targeted as a result of complaints or referrals, 87% were non-compliant, he said.
“So there is certainly a need for enforcement and compliance powers to be strengthened,” Professor Harvey told MJA InSight.
Another Budget nugget – the consolidation of funding for Commonwealth Medical Internships, which will provide 100 additional internships – drew praise from the Australian Medical Students’ Association (AMSA).
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“This is a positive step given the internship crisis is set to continue, with domestic medical graduates in South Australia projected to miss out on internships beginning in 2017,” Elise Buisson, president of AMSA, said in a statement.
There is more to be done, she said. “The next step is to support funding for rural positions for doctors in training so these interns can be retained in rural Australia.
“Rural training positions would bring more young doctors and their families to rural Australia. This directly creates new jobs in these areas and provides rural Australia with increased access to the general physicians and medical specialists they need,” Ms Buisson said.