AusBiotech 2012: Future of health care depends on reforming regulators

The pharmaceutical regulators require a radical overhaul if the health care industry is to lower costs and cope with increased demand in the future, said Dr Richard Barker, Director of the Centre for Accelerating Medical Innovations at Oxford University, speaking at the AusBiotech 2012 conference in Melbourne today.

Barker highlighted the “innovation gap” in the health care industry, which is the result of health and medical research blooming over the past decade while the number of therapeutics reaching the market each year has been declined.

The cause of this growing gap has been the decline of the blockbuster model pursued by major pharmaceutical companies over the last few decades, he said.

However, patent expiry, the evolving science behind the latest generation of therapeutics and a more strict regulatory environment have all worked to drive investment away from health R&D.

“For the first time in living memory we are seeing reductions I total pharma R&D spend,” he said in his plenary address at the official opening of the conference.

A leading cause has been the strictures of the regulatory environment imposed by the likes of the Food and Drug Administration in the United States, the European Medicines Agency and the Therapeutic Goods Administration here in Australia.

Barker claimed that the regulators have exercised an overly risk-averse strategy, particularly since the Thalidomide crisis in the 1960s.

They currently employ “asymmetric” safety-biased criteria, whereby there is little cost to the regulators of preventing a potentially lifesaving drug to enter the market compared to the cost of allowing a risky drug to be approved.

He claimed this trend is predicated on the assumption that new therapeutics will be prescribed by general practitioners to a broad population. As such, drugs that are not suitable for the entire population tend to get rejected.

This has substantially raised the bar for getting a new therapeutic approved for sale in terms of cost and risk.

“Regulatory uncertainty and reimbursement concerns” are driving away investors and venture capitalists, Barker said.

Barker suggested a new flexible model should be introduced, whereby therapeutics are given conditional approval for use in selected populations of people based on the ever-growing understanding of biomarkers and personalised medicine.

Further confirmatory trials can then be conducted to widen the application of the therapeutic and to demonstrate its safety and efficacy in a wider population.

Barker claimed that such an approach could enable new therapies to reach the market sooner, substantially improving health outcomes and saving both governments and private health insurers substantial sums of money, as well as buoying the biotechnology industry, thus leading to further investment and new therapies.

He stressed that the solution requires a multidisciplinary approach, incorporating input from patients, research institutions, biotechnology companies, private investors, the regulators and governments.

“This problem is a societal problem, not a problem that the industry has to solve, or a just problem with the regulators,” he said. “We must approach it as a major societal problem for the 21st century.”

Barker spoke at the opening of the AusBiotech 2012 conference, which runs from today through to Friday in Melbourne.