Australian Prime Minister Tony Abbott began waging a war against red tape, even launching a website dedicated to the notion. The deregulation of the country’s medical device and pharmaceutical industries has been included in that broader initiative, which would help Australia save money as regulatory burden clearly contributes to the ultimate cost of medical products. Abbott’s government is seeking to reform its regulatory body, the Therapeutic Goods Administration (TGA), which oversees both drugs and devices, which could give patients there quicker access to life-saving drugs and devices.
As part of Abbott’s red-tape slashing scheme, the Australian government is considering green-lighting medical devices or pharmaceuticals for sale in the country based on their regulatory approval in, say, Europe or the United States. Early this year, Medicines Australia, a local trade association, released a statement supporting the idea, embracing the government’s intent to “to ensure Australians can access the latest treatments in a timely manner.” For devices where international regulatory agencies have a difference of opinion concerning their safety, TGA could reserve the right to independently review the products.
Still, the idea of marketing products in Australia based on the conformity assessment certifications from European notified bodies has been criticized by some. The CE Mark system primarily weighs the safety of medical devices while the FDA regulatory standard relies on safety and efficacy. The Consumers Health Forum, an Australian-based independent organization, also questioned the notion of “off-loading [regulatory oversight of medical products] to ‘trusted overseas regulators.’" The organization said it "would dumb down Australia’s capacity to determine which new drugs should come to this country.” In addition, the forum stated that this approach would also hurt the ability of Australian regulators to deal with adverse events related to medical goods.
Another complication is the continual disparity of regulatory systems across the globe—most notably between Europe’s CE Mark system and the FDA’s. The disparity between those two systems, along with the observation that many medical devices hit the market in Europe years earlier than they do in the United States, led FDA's medical device chief, Jeffrey Shuren, MD to publicly criticize the CE Mark system in 2011. Shuren proclaimed that European patients were treated as medical device “guinea pigs,” and questioned the CE Mark’s systems ability to keep European patients safe. He noted that several products that were marketed in Europe but not in the United States were later yanked from the European marketplace after safety concerns arose.
Shuren’s viewpoint perhaps became somewhat controversial following the increasing fallout from the Poly Implant Prothèse (PIP) breast implant scandal, which ultimately is contributed to CE Mark reform.
In any event, the issue is not as straightforward as it may seem. While it is true that speeding the approval of drugs and devices would give some patients earlier access to lifesaving treatments, other patients may suffer unintended consequences from novel drugs or devices. Still, it is an impossibility to completely remove risk from the regulatory process. While it is not optimal to make any patients be guinea pigs for untested drugs or devices, at present, there remains no foolproof way to test them beforehand to fully guarantee either their safety or their efficacy.
In addition, with the regulatory barrier to entry in Australia going down, the conditions for innovation could be created, potentially attracting the attention of forward-looking startups and investors.
