The Australian: Cochlear boss rails at regulatory delays

MEDICAL innovation is being held back by suffocating legislation that results in long delays before products get regulatory clearance. Cochlear chief executive Chris Roberts will say in the annual J.J.C. Bradfield lecture tonight that the Therapeutic Goods Administration, which is staffed by "competent and supportive" people, is not to blame. "Instead it is a reflection on the legislative framework under which the TGA operates as well as the resources available toil," Dr Roberts says in his speech, a copy of which has been obtained by The Australian.

The head of the hearing implant maker says that, in one case, his company lagged its European competitor by several years in being able to offer a key product in "dozens" of markets. While European countries and the US rely solely on the ruling of their own regulators, there are 37 countries where products first have to be cleared for use in their country of origin before they can obtain registration offshore. Dr Roberts cites one case where the product approval process took 14 months longer in Australia than in Europe. "That is, after obtaining regulatory approval to sell in Europe, it took 14 more months before Cochlear could even start to apply for product registration in key markets like India," he says.

"In this case, Cochlear ended up several years behind its European competitor in being able to offer a key product into dozens of markets." The lecture is organised by the federal member for Bradfield, Paul Fletcher, and is named in honour ofJ.J.C. Bradfield, the engineer who was the driving force behind the creation of the Sydney Harbour Bridge. Cochlear has delivered hearing implants to about 250,000 profoundly deaf people worldwide over the past 30 years. Its global share of the ear implant market has been in the range of 65-70 per cent. Dr Roberts also says in his speech that it has been enormously beneficial to Cochlear to be able to bring in skilled labour from other countries. This was helped by Australia's attractiveness as a work destination, with the country ranked second of 187 countries in the most recent UN human development index. "Recently, for example, we have found Ireland to be a very good source of talented and experienced people willing to relocate, given the dire economic msituation in which Ireland finds itself," he says.

Dr Roberts also rejects the notion that productivity improvements inevitably mean job cuts. He says Cochlear has introduced major, productivitydriving initiatives in manufacturing in the past five years. Over the same period, the number of people employed in direct manufacturing roles has climbed from 185 to 450.