Vic Gov listens to concern on clinical trial insurance

Cognisant of industry concern, the Victorian Managed Insurance Authority (VMIA) has chosen not to increase the insurance requirements for commercial sponsors of human clinical trials in Victoria, which was intended to take effect from 1 July 2012.

AusBiotech opposed the move in June when it became apparent that the VMIA intended to follow the criticised decision of NSW to increase (double) the minimum requirement for indemnity insurance from $10 million to $20 million, putting it at odds with the rest of the country and giving NSW the highest compulsory limits in the world.

The contentious doubling the minimum requirement for indemnity insurance in NSW has already reduced the attractiveness of the state for clinical trials, and AusBiotech argued that it would be unwarranted and counterproductive for Victoria to follow. AusBiotech works closely with companies reporting that the NSW situation has been pivotal in their decision to conduct clinical trials elsewhere.

Dr Anna Lavelle, CEO of AusBiotech said: “I am heartened that Victoria did not proceed with the increased insurance coverage requirement to $20 million, and will therefore remain competitive and attractive as a clinical trial destination.

“The commercial decision to locate a trial is complex and any unnecessary hurdle disadvantages small indigenous companies and trials where a disease state is less common, thereby discouraging their attraction and disadvantaging local patient access.

“Victoria needs a vibrant, productive, efficient, internationally-competitive and world-class clinical trials industry to support its local competitive advantage in biotech development.”

Nation-wide there are currently 635 trials underway, involving 19,000 patients. More than 320 of these trials are underway in Victoria, giving local access to patients and contributing to the economy.

AusBiotech has been working with the Pharmaceuticals Industry Strategy Group (PISG) and the Clinical Trials Action Group (CTAG) to support national co-ordination of policy on clinical trials across the Australian, state and territory governments and the harmonisation of regulatory requirements to ensure cost reduction and speed to commencement, which will ultimately increase competitiveness globally and make Australia a more attractive destination for trials.