In a decision that has shocked and dismayed the life sciences sector, the Department of Immigration and Border Protection is now applying import tariffs to placebos imported for use in clinical trials.
The sector recently became aware of the decision to apply tariffs to placebos when companies were issued invoices.
Prescription medicines containing active ingredients that have a "therapeutic use" are exempted from tariffs. However, according to a tariff classification guide recently published by the Department of Immigration and Border Protection, placebos not containing active ingredient and "made of food substances such as sugars, starches, oils or fats," can be classified as "foodstuffs" and meet the tariff criteria.
The issue for the sector is that the decision could force companies to identify placebos amongst stock used for clinical trials, potentially running the risk of un-blinding a trial.
The consequences could be significant given the major challenges already facing companies and organisations wanting to run clinical trials in Australia.
These challenges have been recognised by successive governments, with bipartisan political support for a range of reforms.
The coalition committed $7 million to clinical trials reform during the recent election campaign, including seed funding to support a central point of contact for clinical trial sites to improve communication and coordination across sites and jurisdictions.
The Department of Immigration and Border Protection said it would respond to a series of questions lodged by BiotechDispatch. According to the Department, the complexity of the issue meant a response could take several days.