'Fundamental misunderstanding' on clinical trials


The Department of Immigration and Border Protection says the application of tariffs on imported placebos "does not represent any change."

In response to a series of questions from BiotechDispatch, a spokesperson for the Department said a recently published guide "seeks to address incorrect classification practices of which the Department has recently become aware."

According to the guide, 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 Department’s guide is consistent with international practice, including the International Convention on the Harmonized Commodity Description and Coding System, to which Australia is a signatory, and relevant classification rulings from the UK and USA," said the spokesperson.

"These international guides and rulings ensure that the classification of placebos is applied consistently and facilitates trade of these goods for clinical trials globally.

"Placebos should be classified on importation according to what they are. Placebos are not considered to be medicaments because they contain no active ingredient that treats or prevents a disease or illness. Placebos made from food products should be classified to Section IV of the Customs Tariff Act 1995 (The Act) with other edible products."

In a claim that has been widely mocked by industry sources, the spokesperson said: "The requirement to correctly declare imported placebos will not invalidate ‘blinded’ clinical trials.

"The importer’s broker (whether in house or external) would be able provide information on placebos and medicaments to the Department which would be kept commercial-in-confidence."

A senior industry executive involved in clinical trials told BiotechDispatch the Department's claim represented a "fundamental misunderstanding" of clinical trials and the importance of "product integrity".