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    Shane Pearse

    “Just for the record” and without making any judgement as to whether Sigma did or did not breach Medicine Australia’s Code, Sigma also told Pharma In Focus that “none of the Sigma medicines that we detail to doctors are even on the program”, and that the cost to doctors is $8-$10,000.

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    Ken Harvey

    Shane is not the only person who has wondered why there are concerns about the Sigma cruise given that participants are paying for themselves and the education sessions are organised independently.

    There would have been no concern if the cruise had been organised by the Pharmacy Guild and/or the AMA.

    However, because Sigma has organised the cruise (and obtained cheaper fares for participants via a group discount) there is concern that this creates an obligation of reciprocity towards Sigma. In addition, the cruise will give the 3-4 drug reps that Sigma acknowledges will be present (allegedly only to look after the needs of participants) a unique opportunity to build relationships that would greatly assist
    their subsequent detailing. Furthermore, the choice of a luxury ship for an educational venue would appear a clear breach of Section 6.6 of Medicines Australia Code.

    What has subsequently emerged is that Sigma is not obliged to follow all the provisions of Medicines Australia Code because they are a member of the Generic Medicines Industry Association (GMiA), not Medicines Australia.

    The TGA letter of marketing approval for all registered medicines (both innovator and generic) states that, “promotional material … relating to the registered good must comply with the requirements of the Code of Conduct of Medicines Australia”.

    The TGA have interpreted this to mean that there is no requirement that promotional activities not directly related to a registered good, in particular the Sigma cruise, must comply with the MA Code of Conduct.

    This TGA interpretation is a much narrower definition of promotional material than the definition of advertisement in the Therapeutic Goods Act 1989. The latter states that, “that advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

    The end result of the TGA interpretation is a higher standard of ethical conduct expected for innovator compared with generic companies.

    This matter is currently before the Parliamentary Secretary. If he supports the TGA view then this matter will be taken to the Australian Competition and Consumer Commission (ACCC) on the grounds that the TGA is supporting anti-competitive practices.

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