Further to the post below re Ken Harvey’s concerns about Sigma, cruises, and product promotion….the ceo of the Generic Medicines Industry Association, Kate Lynch, has advised Harvey that:
“…under the requirements of the Therapeutic Goods Act (1989), the Therapeutic Goods Advertising Code (2007) and as stipulated in the Therapeutic Good Administration’s letter of marketing approval, Sponsor promotionof all prescription products (whether member or non-member) is required to comply with the requirements of the Medicines Australia code of conduct. Members of the Generic Medicines Industry Association are required to comply with the Medicines Australia code of conduct.”
More info here also.
Harvey adds: “What is interesting is that Sigma is a GMiA member. Given the above, I don’t see how Sigma can wiggle out of this one!”
Meanwhile, Medicines Australia has advised Harvey that it expects Sigma will decline to appear before its code of conduct committee…
Just for the record, Sigma has told the pharma industry news service, Pharma in Focus, that the cruise has nothing to do with promoting medicines and that suggestions to the contrary are “completely false”.
Sigma CEO Elmo de Alwis told the publication that the trip was a networking and educational opportunity for doctors, many of whom had attended previous cruises put together by the company – although he did acknowledge that the event gave company reps better access to GPs…
“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.
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.