Sandoz falls foul of ABPI Code
pharmafile | March 7, 2012 | News story | Medical Communications, Sales and Marketing | ABPI Code of Practice, Sandoz
Sandoz has been rapped over the knuckles for offering non-approved bags and bottles to patients.
It was found to be offering a toy, a water bottle and a backpack to patients treated with a growth hormone deficiency drug.
The complaint was made by competitors Merck Serono, who pointed out that the three objects were being made available as patient support items with Sandoz’s drug Omnitrope (somatropin).
The PMCPA, which enforces the Code, ruled that Sandoz had breached clause 18.2, which says that such things can be provided, but must directly benefit patient care.
It said that the bottle and backpack were in breach, but said the toy did directly benefit patients, and therefore was not included in the ruling.
Merck Serono had three main issues:
• It did not consider that the items were related to the treatment of growth hormone deficiency
• The company could also find no scientific evidence that the items were linked to improved adherence
• It thought the price of the backpack was more than £6 – the cost limit for such items under the Code.
Items do not need to be medical in nature, the Code says – but they should have a “clear specific purpose related to the disease in question”.
While accepting that hydration promoted good health, the PMCPA did not feel that the bottle was directly related to the condition under treatment, and therefore ruled a Code breach.
As to the backpack, Omnitrope has to be stored at 2-8 degrees Celsisus – something for which the bag would not be appropriate.
Thus the panel was not satisfied that it was “related to the treatment of growth hormone deficiency or otherwise directly benefitted patient care”. A breach was again ruled.
On the cost issue, the panel found that each item was £6 or less plus VAT, and thus ‘inexpensive’ as defined by the Code.
Finally, the PMCPA considered the toy was, on balance, an acceptable patient support item since there are difficulties involved in a child adhering to a treatment regime with daily injections.
Testimony from parents and carers mentioned the use of rewards or comforters. Although none referred to this particular toy, the PMCPA thought they supported Sandoz’s view that a toy might be used as a comforter in the initial stages of injections to aid compliance.
Therefore, since it could be argued that giving a child a soft toy to cuddle would directly benefit patient care, no breach of the Code was ruled. Sandoz is not appealing against the PMCPA’s verdict.
Adam Hill
Related Content
Sandoz launches two new bone disease biosimilars in Europe
Sandoz has announced the European launch of two new bone disease biosimilars. Wyost (denosumab 120 …
Sandoz signs renewable energy deal to supply 90% of European operations
Sandoz has entered into a ten-year virtual Power Purchase Agreement with Elawan Energy for the …
FDA approves Sandoz’s denosumab biosimilars
Sandoz has announced that the US Food and Drug Administration (FDA) has approved Wyost (denosumab-bbdz) …
