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When can you take a PMCPA case as case precedent?

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8 months ago
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There have been a number of occasions where similar complaints have been submited to the PMCPA and they have found one case not in breech and another in breech. At what point can you use PMCPA outcomes as case precedent in your defence?

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PharmAffinity Forum: When can you take a PMCPA case as case precedent?

Using PMCPA cases in a complaint response can be tricky. The PMCPA does publish cases but it can be difficult to really understand the nuances between the cases which is why sometimes in scenarios where two cases look similar one can be found in breech and the other not. When a case has been appealed and gone to the appeal board these nuances and specific details are discussed in more detail and included within the report therefore it may be possible to use those cases in a defence. It still may not be appropriate to use a case in a defence response but cases particularly those that have gone to appeal board may be helpful in decision making. 

Anonymous
Answered 8 months ago

It is important to try to understand the full details of the case and how they may differ from another case or situation. There may be important nuances that need to be taken into account. Also, the PMCPA can only consider matters that have been raised by the complainant - so if the complaint is not specific or detailed enough there may be no breach but that does not necessarily mean that the activity or material was compliant with Code.

Sometimes it can be really straightforward - in case AUTH/2812/12/15 Mylan were found in breach of the Code for providing frozen yoghurt from an exhibition stand. Less than a year later Actelion were found in breach for providing frozen yoghurt from an exhibition stand, they had missed the ruling in the Mylan case so did not learn from it.

8 months ago
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