Now here's a "fun" discussion topic that came up in our office. I was explaining to our staff how our company is responsible to track the entire lifespan of our product from design to contract manufacturing, shipping, distribution to final disposal - all in the name of patient protection and risk management/mitigation. The idea being that any one of these stages could affect the risk to the patient (at the end of the day, its patient safety that is the end goal).
Therefore, if any one of these steps negatively impacts our product from reaching the patient, does this count as an increased risk to the system and are we responsible? If there are multiple substitutions on the market, then one can say that this doesn't in fact impact patient safety and therefore the risk is minimal (how those substitutes reach the patient would not be our responsibility)? Do we just do a quick risk assessment and say, "Well that's too bad for the patient that they can't get our product anymore but that's as far as we are willing to go"?
Then it came up that the increased regulatory commitments are causing changes to notifying bodies as well as global distribution as companies assess whether to stay in certain markets, all based on cost and value. Therefore the question is this: What is the role of changing regulatory commitments to increasing risk to a patient if said changes cause a retreat from the market? Do we just note it as part of a management decision and assess the risk to the company itself or in reference to the patient population that will no longer have access to the product?
Sorry for the long post but I just had to ask my esteemed colleagues.