In this case, you're probably right. ...but what if you were selling a medicine that you knew worked, that you really believed in, but that you knew was going

In this case, you're probably right. ...but what if you were selling a medicine that you knew worked, that you really believed in, but that you knew was going to be labeled fake by an arbiter in the employ of your competitor (and I think it's not unfair to say that the FDA is, at times, exactly this)? Might you decide not to spend the money to attempt to achieve compliance? Don't you think that some well-meaning organizations, knowing that they have powerful, well-connected beasts who wish failure for them, might opt to just stay out of Europe (either initially or always) instead of facing the costs of assuring compliance?