Yes, there has been consultation with numerous stakeholders or representatives of the public and patient interest groups, physicians, and industry. The general consensus was that there was not necessarily a net gain in having all spontaneous adverse drug reactions reported, but more to have a strategic approach to target where it's most likely to make a difference.
There was general agreement that hospitals are where physicians, pharmacists, or other health care professionals are observing these adverse events and are able to report them. As you're aware, hospitals are very structured environments where there are already some mechanisms to basically collect that information. So having hospital-based mandatory reporting by a health care professional is thought to be a very efficient way to identify serious adverse events reports that may make a difference in identifying safety signals earlier on.