Na domhain shamhlaíochta: formulary submission guidelines in Ireland and the standards of normal science.

In common with a number of other single payer health systems, Ireland, through the Health Information and Quality Authority, has established guidelines for formulary submissions by pharmaceutical manufacturers. In the last few months, however, there have been a number of questions raised as to whether or not guidelines for economic evaluations in such submissions are consistent with the standards of normal science. Do they require those making the submission to put their claims in the form of testable hypotheses that can support falsification and replication? The purpose of this commentary is to consider whether the 2014 guidelines meet these standards. The assessment presented argues that the guidelines do not meet the standards of normal science. Instead, from this perspective, they are best characterized as na domhain shamhlaíochta (imaginary or false worlds). There is no requirement in the guidelines for claims to be expressed as testable propositions, as hypotheses for expected impact that can be evaluated and the outcomes reported as part of ongoing disease area and therapeutic class reviews. The commentary concludes with suggestions for a reworking of the guidelines to meet the standards of normal science.