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<p>Whilst there was no statutory obligation to consult on these changes to the Human Medicines Regulations 2012, the Department engaged with stakeholder representative bodies representing pharmacists, doctors, patient groups and the pharmaceutical industry about its proposals. As part of that engagement, it also conducted a short written consultation. Some respondents raised concerns about the short duration of the written consultation. In response, the Department has included a review clause in the legislation, putting an obligation on the Department to review the operation of the legislation, one year after issuing the first protocol. In addition, in the Explanatory Memorandum, the Department has committed to conducting a consultation as part of that review.</p><p> </p><p>The Explanatory Memorandum also reflects the main concerns raised in the consultation. Because the consultation was not a public one, the Department’s response to the consultation has not been published but has been sent to all respondents and is available on request.</p> |