The Act then provides for a of exemptions where, for example, unapproved medicines may be prescribed and supplied because of particular circumstances. Issues with current exemptions provisions include: a perceived excessive use of exemptions (eg, the volume of product supplied through the s29 exemption is higher than anticipated when the exemption was originally introduced) not all situations exemptions are justified are covered under the Act (eg, keeping stocks of unapproved medicines for future emergency use by unnamed patients) quality standards for large-scale local compounding of products by pharmacists (the question is whether this activity should be subject to licensing as for local manufacturing of approved products); supply quality assurance for unapproved medicines (ie, assurance that the medicine is what it claims to be, and has been manufactured to standard). The approach taken to exemptions is affected by views about the overall role and reach of regulation. For example, if the objective is to ensure as many products are approved as possible, and as few unapproved products are used as possible (eg, because the regulator does not have the resources to monitor them) then exemptions should be tightly controlled. If, however, the view is that there is often sufficient information available for unapproved products to be judged safe and effective by accountable health professionals, exemptions might simply represent another valid and helpful pathway to product use. The challenge is to: facilitate access to worthwhile (and sometimes essential) products that will never be submitted for approval in New Zealand given the small size of this market protect the integrity of the approval process (ie, contain the use of unapproved products, and encourage sponsors to submit products for approval). The pressure to use unapproved products, however, may be reduced if the costs (direct fees and compliance costs) of obtaining an approval are reduced as a result of the regulator having more options available in the approval process (see Product approvals section above). Further, it may be possible for intermediate approaches to be developed where, under certain circumstances, the regulator may specify the basis on which products may be used (but not marketed) without an approval. Exemptions: options and impacts Options Description Impacts Status quo Prescribing and use of Current problems continue without any unapproved products in a range amendment. of circumstances. For example, desirable exceptions not legally provided for (with consequential adverse effects for health and safety outcomes):
The Act then provides for a of exemptions where, for example, unapproved medicines may be prescribed and supplied because of particular circumstances. Issues with current exemptions provisions include: a perceived excessive use of exemptions (eg, the volume of product supplied through the s29 exemption is higher than anticipated when the exemption was originally introduced) not all situations exemptions are justified are covered under the Act (eg, keeping stocks of unapproved medicines for future emergency use by unnamed patients) quality standards for large-scale local compounding of products by pharmacists (the question is whether this activity should be subject to licensing as for local manufacturing of approved products); supply quality assurance for unapproved medicines (ie, assurance that the medicine is what it claims to be, and has been manufactured to standard). The approach taken to exemptions is affected by views about the overall role and reach of regulation. For example, if the objective is to ensure as many products are approved as possible, and as few unapproved products are used as possible (eg, because the regulator does not have the resources to monitor them) then exemptions should be tightly controlled. If, however, the view is that there is often sufficient information available for unapproved products to be judged safe and effective by accountable health professionals, exemptions might simply represent another valid and helpful pathway to product use. The challenge is to: facilitate access to worthwhile (and sometimes essential) products that will never be submitted for approval in New Zealand given the small size of this market protect the integrity of the approval process (ie, contain the use of unapproved products, and encourage sponsors to submit products for approval). The pressure to use unapproved products, however, may be reduced if the costs (direct fees and compliance costs) of obtaining an approval are reduced as a result of the regulator having more options available in the approval process (see Product approvals section above). Further, it may be possible for intermediate approaches to be developed where, under certain circumstances, the regulator may specify the basis on which products may be used (but not marketed) without an approval. Exemptions: options and impacts Options Description Impacts Status quo Prescribing and use of unapproved products in a range of circumstances. Current problems continue without any amendment. For example, desirable exceptions not legally provided for (with consequential adverse effects for health and safety outcomes):
regulatory-impact-statement-therapeutic-products-regulation.doc.docx