In the future, classification may need to apply to other types of therapeutic product and this development should be enabled legislatively. Product approvals: options and impacts Options Description Impacts Status quo The approval process for The limitations of this approach are that therapeutic products would be it will not enable the regulator to take a set out in primary legislation. risk-appropriate approach, and will quickly become rigid and out of date. The key consequence is limited effectiveness in managing costs and in promoting access. Areas of Alternative approaches (the Reason for preferred approach (most possible change second is preferred in each reasons relate in some way to the case) benefits of flexibility in managing risk) Approval process Process pre-defined, or Flexibility enables processes to be risk appropriate and cost appropriate. Regulatory flexibility to modify process if necessary Product Set out in primary or Flexibility enables categories to be kept categories / risk secondary legislation, or up to date, or kept up to date more sub-categories efficiently (legislation when it can be – Set out in a combination of changed - is costly to change), while primary, secondary, and ensuring appropriate accountability. tertiary instruments of approval Regulator must conduct its Flexibility enables regulator to determine own technical assessment, or best approach based on all the circumstances (including capacity). Mixed model full – assessment, partial Mixed model provides full spectrum of assessment, unilateral alternatives, with benefits for effective recognition cost management. Approval Conditions must conform with Flexibility enables the regulator to align conditions a pre-defined approach, or the conditions with the particular circumstances and risk assessment for a Conditions may be determined particular product or activity. and imposed as the regulator sees fit Less certainty for industry (in of type of conditions), but more certainty that risks will be managed proportionately (which is not without some benefit to industry). Change in Approvals must conform with a Flexibility enables the regulator to modify approval pre-defined approach, or approach to better address or contain risks. Approval may be modified, suspended or revoked as the Greater uncertainty for supplier, but regulator sees fit changes would only be occasioned when risks justify change. Responsible Status quo (mixed More effective risk management is person accountabilities), or possible when a responsible person is designated as a condition of an approval Responsible person or licence. Increases compliance costs potentially, but more costs are proportionate.
In the future, classification may need to apply to other types of therapeutic product and this development should be enabled legislatively. Product approvals: options and impacts Options Description Impacts Status quo The approval process for therapeutic products would be set out in primary legislation. The limitations of this approach are that it will not enable the regulator to take a risk-appropriate approach, and will quickly become rigid and out of date. The key consequence is limited effectiveness in managing costs and in promoting access. Areas of possible change Alternative approaches (the second is preferred in each case) Reason for preferred approach (most reasons relate in some way to the benefits of flexibility in managing risk) Approval process Process pre-defined, or Regulatory flexibility to modify process if necessary Flexibility enables processes to be risk appropriate and cost appropriate. Product categories / risk sub-categories Set out in primary or secondary legislation, or Set out in a combination of primary, secondary, and tertiary instruments Flexibility enables categories to be kept up to date, or kept up to date more efficiently (legislation – when it can be changed - is costly to change), while ensuring appropriate accountability. of approval Regulator must conduct its own technical assessment, or Mixed model – full assessment, partial assessment, unilateral recognition Flexibility enables regulator to determine best approach based on all the circumstances (including capacity). Mixed model provides full spectrum of alternatives, with benefits for effective cost management. Approval conditions Conditions must conform with a pre-defined approach, or Conditions may be determined and imposed as the regulator sees fit Flexibility enables the regulator to align the conditions with the particular circumstances and risk assessment for a particular product or activity. Less certainty for industry (in of type of conditions), but more certainty that risks will be managed proportionately (which is not without some benefit to industry). Change in approval Approvals must conform with a pre-defined approach, or Approval may be modified, suspended or revoked as the regulator sees fit Flexibility enables the regulator to modify approach to better address or contain risks. Greater uncertainty for supplier, but changes would only be occasioned when risks justify change. Responsible person Status quo (mixed accountabilities), or Responsible person More effective risk management is possible when a responsible person is designated as a condition of an approval or licence. Increases compliance costs potentially, but more costs are proportionate.
regulatory-impact-statement-therapeutic-products-regulation.doc.docx