Ethical And Legal Aspects Of Prescribing And Use By Target Populations (D3.09)

As part of an early assessment by the medicine developer, and later dialogues with other stakeholders as to the justification of using a MAPPs approach for product development, one of the questions that need to be satisfied is: “Are there workable tools to ensure appropriate product utilisation?” A pre-requisite for this is in the ability to obtain quality data within the limits of the approved indication and to minimise off-label use.

Centrally regulated tools that include, the Summary of Products Characteristics (SmPc) and Direct Healthcare Professional Communications (DHCP) provide guidance to prescribers. There are many other de-centralized tools, regulated at the member state (MS) level that can have a positive (or negative) influence on prescribing behaviour. These include registries, prescribing that is limited to certain hospitals, specialist certification of prescribers, diagnostic tools, etc. The availability, application and relative impact of these tools on prescription behaviour varies across MS and may present additional legal and ethical considerations for one or more stakeholders.

Work-stream D3.09 has explored some general ethical and legal issues that may arise through the introduction of the MAPPs concept, the implications for each stakeholder – in particular, patients and healthcare professionals (HCP) – and any liability change or shift between stakeholders and ethical considerations of prescribing control.