The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency's (“EMA”) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Monitoring of shortages of critical medicinal products
The proposed Regulation sets up a permanent structure within the EMA, the Executive Steering Group on Shortages and Safety of Medicinal Products, with the task to monitor continuously and prepare for any event that is likely to lead to a public health emergency. In such circumstances, this Group must adopt a list of critical medicinal products and monitor their supply and demand in order to identify any potential or actual shortages. The procedure for establishing this list will be specified by the EMA in a subsequent communication.
The proposed Regulation requires Marketing Authorisation Holders (“MAHs”) whose medicinal products are included in those lists to provide the EMA with the relevant information (e.g., sales and market share data, mitigation plans including production and supply capacity, etc.) to inform a risk and public health impact assessment.
More importantly, MAHs of critical medicinal products must immediately inform the EMA when they become aware of a potential or actual shortage.
All MAHs of medicinal products authorised in the EU must submit electronically, within 6 months from the date of application of the proposed Regulation, information allowing to the EMA to establish and maintain a list of single points of contact. The MAHs must provide a justification to the EMA for any claims that information provided to the Agency is commercially confidential.
How does this fit the broader EU discussions on shortages of medicinal products?
The draft Regulation on shortages of critical medicinal products only partly reflects the broader discussions in the EU and calls to introduce a general legal framework imposing specific shortages reporting obligations for MAHs. In particular, the European Parliament has adopted recently a resolution outlining the need for clarity on the obligations of MAHs to report shortages on medicinal products.
Supporting the development of medicinal products
In addition, the proposed Regulation establishes a new Emergency Task Force within the EMA to provide advice on those medicinal products that have the potential to address public health emergencies. The Emergency Task Force will provide scientific advice free of charge and review the available scientific data relevant to product development. In particular, it will review clinical trial protocols and provide its scientific recommendations with regard to the use of a medicinal product.
Monitoring of shortages of critical medical devices and support to Expert Panels
Under the current regulatory framework, the EMA has limited competence in the area of medical devices. The proposed Regulation has sought to address that limitation by establishing the EMA's Executive Steering Group on Medical Devices which must prepare, during a public health emergency, a list of medical devices considered as critical. Similar to the procedure applied to medicinal products, manufacturers and, where necessary, notified bodies involved in the conformity assessment of critical medical devices must submit to the EMA the required information concerning shortages. Additionally, they have to clarify the reasons why submitted information is considered to be commercially confidential and they are obliged to inform the EMA when they come across information indicating the existence of potential or actual shortages. The proposed Regulation clarifies that for manufacturers established outside the EU and unable to provide the necessary information, the authorised representative must fulfil those obligations.
The proposed Regulation also specifies that the EMA will provide a permanent structure for medical device expert panels, established by the Medical Devices Regulation. In particular, the EMA will provide administrative and technical support to expert panels in their task to provide scientific opinions, views and advice.
The proposed Regulation is accompanied by two other proposed Regulations which are focusing and revamping the mandate of the European Centre for Disease Prevention and Control and the framework for cross-border health threats seeking to ensure a coherent EU wide framework for addressing public health threats. The proposed Regulations will be negotiated through the established ordinary legislative procedure. Once adopted, the Regulations will enter into force and be immediately applicable.