Action Point 3 - Strategy to facilitate information sharing
The first objective of SEARN is dedicated to information sharing, and especially to ‘create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between NRAs in the region’. Information sharing was also the most common and the main demand from the working groups during their meetings in January 2022 and from the Steering group in its March 2022 meeting.
However, the Heads of NRAs and their representatives considered during the Assembly of the Members of SEARN in June 2022 that the level of information shared was insufficient and requested that tangible progress are achieved for this key objective.
To address this situation, the Assembly adopted on 8 June 2022 the SEARN Work Plan 2022-2023 which includes the action point 3, led by Working Group 4 (WG4) Information Sharing: ‘Draft a strategy to facilitate information sharing, including establishing channels of communication and processes’. This work shall also build on and engage with the drafting group dedicated to defining the needs to support the development of the public website and the future internal platform.
To recommend actions to create an environment leading to effective information sharing within and beyond SEARN, and identify the information which should be shared
- To recommend actions to effectively and systematically share urgent information
- To recommend actions to facilitate mutual access to routine administrative information
- To recommend actions to facilitate mutual access to ad hoc information, including to support capacity building (access to SOPs) and reliance
- To recommend actions to share information related to the global benchmarking
- To optimize means and channels of communication
Barriers to information sharing
The following are some of the barriers to effective information sharing among the NRAs in the region:
- Lack of policy/legal framework/guidance that allow sharing of information with other NRAs
- Lack of resource and/or iniquity of resources. Some countries have advanced IT facilities while some do not have such resources
- Language barrier and information asymmetry between the reference and the relying authority. For example, little understanding of the reference authority, non-disclosure of confidential regulatory information and internal considerations
- Staff cannot take the decision directly without a framework or without clearance from top management
- Need to further develop mutual understanding and trust
Addressing barriers to information sharing
The SEARN terms of reverence define information sharing as the first objective of the Network, and specifically to ‘Create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between NRAs in the region’.
In order to renew the political commitment to share information between the NRAs and to lay the basis for a political framework to do so, a declaration from the Members of SEARN has been developed.
Further, it is acknowledged that some information may be especially difficult to share due to legal obstacles (e.g. data from MAH, internal assessment reports). To address these challenges, a Confidential Disclosure Agreement (CDA) template was developed. This template aims to facilitate the establishment of bilateral agreements for sharing of information between SEARN Members, through means to be defined by the parties (e.g. email or more secure channels of communication).
To address the lack of guidance, a common guideline/SOP that facilitates information sharing has been developed, identifying common criterion defining the kind of information that can be shared and the mode of information sharing. In order to minimize the impact on resources, it was agreed to keep such information minimal and to make effective use of the information publicly available.
Guidelines to SEARN members on Information Sharing
The following guidelines were adopted by the Assembly during its meeting on 27 July 2023:
Customizable Template for Confidential Disclosure Agreement
The following Customizable Template for Confidential Disclosure Agreement was developed to facilitate bilateral agreement between SEARN members for sharing confidential/sensitive information:
Declaration from the Members of SEARN to facilitate information sharing
- Define the minimal information required for routine administrative information.
- Propose a format for sharing ad hoc urgent information between Members.
- Address any challenge arising from the implementation of the outputs of action point 3 of the 2022-2023 work plan.