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Update from the Public Policy work team

By Ulrike Kreysa on 20 January 2010
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Public Policy is an attempt by the government to address a public issue. The government, whether it is city, country, state or region, develops public policy in terms of laws, regulations, decisions, and actions.

There are three parts to public policy-making:

  • The problem is the issue that needs to be addressed;
  • The player is the individual or group that is influential in forming a plan to address the problem in question;
  • Policy is the finalised course of action decided upon by the government. In most cases, policies are widely open to interpretation by non-governmental players, including those in the private sector.

The GS1 Healthcare Public Policy work team exists to…

  • Provide strategic leadership in the conduct and interaction with global public policy makers and government authorities; to influence the movement towards harmonisation of product identification, data synchronisation and traceability requirements in alignment with GS1 Global Standards.
  • Provide a forum for open exchange of information between members including discussion concerning actions and trends of global public policy as it relates to healthcare product Identification.
  • Monitor the global landscape of laws, regulations, directives, etc., around the topics of healthcare product identification, data synchronisation and traceability and determine priorities for GS1 to engage in and act upon.
  • Establish a framework and repository of global regulations and directives related to Healthcare Product identification as a reference for membership.

The work team is co-chaired by Jackie Elkin, Medtronic and Scott Cameron, Novartis, who serve as representatives of GS1 Healthcare in interactions, communications and consultation with global public policy makers.

As part of its outreach and communication efforts, the work team has developed several communication tools, including position statements and fact sheets. The work team has also worked with several MO’s to develop a number of official responses to national regulatory bodies.

Notable government and regulatory activities
Some of the major developments currently include:

  • Brasil ANVISA Traceability Regulation announced;
  • European Commission: Anti-Counterfeiting Directive under development
  • India: Ministry of Health and Family Welfare will require GS1 Standards as of 2010;
  • Global Harmonisation Task Force (GHTF) has issued a Discussion Paper on Unique Device Identification (UDI); 2 GS1 Healthcare leadership team members participate in the ad hoc working group; GS1 Healthcare is currently developing an official response in alignment with Eucomed;
  • Turkey National Pharmaceuticals and Medical Devices Database - resolution of issues in progress;
  • USA: FDA Amendments Act – SNI (Standardised Numerical Identifiers) for pharmaceuticals and UDI (Unique Device Identification)
  • World Health Organisation (WHO) IMPACT (Anti-Counterfeiting taskforce) has been re-launched - GS1 is a member of the Technology work group.

The Public Policy work team closely monitors these, and many other, developments, and provides input on global standards through the global and local healthcare user groups.

New database for easier queries and uploads
A document previously known as the “Regulatory Spreadsheet” – the very foundation of our work – has now been transformed into a database, making it easier to perform queries and updates online. This new Public Policy Database is now available for all GS1 Healthcare members and all GS1 MOs.

Share your knowledge!
We need input from all countries – please share your knowledge. Common goals and aligned messages are necessary to successfully influence regulatory bodies and policy makers in order to influence and ultimately reach a globally harmonised approach.

Contact
For more information or to join the Public Policy work team, contact Ulrike Kreysa
 


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