Handling Genetic Sequence Data under the PIP Framework
PIP Framework section 5.2.4 requests the Director-General to consult with the PIP Advisory Group on the best process for further discussion and resolution of issues related to the handling of the genetic sequence data (GSD) of influenza viruses with pandemic potential, under the Framework.
The PIP Advisory Group commenced its work on this issue in June 2013. Since then, it has conducted technical work, in consultation with PIP stakeholders, in order to understand how GSD is developed, shared and used with a view to proposing to the Director-General, options for handling GSD under the Framework that are consistent with and reflect the Framework’s objectives.
Technical Working Group (TWG) on sharing influenza GSD
Established in April 2015 by the PIP AG, the Technical Working Group (TWG) was requested to identify the optimal characteristics and best practices of a GSD sharing system that best meets the objectives of the Framework. The document submitted by the TWG to the PIP Advisory Group in May 2016 was developed from July 2015-May 2016 and included consultation with Member States and stakeholders.
TWG Submission to the Advisory Group (22 June 2016)
Optimal Characteristics of an influenza genetic sequence data sharing system under the PIP Framework
- Comments received on the draft Optimal Characteristics of an influenza genetic sequence data sharing system under the PIP Framework
Draft Optimal Characteristics of an influenza genetic sequence data sharing system under the PIP Framework (November 2015)
TWG Meeting Reports
TWG Terms of Reference
Monitoring the use of Influenza GSD in end-products
This document identifies different options for monitoring the use of GSD in the development of influenza products, such as vaccines, antivirals and diagnostics. This document was developed in consultation with Member States and stakeholders.
Options to monitor the use of genetic sequence data from influenza viruses with human pandemic potential (IVPP GSD) in end-products, REVISED 6 May 2016
Draft Options to monitor the use of genetic sequence data from influenza viruses with human pandemic potential (IVPP GSD) in end-products (September 2015)
Federal Republic of Germany’s comments on the Options paper
GISAID Initiative’s comments on the Options paper
Third World Network's comments on the Options paper
WHO Survey on the sharing of GSD
In July 2015 the Secretariat conducted a survey to understand better how GSD of influenza viruses with human pandemic potential is generated, shared and used by laboratories in WHO GISRS, academia, public health institutions and industry. The Report contains the analysis of responses received.
Technical Expert Working Group (TEWG) on GSD
In October 2013, the PIP AG established a Technical Expert Working Group (TEWG) to assess the scientific, technical, operational and intellectual property implications of using GSD to develop vaccines, diagnostic and pharmaceutical products.
TEWG Final Report to the PIP Advisory Group, REVISED 10 October 2014
TEWG Final Report to the PIP Advisory Group, 15 May 2014