Medicus Mundi International
MMI appreciates the opportunity to address the EB. This statement is supported by PHM and TWN.
We are concerned about the proposed decision text.
On Genetic Sequence Data, we recall that the 2016 Expert Review Group recommended that the definition of the PIP biological material in the Framework be amended to explicitly include GSD.
The proposed decision text in EB144/23 falls short of this recommendation.
The proposed amendment of Footnote 1, Annex 2 does not address all benefit sharing loopholes identified, such as where a manufacturer only uses GSD throughout the product development process. In addition, we are concerned about the non-application of SMTA1 when GSD is shared, as well as the validity of existing SMTA2s which were signed in relation to receipt of PIP materials.
GSD is already part of the PIP Framework, with countries requested to share GSD in a timely manner. Hence, as with PIP materials, use of GSD should also trigger the different components of the Framework including SMTA1 and SMTA2. Failure to clarify that the PIP BM includes GSD undermines the “equal footing” principle of the Framework and thus pandemic preparedness.
On seasonal flu viruses, we are concerned about the negative language concerning the Nagoya Protocol in the draft decision text. As shown by the PIP Framework, the Nagoya Protocol brings significant opportunities and benefits for public health.
Seasonal viruses should not be included in the PIP Framework as it will unravel the entire Framework. In addition, rather than pointing fingers at the Nagoya Protocol, the EB should consider setting up an intergovernmental process to develop a mechanism for virus and benefit sharing on equal footing, specifically with regard to seasonal flu viruses.