Statement on Pandemic Influenza Preparedness (Agenda item: 13.1) by CMC Churches Action for Health Mr. Chairman, I deliver this statement on behalf of the Churches Action for Health, and other like minded NGOs such as the Third World Network, the Berne Declaration and the Peoples Health Movement. Negotiations on a PIP Framework began following the 2007 World Health Assembly when it emerged that the virus sharing scheme was not adequately regulated and was not equitable. Developing countries that shared influenza biological materials faced difficulties in gaining access to affordable vaccines and anti-virals as well as to technology and know-how; while the industry had access to influenza viruses and commercially profited from the virus sharing system without having to share any benefits with the international community. Developed countries also gained from WHO’s virus sharing scheme as they had the resources to obtain vaccines through pre-purchase agreements with the manufacturers. Thus the negotiations on the Framework was about infusing equity in WHO’s virus sharing scheme by ensuring the fair and equitable sharing of benefits to facilitate pandemic preparedness by developing countries. Against this background, we are of the view that the agreed PIP Framework is a “milestone” for WHO. The agreement puts in place for the first time in WHO terms and conditions for the sharing of influenza materials. For instance it has been agreed that WHO Collaborating Centers, H5 Reference laboratories and Essential Regulatory laboratories should not make intellectual property claims over the influenza biological materials. The Framework agreement also obligates the commercial entities in particular the vaccine and pharmaceutical manufacturers to engage in benefit-sharing. However we are of the view that the amount of annual monetary contributions and the level of in-kind contributions expected of the industry could have been higher since they make great profits from WHO’s virus sharing system. Further the granting of non-exclusive licenses at affordable royalties or royalty free to developing countries for the production of products needed in a pandemic should have been listed as a stand-alone mandatory benefit to facilitate the sharing of knowledge, technology, and know-how, which developing countries need to counter influenza pandemic. Despite these, the Framework is an important step forward to better pandemic preparedness and response and we hope that at some stage the level of benefits can be reconsidered and improved. Finally we call on WHO and its Member states to ensure that the Framework and the accompanying Standard Material Transfer Agreements are implemented in a manner that protects and promotes public health and consistent with the objectives of the Convention Biological Diversity and the Nagoya Protocol on Access and Benefit Sharing.