Pandemic influenza preparedness framework for the sharing of influenza viruses and access to vaccines and other benefits
WHO – 25 January 2022 :: 70 pages
The objective of the Pandemic Influenza Preparedness Framework is to improve pandemic influenza preparedness and response, and strengthen the protection against the pandemic influenza by improving and strengthening the WHO global influenza surveillance and response system (“WHO GISRS”), with the objective of a fair, transparent, equitable, efficient, effective system for, on an equal footing:
(i) the sharing of H5N1 and other influenza viruses with human pandemic potential; and
(ii) access to vaccines and sharing of other benefits.
This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits. This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical specimens shared under this Framework.
This second edition of the Pandemic Influenza Preparedness (PIP) Framework reflects an amendment to Annex 2, Standard Material Transfer Agreement 2, Footnote 1, that was adopted by the Seventy-second World Health Assembly in May 2019.The amendment clarifies that, under certain circumstances, the indirect use of PIP Biological Materials will require the conclusion of an SMTA2. The amendment is in effect from the closure of the Seventy-second World Health Assembly (28 May 2019).
6.10 Access to vaccines in the inter-pandemic period for developing countries
6.10.1 Separately from measures to support the WHO PIP vaccine stockpile set out in section 6.9 above:
(i) Member States should urge influenza vaccine manufacturers to set aside a portion of each production cycle of vaccines for H5N1 and other influenza viruses with human pandemic potential for stockpiling and/or use, as appropriate, by developing countries; and
(ii) Member States should continue to work with each other, with the Director-General and with influenza vaccine manufacturers, with the aim of ensuring that adequate quantities of vaccines for H5N1 and other influenza viruses with human pandemic potential are made available to developing countries at the same time as to developed countries, on the basis of public health risk and needs and at tiered prices (see 6.12 below).
6.11 Access to pandemic influenza vaccines
6.11.1 Member States should urge vaccine manufacturers to set aside a portion of each production cycle of pandemic influenza vaccine for use by developing countries; and
6.11.2 The Director-General, consulting Member States and the Advisory Group, will convene an expert group to continue to develop international mechanisms, including existing ones, for the production and distribution of influenza vaccines on the basis of public health risk and needs during a pandemic, for consideration by the World Health Assembly in 2010.
…6.13 Technology transfer
6.13.1 The Director-General will continue to work closely with Member States and influenza vaccine manufacturers to implement the WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply, including its strategies to build new production facilities in developing and/or industrialized countries and through transfer of technology, skills and know-how.
6.13.2 Member States should urge influenza vaccine, diagnostic and pharmaceutical manufacturers to make specific efforts to transfer these technologies to other countries, particularly developing countries, as appropriate.
6.13.3 Technology transfer should be conducted in a manner consistent with applicable national laws and international laws and obligations, facilitated progressively over time, on mutually agreed terms, and be suitable to the capacity of recipient Member States, to empower developing countries to study and manufacture influenza vaccines, diagnostics and pharmaceuticals.
6.13.4 Influenza vaccine manufacturers who receive PIP biological materials may grant, subject to any existing licensing restrictions, on mutually agreed terms, a non-exclusive, royalty-free licence to any influenza vaccine manufacturer from a developing country, to use its intellectual property and other protected substances, products, technology, know-how, information and knowledge used in the process of influenza vaccine development and production, in particular for pre-pandemic and pandemic vaccines for use in agreed developing countries.
6.13.5 Member States seeking to receive technology to produce influenza vaccine should be encouraged to first conduct studies on the disease burden of seasonal influenza with related economic analysis in their country. Should the study warrant, Member States should be encouraged to consider incorporating seasonal influenza vaccination into their national immunization programme, which will enable sustainable functioning of the manufacturing facilities…