# 6043
The PIP (Pandemic Influenza Preparedness) Framework, adopted last May by the 64th World Health Assembly after more than four years of difficult negotiations, provides guidelines for the sharing of biological materials (influenza viruses with human pandemic potential) along with promises of access to research data, vaccines and other benefits to member nations.
The PIP_FQA document on the World Health Organization’s website states that the framework’s primary goals are:"
1) To increase access to pandemic influenza vaccines and other pandemic influenza-related benefits for countries in need in the event of an influenza pandemic; and
(2) to ensure the continued sharing of viruses necessary for continuous global monitoring and assessment of risks for an influenza pandemic and for the development of safe and effective influenza vaccines.
The devil, as they say, is in the details.
And this hard fought agreement contains language designed to deal with a variety of difficult procedural and diplomatic issues, including: intellectual property rights, the sharing of benefits and credit, and protocols for transferring biological material.
You can access more details on the PIP Framework at:
Pandemic Influenza Preparedness (PIP) Framework
In light of the recent flap (not yet resolved) over the publication of controversial bird flu research (see The H5N1 Research Debate Goes On), the World Health Organization has concerns how this matter will impact the recently adopted PIP Framework.
A statement today from the WHO website:
WHO concerned that new H5N1 influenza research could undermine the 2011 Pandemic Influenza Preparedness Framework
Statement
30 December 2011The World Health Organization (WHO) takes note that studies undertaken by several institutions on whether changes in the H5N1 influenza virus can make it more transmissible between humans have raised concern about the possible risks and misuses associated with this research. WHO is also deeply concerned about the potential negative consequences. However, WHO also notes that studies conducted under appropriate conditions must continue to take place so that critical scientific knowledge needed to reduce the risks posed by the H5N1 virus continues to increase.
H5N1 influenza viruses are a significant health risk to people for several reasons. Although this type of influenza does not infect humans often, when it does, approximately 60% of those infected die. In addition, because these viruses can cause such severe illness in people, scientists are especially concerned that this type of influenza could one day mutate so it spreads easily between people and causes a very serious influenza pandemic.
Research which can improve the understanding of these viruses and can reduce the public health risk is a scientific and public health imperative. In order to enable those public health gains, countries where these viruses occur should share their influenza viruses for public health purposes while countries and organizations receiving these viruses should share benefits resulting from the virus sharing. Both types of sharing are on equal footing and equally important parts of the collective global actions needed to protect public health.
While it is clear that conducting research to gain such knowledge must continue, it is also clear that certain research, and especially that which can generate more dangerous forms of the virus than those which already exist, has risks. Therefore such research should be done only after all important public health risks and benefits have been identified and reviewed, and it is certain that the necessary protections to minimize the potential for negative consequences are in place.
In May 2011, the new Pandemic Influenza Preparedness (PIP) Framework came into effect. This Framework was adopted by all WHO Member States as a guide to the sharing of influenza viruses with pandemic potential and the resulting benefits. One specific requirement of this Framework, which pertains to influenza viruses of pandemic potential, and is in keeping with best scientific practice, is for laboratories receiving them through WHO's Global Influenza Surveillance and Response System (GISRS) to collaborate with, and appropriately acknowledge, scientists in countries where the virus originated when initiating research.
WHO recognizes that the scientists who led the work of the new studies received their virus samples from the WHO Global Influenza Surveillance Network (GISN), which preceded GISRS, and before negotiations on the new PIP Framework began. However, now that the Framework has been adopted by all WHO Member States, WHO considers it critically important that scientists who undertake research with influenza viruses with pandemic potential samples fully abide by the new requirements.
Since the PIP Framework represents a major step forward and was agreed upon only after several years of difficult negotiations, WHO stresses that this H5N1 research must not undermine this major public health achievement. WHO will work with Member States and other key parties to ensure scientists understand the new requirements that have been agreed to with the Framework.
While today’s strongly worded statement calls specific attention to the need for bird flu researchers to `collaborate with, and appropriately acknowledge, scientists in countries where the virus originated when initiating research’ there are, quite obviously, other issues under deep consideration here as well.
Not the least of which is how, and under what conditions, to promote and facilitate the sharing of potentially dangerous `dual use’ research data (and/or biological materials) among laboratories and scientists around the world.
Thorny questions, with admittedly, few clear cut answers.
