Update: Pandemic Influenza Preparedness (PIP) Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits: Industry Perspective

Michael Watson, sanofi pasteur
[slides:  Global Vaccines 202X_Watson_PIP Update]
[video: Part I, Part II ]

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WHO outlines “landmark” agreement“ on influenza virus access and benefits sharing

WHO outlined details of what was described as a “landmark” agreement “to ensure that, in a pandemic, influenza virus samples will be shared with partners who need the information to take steps to protect public health.” The agreement was reached by the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness (OEWG/PIP), convened under the authority of the World Health Assembly and coordinated by WHO. The new framework includes “certain binding legal regimes for WHO, national influenza laboratories around the world and industry partners in both developed and developing countries that will strengthen how the world responds more effectively with the next flu pandemic. By making sure that the roles and obligations among key players are better established than in the past – including through the use of contracts – the framework will help increase and expedite access to essential vaccines, antivirals and diagnostic kits, especially for outbreak areas.”

The WHO overview noted that “during an influenza outbreak, knowing the exact makeup of the virus is critical for monitoring the spread of the disease, for knowing the potential of the virus to cause a pandemic and for creating the life-saving vaccines as well as other technological benefits. However, developing countries often have limited access to these vaccines for several reasons:
– they often do not have their own manufacturing capacity,
– global supplies can be limited when there is a surge in demand as is seen during pandemics.
– vaccines can often be priced out of the reach of some countries.

“The new framework will help ensure more equitable access to affordable vaccines and at the same time, also guarantee the flow of virus samples into the WHO system so that the critical information and analyses needed to assess public health risks and develop vaccines are available.”  Dr Margaret Chan, Director-General of WHO, commented, “This has been a long journey to come to this agreement, but the end result is a very significant victory for public health. It has reinforced my belief that global health in the 21st century hinges on bringing governments and key stakeholders like civil society and industry together to find solutions.”

WHO said the working group was co-chaired by Ambassador Juan José Gomez-Camacho (Mexico) and Ambassador Bente Angell-Hansen (Norway) and included the participation of WHO Member States, industry representatives, civil society and other organizations involved in influenza pandemic preparedness. The agreed upon framework will be presented to the World Health Assembly in May for its consideration and approval. The negotiations by 193 WHO Member States began in November 2007 amid concerns that the avian influenza (H5N1) virus in South-East Asia could become a human pandemic, WHO said.

17 April 2011

The text of the agreement is available at: http://www.who.int/entity/csr/disease/influenza/pip_framework_16_april_2011.pdf

http://www.who.int/mediacentre/news/releases/2011/pandemic_influenza_prep_20110417/en/index.html

IFPMA welcomes influenza virus access & benenfts sharing agreement

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said it welcomes the outcome of the WHO Open-Ended Working Group of Member States on Pandemic Influenza Preparedness (OEWG/PIP). The Working Group has reached a decision that will result in an effective global system to prepare for potential future influenza pandemics, recognizing a shared responsibility to help secure the world against future pandemic influenza outbreaks. The IFPMA supports the reported principles of the decision, and awaits with interest the final report of the OEWG/PIP in order to comment on the detail of the framework. It will be crucial to have a system that allows for rapid access to pandemic viruses and for benefits to be allocated to those countries most in need….”

“…IFPMA members made a commitment to the OEWG to ensure that vaccines and antivirals are made available for developing country use in the event of a future pandemic, pledging to:
– reserve at least 10% of pandemic vaccine manufacturing capacity on a real-time basis, for donation to the WHO and/or supply at tiered prices, to developing countries;
– reserve at least 10% of antiviral manufacturing capacity for donation to the WHO and/or supply at tiered prices to developing countries.

“In addition, IFPMA members recognised the importance of local production of vaccines and antivirals in pandemic preparedness. Many research-based pharmaceutical companies are already investing in establishing manufacturing in several countries (Mexico, Brazil, China, Indonesia, Thailand) and funding significant capacity increases in developed countries – also to enable developing country supply. IFPMA members have given assurances to the OEWG/PIP that they will continue to explore such opportunities.

“During the OEWG/PIP consultations, individual IFPMA members confirmed that they were also willing to undertake voluntarily a selection of actions, including production capacity expansion and access to reverse genetics technology, dependent upon skills, knowledge, financial management, public health policy and national regulation.
“It would appear that the OEWG/PIP’s approach to intellectual property rights is in line with WHO reports that have concluded that IPRs have presented no barrier to supply of vaccines and antivirals to developing countries. IFPMA members will continue to ensure that intellectual property rights do not present a barrier at the next pandemic. The IFPMA gave the Working Group assurances that their members were prepared to consider, when appropriate, flexible approaches to meet this goal.

“The commitments tabled at the OEWG/PIP by IFPMA members have considerable monetary value and represent a highly significant contribution to global preparedness for a future pandemic. “It is important that they are built upon with proportionate action by other stakeholders. We believe that national governments should play a crucial role in ensuring vaccines reach their populations, including immunization policy of seasonal influenza as advised by the WHO” said Eduardo Pisani, adding “This would need to be accompanied by regulatory procedures, country surveillance, health system infrastructure, and rules for transfer of viruses to build on the significant contributions to the global pandemic made by IFPMA members.”
http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13824

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Science 29 April 2011:
Vol. 332 no. 6029 p. 525
DOI: 10.1126/science.332.6029.525
News & Analysis
Infectious Diseases
Breakthrough’ Deal on Flu Strains Has Modest Provisions
Martin Enserink
When exhausted negotiators in Geneva finally reached a deal about the global sharing of influenza viruses early in the morning on Saturday, 15 April, the World Health Organization (WHO) was quick to call it a “landmark agreement.” WHO chief Margaret Chan hailed the 45-page document as “a very significant victory for public health.” But the most significant breakthrough may be that, after 4 years of complex and often contentious negotiations, there is a deal at all. The actual text of the agreement—which promises developing countries certain benefits in return for sharing their flu viruses with the world—contains mostly “soft” language that’s not legally binding.

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