The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) 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.
The decision reached by Member States on the framework suggest that the key challenges have been addressed by the OEWG/PIP; such as increasing the capacity of vaccine production and enabling access in developing countries. The financial parameters for IFPMA support to the WHO Global Influenza Surveillance Network (GISN) appear to have been accepted, as have the levels for IFPMA members’ allocations for vaccines and antivirals to be made available for developing country use at the next pandemic.
The OEWG/PIP invited the IFPMA to attend stakeholder consultations. IFPMA found the consultations with the Working Group constructive and productive and believes such discussions will provide a sound basis for the fine-tuning of the framework over the coming year. Eduardo Pisani, Director General of IFPMA explained that “the research-based pharmaceutical industry sought to engage constructively in the OEWG/PIP process, conscious of our industry’s responsibility. We intended to find workable solutions as the basis for a collaborative commitment to addressing the challenge of pandemic influenza preparedness.”
The IFPMA’s submissions to the OEWG/PIP were based on the recognition that the industry had a responsibility to work with the World Health Organization (WHO), Member States, Governments and others to enhance effectiveness for the next pandemic. The IFPMA’s submission was informed by the research-based industry’s experience and sought to build on the important voluntary contributions to the H1N1 pandemic that industry made. For example, IFPMA vaccine manufacturers donated 166 million doses to meet the WHO target of 200 million vaccine doses for developing countries. Antivirals were also donated, and other mechanisms to make them available for poorer countries were adopted. 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.
The IFPMA vaccine manufacturers gave assurances of their continued support to the WHO Global Influenza Surveillance Network (GISN). In 2010, the research-based pharmaceutical industry contributed approximately US$ 2 million for these activities. The IFPMA’s member companies are willing to increase the level of contribution for the coming years and look forward to working in partnership with other contributors, including all other vaccine manufacturers around the world, to feed into the fund allocation process.
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.”
18 April 2011, Geneva