WHO Fine-Tuning Pandemic Flu Preparedness Strategy, Use Of Industry Contributions

The World Health Organization is putting the finishing touches on an implementation plan for industry’s financial participation in the global influenza preparedness strategy. This week the advisory group met to discuss a draft plan presented by the WHO secretariat, which should now come up with a revised version for implementation in early 2014, according to the chair of the advisory group.

The WHO Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits, so-called the PIP Framework [pdf], was adopted during the 64th World Health Assembly in May 2011.

It sought to facilitate the countries’ sharing of influenza viruses with human pandemic potential, while at the same time increasing the access of developing countries to any resulting vaccines. The PIP Framework includes participation by industry accessing and making use of those viruses through a “partnership contribution”.

The draft Partnership Contribution Implementation Plan 2013-2016 is based on the May 2012 PIP Framework Advisory Group recommendations [pdf] to the WHO director general on potential uses of the partnership contribution for pandemic preparedness and response.

The Advisory Group is part of the PIP Framework’s Governance and Review structure, according to the WHO. Among its areas of work, “the Advisory Group interacts with industry and other stakeholders and provides advice to the Director-General on the use of the Partnership Contribution.”

Advisory Group Chair Didier Houssin, president of the French Evaluation Agency for Research and Higher Education (AERES), told Intellectual Property Watch that during the meeting from 7-9 October, the group discussed topics such as the collecting of funds, agreements between the WHO and each virus recipient individual company, and the draft implementation plan for partnership contribution. They also met with civil society and pharmaceutical industry representatives.

Houssin said that the 2012 recommendations were based on principles and criteria of main categories of action. The draft plan that was examined is much more operational and results from the work undertaken with WHO regional bureaus. “We made proposals for improvements,” such as proposals concerning the plan’s monitoring, and indicators, he said.

Those proposals for improvements have been submitted to the WHO secretariat, which is expected to produce a second draft and present it to WHO Director General Margaret Chan, Houssin said. The objective is to carefully identify priority actions to implement with the partnership contribution, he said.

It is expected that as soon as January 2014, funds can be released to help a certain number of countries build laboratory and surveillance capacities, said Houssin. The list of the beneficiary countries is neither final nor public. The provisional list has been established following a set of criteria proposed by the Advisory Group. The WHO secretariat worked with its regional offices, which used those criteria and proposed beneficiary countries.

“We are not a decision-making body,” Houssin said. The Advisory Group makes propositions, which the WHO secretariat will consider and include in the second version of the draft to be presented to the director general. No activities can be launched before the approval of the director general.

On the identification of the companies that would contribute to the partnership contribution, the chair said the WHO secretariat had to identify all of the companies that would qualify. Almost 200 companies were identified and “a little less than 40 companies” were finally retained and will contribute. Their contribution has been calculated on their sales level, he said. Most of these companies have accepted their assigned level of contribution, he added.

The PIP Framework states that “influenza vaccine, diagnostic and pharmaceutical manufacturers, using the WHO GISRS [Global Influenza Surveillance and Response System], will make an annual partnership contribution to WHO for improving global pandemic influenza preparedness and response.”

Industries or other entities accessing biological materials through the PIP Framework can develop treatments and protect them with intellectual property but have to submit to a standard material transfer agreement, called SMTA2, which includes benefit-sharing provisions, such as donations and/or reserve for purchase by WHO at affordable prices of pandemic influenza vaccine and antiviral medicines, and licences to technology relevant to the production of pandemic-related products.

Another agreement, SMTA1, is for the sharing of PIP biological materials within laboratories of the WHO Global Influenza Surveillance and Response System. SMTA1 includes a clause on intellectual property which states:  “Neither the Provider nor the Recipient should seek to obtain any intellectual property rights (IPRs) on the Materials.”

The draft Partnership Contribution Implementation Plan 2012-2016 addresses several issues: Laboratory & surveillance capacity building, the burden of disease, the regulatory capacity building, and risk communications.

According to the recommendations of the Advisory Group of May 2012, 70 percent of the Partnership Contribution is planned to be directed towards pandemic preparedness activities (about UR$ 20 million), and 30 percent would go to pandemic response activities.

The Advisory Group also recommended that from the 70 percent devoted to pandemic preparedness activities, 70 percent be used to build and/or strengthen surveillance and laboratory capacity, 10 percent to conduct disease burden studies, 10 percent to strengthen regulatory capacity and improve access and effective deployment of pandemic vaccines and antiviral medicines, and 10 percent to strengthen the risk communications.

Risk communications relates to the difficulty experienced by ministries of health “in communicating information about complex scientific principles, uncertainty, risk and transparency in decision-making,” during the 2009 pandemic, the Advisory Group recommendations said. “These challenges adversely impacted key response measures, most notably deployment and uptake of pandemic (H1N1) 2009 vaccine,” they said.

The draft document notes that real-time information sources, such as social media, have created demands for “effective, coherent and credible communications during emergencies,” sources said.

Stakeholder Input

According to Janis Bernat, associate director, biotherapeutics & scientific affairs for the International Federation of Pharmaceutical Manufacturers Association (IFPMA), the IFPMA sees the PIP Framework Implementation Plan as an opportunity to strengthen transparency with evidence-based activities including indicators for success, benchmarking and metrics.

It also is an opportunity to increase awareness of “short-term” gains, test interventions to ensure they have positive impact and outcomes, and highlight areas for “mutual recognition” of regulatory approval for pandemic interventions within regulatory capacity building, she told Intellectual Property Watch.

The implementation plan consultation also offers the possibility to suggest improvements for response activities at national levels, she said.

“At the appropriate time, we hope to engage in the reevaluation process via the Stakeholder Consultations with the PIP Advisory Group as we are currently doing. We find that these consultations are very constructive and allow for open dialogue on many important issues related to the PIP Framework.”

Civil Society Concerns

Civil society groups also participated in this week’s meeting. One of the concerns of those groups, according to sources, was that the partnership contribution funds should be only used to supplement and not act as a substitute for usual funding sources for pandemic preparedness activities.

Houssin said this was also a preoccupation of industry, and that the WHO secretariat clearly established that the partnership contribution funds would be solely used for their designed purposes.

According to some sources, civil society groups also asked that the benefit-sharing mechanism not be limited to those who actually manufacture vaccines, but extended to other entities, such as research institutes and universities.

According to the PIP Framework, “Influenza vaccine, diagnostic and pharmaceutical manufacturers means public or private entities including academic institutions, government owned or government subsidized entities, nonprofit organizations or commercial entities that develop and/or produce human influenza vaccines and other products derived from or using H5N1 or other influenza viruses of human pandemic potential.”

Another concern that was raised was that while building surveillance capacity, some awareness should be raised as to what should be done when identifying viruses that are not influenza viruses, according to the Third World Network (TWN).

This concern is in relation to the Middle East respiratory syndrome coronavirus (MERS), for which two Dutch researchers filed a patent application, allegedly without requesting permission from Saudi Arabia. TWN published a paper on the subject in May.

Houssin said that the PIP Framework only covers pandemic influenza risks at the moment. It is up to member states to decide if in the future they would like to extend the system to other viruses, he said.

The Framework “applies to the sharing of H5N1 and other influenza viruses with human pandemic potential,” it says.