Today Krista and I attended a “stakeholder consultation stakeholder consultation regarding the implementation of the World Health Organization’s Pandemic Influenza Preparedness Framework.” The meeting was chaired by Jonathan Margolis, the Acting Deputy Assistant Secretary for Science, Space and Health in the Department of State’s Bureau of Oceans and International Environmental and Scientific Affairs.
The WHO web page on the framework is here: http://www.who.int/influenza/pip/en/. The invitations were sent by the Department of State’s Bureau of Oceans, Environment, and Science (OES). The meeting included about a dozen persons from State and other federal agencies, including USTR. KEI was the only stakeholder to attend.
According to OES, WHO’s Pandemic Influenza Preparedness Framework, or PIP-FW for short, is functioning. Drug companies have been discussing the standard material transfer agreements called for under the agreement with WHO, and receiving samples under interim arrangements for the time being. In return for receiving the samples under the new agreement, the companies have agreed to benefits that will be managed by WHO. But several steps are not yet implemented, including the part of the agreement dealing with funding (see below).
The 2011 WHO publication describing the framework is 68 pages long, including 25 pages describing the framework and more than 40 pages of Annexes. Parts of the document read like a contract, and include specific policies and obligations of various parties. The objective and scope of the PIP-FW are described as follows:
2. Objective.
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.3. Scope
3.1 This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits.
3.2 This Framework does not apply to seasonal influenza viruses or other noninfluenza pathogens or biological substances that may be contained in clinical specimens shared under this Framework
To get an idea of the level of detail, consider just a few paragraphs from the section on the Pandemic influenza preparedness vaccine stockpile:
6.9 Pandemic influenza preparedness vaccine stockpile6.9.1 The Director-General will establish and maintain a stockpile of vaccines for H5N1 and other influenza viruses with human pandemic potential and associated equipment, including syringes, needles and applicators, consistent with expert guidance.
6.9.2 The WHO stockpile will initially include 150 million doses of H5N1 vaccine for use in accordance with expert guidance including the Strategic Advisory Group of Experts on immunization (SAGE). Indicatively:
(i) 50 million doses will be for use in affected countries, according to public health risk and need, to assist in containing the first outbreak or outbreaks of an emerging pandemic; and
(ii) 100 million doses will be for distribution, once a pandemic begins, to developing countries that have no or inadequate access to H5N1 influenza vaccines, on a per capita basis, with use to be determined by those countries.
The Framework deals with a number of issues concerning access to antiviral medicines, diagnostics and vaccines, including, for example, this text on pricing:
6.12 Tiered pricing
As a measure to improve the affordability for developing countries of pandemic influenza vaccines and vaccines for H5N1 and other influenza viruses with human pandemic potential, and antivirals, Member States should urge influenza vaccine and antiviral manufacturers individually to implement tiered pricing for these vaccines and antivirals. As part of this approach, influenza vaccine and antiviral manufacturers individually should be urged to consider the income level of the country, and negotiate with the national authorities of the recipient country, in arriving at the price to be applied in the private and public markets of each country. In this context the vulnerability of the least developed countries should be taken into account.
Among the more innovative and controversial elements of the system set out in Annex 2 is the Standard Material Transfer Agreement 2 (SMTA 2), for transfers of materials outside the WHO global influenza surveillance and response system (GISRS ). The SMTA 2 sets forth the obligations on drug, vaccine, and diagnostic manufacturers, which are implemented as a “menu” of possible actions to expand access to the signatories’ products. To illustrate, consider the obligations set out in 4.1.1.A.
Article 4. Obligations of the Recipient4.1 The recipient agrees to comply with the commitments selected below, in accordance with the terms set out in the Annex to this agreement.
4.1.1 The recipient shall comply with the commitments selected on a timetable determined by the WHO in consultation with the Advisory Group established by the PIP Framework and in coordination with the recipient, based on optimal pandemic preparedness and response considerations
A. For manufacturers of vaccines and/or antivirals, the recipient shall commit to at least two of the following options:
A1. Donate at least 10%1 of real time pandemic vaccine production to WHO.
A2. Reserve at least 10%1 of real time pandemic vaccine production at affordable prices to WHO.
A3. Donate at least X treatment courses of needed antiviral medicine for the pandemic to WHO.
A4. Reserve at least X treatment courses of needed antiviral medicine for the pandemic at affordable prices.
A5. Grant to manufacturers in developing countries licenses on mutually agreed terms that should be fair and reasonable including in respect of affordable royalties, taking into account development levels in the country of end use of the products, on technology, know-how, products and processes for which it holds IPR for the production of (i) influenza vaccines, (ii) adjuvants, (iii) antivirals and/or (iv) diagnostics.
A6. Grant royalty-free licenses to manufacturers in developing countries or grant to WHO royalty-free, non-exclusive licenses on IPR, which can be sublicensed, for the production of pandemic influenza vaccines, adjuvants, antivirals products and diagnostics needed in a pandemic. WHO may sublicense these licenses to manufacturers in developing countries on appropriate terms and conditions and in accordance with sound public health principles.
Where Option 5 or 6 is selected, the Recipient shall regularly provide to WHO information on granted licenses and the status of implementation of the licensing agreement. WHO shall provide such information to the Advisory Group.
According to OES, one important issue that has not been resolved is the detailed system for collecting and allocating the funds called for under the new framework. We were told that companies that manufacture vaccines, drugs and diagnostics will be expected to contribute around $28 million per year, or half the cost of the existing system. They wanted our views on how the money should be raised. [See text on 6.14, below]
KEI’s initial view was that the WHO should consider a fixed percentage levy based upon revenues from relevant vaccines, drugs and diagnostics, with a cut-off to exclude smaller businesses and non-profits. But we promised to provide more input on this question next week during another consultation in Geneva.
Below are the provisions in the agreement regarding the funding issues:
6.14 Sustainable and innovative financing mechanisms6.14.1 With a view to ensuring the sustainable financing of the PIP Benefit Sharing System, particularly for developing countries; and
6.14.2 Having regard to the desirability of all Member States and recipients of PIP biological materials contributing to the PIP Benefit Sharing System, financially or in kind, according to their capacity and over time;
6.14.3 Influenza vaccine, diagnostic and pharmaceutical manufacturers, using the WHO GISRS, will make an annual partnership contribution to WHO for improving global pandemic influenza preparedness and response. It is decided that the sum of the annual contributions shall be equivalent to 50% of the running costs of the WHO GISRS./1/ Such contributions will commence in 2012. The distribution between companies is to be based on transparency and equity, based on their nature and capacities. The Director- General in consultation with the “Advisory Group” will further define the specific amounts to be contributed by each company as well as the mechanism for implementation (see section 6.14.5 below). In so doing, the Director-General and the “Advisory Group” will collaborate with industry. The Director-General will report annually on the outcome to the Executive Board.
6.14.3.1 Member States and other stakeholders are encouraged to consider making donations and in-kind contributions to WHO for improving global pandemic influenza preparedness and response.
6.14.4 The contribution acquired under 6.14.3 shall be used for improving pandemic preparedness and response, inter alia, for conducting disease burden studies, strengthening laboratory and surveillance capacity, access and effective deployment of pandemic vaccines and antiviral medicines.
6.14.5 The Director-General will propose to the Executive Board which proportion of contributions should be used for inter-pandemic preparedness measures, and which proportion should be reserved for response activities in the event of a pandemic, based on the advice of the “Advisory Group”.
6.14.6 The Director-General, based on advice from the “Advisory Group”, will decide on the use of resources. The Director-General and the “Advisory Group” will interact with manufacturers and other stakeholders.
6.14.7 Member States are urged to continue to support the speedy and successful implementation of the WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply by 2015 by providing adequate financial support in accordance with Framework sections 6.13.1 and 6.13.2.
6.14.8 Member States are urged to support the availability and rapid expansion of the safe use of adjuvant technology through WHO as appropriate while at the same time strengthening the monitoring of vaccine safety.
6.14.9 Member States are urged to continue and increase their support to strengthen laboratory and surveillance capacity particularly in developing countries by providing adequate financial and technical support in accordance with Framework section 6.6.
/fn1/ The running costs of the GISRS for 2010 were approximately US$ 56.5 million. The running costs of the WHO GISRS are understood to be a reference index for the partnership contribution of 50%. Such running costs may change over time and the partnership contribution will change accordingly. Such running costs are not to include the partnership contributions themselves.