Immunocompetent

Back when I ran the Sunshine Project, and with the help of Third World Network, I wrote a brief item describing how the WHO Global Influenza Surveillance Network could be reformed. We distributed this at a meeting of the WHO Pandemic Influenza Preparedness Intergovernmental Meeting (WHO PIP IGM). (Yes, it's a mouthful.)

The jist of the following nearly year-old article is still about right. I should have given more attention to sequence data, with the rapid rise of synthetic biology; but it's there in rudimentary form. Take a gander at this short piece if you want to know what some of us are thinking about for a New Global System.

Third World Network
The Sunshine Project

INFORMATIONAL HANDOUT

November 2007

Intergovernmental Meeting on Pandemic Influenza Preparedness: Sharing of influenza viruses and access to vaccines and other benefits

A Quick Sketch of a New Global System for Sharing of Influenza Viruses  

 
In the interest of public health and access to affordable medicines, a new international system is needed for the sharing of influenza viruses. The purpose of this short paper is to describe, in simple terms, the basic principles and methods of operation of such a system, without delving into great detail about problems with the present system. Here some important underlying concepts for the new Global System are presented, followed by a practical description of how it would operate.

In this document, viruses are understood to include sequences, virus genes and proteins (and subunits of both), as well as materials specifically derived therefrom, such as antibodies and complementary DNAs (and genetic constructs encoding the same).

The Global System must not allow patenting of influenza viruses. A fundamental problem currently is that transfer of viruses into the system is resulting in piracy of influenza viruses by companies and other labs, and even by some WHO Collaborating Centres themselves. These patents are ethically unacceptable and ignore the rights of donor countries and influenza victims. They will result in economic and social injustices including more expensive and less accessible treatments. Therefore, all transfers of biological materials and data into and out of the WHO system, including publication of sequence data, shall be with the legal stipulation that these items shall not be subjected to intellectual property claims.

The Global System must respect national sovereignty over influenza viruses. Sovereignty over genetic resources found within a country’s borders is established in international law and most prominently enshrined in the Convention on Biological Diversity.(1) Sovereignty should not be confused with ownership. Respecting sovereignty does not mean that a government owns influenza viruses occurring within its borders, rather, it means that the government has rights in determining how they are used. These rights must be preserved and applied when the viruses are transferred into and out of the Global System.

Specifically, in the new Global System, sovereignty means that governments must grant their prior informed consent to uses of the viruses that they contribute. For key functions such as surveillance and development of vaccine seed strains, this prior informed consent can be pre-negotiated and applied in the form of an agreement like those already routinely used for transfer of biological research materials. For other purposes, including commercial ones, it may be necessary to specifically request consent from the donating country.

The Global System must require the commitment of all participants to the fair and equitable sharing of benefits that arise from influenza virus research. The Global System must provide real, tangible benefits to participating countries, particularly developing countries, who receive next to nothing in return of participating in the current system. This would be the best way to avoid frustration with the system, which in turn could lead instead to mainly bilateral arrangements. The precise benefits will vary depending upon the situation, however, under the umbrella of the New Global System, for developing countries they may include: (1) free access to and assistance with vaccine production such as equipment and know-how (e.g. cell culture systems and adjuvants), (2) vaccine stockpiles under WHO physical control which would be distributed on the basis of public health needs, (3) free or discounted set-asides of a percentage of prepandemic and pandemic vaccine production lots; (4) free or discounted access to other influenza medicines, and (5) commitments of non-enforcement of influenza-related intellectual property rights. How would a New Global System operate? As a practical matter, there would be a number of major changes from the current system for sharing influenza viruses. These include:

Rewriting the terms of reference between WHO and the Collaborating Centres and enforcing them. Current WHO Collaborating Centres are governed by loose and unenforced arrangements. Because of intense commercial interest in influenza viruses and actual and potential conflicts of interest at some Centres, the terms of reference must be radically revamped. In particular, WHO itself will assume responsibility for virus use and transfers, meaning that in these areas, the Centres will no longer have any latitude to do as they see fit. In those matters, they will act only on behalf of WHO and only as specifically authorized in the new Terms of Reference. This means that transfers of virus into and out of the Centres will effectively be governed by the terms of agreement between donor countries and WHO and not ad hoc or peculiar arrangements, or lack of arrangements, between the Centres and donor countries.

In general, movements of viruses will be covered by Material Transfer Agreements.Presently, no such agreements are executed between donor countries and WHO Collaborating Centres meaning that, in effect, the viruses are a no-strings-attached gift from developing countries to the Centres, for the Centres to treat as they see fit. As benefits have not been shared and this practice has led to piracy, this unacceptable situation must be changed, and WHO must no longer tolerate, endorse or encourage it.

Material Transfer Agreements under the New Global System could be of three general types – 1) those from a country of origin to a WHO Collaborating Centre, 2) those of virus seed stock from a WHO Collaborating Centre to a vaccine manufacturer, and 3) all other transfers. The first two transfer types can largely or even completely be governed by pre-negotiated terms elaborated in a standard form.

Such Material Transfer Agreements are not onerous and are by no means unprecedented. In fact, similar MTAs are already the norm for transfers of biological research materials in developed countries. In many cases, MTAs already commonly used for influenza virus transfers between Northern institutions are more restrictive than those likely to emerge under a New Global System.

In the case of a standard MTA between the country of origin to a WHO Collaborating Centre (acting on behalf of WHO), the main purpose is to authorize the Collaborating Centre to perform its important responsibilities (such as identification and characterization of the strain) set forth in the Centre’s Terms of Reference and to preserve national sovereignty over the virus. /Such MTAs will make stipulations and preserve sovereignty in the event of transfers to third parties beyond the Centre that, in most cases, will require execution of a new MTA between the third party and the country of origin. In some cases, for example transfers between Centres and reference labs, or for research by a third party contracted to a Collaborating Centre for research in accordance with the Centre’s WHO Terms of Reference, there may be latitude for transfer for those purposes under the first MTA.

In the case of a standard MTA between WHO and a vaccine manufacturer for transfer of vaccine seed strain, the main purpose is for the vaccine manufacturer to obtain authorization from the country / countries of origin of the seed strain virus and for the manufacturer to make commitments for benefit sharing as pre-negotiated under the umbrella of the New Global System (as described at the top of page 2). This MTA will enable the manufacturer to use the seed strain for vaccine production or further development for vaccine production and will bind the manufacturer to fair and equitable sharing of benefits.

In the case of other transfers, prior informed consent of the donor country will be required, and execution of a new MTA with the country of origin will be necessary if requested by the donor. These include transfers of viruses that are not vaccine seed strain to companies, and use of virus by the Centres in ways not specifically authorized by the Terms of Reference. Because these transfers may be to very different kinds of institutions for widely varying purposes, no complete single set of terms may be applicable. WHO, governments, scientists, and NGOs should discuss these transfers with a view to establishing standard procedures and boilerplate MTA language, which perhaps may evolve into standard MTAs in the future. Importantly, setting final definition of terms of some of these types of transfers aside for the time being will not prevent establishment of a New Global System.

WHO Collaborating Centres and other entities will renounce influenza-related intellectual property claims as a condition of their participation in the New Global System. These include claims on viruses, genes, sequences, proteins, and their use in human and animal vaccines and diagnostics. This will ensure the availability of the system’s resources and outputs for public health uses. In the current system, some Collaborating Centres have made patent claims or argue that they should be made "defensively". "Defensive" patenting is not a solution, it is a symptom of the problem of privatization. Instead of worsening the condition by increasing the amount of patenting, the New Global System should renounce it, and seek to inoculate its resources and products from such claims.

Access to New Global System sequence data will not be impeded, and subject to the first MTA can be made available online. Important conditions will include that all data be available to all persons, and that all who access it must agree not to sell or make any type of proprietary claim to it or for its use. Models of these types of systems can be found for software and other media and these can be adapted for use with New Global System sequence information.

Virus transfers will be comprehensively tracked by WHO, which will maintain a database of them as it will be advised of all such transfers by virtue of its revised relationships with the Collaborating Centres. This data should be available to Member States and the public.
Donor countries will have certain other research-related rights, including those of immediate material return and provision of characterization data, other research results and publications.

Footnote: (1) It has been suggested by some that influenza viruses do not fall under the Biodiversity Convention because they are a potentially harmful type of genetic resource that humans seek to control. This is not only an incorrect assessment of the language of that treaty, in fact, the operations of the Global System and influenza research are very clearly aligned with the intent of the CBD. The collection, obtaining, distribution, and preservation of influenza diversity is a core purpose of the Global System, as that diversity is critical to treating influenza. The fact that governments value such diversity and its preservation is illustrated by the extreme lengths that have been resorted to in order to recreate the 1918 influenza virus.