Immunocompetent

This is a short paper that I wrote late last year on the contradictory and self-destructive US and EU positions on influenza virus sharing and the Revised International Health Regulations. It was originally distributed at a meeting of the Pugwash Study Group on the Chemical and Biological Weapons Conventions and is thus written from a security perspective, and uses terms like "biosecurity".

I generally think that security language is essentially useless and even counterproductive for talking about flu, particularly the ill-defined term "biosecurity" which is dangerous (I try to always put it in quotes). I use it nonetheless because it is (hopefully temporarily) part of the lingua franca of security types (but never public health, I hope!).

Discussion Paper for the 27th Pugwash CBW Workshop, Geneva, Switzerland, 8-9 December 2007
(Edited for distribution on 18 September 2008.)

International “Biosecurity” Cooperation Placed at Risk

US and EU Attempts to Reinterpret the Revised International Health Regulations (2005) related to the Issues of Influenza Virus Sharing and Transparency and the Fair and Equitable Sharing of Benefits of Arising from Influenza Research

1. International sharing of influenza viruses is important for the development of effective diagnostics and vaccines against influenza viruses and is thus important for pandemic preparedness (herein considered an aspect of “biosecurity”).

2. Governments have sovereignty over the biodiversity, including the microbial biodiversity, found within their borders. This sovereignty is most importantly, but by not exclusively, reflected in the Convention on Biological Diversity, which includes influenza and other viruses and bacteria within its scope.

3. Regrettably, many scientists and scientific institutions are not aware of national sovereignty, choose to ignore it, or cling to antiquated notions that genetic resources are the “common heritage of mankind”. Paradoxically, some of the same scientists and the institutions they work for will readily assert their own property rights over viruses and their parts. Confusion about these issues has negatively impacted public discussion of virus sharing.

4. The WHO Global Influenza Surveillance Network (GISN) has, in its 60 years of operation to date, received millions of viruses from across the world. It has distributed these viruses, as well as candidate vaccine seed strains and sequence data, to third parties, including the vaccine industry.

5. The sharing of these viruses has enabled the development of seasonal influenza vaccines, however, in general, only the vaccines for the Northern Hemisphere have resulted in major public health benefit because demand for seasonal influenza vaccine in the Southern Hemisphere is severely limited by socioeconomic factors.

6. The WHO has endorsed a plan to expand seasonal influenza vaccine manufacturing in less developed countries in order to improve pandemic preparedness (herein considered an aspect of “biosecurity”), yet this plan to increase global production is patently preposterous because there is no market for these vaccines. That is, the poor generally cannot afford and have greater priorities than buying an annual flu shot.

7. The details of virus distribution by the GISN are not known to governments and have not been systematically recorded. Only in response to recent concerns raised about virus sharing has the GISN made an effort to track virus sharing. This effort remains interim and may or may ultimately prove to be effective.

8. Indonesia’s decision to reduce sharing of H5N1 influenza viruses infecting humans has resulted in allegations that this situation impacts the pandemic preparedness (herein considered an aspect of “biosecurity”) of other Member States and initially caused criticism from the WHO Director-General and other officials, many of whom began their careers with or are seconded from the US Centers for Disease Control or Health Canada.

9. Among the reasons cited by Indonesia for its decision are the lack of transparency of the GISN, failure of the GISN to provide for fair and equitable sharing of benefits arising from influenza research, and intellectual property claims lodged on viruses and virus parts (RNA, cDNA, etc) by recipients of virus from the GISN system, giving rise to biopiracy.

10. The criticisms of Indonesia and governments supporting its position have extended to attempts by the United States and the European Union to engineer WHO statements and resolutions that imply that by not sharing H5N1 samples, Indonesia stands in violation of its obligations under the International Health Regulations (2005).

11. In fact, the International Health Regulations (2005) do not require sharing of viruses or any other causative agents of outbreaks of disease of international public health concern.

12. Although the International Health Regulations (2005) do not require sharing of viruses or any other causative agents of disease, in diplomatic correspondence senior WHO officials have asserted that they do, in contradiction to legal advice WHO has received and calling into question the independence of the WHO Secretariat in this matter.

13. When asked if the US interprets the IHR to require virus sharing, US officials stumble and vacillate and will not give a clear answer, despite their efforts to get WHO officials to state that the IHR requires virus sharing.

14. When asked about the applicability of international law to influenza virus sharing, the EU has stated that it believes that there are international legal virus sharing requirements that outweigh national legislation.

15. Paradoxically, when Indonesia has requested return of samples of its own viruses from WHO Collaborating Centres in the US (and, apparently, the UK), it has been told that national legislation (export controls) impedes transfer of H5N1 viruses to Indonesia. The EU, and apparently the US, thus argue that the same international regulations that they allege to preempt Indonesian national legislation do not preempt European and US legislation.

16. Although both talk about “collective action”, the policies of the US and EU with respect to the IHR and influenza virus sharing thus reflect arbitrary and contradictory interpretations of international law and ex post facto attempts to modify it.

17. In general, the response of the US and EU to the concerns about virus sharing raised by many developing countries has been to maintain the GISN status quo that those countries find unacceptable. Neither the US nor the EU has brought a significant new idea to the table for how to bring about reforms to that system so as to reflect the concerns about its lack of fairness.

18. Particularly in view of disparities in resources available to respond to a flu pandemic, the naked self-interest and cynical machinations of the US and EU on the IHR virus sharing, as well as apparent attempts to manipulate the WHO Secretariat for the same ends, is alienating many developing countries, large and small.

19. The mistrust created by the GISN’s lack of equity and US and EU policies is so great that the Indonesian Minister of Health has gone so far as to suggest that viruses given to the GISN may be being used to create biological weapons.

20. To date, developing countries of Asia and Africa provide most new H5N1 isolates.

21. Safe handling of H5N1 requires high containment facilities and expertise in infectious disease agents.

22. The organizations, labs, and scientists that collect and handle new H5N1 samples in developing countries are thus frequently precisely the institutions of interest to international “biosecurity” efforts to promote the integrity of research institutions and to ensure that potential biological weapons agents are properly handled and safely stored.

24. These same organizations, labs, and scientists are those that are most likely to be impacted and alienated by short-sighted US and EU policy on virus sharing.

25. Thus, what goodwill has been earned in recent years through US and EU “biosecurity” programs in developing countries is being placed at considerable risk, and the possibility exists for rifts to emerge between infectious disease research institutions.

26. If the US and EU seek a binding international agreement requiring influenza virus sharing and/or sharing of other causative agents of infectious disease, then they should not do so in such a dangerous and fractious manner that builds tensions between countries and may even come to threaten the revised IHR itself.

27. It thus may be concluded that it is not in the interest of the US and EU to continue to construe that the IHR mandates virus sharing, particularly in the absence of making any meaningful proposals to address the concerns of developing countries.

28. An international agreement requiring influenza virus sharing and, eventually, sharing of other causative agents of infectious disease might be achieved as a result of reforming the GISN. Rather than resisting reform, the US and EU should advance their desire to ensure the transfer of these agents by recognizing the double standards and backlash potential of their current policies, and to seriously address the concerns that have been raised by developing countries, rather than defending the unjust GISN status quo.