Effect Measure

Flu virus sharing summit: wrap up

As you will see from the account below the fold, the flu summit was a contentious and complicated affair. Only time will tell if it was even a qualified success, but there are reasons to be hopeful. Tip of the hat to Ed Hammond, one of the NGO participants, who provided the public health community with his perspective at a time when no one else was talking. This involved late hours for him at the end of long days. We are grateful.

Here’s his wrap-up:

Influenza Meeting Ends in Qualified Success

At the end of contentious meetings like the one on policies for sharing flu virus it is tempting to declare winners and losers amidst a huge volume of verbiage and paper. Yet is usually takes time to sort out what happened. The devil is not only in the details but how actors construe the details as we move forward. If forced to make an instant evaluation, I would say that on a scale of one to ten, the outcome is a seven, maybe a seven point five. That’s solidly in positive territory, even if this initial evaluation gets revised a bit downward with time and distance.

By the end of the morning session on Friday (23 Nov), it was clear that the meeting would produce a text, in quasi-legal language, expressing the different ideas of countries on virus sharing and benefit sharing as they apply both in “principle” and in “operational” aspects. But an early stage text rife with contradictory ideas and brackets (indicating lack of agreement) can easily die.

For many readers here the bottom line question will be whether Indonesia will share viral isolates as we go forward, but understanding the process is important to assure that any agreement, interim or otherwise, lasts a week or is more durable.

Bracketed text in the final text represents issues still under discussion. But the [bracketed] text is useless without a plan for coming to agreement upon it. Such a plan was a major outcome of the meeting. rough draft documents now exist containing ideas from many countries and a run-though has been done to start to agree on details. The Inter-Governmental Meeting (IGM) will come together again to keep negotiating. Officially, the meeting is not over, only “suspended” until a near term resumption, probably a 5 day affair in July 2008. Thus, the text from here has the potential to become the durable solution that the world needs to keep viruses moving (and start real benefits for developing countries flowing).

“More meetings” is not an outcome satisfying to many and provides no immediate relief, but it remains the most important outcome of the meeting. The text has many good ideas. As important as what did happen is what didn’t: The US and the EU will not likely succeed in claiming the problems with the GISN [Global Influenza Surveillance Network] can be fixed by maintaining the status quo. The benefits of the system will not be just be a vaccine stockpile. There will also be material transfer agreements (MTAs, or “standard terms and conditions”).

There are many vexing details to work out. The working text and submissions by countries (still on the table) for the operational aspects of the New System, including draft standard MTAs, is fifty nine pages long. The principles text, not as long, is anything but simple. Most importantly, however, there is a plan to work through it all.

The next steps didn’t come easily. The meeting didn’t end until nearly 11 PM, five hours late. From 3 PM onwards, it was occupied with a “statement” summarizing the results of this meeting and a paragraph describing the next meeting. The “statement” should not be confused with the text for future negotiation. These are different documents. While the text remains to be discussed and developed at future meetings, the statement is a short, two page conclusion from this meeting.

Initially the “statement” was to set out two key interim measures to be taken as governments continued to work toreach a long-term agreement (i.e. finish negotiating the text). Those two measures are the establishment of a “traceability system” to track the flow of viruses (and virus parts), and an advisory group to work with the Director General to make suggestions on how to improve the the virus sharing system. But the statement contained poison pills, because the US and the EU want(ed) the GISN reform process stillborn. Neither one presented a significant new idea at this meeting and that inaction at this important time will be what their participation is remembered for.

The unacceptable conditions included references to “security”, vague mandates to the Director General and, as is becoming the norm from the US and EU, explicit and coded references to the IHR [International Health Regulations] suggesting (contrary to its actual text) that the agreement trumps national legislation and requires transfer of biological materials. This latter bit is unacceptable to Indonesia because the US and perhaps the UK have refused to return Indonesia viral isolates, claiming that their national laws prevent it.

If the statement had been adopted as initially presented it is likely the “interim” measures would have become permanent and the text would have wound up in the trash heap. The GISN would have acquired an ornamental advisory board and a traceabililty system of dubious quality. And the security and IHR language would have resulted in the diplomatic equivalent of an Indonesia vs. WHO (with the US pulling WHO’s strings) celebrity deathmatch, resulting in Indonesia either giving up or formally withdrawing from the system.

Fortunately, this didn’t happen. Under pressure from an assortment of developing countries the US and EU abandoned their positions on the statement. Brazil weighed in to reject national security language in the statement and it (and Chile) demonstrated they are at least a match for the US, Canada, and others when it comes to the finer diplomatic arts of negotiating text.

When India asked the EU why it had such a fixation about about inserting international law (mainly coded IHR and security references) into the paragraph about sharing viruses in the interim before a durable solution is agreed, the EU was forced to admit its intention was say that international law trumps national legislation, and that – in simple terms – all governments have a binding international obligation to send disease samples. (NB: the IHR does not require this. Remember, too, the context: Indonesia is being denied return of viruses “because of national legislation” in US and maybe UK).

This attempted manipulation of international rules and the double standard with respect to national law produced a backlash in the entire developing world against the EU. India’s suspicions were confirmed, while Thailand and others weighed in to ask the EU to desist. Africa had already been alienated over failure to consult. Canada made a lonely and clumsy attempt to aid the EU. It failed.

At this point the attempt to fashion a closing statement was on the verge of collapse. Ironically, and perhaps chagrined it might have pushed the EU, it was the US that tried “shuttle diplomacy” between the EU and other countries to come up with a solution. It was a humbling half hour for the US delegation. Agreement remained elusive. The Director General sang “Getting to Know You” (yes; not a figure of speech. She really sang. Think of the poor interpreters]. She then personally joined the fray, shuttling from corner to corner, consulting with countries (who were seated by region).

Ultimately the EU retreated and the poison pill was removed from the statement. Except for the inconvenient fact the Chair and others failed to properly consult with Africa before unveiling the statement (Africa will submit its formal assent next week), the statement has been adopted. We will have an interim tracing system for viruses (and parts of viruses) submitted to WHO Collaborating Centers, and the Director General will work with an advisory group to make recommendations on system reform. The latter will participate in the process of revising the text of the long-term solution. The interim measures will not supplant or impede development of a New System.

On balance, this is not a bad result. Expect attempts to manipulate this agreement at the World Health Assembly in May 2008, and NGO eyes will be fixed upon the Director General’s advisory group (to prevent attempts to undermine the spirit of the agreement there).

In this abbreviated account of four intense days, much has been left out a lot, including the story of how the next Inter-Governmental Meeting (IGM) came to be a real negotiating session, and an open meeting for all countries, held in Geneva, rather than a small and opaque affair in an out of the way place (think Australia) where, if the wealthy countries had their way, Indonesia would have capitulated and GISN would have continued effectively unchanged. But this note account is already long enough.

As for the Indonesian viruses, I will not predict what Indonesia is going to do and I doubt anybody that has followed this process would be foolish enough to do so either. My slightly pessimistic view is, don’t hold your breath. I will observe this: Indonesia is part of an agreement that validates and confirms the importance of continuing to share viruses in the interim before a final agreement is reached to reform the system. That agreement also speaks about national law. The US asserts its national law prevents it from sharing viruses with Indonesia (and many other countries). At this point, it would indeed be an expression of goodwill on the part of Indonesia to send viruses to the CDC, especially if the US is unwilling to reciprocate. This is a stupid position of the US and the impasse must be broken if we are to have a good chance of moving forward. The idea that what’s yours is mine but what’s mine is just mine isn’t something that promotes sharing and equity.

As important as the current Indonesia viruses are, this process is no longer Indonesia versus everyone else. There are many more countries and interests now at the table. This is now about transforming the GISN with the principle of transparency and fair and equitable sharing of the benefits that arise from influenza research and, in doing so, improving pandemic preparedness and public health.

Let’s hope it can be done quickly.

We’ll be keeping an eye on it. Previous happenings and background here, here, here, here and here.

Comments

  1. #1 Gilmore
    November 24, 2007

    Thanks so much for the non – MSM report.

  2. #2 anon
    November 25, 2007

    someone please post a link to a shorter summary

  3. #3 revere
    November 25, 2007

    anon: Feel free to post one if you find one. As far as we know, this is the ONLY inside and detailed account on the net.

  4. #4 M. Randolph Kruger
    November 25, 2007

    And E. Hammond didnt have to send us anything either. Attaboy to Hammond.

    Analysts pour over details like this in the spook world for days and weeks. Two or three Hammond type reports with intentional bias from the right and left generate a really good idea of what went on.

    Had that same type of program come about during assessments for Iraq then we might not have been visiting Saddam. Double Attaboy for Hammond.

  5. #5 RobT
    November 25, 2007

    http://hosted.ap.org/dynamic/stories/A/AS_GEN_INDONESIA_BIRD_FLU_ASOL-?SITE=AP&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2007-11-25-06-31-06

    I think many of us are looking for the bottom line result here, and the result it seems is NOT that Indon will share H5N1 samples or sequences.
    Supari states in the AP report above that they will not be sharing samples anymore, and why should we doubt her?

    If the best result of all these well intentioned folks is that there will be meetings to continue the dialogue in July 2008, well I think that is pathetic. Hopefully it doesn’t turn out to be tragic, as well.

  6. #6 revere
    November 25, 2007

    RobT: I think the message of Ed Hammond’s dispatches was that looking only for a bottom line here doesn’t tell the whole story. He was not optimistic about immediate sharing by Indon but that was not the only thing that happened at the meeting and not the only thing on the table. So we’ll have to see. If the bottom line is only immediate sharing of virus, then you may have a fair take on it. But I don’t think it was the only thing.

  7. #7 M. Randolph Kruger
    November 25, 2007

    Sheyit Rob, its already a tragedy. Under US law Indonesia could be considered a rogue state and that would have been under the Clinton definition to boot.

    Time is not apparently on our side with all of the critters that are dying of it now, be it H7 or H5. Take your pick which one you want to go from. The Indons gambled and lost and as I posted before this would result in a impasse. Are we going to pay to elevate the Indons vaccine capability? Not only no but Hell no. No one told the Chinese that they had to give them up and they do withold for a bit but they do. Sidelines into several countries have it that they are pissed off at Indon but they understand their position. I understand their positions too but its a case where the people with the power are calling the shots. If we paid for a regional vaccine center then they wouldnt just be working on BF. If its on their soil they can make vaccine. Its about the money and this is one of the reasons that Revere and I diverge. If there was ever a case that proves healthcare is a service and not a right, this is it. Supari wants us to put them in business with the carrot being an off antigen sample or two. We cave to this then she will demand that we build the facility first, then later that we provide more funding, then they patent the vaccine that we paid for. Uh-uh. Even the EU balked on this one and with more and more coming out this “bracketing” stuff was just to slow and obstruct what the Indons wanted to do. It became an Indon/US fight because we represent really Sanofi, Glaxo, Sinovac, Bayer, Genentech and hundreds more. Once you cave to extortion, they have you.

    Is the system fair and equitable? No, but the Indons have the most to lose from it. We would have a huge hit, but they would lose the farm. They lose their infrastructure and from todays standards it might take 50 or so years to regain it to todays standards. Just as it did in the Plague.

    My big problem with the whole thing is that we are fighting over samples that are off the final fixed antigen that might provide a researchable bug that can tell us how many and how well its adapting to us. But again, the position that some country is going to dictate to the rest of the world about bug transfers is pretty short sighted. Their gun simply isnt big enough to force that issue. Birds do fly and so far they seem to be spreading the crap all over the planet with great efficiency.

    The other part of this is that July IMO is too late. If they indeed want to hold onto their bugs then fine the world should hold onto its money having sent 2 billion in there and had it squandered. Even the Indons have called it all into question now. Where did it go? They still cant account for any of it. Supari says that she believes its only 20% was snatched. But look at this very nice article from Bali which is far removed from the pressures of Jakarta. Pretty much its own country and note the date.

    http://www.balibs.org/news-update/Bali_Chicken_Flu.shtml

    Will things change? I cant say for certain but there isnt going to be any regional vaccine production center. Nor would the world be stupid enough to sit back and tell Indonesia that they would sign something effectively into law that says that the West would produce and deliver vaccine in quantity and cheaply. Its a product, you have the right not to buy it. Webster has a vaccine for it now in the freezers over at St. Jude, but its so hot even with it reverse engineered that it could kill you in its own right. So what are we really fighting for. Can you even vaccinate someone with the non existent fixed antigenic vaccine that is not distributed, not ready and above all not based upon the Indon bugs?

    So what does Supari really want? Is it posture and position or is really more another stab for yet more West money for a bug that is clearly off antigenic pattern. If it were, we would be in Pan Level 4-5. Have you ever seen the true steps in the pandemic plan for the US. It creates first a level which we are at now to create an off antigen vaccine-Pan 3. We are doing that.

    At level 4-6, we start to bring up the reserves and start trying to get a fixed antigen vaccine. It would take about a month to do it once we had the real bug. Then we go into production. Once it goes public we (the West) wouldnt have to worry about samples. They would be dying at our feet. Production though in this case would be incredibly slow because this shit kills the eggs we grow bugs in and molecular level production would be enough for probably a couple of hundred to a thousand doses (maybe) a day. All the while the bug is mutating so what we start with is not what we will end with.

    Even with regional vaccine centers this wouldnt work because of the distance involved. Its sure to create more or less hairy mutations along the way. Remember seasonal flu in California last year? The emergency rooms were war zones and lots of people were so sick they couldnt even get there. So we have to know that Supari knows this or she is just flat stupid and so far that doesnt seem to be the case.

    Supari is right about one thing though. There is nothing that is in the books to force any country to send samples along. They belong to the country from whence they are found. But only a fool sits with a hand grenade and no pin in it. Sooner or later it goes off. It seems to me that we are hearing the first muffled rumblings of it. If its really coming we get to hear the boom and feel the concussion just a bit later than they will but they get the full monty on the explosion.

    Wonder what they would be willing to pay for a safety pin?

  8. #8 AnnieRN
    November 25, 2007

    And they don’t seem to realize that this isn’t a game of “Hot Potato”–Indonesia can’t simply pass the grenade off to the next player when they get sick of holding it. I can just imnagine that they suddenly wake up one day to find that the worst case scenario has developed there, and then get upset when the identical vaccine–for the virus that they’ve been holding– isn’t available.
    I have a feeling that this is generally a pretty typical third-world response anyway, what with medical care being so hard for people in these countries to obtain. When they have to go over four mountains and, if they’re extremely and rarely fortunate, a flight through the jungle to see the doctor or nurse, they become fatalistic. In my public health work, it’s pretty routine to see the attitude of, “Well I was going to get it anyway…so why stop the behavior that led me to it. Someone will come along with the miracle I need, maybe. My other friends have the same disease, so I’m not alone.” The difference here is that the stakes are so high–with the CFR so high in Indonesia, this seems to be the nuclear version of the virus.

  9. #9 M. Randolph Kruger
    November 25, 2007

    Also Annie, you hit another point. Do you put a very hostile nation into business with bugs from all over the world. There simply isnt as Revere is quick to point out much difference from biowarfare and bioresearch. There is a major bent in this country to get into the biobug business as part of anti-terrorism. So instead we build them a facility that can build bugs with like 68% of the country being Muslim. They have one whole island that is full of terrorists and thats by Muslim standards…..

    I could be wrong but I doubt if you will ever see it. If it comes before they get this thing ironed out, its a self correcting problem. They get hit, we get hit. They get no vaccine, we get some vaccine. Well really likely effectively no vaccine. So again its the reason for the West not to do anything at all except to “feel their pain.”