Examination of Witnesses (Questions 940
- 959)
TUESDAY 6 MAY 2008
Professor Harvey Rubin
Q940 Baroness Hooper:
The notion of joined-up thinking is always very attractive, but
I know from my own experience in government how very difficult
it is, even here in Whitehall, to get joined-up thinking between
government departments or even, dare I say it, within the same
department. When you are looking at these other areas of global
warming, poverty, changes in land use, international travel, lifestyle
et cetera impinging, I see a danger in too many organisations
wanting to become involved and maybe too many of the ones who
you do not want and perhaps some of the ones that you really do
want, like say China, not wanting to become involved. It is really
a question of where do you draw the line. Would you, for example,
in looking at academic institutions, look at the Finlay Institute
in Havana, Cuba, which has done such incredible work in the area
of vaccines? Who will decide who should participate and become
involved? And does it again link up with the funding issue that
I raised earlier?
Professor Rubin: I hope we get to that problem,
that would be just a wonderful outcome. We would have to put together
a governing board—and, you are right, it would not be just
everybody. If you read Dr Jones' paper in Nature, you will
see that these issues of urbanisation—as of this year or
last year, more than half the world now live in urban centres
and, trust me, it is not downtown London, it is slums. This form
of urbanization is going to have an enormous impact on infectious
diseases, so we cannot ignore these non-medical impacts and influences
and we have to be very smart on which ones we do include and which
ones we do not include. There will have to be a board of governors,
and we would have to have people with vast experience, lots of
wisdom, lots of knowledge, saying that these are the issues that
are part of the solution and part of the problem. Urbanisation,
global change, transportation, even the carbon imprint, these
all are part of the problem; and, if you do not have somebody
thinking in an integrated way, you will not get the solution that
I think is the most optimal one. That is, after all, the point
of systems engineering, to get to the optimal solution.
Q941 Baroness Hooper:
I can see this operating as a think-tank, but you want it as more
than that?
Professor Rubin: I have spent too long in my
career just thinking, it is time to do something.
Q942 Baroness Whitaker:
Your point about urbanisation made me think that in fact, although
it certainly makes transmission of infection much easier, it also
makes access to healthcare much easier than, say, up-country in
a rural area.
Professor Rubin: That is not necessarily true.
Q943 Baroness Whitaker:
But that cannot happen so easily in a slum. There are people who
say that, if we really want to reduce these serious infections,
what we should do actually is to aim at getting rid of poverty,
because once you have economic growth, even if 50 per cent of
the population of the world lives in cities, they will have access
to healthcare, they will have better nutrition, better hygiene
and so on. How do your ideas fit in with that view?
Professor Rubin: Actually it is not true. If
you look at the UN report on urbanisation, the comment there is
made that it is probably more dangerous to your health to live
in an urban slum than to live in a rural area. So the issue of
easier and more ready access to healthcare probably will not emerge
from this urbanisation issue. That has to be recognised very clearly.
On the other hand, you are right in the sense that there is this
notion that, if we solve the poverty issue, we will solve the
infectious disease issue; that blatantly cannot be true. Sure,
there is certainly a component of poverty that needs to be addressed,
absolutely; but it is certainly not the only solution, not the
only part of the problem. It is a great point that needs to be
further debated.
Chairman: I want to return to this question
which is troubling me, and I think my colleagues, about enforcement
and compliance mechanisms. Lady Falkner.
Q944 Baroness Falkner of Margravine:
Professor Rubin, you are extremely optimistic and the optimism
is quite infectious; it is a terrific concept that you have got
here. You take me back a little bit to when I was a student doing
regime change; one of the problems of regime change is that on
the one end of the spectrum, as with treaties—and you have
ruled out going down the treaty route—you get a momentum
building up in the States Parties, and then Business and other
interested parties follow or do not; the other end is this people-driven
thing. While I can see the Compact coming about perhaps more than
some of my more sceptical colleagues, I have a bit of trouble—and
I work for an international organisation, so maybe that is why
I am slightly more sceptical—about the other end, the enforceability.
You say in your own paper that we need to address the issue of
non-compliance by establishing a robust platform for public dissemination
and so on, but how do you actually get reluctant States Parties
in States that are perhaps authoritarian or closed states, where
information dissemination itself is a challenge and where the
economic implications of something such as SARS would be quite
significant? How do you get those flows of information and the
co-operation that a Compact would be absolutely predicated on?
Professor Rubin: I have to tell you that this
is one of the major issues of discussion around our own coffee
shops with my colleagues, in particular Professor William Burke-White,
who is a Professor of International Law at the University of Pennsylvania.
He was the person who taught me about this notion of "soft
law" because I originally called this a treaty, and he said
"No, no, not a treaty, it will never fly, certainly not in
certain administrations, even in the United States". Then
I said OK, we will have strict exclusionary criteria that, if
you do not share information, even if you were able to get it,
then you will not be part of the research mission. He said even
that is too draconian, that will not work, because that would
penalise the least well-developed countries. We are working through
that, and I do not have all the answers to that specific question.
Failed States will never be part of this, there is no question
about it; States that are totally authoritarian may have a harder
time. The way that SARS was picked up was somebody using the ProMed
database, somebody was reporting that there is an outbreak of
something here, so it did not really come from the Government
of China. With the advance of technology, therefore, information
will not be so dependent on the federal government, and that is
actually what IHRs are also predicated upon as well, that there
will be non-federal sources of information. One of the problems
with the IHRs by the way is that everything has to get followed
through a point of contact, so that even for the IHRs it has to
go back up through one specific government organisation. One can
gather—correct me if I am wrong—non-governmental information
but formal reporting comes through the government organisation.
I think the only way to get around your issue, which is a serious
one, is the ever-increasing information technology that is going
to become more and more available.
Q945 Baroness Falkner of Margravine:
And the academic community, who do talk to each other irrespective
of State boundaries?
Professor Rubin: Exactly. It is not going to
be easy; I may be optimistic but I am not stupid and it is certainly
not going to be easy. Countries will eventually come around when
they see it is in their best public health interest, and in fact
in their best economic development interest, because this clearly
affects economic development. Those are the two real drivers that
we are counting on.
Q946 Chairman:
I can see the pressure, both economic and moral, that might lead
a country, even an authoritarian country, to say "OK, we
need to co-operate here." But if you looked at a developed
country—and I mean that phrase fairly loosely—which
has got a good structure of law, for example, if their Health
Officer tried to conceal an outbreak of something, they would
be committing a criminal offence and so there is a very real meaning
to the word "enforcement". That does not apply to your
structure.
Professor Rubin: Every country will still be
under the same legislative and legal structures that already exist;
this new organisation is certainly not going to usurp that and
there will be no guys in blue helmets and rifles moving into any
country. So that person concealing an outbreak in a developed
country will certainly still be under the constraints of that
legal structure. We would not usurp that role for sure.
Q947 Chairman:
And you cannot envisage a situation emerging where a government,
faced with the loss of significant trade if it admits to the outbreak
of a particular disease, would not actually say "To hell
with this Compact, we are more worried about the economy than
we are about this disease?"
Professor Rubin: Sure, I would be foolish not
to recognise that. It happened with biological weapons; the Soviet
Union signed that agreement back in the Seventies much as the
United States did and happily went along and developed 60,000
bio-weapons personnel and built huge facilities to develop biological
weapons, even though they signed the convention. There are examples,
the Nuclear Non-Proliferation Treaty, but then you get states
like North Korea, Pakistan and Iran. And so, absolutely, there
is always the problem of abrogating agreements and there have
to be, again, deeply motivated moral, economic, social and scientific
reasons to adhere, and I think again, unlike many other issues,
this one of communicable diseases has that broad appeal.
Q948 Baroness Falkner of Margravine:
Let me come back and help you a little bit. Would I be correct
in saying that your argument in terms of enforcement is predicated
on the fact that it would be in a country's interest, should an
outbreak happen, to go through you because you actually then provide
the expertise to help them combat it in a coherent, across-the-board
fashion, because you have got the drugs link-up, the surveillance
and everything else, so you build up sufficient expertise in the
area to be the fire-fighter who helps them fight the fire?
Professor Rubin: The trusted agent, that is
exactly right. We are not going to have the infrastructure that
the World Health Organization has, they have people on the ground
that they can rush there. The infrastructure to put people together
is exactly what you were referring to, so the trusted agent, the
integrator, that is what we see is needed, you are exactly right.
Chairman: Your comments on deliberate
release of pathogens bring us on neatly to that issue. Lord Jay.
Q949 Lord Jay of Ewelme:
Thank you very much. This is an area which we shall want to cover
adequately in our report, but we have not gone into it in great
depth yet. I was interested in what you said in your report about
the deliberate release of pathogenic organisms as an emerging
threat needing a great deal of attention and your conclusion that
there was a dearth of co-operation among the relevant groups and
that that was a major flaw in national as well as international
strategies. I would be interested if you could say a little more
about that and also just be clear whether you are talking about
what one might call upstream, in other words counter-proliferation—in
a sense to stop these things getting out in the first place, or
whether you are talking about it downstream, i.e. what we need
to do better together when they have got out in order to control
it. Then could you comment on a point which has been to is in
evidence, that the kind of arrangements which are necessary to
control an outbreak of deliberately-released organisms are in
fact much the same as though it had got out by mistake, like SARS.
Could you answer that set of questions?
Professor Rubin: That is a huge set of questions
and I appreciate the opportunity to talk about it. It is a deep
and very complicated issue, because deliberate release could be
anything from an aborted release that really does not go anywhere,
much like some of the anthrax attacks that were attempted, all
the way to a potential new pathogen that is synthesised—a
de novo release. Let me take your last point first, because
I think that is the easiest one. In general, yes, it is basically
the same set algorithms for the identification, response and reporting
for a natural outbreak as well as for a deliberate outbreak. On
the other hand, if it is a deliberate release, it becomes a completely
different investigative set of parameters, in that you now have
a criminal case that you have to worry about. There is this necessity
to maintain the chain of evidence and a whole idea of attributing
culpability, while carrying out an investigation (in some sense
secretly) so that you can get the bad guy, so you do not tip your
hand. That is a completely different kind of investigation—and
the epidemiologists will bear me out -with a naturally occurring
release, where it should be in the open, and you are not trying
to catch somebody. How do you know if it is deliberate or not
deliberate at first? There are various algorithms that one could
think about, so how do we know that the original anthrax attack
in 2001 was not naturally occurring anthrax? It became clear very
quickly that this was not just naturally occurring anthrax and
it became a different kind of investigation, so I do not necessarily
agree that the whole spectrum of response is the same, in fact
it is quite different. There is a wonderful new book out by a
colleague of mine named Barry Kellman, who wrote a book called
Bioterror and Biosecurity, that addresses this very issue.
You should definitely read Barry Kellman's book or talk to him
and he will talk at length about this issue—the dearth of
co-operation. The idea about deliberate release is a difficult
one to think about in terms of enforcement, because you can think
about deliberate release by a rogue scientist; you can think about
deliberate release by a failed State that just in some sense facilitates
the release—much like Afghanistan facilitated al-Qaeda by
allowing training camps; and you can think about deliberate release
actually as a State policy. All three are quite different from
each other: the investigation, the capabilities, the dissemination
parameters would be quite different. In one instance dissemination
could be by a missile, by a State or a failed State, whereas the
chances are that a rogue scientist will not have that kind of
access to a missle delivery system. On the other hand, a rogue
scientist in his basement could be doing a synthetic biology experiment
and making up a compound, an agent that you have never seen before,
one that does not exist in nature any more. So that kind of issue
really has to be placed in the context of a criminal investigation
on an international scale. It is a very complicated process and
one that needs a lot of attention.
Q950 Lord Jay of Ewelme:
If I may take you back a second to Lady Falkner's point, also
in the spirit of help, I think one should not under-estimate the
extent to which moral persuasion can actually be enforced on governments,
and one has seen that over the last couple of days—it was
not self-evident to me that Burma was going to open its borders
to international aid but, if it had not done, so the pressure
would have been huge. So in a sense that sort of thing can make
it work.
Professor Rubin: That is a perfect example.
Talk about a State that is authoritarian that you could not get
into, the media plays a tremendous role in this world and the
moral persuasion is absolutely overwhelming. That is a perfect
example, thank you.
Q951 Lord Howarth of Newport:
First of all my apologies, Professor Rubin, that I could not be
here at the beginning of the session. You observe, in respect
of the deliberate release of pathogenic micro-organisms and that
range of problems, that there is a dearth of co-operation between
the intelligence agencies and other organisations; that is hardly
a surprise, is it, because their methodology is to work in secret
and their whole disposition is to be minimalist in the sharing
of information—they will work with other organisations but
only on their own terms. Can you foresee that you would be able
to engage the intelligence and security agencies in, as it were,
the fullness of co-operation that you and the other participants
would desire?
Professor Rubin: We can do some things but the
impossible takes a little longer. The intelligence community—and
we have very good relationships with them, at least in the United
States—has come to us to ask us to put on workshops on biosecurity,
and we ran some for the National Security Agency. They are very
willing to admit that there are certain areas of expertise that
they need to gather in. I do not believe we will ever be able
to work in an open way with the intelligence community; I think
they will come to us when they need us and they will not tell
us things when they do not want to. That is a fact of life—you
would throw me out of here if I gave you any other answer.
Chairman: That is very straightforward.
Q952 Baroness Whitaker:
Just on that one issue, the academic witnesses we had right at
the beginning of our session did talk to us about committees co-ordinated
by the WHO which looked at this. This may not be quite as full
as the co-operation you were asking for, and obviously they felt
under certain constraints in being very open about what was going
on. But we had no doubt that there was an organisation which integrated
the WHO and the medical academics, our professional representatives
on WHO committees, with the intelligence services. Does this not
happen in other countries?
Professor Rubin: I have a certain level of clearance,
but I certainly do not know the details of some of those relationships.
In our case the intelligence community is an intimate part of
the National Science Advisory Board for Biosecurity which is an
NIH committee; the intelligence community sits on that board as
a non-voting member, they hear what we have to say and they have
given us briefings. I cannot say there is an enormous amount of
information that is shared back and forth; it is generally one
way, and the academic community has said to them, and I have said
to them in the earlier sessions that we are more than willing
to help if we know the questions you want us to help you answer.
Very appropriately, they are not that willing to share that kind
of information, at least in my experience; I cannot speak about
what other folks have been able to do. The intelligence communities
in the United States have clearly reached out to American academics,
me included and colleagues of mine. Generally speaking it is a
one-way conversation.
Chairman: Could we move on to market failure.
Lord Avebury.
Q953 Lord Avebury:
The ISTAR website says that the Global Compact will drive pharmaceutical
innovation. Does that mean that this group of people that you
have sitting in the room to integrate everybody together is going
to decide what forms of pharmaceutical innovation are desirable
and will take those to companies and ask them to perform?
Professor Rubin: I think the answer to that
question is "yes", and we have evidence that that works.
I highly recommend that you speak to Mary Moran at the London
School of Economics, who has written very extensively about public-private
partnerships in developing compounds for the developing world,
and I can tell you from our experience in the developed world—I
will include Philadelphia in the developed world—there is
great acceptance of the concept of public-private partnerships
to develop antibiotics for major urban diseases as well. The Global
Alliance for TB Drug Development has looked at my work over the
past two years and, after a long process said "Hey, the targets
that Rubin is working on are really potentially very important,
let us fund him and see what we can develop out of that",
and then they will take that forward the public-private partnership
way. I believe the answer to that question, and certainly with
the OECD, part of the basis of the Noordwijk Agenda is to find
ways to spur innovation. There is this notion—maybe this
is what you will be getting to—of Trade-Related aspects
of Intellectual Property, the TRIPS Agreement. I do not think
that is a major issue any more. The TRIPS agreement is fairly
flexible and, while I cannot speak for the pharmaceutical industry
who say it is not quite appropriate, I would say that that is
not really an issue any more as far as I am concerned. I believe
we really will be able to spur innovation and there are real examples
of that.
Q954 Lord Avebury:
What you have just said is that somebody is going to provide the
money for the development of these new pharmaceuticals. So, if
it is the market mechanism, the market mechanism is that an agency,
be it the Global Compact or the Global Alliance for TB, or GAV
in the case of the Advance Market Commitment, is going to pay
for the innovation. You are suggesting that the Global Compact
will come in and take over from all these agencies, so you have
to have one person to decide who is going to fund what and who
is going to develop which particular pharmaceutical instead of
having a certain amount of diversity and freedom of different
organisations, who may be experts, as in the case of TB, or as
in the case of Pneumococcal disease, which your Global Compact
would not address?
Professor Rubin: With all due respect, that
is not what I am saying, I am not saying that it will be one person.
I am saying that we will include all these organisations as fully-fledged
members and we will encourage these public-private partnerships
with their own sets of experts and their own boards of directors.
We may bring new faces to the table, we may bring new entities
to the table, new ideas, new surveillance data; that is the idea,
not to take over what is working well; maybe to close down things
that are not working well is a real possibility, if we have that
kind of moral capability and persuasion.
Q955 Lord Avebury:
I am sorry to be a Devil's Advocate, as I seem to be, but are
you not adding a layer onto what already exists?
Professor Rubin: We are absolutely adding a
layer, at a most necessary level.
Q956 Lord Avebury:
What is wrong with the mechanism of the Global Alliance?
Professor Rubin: Nothing—it works extremely
well as far as it goes.
Q957 Lord Avebury:
So why do you want to add something to it?
Professor Rubin: Because we need integration
with the bigger picture, that is why. If the single system is
working—well that is fine, let the single system work fine.
However in any complex organisation, where there are multiple
data types, multiple players, and multiple systems, there must
be that layer of integration; if not, the system falls apart.
The very fact that your Committee exists is a tacit agreement
that the system is not working; if the system was working so well,
let us go out and have a beer.
Q958 Chairman:
That might be a good idea but, before we do that, could I suggest
that another way of putting Lord Avebury's point might also be
to say that actually what we need in the countries that have not
got a developed healthcare system would be an effort to develop
infrastructure that creates the healthcare system in those countries,
and that without that any number of special institutions or new
bodies will not actually be able to deliver a good healthcare
system.
Professor Rubin: That is absolutely part of
the Compact. There is no question that we lack the individual
people power, we do not have enough individuals out there in the
health system not only to develop the whole scientific side of
it but to deliver once things start to work. At OECD and Noordwijk
the Finance Minister from Liberia got up; she gave us the most
horrendous set of data—I think she said there were 40 doctors
in her whole country and that the amount of money they are able
to use to support the health mission of her secretariat was far
below that recommended by the World Health Organization. You debated
this notion of aid to Africa just a short while ago; there is
no doubt that, even if we are vastly successful in developing
new compounds, if they do not get into the villages, if they do
not get into the hospital across the River, all of this is for
nought.
Q959 Chairman:
Finally, you talk in your paper of a need for someone to seize
this idea and take it forward. Obviously, you would like that
to happen. But who were you thinking of doing that? Would you
like the government to do it?
Professor Rubin: You asked me for a list of
NGOs and people who are interested in this; there are lots of
people who are interested in this and the scientists gave me a
voice. We could short-circuit that time from NGOs and academics
to full implementation if we did have a highly respected government
to take this as their own enterprise. I have my thoughts about
which country should be that country, and I am delighted that
you folks have shown this level of interest. I have to tell you
that it would be wonderful if the Government of the United Kingdom
and the English people would be able to step up to the plate and
become the champions of this issue. You have the right global
perspective, you have already invested an enormous amount of work
and it would just be wonderful.
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