Examination of Witnesses (Questions 780
- 799)
TUESDAY 22 APRIL 2008
Dr Harvey Bale Jr, Mr Guy Willis, Dr Stefanie Meredith,
Dr Ryoko Krause and Dr Eric Noehrenberg
Q780 Baroness Whitaker:
The ethical considerations are presumably the same, are they?
Dr Bale: Yes, they are huge.
Q781 Baroness Whitaker:
Identical with the ones in the West?
Dr Bale: The existence of ethical review boards
is much more difficult in developing countries, where the standards
have to be much more developed along the way to do many more clinical
trials that are needed. A lot more development has to be done.
Mr Willis: A Dutch NGO did a study into this
recently and found that most of the clinical trials that are taking
place in developing countries are offshoots of clinical trials
that are multi-centre clinical trials which are usually directed
by companies or institutions in the developed world. The ethical
standards that apply in the developed countries are, by extension,
applied in the developing countries.
Q782 Baroness Whitaker:
I just wanted to clarify that. What I want to ask is about generic
drugs. I think you say that 95 per cent of pharmaceutical products
on WHO's Essential Drugs List are not patented. Does this include
the essential drugs for HIV/AIDS, Malaria, TB and influenza? Are
they generic?
Dr Bale: That is a mix. They are patented in
the UK, for example, and not patented typically in India or Bangladesh.
A very interesting transformation took place in the Essential
Drugs List. It takes a very long time to get a drug typically
added to the list because of bureaucracy, questions about affordability,
et cetera—
Q783 Baroness Whitaker:
WHO bureaucracy?
Dr Bale: Yes, process. The Essential Drugs Committee,
which was an observer, that meets twice a year, not very often—
Q784 Baroness Whitaker:
So are you saying you might have to wait 12 months to get on the
list?
Dr Bale: At least. The HIV/AIDS drugs were not
added to the Essential Drugs List until, I think it was, 2001,
2002.
Dr Noehrenberg: 2002.
Dr Bale: For example, AZT has been around since
1987 and is now generic. AZT is the one drug in the HIV/AIDS class
that is now generic. A large number of the others will become
generic very soon. At the same time, because India and a number
of other countries did not have patent laws until the early to
mid-decade, at the beginning of 1995, you have a large number
of the HIV/AIDS drugs available generically. Some of these drugs
are good quality drugs. You cannot and should not associate a
generic product with a substandard product. There are many substandard
products available in developing countries, but there are also
good quality generic products that are available. HIV/AIDS is
kind of the big exception to that rule.
Q785 Baroness Whitaker:
I think you also say that copies of products tend not to reach
the poorest peoples. Could you just spell out all the reasons
for this, because this is very crucial.
Dr Meredith: Where shall we start!
Q786 Baroness Whitaker:
I can think of some, but you tell me your views.
Dr Bale: What is the statistic? How many millions
of children die of diarrhoeal disease each year? The numbers are
staggering, yet oral rehydration therapy costs pennies.
Q787 Baroness Whitaker:
Indeed?
Dr Bale: If you go to basic antibiotics, one
of the biggest killers in Africa today is respiratory disease,
pneumonia, upper respiratory, lower respiratory; and antibiotics
are cheap. A doctor will prescribe for me erythromycin and I will
happily take it, it is a very cheap antibiotic. We cannot get
this product into these countries.
Q788 Chairman:
Why not?
Dr Bale: Because of the delivery systems. Let
us start from the top and take the worst case example, Robert
Mugabe, does he care? He is extreme; but, if you ask the WHO what
is the biggest barrier to access to medicines today, they will
tell you it is lack of sustained political commitment to public
health.
Q789 Baroness Whitaker:
So there might be entry restrictions on imports?
Mr Willis: Before you even get into that, it
is simply the amount of money that they spend on healthcare.
Dr Bale: You are addressing just poverty, and
that is a factor.
Q790 Baroness Whitaker:
Poverty means you cannot afford the drugs if they cost something.
Mr Willis: It means that most sub-Saharan African
countries are spending per capita, per person, per year less than
$5 (on medicines).
Q791 Baroness Whitaker:
So there are two aspects to that, the individual cannot afford
the drugs and the government cannot afford the health infrastructure,
the transport?
Mr Willis: That is just talking about what the
government spends. Typically in sub-Saharan Africa the ratio is
4:1 or 5:1. Out of pocket expenses are typically four or five
times what the government spends, so total healthcare spending
in Nigeria is in the order of $50 per head, but 40 of that is
coming out of the pocket of the individuals concerned. That is
before you get into tariffs.
Dr Bale: There is a lady here in Geneva with
the Global Fund who was the former drug regulatory chief in Gambia,
who says that the quality control systems in Gambia have not been
updated for over 20 years, so they do not have the capacity to
even evaluate which drugs are good quality drugs and which are
bad quality, let alone ensure that the good quality drugs get
into the systems in remote areas.
Dr Krause: During the first year of GAVI's activities
they have agreed and decided to give free vaccines to 72 least
developed countries around the world. It is not a matter of price.
It was totally free and sent to individual countries in the proper
way by UNICEF, but those countries that could have received free
vaccines did not move forward in incorporating Hepatitis B and
Hib vaccines in their immunisation schedules because they did
not have any infrastructure for the cold chain, no delivery system
and no healthcare system. They had no structure or system to implement
vaccination campaign where infants and children to be vaccinated.
For each vaccine, even when it is a zero cost or one cent, additional
costs of about $8 to $14 per dose may be needed to implement vaccinations.
The amount of additional cost depends on the level of infrastructure
in those countries. That is the reason why GAVI Phase 2, which
started in 2006, Is focusing on how to strengthen the health care
system and to make each government committed to the vaccination
programs. Some countries immunised the children only when it was
free and, if it became a few cents, they decided to stop immunisation
programmes on those particular vaccines and did not care about
the children who were dying. Now they are requesting GAVI recipient
country to contribute in paying a small amount for each dose the
country receives so that no government will receive free vaccines.
Receiving free materials does not link to the recipient government's
commitment. GAVI now focuses much more on the infrastructure,
healthcare system strengthening and are not giving out the free
vaccines any more.
Dr Meredith: I will give you some examples.
I have spent most of my life working in Africa and I am really
committed to seeing something different. You can go to the central
stores in, let us take Tanzania or Rwanda, and the drugs are there,
there are the basic essential drugs; but, when you are in a health
post that is 1,000km from Dar es Salaam, there is nothing there.
The whole supply chain management is a problem. It is a problem
because the person at the health post actually has no training
in how to keep an inventory and order. But, even worse, if he
does have the training and the capacity, and some of them do,
the road has been washed away during the rainy season, the landline
telephone does not work. Nowadays, with mobile phones things are
changing and there is the possibility; but, if there is no transport
from Dar es Salaam to Mahengi, you do not get your drugs for three
months and there is nothing there. For me, one of the major problems
is also trying to address building capacity for much better infrastructure
and supply chain management. The same is true in Rwanda, which
had $90 million when I was working there in 2006 just for HIV/AIDS
alone for a population of a round seven million, and at that point
about 3.5 per cent of the population was infected with HIV. $90
million is vastly over, in fact 300 per cent more than was actually
needed, but still at the health posts there were not the drugs.
They had the HIV drugs but none of the other essential drugs because
there had been vertical training. That is infrastructure, lack
of integrated policies and we need a broad sectorial approach
to improving that.
Q792 Baroness Whitaker:
I absolutely endorse what you are saying.
Dr Bale: We are happy if you stay for another
hour!
Q793 Baroness Whitaker:
It is our job to make recommendations to bear on the UK Government.
With the best will in the world they have not too much influence
on the range of tariff regimes, infrastructure, they have to choose
where they can influence. To remedy this situation, to enable
poor people to get generic drugs, what is the most useful thing,
or things, that the UK Government can do, either at the political
level or the aid level?
Dr Bale: We are starting a dialogue now with
DFID. By the way, I think your Government is really a stand-out
leader in this regard. Between DFID, USAID and a few other aid
agencies focusing on health, this is enormous. First of all, I
do think that the British Government should encourage institutions
like the World Bank to focus more on these infrastructure issues.
Instead of big mega-projects, like dams and telecoms and all that,
that is fine but there is a bit of advocacy needed, because the
UK Government is very influential in World Bank circles, and there
needs to be more multilateral focus in this whole field of health.
There are two issues. Not just supplying drugs—everybody
seems to be keen about supplying drugs, UNITAID, et cetera. But
let us get the infrastructure in place, let us build quality,
let us keep counterfeits out. There needs to be a lot more focus
on quality control, just as Stefanie, Eric and others have indicated.
We have got to do that bilaterally, besides advocacy at the multilateral
level, focusing against some of the programmes. We would love
to work with DFID, for example, on this Gambia project. We would
like to set up a model, in effect an exemplar, a project, a pilot,
to use the Gambia, which is a small country of a million people,
but still lots of problems, poor health quality control facilities,
almost none. We are going to try to go in there and help. We have
the skills and expertise but are not typically in a position to
provide financing on a sustainable basis for 20-30 countries.
It is a combination of public-private partnerships. We will bring
the skills, we will put the resources in there and help get people
there, companies committed, and it will cost them money. This
is what we do with MMV, we get companies who are willing to devote
laboratory resources to help develop a new anti-malarial drug,
and it has spun on, most recently in the case of Ranbaxy in India,
who picked this up to develop the drug further. It is a combination
of what we call PPP, public-private partnerships.
Q794 Lord Avebury:
Is it DFID which is in the lead in the Gambia model?
Dr Bale: Right now we are at an early stage
on Gambia, but DFID certainly seems to be in the lead on a number
of health-related issues in developing countries. We hope to work
with DFID. I would suggest DFID is a good natural partner in the
case of the Gambia.
Q795 Lord Jay of Ewelme:
This is a question, following up what Stefanie Meredith was saying.
I guess we have all been to rural areas and seen the shops and
stores where there are not the drugs but there is, let us say,
Coca-Cola. My question is! is there scope for the pharmaceutical
companies to work with private sector distribution networks to
get the drugs through to places where at the moment other goods
get through but drugs do not?
Dr Meredith: It is unfortunate that many people
bring up the whole thing with Coca-Cola, including Margaret Chan
of WHO, because it is completely different.
Q796 Baroness Whitaker:
Why?
Dr Meredith: In the health posts that I am talking
about, it is public sector. In the small private sector shops
the profit margins are very small, but in Coke the profit margins
are larger. They are all bottled in-country, these are local products
and the cold chain is local. We should also add that, unlike the
majority of medicines, you don't need a doctor to ;prescribe Coca-Cola.
Dr Bale: Coca-Cola controls it from A-Z. Coke
is in charge.
Lord Jay of Ewelme: It is just that there
are private sector mechanisms for getting products from Dar es
Salaam to the rural areas. If that exists, why can it not be used
in some way for other products?
Lord Desai: Forget Coca-Cola, heroin
always gets there!
Q797 Chairman:
Do not go there!
Dr Bale: Again, in that case it is the drug
lords who control the chain. Our role in this is frequently we
are at a disadvantage. Even if we have companies in the countries—and
we have companies in Kenya, Nigeria, South Africa—they cannot
get out and direct the public health authorities to do this and
this. What we are hoping we can do is train them. This is where
we think the value of what we can do in Gambia comes into play.
At the end of the day we cannot own those health outlets.
Dr Meredith: What you are talking about is better
and more innovation in distribution.
Q798 Lord Jay of Ewelme:
Yes.
Dr Meredith: In fact, there are some innovative
examples of essential drug franchise stores that were started
in Kenya which were using something very much like this. I would
recommend very strongly that we look more at expanding these franchises.
Q799 Chairman:
A final word from Dr Noehrenberg.
Dr Noehrenberg: Thank you very much. Lord Jay
raises a very important point. When I came to IFPMA from UNAIDS,
where I was responsible for our relations with the private sector,
this question was posed to me quite often: why is it that the
private sector can reach out there. As Harvey and Stefanie have
noted, every step along that chain in the private sector, every
single person, makes a significant profit until the final end
user, even out in the rural areas. What the private sector can
do, and has done through organisations such as the Global Business
Council or Global Business Coalition on HIV/AIDS, is to offer
the private sector expertise on distribution, storage, management,
in a way to get a more effective outreach into the rural areas.
If you look through the printed copies of the book—that
is the advance version and we are going to come out with the official
printed copy in coming weeks—you will see specific initiatives
which go to that exact issue, how to work with governments to
reach out there. Your point is very well taken, your Lordship.
The fact of the matter is that the public sector does not have
the same incentives for each step along the way to get out to
the people there in the rural areas, but by true collaboration
and exchanging experiences it can become more effective. That
is something that could be used to promote partnerships. May I
make one last point? One of the most effective ways of getting
AIDS drugs out to people in sub-Saharan Africa and the least developed
countries is by what is called the Accelerating Access to AIDS
Drugs Initiative. It was started in 2000 by a group of five companies,
including GSK of the UK, and works with five UN agencies: WHO,
UNDP, UNAIDS, the World Bank and UNPF. That now reaches to well
over 800,000 people living with AIDS in sub-Saharan Africa and
other developing countries with quality triple therapy treatment.
Furthermore, the second-line antiretrovirals offered through that
programme by the companies is lower in cost than those offered
by generic copiers from India and other countries. That is proven
if you do analysis of statistics on prices collected by Médicins
Sans Frontie"res and WHO. The companies we represent
are committed to expanding access, to offer drugs at cost, low
cost, even for free, as appropriate. Furthermore, they also cover
the costs of transportation, insurance, et cetera, to the purchaser,
whereas many of the copiers of products do not do so. This goes
to questions raised by Lady Whitaker, Lord Jay, Lord Avebury and
others. We are committed to making access a reality and we are
doing what we can to make it possible. Where we can do it alone,
it does work, but it is even more effective through partnerships
with the public sector, NGOs, faith-based organisations in many
places. We are trying to do our best to make it possible, so whatever
can be done would be very helpful.
Chairman: Thank you very much indeed,
that has been extremely helpful. There are one or two points you
have raised which we will look at further that will bear further
examination—the infrastructure one in a way being the most
important one that we need to give some more thought to. If you
do get any more ideas or thoughts, or want to elaborate one or
two points more specifically, please do so, and if you write to
Mr Preston in the House of Lords it will come to all of us. Once
again, thank you for your hospitality but also for your very clear
answers to our questions. Thank you very much.
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