E-DRUG: Brundtland speeches in Norway meeting
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[To assess WHO's position in the price differentiation meeting
it is interesting to note the opening and closing speeches of
Dr Brundtland (ex-PM Norway!) in the Norway meeting.
A summary report of the meeting is promised by 15 May (around
the World Health Assembly), and all presentations will become
available on the Internet. NN]
Dr Gro Harlem Brundtland
Director-General
World Health Organization
WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs
H�sbj�r, Norway, 8 April 2001
Opening Remarks
State Secretary,
Ladies and Gentlemen,
Let me add my own warm welcome to you all, and extend my thanks to the
Government of Norway for hosting this important meeting.
Exactly one year ago - in the first week of April 2000 - I addressed the
Parliamentary Commission on the Investigation of Medicines in Brasilia on
the subject of access to essential drugs and vaccines. My focus then - as
it remains today - is how we can ensure that vital medicines are accessible
to all the people that need them - regardless of their income, regardless
of the health conditions they are suffering from, regardless of the country
they live in. Reliable access to medicines on the basis of need rather
than on the ability to pay. That is the goal. That - I believe - is what
brings us all together here.
Just twelve months on: and a great deal has happened. With the rapid
unfolding of events, almost on a day by day basis, one could be forgiven
for believing that the situation has been transformed. Perhaps in some
ways it has.
Greatly increased access to treatment for people living with AIDS, TB and
malaria in low income countries is now on the agenda in a way that many
would not have thought possible a year ago.
Real reductions in the price of drugs for treating people living with AIDS
are now beginning to happen.
And perhaps most important of all: access to pharmaceuticals is no longer
an issue for health professionals and government officials alone. It is
headline news. A much wider constituency is now engaged - with all the
complexity that this brings in terms of new possibilities and public
expectations.
These are significant changes. We should give credit to those who have
helped to bring them about.
In the last twelve months, we have witnessed an unprecedented effort,
driven by committed people in governments, non-governmental organizations,
activist groups, UN agencies, bilaterals, different branches of the
pharmaceutical industry, and the media. Together we have begun to tackle
the obstacles that are preventing essential drugs from reaching the
millions who need them. Popular outrage, political will, market forces and
the best of science: a powerful coalition. There are things we can
rightfully celebrate.
But let us pause. The excitement of the campaign and the growing attention
of the international media must not divert us from basic realities. For too
many of the world's poor people - those with an income of one or two
dollars a day - nothing very much has changed at all. The onset of serious
illness in the family too often leads inexorably to death, disability and
impoverishment.
In over 30 countries public spending on medicines is less than two dollars
per capita per year. I recently heard the Minister of Health from Malawi,
describing how changes in the value of the local currency had reduced
planned government spending on drugs this year from $1.25 to just 75 cents
per head.
Inevitably, in such circumstances, the cost of care falls to the individual
and the family. Few poor people have access to health insurance. They have
to pay for drugs when they get sick. Out-of-pocket payments - a large
proportion of which go on medicines - constitute up to 90% of total health
spending in some poor countries. No matter what the time of year, no matter
what the state of family finances, the situation for many is stark: no
cash, no cure.
Access to care is not just about access to drugs. It is about access to
effective health systems. Safe and reliable care requires trained staff who
receive their salaries on time and who stay in post. It requires supplies,
buildings, information systems, supervisors. All this and more is needed
for the safe diagnosis and treatment of childhood pneumonia - let alone
more complex problems like the management of multi-drug resistant TB or
HIV. We will hear in this meeting about huge differences in access to
health services that exist between and within countries.
A substantial increase in development assistance can make a difference. The
OECD estimates that total Official Development Assistance for health - for
all purposes, for all countries, from all sources, loans and grants - is
currently about $3.5 billion a year. We now suspect that this estimate
might be a little low. But just to treat one million people with AIDS in
Africa, with the prices now on offer, would require that the $3.5 billion
be increased, almost immediately, by one third.
This then is the background against which we must frame our discussions and
measure our progress. Drug prices are critically important. New financing
even more so. But we must never forget that some of the most basic problems
of development are not going to be amenable to quick-fix solutions.
Ladies and Gentlemen,
Let me turn now to meeting itself. We have a unique opportunity over the
next three days. WHO's collaboration with WTO has helped to bring together
an extraordinarily exciting and knowledgeable group of people, representing
some of the most important actors concerned with access to essential drugs
in the world today. We all come to the meeting with different perspectives.
The ethical and financial stakes are very high. So are the issues we are
dealing with emotive and complex. There are different and deeply held
opinions as to the way forward.
Let us be clear about the purpose of the meeting. Achieving greater clarity
about strategies that will make the prices paid for key pharmaceuticals
more closely in line with the economic circumstances of the purchasing
countries. This is our task.
We are not here to make decisions. Nor are we here to prepare a grand plan
- as I have seen in the press.
For WHO, however, the results of this meeting will be an important input
to be considered by our Member States when they debate the follow-up of the
Revised Drug Strategy at the forthcoming World Health Assembly.
I find it helpful to think about moving from positions to principles. If we
are to move forward on the issue of differential pricing in a way that
ensures more equitable access, there are many questions that need to be
addressed. We need principles that can act as a lode stone or a compass as
we, and many others, deal with the details and the practical problems that
lie ahead.
Let me give you an example. If I were to put myself in the position of a
Minister of Health or Minister of Finance, I would attach considerable
importance to predictability and sustainability. Is the price I am paying
for drugs now going to change dramatically next year? How long - as they
say - does the current offer last? Predictability and sustainability of
demand is just as important to the producers of medicines. We can use these
principles as a yardstick against which to assess the effectiveness of
different approaches to improving access.
Another principle is to recognise that if we are to achieve the goal of
more equitable access to good quality health care, all the different groups
represented here today have a role to play. It is easy for diversity to
appear as an obstacle to progress. The challenge, indeed our main challenge
at this meeting, is to turn diversity into creativity.
We must remember the capacities that each of the different actors brings to
the table: the major investments and risks born by the research-based
pharmaceutical industry in developing new products; the convening power and
country experience of the UN, underpinned by the mandate provided by its
Member States and Governing Bodies; the resources available from
development banks and other donor agencies; the role of the generics
industry in promoting commercial competition for drugs no longer protected
by patents; and the critical role of governments in low income countries.
We need WTO as an effective and fair forum for negotiating trade rules and
resolving disputes. We need groups and individuals that provoke us into
thinking differently - groups that force us to confront problems and
solutions from radically new perspectives. And of course we need those NGOs
and other bodies that demonstrate effective ways of improving access
through their work on the ground in low income countries.
Productive working relationships do not necessarily mean we will agree on
everything. Nor do we become, or adopt the agenda of, those with whom we
collaborate. In WHO, just to give an example, we meet regularly with NGOs,
with staff of the WTO, with the CEOs of several research-based companies,
and with generic manufacturers. We often get the impression that each of
these groups thinks that we favour one or more of the others. This
suggests to me that we probably have our position about right.
As we move from positions to principles, let us also try and get away from
some of the unhelpful dichotomies and repetitive arguments that have
characterised the debate about access to drugs. Reducing prices versus
investment in health systems, for instance. Both are important. They are
complementary, not competitive agendas to be used in defending rigid
positions. If we are going to fix the pipes, we have to put water in them
to see if they work.
But in our search for principles, there are also some fundamentals. Drugs
are not a commodity like any other. Access to health care is a human right
and many of the actors I have mentioned have an obligation to see that this
right is progressively realised. Access to essential drugs is part of this
obligation. Not just for one set of health conditions, but for all.
We need new technologies. We do not yet have a cure for AIDS and our
present tools for HIV/AIDS, TB, malaria and for many other conditions leave
much to be desired. Continuing innovation - which requires both incentives
to invest in the diseases that drive poverty and protection provided by
international agreements on intellectual property - is essential.
We have some fundamental positions on the way health systems function.
Particularly about the way they respond to peoples needs, about fairness,
responsiveness and solidarity in the way they are financed - and about the
key role of government in overall stewardship. Health care provision is not
just the business of the public sector, in all our deliberations we must
factor in the important role of the private sector, NGOs and civil society
groups. The task of governments is to set the frameworks, to make the hard
choices, and to ensure delivery of required services.
Our job in WHO and in the other UN agencies is to do what we can to help
governments make wise choices, based on the best information and evidence
available. This includes monitoring the impact of international agreements
on trade of services and intellectual property on health.
As I talk to Ministers and Heads of State about the health crises they are
confronting, I realise that recent developments have in some ways made
their task harder. Reducing the prices of previously unaffordable medicines
has fuelled public expectations. A significant and sustained increase in
external financial assistance has to be part of the answer. But external
aid cannot and should not remove the responsibility of governments to set
priorities.
Ladies and Gentlemen,
This is a long awaited meeting. I am sure that its outcome will be
scrutinised carefully in the weeks and months to come.
Achieving greater clarity about approaches to ensuring more equitable
access to drugs is an important part of a larger picture. That picture is
one in which people, particularly poor people, are not excluded from care
by virtue of their poverty. It is one in which poor people can expect to be
treated with respect and receive quality treatment whenever and wherever
they fall ill. And it is a picture that for a large part of the world's
population remains distant and hazy. We can make an important contribution
to bringing it into sharper focus.
I look forward to joining you in the debate.
Thank you.
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Dr Gro Harlem Brundtland
Director-General
World Health Organization
WHO/WTO Workshop on Differential Pricing and Financing of Essential Drugs
H�sbj�r, Norway 11 April 2001
Closing Remarks
Ladies and Gentlemen,
In my view this has been an extraordinary meeting. Extraordinary in the
sense of the complexity of the issues we have been discussing.
Extraordinary, too, in the wide range of views that we have heard
expressed. I believe we have achieved a great deal.
Over the last three days we have come a long way in clarifying what it will
take to make a real difference in ensuring that poor people in low income
countries have access to the vital medicines they need.
As I said at the outset, our purpose was not to make decisions or to
prepare detailed plans. Nevertheless, I believe that the discussions here
in H�sbj�r have laid the groundwork for positive actions in the future. By
focusing both on innovation for the future and increasing access in the
present, they build on foundations laid at the recent meeting convened by
the UN Secretary-General.
The problems we are discussing are urgent. Reaching the targets set by both
the leaders of developed and developing countries alike, for reducing the
burden of disease caused by HIV/AIDS, malaria, TB and the other health
conditions that create and perpetuate poverty will not be easy. I am
convinced that it will not be possible without a massive increase in the
scale of the national and international response. And access to essential
drugs is a critical component of that response.
What have we learnt?
We have heard quite clearly that the price of drugs matters - it matters to
poor people, and it matters to poor countries. But little progress will be
possible without a significant investment in building effective health
systems. We have heard too that even with lower prices - particularly in
the case of anti-retrovirals - additional finance will be essential.
We have heard that the protection of intellectual property is a necessary
factor in stimulating the innovation needed to produce new drugs, vaccines
and diagnostics. It is equally clear, as we have heard this morning, that
effective protection of intellectual property needs to be combined with
incentives that will drive research and development in the direction of the
health conditions that disproportionately affect the poor.
The present regime of international trade agreements has been designed to
strike a balance between the rights of patent holders and the rights of
patients. The TRIPS agreement contains important public health safeguards.
It has been argued here that we do not yet have sufficient experience to
judge their real effectiveness. But we have also heard at this meeting some
important reassurances that countries' rights to exercise these safeguards
must be respected.
When it comes to increasing access to drugs through lower prices, we cannot
rely on one single solution. As one presenter put it: we need a mix of
mutually supportive strategies. Such a mix of strategies needs to be geared
to the circumstances of individual countries.
We have focused particularly at this meeting on differential pricing. And
here we have an important body of experience on which we can draw. The
presentations we heard yesterday show that differential pricing is
feasible. It can result in prices that are between 1% and 10% of those
charged in high income markets. This has happened through a combination of
high volume purchasing by governments and international agencies, adequate
and reliable levels of finance, advocacy, corporate responsibility and
market forces.
For differential pricing to work on a large scale, I think we can all agree
that there must be watertight ways of preventing lower priced drugs from
finding their way back into rich country markets. We have heard suggestions
as to how this can be achieved. These ideas now need to be tested to show
that strategies to prevent diversion can really work in practice.
There were other important lessons that came out of our review of current
experience. It reinforced the point that just making drugs available - even
at no cost - does not guarantee that they will be utilised. All the other
pieces of the picture have to be in place as well: the distribution
systems; the partnerships between public and private providers; the
agreements between governments and development agencies; and - as several
of the presenters stressed - clear and explicit goals and objectives. There
are lessons from the experience of the onchocerciasis control programme,
for example, that could benefit countries seeking to take up the offer of
drugs to prevent mother-to-child transmission of HIV.
The need for significant increases in international financial assistance
has been a recurrent theme. We in WHO believe there is a strong case for
the establishment of a new international health fund. It will give
political prominence to priority health issues including HIV/AIDS - and is
a tangible response to earlier commitments on the part of the international
community to mobilise more money. It offers the opportunity to capture
resources from new partners, particularly those who do not have a strong
country presence. It is also a means of ensuring more resources to those
countries without a strong donor presence.
The issue that has struck me in this discussion is not just that we need an
absolute increase in the level of resources, but that we need to think
carefully about how these resources are provided. We need mechanisms that
transfer money rapidly to countries. We need to combine speed with
transparency and accountability. We need mechanisms that ensure that
decision making and priority setting remains, where it belongs, at national
level. Moreover, if funds are to be used to procure commodities, we need to
build on what exists - both nationally and internationally. No reinvention
of wheels, and most important, no undermining of existing capacities and
systems.
Colleagues,
We knew at the start of this meeting that there would be tensions and areas
where it would be difficult to agree. This is inevitable. But our task here
is to think through the implications of different options - even if we do
not always reach a consensus on their viability.
One of the issues that remains unresolved concerns the extent to which
price reductions can or should be achieved by relying only on negotiation
with producers. Much of the discussion about differential pricing is based
on the assumption that it is possible to agree on a fair price - based, for
example, on the marginal cost of production.
At the same time, we have seen the effect of competition on the prices of
drugs.
We have heard arguments both for and against voluntary licensing of
patented drugs. On one hand it is said there is no economic justification
for this strategy. On the other hand it has been suggested - not just as a
means of introducing competition and thus lower prices, but also as a way
of ensuring that lower cost drugs produced by the licensee are easily
distinguished from those produced by the patent holder for high cost
markets.
Of course, voluntary must really mean voluntary. But the question we need
to ask ourselves is: what conditions or incentives would be necessary to
introduce greater competition through voluntary licensing - in ways which
are consistent with international trade agreements - on a larger scale?
There are other issues too that merit our further attention.
I will just take three examples - but there are others that are set out in
our background paper. First, we have touched several times on the issue of
how to handle differential pricing in the context of middle income
countries. In addition, these countries represent a potential market for
the diversion of cheaper drugs.
Second, we need greater clarity around the issues of parallel trade. And as
we heard yesterday, those directly involved - both trade and health
officials - need better and more accessible information on what is and is
not legal.
Lastly, for any strategy designed to lower prices and increase access,
predictability and sustainability must remain the watchword.
Colleagues,
In closing let me say a few words about next steps.
The issues we have been discussing are essentially political. And as such
require political solutions, through political processes. We need to be
sure we have all the evidence that is available, but there are no technical
right answers to most of the things we have been discussing.
For us in WHO, the next step is to report on this meeting to our Member
States when they debate the follow up to the Revised Drug Strategy at the
World Health Assembly next month.
The test of a meeting like this is not the production of a plan. Nor is it
the quality of the report - although I am sure in this case, it will be a
good one. The test is whether better understanding - of the issues and of
each other's position - can be translated into positive action within our
own areas of influence.
Thank you.
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