[e-drug] Brundtland speech on 25 years essential drugs

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E-DRUG: Brundtland speech on 25 years essential drugs
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[Below the speech by the outgoing WHO DG on the occasion of 25 years of
essential drugs, last monday 21 October.
Keep this speech as it contains promises made by WHO!
http://www.who.int/medicines/organization/par/dg_edm_anniversary.pdf
WB]

WHO/DG/SP/
Dr Gro Harlem Brundtland
Director-General
World Health Organization

"Access to Essential Medicines as a Global Necessity"
25th Anniversary of the WHO Model List of Essential Medicines
Geneva, 21 October 2002

Colleagues, Friends, Ladies and gentlemen,

It is a great pleasure for me to join you in the celebration of the
25th anniversary of the first Model List of Essential Medicines. To
understand the revolutionary nature of the idea behind the Model List,
and the tremendous
importance of this List over the past quarter century, we must take a
minute to look back.

The twentieth century opened with only one widely available modern
medicine: aspirin.

In the 1940's, the first antibiotic, the first mass produced
anti-malarial, and the first antitubercular were introduced. The 1950s
and 1960s saw the rapid introduction of oral contraceptives, diabetes
medicines, and then medicines for mental illness, many infectious
diseases, cardiovascular diseases, and cancer.

By the 1970s, effective medicines - though not always ideal - existed
for nearly every major illness we know. Yet, for half the world's
population, it was as if they were still living in the 1880s. For them,
modern medicines were unavailable, unaffordable, of poor quality, or
ineffectively used.

The World Health Assembly of 1975 was a watershed. This Assembly
introduced the concepts of "essential drugs" and "national drug policy".


Seeing how central and everyday these concepts have become to public
health, it is impressive to think that they are not much more than 25
years old.

The Assembly hoped to begin closing the huge gap between those who were
benefiting from the pharmaceutical harvest of the mid-1900s and those
who could not access these medicines.

It began developing this bridge by building on precedents set in
Scandinavia, on the North America formulary literature, and on
pioneering efforts by countries as diverse as Papua New Guinea, Peru,
Sri Lanka, and Tanzania.

In October 1977, WHO produced the first Model List of Essential Drugs
and, in 1978, the Declaration of Alma Ata identified "provision of
essential drugs" as one of the eight elements of primary health care.

The Model List has clearly filled a need. By the end of 1999, 156
countries had a national list of essential medicines; three-quarters of
these lists had been revised in the five preceding years.

Over the past few years, the Model List has developed rapidly on
several fronts in response to a growing global demand for wider access
to essential medicines.

The new procedures for updating and disseminating the WHO Model List
were approved in 2002; a process that was strongly supported by the
Executive Board and the Assembly.

In April 2002, WHO included 12 anti-retroviral medicines and the first
artemether-based antimalarial medicine on the Model List.

Our new Essential Medicines Library now brings together all WHO's core
evidence and normative information on all essential medicines.

The new WHO Model Formulary was issued for the first time two months
ago, based on the Model List of Essential Medicines. It presents all
relevant medicine information and summaries of most WHO's clinical
guidelines. It is available in hard copy and as a searchable web
version.

This has led to a complete renovation and re-actualization of the whole
essential medicines concept. The new WHO Model Quality Assurance System
has, for the first time, led to the prequalification of manufacturers
and products for HIV and malaria on behalf of all UN agencies.

The last decade has seen inequities in health care increase, with
reduced public budgets and increased reliance on the private sector.
There is now a global cry for equitable access to essential medicines
for the prevention and treatment of HIV/AIDS. This also applies for
access to other essential medicines, especially those for common
childhood diseases, major
infectious diseases and chronic conditions such as diabetes,
hypertension, epilepsy and mental disorders, which benefit from
long-term treatment.
New international agreements, including the WTO TRIPS agreement and the
WTO agreement on Technical Barriers to Trade (TBT), will undoubtedly
affect access to medicines in developing countries. The recent UK
Commission on IPR provides a very comprehensive analysis of the
potential impact.

WHO is closely involved in the negotiations - and the wider debate - on
intellectual property, where it is relevant for public health. The basis
for our position is very clear: no clause in any trade agreement should
work in a way that denies - to those who need them - access to
life-saving medicines for common diseases. This applies wherever they
live and whatever
their ability to pay.

In accordance with this position, WHO has formulated global guidance
and is giving practical advice to Member States on the consequences and
possibilities that lie in the rules on intellectual property being
negotiated within the World Trade Organization.

We have come a long way since 1977. But the challenges ahead are
great.
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.

Thirty-eight countries spend less than two dollars per person per year
on medicines, while many of these countries have large numbers of people
living with AIDS. Overall health expenditure may be as little as ten -
twelve dollars per person.

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 per cent of total health spending in some poor
countries. For many the reality is stark: no cash, no cure.

Drug prices are only part of this challenge. Access to essential
medicines depends on a nucleus of key factors: rational selection,
affordable prices, sustainable financing, and reliable supply systems.
These four components of the strategy are inter-dependent. Lower prices
attract more donor and government financing; radically increasing drug
availability boosts health systems development; more effective supply
systems mean greater coverage; and more coverage increases sales
revenues.

High quality health care depends on choosing those medicines with the
best combination of safety, efficacy, quality and health impact. Over
1500 new medicines have been introduced during the last 25 years. Many
of these represent genuine therapeutic innovations which can and should
have a major public health impact. Health systems and health care
providers
everywhere struggle to select those drugs which best suit their needs.
New essential medicines are expensive. For example, the new
artemether-lumefantrine combination for malaria is about 25 times as
expensive as chloroquine, even at the preferential price negotiated by
WHO for the public sector in developing countries.

Treatment of multi-drug resistant tuberculosis is about fifty times as
expensive as a simple DOTS regimen.

Last week, we presented new evidence which shows that a few commonly
available medicines such as statins for the lowering of cholesterol and
low-doses of common blood pressure drugs and aspirin - given daily to
people at elevated risk of heart attack and stroke - can save the lives
of millions of people at risk of cardiovascular disease each year on a
global basis. This highly effective combination therapy could be much
more widely used in the
industrialized world, and is increasingly affordable in the developing
world.
These medicines are off-patent and relatively cheap. The drug
combination would cost less than 14 dollars for each person annually.
Still, it might not be affordable to poor countries facing the
traditional burdens posed by communicable diseases and the growing
burden of noncommunicable and chronic diseases.

The recent WHO Commission on Macroeconomics and Health highlighted the
need for major new injections of resources from high income countries.
It called for a major increase in the resources invested in health in
the poorest countries over the coming two decades. Moreover, it argued
that the old dogma which says development assistance is only
cost-effective if it
focuses on prevention - not treatment - is outdated. The recent
developments within a number of diseases, such as HIV/AIDS, TB and
malaria - and now with cardiovascular diseases - show that prevention
and treatment are integrally linked. Spending money on essential
medicines - and on the systems needed to deliver them effectively,
equitably and safely - is a
good health investment.

We need to find ways to respond to these great challenges. Essential
drugs are not an ordinary commodity. Access to health care is a human
right. Governments and international agencies have an obligation to see
that this right is progressively realized. Access to essential drugs is
part of this obligation.

The concept of essential medicines has global relevance and is a global
necessity.

The Millennium Development Goals include access to essential medicines
as one of 17 health indictors. The world is committed to expanding
access to essential medicines and WHO is committed to supporting this
goal.

WHO has two critical functions for essential medicines: to develop and
promote global normative guidance, and to give technical support to
Member States.

Some of the normative work and all technical support puts emphasis on
promoting equity and sustainability, with a focus on fulfilling the
needs of poor and marginalized populations.

WHO works with all stakeholders - both at the global level and in the
countries. Besides the Ministry of Health, this includes especially the
nongovernmental sector and academia.

WHO needs to remain evidence-based and totally independent from
commercial interests so that we can ensure an independent development of
normative work. Member States should always feel confident about the
independence of our policy advise.

For our future work, this means continued support to countries, with a
focus on results.

Within country support, more focus will be put on capacity building
through normative information, practical policy guidance and training.

More focus will be put on supporting Member States in aspects of good
governance and formulation of essential government functions, such as
promoting the right mix between public and private functions and
regulating the private sector.

We will continue development of the evidence base for drug selection,
based in part on WHO's independence as a source of scientific
information.

Scientific and normative work benefits all Member States and needs to
remain independent from individual donor decisions.

It is certainly part of WHO's core functions and will remain so.

More focus will be put on strengthening the functions of district
hospitals in ensuring equitable access to primary care.

Access to essential medicines is part of the progressive fulfilment of
the fundamental right to health. The rights-based approach will be
further developed and supported as a means of empowering NGOs and the
general public in making their governments accountable.

More focus will be put on further developing and supporting health
insurance as an important approach in making health care more affordable
for all, and in promoting access to costeffective health care. WHO will
follow a pragmatic approach to critical issues, such as affordability
and the use of TRIPS safeguards to ensure access, building on good
governance by countries.

The promotion of the essential medicines concept will be further
intensified through close collaboration with other clusters, other UN
agencies, the World Bank and NGOs.

Ladies and Gentlemen,

We are in the middle of a great struggle to increase investments in
health as part of the fight to reduce poverty and achieve the Millennium
Goals. We have to show that we have effective means to achieve
measurable improvements in health. We need to find effective ways of
delivering basic health care to all - also to the world's one billion
poorest people. A key part
of this challenge will be to ensure a widening access to essential
medicines.

The Model List  of Essential Medicines is a key tool in this work. Let
us all work to make the next 25 years even more successful than the
quarter century we celebrate today.

Thank you.

[end]


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