E-DRUG: Brundtland adresses Brazilian Parliament on generics
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[Dr Gro Brundtland, DG of WHO, testified this week in the Brazilian
Parliament
to support the concept of generics and essential drugs. This in the context
of an attack
on the current Brazilian generics drug policy. Maybe some Brazilian
E-druggers
can give more background on what is going on in Brazil? WB]
Dr Gro Harlem Brundtland
Director-General
World Health Organization
Opening remarks
Parliamentary Commission on Investigation of Medicines
Brasilia 4 April 2000
Mr Chairman, Distinguished Members of the Commission
As Director-General of the World Health Organization, I am very pleased to
be here today. I wish to thank you for your invitation to address your
Commission on the vital subject of access to essential drugs and vaccines.
I am greatly encouraged by the importance which the Parliament and
Government of Brazil is giving to this subject.
I start with a statement of principle. The people of our world do not need
to bear the present burden of illness. Most of the severe illness that
affects the health and well-being of the poorer people of our world could
be prevented. But first, those at risk need to be able to access health
care - including essential medicines, vaccines and technologies. Millions
cannot - they cannot get the help they need, when they need it. As a
result they suffer unnecessarily, become poorer and may die young.
A country's health service cannot respond to people's needs unless it
enables people to access essential drugs of assured quality. Indeed, this
access represents a very important measure of the quality of the health
service. It is one of the key indicators of equity and social justice.
The essential drug concept is widely accepted today as an approach for
promoting modern, evidence-based, and cost-effective health care. It
focuses therapeutic decisions, professional training, public information
and financial resources on those drugs which represent the best balance of
quality, safety, efficacy and cost for a given health setting. Health
systems of all types, from basic health systems in the poorest countries,
to highly developed national health insurance schemes in the wealthiest,
have recognised the therapeutic and economic benefits of an essential drugs
approach.
In the implementation of National Drug Policies, recommended by WHO,
several countries today are promoting two major policy lines: the first is
fundamental and concerns the promotion of essential drugs as the best
approach from the health viewpoint, and this is supplemented by promoting
the use of quality generic drugs as an important strategy to promote both
affordability and access.
The National Drug Policy, launched by the Government of Brazil in 1998 in a
broad consultation process with all stakeholders, follows the essential
drugs principles and strategies recommended and promoted by WHO. You may be
pleased to know that a summary of the Brazilian National Drug Policy has
been published in Spanish, English and French by the WHO Department of
Essential Drugs and Medicines Policy. It is presented as a good example
for other countries in this region and in other parts of the world.
Much has been achieved in expanding access to drugs and vaccines during the
last two decades. Yet, we have a long way to go before everyone can get the
medicines and vaccines they need at an affordable price.
At the beginning of the 21st century, one-third of the world's population
still lacks access to the essential drugs it needs for good health. In the
poorest parts of Africa and Asia, over 50% of the population do not have
access to the most vital drugs.
According to the latest figures that WHO will be presenting in the
forthcoming World Health Report, 10.3 million children under five years of
age died in developing countries last year. About 8.6 million of these
deaths are due to communicable, perinatal and nutritional conditions. A
large proportion of these deaths could be prevented if those at risk could
access essential drugs.
We all have got used to hearing such figures: we do not forget that they
describe scandalous inequity. All of us working as partners in this
endeavour need to respond to the challenge in a strategic manner. I am
delighted to hear that Brazil is showing what is needed by making major
efforts to improve access to essential drugs and so promote equity in
people's health.
Developing countries, with three-quarters of the world's population, get
only a quarter to a third of the income generated by the world economy.
While developed countries are trying to cope with cost control of drug
expenditure as a major concern, developing countries still face issues such
as the high cost of newer essential drugs, the lack of a primary health
care infrastructure, insufficient funding for health and pharmaceuticals
and, on occasion, ineffective management of available resources.
Access to drugs is a critical component of a health sector strategy.
Governments face difficult choices: they cannot invest in a few costly
drugs and ignore all the other aspects of care. It is our role to help make
those choices less difficult.
Many factors determine the complex question of access; such as
distribution systems, financing procurement and prices. Medicinal drugs
are not ordinary commodities: their procurement, storage, inspection and
distribution need special skills.
In line with the Revised Drug Strategy which was adopted by last year's
World Health Assembly, WHO, in close cooperation with the World Trade
Organization and the World Intellectual Property Organization, is ready to
provide advice to ministries of health on how to assess the public health
consequences of international trade agreements. That includes informing
them on provisions relating to the public health safeguards included as
part of the TRIPS agreement.
We now need to study how the global rules and regulations work in practice.
One assumption of strengthened intellectual property rights was that more
research, development and production would take place in developing
countries and that prices would come down. We have to ask: is this
happening?
On intellectual property rights WHO's position is clear: they must be
protected. We depend on them to stimulate innovation. Patents for
pharmaceuticals should be managed in an impartial way, protecting the
interest of the patent holder as well as safeguarding basic public health
principles.
There are no simplistic solutions and there are no magic bullets. Still,
complexity is a challenge, not an obstacle. There are several possibilities
to explore.
WHO will support any measure which will enhance access to all essential
pharmaceutical products in a sustainable way. We have to find a way to
bridge the issues of commercial viability and right to access.
We need to build new bridges between supply and demand. Today's gaps amount
to a giant market failure. To succeed we will need broad partnerships
between governments in developing and industrialised countries, financial
institutions and the pharmaceutical industry. We will need to build an
emerging consensus on the needs of the poor and the basic requirements for
improving their access to life saving drugs.
How can we arrive at a situation where the poor get sustainable access to
drugs at affordable prices? The pharmaceutical companies have a moral
obligation to contribute to the solution. But we also need to see
protective tariff barriers and distribution margins come down, and we need
to get political acceptance for the concept of "equity pricing", especially
for newer essential drugs of vital public health importance.
Equity pricing means that the poor would not have to pay the same price for
life-saving drugs as those who are better off.
To accept this principle is a political decision. Governments of
industrialised countries must lead in its establishment: Meanwhile,
governments in developing countries must do their share to facilitate
access by improving financing, importation, purchasing and distribution
systems for medicines, vaccines and medical equipment in their own
countries.
WHO will take this public health debate forward, with our Member States,
with our other United Nations partners, with civil society and with
industry.
The strategies and policies to combat poverty and ensure access to health
and pharmaceuticals in such a vast and complex country as Brazil need to be
comprehensive and clearly oriented to ensure population-wide access to
health services and pharmaceuticals.
Given the emphasis on ensuring access to medicinal drugs, the Brazilian
National Drug Policy also highlights generic drugs and stipulates mandatory
adoption of generic names in all public purchases and promotes prescription
and use of generic drugs as one of the important components of the Policy.
I do not want to propose a universal definition of a "generic" drug. It is
a matter on which opinions differ. Let me, for present purposes, consider
as a "generic medicine" a "copy of an original, marketed product on which
the patent has expired and which is marketed as equivalent to, and
therefore can be interchanged with, the innovative brand".
In terms of health sector reforms, promoting generics can help meet the
objectives of reforms by improving affordability, reducing cost, increasing
choice and helping to rationalise both the selection and use of
pharmaceuticals.
Since these strategies can make drug markets more competitive and efficient
and can contribute to the goals of improved equity, quality and efficiency
in health, they are of significant value as reform measures. The current
changes occurring in the Brazilian health sector represent an excellent
opportunity to promote and benefit from these strategies.
Policies promoting generics are frequently only associated with the public
sector. But these strategies can be just as beneficial in the private
sector because they promote efficiency within pharmaceutical markets. This
is particularly important in developing countries, where up to 90% of drug
consumption is through the private sector. Consequently, as with health
sector reform in general, a generic policy will be most successful and
yield greatest benefit if it is comprehensive; it needs to be implemented
in both the public and private sectors to cover all groups of society.
The public-private separation in pharmaceuticals is, in a way, artificial
anyway. Health professionals may be active in both sectors and patients may
receive prescriptions in the public sector to be filled in the private
sector. Given that - in many countries - the vast majority of
pharmaceuticals are obtained in private markets, the benefits of generic
drug strategies can only be realised when they receive widespread
acceptance in both public and private sectors.
The essential drugs policy recommended and promoted by WHO identifies four
key elements for ensuring the success of a generic drugs programme:
1. Supportive legislation and regulation;
2. National capacity for quality assurance;
3. Professional and public acceptance;
4. Economic incentives and information.
In other words, generic strategies involve much more than legal mandates;
they are processes requiring support and enforcement, they must respond to
the concerns of involved parties and they must provide adequate economic
incentives.
In Latin America, several countries have already enacted legislation
relevant to generic strategies but, in most cases, implementation is
limited. Overall, the results indicate that lower prices have been
observed where solid and transparent legislation exists.
In the United States of America, generic drugs represent half of the market
in volume. Although this market share is one of the highest in the world,
the process leading up to this has been long and bumpy. Many hospitals in
developed countries have lists of approved drugs which identify products by
generic name.
The European Union has agreed on three major policy regulations regarding
pricing and reimbursement of pharmaceuticals:
(i) to contain growth in pharmaceutical expenditures;
(ii) to enhance competition by making the market more transparent and
encouraging generics;
(iii) to raise the cost-awareness of patients by better informing them of
the cost-benefit ratios of therapeutic alternatives.
WHO has, for a long time, been encouraging drug policies based on the
promotion of generic drugs of assured quality. This has proven to be a
cost-effective strategy in containing drug expenditure.
WHO is, therefore, in favour of so called "early workings" of patented
drugs for generic manufacturers, to encourage competition; this is also a
major motivation in the research for improved products. This includes the
use of patented drugs for research and testing, which necessitates prompt
registration and early production of generic drugs. Countries with
variations of early workings provisions include Argentina, Australia,
Canada, Hungary, Israel and the USA.
Mr Chairman,
It is becoming increasingly clear that poverty not only causes ill health,
but that ill health keeps people in poverty. We have compelling evidence
that investing in health is a measurable, results-oriented and effective
way to reduce poverty. If there is one universal element that features in
every economic transition over the past two centuries, it is that improved
health results in lower child mortality and longer life expectancy.
Access for all to essential drugs and vaccines is also a shortcut to lower
mortality and better health for the entire population. Improving such
access is among the most effective health interventions any country can
make.
Health is not a peripheral issue that only more affluent economies can
afford to spend money on. It is a central element of development. And
access to drugs is a central element of any health policy.
Our shared mission is to make medicines available to all who need them
regardless of their income. It is possible - if we act together.
Thank you.
--
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