- Keywords > compulsory licences
- Keywords > globalization
- Keywords > innovation and intellectual property
- Keywords > Intellectual Property Rights (IPR)
- Keywords > patent system
- Keywords > patentability criteria - policy options
- Keywords > trade and innovation
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
- Keywords > Uruguay Round
(1998; 97 pages) [French] [Spanish]
1. Speech of the WHO Director-General, Dr Gro Harlem Brundtland
Executive Board Members,
Representatives from Other Member States,
Ladies and Gentlemen,
This gathering is one example of a new, more open approach to the work of WHO’s Executive Board. I welcome you into this process and invite you to participate actively and share your experience.
The 51st World Health Assembly in May saw a debate on the revised drug strategy resolution. We all remember the outcome. After hours of negotiations the resolution was referred back to the Executive Board. This week you are meeting as a working group of the Board to reconsider the issues.
The real purpose of this week’s work is to move our thinking further - on how we can secure fair and equitable access to drugs - on the health implications of expanded world trade - and on how WHO can best play its role to reach that goal. It is not a quick fix. We need to create a process that can build momentum for change. I wish to look ahead - one year, two years - and be able to set an agenda that we can pursue together.
Before looking ahead, let us first take this opportunity to reaffirm WHO’s strong commitment to national drug policies and to the concept of essential drugs and vaccines.
As some here may recall, in 1975 - faced with serious problems of availability, cost, quality, and use of drugs in developing countries - the World Health Assembly adopted a resolution which first put the concepts of “national drug policies” and “essential drugs” into the international public health vocabulary. In 1981, the Action Programme on Essential Drugs was formed to provide direct support to countries to implement these concepts.
At the beginning, the concept of a national drug policy was unfamiliar. Few countries had essential drugs lists. National treatment guidelines were rare. Teaching about prescribing was unsystematic. Of greatest concern, was the observation that less than half the world’s population had regular access to essential drugs.
Today, nearly 90 countries have national drug policies in place or in preparation. Three out of four countries - over 140 in total - have adopted national essential drug lists. These national lists are widely used for drug purchases, training, and public education about medicines. Nearly 100 governments have developed national treatment guidelines. And the WHO approach to prescriber training is being adopted by leading medical universities in countries at all levels of development.
Most importantly, through a combination of public and private health systems, the absolute number of people with access to essential drugs has nearly doubled over the last twenty years.
These few examples illustrate what can be achieved when countries, with support from WHO and other international organizations, become committed to a shared vision. But there is still much to do.
Medicines are still unavailable or unaffordable for too many people - especially the poor and those most in need. Prescribing and consumer use of medicines is too often ineffective, wasteful, or even harmful. Poor quality drugs constitute a continuing health hazard.
Our aim must be to ensure equity of access to essential drugs, rational use, and quality. This is simply part of the fundamental right to health care. Achieving these objectives remains one of WHO’s highest priorities.
We remain committed to national drug policies as part of national health policies. The national drug policy process can and should engage the public sector, professional bodies, the private sector, consumers, academics, and other concerned partners. Together they can develop a common vision and plan of action.
WHO will continue to promote the essential drugs concept. Essential drugs and vaccines save lives and improve health. In updating the WHO Model List of Essential Drugs, we will look carefully at the evidence for drug selections. We must ensure that the list reflects current therapeutic needs and changing drug resistance patterns.
We will work with governments, other UN agencies, NGOs, the private sector and other interested partners to find new ways to increase access, to improve the use of medicines, and to assure the quality of medicines.
We are structuring our work to ensure that WHO speaks with one voice in the area of pharmaceuticals and essential drugs. Through the Action Programme on Essential Drugs, WHO remains committed to working with countries to develop and implement effective national policies and programmes.
Let us consider more carefully the critical issue of access.
As we have seen, much has been achieved during the last twenty years. Nevertheless, one-third of the world’s population still has no guaranteed access to essential drugs - and most of these people have little or no access to primary health services either. That has to change and that should in itself be a strong unifying force in our efforts.
The inequities are striking. In developed countries, there may be one pharmacist for every 2000 to 3000 people. A course of antibiotics to cure pneumonia can be bought for the equivalent of two or three hours’ wages. One-year treatment for HIV infection costs the equivalent of four to six months’ salary. And the majority of drug costs are reimbursed.
In developing countries, there may be only one pharmacist for one million people. A full course of antibiotics to cure a common pneumonia may cost one month’s wages. In many countries, one year of HIV treatment - if it were purchased - would consume the equivalent of 30 years’ income. And the majority of households must buy their medicines with money from their own pockets.
How can such profound inequities be addressed? What actions can be taken to address the needs of those who do not have access to essential drugs?
We must work with countries - especially those in greatest need - to put into practice what is already known about drug management, distribution systems, and financing systems.
We need to gather evidence on which approaches are most effective. The Action Programme on Essential Drugs is currently undertaking initiatives which address drug supply strategies and health reform, generic substitution, price information, effective drug regulation, and drug insurance.
We must work with all interested partners - governments, UN agencies, the private sector, NGOs and others - to find innovative approaches to bring prices down, to increase financial resources, to improve supply systems, and to ensure that drugs arrive where they are needed. I invite you in your discussions today, and throughout the week, to identify additional ways in which WHO can help tackle the problem of access to essential drugs.
Let us turn to the issue of trade and health.
The revised drug strategy resolution addressed many issues - such as national drug policies, drug regulation, quality assurance, drug prices, ethical drug promotion, and patient information. But it was the question of new trade agreements and pharmaceuticals which attracted the most attention.
What is the relationship between trade and health? Do health people and trade people have anything to say to each other? Yes we do and we have been talking for quite some time already. Here are some examples:
Food safety has been on the leading edge of WHO interactions with the World Trade Organization. As a result of early WHO efforts, the standards, guidelines and recommendations of the Codex Alimentarius are specifically stipulated as the international reference for food safety in the relevant WTO agreement.
Earlier this year, WTO transmitted to all Member States the information that there has not been a documented outbreak of cholera from commercially imported food. This appears to have contributed to the European Union lifting its embargo on fishery products from a number of developing countries.
With respect to pharmaceuticals - including biologicals such as vaccines - international norms and standards are not specified in WTO agreements. Here, WHO’s role must be viewed as the only representative organization worldwide with a mandate and technical expertise for setting health-related norms and standards.
Aside from the question of norms and standards, WHO has official observer status on the WTO committees which administer the Technical Barriers to Trade (TBT) and the Sanitary and Phytosanitary (SPS) agreements. This status allows WHO to intervene in these committees to present public health perspectives, to provide information to WHO Member States, and to assist in solving problems as they arise in the implementation of agreements.
Where public health issues are involved, WHO has been called upon to provide expert views in the WTO dispute settlement process. WHO also has enlisted WTO collaboration on WHO documents on health aspects of trade and has joined WTO in-country training sessions.
On some points of health-trade interaction, WHO actually has the leading role. Take the International Health Regulations - a legally binding instrument administered by WHO. It covers the health aspects of the movement of people and goods. WHO has invited input for revision of these regulations from the concerned WTO committee.
What can we learn from WHO’s experience thus far in trade and health? There are several lessons, I believe.
First, there clearly are important trade issues which require a public health perspective. WTO does not have that expertise. WHO and WTO need to work together within the international system. Food safety, international health regulations, trade in health services, pharmaceuticals, and biologicals are all areas in which health and trade intersect.
Second, as a source of technical expertise and holder of public health values, WHO must ensure that health concerns are weighed appropriately when trade and health intersect. When trade agreements affect health, WHO must be involved from the beginning. We need to analyse and monitor how new international agreements can support public health.
Third, we must recognize that the intersection of health and trade brings together a stunningly diverse set of organizations, perspectives, and values. You may see this diversity as a barrier. I see it as an inescapable reality and perhaps even an opportunity. If, through this broad process that I am calling for today - health and trade people come to understand each other better - then we will have achieved a great deal.
WHO can assist, but governments must also develop their own views. After all - it is the same governments that are sending their representatives to the different negotiations. Governments must be consistent and send the same message in different international bodies.
We cannot slice the world into pieces - one for health, one for trade and one for environment. Health Ministers and Trade Ministers must meet and speak. My message to countries is that they install mechanisms to secure better coordination between ministries responsible for trade and health - as well as other relevant ministries - seeing to it that public health concerns are duly taken into account.
Fourth - and most important - I am convinced that the way forward is through open dialogue and direct interchange among interested partners. Yesterday I met with Mr. Ruggiero, Director General of the World Trade Organization. I urged that WTO take a more active role in understanding the health perspective and I confirmed that WHO will work seriously to analyse the trade perspective. We agreed to meet twice a year to address a prepared agenda related to world trade and health.
Appropriate mechanisms are needed to assist trade officials to understand the health implications of WTO agreements. Similarly, mechanisms must be found to ensure that health officials understand clearly the relevant sections of trade agreements. Here WHO has an important role to play.
Let’s then move to the development of needed new drugs.
Never has the world had so many therapeutic weapons for the diseases which afflict humanity. At the same time, there is a critical need for certain new drugs and vaccines. This is true for emerging diseases, but also true because of the serious threat from growing resistance to drugs for common killers such as malaria, tuberculosis, bacterial meningitis, and pneumonia.
To develop new drugs we need an innovative pharmaceutical industry, with appropriate incentives for innovation and protection of intellectual property rights. Experience demonstrates that protection of intellectual property rights goes hand-in-hand with successful research and development.
The WTO agreement on intellectual property, or “TRIPS” as the agreement is commonly called, provides WTO members with the minimum global standard for intellectual property. WTO member countries are working to see how best to implement this agreement.
Let us agree: countries are affected in different ways by the new trade agreements - according in part to their level of development.
From a public health perspective, there are a few key questions: will drug prices increase? Will production and availability be affected? Will R & D increase on drugs for priority public health problems? On these questions, let me say, WHO will be watching. I invite governments, industry, NGOs and other partners to establish with WHO an appropriate mechanism for monitoring the actual effects of the new trade agreements. Let us work together on these questions.
During the many hours spent on this resolution in May, the group was unable to agree on common language concerning trade agreements and pharmaceuticals. A lot of effort was put into some key words.
Today let us ask ourselves: What do we want to achieve? What is the best action taken by Member States - in the Executive Board, in the World Health Assembly and by the WHO Secretariat? The Secretariat can support and assist - and is ready to engage with all its energy in this critical endeavour. It is you, the Member States who must decide the guidelines. I urge you to opt for a broad process with perspectives for change towards equitable access to essential drugs.
Finally, let us talk about partnership.
I have committed WHO to reaching out - to the private sector, to NGOs, and to others in civil society who have an interest in health development and who can make a contribution. We must accept the legitimacy of all stakeholders. Each has a commitment to health - each in its own way.
Last Friday we had our first roundtable meeting with NGOs active in pharmaceuticals and essential drugs. Our discussions covered a number of areas, including the role of consumer organizations and health-related NGOs, access to drugs in developing countries, and rational use of drugs. I was impressed by the knowledge, diversity, strength of commitment, and openness of these organizations.
Next week I will hold a similar roundtable with senior executives from the research-based pharmaceutical industry. There we hope to map out the challenges, to see better what WHO and industry can achieve together. The concept of “roundtables” applies to a process, not simply a meeting. There will be follow-up work from these two roundtable discussions. We will ensure that the roundtable process includes all key partners. We are challenging our partners to do more to promote rational use of drugs, access to essential drugs and innovation for needed new drugs. There have been and will be similar meetings with partners concerned with breast-milk substitutes, tobacco cessation, diagnostics, and other areas.
Reaching out is a broad concept. I will ask the Regional Offices to gather information on the local factors inhibiting access to drugs in their regions - and the results from these surveys will be shared with other agencies such as the World Bank, UNDP, UNICEF and UNCTAD so that together we may design programmes that can improve access to essential drugs.
I also wish to see WHO work with the World Bank, UNIDO and UNDP to stimulate the transfer of technology and capacity building in local production at a country level, as appropriate.
Finally, I welcome the good relations between WHO and the Movement of Non-Aligned Nations - grouping the majority of the developing world. I have noted the commitment to a wide range of pressing health needs, including access to essential drugs, expressed in recent meetings of the Ministers of Health and Heads of State.
Mr Chairman, Colleagues, Ladies and Gentleman,
This will be a demanding few days. This represents a new way of working for the Executive Board - maybe you find it effective. Maybe you will suggest new ways. You may see it as a challenge, but it is also an opportunity.
I wish you well in your deliberations.