The International Conference of Drug Regulatory Authorities is an important forum for senior drug regulatory officials from all parts of the world. This forum is of particular value to representatives from smaller authorities with limited resources. On behalf of the World Health Organization, I wish to pay tribute to the German Ministry of Health, to Minister Fischer and to Professor Hildebrandt, Director of the Federal Institute for Drugs and Medical Devices and his staff, for all the work that they have put into the preparation and organization of this Conference.

The main responsibility of drug regulation is to safeguard the availability of good quality, safe and effective pharmaceuticals to all citizens. This is critical to any healthcare system. Access to drugs and vaccines is routine in many countries. But parallel to this, we also see the negative consequences on populations who are denied access even to the most essential drugs.

A vital part of health care is availability and rational use of essential drugs and vaccines. WHO continues to establish and develop clear and practical norms and standards to assist countries in the assurance of the quality and safety of drugs. This is a goal supported and pursued by all parts of the Organization.

The newly established Department of Essential Drugs and Other Medicines is WHO’s main instrument in promoting the essential drugs concept. We are giving renewed commitment to helping countries establish and sustain operational healthcare systems, of which access to essential drugs and medicines remains a bedrock principle.

Much progress has been achieved over the years, but much remains to be done. Lack of essential drugs, irrational use and poor drug quality remain a serious global health problem. Let me mention just a few.

• The wide use of injections and the high prevalence of unsafe practices put communities at risk of bloodborne diseases such as hepatitis B and C, and HIV.

• Over one-third of the world’s population still lacks access to essential drugs and even the most basic diagnostic technology. In the poorest parts of Africa and Asia, this number climbs to over 50 per cent.

• Fifty to ninety per cent of drugs purchased in developing countries are paid for out-of-pocket. The burden falls mainly on the poor who are not adequately protected by health policies.

• Up to 75 per cent of antibiotics are prescribed inappropriately.

• Worldwide, an average of only 50 per cent of patients take their medicines correctly.

• Ten to twenty per cent of sampled drugs fail quality control tests in many developing countries. While counterfeit medicines have been detected in both developed and developing countries.

I have pointed out some of the main problems we face with regard to pharmaceuticals. They are well known to us. But at the same time we are facing new challenges:

Increasing globalization touches almost all sectors of our lives. This has an impact on health and includes both the availability and the development of pharmaceuticals and vaccines. We are facing many new issues due to the pace of change and the movement towards an open market economy, massive increases in the cost of health care provision and new innovative treatments, privatization, and free trade.

The establishment of the World Trade Organization (WTO) and the implications of WTO agreements such as Trade Related Intellectual Property Rights (TRIPS) and Technical Barriers to Trade (TBT), increasingly sophisticated technologies and techniques in health care, biotechnology and the revolution in information technology such as the internet and telemedicine, all come together and create a new and complex platform for governments and other actors in the field of pharmaceuticals. It is difficult for any health care system to cope with these challenges but it is particularly difficult for countries with limited resources. WHO will continue to play its role as an active adviser to authorities who face these new challenges.

Today I wish to spend time on another key issue related to regulation. Speaking to this audience, I would miss an opportunity if I did not clearly state that the time has now come for concerted regulation of tobacco products. In this century - a century of astounding public health gains - tobacco control stands out in most countries as an appalling failure. Too few resources have been committed; too often national governments have chosen soft options over effective measures. If you think I am being too critical, consider the facts: More people smoke today than at any other time in human history. Worldwide, the tobacco death rate is up - way up. As I speak, four million people are killed each year by tobacco-industry products.

• Half of all long-term smokers will be killed prematurely by tobacco-industry products.

• Five hundred million people alive today are likely to be killed by tobacco.

• Half of these will die in their productive middle years. This robs families of economic support and countries of the contribution of its most experienced workforce.

But this is only the beginning. It will get worse, much worse, before it can get better. Tobacco promotion is linked to smoking initiation. Often among the very young, initiation leads to addiction. 80 per cent of smokers reveal that they were addicted before the age of 18. That is not freedom of choice.

Addiction results in prolonged use. And tobacco use causes avoidable, premature deaths decades later. So the focus of today’s tobacco promotion will largely determine who will be killed by this product in 2025. And by that date, leading experts predict, tobacco-industry products will kill lo million per year. That is almost a tripling of today’s level. Tobacco will then be the single largest contributor to the global burden of disease.

And perhaps saddest of all, smoking is growing rampantly in the developing world. Nearly all the consumption growth - and the seven million extra deaths per year - are expected in developing countries. With present tobacco marketing expansion in Asia, Latin America and Africa, tobacco companies are building their customer base and in the process impeding the economic development of the poorest nations. So without new and more vigorous and effective interventions, those countries least capable of addressing the problem are soon to be hit the hardest.

This is the challenge facing you in each of your countries. This is the backdrop against which WHO has stepped up its tobacco control activities. Part of the failure of past tobacco control stems from the incongruous way tobacco products have been regulated. Tobacco’s selling price is often influenced through taxes. The cigarette box is marginally controlled in many countries through mandated health warnings. And tobacco advertising is controlled only in some countries.

But the root problem is not the cigarette package, or the price, or the advertising. The problem is the product itself. Cigarettes are inherently dangerous products. The tobacco companies, despite knowing this for many years, have steadfastly chosen not to remedy this, and to press forward their sales. It is this failure of the marketplace to solve the problem that is our invitation to step in and make a difference. Though this will not be easy, too often the challenges have been overstated, and too often countries have chosen to tinker on the edges rather than attack the root cause.

One of the largest transnational tobacco companies opposes regulation. But this company is not unfamiliar with product regulation because it has a food products division, and the contents of these food products are of course often regulated. How can any of us justify that the contents of food products, made by a company, are regulated but that the contents of cigarettes, another of its products, are not? The tobacco companies will inevitably tell you that they are selling a simple agricultural product - chopped-up tobacco leaves rolled into a little paper tube. This is categorically untrue. Cigarettes are among the most highly engineered consumer products available.

The companies say that nicotine occurs naturally and inevitably in tobacco, rather like seeds in an apple. There is evidence that nicotine delivery to the smoker may be skilfully controlled so that the cigarette delivers a sufficient dose of nicotine to create, then maintain addiction. So-called “light” cigarettes deliver lower tar and nicotine to the machines, but under actual smoking conditions smokers obtain just as much tar, just as much nicotine from “light” brands as from regular cigarettes.

Unregulated cigarette design lets the tobacco companies fool smokers into believing they are choosing less hazardous products. This is a misconception. Health concerns should not be exploited as a marketing opportunity.

If you still believe the industry is simply stuffing tobacco into paper tubes, not fine-tuning nicotine delivery, consider this quote from a senior scientist working for a tobacco company, uncovered recently from a long-hidden document. In 1972, he said:

“The cigarette should not be construed as a product but a package. The product is nicotine. Think of the cigarette pack as a storage container for a day’s supply of nicotine. Think of the cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle of nicotine.”

We know the status quo is not an option. Too many lives will be lost; too much economic potential will be wasted if we avoid our responsibilities. We know that the global nature of the problem will require partnership between national governments, between governments and international agencies, and between the public and private sectors.

WHO’s prime contribution to international tobacco regulation will come through the Framework Convention on Tobacco Control (FCTC), the world’s first global convention on tobacco control. That effort is ongoing, but the Convention will not be a full solution to the problem. The treaty will only be effective if it works in conjunction with and builds upon sound domestic interventions.

You may be wondering how the problem of tobacco smoking relates to your work as drug regulators. I am fully aware of the business you are in - regulating medical or pharmaceutical products. But there are a few reasons why we thought you should spend some time discussing tobacco at this forum. First, one of your main responsibilities is to regulate drugs to protect the health of consumers. In order to protect the health of consumers, governments have the general responsibility of restricting the distribution of dangerous products. This responsibility usually covers pharmaceutical products as well as toxic chemicals and addictive drugs, and is often given to drug regulatory authorities.

Drug regulation is also needed to promote health. Marketing of pharmaceutical products should be regulated so as to ensure not only the safety, but the efficacy of the product. This principle should apply to nicotine replacement therapies in the same way as for other medicines.

Many drug regulatory authorities are already assessing the efficacy and safety of nicotine replacement therapies. It would seem that more drug regulators will be asked to do the same in the future. Furthermore, drug regulatory authorities are often consulted during discussions on access to drugs. For example, whether the drug should be included under health insurance schemes, or debating who should be authorized to prescribe or distribute the drug, including self-medication. Thus, there are a number of technical questions drug regulatory authorities would have to consider in connection with smoking reduction. All this would support the initiation of a serious discussion on tobacco at this forum.

In my view, in the mid-term, three things need to happen: Experts from various countries should meet to determine our present knowledge about tobacco products; to set a short term research agenda to fill the knowledge gaps; and to chart the technical details of this essential change in course. I will commit WHO to convening such a meeting with many of you by the end of the year.

Your governments need to take action at home. The legal framework to regulate tobacco product content and design should be set in place. Then those matters for which existing knowledge is sufficient should be addressed. For example, cherry flavoured chewing tobacco is sold in several countries. What more do we possibly need to know to decide that fruit- or candy-flavoured tobacco should not be sold? The answer is simple- nothing.

Together we must translate national successes into international gains. Governments must push for the inclusion of effective tobacco content and design controls in the protocols to the Framework Convention on Tobacco Control. Together we can accomplish this, but it is the Member States of WHO that must be driving the process. Hopefully with the enthusiastic support of NGOs and with society, we will be able to keep up the momentum.

Together we can do what the tobacco industry has chosen not to do. Together we can reverse the trends of what is developing into a major pandemic.