Safeguarding health in an interdependent, lopsided world
Dr Margaret Chan
Director-General of the World Health Organization
Commissioner Hamburg and the many other friends of WHO in this audience, colleagues in public health, and I do mean international public health, ladies and gentlemen,
It is a great pleasure for me to address an audience at the US Food and Drug Administration.
Over a long stretch of years, FDA has been widely respected as the world’s toughest and most conscientious regulatory body. The criteria used by this agency to determine that a food, medicine, or cosmetic is safe are considered the gold standard for the rest of the world. If FDA says it’s OK, it really is OK.
I want to mention another area where FDA leadership is greatly needed by the rest of the world. This concerns the battle to reduce deaths and disease caused by tobacco use. Sabotage by the tobacco industry, using traditional and novel tactics, has reached new heights.
Tactics that were previously covert are now out in the open and extremely aggressive. The high-profile commercial and investment arbitrations targeting Uruguay and Australia are deliberately designed to instil fear in countries wishing to introduce similarly tough tobacco control measures.
In another extraordinary legal action, FDA faces a lawsuit filed by five cigarette manufacturers over new regulations to introduce appropriate and effective graphic health warnings on cigarette packages.
Numerous other countries are being subjected to the same kind of aggressive scare tactics. It is hard for any country to bear the financial burden of this kind of litigation, but most especially so for small countries like Uruguay.
Big Tobacco can afford to hire the best lawyers and PR firms that money can buy. Big Money can speak louder than any moral, ethical, or public health argument, and can trample even the most damning scientific evidence. We have seen this happen before.
By remaining steadfast against these bully tactics, FDA gives other countries a strong message of support: stand firm together. Do not bow to pressure.
WHO stands by FDA in these efforts. I appreciate, in particular, FDA’s Center for Tobacco Products, which has just celebrated its second anniversary. In support of FDA’s work on tobacco control, WHO has strengthened its collaboration with this initiative.
We look forward to the inaugural International Tobacco Regulators Conference, jointly hosted by FDA and WHO, to be held in Washington, DC later this year.
It is horrific to think that an industry known for its dirty tricks and dirty laundry could be allowed to trump what is clearly in the public’s best interest.
WHO is committed to combating the tobacco epidemic, side-by-side with FDA, with the aim of stopping this industry’s massive contribution to morbidity and mortality dead in its tracks.
Ladies and gentlemen,
I fully appreciate that your job is not an easy one. Concerning guarantees of safety, the American public is likely the most demanding, and unforgiving in the world.
Your work is closely scrutinized, and something about the FDA is in the headlines nearly every week, often in the financial section of the news.
The challenges you face are growing ever more complex, entangled as they are in the intricacies of food and pharmaceutical trade in a world of radically increased interdependence.
Emerging and epidemic-prone diseases have become a much larger menace in a world bound together by the tremendous speed and volume of international travel, and live-wired by chat rooms, blogs, and Twitter.
Outbreaks of foodborne disease have become an especially large menace. Large in their potentially wide geographical spread, often involving multiple countries. Large in the costs of recalls measured in the tonnes. And large in the complexity of investigations, especially when a meal may contain food items and ingredients from all around the world.
Today, problems can arise from any link or kink in a convoluted food chain. Adding to the complexity are the increasing use of formerly exotic cuisines where ingredients like, say, a sprinkling of bean sprouts as a garnish, are almost subliminal and unlikely to be recalled in a food history.
This problem was experienced most recently in Germany’s especially large and lethal E. coli outbreak that began in May. Foodborne diseases always cause considerable collateral damage to the food industry. Consumer fears and costly reactions can linger long after the risk itself has vanished.
Foodborne outbreaks can also cause a political uproar when fingers start pointing at the source and blame lands on a particular country, usually with tremendous losses for farmers and the agricultural sector.
Other new challenges arise from the world’s real-time interconnectedness.
The rise of social media means opinions, also on scientific issues, get taken as fact and widely propagated, while traditional safeguards, like peer review and precise scientific and statistical methodologies, fly out the window.
The public needs to understand that science is not a democracy in which the most articulate bloggers, the most popular websites, or the loudest politicians get to decide what is best for public health.
Public health depends on community participation and social inclusion. But it does not need a resurgence of measles outbreaks largely attributed to unfounded public fears. As we have learned with the MMR vaccine and autism scare, defeating these fears with first-rate science no longer works as well as it did just a decade ago.
As Commissioner Hamburg has said on other occasions, challenges like these have no quick solutions. They need a multifaceted approach with responsibilities shared among many parties.
The enormous challenges of safeguarding health in the years ahead are eloquently and convincingly analysed in FDA’s July special report outlining a new pathway to global product safety and quality.
FDA recognizes that safeguarding the health of the American public now means acting on a global stage. It also means moving from a reactive to a proactive response, and taking on all the important, yet sometimes politically delicate work this entails.
Something similar happened when the International Health Regulations, administered by WHO, were revised in 2005. Central to the revision was a move from a reactive response, aimed at blocking international spread at borders, to a proactive response that aims to stop a health threat at its source, before it has a chance to spread internationally.
As FDA moves forward to address these new challenges, you can count on WHO as a supportive and admiring partner.
WHO must also deal with these problems, and many others in our mandated role as a global health guardian, a protector and defender of health. WHO’s job has likewise become harder in a world where at least a billion people have no access whatsoever to the most basic health care.
In the interest of a safer and more secure world for everyone, WHO and its partners must shrink some big and growing gaps.
Globalization was thought by many to be the rising tide that would lift all boats. This did not happen. Instead, globalization has tended to lift the biggest boats and swamp or sink many smaller ones.
Today, the differences, within and between countries, in income levels, in opportunities, especially for youth, in health outcomes, life expectancy, and access to care are greater than at any time in recent history.
The difference in life expectancy between the richest and the poorest countries now exceeds 40 years. As documented in last year’s World Health Report, annual government expenditures on health range from as little as $1 per person to nearly $7,000.
As the report also notes, higher spending on health does not guarantee better health outcomes. Policies make the difference.
Analysts of the root causes of this year’s Arab awakening have reached a welcome conclusion. Greater social equality, within and between countries, must become the new political and economic imperative for building a more secure and stable world.
Ladies and gentlemen,
Prevention is the heart of public health. Equity is the soul. And these days, politics must be our bedside manner if we want to get results.
When I took office in January 2007, I made improvements in the health of women and the people of Africa my top priorities in terms of measuring the overall performance of WHO.
At that time, with progress towards the health-related Millennium Development Goals stalled, I was fully aware that weak health systems were the principal barrier holding progress back. In large parts of the developing world, decades of neglect allowed health systems to crumble.
A few statistics give you an idea of the scale of the problem. The world faces a shortage of around 4 million doctors, nurses, and other health care staff, with the shortage greatest in sub-Saharan Africa.
At present, some 85 countries, representing 65% of the world’s population, do not have reliable cause-of-death statistics. This means that causes of death are neither known nor recorded, and health programmes are left to base their strategies on crude and imprecise estimates.
Understandably, the strengthening of health systems, including regulatory capacity, was among my top priorities.
Regulation is among public health’s most powerful preventive tools. Regulatory capacity underpins some of the best work done to safeguard public health. Good regulatory capacity, backed by strong enforcement, confers population-wide protection in an efficient and cost-effective way.
The power of regulation extends beyond ensuring the quality and safety of foods and medicines.
Legislation and enforcement are central to the prevention of road traffic crashes, which claim more than 1.2 million lives worldwide each year.
Reducing the harmful use of alcohol depends on the concerted action of national authorities, traffic police, licensing officers, the criminal justice system, and safety authorities, in addition to health officials.
The obstacles that stand in the way of better health for women are not primarily technical or medical in nature. They are social and political, and they can be modified, also through legislation.
Legislation can protect women from domestic violence, ensure their right to own property and use the money they themselves earn, and prevent the marriage and childbearing of girls at an age when their own bodies are not yet mature.
Regulation contributes to equity. Everyone in the world deserves the same assurance that the air they breathe, the water they drink, the food they eat, the medicines they take, and the chemicals they encounter will not damage their health.
And regulation is a political hot potato. WHO, and FDA, know this from long experience.
When public health is vaccinating children, distributing bednets, or saving the lives of pregnant women and new mothers, everything is fine.
But when public health policies threaten corporate profits, commercial interests trump health concerns nearly every time. Or at least they make the battle for better health much, much harder.
I am thinking about the marketing of breast-milk substitutes, the protection of intellectual property rights versus the need for affordable medicines, especially generic medicines, the obesity problem, especially in children, and the documented contribution of processed foods and sugar-loaded beverages.
Such issues bring the biggest political battles, the toughest negotiations, and the greatest tests of health diplomacy I have personally ever witnessed.
This is not a level playing field at all. Just compare the resources available for public health campaigns to the corporate resources invested in the advertising and marketing of tobacco, junk food, alcohol, and super-sweet drinks.
Unfortunately, this is the way our world has been designed, by politicians and economists, to work. This is how the international systems, whether for trade or global finance, work.
Such systems create benefits, but have no rules that guarantee the fair distribution of these benefits.
The world will never become a fair place for health all by itself. This happens only when equity is an explicit policy objective.
And this brings me back to the issues of equity and capacity. What good are international safety standards when countries have no capacity to implement and enforce them?
The 2009 H1N1 influenza pandemic demonstrated vast inequities in access to diagnostic tests, antiviral medicines, and pandemic vaccines. To prepare better for similar events in the future, WHO is helping developing countries to rapidly establish manufacturing capacity for the production of influenza vaccines and medicines.
I want to thank the US government, and the Centers for Disease Control and Prevention in particular, for their invaluable support throughout the 2009 pandemic. This support came on top of years of direct technical support for capacity building in the developing world, especially for diagnostic and basic laboratory capacity.
That long-standing support made a tremendous contribution to worldwide preparedness, and will hold us in good stead for the future.
Ladies and gentlemen,
This century began with unprecedented momentum and money for health development.
The decade that followed saw a world beset by one global crisis after another. The economic downturn keeps getting deeper.
In this new era of financial austerity, the best way to maintain the momentum for better health is to run programmes with a thirst for efficiency and an intolerance of waste.
At a time of severe financial constraints, donor countries are under intense domestic pressure to demonstrate that investment in foreign health development brings measurable results and demonstrates good value for money.
This creates a dilemma for WHO. The impact of much of our work is difficult to measure, or behind the scenes and out of the headlines, or even largely invisible until something terrible goes wrong, like a disease outbreak, or when air pollution or water contamination or the level of additives in food exceeds our safety standards.
Donors are impatient. Capacity building takes time.
Let me conclude with two examples, one of waste, and one of efficiency. These examples also illustrate how WHO works.
In July, WHO urged countries to ban the use of inaccurate and unapproved commercial blood tests to diagnose active tuberculosis. WHO meticulously gathered and verified solid evidence that these tests are inconsistent, imprecise, and put patients’ lives at risk.
The tests are unreliable. False-positives mean that patients take toxic medicines for months, for no reason. False-negatives mean that people take no precautions to prevent infecting others.
More than a million of these inaccurate blood tests are carried out each year, often at great financial costs to patients, who may have to pay up to US$ 30 per test.
Certainly, it is the right thing for WHO to sound an evidence-based alarm and urge a ban on these tests, just as it is right for WHO to campaign against the continuing use of monotherapies for malaria, especially by doctors in private practice. But how do we measure the impact of such work?
There is a second question. What allows unapproved useless tests and dangerous medicines to become widely used?
Lack of national regulatory and enforcement capacity gives these products their entry point. Once on the market, greed in the private health sector perpetuates their use, despite all the harm to health and all the wasted money.
My second example, of opportunities for greater efficiency, is more directly relevant to the work of FDA.
For pharmaceutical products, WHO maintains a number of long-standing programmes designed to strengthen regulatory capacity, ensure the quality of medicines and vaccines, rationalize the use of medicines, and reduce their costs, with particularly strong support for the production of quality generic medicines.
FDA’s long-running technical and scientific support for these programmes is well-known and deeply appreciated. Let me single out your support in biological standardization, in strengthening national regulatory capacities, in combating poor quality and unsafe medicines, including counterfeits, and in improving pharmacovigilance worldwide.
For example, WHO’s Practical handbook on the pharmacovigilance of antiretroviral medicines depended heavily on the expertise of FDA’s senior official, Dr Gerald Dal Pan.
Your Center for Biologics Evaluation and Research is a valued WHO Collaborating Centre, especially for the quality control and regulation of blood products.
More recently, the WHO prequalification programme has expanded from its initial purpose of ensuring that UN agencies, GAVI, and the Global Fund get the best quality products at the best prices when purchasing medicines and vaccines for use in mass campaigns.
Today, this programme operates in ways that allow manufacturers from low- and middle-income countries to enter the market and, when strict quality and safety standard are met, compete with established manufacturers.
Supplies become more reliable, forecasting is facilitated, and competition brings prices down, often substantially, changing the dynamics of the market for public health vaccines and medicines. This expands the purchasing power of development dollars, and this means expanded access to medical products for the poor.
The strengthening of capacities, including the hands-on training of drug regulators, is a built-in feature of the programme.
The programme contributes to the current move to harmonize quality standards globally and close the doors to poor-quality medicines.
Equally important, a fairer playing field is being created. Products, whether manufactured in wealthy or developing countries, are increasingly being judged by the same standards.
Perhaps most important, the prequalification programme has teeth. On-site inspections to ensure compliance with international standards are repeated at regular intervals.
Products can, and frequently do, get de-listed if quality is not maintained. The prospect of de-listing is a very powerful incentive to maintain high quality standards.
I do not want to make all of this sound too easy. It is, in reality, a delicate balancing act, or to repeat your Commissioner’s words, a challenge that needs “a multifaceted approach with responsibilities shared among many parties.”
Manufacturers want to make a profit. Donors want to optimize the use of funds by increasing the number of people reached. Procurement agencies want to purchase quality-assured medicines at the best prices.
The challenge is to ensure that each party achieves its objectives without overly detracting from the objectives of others. But the reward, especially in stretching the purchasing power of development dollars, can be enormous.
In a major collaborative effort, Chinese authorities and WHO have worked for five years to upgrade the manufacturing practices for medical products in China to meet the highest international standards.
This long collaboration culminated in March when WHO prequalified China’s regulatory authority for vaccine production.
This move gives Chinese manufacturers the “green light” needed for local manufacturers to go global in their exportation of quality-assured vaccines. Outside analysts predict that this new development will eventually revolutionize the market for public health vaccines, slashing prices even further.
The process of winning this endorsement involved changing China’s overall vaccine approval framework, from market authorization and licensing, to post-marketing surveillance, to regulatory inspections of manufacturing sites and distribution channels.
In a value-added way, these measures will also upgrade the quality of Chinese medical products produced primarily for domestic use. This is an ideal example of a win-win solution.
Ladies and gentlemen,
The world needs global health guardians, protectors and defenders of health.
FDA is now taking on this role out of necessity. WHO performs this function as a constitutional mandate.
FDA’s work is the gold standard for a health regulatory body. As we continue to work together, can we lift the standards of the world’s national regulatory authorities closer to those of FDA?
Frankly, the honest answer for the immediate future is no. But we can close more and more of those doors to poor quality medicines. Of this I am sure.
As Americans like to say: let’s go for it!