Regulatory Systems Critical to Global Health, Says Harvard Dean and 2013 RAPS Opening Keynote Speaker, Julio Frenk

Posted 31 July 2013 | By

When 2013 RAPS: The Regulatory Convergence opens in Boston on 30 September, attendees will hear an opening keynote presentation from one of the world's leading advocates for improving global health, and who also has implemented health reform himself as a former national health minister.

Julio Frenk

Julio Frenk, MD, PhD, MPH, is currently dean of the Harvard School of Public Health as well as being a professor of public health and international development as part of a joint appointment with School of Public Health and the Harvard Kennedy School of Government. Previously, he served as the minister of health of Mexico from 2000 to 2006.

As health minister, Frenk pursued an ambitious agenda to reform the nation's health system, which included introducing comprehensive national health insurance, expanding healthcare to tens of millions of previously uninsured Mexicans. He also has served as a senior fellow in the global health program of the Bill & Melinda Gates Foundation, and received the Clinton Global Citizen Award for changing "the way practitioners and policy makers across the world think about health."

Regulatory Focus recently had a chance to speak with Dr. Frenk about global health, healthcare reform and the important role of regulatory systems.

Regulatory Focus: You have focused a lot of your career on global health and the challenges of improving global health. What are the most pressing challenges today?
Julio Frenk: I would say that when it comes to the disease profile of the world, one can think of it as a triple challenge. First, there is an unfinished agenda of common infections, malnutrition and maternal mortality. Seven million children die from preventable causes each year. And that's down from 12 million. Second, there is the burden of the growing tide of non-communicable diseases-cancer, diabetes, mental illness-that now account for the majority of diseases around the world. Third, there are the health problems related to globalization, including pandemics and the health consequences of climate change.

Health systems around the world are unprepared to deal with these challenges. In the US, many people are left out of the health system. But those problems and discussions also are happening around the world-in China, in Mexico. There is a universal quest to better organize the delivery of healthcare while addressing the upstream determinants of health. In the end, you have a common health system and that system is failing to keep up with the global challenges.

RF: You mentioned Mexico as one of the health systems dealing with these challenges. What can you tell us about the reforms you instituted there as health minister?
JF: Mexico had a similar situation to the US. A large part of the population was uninsured, and what we did was to expand insurance and develop a whole new regulatory agency. Regulatory capacity is an essential part of health reform.

Mexico's health reform was built on three pillars: One, extend insurance. Two, improve quality of care; and three, develop a modern, efficient and transparent regulatory agency in a way that allows you to intervene in the upstream determinants of health. In other words, help ensure people don't get sick in the first place.

Eventually, we achieved comprehensive reform. My point here is that when you expand insurance, obviously, you are removing a financial barrier to healthcare; you also must intervene in the upstream causes of health problems. You need a proactive preventive strategy-insuring that the air we breathe is clean, that the water we drink is clean, that the drugs we use are high quality and affordable. Having a sound regulatory strategy in place is an essential part of health reform.

RF: You emphasized the importance of regulation in effective health reform. What role do government and regulatory agencies, and the regulations governing healthcare products play?
JF: I think there are two fundamental roles. The first one is health protection-protecting people from risks they may be exposed to in an involuntary manner. Health is a very complex condition of humans; there are multiple determinants of health and disease, and a good part of those are things they may be exposed to passively-the air we breathe, water we drink, food we eat.

There are also active exposures. Those have more to do with modifying peoples' behavior. For example, smoking. That requires a different strategy, not so much regulatory. That's a fundamental duty of government. One of the main motivators is to protect against common threats.

The second big use of regulation is in allowing the market for healthcare services to function better. The healthcare market is an extreme case of what economists call asymmetries of information. Consumers don't have the medical expertise. That's the reason we go to the doctor in the first place. We need to know if the pain we have is serious or not.

Most people cannot judge the quality of care in an obvious way. It is not obvious what is a good hospital or a bad hospital. So accreditation of hospitals can help correct the fundamental asymmetries of information. It's the same with drugs. People cannot judge the quality of information [about a drug] like they would judge the quality of candy or cereal. If I'm not satisfied [with candy or cereal], the consequences are trivial. Medicine is very complicated. Doctors study years. Human biology is very complex. If you get it wrong, consequences can be fatal.

RF: How did you address these asymmetries of information through the regulatory agency you developed in Mexico?
JF: We had a process to approve drugs but it was not as strong as it could be. Because of the free trade agreement, it was important to have some harmonization with FDA.

Developing systems that are corruption-proof is also essential for good government around the world. For most emerging economies around the world, you have a huge risk in inefficient, but also corrupt, regulatory systems. And because of the globalization of trade, this can affect not only citizens of that country, but also people around the world.

RF: Can closer alignment of regulations across different regional health authorities help improve overall health for people around the world?
JF: I think harmonization and convergence is important for many reasons. First of all, because most countries of the world don't have the regulatory capacity, so adapting regulations used elsewhere would be a positive step. Also, we have a global market and many health-related products are exported, and it makes that trade more efficient if we had a better harmonized system.

Bear in mind that the health industry is one of the largest is the world. Anything that can improve how that huge sector of the economy operates is good for global trade.

RF: What do you plan to talk about in your keynote presentation 2013 RAPS: The Regulatory Convergence?
JF: I am planning to discuss the dramatic changes that have happened in human health and provide an overview of how we have ended up with the triple burden I mentioned. I also will examine the growth of complex health systems and the crucial regulatory function, and talk a little about the need for greater global collaboration and the need for shared learning. There is an absence of good analysis in many parts of the world.

I have a feeling that we haven't done as good of a job in studying regulatory systems. This is a completely neglected area of analysis and discussion when we talk about improving healthcare. Any comprehensive reform that extends insurance and improves care also has to address upstream determinants. That is a core component of the health reform in Mexico.


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