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Carl B. Feldbaum
President
Biotechnology Industry Organization
June 10, 2002
BIO 2002
Toronto, Canada
Ladies and gentlemen,
Today I want to talk about a foreign policy for our great transformational endeavor. It is time we had one. We need one now to decently and properly position our industry for the future.
From its inception, biotechnology has been a uniquely international enterprise. An American and an Englishman working together elucidated the structure of DNA almost 50 years ago; more recently, the Human Genome Project linked researchers around the world, from the Baylor College of Medicine in Houston to the Beijing Human Genome Center.
Today our industry's researchers hail from African villages and Manhattan high rises; from Munich and Melbourne; from London, Ontario, and London, England; from Scotland and Nova Scotia - New Scotland; from Calcutta and Calgary. But in the beginning, the infrastructure that supported these efforts - intellectual property, venture capital, streamlined technology transfer - was less widely dispersed and the world's brightest biotech researchers clustered in only half a dozen scientific Meccas.
Previous technological revolutions have spread around the world. Think of the domestication of animals and agriculture, the development of the printing press, the assembly line, television and the Internet. Following in their footsteps, biotechnology's global diaspora seems inevitable, especially since governments are promoting it. Japan has launched an ambitious program to build a national biotech industry 1,000-companies strong by the year 2010. Taiwan and Singapore have each pledged to invest hundreds of millions in U.S. dollars directly into biotech companies. Such programs have already worked wonders in Germany and Israel. Both nations combined generous incentives with streamlined technology transfer from world-class research institutions to build dense biotech corridors.
So it seems appropriate to host our annual meeting outside the United States, here in Canada, home to the world's second-largest concentration of biotechnology companies, more than 360 firms strong.
But as our science and business emigrate from early strongholds in the United States, Canada and Europe across oceans and borders and into new cultures, international tensions over biotechnology continue to grow. In just the last few years, controversies have roiled over R&D spending priorities, genetic patents, bioprospecting, transgenic agriculture and drug pricing.
These controversies stem from three separate forces. First is our shared desire to distribute the benefits of biotechnology as widely and as equitably as possible, both the products and the economic benefits the industry brings. Second, there is the hard but realistic need to earn back a return on one's R&D investment. Finally, there is the determination in some circles to hold our technology at bay, to halt the spread of biotech crops and certain other technologies, such as stem cells, that may change trade balances, threaten entrenched agricultural interests or question tradition or religious values.
My premise today is that our industry needs to formulate its first foreign policy, one which is cognizant of the miserable judgments and mistakes of other industries - and avoids them. Our goal must be to ensure the widest possible dissemination of biotechnology's benefits while respecting the diversity of the world's nations and peoples. For a model, I looked to President Woodrow Wilson's Fourteen Points, which articulated his international goals after the carnage of World War I. Wilson's vision, once considered naïve, was to distribute the benefits of democracy while respecting the differences among nations.
Since we live in an age of e-mail brevity, I will limit the foreign policy points to my top 10. Here they are:
First: The industry must work with governments and international bodies to integrate biotechnology into compelling responses to public-health crises. The resurgence of threats to public health - from the AIDS pandemic in sub-Saharan Africa to the anthrax attacks in the United States - sharply reminds us of our vulnerability to humankind's age-old microbial nemeses. People in developing nations need no reminder. Almost 11 million children die each year of diseases that are preventable or treatable.
Addressing this perennial public-health catastrophe demands actions that improve nutrition, sanitation and water supply. In many regions, war and population displacement have magnified the effects of extreme poverty, leaving millions without access to even the cheapest antibiotics and vaccines. Forgive me, but genomics alone cannot solve these problems.
But biotech R&D can do its part in the developing world by producing vaccines that don't require refrigeration and are nasally or orally delivered. That investment in prevention can be made alongside continuing investment in diseases that afflict wealthy societies, especially as incomes rise and lifespans lengthen. Although some have attacked this disparity in R&D investment, I counter that health care need not be a zero-sum political battle between disease constituencies or between industrialized and developing nations. Particularly in the private sector, substantial financing is always available for yet another fine idea, provided the proper market and regulatory mechanisms are in place. Which brings me to my second point . . . Biotech health leaders must devise an orphan-drug program for diseases of the developing world. For a model of how we might stimulate expansion of research into diseases that plague developing nations - such as malaria, cholera, tuberculosis and sleeping sickness - we might look to the successful U.S. orphan-drug program, which governments in Europe, Japan and elsewhere have emulated or are considering. The U.S. Orphan-Drug Act of 1982 created incentives such as clinical trial support and market exclusivity for companies that develop products to treat orphan diseases, that is, diseases afflicting fewer than 200,000 Americans. The program has been an enormous, unequivocal success: In the decade before its launch, fewer than 10 drugs and biologics were commercialized for rare diseases; in the years since, more than 200 drugs and biologics for rare diseases have reached the market. These drugs treat everything from lead poisoning and growth disorders in children, to leprosy, leukemia, hemophilia and juvenile rheumatoid arthritis. To support my point, all this was achieved while R&D investment in biotech increased for diseases affecting much larger populations. I pledge that BIO will work with the U.S. Administration and Congress to create powerful incentives for companies to tackle diseases of the developing world. And we will work with our Canadian and other international partners to do the same.
Once such drugs are developed, working out their means of distribution will undoubtedly be a contentious process, given the multitude of parties involved and their disparate economic and political interests. The U.S. biotech sector will need much closer, more trusting and trust-worthy relationships with foreign governments, the World Health Organization and non-governmental organizations - NGOs like Medicins sans Frontieres - Doctors Without Borders. My third point is that agricultural biotechnology must be more seriously considered as a significant part of any program to address the nutritional needs of the developing world. Unfortunately, and somewhat ridiculously, this issue is relegated in some developed nations to triviality in the tabloids. The tabloids are trivial? What a surprise. But what is surprising - amazing really - is that the tabloids actually lead this public debate in some developed nations. For many of our African and Asian friends - an increasing number here in this room - this matter needs to be taken much more seriously, and now. Put simply, biotechnology provides new tools to plant breeders to accelerate the development of new varieties and hybrids. As we have already seen, new plants can combat vitamin and mineral deficiencies by making crops such as cassava and rice more nutritious, and they can increase yields by boosting disease resistance and improving plant hardiness in hostile environments. Not trivial benefits to people in developing nations.
Once again, we need to find new, trustworthy ways of working with foreign governments and NGOs on the many "orphan-crops" that are not internationally traded commodities but are nevertheless critical staples for the world's poorest people living in some of the world's harshest environments. Already, biotechnology companies have taken the lead by donating the genome of rice - a landmark event because, of all the grains, rice is closest to the ancestral grass from which all the world's important seed grains have evolved. Knowledge of its genome will be fundamental to improving many crops. Our researchers are working hard on such projects as disease-resistance and more productive sweet potatoes, a staple crop in sub-Saharan Africa.
All this is not some version of technocratic colonialism - researchers and political leaders of developing nations are in fact the most ardent supporters of biotechnology-based solutions to hunger and ill health. Listen to U.N. General Secretary Kofi Annan, a citizen of Ghana. He has charged world leaders with facing "the implications of a steadily shrinking surface of [farmable] land, at a time when every year brings many millions of new mouths to feed. Biotechnology," he says, "may offer the best hope, but only if we can resolve controversies and allay the fears surrounding it." - My fourth point is that markets should be open for demonstrably safe and effective biotechnology products. I touched on part of this a minute ago: particularly in Europe, "Franken foods" hype has been used to erect ill-founded trade barriers to biotechnology-enhanced crops, including a lengthy moratorium on new crop approvals. But now we're also fighting those who would like to use the Biosafety Protocol and Codex Alimentarius as trade barriers to biotech food and agriculture products. We would hope that global regulatory systems, particularly those already guided by international treaties, not be hijacked in spasms of anti-Americanism. There, I've said it. Which brings me to point five . . .
For biotech's positive outcomes to truly flourish, we need to agree that both international and national regulatory regimes be based on science. As more and more nations upgrade their regulatory systems to consider complex biotechnology products, we urge them to detach that process from politics and ideology, even superstition. This is not easy - in the U.S., Canada, everywhere - every new technology inevitably provokes a political confrontation between alarmists and the scientific community. And it always has. Back in the 1970s, when the U.S. industry began, recombinant DNA itself provoked a wildly irrational response. The Mayor of Cambridge, Massachusetts no less, once proclaimed, "God knows what's going to crawl out of the laboratory!" He appointed a Commission to study the clear and present danger that Harvard's petri dishes posed to the local townspeople. What, in fact, crawled out of Cambridge labs were a generation of new therapies for deadly diseases including Gaucher's disease, and beta-interferon for multiple sclerosis.
Back then, the protocols for managing biotechnology were developed by researchers and regulatory officials who scrutinized the data and saw that the risks were negligible and could be contained. The research moved forward, and today recombinant DNA experiments are performed in high school science labs. And not just in Cambridge, San Francisco or Seattle. I am talking about high school labs in Trumbull, Connecticut, and Hailey, Idaho. Again and again, the science proves the alarmists wrong. My sixth point is to recommend that regulations or at least applications be harmonized, as much as possible, across international boundaries. Such efficiencies will save a great deal of duplication of effort, which could get some life-saving therapies to many patients in the nick of time. I'm happy to report these efforts are already under way. With very little fanfare, last year the International Conference on Harmonization approved the Common Technical Document, a drug-approval application format for use in Japan, Europe and the United States. In some cases, it will save additional testing and months of reformatting. In addition to the CTD, the organization has quietly issued dozens of guidelines to standardize drug development requirements and is currently working on international standards and information-sharing guidelines for areas of drug regulation such as quality control and safety pharmacology. BIO salutes them. Although it can take years of negotiation to reach regulatory compatibility, we hope such international cooperation among regulators becomes the norm.
One final area of harmonization that is critical to the growth of our global industry is the creation and acceptance of a common bioinformatics language to be used by researchers worldwide. I am speaking of the integration and interoperability of informatics tools known as I3C. It's good to have your own acronyms. But seriously, if our international community is to reap the health benefits inherent in genomics and proteomics we need to ensure that the best informatics tools are available and usable by everyone. To this end, BIO has joined with IBM, Sun Microsystems, The Whitehead Institute, Millennium Pharmaceuticals, the University of Manchester and over 100 companies and institutions worldwide to establish that common language. - My seventh point is that all these efforts to expand the reach of biotechnology and streamline its regulation will be for naught if governments refuse to respect biotechnology-based intellectual property. You know the importance of this issue. BIO has fought this battle for a decade now. For the 90 percent of biotech companies that have yet to bring a product to market, patent portfolios are their only assets. What a biotech company owns and markets are essentially ideas: for example, the discovery of a potential point of intervention in a disease process or the identification of a gene or inhibiting compound that might affect that process. But the work only begins there, even though the company may well earn a patent. Without patents to provide some period of market exclusivity, the hard, cold fact is that researchers and investors would never dream to recoup their investment in R&D. Without stable national and international systems of intellectual property protection, biotech enterprises and the benefits they bring are simply not possible.
- My next point addresses the implications of what has come to be called "bioprospecting." Within the world's millions of species lurk genes, proteins, and hormones that can be used to treat diseases of humans, other animals, and many plants. As researchers prospect for them, we must follow ethical guidelines that respect cultures and ensure fair compensation to indigenous peoples. BIO is developing a set of principles for our members, most of whom are inexperienced in negotiating, say, a royalty deal with a provincial government in Peru. The principles would include provisions for informed-consent and benefit-sharing. The process will engender a host of complexities - for example, how are rewards to be distributed if a useful medicinal plant is native to more than one region? How do we recognize intellectual property arising from "folk" medicine? Some of these matters require international cooperation and treaties, but we believe first and foremost that our member companies must respect the laws of nations and cultures of localities where they perform research.
Number nine: the biotechnology industry must promote biodiversity on the path to achieving sustainable development. Not only is biodiversity worth preserving in its own right - as the product of billions of years of evolution that can never be replicated - it is of course a critical raw material for our industry. We can contribute to biodiversity preservation. We can identify and analyze new or formerly unknown species in our quest for promising compounds and genes, the precursors of products.
As you know, the core concept of sustainable development is to proceed with economic activity as a means of eliminating poverty while at the same time placing equal weight on environmental protection. Today, sustainable development may actually be closer to our grasp because of industrial biotechnology. It is a versatile tool for producing renewable energy, reducing water and natural resource consumption, lowering production of greenhouse gases, and minimizing the generation of toxic waste - not simply removing toxic pollutants but preventing pollution at its source.
Perhaps there has never been a more important time for us to move away from petroleum-based economies toward renewable carbohydrates. Companies are already using advanced proteomics in making ethanol fuel and plastic from corn sugars and soybeans. Consider what that means, especially today. - Looking back to September 11th brings us to my 10th and final point, that biotechnology should be used to develop treatments and protective products for both military personnel and civilians, but it must never be used to develop weapons. This point really needs no explanation.
September 11th also raised practical issues about security at companies and university labs engaged in biotech research. In the United States, legislation was proposed that would have severely restricted access of foreign nationals to biological materials, and the Commerce Department reminded companies and labs of previously unenforced government regulations concerning sharing sensitive technical information with foreign nationals. For our industry, which depends on the rapid cross-fertilization among the best ideas and the brightest people, such measures are anathema. Somehow we must guard security while maintaining the largely unfettered flow of ideas and people in the industry - a flow that's especially vital to those nations just beginning to build a biotech industry.
U.S. Secretary of State, Colin Powell, has said that now is the time to combine "Science and statecraft." He's talking to us. BIO wants to work with national and local biotechnology organizations around the world. I realize that as a U.S.-based association we risk seeming arrogant in raising and addressing these issues. But I hope that the 10 points I have listed today will serve as points of departure for what should be a constructive conversation. As Winston Churchill said, "Courage is what it takes to stand up and speak; courage is also what it takes to sit down and listen."
Biotechnology products, issues, dilemmas and consequent controversies are reaching around the world. Our researchers spring from every corner of the planet, and our science can now benefit the health, agriculture, industry and environment on every continent and indeed, even in the oceans between. Any endeavor with such reach and such responsibility can be well served by a few modest overarching principles. So today I've proposed ten points of a biotechnology foreign policy.
But there's really little foreign about them.
Among the folks in this room, at this international conference, representing over 50 nations, who is the foreigner? We are all in this great endeavor together, and I believe we are wise enough to learn from the mistakes of other industries and get our international responsibilities set right this time.
I sure as hell hope so.
I ask you to join me, join BIO, in this international endeavor. There's no cost in this, no membership fee. I just ask that you do what you do best, which is think. You have just heard where I stand. E-mail links us internationally. Simply e-mail me at cfeldbaum@bio.org with your thoughts on how we might proceed.
Working together, we will take this to the next step and beyond.
Thank you.
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