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Acting Wisely

Biotechnology's Foreign Policy
By Carl Feldbaum

{Excerpts from a speech June 10 in Toronto to BIO 2002: the International Biotechnology Convention and Exhibition. Carl Feldbaum is president of the Biotechnology Industry Organization}

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.

Carl Feldbaum addresses BIO 2002 (Photo courtesy BIO)

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.

Research into the biodegradability and compostability of polymers, plastics, paper products and packaging materials at VTT Biotechnology, Finland (Photo courtesy VTT)

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.

Since we live in an age of e-mail brevity, I will limit the foreign policy points to my top 10.

1. The industry must work with governments and international bodies to integrate biotechnology into compelling responses to public health crises. 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.

2. 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.

   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 trustworthy relationships with foreign governments, the World Health Organization and non-governmental organizations - NGOs like Medicins sans Frontieres - Doctors Without Borders.

3. 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. 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.

   Genetically modified rice (Photo courtesy Monsanto)

   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.

4. 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.

5. For biotech's positive outcomes to truly flourish, we need to agree that both international and national regulatory regimes be based on science.

   Lab at the Hong Kong Institute of Biotechnology (Photo courtesy HKIB)

6. My sixth point is to recommend that regulations or at least applications be harmonized, as much as possible, across international boundaries. 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 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. 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.

7. 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. 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.

8. 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.

   Increasingly rare, Holy Wood (Bursera graveolens), the original source of quinine, is used as an analagesic, anti-inflammatory, aphrodisiac, diuretic, expetorant, insecticide. (Photo by O.M. Montiel courtesy Raintree Nutrition)

9. 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.

10. 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 anduniversity labs engaged in biotech research. In the United States, legislationwas 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.