Text: U.S. Ambassador Schneider on Biotechnology Issue

03 April 2000

Text: U.S. Ambassador Schneider on Biotechnology Issue

Cites European efforts to regain confidence of consumers

Cynthia Schneider, U.S. ambassador to the Netherlands, says a history of European food scandals such as "mad cow" disease has contributed to a climate of uncertainty and distrust about biotechnology products.

In remarks delivered March 22, Schneider said the European Union is trying to overcome these negative perceptions by working on ways to develop a food safety authority that will give more security and confidence to consumers in Europe.

Schneider said that a science-based system of regulation is just beginning to take shape in Europe. She said that in the United States, under a well-established, science-based system of regulation that involves several government agencies and testing by independent scientific advisory bodies, biotech foods and medical products have been used for more than 10 years with no problems.

Schneider said that while there is "a bit of a stalemate" between the United States and the European Union with regard to the admission of genetically modified products into Europe, the Biosafety Protocol recently adopted in Montreal "was a good example of coming together, working out an agreement that is acceptable to different points of view and allows us to move forward."

Schneider also cites examples of how biotechnology can help feed present and future generations while minimizing additional strain on the environment, enhance the nutritional value of food products, and even deliver vital medical help through food products.

Following is the text of Schneider's remarks:

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Biotechnology and Europe: Promise and Paradox
Ambassador Cynthia P. Schneider
University of Nijenrode, March 22, 2000

I would like to lay out some ideas, problems, and situations relating to biotechnology, particularly focusing on this technology's conflicted, even paradoxical reception in Europe. I will touch a bit on the substance, a bit on the benefits, a bit on consumer reaction/public relations, and a bit on regulation.

Biotechnology is one of those areas in the general category of technology that has emerged as an extremely important part of the world economy, but which basically did not exist 10 to 15 years ago. Even within that context, the picture of biotechnology has changed rather dramatically over the last years. Just two years ago, Business Week had stories proclaiming the "biotech century," and even a headline which we might now look at a little askance, "Europe catches biotech fever." Now some people might say, "Yes, but it's a disease." But there are a lot of interesting paradoxes with the situation of biotechnology in Europe. You have from the media a sense that there is a great deal of reluctance, on the other hand, as you all probably know, biotech is big business here.

I will give you some statistics. In April, 1999, an Ernst and Young survey found that the biotechnology sector in Europe is one quarter the size of that in the U.S., but growing twice as fast. The UK government estimates the size of the biotechnology market at 30 billion pounds and predicts it will grow to 100 billion pounds by 2005. Here is a ranking of European countries in the number of biotech firms: the United Kingdom, 270; Germany, 225; France 150, followed by Israel, Sweden, Switzerland, and the Netherlands.

The United Kingdom has the largest number of biotechnology firms; yet, it also has the strongest resistance. It is in the United Kingdom where genetically modified food products were removed from the shelves by some of the largest food chains. And this is just one example of the many contradictions that exist in the picture of biotechnology in Europe. You have a thriving industry in the United Kingdom but a hostile climate, if not on the part of consumers, at least on the part of the media. You have the situation of environmental groups accepting the use of more pesticides in order to avoid genetically modified crops. Or consumer activists who advocate depriving consumers of the right to choose products made available with the aid of biotechnology. Or multi-national corporations who advocate their products on the basis of their potential to solve the world food crisis.

Before I go into some of the factors that might cause this particularly complex situation in Europe, let me just give you a brief overview of some aspects of biotechnology just in case some of you - like me - are not scientists. First of all, biotechnology is not just one thing. And it most definitely is not just food. Biotechnology includes food, pharmaceuticals, and genomics. A whole range of scientific disciplines, including biology, physiology, and pathology contribute to and benefit from biotechnology's discoveries. Computer science is very important for much of the most advanced biotechnological research, which in turn stimulates the development of a whole new generation of computer products.

Basically, biotechnology uses modern scientific techniques, including genetic engineering, to improve or modify plants, animals, and microorganisms. Actually, biotechnology in agriculture, the most controversial area, is not new except in the degree of predictability and accuracy that genetic transfer through DNA offers in comparison with traditional plant breeding methods. What scientists can now do is to splice plant or animal genes bearing particular traits into the DNA of other organisms. Although splicing DNA sounds rather scary, it is actually much more predictable than traditional plant cross-breeding, or crossings that occur in nature. And with genetic engineering, scientists can enhance nutritional content, adding vitamins and minerals; they can enhance texture and color, rendering the product more attractive; and they can increase yields by building in resistance to pests, diseases, and drought.

I want now to look with you at some of the benefits that biotechnology offers, as well as some aspects of the climate in Europe, some hesitations, some reasons behind them. And we will look briefly at the regulatory picture and the economic repercussions of factors behind biotechnological development in individual countries.

First of all, I think that one general European impression is that biotechnology consists of genetically modified food. This is an extremely small aspect of the technology. The pharmaceutical advances of biotechnology have largely been accepted and embraced in Europe. So you don't hear so much about that, even though that's an area where European companies, like Aventis, are very prominent, and where European consumers buy biotech products. The controversy in Europe is about food.

The medical benefits of biotechnology are one of its strongest points. One fundamental way in which biotechnology and the accompanying research will change medicine is that, with the advances of knowledge that will come with the mapping of the human genome (which will be completed within a few months), medicine will be transformed from something that is applied diagnostically and in the aggregate to something that is applied in anticipation of problems - and very specifically. Now, when you are sick, you go to the doctor and you get an antibiotic. And maybe the antibiotic will work, maybe it won't, maybe there's resistance; maybe it will treat something else; maybe it will treat what you have. But when we have more knowledge of the way the human body works, and what kind of signals it contains as to predisposition for certain kinds of diseases, then we will be able to prescribe medicines that are not only specific for that particular condition, but for that particular patient, and we will prevent diseases rather than only trying to cure them. It is conceivable that within our children's lifetime, the number of fatal diseases will be greatly reduced. How diseases are detected and treated will have changed dramatically. This quantum leap will come from the knowledge acquired through biotechnological research and through medicines that are developed using biotechnological processes.

Another way in which biotechnology is changing medicine is through the area of biopharmaceuticals. These are medicines that are expressed and grown and developed through other products. One prime example is well known in the Netherlands because of the famous "Pharming" case, a kind of cautionary tale of what can go wrong if you don't look ahead. In the 80s, the Dutch company, Pharming, developed the means to grow medicine in cows' milk. The government decided that the Netherlands did not want to get into this. I think that a problem was that the bull had a name, Herman, and it was not publicly palatable that he was being used as a sort of factory for medicine. So the company was not allowed to operate here. It moved to Belgium. There Pharming operates under the same person, George Hersbach, and produces medicine that is now sold in the Netherlands and used by people here to treat Pompe's Disease.

This is not just an economic tale of sending the income out of the country. The Pharming case, and many others, raise very challenging ethical problems. There are those who would say that it's unethical to develop medicine that way - using an animal. But this is the only way medicine has been developed to treat Pompe's Disease. If this technique had not been developed, the people who suffer from that disease would have no relief. Now they do.

Biotechnology is also being used to create environmentally friendly materials. There is some very interesting work going on in the Netherlands. At one research institute, a steering wheel and other car parts are being made out of potato starch rather than plastic. With new techniques developed by Dupont to grow plastics in plants, the technology is coming full circle.

One of the areas where biotechnology offers the greatest promise to a seemingly intractable problem is in increasing yields of crops. This is something that relates both to agriculture and to the environment. We all agree that, with the growing population, we are facing a serious problem as to how we are going to feed the world. Obviously, many are not being fed now. But thinking of how to increase the amount that is grown to feed greater future numbers is even more challenging. To give you a concrete example, I will quote from Dr. Chris Sommerville, "In 1950, we grew worldwide about six hundred million hectares of cereal, about 5.5% of the earth's surface. If we were growing the same type of cereal today, we would be using about 1.4 billion hectares of land - or actually most of the arable land on earth. Because of improvements by plant breeders we are still using only about six million hectares of land." So the same area of land as was used in 1950 is being used today to feed a much greater population.

This reveals another paradox. You hear that biotechnology poses a threat to the environment. But biotechnologists and environmentalists alike agree that the greatest threat to the environment is to exhaust our land, by taking more for agriculture.

Increased yields first occurred through the Green Revolution, now we need new techniques. Biotechnology increases yields by equipping crops to grow in inherently unfriendly conditions, such as drought, or to resist pests. These increased yields enable us to remain within the area of land under cultivation now - and not have to expand and take over more. And also, very importantly, it enables people to grow crops in unfriendly climates. This capability offers hope for areas of the developing world. At a conference on biotechnology held earlier this year in The Hague, "Biotechnology: The Science and the Impact," we had a very interesting exchange that captured different perspectives on the potential of biotechnology for the developing world. The speaker from Greenpeace, Benedict Haerlin, talked about the value of using organic agriculture. And one of the other speakers, J.H. Monyo, of the Food and Agriculture Organization of the United Nations, raised his hand and said, "I'm from Africa. I grew up on organic agriculture. My continent depends on organic agriculture. And it's starving. We have tried organic agriculture. It works well in some places. It works less well in others. We would like the potential to try another technology."

Biotechnology also contributes to the elimination of pesticides. Already, the use of cotton genetically modified to produce chemicals characteristic of Bacillus thuringiensis (Bt Cotton) has diminished the need for pesticides by over 900 thousand kilograms per year in the U.S.

Another area where biotechnology offers promise for the developing world in particular is in the production of food products with extra nutritional or medicinal properties. A product of this type that has received a lot of publicity is Golden Rice, which is a strain of rice that is grown to contain vitamin A. This is very important for those countries where people - very often children - suffer from Vitamin A deficiency, which can lead to various diseases, blindness, and ultimately, death. We have the opportunity to provide the people with resistance to this disease through their normal diet. Golden Rice is being developed by a Swiss scientist, Ingo Potrykus, working for a Swiss foundation with support from the Rockefeller Foundation. It will be delivered free of charge. Rights to the intellectual property have been waived. Golden Rice sets up an excellent model. I hope it will be followed.

There are other kinds of products. The Carter Center in Atlanta delivers protein-enriched corn to different places in Africa so that the women can wean their children directly onto this corn. Other innovations are being pursued - hepatitis-B vaccine, for example, in bananas. This new kind of engineering technology offers a way both to nourish people and to build up resistance to diseases.

I will mention one ingenious Dutch project. A lab is working on petunias to introduce vaccine into their pollen. Then the pollen is harvested by bees, and the vaccine is incorporated in the bees' honey. The honey can be shipped all over the world and forms an easy delivery mechanism to people who need the vaccine.

So, you say, "This sounds so great. What's the problem?" Well, there are a lot of problems, and they are very understandable. First of all, this is an extremely complex science. How many consumers are going to sit down and read about DNA splicing and be reassured about that before they go purchase the product? And, for most consumers, it boils down to a product in the supermarket. So that presents a real challenge. It comes down to marketing, communication. How do you explain this new technology so that the people can at least make an informed choice?

This has been a problem from the start. A lot of people say, "I'm not interested in this generation of genetically modified products. I'm going to wait for the next generation that delivers a concrete benefit to the consumer." They are right. This generation, after all, delivers the primary benefit to the producer in terms of increased yields and greater pest resistance. The benefits to the consumer in the first generation are indeed less tangible. The problem is, of course, that the next generation of products won't be developed if this generation is stopped.

There is a real problem here. There definitely has been a lack of communication, a lack of understanding about what these products are all about. The vacuum has been filled extremely effectively by the people who oppose biotechnology. I think there is a need for scientists to come forward and explain what this is all about in ways that people can understand and apply to their own lives.

There are, of course, other specific reasons why this is such a difficult problem in Europe and not so much in America. They have to do with the history of European food scandals involving BSE (Bovine Spongiform Encephalopathy, or "mad cow" disease) and dioxin. Understandably these have contributed to a climate of uncertainty, distrust, and fear. The European Union is trying to overcome this negative climate, and is working on ways to develop some kind of food safety authority that will give more of a universal standard and lend more security and confidence to the consumer in Europe.

The approach that is being taken here is in some ways similar and in some ways different from that in America. I think that regulatory differences also contribute to the different climates in America and in Europe. We have a government-established but science-based system of regulation that involves several different agencies - the Environmental Protection Agency, the Food and Drug Administration, and the Department of Agriculture. New products are tested and regulated through independent scientific advisory bodies.

The European Union's system now is beginning to take shape. David Byrne, Commissioner for Health and Consumer Concerns -- very able, very open, and well informed -- explains that scientific advisory bodies will play an important role in advising the new commission, but that ultimately he feels, and it is generally felt within the European Commission, final decisions should be made by politicians because they have a responsibility to the public. Therefore, Commissioner Byrne sees a division between the risk-assessment by scientists and the ultimate evaluation of that assessment by people entrusted with political positions, with jurisdiction over the public.

At the moment, we have a bit of a stalemate with the European Union in our trade relations. There is a directive that is under consideration with the European Union regarding the admission of genetically modified products into Europe. While that is still being considered, there is, in effect, a moratorium on the admission of any new product. So you have a situation where there have been 50 varieties of biotechnological agricultural products introduced in America and two in Europe. Our governments are talking about these problems and trying to resolve them together. I think the Biosafety Protocol in Montreal was a good example of coming together, working out an agreement that is acceptable to different points of view and allows us to move forward. There is high-level dialogue between members of the public and private sector on the European and American side, bolstered by a real desire not to let those understandable differences in attitude poison the overall atmosphere in trade and economic relations.

Let me just raise one other aspect of biotechnology that isn't always brought into the discussion. The EU currently spends 50 percent of its budget on agricultural subsidies to sustain agriculture. That yields a 3 to 5 percent margin. If elsewhere outside Europe farmers are able to equal that 3 to 5 percent in increased productivity, the subsidy will have to be raised. And if there isn't any increased productivity in Europe through new technology, the only other choice is to increase the subsidy. The EU will be paying more to sustain a less efficient agricultural sector.

I will just give you one way to measure relative technical advances - the development of new patents. Between 1985 and 1998, patents in the Netherlands increased - and this isn't just in biotechnology, it is overall - increased 66 percent. But in Taiwan they increased 137 percent and in Korea they increased 1600 percent. That suggests a shift that may be a result of the new economies developing in technology and biotechnology. There certainly have been important steps by the government here to foster and encourage those new economies.

I have concluded with practical projections of economic advantage. But I believe my first arguments for supporting biotechnology are much more striking. This technology can help us to feed present and future generations while minimizing additional strain on the environment. It can enhance the nutritional value of food products and even deliver vital medical help through food. Biotechnology is the cutting edge of medicine, both in the understanding of the human body and in the development of medicines and other therapies. Under the science-based American regulatory system, biotech food and medical products have been used for more than 10 years with no - I repeat, no problems. We all recognize potential problems. This recognition is our surest defense. Continued, careful work will realize biotechnology's enormous promise. The dangers of the alternative are not immediately obvious in the prosperous, temperate, North. But the future demands that we accept and profit from this rich technology.

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