Social and political acceptability of modern biotechnology tools

B A S I C    L E V E L

Biotechnology is a modern advanced technology grounded on science disciplines like molecular biology, biochemistry, cell biology. It accepts a lot of new techniques such as cell and tissue cultivation, cell fusion, gene recombination, microbial fermentation, and also duplication and recombination of organisms at a cellular, chromosomal, and gene level.

Contents

 

Modern Biotechnology at a Glance

Biotechnology is a modern advanced technology grounded on science disciplines like molecular biology, biochemistry, cell biology. It accepts a lot of new techniques such as cell and tissue cultivation, cell fusion, gene recombination, microbial fermentation, and also duplication and recombination of organisms at a cellular, chromosomal, and gene level. In this way, it can make organisms answering to human needs, produce new products and breed new plants having novel features of high output and stress resistance. Modern biotechnology is composed of four technological systems. They are genetic, cell, enzyme, and fermentation engineering, of which genetic engineering and cell engineering are the most advanced ones.

Besides the great social and economic benefits of modern biotechnology, there is a possibility it to harm human health and the environment. This can result in many socio-economic problems, such as destroying original social and economic patterns, posing threats to biodiversity and traditional crop varieties, injuring countries or communities’ socioeconomic welfare, violating traditional ethical, moral, and religious values.

The modern biotechnological practice in the production of fiber, pharmaceuticals, and food has a powerful development of the late 20th and beginning of the 21st century. This emerging technology is often accepted as the next technological revolution possessing the potential to change fundamentally the way of societal arrangement regarding production and distribution of goods. Considerable investments have been already made in biotechnological research for new products’ development. Currently, science and technology are expected to bring consumers a big variety of genetically modified (GM) products. Besides, many GM products have already entered the food distribution chains. Despite its promise to bring significant benefits to society, public acceptance of modern biotechnology is quite diverse at the world dimension. To enable biotechnology to contribute major benefits for human beings, the international society has paid serious attention to the biosafety of the overall biotechnological production to promote its better acceptance.

Practical Applications of Modern Biotechnology

Nowadays, biotechnology has been classified into few categories based on its applications. They are depicted in Fig. 1

Social Attitude to Modern Biotechnology

In general, biotechnology intends to emphasize the potential benefits to society through reduction of hunger and malnutrition, suspension and healing of diseases, and increase of health and general well-being. On the other hand, there is an opinion that GM products are used as a needless interference with nature and can cause unknown and potentially disastrous consequences. At the same time in the U.S., GM crops entered the grain supply chains without raising major public concern. Besides, agricultural biotechnology is facing significant opposition in Europe and many other developed countries. Regarding the obvious public troubles about the perceived risks for humans and the environment, European Union (EU) accepted rather limited regulations on all transgenic crops in any part of the EU food system. At a global level, the situation is even more diverse: in the U.K., objection movements throw down GM crops on different occasions. Until recently, Brazil and India refused to approve any GM crop. Due to similar consumer concerns, some fast-food supply chains decided not to use GM potato in their products.

The reason against the use of gene technologies in agricultural production is grounded on the fact that some people and institutions see risks to humans and the environment, while others oppose it minding moral, ethical, and social concerns. Biotechnology frequently is running down because of its tools’ application in plants and animals, especially gene transfer across species, based on understanding “realms of God” and against “Law of Nature”. Also, there is an opinion that since genes are naturally occurring parts, which are an object of discovery (not of invention), patent ownership of genetic findings and processes is morally and ethically insolvent.

Public discussions on agricultural biotechnology also pose some social and political debates. There is a talk concerning the application of modern genetic technologies in production of commodities in developed countries that are currently imported to developing countries. It is claimed that such developments will have significant negative effects on the poverty situation in the Third world and will lead to global instability. At the same time, other researchers have the opposite opinion. Another source of care is the possibility that farmers will become steadily dependent on multinational corporations for their “means of production” bringing harmful economic, social and political effects.

The importance of this subject defines the need for a full understanding of public interests and concerns regarding an agreement between private and public decisions concerning food biotechnology. Consumer acceptance of biotechnology is strongly related not only to expected risks and benefits associated with GM products but also to their moral and ethical dimension. Further, public views about multinational corporations, trust in government, science, and technology development also reveal their attitudes towards biotechnology. It is found that consumers’ cognitive factors (e.g., levels of risk aversion, opinions about GM foods) impacted the acceptance of GM food products, while the socio-economic factors did not have significant effects. Thus, the public perceptions of biotechnology possess a lot of dimensions and are possibly affected by multiple forces, preferences, and events. For instance, positive benefits (e.g., nutritional benefits from improved/new products, environmental benefits via reduced use of pesticides, etc.) can encourage consumer acceptance of food biotechnology. On the other hand, sensibility about risks to humans and the environment is expected to have adverse effects on public acceptance of GM products. Thus, the activities to analyze and determine the factors influencing consumer attitudes towards biotechnology have to follow the procedure, denoted in Fig. 2.

Societal Impact

To evaluate the impact of modern biotechnology on society, it is not enough only to measure it by specific indicators. When the focus is on such dimensions like increase the number of patents on genetically modified organisms (GMOs), this will not indicate the dynamic forces shaping the impact of biotechnology on industrial and societal structures. The impact analysis is combining complex problems and has a variety of diverse inputs, which possess both short- and long-term effects and influence the results of the problem or use of technology, in an unrespecting way. To realize the sense about the nature of links between societies, individuals, and the balance of forces between social groups facing new technologies is of basic importance.

Establishment and spreading of knowledgeSocietal Impact

A starting point is the result of the technological impact, which depends upon the establishment and spreading of knowledge. It is regarded as preferred values, social practices, and norms of behavior of involved actors in the development and use of biotechnology. The knowledge extends beyond the collection of information on biotechnology, such as techniques, risks, etc. It also embraces the way they are shown and commented on by individuals. Risk and safety for the public cannot be assayed in the same manner as scientific risk is done. To account for these differences, it is necessary to explain how trust is created between consumers and manufacturers. In brief, such a definition of knowledge gives a piece of analysis on the impact of biotechnology and more broadly, environmental policies and practices.

From a conceptual point of view, this approach could be treated as a knowledge-based discourse. It is useful considering the expression of the biotechnological impact in the sense of the educational, social, and political background. The environmental discourses of biotechnology knowledge, and more specifically, how it is constructed, accepted, and perhaps most importantly, spread and sustained within society are taken into account as well.

Science and Technology (S&T) impact on society

In the EU there is a discussion on biotechnology and especially concerning genetic engineering and impacts arising from this technology. This issue has to be addressed strongly linked to the result of social interactions. Therefore, the way of realization of these dynamic forces should account for the interrelations and the form of resulting complexity between actors.

Another point to estimate, are two major topics when examining potential technology impacts. These are i) the immediate impact of the use and development of the technology and ii) the technology transcending risks. That means dependence on the long-term application of the technology and how to achieve and sustain a dominant position in its impact upon society from education, political and social perspectives. This could be sustained generally through more concern about the long-term consequences of S&T activities noted below:

– Publication of educational efforts in society: Performance of intensive efforts to include scientists, key public opinion leaders, and media in an existing debate on biotechnology and especially about genetic engineering. The core objective is to avoid an informational vacuum, which can facilitate anti-biotechnology activity and generate negativism in knowledge structures.

– Role of regulatory policy in society: Focusing on effective risk communication and understanding the fact that the public perception of risk can be very different from that of the scientific community.

Perception of modern biotechnology applications

Three major topics are identified and based around: i) the science, ethics, and gender of biotechnology ii) the International political economy, trade, and the environment; iii) the state and system security and warfare through biotechnology. These general themes are coming from consideration for the international relations of biotechnology. They imply the concept of power in the International Political Economy (IPE) to frame the differing discourses and complex issues of technology impacts. Based on these topics the several indicators are regarded (Fig. 3):

Modern biotechnology is regarded as a complex emerging field that exhibits high science combined with limited knowledge of part of the society. It is related to attitudes towards the natural environment, technological progress, religious and moral beliefs, and several other sets. A matrix of variables including interest of the public domains, such as science and politics, optimism about technologies, social and cultural values, engagement with the issue of biotechnology and confidence in the industry, regulation, and other civil society groups, all these factors contribute to the public’s representation of and opinions about biotechnologies (Fig. 4). Background characteristics such as gender, education, age, and religion have been found to affect people’s attitudes as well.

The serious debate on the acceptance of genetic engineering is accompanied by many pieces of evidence that object to the focus on specific applications of the technology than genetic engineering per se. Studies are showing that consumer attitudes regarding gene transfers are influenced by the type of transfers. The range of acceptance encompasses the following: i) plant to plant gene transfers; ii) animal to animal transfer; iii) animal-plant or human-animal, the last being least acceptable.

A survey on perception on modern biotechnology applications, performed among people from different countries/continents indicated that medical applications (leading to the development of medicines and vaccines, and genetic testing) are very much acceptable in comparison to food or crop biotechnology applications. However, medical applications linked to xenotransplantation or animal cloning for milk production meet serious problems. The Asian people, for instance, are less troubled for medical genetically engineered products than for genetically modified food. The investigation concerning cloning of human cells and bioremediation among the Europeans is put at the intermediate level, less assumed than genetic testing but better confessed acceptable than genetically modified crop and food.

Another survey reported that genetic testing still scored the highest support within the European population, followed by human cell cloning, the production of GM enzymes for environmentally friendly soaps, and xenotransplantation, At the bottom of this range are placed GM crops and food. Also, higher support is given to technics for the manipulation of bacteria to clean oil spills followed by disease-resistant crops; afterward are applications for fat meat and better taste tomatoes and the less support receive technologies for enhancing milk production in cows.

The Malaysian consumers are more open for use of modern biotechnology applications, which do not involve inter-species gene transfers, like food production and GM crop that only involve the transfer of plant genes. For them, the gene modifications are more acceptable in the following order: i) transfer oil palm genes to reduce its fat (saturated) content, ii) transfer human genes into bacteria to produce insulin, iii) transfer bacterial genes into soybean to make it resistant to herbicides.

An individual’s attitude towards a new technology depends on several related factors such as his/her perception of its risks and benefits, and socially communicated values and trusts in institutions representing these technologies. Concerning public perception of biotechnology, it is speculated that the attitude to genetic engineering is determined by the worth of potential benefits offered, knowledge on genetic engineering, and scientific world-view, from which the perceived risk (rational worries) and anxieties or fears (irrational worries) must be excluded. Additionally, various minor factors such as background factors must be added. It is considered that the main effect on acceptance seemingly is based on the knowledge level, awareness of benefits, confidence, and trust.
The studies of public attitude towards biotechnology indicate a lot of similarities with risk perception studies. Some authors have used the psychometric approach based on cognitive psychology and it is accepted as the most mature and dominant paradigm in risk perception studies. These psychometric methods are settled on the ground of the following views:

  • To perform “risk” as a subjective idea, and not an objective one;
  • To involve technical/physical and social/psychological outlooks in risk criteria;
  • To take opinions of the “public” (i.e., laypeople, not experts) as the subject of interest.

Thus, the public acceptance of modern biotechnology is based on analyzing the cognitive structure of risk judgments, commonly using multivariate statistical procedures like factor analysis, multi-dimensional scaling, and multiple regression. This psychometric approach assumes that the public does not perceive technological risk due to a single dimension linked to expected injuries or fatalities close to a risk assessor’s viewpoint but interprets risk as a multidimensional concept, concerned with broader qualitative dimensions.

The key varieties of a risk perception study are the perceived magnitude of risk or dread, risk acceptance, familiarity with the hazard, and at least – the factor benefit. The importance of another dimension, ‘interference with nature’ in risk perception studies on genetic engineering is also very important.
Biotechnology is at the confluence of science and ethics. The development of technology is linked with an ethical vision, which in turn is shaped by specific issues. Loads of biotechnology can be evaluated for their benefit to human society. But it has to be considered that biotechnology has also a dangerous part. It can provoke unanticipated consequences, which can cause harmful effects or dehumanize people. So, the ethical issues of proposed effects must be carefully investigated.

The ethical evaluation of new technologies, including biotechnology, requires a different approach to ethics. There is a necessity for changes because a new technology can have a more profound impact on the world due to i) restrictions to a rights-based ethics approach; ii) the importance and difficulty of predicting consequences; iii) opportunity now to manipulate humans themselves.

The ethical questions concerning biotechnology are very different. Due to the potential for deep change in the human future, such questions must be carefully considered. In the first place, it is necessary to articulate and predict the responsibilities towards nature and others, including future generations, and then to focus on rights and freedom. The real power and potential of biotechnology require strong caution to ensure ethical progress, as biotechnology is accepted as a significant force to improve the quality of people’s lives in the 21st century.

Biotechnology is intrinsically linked to science and scientific knowledge. But sometimes there is doubt that biotechnology is closely tied to ethics. Lastly, different biotechnological trends are promoting a certain vision of life, some of which are good for life and deserved to be encouraged or pursued but others are bad and should be eliminated. This vision impacts people’s choices and influences their sense of ethically appropriate biotechnology.

At times, the link between biotechnology and ethics is described as a conflicting point. Once, there is an impression that ethics is needed only in case one wants to tell others that they are doing wrong things. To a certain degree, this is lucid, since dispute, debate, and argument are common parts of ethics consultation. But ethics is just as important in the case of consensus that the chosen pathway is good and right. Of course, there isn’t any necessity for an ethical debate when the search is a cure for cancer. Thus, the solution to perform such a search is predicted by a common understanding that to cure cancer there is an ethical reason. The efforts, resources, and creativity devoted to working out better treatments are ethically eligible and the majority of these achievements due to biotechnology.

Benefits and Risks from Biotechnology Applications

The societal acceptability of benefits and risks imposed by modern biotech applications concern:

  • Benefits vs. risks societal dispute
  • Risk acceptance as a key element in risk perception
  • Tools for measuring public attitudes towards risks and benefits: risk management

Benefits vs. risks societal dispute

To determine the acceptability of biotechnological applications it is very important to evaluate the perceived benefits and risks. The diagram on Fig. 5 summarizes them.

Risk acceptance

Another key variable is risk acceptance which is important to measure risk perception. But it is rarely used in attitude towards biotechnology studies. Highlighted the harsh situation with modern technologies, they are always linked with some kind of risks that pose serious problems for societies. Policy-makers have considered cost-benefit analysis as the basis of decision-making methodology for societal risk acceptance. The core question to be solved in the risk-benefit analysis is: whether this product (activity, technology) is eligible safe or how safe is safe enough? There are two main approaches for performance of risk-benefit analysis (Fig. 6).

Risk Management

The management of risk is the process that aims to diminish the effect and to balance the way people respond to it. If one wants to push away all risks, this is not a viable goal. People readily take risks performing a wide range of activities. Thus, the question about the acceptable risk is not entirely technical; its answer depends on values. In a simplified way, it is possible to set a simple threshold for acceptable risk, for instance – one in a million-lifetime risk. All the activities riskier than this threshold are “unacceptable “as well as all those less risky are “acceptable”.

However, there are two reasons why this approach is not working. The first is linked to the above-mentioned risk perception. The people are not reacting to risk simply; the acceptability of risk in the public’s mind is not simply a matter of the presumable fatal things but involves other elements of the activity. For instance, if the activities are taken voluntarily if the process leading to the risk is new/old or familiar, if the process provokes an intuitive, emotional dread reaction or not. That is why, to define an acceptable risk, the processes of risk communication and engagement described above must be included. In the second issue, some activities are essential and must be encountered even if they cause relatively high risks.

Besides, there could be other cases where inexpensive alternatives exist to perform less risky or modified activities. In these cases, the risk might be well predicted as unacceptable, due to ready alternatives. This is an economic issue that deals with several resources dedicated to risk reduction. Besides the economic problems, it is possible to consider risks, not in terms of absolute values but to their internal differences between alternatives.

However, very often it is not possible fully to escape risk; rather one must choose among different risks. Therefore, no definite acceptable threshold of allowable risk exists, as well as there is no single convenient monetized value for risk diminution. Societal desire to invest in risk reduction depends on the wide range of factors that manage risk perception, like the fear associated with the risk, its catastrophic potential, etc.

Social benefits of modern biotechnology

Biotechnologies are being used widely in such fields as medicine and hygiene, agriculture, forestry, breeding, fisheries, energy and chemical industries, metallurgical and mining industries, food, and light industries, environmental protection. Modern biotechnology has gradually demonstrated its huge potential contribution to productivity, though it has a short history of only tens of years so far. Modern biotechnology will become powerful means to reduce the world’s constraints in the fields of food, health, energy, resources, and the environment. The development and application of modern biotechnology will, over a long time, affect human beings and society deeply.

Biotechnological industries are likely to become the leading industries in the 21st century. For example, crop varieties, produced by biotechnology, with novel traits of high productivity and stress resistance (aridity, coldness, high salt, etc.) are expected not only to increase grain production but also decrease the use of agricultural chemicals (such as pesticides, herbicides, and fertilizers), which will be beneficial to the environment. In the respect of medicine and hygiene, many drugs such as DNA vaccines, protein engineering medicine, monoclonal antibodies, anti-sense RNA drugs have been developed by biotechnology. Transgenic animals and plants producing some kinds of medicines (such as vaccines and hormones) may help to reduce illness in the process of everyday diet. Human Genome Project (HGP) and the research into some disease genes will discover the genetic reasons for some illnesses. Environmental pollution is getting worse at present, but biological transformation reactors created by biotechnology promise to absorb pollutants or wastes and decompose them into materials of low or no toxicity.

Therefore, in the present society characterized by knowledge-intensive industries, countries all over the world, especially the industrialized ones, take biotechnology seriously. Large quantities of manpower and financial resources are allocated to R & D in biotechnology. Relevant development strategies and policies are drawn up and support mechanisms created to stimulate the development of biotechnology.

Acceptance and diffusion of modern biotechnology

Although there have been many studies on public attitude or perception towards biotechnology and some researchers tried to identify factors predicting attitude using either regression or correlation, there are limited studies that try to construct a structural model predicting attitude towards biotechnology.

The first documented model was developed by Kelley (1995) who proposed a structured way for the approval of genetic engineering by the Australians (Fig. 7). Later, Pardo et al. (2002) proposed another model for explanation of European attitude towards biotechnology applications. Kelley found out that approval of genetic engineering was mainly predicted by agricultural and health goals (beneficial aspects). On the other hand, scientific and genetic engineering knowledge did not predict approval. Demographic variables also did not directly affect the approval of genetic engineering (their effects were not statistically significant). Gender was found to affect knowledge and scientific world-view while age was found to affect knowledge, goal, and scientific world-view, thereby exerting a very weak (indirect) effect on approval. Education had a large effect on knowledge but not concerning attitudes. Occupation and religion did not have any effect on any of the intermediate variables. Green supporters were less favorable to genetic engineering (negative direct effect on the approval of genetic engineering) as compared to Labor Coalition supporters (politic).

It is often speculated that biotechnology is the technology to deeply transform the economy and society. Following such opinions, the development and application of biotechnology have considerable potential for far-reaching economic, social, and environmental impacts. That is why biotechnology is of strategic importance to knowledge-based economies and their governments. Nations that failed to develop biotechnology capabilities fail in realizing economic impacts.

Biotechnology-related applications are diffused over several very different industrial sectors, e.g., food production, textile finishing, pulp and paper, agriculture, power generation, chemicals and petrochemicals, and pharmaceuticals. The products manufactured by these sectors do not usually distinguish between alternative production processes. Thus, for many products, a distinction between biotech and conventional (e.g., chemical) production processes and also the introduction of some new ones would be necessary. Moreover, biotechnology is a dynamic field and certain biotechnological production methods will probably soon be re-developed, and completely new, products will appear. Current official statistics and existing companies’ surveys can provide specialized information about the diffusion of biotechnological applications, and their economic impact. The data have been constantly renovated and different techno-economic studies are performed to provide future production foresight and scenarios. Applying a blend of methods and sources, they frequently focus on expert judgment, case-studies, and various statistics.

An alternative to measuring the diffusion of biotechnology in use for major manufacturing sectors is the biotechnology-related-sales (BRS) concept. Existing studies have used various approaches for measurement (definition of the biotechnology aggregation level, examined sectors, scenario assumptions, etc.). Moreover, to assess the impact of biotechnology diffusion, an input-output model and relevant indicators have been introduced to study its effect on employment. The model studies in a comparative manner how biotechnology is affecting major application sectors. It compares the market penetration in 2004 and 2020 through the diffusion rates, measured with upper and lower limits. This approach helps not to overestimate the impact of biotechnology while capturing certain innovative biotechnological applications. The data of this survey indicate a nearly similar diffusion pattern in pharmaceuticals, food-processing, and agriculture. Diffusion is expected to increase in all sectors greatly by 2025, as indicated by the penetration of certain product groups. However, it was shown that there is a serious level of suspicion about the diffusion of biotechnology; the expectations for 2025 are highly uncertain. The analysis of this tendency, indicate that there are diffusion barriers specified in Fig. 7.

Figure 7. Main barriers interfering Biotechnology diffusion

Possible negative impacts of modern biotechnology

Socioeconomical Impacts

Motivated to perceive great economic profit, a lot of famous international business corporations made considerable investments of capital in the R & D of biotechnology, and in this way are changing the previous world’s social and economic trends. Such an example is the company Monsanto (formerly US-based, and now a part of the global consortium BASF). Traditionally working in the chemical industry, after 1985 the company made serious business rearrangements, invested in 3 biotechnological sectors, and became a major consortium dealing with R & D in bio-science. After 1998, about 20 million hectares of fields all over the world were planted with Monsanto’s GM seeds. Soon after that, Monsanto took an advance on the crop seeds international market through a completely integrated system for trading GM seeds and agricultural chemicals. In this way, Monsanto received control on a big part of the human population food chain gaining tremendous profit feeding them with GM crop. This is an example of how in the current globalized world, a possibility for a few multinational corporations to decide on human food consumption emerges.

In the case of use in dairy, bovine growth hormone (BGH) produced by genetic engineering, the milk yield of a dairy cow can increase by 30 percent., which means 10 percent less fodder usage. So, the result is very impressive for the dairy industry.

A lot of medicines, like vaccines for treating malaria and cholera are provided to patients via new antigens synthesized through modern biotech methods. They make the rates of illness and death in many countries (especially in the developing ones) falling rapidly, concurring the population growth rates. In this context, a question arises about the impacts on the already insufficient economics and infrastructures of the said countries.

Impacts on biodiversity and sustainable agriculture

Many GM crops contain foreign genes from other plants, animals, and microbes. All these foreign genes can be transferred to other plants in nature through the pollens of genetically transformed plants and will cause pollution to the natural pool of genetic resources. Hence, as the majority of transgenic plants possessed economically useful features, like high productivity, disease-pest resistance, stress resistance, and farmers are attracted to economic interests to grow these plants rather than traditional crop varieties, the predicted danger for the natural resources is serious. Also, the technologies for breading of a monoculture of crop varieties in some fields may add to the loss of biodiversity. So, in a long term, this degradation of the genetic base may reduce the natural resistance of plants to diseases and insect pests and this may cause diminish in the crop yields. In this way, the global sustainable development could be compromised.

Bacillus thuringiensis (Bt) is a soil bacterium, which is used to synthesize a toxin against insects within plants. It has been used as a microbial pesticide for many years and the genes coding these insecticidal toxins could be introduced in the cell of many crops such as cotton, soybean, and rape, to create pest-resistance crops. In this case, the experts in environmental protection and the Green Peace Corporation are troubled by the fact that the toxin production is realized in the late life cycle of the transgenic plants and there is an opportunity to increase commonly the resistance of pests to the Bt toxins. So, this situation would lead to bigger usage of Bt-based pesticides, due to loss of their efficacy and causing heavy economic losses.

Impacts on public welfare

The exploitation of genetic engineering technology to humans could facilitate the diagnose and cure of genetically related diseases such as some cancers, hemophilia, etc. But such gene diagnosis may also have an opposing effect on the employment and marriage prospects of human beings. Through genetic engineering animals, plants and microbes can be transformed into bio-factories for the production of different kinds of chemicals. Thus, they can be treated as constant biological producers and at the same time, the rising potential for products outcome can cause socioeconomic problems. Assume that specific microbial strains are engineered to produce a valuable substance on large scale. In such a case, it is important to forecast the impact of this production on the world’s major producers of the same substance. If this substance counts for a significant percentage of the income of a given country, what would be the influence and consequences of this biotech production on the country’s agriculture and financial infrastructure.

Biosafety issues of modern biotechnology

Inconvenient application of biotechnology can cause many risks, like other advanced technologies. For instance, the newly introduced genes in crops made by genetic engineering can lead to allergic reactions. The economically important features of pest-resistance, herbicide-resistance, or stress-resistance, introduced in plants may get these transgenic hosts away from agricultural cultivation systems. The genes for resistance in transgenic plants can be transferred to their wild weedy relatives, and the latter can be transformed into “super” weeds, which control will be very difficult. Thus, the large-scale releases of transgenic pest-resistance crops into the environment will cause severe selection pressures to enforce the resistance of target pests.

The transgenic virus-resistance plants that are already transformed with foreign virus genes possess virus-coded proteins that may recombine with the genetic material of other viruses to yield new types of viruses with higher toxicity. If the selective killing of the target pests and pathogens is not possible, the transgenic pest-and-disease resistance crops can at once poison other organisms and also may cause harmful action via food chains on beneficial microorganisms, insects, birds, and mammals.

Moreover, many biotechnological products are alive organisms and can move and reproduce by themselves. Once they are released into the environment and are proven to be toxic, then it is nearly impossible to discard them, and the harm they create can rise with time becoming more and more serious. In this way, environmental releases of transgenic plants on a large-scale may damage the natural ecological balance in a longtime perspective.

Biosafety concerns have hindered the R & D applications of biotechnology. The public in lots of countries has signified its negative opinion, repulsion, indeed dread regarding biotechnological products. This is voiced even through demonstrations, crushing fields crops, banding the import, or baying the biotechnological products. This makes the biosafety issues at the very top of the agenda of many countries and international societies. Laws and regulations on biosafety are formulated in many countries, and biosafety issues are regarded in many international documents and treaties, like Agenda 21 and The Convention on Biological Diversity.

Conclusions

Biotechnology is on the way to become seriously relevant to the economy and can gain considerable importance in several application sectors in the next 10 to 15 years. However, the overall effects of modern biotechnology on the economy are quite diverse. For instance, employment estimations show that increasing the part of biotechnology in application sectors and its link to suppliers indicate the trend for reduction of employment due to productivity effects. The economic importance of biotechnology rises because of its diffusion in mature manufacturing sectors. However, diffusion in these main application sectors can influence only limited parts of overall employment. Only if biotechnology increases in other sectors might a major economy-wide impact emerge.

The deepness of biotechnological transformation of the economy depends strongly on its potential to propose the creation of new products and to improve the efficiency in the production of existing ones. Hence, it is expected that biotechnology would enable the creation of many products but the potential to raise labor productivity is estimated to be restricted. One important view is that biotechnology may transform the economy and society differently, cooperating with other technologies like ICT. Major boosts for such economic growth may emerge in combination with other technologies or efficiency gains, which raise productivity and purchasing power to realize the fruits of biotechnology.

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References

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Regulatory Tools and Frameworks for Modern Biotechnology

A D V A N C E D  L E V E L

The Policy Agenda’ 2030 reveals an EU concept aiming to give a vision to the main regulatory measures and aspects in the development of modern biotechnology, its products, and services regarding some OECD and non-OECD countries.

Contents

 

Modern biotechnology regulatory framework

The Policy Agenda’ 2030 reveals an EU concept aiming to give a vision to the main regulatory measures and aspects in the development of modern biotechnology, its products, and services regarding some OECD and non-OECD countries. Focusing on national insurance, an inspection tool is designed to elaborate on relevant international agreements. Thus, to improve current regulatory frameworks regarding nature the modern biotechnology development is on the modern agenda. The regulatory picture goals to improve current regulatory frameworks for modern biotechnology development and link them to the bio-economy

The main reasons for this improvement are depicted in Fig. 1.

Figure 1. Main reasons for the improvement of regulatory frameworks for modern biotechnology

 The regulation of biotechnology indicates a broader issue concerning the way different societies are managing the transition to a knowledge-based economy. This is due to the new opportunities that are linked to the challenge of managing potential risks, and use innovative knowledge and techniques for shifting to a more sustainable pattern of economic activities. That approach seems fully consistent with the political aims of shifting towards more environmentally friendly practices, processes, and products.

The concept of knowledge as an economic priority is comparatively new. It is wider compared to intellectual property and education because integrates useful knowledge in individuals, groups, organizations, networks, infrastructure. Lots of it is implicit, tacit, and largely invisible, but of growing significance in modern economies, in which service activities constitute an ever-increasing proportion of total output. Thus, the term “dematerialization” has become familiar. The trends towards greater information- and knowledge-intensity of goods and services are typical for the life sciences and biotechnology.

 

Sectoral policy in the field of Modern Biotechnology

The new knowledge in the life sciences and biotechnologies is a unique and sensitive subject of discussion since it concerns the life fundamentals: reproduction, disease, and death of humans. The domestic animals and plants on which the society relies and our link with the natural environment also count. All these matters are culturally and politically worth in each society. The new knowledge is subjective to established products, markets, competitive positions, administrations. It is also widespread across many sectors. That is why the perceptions and policy responses often lack coherence unless they are announced by enough represented prospects from several sectors and unified the responsibilities of various administrations.

Hence, the different areas, on which modern biotechnology is already having an impact or is likely to have, based on the experience of several EU countries, are listed in Fig. 2.

The term “area” is used for convenience; it is somehow vagueр since the new knowledge can change or alter the relations between different areas. For instance, food ensures nutrition, which is linked to health. What is important is the way, in which the new knowledge reshapes food toxicology. Also, agriculture is a user and a source of energy. However, it produces non-food products, and thus – it interplays with industry, both for its inputs and for its outputs.

Evaluating human activities, agriculture and food has possibly the biggest effect on the environment. Health care pervades the use of products and technological processes comprising their manufacture. Food increased its value due to technological transformation and industrial processing.

These liaisons may be an indication for limits shifting and initial changing of economic activities, and such restructuring may on a period of decades lead to radical changing of society. Thus, needs arise for rethinking how we build our perceptions and what is our management of changing realities.

A lot of countries have developed and published their concepts for national strategies of biotechnology. This can be considered as an answer to the multi-dimensional pattern of biotechnology and can give a framework for building up coherence and coordination within the actions of different ministries and agencies.

Figure 2. Sectoral policy in the field of modern biotechnology (MB)

The main suspense is evolved between ministries of Research, Industry, Education, and to some extend – Agriculture and Trade, all searching to increase innovation and competitiveness. Other ministries are with broad obligations to protect the consumer and the environment from potential risks or harmful effects coming from innovation and new practices. Also, some ministries can act dually – the Health Ministry may wish not only to defend the citizens’ health but also to support the strongly research-based and competitive pharmaceutical industry. At the same time, it will try to take care of the costs of health care by price controls, and the introduction of generic producers. In this way, the national strategies for biotechnology may thus be confused in trying to find a reconciliation of such tensions, as different societies are quite diverse in the choices they have made, regarding the innovation risk acceptance, and the precautions they constrain during development and marketing of new products.

This problem (tackling regulation) reflects in national or regional political debates contributing to the rise of pressure within geopolitical trade between countries or economic consortia that have implemented different solutions. Thus, supporters and opponents of the need for regulation, specific to modern biotechnology, have formed. The latter profess an opinion that, since biotechnology products can be addressed under existing provisions for foods, drugs, seeds, pesticides, etc., there is no need for any change of the regulatory framework. The former is focused on the fact, that the radical discoveries and unprecedented innovations arising in modern biotechnology need the development of regulation specific to its products and practices. Most countries have elements of both philosophies and face permanent discrepancies between sectoral and technology-specific regulations.

The main characteristics of the regulatory debates about the economic sectors impacted by modern biotechnology are presented here, below.

Agriculture and Food

Agriculture has been subjected to continuous restructuring over the past two centuries. It is accompanied by wide rises in productivity and a progressive reduction of the human labor on the farm. From occupation more than 50% of the workforce in most countries, and still in many developing countries today, it falls to below 2%. This shift is the result of long technological innovation; and thus, the applications of modern biotechnology in agriculture are a part of the historical development of innovation.

Besides the dependence of modern societies upon these exults of innovations, they need a massive restructuring of agriculture and corresponding social tuning. Critics have speculated about the destruction of social structures and rural community life; due to the “industrialization” of agriculture and food processing, and the serious loss of craft skills. This is linked also with the dangerous impacts on the environment as well as on biodiversity of monocultures, agricultural chemicals, and farm practices (e.g., the suspension of hedges, the clearance of woodlands, and the demolition of natural ecosystems).

Besides the reduction of the labor on the farm, major industries have made different production units around the agriculture sector, like plant breeding and seeds, animal breeding, vaccines, agrichemicals, sophisticated machinery. Recently, ICT-based innovations like IT software, and access to globally available databases and websites, resulted in a great diversity of food and non-food products. In this way, modern biotechnology is proposing continuously new knowledge and technical innovations at many points along these chains – animal vaccines, improved seeds offering various benefits such as pest and herbicide-resistant plants, improved enzymes to facilitate processing and create higher added value products. For the most important cultivated crop plants and domesticated animals, and their pathogens, the full genome sequences are already made, or will be shortly provided. Also, concomitant efforts are made (and occasional successes) in respect to gene reading and to their function in animals and plants interpretation, which is important for the control of pests.

There is an understanding that all such innovations have to be performed with serious attention to their effects on the “ecological footprint” of agriculture.

In the majority of economic sectors, regulatory structures and standards of different character and history exist, which are depending on some economic reasons and are following international norms to ensure and prompt innovation and trade, as well as to share the funds used for the supporting research. However, the bigger part of the agricultural restructuring lacks governmental regulation. That is the reason for the work of OECD on food safety assessment. Historically, almost all the foods for consumption have been unregulated (besides hygiene factors, such as limits and controls on additives, processing agents, and contaminants).

The high-profile debate on the regulation of foods derived from modern biotechnology applications has transmitted an unfamiliar message to consumers. Society does not pay attention to the details; it considers the products of this dramatically novel technology to have something strange, threatening, and potentially dangerous. Such suspicions – and campaigns built upon them – have been a constant accompaniment of debates on the regulation of GM foods over the past twenty years. Unfortunately, they are still active – regardless of the scientifically-based messages of guarantee. The problem is that both scientists and governments have been wrong before. Just consider the HIV-contaminated blood, mad cow disease, or whatever, all reinforce public doubt and suspect of experts’ and government opinion on modern biotechnology implications. Many governments have addressed these negative influences through the establishment of independent agencies, with strong scientific competence. Some are long-established, such as the US Food and Drug Administration (FDA); others are more recent, such as the European Medicines Agency (EMEA) and the European Food Safety Authority (EFSA). They comprise important players in the international regulatory network for modern biotechnology.

Health care

In health care as elsewhere, there is a strong historical tradition: since the discovery of penicillin and the subsequent development of the fermentation pharmaceutical industry, the use of microorganisms to produce molecules of high-value clinical importance is well known. Historically, applied microbiology and process engineering have immensely enhanced the productivity and diminished the costs of such products. Modern biotechnology continues to offer prospects for further major cost reductions. For example, a press article pointed out that “It costs around $1,000 to produce 1 gram (0.035 ounces) of protein from animal cells, making many such vaccines prohibitively costly for even the wealthiest countries, and completely out of reach for destitute countries. Producing the same amount from gene-altered plants would cost less than $20 — and that means pharmaceutical companies could give higher priority to finding cures for rare and “orphan” diseases across the globe”. Penicillin is a microbial metabolite: more challenging are the molecules not naturally produced by microorganisms, or producible only in animal (including human) or plant cells. Starting from the 1980s, a series of technical achievements of genetic engineering provided such scarce and expensive molecules as human growth hormone, insulin, and the various interferons.

New facilities for imaging and therapy were opened up by biotech innovations like the production of monoclonal antibodies. The sequencing of genomes – of man, of animals, of their pathogens – opens up further vistas for understanding, and ultimately for new or improved vaccines, diagnostics, and therapies.

In most OECD countries, there have been developed over the past several decades’ regulatory structures for health care products – the corresponding legislation often triggered by conspicuous product failures. These regulatory authorities interact internationally, mainly because expertise is scarce; they are strongly science-based and were in place long before the innovations of modern biotechnology. They thus provide a ready-made matrix for assessing the possible risks of the latest biotechnological innovations. In the debate between sectoral and technology-specific regulations, the authorities responsible for the safety of pharmaceuticals have generally retained responsibility for the products of modern biotechnology. Most pharmaceutical products are consumed only in response to a specific and most commonly temporary need. In this case, the consumer’s main interest is in efficacy, not in the production technology. The authorities that approve the launching of new products on the market have long experience of finding the compromised decisions for benefits vs. risks, evaluating innovations in comparison with available products or treatments. Thus, there were very few problems of acceptance of the products of modern biotechnology in health care, particularly as it was able to offer several defined successes, both in reducing production costs and in offering products that satisfy unmet needs.

In health care, modern biotechnology is of great significance in revealing at the molecular level – the level at which genetic disease, viruses, and cancers operate – of all disorders of the genetic machinery, inherent or induced. Genome sequencing is performed now at progressively declining costs; the results are worldwide available in public databases, along with the relevant software for scanning, comparison, and interpretation. These facts illustrate the enrichment of the knowledge base for health care. These observations are relevant not only to basic research but also at the clinical level for individuals. The broad availability of personalized information implies both the treatment and the structure of the pharmaceutical industry. New in silico and wet models offer new opportunities for research and development of more effective diagnostics, prophylactics, and therapies. In this context, regulations have to adapt to the products of the new technology, and clinical responsibility has to adapt to the huge volume of information, and on the means of rendering this information in a way that guarantees the delivery of adequate health care – advice, diagnosis, prophylaxis, therapy. The regulatory area has to consider the strong internationalization of biomedical research and to rely on the support of the health care sector on issues like ethical implications of genetic testing, the control of personal information, and the use of sensitive materials such as stem cells (on these last, religious authorities also have much to offer). In this way, the national debates persist, with governments adopting opposing solutions, reflecting national traditions, religious views, and values. The diverse solutions, however, do not generally create international problems. Within the European Union, compromise solutions are reached with strong subordination: European funding supports research projects, parts of which are conducted only in countries where such research is legal. Regarding genetic testing and the use of personal data, there are various ethical issues. Undoubtfully, there is a need to protect personal data. However, differences between EU and US regulations concerning personal data protection cause difficulties when for instance multinational clinical trials are conducted and the resulting data are handled. The availability of national databases of human genomic information demands the development of an international infrastructure of this information and of software to understand it. Since this has potential implications for clinical practice, corresponding regulations for maintenance of personal information, while enabling the clinicians to handle the individual’s genetic data, compare them in the database, and derive useful information is needed. The needs for coordinated regulation are obvious, since in some countries, private companies are offering genetic testing and interpretation, and issues of quality control and confidentiality are on the policy-maker’s agenda.

Energy

There is a big discussion of biomass energy at a time when the oil price is touching records. Thinking in perspective over the next two or three decades, it is essential to discuss the factors that in recent years have raised the price of energy, particularly oil, and have stimulated the search for new and alternative sources of energy. The rate of decrease in energy intensity in the technologically advanced world has progressively fallen since the 1970s. Nevertheless, different countries show wide variation in their energy intensity, growth longevity in absolute energy consumption is expected. The part of the oil is expected to grow in absolute numbers regardless of the higher price; coal also rises, while renewables enlarge their part slowly.

There are important political and environmental factors that sustain the meaning of energy high on the political agendas over the world: They could be described in short through the list shown in Fig. 3.

Figure 3. Political and environmental factors sustaining the energy matters on policy agendas.

The political attention is transformed in policies supporting and searching the way for reducing the use of energy through funding of alternative technologies research, costs protection, fiscal subsidies, as well as demanding on companies to get over technical limitations. The oil-producing companies are fostered to further explore new oil sources to maintain the environment and to raise extraction capacity and efficiency in operating oilfields.

The main question is whether these issues have to be transformed in a manner or as mandatory obligations. In some cases, it is possible for most European countries which are capable to meet their Kyoto targets to diminish carbon emissions and energy use.

The Commission Green Paper ‘Towards a European strategy for the security of energy supply’ sets up the objective of 20% substitution of conventional fuels by alternative ones in the road transport sector by the year 2020. The Conclusions emphasizes that “more than anything, political will, and engagement at a national, regional and local level are necessary if the objectives here are to be achieved.”

Although the US has not signed the Kyoto Protocol, the production of bioethanol in the US has been supported by convenient fiscal conditions and a price list to take care of domestic producers against the received from Brazilian exports. The current plans of the big companies for renewable energy in North America and Europe show that they find the governments enough credible and the political attitudes quite positive for ensuring the commitments they are taking.

Modern biotechnology concerns the production of biofuels through many approaches and due to a variety of biomass sources and downstream technologies (Fig. 4). Thus, it is difficult to distinguish the input of modern biotechnology from other relevant sources. Modern biotechnological tools can be used to make the biomass source more suitable and economically feasible for the conversion into biofuel. Modern biotechnology can help the plant engineer to make crops with improved capability to fix carbon – especially if the C4 mechanism can be introduced into special crop species and a greater quantity of easy utilizing fermentable sugars are available. Such improvement could be realized as well for the bioethanol production through a transformation of the fermentation organism by enhancing its growth and efficacy for sugar conversion in alcohol and rising its ethanol tolerance.

The application of GMOs within fermentation facilities is marked by regulation as “contained use. The use of modified crops for biofuels is concerned by regulations on the field release of GMOs. As with biopharmaceuticals, concerns exist about the feasible amalgamation of food ingredients with molecules of non-food origin. For instance, starches, sugars, and vegetable oils are with a substantial role as foods, and their presence is less challenging the public concern.

From a technological point of view, the long-term expectations are focused on the so-called “second-generation” biofuels, obtained from lingo-cellulosic or ‘woody’ material sources (e.g., straw, timber, woodchips, or manure). These materials are rich in fiber and can only be transformed into liquid biofuels using advanced technological processes, which are still under elaboration. National preferences for these second-generation fuels reflect the local climate, specific crops, and processing conditions: US preference is for bioethanol production to be mixed with petrol; the EU is finding potential in biodiesel from vegetable oils. Brazil and the US are the main regions producing bio-ethanol, and the EU has the biggest fabrication of bio-diesel. Germany, France, Sweden, and Spain are the leading EU countries concerning the use of biofuels for transport.

However, countries like Malaysia and Indonesia are concerned to utilize palm oil from plantation cultures having a major environmental impact on tropical forests. Besides, the rising proportion of the corn harvest used for fuel production influences the corn prices. All these considerations are politically as well as ethically important questions regarding the potential conflict arising between food and fuel. At the same time, this yet is not referred into regulatory initiatives.

Figure 4. Approaches for biofuels production from a variety of biomass sources and downstream technologies. Source: “An EU strategy for biofuels”, European Commission communication COM (2006)34.

Industrial processing

Modern biotechnology has been introduced in some fermentation industries that influence “traditional biotechnology”. These technologies have close elements in their scientific ground, based on process engineering science, like microbiology and biochemistry. These disciplines are differed in the degree of the introduction of genetic engineering in modern biotechnologies, with reasons linked to the variety of the different product sectors they deliver.

During the 1970s in some countries, a new discipline “biotechnology” was established, based on microbiology, biochemistry, and process engineering, and the implementation of genetic engineering.

The fermented drinks from traditional industries are an object of define public interest and at the same time, tentative to the introduction of new techniques. This disadvantage is bounded in particular with viticulture since diverse disease problems could be successfully treated by such technologies. Also, in the beer industry, various tools for polishing the yeasts producers that can solve problems of off-flavors and spoilage are exploited. However, the possible benefits from such improvements cannot help to overweigh the commercial risks.

In contrast, antibiotics fermentation production has a long story of technical improvements and realization of commercial and clinical success. A comparison was made to evaluate the low-cost production by genetically modified bacteria or animal cells of previously insufficient and expensive molecules of pharmaceutical interest. The exploration of GMOs, incl. animal and plant cells are an object of regulatory initiatives – for instance in the EU this is regulated by Directives regarding the use of GMMs.

Fermentation processes with microorganisms can be effective but the building of a plant for such technology with the relevant infrastructure for upstream and downstream processing needs a considerable investment capital. Hence, modern biotechnology can offer two optional ways for production that are economically feasible but facing strong regulatory obstacles:

  • Transgenic plants;
  • Transgenic animals.

These routes are not classified as “industrial processing” but they can have a competitive advantage over traditional production methods. Plants giving non-food molecules with pharmaceutical interest possess a history in traditional medicine and the “Health foods” sector. “Herbal remedies “being popular, are bringing some skepticism from professional pharmacologists, but do not generally indicate antagonism; like “organic foods”, they represent a separate sub-sector having their performance, and accompanied with some regulation of standards.

The food and drink industry has expressed strong concern about the risks of their raw materials being “contaminated” by biologically active molecules produced in traditional food plants such as corn or rice. Such concerns apply to the use of transgenic animals. Although large animals may be more easily confined than the pollen produced by plants, there is popular hostility to scientists “messing about with” the genetic inheritance of animals by the methods of genetic engineering. The legislation in many countries defends the welfare of animals used in scientific research and those used in agriculture.

It is an open question of whether and how existing regulations for animal protection satisfy these concerns. The use of processing aids such as enzymes has a long history of use in food and other industries, and regulatory attention has not inhibited innovations to improve enzymes, or to transfer genes coding for useful enzymes from natural isolates into production organisms open to industrial process environments.

The use of rare and valuable properties of germplasm found in various countries has to some extent inspired the Convention on Biological Diversity and its novel concept of national rights over access to indigenous species.

The OECD has issued important reports on industrial biotechnology. In 1998, its report, “Biotechnology for Clean Industrial Products and Processes: Towards Industrial Sustainability” described the significant contributions that modern biotechnology could make towards cleaner industrial products and processes, with corresponding environmental benefits. As it emphasizes, although bioremediation of contaminated environments is important, the preferable alternative for the future is to develop processes that are inherently cleaner and not creating contamination problems. In its “Conclusions and Policy Implications”, the report lists ten key points – only one of which mentions regulation: “Government policies to enhance the cleanliness of industrial products and processes can be the single most decisive factor in the development and industrial use of clean biotechnological processes. Legislation, regulation, guidelines, standards, government procurement, and supported R&D can encourage or discourage the use of clean processes based on biotechnology. Obstacles can arise from the following: absence of policy or enforcement, insufficient international harmonization, policy contradictions, and policies that ignore the particular conditions of individual sectors. Government policy should promote the best clean technological processes and encourage their widespread for industrial application. Governments can encourage the employment of clean technological processes so that biotechnology can be used when it is found to be appropriate based on economic analysis and assessment of environmental cleanliness.”

Few if any governments have pursued the implementation of regulations to act as direct promotors of cleaner industrial processes, despite the demonstrated potential of modern biotechnology in this respect. The industry may be uncertain, since the innovative technology may be seen as threatening or risky by engineers whose whole training and career experience have been connected with the traditional materials and methods. Partly responding to such concerns, the OECD published a report, “The Application of Biotechnology to Industrial Sustainability”, presenting 21 case studies, drawn from a wide range of industries, and eight different countries. The conclusion in the Executive Summary of the document says that: “… the studies show that the application of biotechnology invariably led to a reduction in either operating costs or capital costs or both. It led to a more sustainable process, a lowered ecological footprint in the widest sense, by reducing some or all of energy use, water use, wastewater, or greenhouse gas production. These case studies suggest that decision-makers regarded environmental friendliness as secondary to cost considerations but it is sometimes difficult to separate the two since the reduction of input usually means a reduction in the cost as well.

Government policy-makers can keep the balance of risk-taking by developing a sustained, stable legislative base, offering financial motivations for improved sustainability, and providing R&D funding for bridging the enabling disciplines.

Management of relations with the natural environment

The new knowledge and techniques of the life sciences offer a deeper understanding of living entities – from genes to ecosystems, and the impact of human activities on these organisms, populations, and ecosystems. This knowledge and techniques offer many possibilities for reducing human impacts on the environment and reversing the effects of some former damage.

In the context of regulatory frameworks, Environment Ministries might encourage the development of more environmentally friendly and sustainable products, processes, and practices by intelligent regulation. This does not yet take place on a wide scale because of doubts and concerns for the long-term impacts. For the development of suitable policies, it is useful to distinguish between the direct benefits to the environment, by cleaning up polluted sites (e.g., bioremediation) and indirect benefit to the environment, by the development of processes and/or the use of less polluting practices.

OECD has clarified the potential role of biotechnology in bioremediation, starting with a major report in 1994: “Biotechnology for a Clean Environment: Prevention, Detection, Remediation”. This activated a series of follow-up workshops:

  • A workshop on “Bioremediation”, held in Tokyo, November 1994 and emphasized the efficient and safe reduction of pollutant hazards, as well as long-term applications of biotechnology for environmental quality.
  • A workshop on “Wider Application and Diffusion of Bioremediation Technologies”, held in Amsterdam, November 1995 and focused on remedying pollution in soil and air, particularly in the context of the industry.
  • A workshop on “Biotechnology for Water Use and Conservation”, held in Mexico City in October 1996 and covered both remediation and prevention/conservation issues.

This work progressively broadened over the following years, focusing more on cleaner industrial processes – the resulting reports cited above and the case studies demonstrated the potential to combine both economic and ecological benefits.

Regulatory aspects in many countries have featured as constraints in the development of biotechnology applications for the environment. The regulations covering the release of GMOs are based on a systematic assessment of risks, but do not consider potential benefits; do not compare proposed innovative products and practices with the existing ones; and do not include any requirement for cost-benefit assessment. The regulations seem to be motivated by fear or assumption of potential adverse impacts, a standpoint that similarly drives legislation relating to liability for environmental damage.

Similar observations were made concerning the Cartagena Protocol. In the short term, the absence of regulatory frameworks and the necessary means of enforcement is seen by many countries as a reason for maintaining very restrictive modern biotechnology applications, despite the major potential benefits which it offers.

There is a possibility of regulations encouraging the development of cleaner and more environmentally friendly technologies, including biotechnology, and this is explicitly recognized in the EU’s ongoing initiative, Environmental Technologies Action Plan (ETAP). Following extensive consultations with the Member States, industry, professional associations, and other interested stakeholders, the European Commission in January 2004 published a detailed communication and progress reporting on the subject. National “Roadmaps” have been published by most Member States. Biotechnology, unfortunately, presents in the national Roadmaps mainly as “Biomass”.

Intellectual property rights and security

Intellectual property rights

Intellectual property rights in respect to modern biotechnology are a conflict subject. The conflict points can be determined between the R&D-based pharmaceutical industry and generics producers, and between the companies-holders of intellectual property and the developing countries distressed with many problems but unable to afford the relatively high prices of the innovative solutions for them offered by the said companies. These issues are well recognized, and the global trade agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) has established a framework within which such conflicts are tracked. The developing countries are also demanding that patent applications regarding the use of biotic materials (e.g., germplasm, tissues, cells) have to declare the source/origin of these biomaterials. This is a debate that currently is going on in the World Intellectual Property Organisation (WIPO). Besides, there are policy debates provoked by the implementation of the Cartagena Protocol on Biosafety. Thus, presently anticipated changes in intellectual property law or the TRIPS agreement are pending, although obligations are arising from the Convention on Biological Diversity (CBD).

Security

Defense institutions have recognized the potential of chemical and biological weapons for years. Hopefully, a limited one due to the Biological and Toxins Weapons Convention (BTWC)18 (1975) and the Chemical Weapons Convention (CWC) (1994) that have been ratified by many countries. The use of biological weapons is prohibited by the Geneva Convention of 192519; the BTWC forbids the biological agents or toxins of microbial origin to be developed, produced, stocked, acquired, and maintained, in categories and amounts that are not justified for prevention, protection, or other peaceful intentions. Neither is allowed the use of weapons, equipment, or means of delivery envisaged for use of the said agents or toxins for aggressive purposes or in armed conflicts.

The informal structure Australia Group (AG) of countries is an important tool for restricting the spread of materials, equipment, and knowledge that could enable and encourage the development of these kinds of dangerous weapons. This AG objective is “to ensure, through harmonization of national licensing measures and information exchange that exports of certain chemicals, biological agents, and dual-use chemical and biological manufacturing facilities and equipment from participating countries, do not contribute to the spread of chemical or biological weapons“. Namely, this mission supports the goals of the BTWC and CWC. The AG includes the well-developed economies of Europe and North America, as well as Australia, South Korea, Japan, Argentina, and New Zealand, all participants in the BTWC. AG has a control list directly linked to national export control ones. It is also linked to the EU legislation under Article 11 in Regulation 1334/2000 that specifies the Community regime for the control of exports of items and technology with dual-purpose and dual-use. By the end of the 1980s, there was increasing evidence about the transformation of dual-use materials into biological weapons programs. To answer this serious concern, AG shortly added biological controls and the controls on the equipment used to manufacture chemical and biological weapons to its control list. This control list is a document subjected to regular updating to reflect the technological changes and the associated threats and policies.

After September 2001 terrorist attacks in the US, the AG enlarged its focus and included the CBW terrorism in the control targets. For this purpose, it has amended the parameters of items on the control list and included the aforementioned dual-use materials and technologies. For instance, before 2001 the AG control on fermenters applied only to the export of those with capacities > 100L, typically designed for major industrial applications. Now, the control is changed to a significantly lower threshold – > 20 L.

Nowadays, the knowledge about living organisms, including man, animals, and cultivated plants’ pathogens is so huge, that it is unthinkable for responsible governments to ignore the possibility of such knowledge being used for violent purposes by other actors, that are not aware of breaking the international conventions. This apprehension, added to the “dual-use” issues, is likely to be transformed into a permanent characteristic of the regulatory environment. Thus, there is a need for policy responses through internationally coordinated efforts to provide a clear overview of the main issues.

The report “Biotechnology Research in an Age of Terrorism”, prepared by US National Academies: the Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology (cited as the “Fink Report”) and published in 2004 refers to the experience of the Asilomar Conference in 1975, and the following guidelines for work with recombinant DNA designed by scientists from NIH RAC. These guidelines were based on the goals to “prevent any untoward events, reassure the public, and allow the rapid and efficient progress of academic and commercial applications of these technologies.”. In this report, it is noted as well that in a cooperative statement, in November 2002, the presidents of the US National Academy of Sciences and the UK Royal Society appealed the scientists to support their governments to fight the threat of bioterrorism: “Today, researchers in the biological sciences again need to take responsibility for helping to prevent the potential misuses of their work, while being careful to preserve the vitality of their disciplines as required to contribute to human welfare.”

The Fink Report proposed to launch a set of stages at which experiments and their data would be checked and reviewed, to ensure that biotechnology innovations with potential for bioterrorism/development of weapons would receive responsible opinion and justification. In this context, seven main recommendations were made, listed in Fig. 5.

The Fink Report recommendation was implemented by the establishment of a specialized Board with the purpose to be an effective element of regulatory oversight. This Board was charged (as a US government body) with developing policies for publication, communication, and dissemination of dual-use research results and the long-term goal to promote the adoption or harmonization of its policies with other nations. The key factor in the longer term is seen to be self-regulation by the scientific communities and consciousness of their responsibilities.

Figure 5. Fink Report main recommendations.

Test: LO6 Advanced Level

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References

  • Australia Group (AG) https://www.dfat.gov.au/publications/minisite/theaustraliagroupnet/site/en/introduction.html
  • Council Regulation (EC) No 1334/2000 of 22 June 2000 setting up a Community regime for the control of exports of dual-use items and technology https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32000R1334
  • DHHS, National Science Advisory Board for Biosecurity Charter, 2004. General information regarding the NSABB is available at http://www.biosecurityboard.gov/.
  • Directive 2004/35/CE of the European Parliament and the Council on environmental liability concerning the prevention and remedying of environmental damage https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004L0035
  • Driessen, P. 2006. “Commentary: Delaying technology is deadly”, Washington Times
  • ETAP. EC COM (2004)38, January 2004, Stimulating Technologies for Sustainable Development: An Environmental Technologies Action Plan for the European Union
  • European Commission Biofuels Directive 2003/30/EC on the promotion of the use of biofuels for transport. 2003.
  • European Commission’s communication to the Council and the European Parliament: “Stimulating Technologies for Sustainable Development: An Environmental Technologies Action Plan for the European Union”. 2004.
  • European Commission, COM(2005)628, Biomass action plan.
  • European Commission, COM(2006)34, An EU Strategy for Biofuels.
  • European Commission, COM(2006)545, Action Plan for Energy Efficiency: Realising the Potential.
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