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.