A Global Roadmap for Modern Biotechnology
An issues-based navigational tool with policy options for decision-makers in the public and private sectors

Prepared by
ICC Joint Working Party on BioSociety
under the auspices of the
ICC Commissions:

•	Environment
•	International Trade and Investment Policy
•	Int ellectual and Industrial Property
•	Marketing, Advertising and Distribution

Table of contents

I.	Introduction
II.	Guiding Concepts
III.	The Roadmap
	1.	Promoting innovation in modern biotechnology
		•	Pillars of innovation
		•	Promoting innovation and regulatory reform
	2.	Realising the economic, social and product benefits of modern biotechnology
	3.	Building trust for users and consumers
	4.	Exploring health and environment issues associated with modern biotechnology
	5.	Developing the benefits of biotechnology through sound trade, competition, and intellectual property policies
		•	Competition, market access, and the WTO
		•	Intellectual property
		•	Investment policies
IV.	Specific capacity-building programmes

I. Introduction (back up)

This Global Roadmap for Modern Biotechnology has been formulated in recognition of biotechnology as a rapidly emerging, intrinsically complicated, and far-reaching new technology. Developing this technology into an industry confronts many of the challenges common to emerging, technology-based industries, including: research & development; creation of investment capital; technology transfer; market penetration; protection of property rights; pricing and regulation. In guiding the evolution of the biotechnology industry it will be useful to draw upon the many available lessons learned from modern economics, market development, and government intervention. Additionally, the emergence of biotechnology is accompanied by a variety of understandable societal concerns, including: maintenance of nature's balance; conserving natural diversity; ensuring that foods derived from modern biotechnology are safe and consumers have the right to choose. Biotechnology offers a most appealing vision of the future, one in which we can cure more diseases, feed the world's population, and protect the environment. But these new hopes bring new responsibilities that will test whether mankind can meet the challenges posed. In order to realise the benefits of biotechnology for the good of humans and the environment, we will need to make wise decisions, humbly accepting the needs of nature and the limits of our ability.

The purpose of this Roadmap is to present a framework within which these important decisions can be made. It is proposed as guidance for business, governments, and other relevant organisations to utilise as they contribute to the rational development of the r ules and conditions necessary for the stable and predictable development of this new industry. The Roadmap is the fruit of discussions among an international, multilateral business forum, and it was developed by the world's leading international business organisations. Our approach is to present an inventory of fundamental business views concerning biotechnology. It is our hope that the sharing of these views will facilitate necessary, transparent and coordinated discussion between and among industry, government and civil society.

Business has a strong market incentive to foster and maintain consumers' trust, and for this reason business must accept its responsibility to ensure that products derived from biotechnology meet the highest international standards of quality and safety. Business has and will continue to support government activities that ensure that the adoption of any new technology is undertaken in such a way as to appropriately protect human health and the environment. And business is prepared to be open and transparent -- providing meaningful information to consumers about products in any areas of concern. Moreover, business will seek to promote a safe, secure environment through self-regulation, information sharing and technological innovation.

Governments will also have a critical role to play, not only in advancing the benefits of modern biotechnology, but also in protecting and informing the public. Business is prepared to work with governments to facilitate transparency -- whether through public education about existing and possible future regulatory proposals, or by providing education about the underlying science of the technology. Together, we can ensure that the biotechnology industry evolves responsibly in order to deliver the anticipated benefits to society. Managing the uncertainties of innovation through rigorous risk assessment and risk management, built on a foundation of sound science, and including transparent consultation with representatives of all members of society, ensures that the most beneficial societal choices will be made with respect to technological innovation.

All parties, but particularly business and policy makers, should work to enhance societal understanding of the critical nature of an agreed scientific review process, which allow continued investment to fuel the process of biotechnological innovation. This is intended to be a "living document" which evolves as policies develop and the technologies are implemented. To this end, I invite readers to send me their comments for improvement.

Maria Livanos Cattaui
Secretary General

II. Guiding concepts (back up)

The following core concepts should guide both business and government in their actions concerning biotechnology:

1.	Biotechnology is an innovative, enabling set of technologies, which is transforming what we know about our world; and when developed prudently can help to achieve many of the world's social, human health, environmental, and economic goals.
2.	The public and private sectors are jointly responsible for the development of biotechnology in order to realise its full potential. Actions which are undertaken cooperatively can enhance the effectiveness and usefulness of results.
3.	Since it provides important new discoveries and dimensions which could greatly improve the quality of life, biotechnology should be approached with an appropriate enthusiasm but always balanced with humility about unforeseen consequences.
4.	By adopting transparent and responsible conduct in research, development and marketing, business can build greater public trust and confidence in biotechnology by ensuring that consumers better understand the risks and benefits associated with biotechnology products and can exercise choice.
5.	In order to achieve the societal benefits of biotechnology and its numerous applications, public education, genuine understanding, and constructive dialogue will be paramount. All responsible public, private and civil society actors should foster processes of education, based upon science, objective information sharing, and consensus building, to ensure greater public understanding, not only about technology but also the health, environmental, nutritional, and economic benefits to be derived from its successful application.
6.	Biotechnology depends upon innovation. Governments, working together with business and industry can create a transparent, enabling framework that encourages responsible innovation, both domestically and internationally.
7.	Biotechnology is global in scope. In addition to its potential benefits for industrialised nations, biotechnology can play a critical role in helping developing countries address many of their most pressing challenges - economic growth and the alleviation of poverty, food security and improved nutrition, the eradication of many threats to human health, and sustainable development. Business will continue to contribute to the global uses of biotechnology through the sharing of benefits and capacity building.
8.	As with any emerging industry, the protection of intellectual property rights and progressive trade policies are essential to ensure continued innovation and to stimulate investment in biotechnology.

 

III. The Roadmap (back up)

This Roadmap presents a framework within which important decisions on modern biotechnology might be taken. It is proposed as guidance for business, government, a nd other relevant organisations to utilise as they contribute to the rational development of the rules and conditions necessary for the stable and predictable development of these innovative new tools.

It is intended to be a "living document" which evolves as policies and technologies develop.

The Roadmap focuses on five (5) topic areas for establishing a constructive dialogue critical to advancing the biotechnology industry.

1.	Promoting innovation in modern biotechnology.
2.	Realising the economic, social and product benefits of modern biotechnology.
3.	Building trust for users and consumers.
4.	Exploring health and environmental issues associated with modern biotechnology -- including potential risks and tools for risk management.
5.	Developing the benefits of biotechnology through sound trade, competition and intellectual property policies.

Each topic area provides fundamental business views on key conditions and issues affecting future development of modern biotechnology; looks at solutions already developed by governments and business; accounts for respective roles of governments and business; and offers suggested actions for both governments and businesses to consider or adopt.

1. Promoting innovation in modern biotechnology (back up)

Pillars of innovation

(back up)

From the steam engine to the aeroplane, from electric power to the transistor, from the telephone to the microchip - scientific discovery combined with technological innovation has dramatically improved our lives, our societies, and our economies. Biotechnology is both an innovative technology that transforms what we know about the world, and a far-reaching enabling technology which can help change our world for the better.

Biotechnology is the use of cellular and molecular processes to solve problems and/or make products. Classical biotechnology makes use of knowledge and discoveries dating back as early as 5000 B.C., where in Mexico, hybridisation o f corn first took place. It builds upon Austrian Monk Gregor Mendel's discovery of the laws of heredity, and the emergence of modern biotechnology from the landmark 1953 discovery of the double-helix model of DNA by James Watson and Francis Crick. While biotechnology is not new, modern biotechnology builds upon classical knowledge to produce almost unimaginable possibilities. Modern biotechnology products are all around us: on farms, in supermarkets, protecting the environment; in the chemical industry, in bio-electronics, and in modern science. In the medical industry, as just one example, biotechnology can lead to new vaccines to improve the prevention of illness; or new diagnostic tests to help detect hereditary infections; or new medicines that offer patients and doctors more effective treatments. Such innovation boosts all sectors of society; it can be as important for the family farm as it is for high-tech business. In the process, entirely new industries and new high-wage jobs have been and will continue to be created.

However, in order to best realize the benefits offered through modern biotechnology, it will be important to support innovation. Three important policy pillars which support innovation include: (1) enabling an expanding knowledge base; (2) facilitating the application of research & development (R&D); and (3) protecting intellectual property rights.

Before research and development can occur, it is necessary to have an expanding knowledge base upon which entrepreneurs can create wealth. Wealth from new knowledge-based enterprises is based on the entrepreneurial capacity to generate and exploit highly developed ideas into products and services. This requires governments and industry to work together to develop not only the science, but also to ensure that the knowledge is widely diffused throughout society. Governments can take an important step in expanding the knowledge base through funding of basic scientific research, and ensuring that co-operation between the public and private sectors is not unduly limited. Government and industry must work to enhance networks and information flows within emerging knowledge-based areas of the economy to build investment capabilities and accelerated commercialisation of new ideas and technologies. Building awareness and understanding in the wider community of the need to enable broad skilled, entrepreneurial and adaptive personnel who use innovation to commercialise new ideas and technologies is the final element necessary in enabling an expanding knowledge base.
The pace of new advances in biotechnology, the increasing cost of R&D, ever-shorter product life cycles, and the rapid worldwide diffusion of technologies are significant challenges to companies investing in speculative or longer-term R&D. At the same time, it should be recognized that this is not a sustainable situation, precluding potentially substantial social benefits that can result from investment in basic science. The problem of capturing private returns on pre-commercial R&D is especially great in widely dispersed and fragmented industries such as biotechnology. Government cost-sharing can provide a bridge, which mitigates under-investment in R&D and supports diffusion to society of the benefits of R&D. The social rate of return on R&D investments, where the benefits accrue to many firms and to consumers in the form of less costly and higher quality products, is considerably higher than the average private rate of return on investment for individual companies, thereby providing a necessary impetus for continued public support.

Moreover, once investments have been made, the rewards of innovation can be perpetuated through better protection of intellectual property. Along with policies that support venture capital, an entrepreneurial spirit, and the ability to capitalise effectively on new knowledge wherever it arises, the incentives created by intellectual property rights are necessary to ensure continued innovation and to stimulate the investment of resources needed to market these innovations.

Promoting innovation in modern biotechnology: pillars of innovation

Business	Government
Creating a climate which fosters private-sector innovation and commercialisation
In order to keep pace with the need to carry out interdisciplinary R&D, companies should begin to integrate calculations of R&D risk and relevance over both short- and long-term horizons.	Governments should seek to incorporate policies that protect investments, ensure the protection of intellectual property rights, enable fair competition and market access for biotech products, and avoid distortive trade and regulatory policies. The consequence of government support and implementation of such policies is innovation, new R&D, and economic growth.
Recognising the importance of support for basic science
Business can respond to the pressures of concentrating its scarce resources by collaborating with others on high-potential areas with long-term payoffs -- for both the companies involved and for society.	By promoting creativity and emphasizing peer review, governments can help focus the priorities for basic science and refine systems for selecting excellence in ideas, individuals and institutions.
Supporting industry-led biotechnology development partnerships
Business can extend scarce R&D resources by setting clear spending priorities, focusing on core competencies, and removing organisational and attitudinal barriers to partnerships-which in turn can maximise their own R&D efforts as they compete in the marketplace. Integrating international developments into domestic R&D in a timely manner, through constructive collaboration, can expose companies, universities, and national laboratories to the best research and manufacturing practices in biotechnology.	Governments can help to mitigate potential gaps in funding of mid- and long-range R&D by assisting industry and academia with finding new ways of working in concert to develop and carry out a complex, cumulative research agenda. Governments play a key role in shepherding international collaboration and innovation by substituting mandates and controls with policies which facilitate interaction.
The social role of biotechnology-specific liability rules
Business can clarify general questions of liability and biotechnology, especially the applicability of existing general liability systems to biotechnology and the need for general, as opposed to technology-specific, development and application of any potential additional liability laws, by submitting to relevant international and domestic governmental organisations findings about the risk and impact of liability rules on innovation.	By working with business and other stakeholders, governments can better identify areas of risk that require preventative measures beyond existing liability systems, and avoid legislative activities that can impede advancement and innovation in biotechnology.

Promoting innovation and regulatory reform

(back up)

As described above, innovation is essential for the advancement of the biotechnology industry-and for society to gain access to the potential benefits. This Roadmap suggests that creating a proper balance between necessary regulatory regimes and an accommodating climate for investment will be extremely important to the form and pace of biotechnology industry development. Careful consideration should be given, therefore, to avoiding regulatory regimes that have the potential to interfere with innovation or impede, rather than advance, industrial development. The appropriate use of government regulations and interventions can safely and rationally shepherd the emerging biotechnology industry toward its potential.

Additionally, the rapid evolution of the industry will put additional pressure on regulatory regimes to adapt and stay current. For example, biology, chemistry, nanotechnology, and the full range of advanced information technologies are rapidly converging to provide new technology platforms such as genomics and combinatorial chemistry. This convergence phenomenon is dramatically forcing companies to reshape business models in order to become more innovative and productive. Similarly, governments may be able to improve the effectiveness of regulatory regimes by modifying them to address emerging issues stemming from this convergence of technologies. Convergence, especially between biotechnology and information technologies, is leading the need for a concomitant regulatory convergence.

Business encourages governments to take a balanced and pragmatic approach toward regulation -- recognizing the need to create appropriate regulatory regimes, which protect against risks to the environment and human and animal health, yet avoid "non-tariff" barriers to trade and development. In doing so, public policy can achieve greater good when its perspective is extended to include science-based judgements, benefits as well as costs, and the long-term as well as the short-term.

Promoting innovation in modern biotechnology: innovation and regulatory reform

Business	Government
Regulatory harmonisation and mutual recognition
Regardless of the issue or the industry, regulatory regimes establish the rules of the process. For those involved to be efficient and avoid extra costs, the rules need to be predictable and consistent. If these basic elements do not exist or are in conflict with other regimes, business can face increased economic costs of trade, and increase the risk of trade disruption.	Governments can facilitate international harmonization by drawing upon internationally recognised standards and guidelines. For example, the SPS Agreement recognises the Codex Alimentarius Commission (Codex) for food safety; the International Office of Epizootics (OIE) for animal health; and the International Plant Protection Convention (IPPC) for plant protection. Where harmonisation of regulatory measures is not possible, governments can facilitate the use of options, for example, the principle of equivalence set forth in the World Trade Organization (WTO) SPS Agreement, which requires countries to demonstrate that its measures provide equivalent levels of health protection. WTO members can benefit from draft guidelines (March 2000) mandated by the SPS Agreement, which request countries to examine past practices and international norms in related areas before putting new SPS measures in place.
The consequences of convergence in biotechnology
In order to keep pace with the convergence phenomenon in biotechnology, businesses are developing and using new research and development strategies, product development techniques, and products and services.	The following principles could be useful for governments to consider when preparing for, and reacting to, changes caused by convergence: Foster competition; Facilitate market-oriented mechanisms that are transparent, proportionate and based on sound science and least trade-restrictive; Incorporate prudent cost-benefit analyses.

 

2. Realising the economic, social and product benefits of modern biotechnology (back up)

Biotechnology provides significant potential for economic growth, efficiency, productivity gains, and employment in both technology and services sectors of the industry.

Balancing the virtually limitless potential economic, social and product benefits accruing from modern biotechnology with concerns about possible negative socio-economic impacts presents a challenge in communications and understanding. Policy makers and industry will need to communicate benefits to consumers, as well as solicit public comment and react to concerns.
This part of the Roadmap assesses a number of the critical issues associated with creating a balance between encouraging and promoting the benefits while addressing real or perceived concerns over the socio-economic impacts of this new technology.

Realising the economic, social and product benefits of modern biotechnology

Business	Government
Communicating and demonstrating benefits
The communication of genuine and transparent product information -- to consumers, by business -- can go a long way in ensuring an informed societal understanding of the benefits of biotechnology.	Education is an important social responsibility for all governments. Considering the potentially significant social concerns about applications of biotechnology, governments can improve society's understanding of this complex issue by implementing public information programmes across the wide range of issues affecting the various applications.
Capacity building
Capacity building seeks to strengthen targeted human resources (professional and technical) in particular institutions and to provide the means whereby these resources can be marshalled and sustained effectively to perform planning, policy formulation, and implementation tasks. Wherever biotechnology is applied, and especially in developing countries, business can work with governments and international organizations to offer advice and resources to ensure that the "capacity" exists for the safe, efficient and competent introduction of biotechnology products. (The Appendix below, lists specific capacity-building programme that have been undertaken by and in partnership with business.)	A variety of international organizations (World Bank, IMF, CGIAR, FAO, UNCTAD) and international agreements, particularly the Cartagena Protocol, provide governments with frameworks for undertaking capacity building efforts that could be adapted and applied to the introduction, use, and regulation of biotechnology. Critical areas of focus would include risk assessment and management.
< div align="center"> Skills development
An important part of capacity building is the development of technical skills. Since biotechnology is an advanced technology, with a high skill level, business can play a useful role in providing relevant information and training to both public and private capacity building programmes.	Addressing the technical aspects of educational responsibility, governments can develop and support both formal and non-formal skills-development programmes -- with a focus on basic life sciences.
Ensuring global participation
Existing national and international business organizations can usefully extend their activities into the field of biotechnology and product applications. They can also adopt and adapt programmes to expand the participation of business both in and for developing countries toward education, capacity building, and promoting the uses and benefits of biotechnology.	Existing inter-governmental organizations can increase their effectiveness in addressing and elevating biotechnology issues on their working agendas and by building inter-organizational partnerships.
Economic development
Biotechnological innovation shows considerable potential for enhancing the productivity of both labour and capital, leading to higher wages and incomes and to a more rapid rate of job creation. These are benefits available to both business and consumers alike. With sound business planning, communication and co-operation with consumers and governments, and the rational introduction and use of biotechnology processes and products, businesses large and small can contribute to, and benefit from, economic growth through job creation, investment, and productivity gains.	Government partnerships with organizations like the World Bank and the FAO can be valuable catalysts to assist developing countries in facilitating capacity-building, technology transfer, and practical applications such as the introduction of new technologies, best practices and training. Governments could work to ensure that these organizations become effective in creating a stable investment climate by communicating important messages and quantifying the benefits of biotechnology in socio-economic terms, nationally and internationally.
Food security
The agri-food business sector can play an important role in ensuring food security through agricultural innovation, such as increased production of grains and other foods, and through increased trade in agricultural commodities and agri-food products.	Food security is a n important element, not only for sustaining quality of life, but also for stimulating national economic development. One way governments can ensure a safe and reliable food supply is WTO commitments to achieve progressive agricultural trade liberalization. Such commitments encourage the efficient and balanced exchange of food between countries and provide a conducive climate for the transfer of new technologies. Removal of non-trade barriers also contribute to increased exports and revenue.
Sustainable development
Companies engaged in the development and introduction of modern biotechnology can contribute to the public dialogue on achieving sustainability by demonstrating how biotechnology products - among other things - contribute to heath improvements, economic development, food security, environmental protection and waste minimization. The communication of these success stories should review the various initiatives that reveal the potential of biotechnology and define the principles of sustainable development.	The challenge of sustainable development emphasises the long-term nature of the search for sustainable solutions. By taking an equally long-term view toward biotechnology and its applications, governments can better integrate the inherent economic, social, and environmental challenges and opportunities.
Reaping the benefits of agriculture
In many developing countries, agriculture is the predominant economic activity - with food security the top political and social priority. Biotechnology can generate significant solutions in these areas. Business can take further research and joint ventures to ensure that specific product needs are met and that policy makers are provided with capacity building support.	Economic growth spurred by biotechnology can help raise per capita income, living standards, and development opportunities. Moreover, biotechnology-driven efficiency gains in the food and agricultural sectors, have the potential to advance economic development and trade liberalisation policies, particularly in the developing world. These developments have the added potential to reduce environmental impacts and thereby result in more efficient use of water, land and energy. Governments can facilitate these potential improvements by encouraging voluntary industry initiatives to promote best biotechnology practices and environmentally sustainable food production techniques. Other very useful forms of facilitation include: provision of credit to poor farmers to enable them access the technologies; encourage private, locally-based biotechnology laboratories and help establish seed distribution mechanisms; set market information centres through community-based initiatives to ensure a complete cycle from production to marketing.

 

< /a>3. Building trust for users and consumers (back up)

If an innovative technology is to achieve its full potential, it must demonstrate a net added value for stakeholders. Furthermore, it must be perceived as beneficial by consumers, embraced by users, and facilitated by regulators. In short, it must find its true market. Trust is a critical element implicit in this formula, due to the exceptional developments in biotechnology and the highly complex nature of the technology. This section of the Roadmap discusses the "trust factor" and its impact on the development of the biotechnology industry.

Modern biotechnology possesses the characteristics of a new technology with realized potential in certain areas, promising potential in others, and future potential at the cutting edge of science where biology, chemistry and physics are converging. A variety of the benefits of biotechnology applications and products have been discussed. This Roadmap is essentially a strategy for the eventual achievement of the positive contributions biotechnology can make to society, the economy, and sustainable development. However, the rapid, and to many exciting, development of biotechnology has not occurred without significant levels of legitimate concern. Some questions for instance include whether 'cloning' is ethical, or whether humans can safely digest foodstuffs derived from the products of modern biotechnology. Public controversy can undermine trust in modern biotechnology, and the regulatory and other safeguards that underpin its use, by impeding the development of beneficial technologies.

Clearly, a dynamic tension and constructive debate between the political, business, public and technical communities is essential for ensuring necessary checks and balances in the development of new technologies. Discussed in topics one and two above, the communication of genuine and transparent product information -- to consumers, by business -- can go a long way to ensure an informed societal understanding of the benefits of biotechnology. Moreover, it has been established that governments can play a critical role in creating a sound regulatory regime and by providing responsible education and information. However, to the extent that balanced discussion and fact-finding is influenced - or worse -- undermined by opposition groups or a media in search of polemic, then advancement in biotechnology is at risk. Likewise, the potential social gains extending from biotechnology products are threatened. It is therefore the responsibility of business to give consumers a clear, comprehensive, and meaningful understanding of the ways in which economic and safety concerns associated with new biotechnology products and services are assessed and managed. It is the responsibility of all societal actors- government, business, academia, civil society, and the media- to ensure an open, objective and transparent public policy debate, leading to balanced coverage and informed understanding of critical issues.

All stakeholders should guard against a context which works solely to undermine technological development. Consumers of goods and services are the ultimate determinants of all business successes and failures. If their trust in a new technology is undermined, serious obstacles can arise which can potentially distort the research and development investment cycle and may prevent the commercialisation of new technologies and the products and services which they generate. No business can ignore these factors and, in a well-regulated free market setting, no business can survive the flight of its customer base. Thus, alongside the drive for innovation, a far-sighted business will commit itself to exploration and iteration, respecting legitimate concerns and dealing with them thoughtfully and openly.

Building trust for users and consumers

Business	Government
Open, informed debate driving innovation
Open communication by business is important to a balanced biotechnology debate. Business efforts to share critical information - within the bounds of commercial discretion - can build societal trust and lead to a more informed debate. By providing balanced, informed and non-inflammatory coverage of developments in biotechnology, media can help to create an educated and informed consumer base.	Governments have an excellent opportunity to bring together informed, trusted societal observers and experts to debate the true cost-and-benefit profile of biotechnological innovation. To improve the debate on biotechnology, governments should consider replicating such events as the OECD meeting in Edinburgh in February 2000.
Communicating risks and benefits
Early action by business to communicate the full risks and benefits - as far as known - of new biotechnologies and products is essential if the true benefits of technological innovation are to be captured for broader society. The degree to which business balances its commercial interests, particularly that of confidentiality, with the need for transparent communication can only be achieved through informed dialogue with the full range of societal actors. Business receives its license to operate from society.	Through policy frameworks, legislative enablers and regulatory provisions, government can greatly influence the understanding of new technologies. Governments should proactively communicate not only the risks and rewards of a new technology, but also how they are using legislative and regulatory mechanisms to address the issues. International organizations can contribute to the dialogue by communicating their ongoing activities related to biotechnology.
Creating a framework for rational scientific assessment
Business is confident in the proven abilities of intergovernmental bodies such as the WHO, the FAO, Codex, and the OECD, along with other standard-setting institutions, such as ISO, to provide a sound foundation for rational scientific assessment. Business encourages these bodies to continue thei r efforts to ensure that balanced assessment derives from the evaluation of scientific, technical and socio-economic impacts of innovative biotechnologies.	Sound political leadership and an informed policy framework can assist governments in maintaining rigorous, independent mechanisms for the structured scientific assessment of innovative biotechnology. Government policy frameworks that incorporate rationale scientific enquiry and appropriate risk-benefit methodologies into policy/regulatory decisions will be more effective that those influenced by the volatility of the daily policy debate.
Effective use of multi-stakeholder processes
Business knows that it is a critical stakeholder in the development and use of new technologies and that it will need to take a prominent role as a willing partner with other stakeholders in the biotechnology dialogue.	Governments should consider adopting a "facilitator" role in order to improve discussions with each group of stakeholders. Governments can also use these opportunities to explain public sector positions during forum dialogues.
Appropriate use of labelling
Similar to actions by governments, the business community is debating the appropriate international standards for product labelling. It is hoped that this Roadmap will help bring greater clarity to broad business thinking on the issue. Within this context, business understands and accepts that with innovative technologies and products, the individual consumer (as well as broader society) may demand information beyond that which is required for existing technologies and products. Under these circumstances, business urges that any "stricter" requirements for information disclosure associated with biotechnological products, either on a regulatory basis or stemming from an informal consensus of consumers, be driven by balanced, science-based, and well-informed debate. The participation of independent specialists and credible experts, alongside government, consumer and business representatives, can add great value to such a discussion.	Advancements in biotechnology and the associated debate over labelling provide governments with an opportunity to explain to the public the various rationales and factors upon which labelling is conducted. Within this more informed context, consumers might better understand government requirements and uses for labelling of products of biotechnology - ultimately leading to more educated consumer input to government decision-making.

 

4. Exploring health and environment issues associated with modern biotechnology (back up)

When considered with respect to a potenti al health or environmental impact, "risk" is a function of two factors: the inherent hazard of a product, and the exposure of that product to a specific ("target") organism. Particularly because no products or technologies are risk-free, science-based risk assessment is a key element in sound risk management and decision-making concerning the products of biotechnology.

More specifically, "risk assessment" and "risk management" involve related but distinct activities, and are well-developed concepts of general application to products irrespective of the processes or technologies involved. According to definitions from the OECD's Working Group on Harmonisation of Regulatory Oversight in Biotechnology: (1) "Risk/safety assessment involves the identification of potential . . . adverse effects or hazards, determining when a hazard is identified, and the probability of it occurring"; and (2) "the term "risk management" is used to describe measures taken to minimise hazards identified in a risk/safety assessment." Therefore, there are distinct differences which biotechnology policies, programmes, and requirements need to reflect.

Some measure of scientific uncertainty will be present in virtually any assessment of the health and/or environmental impacts of consumer products, including biotechnology products. As such, "caution" to ensure that decisions necessarily reflect the best scientific information available is an important element of both risk management and risk assessment.

Given the diversity of biotechnology research, processes, and products, both the assessment and management of potential risks associated with bio-engineered plants, micro-organisms and animals are best taken on a case-by-case basis. This approach focuses upon the traits and characteristics of the organisms involved, while remaining neutral on processes/technologies that are employed to develop such organisms.

Business advocates efforts that work toward maximising harmonisation and mutual recognition of principles, criteria, and procedures for both risk assessment and risk management activities affecting biotechnology products. National governments, regional bodies, and international organisations are well positioned to establish priorities in the development and implementation of harmonised and mutually acceptable elements of risk assessment and risk management programmes. In fact, programmes such as UNDP's ASARECA and UNIDO's BINAS have been successful in fostering and strengthening biotechnology risk assessment activities in developing countries and countries in economic transition. Programmes of this sort, which focus upon capacity building and co-ordination with other international scientific organisations, can provide considerable support to the development of science-based approaches to biotechnology risk analyses in these countries and geographic regions.

With this Roadmap as a guide, business and government can work together in tackling the challenges presented by risk.

Health and environment issues associated with modern biotechnology

Business	Government
Risk assessment
In order to achieve the following harmonised risk assessment goals between nations: (a) mutual acceptance of information and data used in risk assessments; (b) mutual recognition of risk analyses and conclusions, Business will work to create consensus around the following three basic components of sound, transparent risk assessment programmes: Component 1: Business is committed to the development of mutually-accepted protocols, methodologies, and similar procedures which are a part of (or are related to) risk assessments concerning biotechnology products - including sampling, analytical testing, good laboratory practice and quality assurance, assessments of potential health and environmental impacts, and exposure evaluations. Component 2: Business will work to achieve consensus with representatives of governments and other stakeholders concerning risk assessment principles and guidelines for various organisms (e.g., plants) and potential impacts (e.g., human allergy, weeds). Component 3: Business supports activities to identify and gain agreement between nations concerning the types and amount of information and data that are both appropriate and necessary to carry out risk assessments for various biotechnology products and potential health/environmental impacts.	Governments and international organizations can improve risk assessment practices through endorsement and support of the harmonized risk assessment goals. Component 1: By establishing work programmes to develop harmonised protocols and methodologies, such as the existing work of the OECD Chemicals Programme, international organizations can advance the reliability and usefulness of biotechnology risk analysis practices. Component 2: Appropriate international scientific bodies working through partnerships with business and other stakeholders can improve specific risk assessment principles and guidelines. Component 3: In the future, and building upon affirmative outcomes achieved in the two preceding activities, regional and international organization programmes can further mutual agreement on the information and data which should be available and used for particular risk assessments.
Risk management
Care should be taken that risk management decisions be made on a product-specific (and not a process or technology) basis. Consideration of cost-benefit and other economic analyses, acceptable levels of risk a nd uncertainty, and alternative approaches to managing risk as identified in the risk assessment can result in risk management measures which are transparent, well defined and consistent. Business recognises its obligation and accepts responsibility for taking voluntary risk management actions in order to address identified health/ environmental risks associated with specific biotechnology products. Such actions should be case-specific and appropriate to the risks and other factors actually presented. ••• In order to provide clear, objective, and appropriate information, business advocates the use of "risk communication" as a measure to address potential health/environmental impacts that have been identified through sound risk assessment. ••• Business endorses the biotechnology risk management rules and activities of the WTO, particularly the Agreement on the Application of Sanitary and Phytosanitary Measures (the "SPS Agreement"). ••• In accounting for the residual uncertainty which is present in the outcomes of virtually all scientific risk assessments, protective and targeted risk management measures will help ensure that risk management measures are proportionate to assessed risk(s). ••• Business encourages efforts to harmonise and make consistent risk management policies and programmes between national and regional authorities, particularly as a corollary to harmonisation of risk assessment protocols, principles and guidelines, and information/data sets.	National and regional risk management frameworks and actions, which are grounded in scientific risk assessment and other objective, documented factors, can be most effective when they address biotechnology products and not processes; and when, to the extent practicable, they are based upon existing institutions and programmes for managing risks associated with new foods, biomedical products and chemicals. This will be especially useful in building public confidence, minimising inappropriate responses to specific identified risks, and ensuring that acceptable levels of risk do not create associated market or social costs, e.g., barriers to trade. Government authorities should impose mandatory risk management requirements only when it is demonstrated that voluntary actions by business will not be sufficient to address identified risks in an appropriate, timely and efficient manner. When and if mandatory obligations are imposed, they should be the least restrictive (from among the variety of possible measures) and consistent with the objective outcome of risk. ••• Governments can also play a role in "risk communications" by addressing prod ucts (and not processes/technologies); by accurately communicating the outcomes of scientific risk assessment; by ensuring risk management measures are proportionate to the identified risk. ••• Continued government support of agreements such as SPS can send effective signals that risk management regulatory structures and decisions are based upon scientific principles, are not maintained against available scientific evidence, and are not more trade-restrictive than necessary to achieve the desired level of health and environmental protection. ••• Article 5.7 of the SPS Agreement provides useful guidelines for governments when incorporating "precaution" into risk management actions -- thereby helping to ensure that actual outcomes are proportionate to the results of the risk assessment activities taken to date. Article 5.7 also establishes a useful model that provides governments with the flexibility to review provisional risk management measures (within a reasonable period of time) in light of new risk assessment information and findings. ••• Parallel to efforts taken to harmonise their risk assessment programmes, governments should consider activities that can increase national understanding of risk management policies and systems and minimise unwarranted differences therein.

 

5. Developing the benefits of biotechnology through sound trade, competition, and intellectual property policies(back up)

Competition, market access, and the WTO

(back up)

Competitive markets are an effective means for maximising economic progress. By the same token, competitive policies applied to biotechnology (more so than government intervention) have the potential of enabling consumers to derive the full benefits of biotechnology market development -in terms of innovation, consumer welfare, and economic growth. Moreover, as markets become increasingly global, competition policy will need to be addressed in the more complex international context.

As biotechnology goods and services increasingly enter the marketplace, it will become important to allow these products to compete on an equal footing with existing products. It is, therefore, timely to ensure that competition and market access policies stay abreast of rapid advances in biotechnology and in business models. For instance, policies which impose non-tariff trade barriers, or non-market based government interventions (such as those designed to regulate prices and consumption of new biotechnology-derived drugs or agricultural products), have the potential to impede trade and competition -- in turn impeding biotechnology product access to markets and consumers and possibly denying consumers, especially those in the least develo ped nations, the benefits of trade in innovative human health and agricultural products.

Realising the benefits of biotechnology through sound trade, competition, and intellectual property policies: Competition, market access, and the WTO

Business	Government
The WTO's trade-related disciplines can benefit biotechnology -- but could require additional consistency, flexibility and transparency.
In response to the growing world interest in all trade-related issues relating to biotechnology, business could utilize various "issue task forces" to provide constructive analyses of issues and informative papers on the trade-related aspects of biotechnology. The SPS Agreement is a critical component of the important advances achieved in the WTO Uruguay Round negotiations to establish a rules-based system to avoid restrictions in international trade in agri-food products. The SPS Agreement fully sustains WTO members' rights to protect animal and plant life and health domestically as they see fit. In fulfilling these responsibilities, however, members have agreed that their SPS measures will be based on scientific principles and scientific evidence. Reliance on science and objective evidence is critical to preventing the use of health and safety regulations for protectionist purposes.	GoverBasic WTO principles and specific WTO agreements governing trade in goods, trade in services, Technical Barriers to Trade (TBT), agriculture, including sanitary and phytosanitary measures (SPS), investment, and trade-related intellectual property (TRIPs) are all applicable to, and can be used constructively by, governments concerning trade issues associated with biotechnology. WTO members, possibly through a WTO Working Party on Biotechnology, and based on the existing text of the SPS Agreement, could clarify the justification of any measure banning or limiting the importation or environmental release of a biotechnology product. Such a Working Party could also identify barriers and constraints to the trade-related aspects of biotechnology, and ensure WTO-consistent regulatory regimes for biotechnology.
Non-market based interventions have the potential to increase costs and constrain innovation in biotechnology
Business recognises and supports the efforts of governments and consumer groups to contain costs and provide efficient human services related to biotechnology. In the area of health care, for example, business is focused on lowering the cost of disease by investing in health care - through more effective treatments, more efficient delivery systems and continued gains in quality and productivity.	Competition, in both public and private sectors, will be a key to success in biotechnology. Through the WTO, members can ensure that science-based government interventions encourage trade and investment in innovative products and technologies such as those in biotechnology. Due to the potentially significant social benefits of products intended for human health, particularly medicines, governments should consider eliminating or reducing tariffs on these products. They could also explore the accelerated reduction of tariffs on other biotechnology-related products through sectoral initiatives such as the Chemical Tariff Harmonisation Agreement (CTHA).
Promoting standards that improve consumer welfare and the mutual recognition of product testing which can speed up the introduction of life saving innovations are important trade policies for biotechnology
Business, through full industry partnership, will continue to work with all relevant international standards-setting bodies and interested stakeholders to develop international and regional standards that are necessary for the development of biotechnology and the public's trust in it.	Governments should avoid mandating unnecessary technical standards -- but where they are warranted, governments can co-ordinate their efforts to harmonise biotechnology approval processes and regulatory standard setting. Regional and pluri-lateral forums, such as the Asia-Pacific Economic Cooperation (APEC) and the Free Trade Area for the Americas (FTAA) initiative, provide excellent fora where concrete progress can be made. Government-to-government cooperation can also facilitate the harmonisation of standards aimed at efficiently and accurately testing products derived from biotechnology.
Avoid trade distorting policies
The global business community can contribute to biotechnology trade issues resolution by analysing existing legal and policy barriers to trade in biotechnology- and making recommendations where appropriate.	Governments can avoid establishing non-tariff trade barriers to biotechnology products, services, and information by establishing clear science-based definitions and procedures for topics of concern -- such as the identification and assessment of risks to biodiversity in implementing the Biosafety Protocol. The following guidelines could be considered by governments: • That the burden imposed on trade is not excessive in relation to the risk reduction expected to be achieved -- as determined by an objective balancing of interests; • That the purpose served by the standard, import requirement, or approval process used to implement the measure, could not be achieved by actions with a smaller effect on trade.

 

Intellectual property (back up)

Intellectua l property protection is one of the central public policy pillars on which the knowledge-based industries of the 21st century rest. The incentives created by intellectual property rights are necessary to ensure continued innovation and to stimulate the investment of resources needed to market these innovations. These principles also apply to the development of the biotechnology industry, and therefore, adequate and effective protection and enforcement of intellectual property rights in biotechnology are a critical priority. Many biotechnology companies, for example, invest more than 45% of their annual income into R&D, meaning that nearly half their value is embedded in and exposed as intellectual capital.

By enacting and enforcing strong intellectual property protection related to biotechnology, countries are able to nurture their own research-based biotechnology industries, to attract foreign investment in biotechnology, and to provide state-of-the-art health care and environmental protection to their citizens. Moreover, as biotechnology becomes a principal foundation for economic growth and development, protecting these intellectual property rights can also provide countries with an opportunity to create high-value jobs for the 21st century.

The increasing commercial application of new technologies, such as biotechnology, leads not only to the development of new types of products and services, but also to new forms of distribution and methods of infringement. The range of benefits, promise, and fundamental nature of biotechnology also raises questions about basic concepts of patentability (in some countries) when it is applied to life forms and biological material. Intellectual property policy must therefore be mindful of the politically and ethically sensitive nature of some of the subject matter related to biotechnology.

The policy challenges presented by the increasingly genomic-centred approach to biology, in which information is the foundation, requires public policies that carefully address who owns what information, and who can have access to it on what terms. It also is important to remember that intellectual property rights not only protect ideas and inventions but also have an impact on transfer of technology. If effective patents for biotechnology inventions are not granted, there will be a potential inhibiting effect on the transfer of technology and, ultimately, on research and development. Governments should be cautious with measures such as compulsory transfer or compulsory licensing, which could result in the desired technology not being transferred or, at worst, not developed. Moreover, the absence of patents could diminish the willingness of companies to invest in a country; it may retard the climate for innovation generally in the country and it could lead to a loss of competitiveness in a knowledge-based society.

Realising the benefits of biotechnology through sound trade, competition, and intellectual property policies: intellectual property

Business	Government
Patents
Patents are crucial to almost all areas of biotechnology. They are the keys to translating inventions into concrete products and disseminating these new products widely. Patents provide the means to establish the necessary cycle of investment, research, innovation, and reinvestment that maximises the public benefits derived from biotechnology. Moreover, a patent related to the role of a gene does not confer ownership of the gene or invention to a company or university. The patent only protects the invention from theft by another economic actor, whether from the private or public sector. Major differences between countries still exist with respect to the patentability of biological materials: the U.S. allows organisms of all kinds (except humans) to be patented; Europe excludes patents on plant and animal varieties, and some developing countries reject all patents on biological materials. While remaining sensitive to genuine ethical concerns in biotechnology, business will continue to support the full implementation of the WTO TRIP agreement's minimum standards for patentable subject matter and to articulate appropriate standards of novelty, utility, and non-obviousness that should be applied to biotechnology-related inventions. Business will continue to provide information on the intellectual property implications of new technology.	Utilizing mechanisms like the WTO TRIPs Agreement and the WIPO agreements (updated), governments can continue to enforce effective and efficient protection of biotechnology patents. The following guidelines are relevant to the establishment of a balanced and realistic framework of accountability that: • respects international norms • allows free and fair competition • provides incentives for increased co-operation • deters and responds to infringements • promotes responsible business practices • does not create distortions in trade and investment • preserves an appropriate role for courts. Full patent protection for plant and animal inventions should be considered of critical importance by all WTO members. General exclusions - as for example, biotechnological inventions - clearly are not consistent with TRIPs or evolving global norms. Working together, governments and business should address the value of developing amendments to national/regional patent laws. Discrimination as to the place of biological or chemical invention, the field of technology, or whether the products are imported or locally produced should be avoided in government policy making.
Information products, e.g., databases
Business will contribute to WIPO work on info products and is working to determine the best approach to balance interests of companies (that invest in the development of databases) with the interests of those who rely on them.	Governments should continue to work, through the WIPO and consultative forums, toward adequate protection of intellectual property in databases.
Health care
Business and WHO dialogue can improve cooperation in a number of biotechnology-related areas, including intellectual property rights and technology transfer. Business and WHO also are exploring how innovative financing mechanisms, which respect intellectual property rights and include royalty payments to rights holders, can be used to tackle specific health problems, e.g., New Medicines for Malaria Venture Project. Business also will continue to promote awareness of the essential role of intellectual property protection in stimulating research and innovation in biotechnologies related to medicine and human health. Surveys and experience in countries such as Italy and Argentina show that restricting intellectual property rights does not result in substantially lower prices for pharmaceuticals or improved healthcare.	The definition of policies that affect intellectual property rights could be enhanced as inter-national organisations dealing with health policy and biotechnology, such as WHO, begin to work more closely with WIPO and WTO. Governments can help by ensuring co-ordination among their policies on health, biotechnology, and intellectual property. Better coherence and co-ordination among healthcare, biotechnology, and IP policy would ensure the cost problem in the healthcare sector is assessed with balance vis-à-vis intellectual property rights. Of special note is the fact that of the 306 products on the current WHO Model List of essential drugs for developing countries, only 15 [or five per cent] are currently under patent protection. This shows that the underlying issue is not patents constraining access, but the need for governments, multilateral institutions and industry to work together to strengthen health infrastructure - including the regulatory requirements for the distribution of medicines, under conditions that guarantee safe and effective use by patients in a clinically appropriate setting.
Business method patents
Business method patent applications that do not fulfi l the statutory criteria for patentability are a concern for business and should therefore be an important subject of dialogue within the business community.	The development of business method patents has grown rapidly in the United States and, currently, is being discussed globally. Recent landmark cases have highlighted the issue and its broad commercial implications, stimulating significant activities to protect biotechnology business methods perceived to be novel by the applicants. Rigorous application of statutory requirements for the granting and validity of patents is necessary to protect the quality of business method patents and to direct the activity to truly novel business areas and methods.
Indigenous and traditional rights
Increasing commercial interest in plant and animal species in industrialising countries, and in traditional cultural expressions and medicinal remedies, have raised questions of ownership of such resources previously assumed to be in the public domain. The existing system of IP rights has been criticised for allowing individuals or entities to appropriate commercially valuable resources such as plant varieties. On the other hand, the holders of these resources have started themselves exploring the concept of communal intellectual property rights. Business remains open to practical proposals for the protection of communal or indigenous intellectual property and will engage in constructive discussion. Careful distinctions, however, must be made between constructive proposals for a new system and changes that may undermine or subvert existing systems. The public domain should not be defined too narrowly or encroached upon without good reason.	Following the Convention on Biodiversity (CBD), several national governments have passed, or are considering enacting, legislation regulating access to biological resources. The WTO TRIPs Agreement provides useful guidelines for establishing measures regulating access to biological resources. Additionally, WIPO roundtables are useful forums, bringing together traditional rights holders, business, and other interested parties to engage in a dialogue on these issues.
Environment and genetic resources found in nature
Business believes that is important to advance the message that intellectual property rights are compatible with the protection of the environment and can promote the objectives of the CBD -- such as sustainable use of genetic resources and equitable sharing of benefits. As biological resources become scarcer and more valuable, the debate over the control of these resources is likely to become more intense. This is why business should take precautions to guard against perceptions that national sovereignty over biological resources is undermined by the patenting of such resources, or that patenting of genetic resources encourages unsustainable use and "biopiracy." Business believes that properly str uctured intellectual property rights can be compatible with the protection of the environment and can play a valuable role in advancing environmental goals.	Governments and business can coordinate their policies on the environment and on intellectual property to guard against legislation which, while protecting the environment, may have unintended impacts that could undermine intellectual property rights. The Biodiversity Convention, vis-à-vis patent law, is the most effective means of governing the issue of rights to source natural resources that may be important to biological diversity.

 

Investment policies (back up)

Because trade and investment are inherently intertwined, an integrated effort to liberalise trade and investment with the long-term goal of equal access to markets and technology can improve the long-term stability and expansion of global biotechnology. Expanding global biotechnology infrastructure includes growing Foreign Direct Investment (FDI) and trade between parent firms and their subsidiaries, or among entities in various strategic alliances. FDI is essential for global research and development; trade in products, services and information; and capital formation in biotechnology. It has a positive impact on growth, development, productivity and competitiveness for both international enterprises and host countries.

Realising the benefits of biotechnology through sound trade, competition, and intellectual property policies: investment policies

Business	Government
Protecting investment in biotechnology
Through Foreign Direct Investment (FDI), and an increasingly global web of strategic alliances to encourage new research, development, and commercial application, business can propagate critical technologies and skills around the world. Business recognises its responsibilities and self-interest to continue expanding the benefits of FDI in the global economy by promoting technical excellence, management skills, and overall value delivered to customers wherever it operates in the world. Business identification of and definition of "best practices" for companies operating in host countries can provide useful models that lead to enhancing the protection of the environment and human health.	Government safeguards on investor and host country biotechnology investment interests can improve the transfer and use of new technologies, create new market opportunities, promote innovation, and foster capital formation. Through multilateral investment rules or bil ateral investment treaties, governments can promote investment liberalisation and adopt minimum standards permitting investors to protect their investments, operate freely, and expand. Most-favoured nation clauses and national treatment provisions should be adopted as useful mechanisms for achieving these results. Performance requirements, such as compulsory local content and domestic sales; import prohibitions, quota or other restrictive measures; compulsory export performance; compulsory foreign currency earnings targets; exchange restrictions; compulsory local equity; and compulsory transfer of technology or information should be considered as potentially counter productive to objectives for increasing investment in biotechnology. Countries should take caution to ensure health, safety, or environmental standards are not lowered in order to retain or attract investment.
Government procurement
	Expansion of the WTO Government Procurement Agreement is a possible measure to prevent potential discrimination in government procurement of biotechnology products and services. WTO members which are not currently parties to this agreement should be encouraged to ratify it and to bring their procurement policies into accordance with the Agreement.

 

IV. Specific capacity-building programmes (SEE ANNEX ATTACHED) (back up)

A compilation of specific capacity-building programmes undertaken by and with industry related to biotechnology in developing countries

Roadmap annex (download pdf file)