At the outset of civilization, inventions could be freely reproduced by anyone; secrecy was the inventor’s only form of protection. Eventually, however, the lack of compensation for the innovator, coupled with a lack of public access and subsequent innovation delayed technological development and curtailed societal benefits. As a result, a social contract was established: inventors would disclose the invention allowing future reproduction, and society would grant them a monopolist/market exclusivity position for a certain period of time (currently harmonised at 20 years) in order to benefit from the commercial exploitation of the invention.

More recently, health and safety regulations have introduced time-consuming assessment processes prior to the release of some products, including in the biotech sector. As a consequence, critics claimed that the effective patent period had been reduced, and that therefore, the “contract” was no longer being honoured – to the detriment of the patent holders. In addition, some “regulated” innovations cannot be patented according to the usual criteria, although they involve ingenious activities, major investment, and provide solutions for public health or productive activities.

So far, at least two general approaches for compensation in such situations have been developed: patent term restoration and test data exclusivity. Under patent term restoration, first introduced in US law, a novel product can receive a patent extension of up to half of the “regulatory delay.” Test data exclusivity - adopted in the US, EU and China, among other countries, and included in several Free Trade Agreement negotiations - implies that data submitted by a first product applicant cannot be used for similar products presented by other applicants, within a defined protection period, without the permission of the right holder.

These measures were introduced to compensate patent holders for alleged deviations from the original “contract”. However, an inversed situation now seems to emerge for some biotechnology inventions. Genetically modified (GM) crops, in particular, may become a “perishable technology” due to certain sanitary regulations and/or natural processes. As detailed below, this jeopardises the half of the contract in which society should benefit, since no one profits from the invention after patents have expired.

Regulatory constraints

Currently, it takes roughly a decade to develop a GM crop and obtain its approval in multiple countries for “worldwide” trade clearance. Under the present system, a European Community authorisation, for example, is granted for a period of ten years. As a consequence, by the time the first authorisation period is over, patents on the product have expired or are about to expire. This would be the right moment for breeders and small seed companies to perform incremental innovations by incorporating the transgenic event (event) in local varieties, given that it is entering the public domain. Moreover, local companies already commercialising the event under a licence would have legitimate interests in keeping their business running when no patent royalty is due.

This way, the final incorporation of transgenic events in the public domain could partly offset the alleged “imbalance” between patent protection of biotech inventions and the sui generis protection of germplasm and breeders´ work – an issue that has been repeatedly raised in the FAO Commission on Genetic Resources for Food and Agriculture, among other fora – since, in the end, the events would switch from “proprietary inventions” to “ordinary genetic resources”.

In turn, this would also lower the price of seeds containing older, yet useful technologies for farmers with limited resources, while more competitive farmers would still adopt the newest events. A seed price reduction in exporting countries would further benefit importing countries by lowering the cost of food, biofuels, and other agro-commodities.

Yet another lively debate focuses on farmers´ right to save seeds from their harvest to reseed the next year, particularly in cases where the seed carries a transgenic event. Although countries hold diverse positions on the topic, the issue would become irrelevant after the patent expires. Therefore, biotechnology in the public domain would also lower the production costs of agro-commodities in more restrictive countries.

Unfortunately, all these potential benefits to global society are lost if the original developer does not apply for an authorisation renewal (currently, when the first authorisation period expires only the original applicant is able to request an extension). This pattern might continue if the original developer launches a similar but new GM crop with enhanced characteristics - and covered by new patents.
In addition, due to mergers and acquisitions, the commercial development of biotech crops is mostly concentrated in a small number of companies based in a few developed countries. Therefore, patent expiration is an important asset to counter this concentration and the “genetic divide” it leads to. Nevertheless, under the scenario depicted above, the market will continue to be concentrated regardless of patent expiration. This, in turn, will keep seed and food prices artificially high and lower crop biodiversity, with the associated risks to food safety.

Biological constraints

In addition to the situation described above, some GM crop technologies may expire due to biological evolution. Herbicide resistant crops, for instance, are useful as long as weeds do not evolve to also resist the herbicide; and insects can eventually evolve to resist the insect-control substances produced by some GM crops. Past experience with conventional and biotech crops suggests that the timescale for the spontaneous development of resistance to pesticides is around a decade. As in the previous case, when the time for an open market – and its implied benefits for global society – is approaching, the opportunity may be gone.

However, insect refugees, herbicide alternation/combination and other field management strategies have been developed to delay the emergence of resistant insects or weeds. Appropriately and continuously applied, such strategies can extend the lifetime of the relevant technologies for many decades.

A Role for Corporate Social Responsibility

Most of the revenues for society from the patent system are based on the disclosure of the invention and the subsequent possibility for anyone to exploit it. However, the disclosure of the invention - so far considered the only requisite to this end - is just not sufficient to fulfil the second half of the agreement (i.e. the later free commercial use of the invention) in the situations described above. Therefore, in order to balance their demands for test data protection and IP enforcement measures, companies should do their part to honour the “social agreement.” In particular, “corporate social responsibility” efforts could translate into actions to assure that the technology would really be available to the public after the exclusivity/monopolist period is over.

One line of action would be for the company to continue asking for renewals in “time limited” marketing approval systems, so the products could be marketed indefinitely by others with an interest in it (as long as the product was actually being marketed by others after the first renewal). This would not represent a huge expense since the new information requested is simple to produce; besides, due to its nature, this information is far easier to gather for the original developer than for other interested parties. Such a move need not preclude governments from reviewing their policies and allowing any interested party to apply for renewal, or to automatically grant a renewal following a decade free of incidents.

Another line of action for companies could be to encourage and support farmers in adopting strategies that delay the emergence of resistant weeds or insects, or any other avoidable threat to the lifetime of these technologies. Companies should effectively help combat the rise of adapted pests once they emerge in the field, even after they have lost commercial interest in the GM crops, herbicides, or insecticides involved.

An additional positive corporate policy might involve contributions to biotech “open source” initiatives, through providing genetic materials that have fallen in the public domain, test data, and information on expired patents. Since there is no unique International Patent Classification (IPC) code for identifying biotech products (a problem that is currently under study by the OECD), the identification of biotech patents is not straightforward. Of all the areas of biological innovation, agriculture is probably the most cross-sectorial field, as it affects food supply, the environment, health, energy, raw materials, and the general economy of most countries. Technologies applied to agriculture are also highly interdependent. Therefore, extraordinary efficacy would be expected when innovative tools are applied, and contributing to a “Biotech bazaar” would be another commendable endeavour for biotech companies.

Tools currently available to help keep a balance in the patent contract are applicable mostly during the patent extension period, and are not satisfactory to deal with the scenarios described. In contrast, corporate social responsibility policies like those proposed in this article would allow technologies to be more effectively incorporated into the public domain after patent expiration. In this way, the spirit of the original patent agreement would be fulfilled, which would be fair and beneficial for society worldwide.

Developing countries, which rely more on cheap technologies in the public domain, would derive most benefit from such corporate policies. In many cases, developing countries have adequately enforced international intellectual property agreements and they are sometimes under bilateral requests to incorporate additional enforcement measures. So far, however, they have received little reciprocity regarding technology transfer and genetic resources.

In addition, companies supporting the effective entry of agbiotech products into the public domain after patent expiration would also contribute to those developed countries that depend on developing countries for their food security, or those that seek to establish fair and healthy internal agricultural markets.

The authors are professors at the Argentine National Universities of Quilmes (Biotechnology School) and Buenos Aires (Centre of Interdisciplinary Studies on Industrial and Economic Law). They also serve as technical advisors at the Secretariat of Agriculture, Livestock, Fisheries and Food (Biotech Office and Markets Bureau). The information and views contained in this article are the sole responsibility of the authors and do not necessarily represent the opinions or policies of any organisation, institution or government.

The tests, conducted jointly by the Burkina National Agricultural Research Institute (INERA) and Monsanto, began in late June. The strains of Bt cotton, developed from local varieties, have been approved for both production and general sale. Burkina Faso’s National Biosecurity Agency has authorised 15,000 hectares for seed production.

Bt cotton is a second-generation product that contains a protein from the Bacillus thuringiensis bacteria, which shields it from specific lepidopteron pests such moths, butterflies and caterpillars. Burkina Faso experiences frequent droughts and insect infestations that sometimes damage up to 90 percent of the crop.

Researchers at INERA argue that Bt cotton requires only two pesticide treatments per season, opposed to the six to eight treatments for non-modified cotton. Using GM strains would therefore cut pesticide use by 60 percent, lowering costs by about 20 percent. Estimated total earnings, counting savings and increased revenue from higher yield, would increase by 90,000 CFA per hectare each season. In terms of costs, local farmers will be provided seeds at a discount; Monsanto will receive only 28 percent of the royalties from the seed sales.

Added revenue could boost Burkina Faso’s struggling economy, which is mainly based on subsistence agriculture and the cotton cash crop earnings that make up 50 percent of its exports. Burkina Faso is currently the top cotton producer in West Africa. It harvested over 660,000 tones in the 2006-2007 season. However, its harvests have fallen by over half this past year. Savings on the cost of insecticide treatment could possibly boost yield and remove barriers to international competitiveness, said Dr. Ouola Traoré, head of the Cotton Program at INERA.

However, safety concerns about GM products persist, and the use of cottonseed for edible oil in the West African region has raised some alarm. INERA researchers, however, are assuring the local population that tests are currently conducted not only to assess the effectiveness and financial viability of Bt cotton, but also to analyse its impact on the environment and its safety for animal and human consumption.

ICTSD reporting; 18 July 2008, “Burkina launches Monsanto GMO cotton to boost crop,” REUTERS; 12 July 2008, “Burkina Faso has commercialized Bt cotton,” AFRICA SCIENCE NEWS SERVICE.

The EU cited the 25 May decision as an example of its good faith efforts to comply with the WTO ruling from September 2006, which found that European countries illegally hindered the trade of GM foods (see Bridges Trade BioRes, 6 October 2006, http://www.ictsd.org/biores/06-10-06/story1.htm). The panel ruled that several aspects of the EU’s approval process for GM products violated the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). Specifically, it ruled against the EU’s failure to approve a number of biotech products (referred to as ‘product-specific measures’), and against national-level bans in several EU member states on the marketing and import of specific biotech products that had already been approved at the EU-wide level. The ruling was based on a complaint brought in 2003 by the US, Argentina and Canada.

The announcement confirming that Austria has lifted its national level ban came long after the original November 27, 2007 deadline originally set for compliance. While Austria will allow the import and processing of GM corn, it will not allow it to be planted in Austria.

The decision comes as a victory for the European Commission (EC), as the Austrian government has long been among the most resistant toward GM crops. Austria banned the import and processing of MON810 in June 1999 and T25 in April 2000 because of concerns on the effect on non-target organisms and the risk of cut-crossing GM maize with wild relatives.

Forcing individual Member states to comply with EU WTO obligations on biotech foods is a difficult process. Efforts by the European Commission to force the repeal of Austrian safeguard measures through a draft decision have been rejected by EU ministers in the Environment Council (see Bridges Trade BioRes, 19 January 2007, http://www.ictsd.org/biores/07-01-19/inbrief.htm#4.

On a related note, the UK has renewed discussion on relaxing EU rules on GM animal feed imports, citing rising food prices. At a 19 June summit in Brussels, UK Prime Minister Gordon Brown indicated the UK’s willingness to open its market to GM products after discussion with the Agricultural Biotechnology Council.

ICTSD reporting; “EU says Austria has lifted a ban on importing, processing genetically modified corn,” ASSOCIATED PRESS, 24 June 2008.

The 25 June report, entitled “Another inconvenient truth: How biofuel policies are deepening poverty and accelerating climate change,” urges the EU to reconsider its controversial target to make biofuels 10 percent of transport fuel by 2020 (see Bridges Trade BioRes, 18 April 2008, http://www.ictsd.org/biores/08-04-18/story2.htm and 25 January 2008, http://www.ictsd.org/biores/08-01-25/story1.htm). It claims the target has created a supply scramble in the South, exposing the most marginalised communities to land grabbing, exploitation and deteriorating food security. Higher food prices have pushed 105 million more people into poverty and have threatened the livelihoods of almost 300 million, Oxfam says.

Subsidies and tax exemptions for biofuels, as well as import tariffs in the EU and US that prevent the entry of feedstock, make it more profitable for farmers to grow biofuel instead of staple crops, the report finds. The clearing of forests for biofuel crops also has resulted in a net increase in greenhouse gas emissions. Oxfam estimates that the EU target could increase carbon emissions by 70 times by 2020 because of changing land use in exporting developing countries.

While the EU target is currently spurring a troubling agro-industrial model, the report argues, biofuels hold promise. There are opportunities in biodiesel for poor, rural areas — particularly in smallholder production crops such as oilseeds.

“The EU must ensure that transport emissions reductions do not come at the expense of poor people’s livelihoods,” Oxfam writes. “If not, it must accept that the ten percent target will not be reached sustainably, and therefore should not be reached at all.”

The report, “Another inconvenient truth: How biofuel policies are deepening poverty and accelerating climate change,” is available at: http://www.oxfam.org.au/media/files/AnotherInconvenientTruth.pdf.

ICTSD reporting; “Biofuel use ‘increasing poverty’,” BBC, 25 June 2008; “Biofuels pushing 30 million into poverty,” REUTERS, 25 June 2008.

WEBSITE: NONTARGET EFFECTS OF GENETIC MANIPULATION. The Nature Institute has unveiled a new website designed to set the public debate about genetic engineering upon a more accessible scientific foundation. Distilling a voluminous technical literature, the website gathers together — often in the researchers’ own words — information about both the intended and unintended consequences of transgenic experiments. The emerging picture tells a dramatic story — one that has scarcely begun to inform the public conversation to date. The website is part of The Nature Institute’s ongoing project on “The Nontarget Effects of Genetic Manipulation.” See the website at available at http://nontarget.org.

THE RIGHT TO FOOD AND THE IMPACT OF LIQUID BIOFUELS (AGROFUELS). By Asbjørn Eide, 2008. This study examines the impact of biofuel production on the enjoyment of the human right to adequate food and the fundamental right of everyone to be free from hunger. It follows from internationally recognised human rights that States have a core obligation to ensure freedom from hunger for all, and that any decisions which may negatively affect the enjoyment of the right to food should be reviewed. This has also been reiterated by the UN Human Rights Council in its resolution adopted on 22 May 2008 as the result of its special session on the food crisis from a human rights perspective. This paper therefore explores whether and to what extent biofuel production has undermined or is likely in the future to undermine or weaken the access to food for vulnerable people, and whether there are any overriding ethical concerns that can justify biofuel production even if it harms access to necessary and sufficient food to avoid hunger. Download at http://www.fao.org/righttofood/publi08/Right_to_Food_and_Biofuels.pdf.

“Traditional knowledge and intellectual property rights: A note on issues, some solutions and some suggestions.” By Krishna Ravi Srinivas. ASIAN JOURNAL OF WTO AND INTERNATIONAL HEALTH LAW AND POLICY, Vol. 3, No. 1, pp. 81-120, March 2008. This article discusses the issues in intellectual property protection for traditional knowledge. After discussing the definitional issues in traditional knowledge, it examines the current global debates on this issue. It identifies some solutions and provides an analysis of the solutions. It then highlights the North-South divide in this issue and the predicament of the south in finding an acceptable solution. It ends with some suggestions for arriving at a solution and argues that there is a need to go beyond intellectual property rights to resolve this issue. This paper is available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1140623.

TRENDS IN SUSTAINABLE DEVELOPMENT 2008-2009, 2008. By DESA, April 2008. The report finds that efforts to reduce poverty and improve food security in developing countries are hampered by declining support for strong agricultural growth, long considered a hallmark of successful poverty reduction strategies. Strong agricultural growth is four times more effective than growth in other sectors in benefiting the poorest half of the population. Download at http://www.un.org/esa/sustdev/publications/trends2008/.

The largest ever gathering on biosafety took place in Bonn from 12-16 May. Participants at the fourth meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP 4) under the Convention on Biological Diversity (CBD) discussed a range of issues, including transport and packaging of genetically modified organisms (referred to as living modified organisms, or LMOs, in the context of the Protocol), risk assessment and management and the inclusion of socio-economic considerations in biosafety policy-making. Most attention and debate, however, focused on the topic of a liability and redress regime.

Following immediately after COP-MOP-4, representatives from 191 countries participated in the ninth meeting of the Conference of the Parties (COP-9) to the CBD May 19 to May 30. Discussions focused on steps to conserve and sustainably manage the world’s biodiversity — increasingly recognised as being linked to other pressing concerns such as food security, climate change, and poverty alleviation. Indeed, in a message to the high-level segment of the meeting, UN Secretary-General Ban Ki-moon emphasised that biodiversity loss has “profound economic and human dimensions.” Achim Steiner, Executive Director of the UN Environment Programme, characterised biodiversity as “our economic foundation,” and noted that arranging the economic framework in a way that destroys the environment is like “burning money.”

Links to trade rules and economic policies also came up in the discussion of specific agenda items, including on two of the most difficult topics: negotiations on an international access and benefit-sharing (ABS) regime and addressing the potential impacts of biofuels on biodiversity.

Meeting on biosafety reaches political agreement on liability and redress

After four years of intensive negotiation, parties to the Cartagena Protocol did not meet the COP-MOP-4 deadline for the adoption of international rules and procedures for liability and redress of damage resulting from transboundary movements of LMOs.

Participants reached a significant political consensus, however, agreeing to work towards legally binding rules and procedures and establishing a timetable and a framework. Ursula Heinen, Deputy Minister for the German Federal Ministry of Food, Agriculture and Consumer Protection, stressed the importance of the outcome, stating that the “legally-binding rules and procedures for liability and redress will ensure the implementation of the Protocol in the next two years.”

The choice of instrument had been highly controversial, as was the approach regarding the rules on liability and redress. Many Parties — particularly developing countries — favour a civil liability approach, with rules establishing the possibility of compensation for damages. Other Parties propose an administrative approach — a mechanism allowing national authorities to hold biotechnology operators responsible for any damage to biodiversity. According to the compromise reached, Parties will work towards a legally binding regime based on the administrative approach, which would nevertheless contain a provision on civil liability. Parties, however, will be proceeding on a “nothing is agreed until everything is agreed” basis.

The instrument for liability and redress will be discussed in October 2010 at the next meeting of the COP-MOP in Nagoya, Japan. Two preliminary meetings, hosted by Malaysia and Mexico, will negotiate the details of the instrument.

CBD Parties agree on roadmap for access and benefit-sharing

After the last meeting of the Access and Benefit-sharing (ABS) Working Group made significant headway on the nature, scope, and objectives of an international regime (see Bridges Trade BioRes, 8 February 2008, http://www.ictsd.org/biores/08-02-08/story1.htm), the main issue for COP-9 was determining the next steps for the negotiations in view of the 2010 deadline. Discussions addressed the number of inter-sessional meetings of the Working Group, as well as the establishment of expert groups to discuss specific technical issues. Securing the necessary funding to conduct these meetings also formed part of the debate.

After discussions in a consultative group and informal consultations, Parties agreed that the ABS Working Group would meet three times prior to COP-10, with each meeting preceded by two days of informal consultations. In relation to the expert groups, the number and focus of upcoming meetings was still unclear at the time of press, but issues suggested by provider countries included questions on disclosure requirements, other measures to prevent misappropriation, and enforcement of judgments in user countries. Discussions on disclosure requirements — which would oblige patent applicants to disclose the use of any biological resources or associated traditional knowledge in their inventions, as well as to provide evidence of prior informed consent and equitable sharing of benefit — are also taking place in the Council for Trade-related Aspects of Intellectual Property Rights (TRIPS Council) in the World Trade Organisation (WTO) (see Bridges Trade BioRes, 20 March 2008, http://www.ictsd.org/biores/08-03-20/story3.htm).

Biofuels: A controversial new entrant in the CBD discussions

The relationship between biofuels and biodiversity, a new issue in the CBD context, proved the object of much discussion and controversy at COP-9. Pursuant to a recommendation by the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA), a note by the Executive Secretary of the CBD presented an overview of recent developments on biofuels, examined the potential positive and negative impacts of biofuels on biodiversity, and explored possible options for considering biofuels in the various programmes of work of the CBD.

Conclusions included the recognition of significant uncertainties on the impacts of biofuels on biodiversity, climate change, and livelihoods; of the variation of these impacts depending on how and where biofuels are produced and used; and of the importance of criteria, standards and certification developed to help identify and promote biodiversity-friendly biofuels. During discussions, several Parties called for action on biodiversity guidelines to ensure sustainability of biofuel production.

Sustainability criteria for biofuels — currently being developed by several countries and international organisations — are becoming a contentious trade topic (see Bridges Trade BioRes, 16 May 2008, http://www.ictsd.org/biores/08-05-16/story2.htm). At COP-9, concerns were also raised regarding references to mandatory standards for biofuels and compatibility with WTO rules. Towards the end of the meeting, biofuels remained one of the outstanding issues being considered by a high-level group, as well as being discussed by the Friends of the Chair on Agricultural Biodiversity.

The next issue of the BioRes will provide an update on this topic.

Additional resources

For daily reports and a summary of the negotiations, see the Earth Negotiations Bulletin, available at http://www.iisd.ca/news/news.html.

ICTSD reporting; CBD Press Releases. “Agreement Reached to Work towards a Legally Binding Instrument on Liability and Redress with regards to GMOs,” 16 May, 2008. “Governments Open Meeting in Bonn to take Action on Declining Biodiversity Resources,” 19 May 2008. “World Leaders Redouble their Commitment to Fulfil their Commitment of Heads of State and Government to Substantially Reduce the Rate of Loss of Biodiversity by 2010,” 28 May 2008.

Agricultural biotechnology, and particularly as it involves genetic modification, promises a number of important benefits. These include improving agricultural yields by increasing the resistance of crops to pests and enabling them to flourish in harsh natural environments, improving the productivity of farmers, and reducing pesticide use. While these benefits have largely been confined to the agricultural sector, and the immediate physical environment surrounding it, future technological advances may yield additional benefits, including the
development of foods that improve the health of consumers.

At the same time, concerns have been raised about the potential negative impacts of genetic modification. From an environmental perspective, critics note the possibility of cross-pollination and gene flows to traditional varieties and the inability of regulatory systems to adequately manage the trade in genetically modified (GM) seeds in a way that ensures their segregation from traditional
varieties. With respect to development impacts, scepticism has been expressed about the ability of agricultural biotechnology to fulfill its promise, given the trends such as lack of focus on the development of crops and traits that would meet the needs of resource poor farmers, difficulty of poorer groups in accessing technologies protected by patents, and the potential for biotechnology innovations to displace traditional agriculture.
Agricultural biotechnology thus poses particular challenges and opportunities for regulators and policy-makers. In itself, however, it is neither good nor bad: agricultural biotechnology is merely a tool that, in order to serve sustainable development, should be oriented towards economic, social, environmental and other public policy objectives. Countries must define their broad agricultural and development policy objectives and only then determine whether, how or to what extent the development and adoption of GM technologies and products can facilitate them. In this regard, there is a range of needs and priorities that regulators and policy-makers may have to take into account and balance in their choices.

These needs and priorities include promoting food security, reducing agricultural poverty, increasing access to global markets, improving environmental quality and the welfare of agricultural workers, protecting biodiversity, improving public health through safer or healthier foods and encouraging the domestic development of research and development. Establishing an adequate approach to agricultural biotechnology - addressing and balancing the different needs, priorities, and objectives in national, regional, and international instruments and policies - is a complex task.
Developing countries have particularly struggled to develop policies and regulations that consider and respond to the specific challenges and opportunities posed by agricultural biotechnology. The need for such policies and regulations, however, is mounting. For the most part, developing countries do not produce GM crops, but the importation of such crops and derived products is increasingly widespread. Efforts are thus underway to evaluate the implications on their respective economies, environment, and societies, and to adopt the policies that will orient the use of agricultural  biotechnology towards national, regional, and international sustainable development goals.
The objective of this report is to identify the particular policy and regulatory considerations and options for developing countries in connection with the development and commercialization of GM technologies and products. In addition, this report aims to examine some of the policy-making processes that facilitate the review of these considerations and options. After this introduction, Section II explores the distinctive issues raised by agricultural biotechnology in developing countries, and describes the different options and considerations for relevant regulations and policies. Section III provides case studies on the way a number of countries, both developed and developing, have addressed the various promotional and regulatory issues posed by GM technologies and products. Section IV then elaborates a series of frameworks that should enable policy-makers to think through the various policy issues and options raised by agricultural biotechnology. Section V focuses on public participation, an important component in the design, implementation and monitoring of an agricultural biotechnology framework.
Section VI concludes the paper with some final analysis and remarks.

This dialogue also seek to draw upon and build synergies between the activities of CIPP and ICTSD in the area of biotechnology - ICTSD’s project on Building Capacity on Trade and Biotechnology Policy-making aims to strengthen the capacity of developing countries to better formulate their biotechnology strategies and priorities as they relate to trade and sustainable development, and integrate them into national, regional and international policy-making processes. The CIPP’ project is examining how intellectual property can be rationally used by policy-makers, academics and others to improve socio-economic and political indicators and.

This dialogue focused on the challenge in making biotechnological innovation accessible to those most in need through three sessions: 1) access to agricultural and health-related products; 2) access to agricultural and health-related knowledge; 3) access to business & money for agricultural and health-related biotechnology.

Each topic was presented with short position statements by participants followed by an actively moderated discussion between the panelists and the other invitees. These discussions addressed a series of questions, including:
- to what is it that access is needed?;
- who needs such access?;
- how is access secured?;
- how are access needs priorized?; and
- how do we mitigate potential risks of access?

Since almost the beginning of human civilization, exploiting variation in the characteristics of the plant and animal genetic resources that are used for producing food and other agricultural products through breeding has been at the heart of efforts to increase and diversify agricultural production and productivity, enhance food security and incomes, and adapt farming to changing environmental conditions and social needs. Initially, this was achieved simply by selecting and reproducing preferred individuals or spontaneous variants, and indeed this practice remains important today as the basis for producing new generations of cultivated landraces and indigenous breeds. However, the crops, trees, livestock and fish that are farmed today have arisen largely from the introduction of scientific breeding at the beginning of the twentieth century, with the inclusion of crosses into breeding schemes prior to artificial selection and application of Mendel’s laws of inheritance to improve both simple and quantitative traits providing the foundations for modern genetics.

Today, thanks to continuing investments made in research and technology development, the process of producing improved varieties, clones, breeds and strains of agriculturally important species has become progressively more accurate, reliable and efficient. Nevertheless, one of the continuing technical constraints to more effective breeding is that selecting material with one or a combination of the characteristics required by farmers, foresters, industry and consumers still relies mainly on physical and agronomic attributes (phenotype). Some of these characteristics are influenced by the environment and are therefore not necessarily a good guide to the actual heritable genetic composition (genotype) of the material in question. Others may not be visible or may only be detected in mature plants and animals. Others again may be difficult or very costly to screen, and many characters such as drought tolerance and milk composition are controlled by a large number of genes whose mode of action as well as their interaction with each other and with various environmental triggers is mainly unknown. Improving the identification, selection and monitoring of specific characters in plants and animals through breeding schemes is therefore a critical need to secure future improvements in genetic resources for food and agriculture.

Since the first description of DNA structure over 50 years ago, scientists have made tremendous strides in identifying genes and gene functions, making it increasingly possible to detect genetic differences (DNA polymorphisms) for traits among individual plants and animals in a much more direct way, thereby assisting in the selection of desired traits. The central technology involved is molecular markerassisted selection (MAS), using sequences and/or banding patterns of DNA that have been shown through linkage mapping to be located in or near genes that affect the phenotype. These molecular markers can then be used to assist breeders track whether the specific gene or chromosome segment(s) known to affect the phenotype of interest is present in the individuals or populations of interest.

Although the ultimate goal of identifying the location, function and most favourable alleles of each gene through genome sequence and post-genomics research, and then using markers to select for economically important genes in breeding programmes, is still decades away, in recent years the use of MAS in agriculture has moved progressively from theory to practical application. In the process, it has generated both high expectations for increasing genetic progress through breeding, and raised a number of unresolved challenges. These include: selection of the most appropriate methods and tools for MAS among the many now available for the task at hand, analysing and managing the data produced given the increasing trend towards highthroughput techniques and the constraints imposed by suboptimal levels of resources currently attached to breeding and science and technology including biotechnology, and dealing with intellectual property rights, especially in developing countries.

Since its foundation, FAO has recognized that the biological basis for sustainable agricultural production, fighting hunger and world food security lies in the genetic resources used for food and agriculture. It has also recognized the enormous contributions that have been made to the improvement of these resources through both traditional and more advanced breeding, as well as the ever-increasing role played by biotechnology in improving breeding processes and products. As a knowledge organization, one of FAO’s major roles is to provide its Members and their institutions with factual, comprehensive and current information relevant to sound stewardship of crops, livestock, forestry and fisheries, thereby ensuring its availability as a global public good. This book, by providing a comprehensive description and assessment of the use of MAS for increasing the rate of genetic gain in crops, livestock, forestry and farmed fish, including the related policy, organizational and resource considerations, continues the Organization’s tradition of dealing with issues of importance to agricultural and economic development in a multidisciplinary and cross-sectoral manner. As such it is hoped that the information and options presented and the suggestions made will provide valuable guidance to scientists and breeders in both the public and private sectors, as well as to government and institutional policy- and decision-makers.