In fact, in their day-to-day decisions, of farming Lowe et al. In addition, consumers have also small-scale farmers already integrate biophysical factors with been sensitized by the initial mismanagement of some of those social, economic, cultural and environmental considerations to crisis, where they were sometimes wrongly reassured that food manage complex farming systems. This approach contrasts with was safe when it was not Rollin et al. They constitute the who, in increasing numbers, are turning to organic food and mis- perfect marketing strategy by creating differentiated, value-added trusting new food technologies such as GMO and irradiation, products, appealing to health a basic and universal human need although several studies have concluded that these new technologies and directed to a premium-price sector.
According to Rollin et al. Particularly, people in Europe are more reluctant in adopting functional foods than in Asia or North America Grunert, ; Siro, 3. Actually, a positive or negative the health lobby, advocates of sustainable development, rural and perception of a functional food product is based strongly on the countryside interests and food campaigners Lowe et al. In addition, there are ment, animal welfare and fair trade.
These consumer criteria may be strong differences between different population groups. For traduced, at the professional level, into four kinds of quality Boller example, women, people with higher income and married couples et al. As quality and social quality. Other tendencies include products engineered to Markovina et al. In fact, consumer 3. Functional foods willingness to compromise on the taste of functional foods for health is decreasing over time and constitutes a highly speculative As already mentioned, one of the most important reasons why and risky strategic option Verbeke, The trade.
According to Traill et al. Although consumers are reluctant to a small amount extra Traill et al. Even so, it is not clear if make major changes to their diets, they may be prepared to this amount is enough to cover the increase in production costs of substitute existing foods for healthier alternatives.
And functional some functional foods compared with their traditional counter- foods claim to be these alternatives. A functional food is 3.
- An Integrated Approach to New Food Product Development by R. Moskowitz
Organic products, though, have been claimed to be Table 1 also more respectful to the environment than their conventional Average prices of organic and conventional food products in the USA. Concerns focused initially on chemical pesticides, but Eggs Retail Dozen 1. Environmentalists Spinach Retail Pound 4. Indeed, consumers perceive foods labeled as organic to be Broccoli Wholesale market 16 count Thus, since the Pea Wholesale market 10 pounds Steurbaut, ; Woodhouse, Therefore, more research should be done on how the yields in organic farming can be 3.
Diet composition can have implications for land use and rural In addition to environmental aspects, price and organoleptic environment of a similar order of magnitude as those related to features of organic products must also be considered. In a similar population growth or changes in agricultural productivity way to what occurs with functional foods, several studies have Gerbens-Leenes et al. Indeed, as shown in Table 1 addition, conventional farmers in developed countries may also be USA data , there is a big difference between the prices of both affected, since they have to cope with the changing institutional kinds of products at the retailer level.
On governmental organizations. Moreover, it must be considered that since the economic recession has strongly affected the demand for organic products, Table 2 Product share and value of the organic market in the UK. Meanwhile, organic baby foods are the Beverages 7. This Fresh meat 4.
In this context, experts recommend adjusting the Breakfast cereals 1. Source: Soil Association For consumers, this philos- lated points of view , which may be easily seen in agricultural ophy would be traduced as providing healthy and environmentally- production models. Such models have been traditionally developed friendly foodstuff at an affordable price. For the food industry, it considering this isolated sector, in order to predict changes in would represent meeting the four kinds of quality described by agricultural inputs, outputs and prices across continental, national Boller et al.
All aspects or regional scale. However, these classic models have certain limi- of production are formalized in integrated production schedules, tations, such as the inability to provide spatially explicit predictions recognized by the relevant regional or national authorities and of land use change, but rather probabilities of particular changes in overseen by accredited independent bodies Patrie, In the regional or national distribution of different types of agriculture Europe, farmers in most countries apply integrated production Traill et al.
Furthermore, modern food chains have several methods, but in an unharmonized manner due to the absence of agents that were not considered by those classical models, such as a common legal base. The demand for safe, fresh, various factors on crop performance, such as irrigation, fertiliza- natural food is beginning to rely on imports.
This situation is cient way. Due to the heterogeneity of these data, including these also unfair for farmers in developed countries, who in most cases have inputs, different crop varieties and the particular properties of each frequently been paid a minute fraction of the market value of their geographic location, the pursuit of these models constitutes products. As far as new crop varieties are concerned, advances in a challenging issue for researchers all over the world. Supply chains have become more population extended and complex, and its intermediaries have taken on a more Concerning rural population, the traditional small and middle- prominent role between producers and consumers Lowe et al.
Thus, alternatives to countries had been largely established and maintained by industrial agriculture i. New institutions more explicitly the need for cross-subsidy of food producers. This situation brings about a rapid de-ruralization of subsidies in absolute terms ad per hectare than conventional farms. This middle point seems to have been network in Europe implies stabilizing populations in rural areas. Such an approach affected by off-farm income earning opportunities. This indicates also meets the integrated consideration of primary production that that cross-sectoral linkages and spatially explicit contexts should be was not possible with classical agricultural production models.
In considered when modeling and predicting production, consump- addition, integrated management also takes advantage of modern tion and investment decisions of rural households. Boller et al. Public and private standards and regulatory aspects as carried out a thorough review of integrated production a response to changes in the agri-food system systems principles and technical guidelines.
In this way, public regulations try to protect small ensuring a high level of consumer protection and restoring and producers and low-intensity farming. After that, an resources associated with the limited number of employees and entire new raft of legislation known as the hygiene package was small facilities Lowe et al. Thus, created to merge, harmonize and simplify the very detailed and farmers that obtain low-productivity crops, such as those dedicated complex hygiene requirements, which were previously scattered to organic farming Backer et al.
Public The need for new integrated approaches to minimize food risks subsidies are often aimed at the promotion of rural areas with has led to several consequences.
An Integrated Approach to New Food Product Development
Food companies must ensure full lower productivity Adamczyk-ojewska, , especially those traceability of food chains, which is known as farm-to-fork proce- with higher environmental and landscape value Torquati, Boggia, dures. Hammoudi et al. The supply chain. These requirements have forced food indus- complementarity of private and public standard. This issue is especially pertinent But perhaps one of the most important consequences for in the international trade context, as the effects of market distor- primary producers has been the proliferation of private standards.
GlobalGAP is products and the new product labels will contain more information a retailer-led private sector body that sets Good Agricultural Prac- to allow consumers to make more informed product choices. NHPs might be manufactured from plant- state and even beyond the structures established by the WTO based materials or other ingredients also commonly found in foods.
Food product design
Journal of Water and Land Development, 8, e To solve this problem, regulations on health claims are Almeida, C. Evaluation of economic and environmental impacts of becoming more rigid every day. New laws are being designed to integrated pineapple production in the State of Tocantins-Brazil.
Acta Horti- protect consumers from misleading and false marketing culturae, , e Functional foods development in the European market: a consumer perspective. Journal of Functional Foods, 3, e Kuhl, Health claims used in functional foods commerciali- Asselin, A. In Europe, demonstrate greater willingness to pay for functionality. American Journal of health claims process guidelines are described in the European Agricultural Economics, 87, e Atyukova, O. Sustainability of development of rural territories. Assessing the ecological Walter, On the other hand, organic foods production and soundness of organic and conventional agriculture by means of life cycle assessment LCA.
British Food Journal, , e Consumer response to food scandals and scares. Barrena, R. The link between household structure and the To sum up, it can be stated that public and private standards level of abstraction in the purchase decision process: an analysis using a func- tional food. Agribusiness, 26, e Due to the number Betoret, E. Functional foods development: of roles that they play throughout the agri-food chain, these trends and technologies.
Food Policy, 36, e For this reason, there are several kinds of organizations Boller, E. Bravin, E. Economics evalu- ation of apple production systems.
Acta Horticulturae, , e Final remarks Breustedt, G. Organic or conventional? Optimal dairy farming technology under the EU milk quota system and organic subsidies. Agri-food systems comprise complex technologic, social, Busch, L.
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The implications of global standards for national agricultural economic and environmental linkages that require integrated research. Bigman Ed. Wallingford: research approaches. Virgil, vigilance, and voice: agrifood ethics in an age of global- attitudes, as well as the growing preoccupations about living ization. The transformation of the global agrifood system. Rural Sociology, 69, e A new world of standards. Busch retailer. Consequently, food supply chains have had to give response to Dordrecht: Springer. Carvalho, M. However, there is some evidence pointing to the fact that Microbial biopesticides for integrated crop management: an assessment of those trends are the result of successful socially-oriented marketing environmental and regulatory sustainability.
Community and consumption. European Journal of Marketing, 31, e Modelling the impacts of policy on entry into organic farming: evidence from Danish-UK comparisons, consumers to change their shopping habits, and objective and e Land Use Policy, 28, e Moreover, since the economic European Commission.
Integrated crop management systems in the EU. An analysis of the EU organic sector. Falguera, V. Effect of UV irradiation on enzymatic to important consequences not only in different kinds of food activities and physicochemical properties of apple juices from different varie- production, but also in rural environment and population. Land use ties. Organic farming in Switzerland: opting in and opting out.
Agrarforschung Schweiz, 18, e Fischer, G. Global and case-based modeling of population Modeling those changes in land use presents several challenges, and land use change. Stern Eds. The success on these Food Ethics Council. Just knowledge?
Governing research on food and farming. A method to integrated production systems have met the balance point to determine land requirements relating to food consumption patterns. Agricul- optimize food production in farms. Estudio de Mercado. Observatorio del Consumo y la age. Cambridge: Polity Press. Financial consequences of cross-compliance Environment. Land Patrie, B. Analyses of health plan administrative practices for orphan drugs Recommendation could identify barriers to patient access to these products, for example, high rates of denied requests for prior approval of orphan drug prescriptions.
Systematic review of the evidence on the outcomes of off-label use of drugs for rare diseases Recommendation could encourage health plans to reimburse uses that are backed by evidence.
Adequate organizational structures and resources are the foundation for all other elements of a national policy. Chapter 3 discusses the mismatch between FDA 's resources and its responsibilities for review, guidance, and consultation. Chapters 3 , 4 , 5 , and 7 describe shortcomings in public and private resources for rare diseases research and product development.
The committee recognizes that increasing resources will be more difficult than ever given current and projected budget deficits, but it also notes the potential benefits of modest but well-placed additions of resources, for example, in the orphan products grants program.
As described in this report, some of the recommended investments in resource sharing and other infrastructure for rare diseases research will likely produce spillover benefits in the form of better understanding of common diseases. Resources include not only financing but also infrastructure and other support for rare diseases researchers and sponsors of orphan products. Several aspects of the recommendation for an NIH action plan Recommendation would target infrastructure, as would steps to promote resource sharing Recommendations and As with any complex process or any complex organization, the development of a coherent strategy for setting priorities, establishing goals, and assessing progress is itself complex.
None of these activities is cost-free, and as noted above, increases in federal funding face a very difficult environment. The creation of an NIH action plan Recommendation would focus attention on key aspects of rare diseases research and orphan product development and would draw other parties into the planning process. That action plan proposal is, however, focused on NIH. The recommendation below calls for a task force on rare diseases that would extend beyond NIH and contribute to a broader process of setting priorities and assessing progress.
The analyses presented in earlier chapters support the emphasis in the policy framework on a coordinated, collaborative approach to rare diseases research and product development. Today, each of the many public and private groups involved in rare diseases research and product development contributes to the common goals of understanding rare diseases and developing more effective means to prevent, diagnose, and treat them.
Nonetheless, gaps and duplication of effort are evident. Current collaborations and coordinated efforts are promising but fall short of what is possible. For example, at NIH , support by the individual institutes for research on rare diseases is difficult to track and therefore to assess and coordinate. The extent to which institute-specific research programs on rare and neglected diseases, unmet needs, and translational research will reinforce each other or work together is unclear. The NIH Office of Rare Diseases Research was established to coordinate and stimulate attention to the study of rare diseases, but it has limited resources and limited influence on the decisions of individual institutes.
Other concerns are that NIH study sections sometimes lack the guidance and resources to properly evaluate rare diseases research proposals and that NIH-funded research sometimes fails to meet FDA requirements for the approval of new drugs. Within FDA, the degree of consistency in review unit evaluations of orphan drugs is a concern and an issue for the new Associate Director for Rare Diseases in the Center for Drug Evaluation and Research.
In the private sector, patient advocacy groups often cooperate but also sometimes compete with each other in areas such as the development of patient registries and the pursuit of disease-specific congressional earmarks. Groups also vary in their experience in working with federal agencies, industry, and academic investigators. Pharmaceutical, biotechnology, and medical device companies have not traditionally worked with their peers, although some pharmaceutical companies are now developing precompetitive shared resources as discussed in Chapter 4.
The potential for medical devices to treat rare conditions is too often not considered. In an area defined by scarce resources, incremental increases in efficiency can have a disproportionately large impact. To encourage more collaboration and more efficient use of resources and build on the initiatives and recommendations discussed in earlier chapters, the committee proposes the creation of a time-limited task force on accelerating rare diseases research and product development.
This task force would bring together leaders of key groups. Recognizing that mobilizing such a task force might be difficult in the private sector and that high-level backing is crucial, the committee concluded that the responsibility for creating the task force should rest with the Secretary of Health and Human Services. Nearly all of the government agencies discussed here report ultimately to the Secretary. The objectives of the task force would be to promote, coordinate, monitor, and assess the implementation of NIH , FDA , and other public- and private-sector initiatives on rare diseases and orphan products and to support additional opportunities for public-private collaboration.
As envisioned here, the task force would bring together a network of stakeholders for accelerating research and development. In the public sector, it would draw on representatives of the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, the Department of Defense, and other relevant federal agencies.
From the private sector, it would recruit senior participants from the pharmaceutical, biotechnology, and medical device industries; patient advocacy groups; private foundations; and academic and other research institutions. International agencies and other relevant parties would be involved as appropriate. The committee does not envision the task force as open-ended. It might extend for 4 to 8 years, at which point alternatives would be evaluated. If this approach is to be effective, identifying and engaging the key public- and private-sector stakeholders is an important first step.
The involvement of international counterparts of federal agencies and private organizations will also be desirable, especially for many extremely rare diseases for which global research participation is critical. Creating a venue for meaningful interactions and decision making among these groups will require arrangements for convening task force meetings, conducting analyses and developing strategies, following through on recommendations, and creating a scheme for monitoring progress.
One major challenge will be identifying and sustaining a stable funding source for these administrative and analytic activities. The proposed task force would build on existing initiatives and partnerships as well as explore new arrangements. Another example is the potential for new public-private partnerships involving the federal government, industry, and patient advocacy groups to identify high-priority lines of research, jointly fund such research, and otherwise combine resources to accelerate the process of converting basic research findings into therapeutic discoveries and ultimately into effective preventive, diagnostic, and therapeutic measures.
Although research on individual disease pathogenesis and treatment is essential, this research can potentially be further accelerated by identifying networks of biological pathways that are common to clusters of rare diseases. The task force can also explore incentives and other strategies beyond those identified in this report to further engage the biopharmaceutical and medical device industry in various stages of the drug and device development process. As a result, rare conditions that are actually subsets of common conditions will become more frequent.
Researchers and companies studying these subsets will encounter the challenges of conducting research and developing products for small populations. Well-organized and appropriately funded collaborative initiatives to accelerate research and product development for rare diseases may provide models for a broader array of diseases in the future. A task force on rare diseases research and product development will not lessen the need for participants to improve their individual efforts and relationships as outlined in this report.
Individual improvement will strengthen the foundation for collaboration. In summary, the development of more effective drugs and medical devices for people with rare diseases represents an enormous challenge as well as a timely opportunity to improve public health. A successful response depends on further movement toward a more collaborative, coordinated, open, and sustained approach to rare diseases. Although the effort and investment needed are great, the stakes are high.
The potential benefits justify a renewed, high-level commitment to accelerating rare diseases research and product development.