Introduction
The occurrence of neural tube defects (NTDs) is usually brought about by a constellation of factors. Although it took lengthy periods before a relationship between the folic acid and NTDs was made, evidence has shown that there is significant association in the causation (Kadir & Economides, 2002, p. 255). In fact, the risk of concurrence and recurrence of the general abnormalities are minimized by the application of peri-conceptional folic acid supplementation. Although variations exist on the recommended dosages in several countries, improvements in health have been observed.
Relationship between peri‐conceptional folic acid intake and NTD
Intensification and increased calls for fortification have gained momentum in the last ten years aimed at enhancing the uptake of folic acid among the marginalized populations in the United States and Australia. While fortification has gained acceptance, critics of the approach argue that it is associated with masking of macrocytic anemia which is believed to cause irreversible brain damage to women, thereby interfering with the functioning of antagonistic folate drugs. Furthermore, lack of solid empirical evidence denoting the efficacy and benefits of utilizing the intervention curtailed the development of a policy framework regarding the drugs. Empirical evidence from across the world has denoted high benefits and efficiency with regards to the utilization of folic acid hence acting as a justification for the enactment of mandatory folic acid supplementation. A study conducted in Canada produced positive outcomes whereby the incidence of open NTDs reduced by more than half in the Nova Scotia after three years of fortification (Gucciardi et al, 2002, p. 342; Persad et al, 2002, p. 242).
In relation to empirical studies, several countries have developed policies in tandem with efficiency depicted in the current studies. Abraham and Webb (2000, p. 76), asserted that marginal improvements in terms of folic acid consumption must be reinforced with mandatory food fortification policies in line with other countries such as US and Canada. In addition, empirical studies in Chile, Canada and United States denoted an insignificant relationship between high folate levels with deficiencies in vitamin B12 (Oakley et al, 2004, p. 840). The Mandatory fortification program in Australia has received criticism with concerns over its tendency to introduce adverse risks to the general population. Introduction of a mandatory fortification of about 200 micrograms was preferred due to its success in the international arena. This was also in relation to the existing frameworks regarding the utilization of thiamine. In their argument, critics denote an increased level in cases of cancer growth at risk groups, interference with drug treatments and the unjustified exposure of more than 20 million Americans to excessive folic acid.
Policy options and the scientific and ethical dilemmas
Scientific evidence denoting an increased relationship between folate fortification and prevention of the occurrence of neural tube defects has been recorded in many studies. Mandatory fortification requires food manufacturers to provide additives such as minerals or vitamins to certain types of food. This is mainly undertaken in response to a widespread incidence of a certain public health problem that has a serious and significant impact on the economy and social life. For instance, the Australian government requires the addition of folic acid to all wheat flour at the manufacturing level. In an effort to stem down the incidences and prevalence of NTDs, the government further proposed the addition of 230-280 micrograms of folic acid in every 100 grams of wheat flour with an aim of achieving a residual level of about 200 micrograms (Food Standards Australia New Zealand (FSANZ), 2006, p. 4). The adoption of the mandatory fortification may prove effective in lowering the incidence levels of NTDs, but concerns about the health impact to the millions of a non targeted population has cast doubt about its usage. Although little health effects have been observed in this category of population, longitudinal studies are currently being done to ascertain the long term effects of the folic acid with regards to its reaction with the metabolic pathways.
Voluntary fortification refers to the approach where manufacturers are given the liberty to choose the type of vitamins and minerals they have to add to their food products provided they are spelt out in the public food standards code in the country. In view of the above, breakfast cereals are mainly given the liberty to add a wide variety of vitamins and minerals (McLennan & Podger, 1997, p. 76). This approach has taken root in many countries owing to lack of concrete evidence to occasion the embracement of mandatory fortification. This uncertainty has forced majority of the millers in the world to employ voluntary fortification as their preferred approach hence watering down earlier attempts to legislate mandatory fortification. Embracement of this approach has led critics to assert that manufacturers may fail to provide for the required vitamins and minerals thereby resulting in failure to confer preventive effects to the targeted groups. More importantly, retention of the right of choice may occasion part of the targeted population to avoid taking the required minerals resulting in the perpetuation of the status quo (Lancaster & Hurst, 2001, p. 53). Reliance on causal relationships on the effect of folate in reducing cardiovascular diseases has led some quarters to cast an ethical challenge on the adoption of mandatory and voluntary fortification (Wald et al, 2002, p. 1203).
In other instances, the embracement of a combined mandatory and voluntary fortification scheme has received appreciation from various stakeholders. The fact that it allows for the generation of products with different ingredients makes it useful to manufacturers and consumers since it retains the freedom of choice (Baggott, 2007, p. 12). Although it may not serve the purpose of reducing incidences of neural tube defects, it lowers the occurrence of uncertainties with regard to health outcomes in non-targeted groups.
Competing interests and values among various stakeholders
Owing to the dynamic nature of the food industry, regulation touching on the processing and eventual consumption of food stuffs has elicited heated debates with concerns over health and safety taking centre stage. Since the introduction of mandatory food fortification in Australia and New Zealand, several stakeholders have come out strongly to criticize the program (Barilai, 2003, p. 7). While its intention has been for the sake of health and safety of the citizenry from the start, several people read different messages from the laws and policies. Based on empirical studies conducted across several countries, the Australian government embraced mandatory fortification of bread and voluntary fortification for other products with the main aim of ensuring that women are able to access the minimum dosage levels required for healthy living (Lawrence & Worsley, 2007, p. 24). Taking into account the economic and social implications, the paradigm shift has been on stakeholders. As a matter of fact dissenting views and discontent has become the norm owing to dwindling fortunes for manufacturing companies.
The Australian government, just like any other authority, believes that the introduction of the mandatory policy is meant to curtail the occurrence of neural tube defects among the population. Based on factual and empirical evidence, the government has remained stead fast in advocating for the embracement of folic food supplements in the face of wide criticisms from different quarters. In addition, the government supports a holistic approach that entails the continuation of and expansion of existing programs aimed at maximizing the achievement of positive outcomes in the long term. In addition, the government remains committed in monitoring the safety of folic fortification. Health and regulatory authorities in Australia play a crucial role in ensuring that the impact of the mandatory fortification remains at stable levels aimed at protecting and safeguarding the populations’ health while restoring their confidence in products (Cloherty, 1998, p. 21). In addition, the governments’ commitment to expand its campaign has caused discomfort among manufacturers despite the availability of supporting epidemiological evidence.
Manufacturers were greatly affected by the shift in policy owing to liabilities occasioned by folic acid fortification. Basing their argument on potential litigation in cases of occurrence of adverse health effects, the flour milling companies have engaged the government in heated debates (Greenhalgh & Russell, 2002, p. 4). Supported by several research studies conducted within Australia and New Zealand, the flour millers argue that metabolism of excessive folic acid in the body is poorly understood and hence there is need to avoid interference with other body functions. Although scientific results show divergent values on the safety and benefits of folic acid, millers term the governments move as an inconsiderate move that failed to take into account technical limitations in providing for folic levels. In relation to a 2-3mg/kg of flour, dosing and verification remains a nightmare for millers (Chen et al, 2008, p. 24). More importantly, the complexity in terms of reaction exemplifies the difficulty that milers will have on meeting the legislative levels of foliate.
Buoyed by lack of a solid evidence of on efficacy and safety of folic acid, consumers are at loggerheads with the inception of the directive owing to potential health effects on fortification. Despite the fortification targeting women at their fertility age, the mandatory requirement for fortification of flour has exposed millions of Australians to unnecessary foliate levels. Consumers are discontented with the loss of choice with regard to flour and bread products (Lang et al, 2009, p. 25). Alternative products are unable to meet the demands hence forcing consumers to grapple with unnecessary foliate metabolism. In view of uncertainties occasioned by the mandatory fortification, there is need to listen to consumers voice thus allowing for voluntary fortification as in New Zealand and UK (Bridgman & Davis, 2000, p. 32). Delays in putting into action the policy is informed by the development of adverse reactions of folates within the body over time.
Relevance of the policy making theories
Theories guide the development of public policy through enhancing the understanding of linkages between different actors in a certain field. The utilization of structuralist theory, where the individual is usually taken to be of little value in the policy making process, finds some application in this study (Lang & Heasman, 2004, p. 26). While institutions or the economic impact to the overall society takes precedence, the theory takes some consideration on the effects of the policy at the individual level, albeit at a low level. The theory is relevant since it helps in the understanding of the reasons that led to the embracement of mandatory and voluntary fortification in various countries. Despite a glimmer picture depicted by scientific evidence, the government nevertheless adopted these policies hence putting uncertainties on the health of their citizens (Nestle, 2007, p. 21). More importantly, less value accorded to individuals may have led to the hasty adoption of these policies, while a closer look or antagonism from several quarters resulted in backtracking of the plans.
On the other hand, elite theory espouses that the decision making power during the policy making process is vested in a certain clique of individuals that are behind the financial support to policy discussion groups. In such a case, individuals’ usually sponsor research firms to conduct empirical studies with an aim of validating their argument. In this case study, the theory may have an application owing to the enormous information regarding the efficacy of folate unlike the scanty evidence on the contrary (Romano et al, 1995, p. 32). The propensity of pharmaceutical companies funding the initiative looks likely due to enormous profits that they are set to receive from the fortification of flour with folic acid.
The extent of the application of pluralism theory is high owing to the monopolistic nature of healthcare in majority of developed countries (Werler et al, 2005, p. 15). In Australia, mandatory fortification has largely become a government strategy to curb the impact of NTDs on the general population. In this case, the political framework and technocrats in the department of health developed a policy aimed at reducing the economic impact of NTDs. With support from interested stakeholders, the government was able to institute these policies without necessarily consulting all the concerned parties. The single handedness resulted in a widespread outcry from concerned parties such as consumers and manufacturers as espoused in the theory.
Justification for the policy response
The adoption of mandatory fortification has caused a stir in Australia and Europe. While its impact on preventing occurrence of NTDs in Australia has been emphasized, pundits believe that the move brings more harm than benefits (Reider, 1994, p. 9). More importantly, the impact of a socio-economic platform has cast doubts of its sustainability. In spite of high levels of effectiveness witnessed with regards to peri-conceptional folic acid supplementation particularly in randomized controlled trials, a similar trend has become elusive at the population level in Australia and western countries (Schwartz, 1987, p. 13). The observed disparity is mainly occasioned by several intertwined factors. Failure to start on supplementation at the right time is responsible for majority of NTDs cases.
Closure of the neural usually occurs between the third and fourth week. Taking into account that about half of the pregnancies are unplanned, majority of pregnant mothers are unaware of their status by that time (Kadir & Economides, 2002, p. 255). An increase in the number of women engaged on folic acid supplementation has increased over time owing to improved methods of communication, level of awareness and better diagnostic techniques of pregnancies (Walt, 1999, p. 17). More importantly, supplementation receives below par outcomes due to the high probability of decreased utilization by socially disadvantaged women. A general dislike amongst women particularly on the notion of taking folic acid as a tablet is mainly blamed on the negative outcomes in the utilization of folic acid (Kadir & Economides, 2002, p. 255).Taking into account the prevailing circumstances particularly with regard to the utilization of health seeking behavior and occurrence of pregnancies, it is justifiable to institute mandatory fortification. The availability of scanty information regarding its harmful effects on the human body should not curtail the rolling out of the program to populations experiencing high incidences of NTDs.
Conclusion
Periconceptual folic acid supplementation has resulted in the reduction of incidences of NTDs in several countries. Although several studies have depicted its efficacy, discontent remains high with regards to its wide application. Mandatory fortification is receiving wide usage in Australia despite western countries adopting voluntary fortification. The pluralism, elite and structuralist theories play a part in influencing the institution of these policies. In fact, pluralism plays a large role owing to the monopolistic nature of the health sector. Competing values and interests coupled with ethical dilemmas influence the eventual adoption of policies regarding health matters. The benefits conferred by mandatory fortification in terms of decreased incidences and causal relationship in lowering cardiovascular disorders justify its adoption in Australia. While the approach offers more benefits than harm, it is imperative to understand that the insignificant side effects might result in the development of a myriad of problems in the long term. Caution must be exercised and there is need to revisit the issue.
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