“Expert knowledge; published research, existing research; stakeholder consultations; previous policy evaluations; the internet; outcomes from consultations; costing of policy options; output from economic and statistical modeling”.

This essay will explore the ontogenesis of ‘evidence based’ health policy making whereby according to Buse et al (2005, p.6) “health policy is assumed to embrace courses of action (and inaction) that affect the set of institutions, organizations, services and funding arrangements of the health system”. The essay will use various case study examples to highlight the roles played by evidence from research, social and bureaucratic point of view. The National Institute for Health and Clinical Excellence (NICE) in 1999 gives advices on the betterment of acceptable health guidelines for prevention and treatment of diseases in England and Wales.

The concept of policy making was not well know before as it these days. The two fundamental rationale for the establishment of health policy includes change in the public health policies and the health care policies ( Gray, p.95, 2001). Public health policy refers to improving the physical, social and biological surroundings. Health care policy refers to financial and administrative changes (Gray, p.95, 2001). Recently the policies are established based on evidence which was not the case before. Health policy making used to be more of recommendation or suggestion based in the past. Quantitative research evidence is likely to be more appreciated in delivering health services (Rycroft-Malone et al 2004).

The rise of evidence based healthcare took place in the 1990s in such a way that healthcare researchers, professionals and the health system adopted research evidence for research in clinical decision making. This rise was entitled as evidence ‘based healthcare movement’ (Davidoff et al. 1995; Sackett and Rosenberg 1995). The terminology evidence based policy has emerged from the notion of evidence based practice, both of them being ushered from evidence based medicine (EBM). The origin of EBM extended back to the mid 19th century in Paris (David L. Sackett 1997). EBM is widely used in the United Kingdom and in the United States by policy creators and therapist for promoting health and treating illnesses which signifies that EBM has both informative and scientific role .

The development of evidence based healthcare was driven up by research-practice gap which means that it took long time for the effective interventions to come into clinical practice and it also took a long time to discard the interventions which were ineffective (Antman et al 1992). The problems of these interventions were classified as underuse, overuse and misuse by the Institute of Medicine (1999). For patients suffering grom heart attack , thrombolytic treatment for myocardial infarction is used as a treatment which decreases the chances of the patient to get another heart attack and it also decreases the mortality rate (Walshe, 2006, p.480). Since it had an evidence of a decade or more it became the ‘poster child’ for the EBM movement. Example for overuse : merger of an organization due to difficulties in service quality, volume and monetory viability. Example of underuse : substitution of GP’s with health care professionals for providing the basic healthcare treatment. It generally involves the primary care and accident and emergency departments. Example of misuse : The fosterage and application of total quality management (TQM) (Walshe, 2007, p.481).

Development of basis for evidence involves 8 principles (Kelly et al 2007) :

Princliple 1: An assurance to the value of equity.

Principle 2: Acquiring an evidence based proposal.

Principle 3: Variance in technology.

Principle 4: Gradients and gaps.

Principle 5: Social values and its result.

Principle 6 and 7: Social structure and dynamics.

Principle 8: Clarifying partiality.

The new labour government which was formed in 1997 declared publically that ‘what matters is what works’, directing a reform from imaginary or visionary theorization to a more practical and technological approach in which a negligible role would be played by evidence of effect and impact (Cabinet Office 1999). A variety of reports and data were generated by the Cabinet office and National office for evidence in policy making and the centre for Evidence Based Policy and Practice has been supported by Economic and Social Research Council (ESRC) (Jennifer Dixon, p.481, 2006). For conducting standardized and organized survey of the best evidence on the effects of social and educational policies and practices, The Campbell Collaboration was established (The Campbell Collaboration 2003). In 1997 the Canadian Health Services Research Foundation (CHSRF) was established by the government funds and its aim is to assist evidence based decision making in various health sectors( Dixon, p.481, 2006).

Health policy process involves diverse universal bodies like World Health Organization, the World Bank and the World Trade Organization (Rob Baggot, p.199, 2007). Health Policy Process also comprises of the nation states and their alliances, the G8 group of nations being eminently prevailing. Health policy is also influenced by a wide range of non-governmental organizations which represents professional and sectional interests as well as take up a position from which they can examine bureaucratic policies and recommend policies of their own (Chris Ham et al 1995). Health policy in the UK is formulated by authorities outside its communal horizon. The three key elements include global influences, international institutions and organizations as well as multinational corporations (Rob Baggot, p.197, 2007).

Sackett and colleagues (1996) distinguishes EBM from EBP, and defines EBM as meticulous, accurate and wise application for the care of individual patients using current evidence in decision making whereas EBP is more about policy decisions for a group or bunch of people and not individual patients. In case of EBM randomized control trials are carried out which can raise certain arguments about outcomes, which is not the case with EBP. Black (2001) specifies that EBP in not merely a continuation of EBM but it differs qualitatively. The outcomes for policy generally depends on people’s thinking and judgemental behavior (Sackett et al 1996).There are two types of critical commentary for EBP, the first being ‘internal’ critical commentary, which focuses on the appropriateness of the diverse range of methods for gathering, analyzing and using evidence as a foundation for recognizing and enhancing policies ( Head n.d.).. The ‘external’ commentary is the second type of critical commentary which focuses on in what manner and place are the EBP benefaction more effective and the way in which they fit into the broad picture of policy debate and evaluation ( Head n.d.).

Morgan (2010) recognizes six factors that forms the base for the growth of evidence based health policy (EBHP). They are as follows :

The significance and advantage of having multi-disciplinary unit.

The requirement to possess ample evidence substructure to draw upon.

The indirect correlation between policy and research.

The demand for policy exertion to be locally sensitive.

The advantage of stakeholder engrossment.

Aid from the national Government.

These six factors yields a powerful foundation on which EBHP may be established (Morgan 2010). If these above mentioned factors are not satisfied in evidence based health policy then the consequence may be resistance of policy change.

According to Carolyn Tuohy (1999, p.14) reformation occurs at certain favourable times and not others and it involves not only health care arena but also the political system. In addition, Tuohy (1999, p.14) mentions that reformation is influenced by various parameters such as history, series of reform and evidence based choice and two other terms which she outlined as ‘institutional mix’ and ‘structural balance’. She describes ” ‘institutional mix’ as the eveness of power between three main forms of social control : state hierarchy or authority based control; professional collegiate institutions or skill based control and market or wealth based control. She refers ‘structural balance’ as the evenness of power between the three main stakeholders : the state, healthcare professionals and private financial interests”. Tuohy argues that reform of healthcare would be different across different countries and would be incremental most likely.

Evidence based health care focuses primarily on safety measures, analysis, detection and care of health related problems ( Haynes et al 1998). It is also important as well as necessary that the evidence based policy should be put into practice at the right pace, in the right position and in the right manner ( Haynes et al 1998). The outcome of the policies that are not designed properly or not tested may be detrimental (Tunis et al 2003). The data (i.e. efficacy and effectiveness) obtained for patients treatment is important but is not relevant for policy makers when it is considered for the constitution or implementation of regulations (Sturm et al 2002). Policy makers require evidence about healthcare proposals rather than efficacy and effectiveness data. According to Sturm et al (2002) randomized trials tend to be difficult in acquiring the information because RCT requires vast samples and a large unit, lesser duration would leave negligible time for conducting complex randomized studies and lastly there is a frequent change in the policy and healthcare arena. Ministers and civil servants must be willing to indulge themselves in the result monitoring which channels policy making (Ham, 1999, p.202). The clinicians and managers are not able to seek the evidence based practice because it is difficult to find the correct evidence for assisting decision making.

The group of people who have high expectations for high quality evidence includes the clinicians, physicians, health policy makers, common public, patients and health care administrators (Tunis et al 2003). Amongst all of them patients and physicians more concerned for high quality evidence. The patients and physicians are guided by medical professional socities for shaping medical conclusions (Tunis et al 2003).

Evans (2005) had analyzed the current reforms for over 11 European countries mentioned in the Journal of Health Policy Politics and Law. Evans (2005) observed that the reforms over the past 50 years were analogous , i.e. variation in the reform but ‘parallel development’. There are two apparent aspects of reform. The first aspect being the collection of payments for healthcare either by taxation or by mandatory social insurance which was linked to the World War II. The second aspect was the cost which was drive up by the highly motivated and intelligent opponents like the general practitioners and the pharmaceutical industries (Evans 2005).

Nutley et al (2002) points out that a very narrow range of evidence is used by the United Nations in the public sector, precisely for research and statistical data, evaluation of policies and proficient information. According to Maynard’s (2005) observation the inadequacy of transperancy in describing public policy goals, creating trade-offs and allineating incentives was due to the underpinning of poor evidence of reforms in Europe.

Evidence can be graded in terms of effectiveness in the National Service Framework on Mental Health (Department of Health ,1999)

Type I evidence – at least one good systematic review, including at least one randomised controlled trial.

Type II evidence – at least one good randomised, controlled trial.

Type III evidence – at least one well-designed intervention study without randomisation.

Type IV evidence – at least one well-designed observational study.

Type V evidence – expert opinion, including the opinion of service users and carers.

Subtler strategies would be required by the clinicians to alter their usual procedure as evidence in itself is not adequate (Dopson et al 2002). Systematic reviews of RCT’S are carried out in order to overcome inadequate evidence. These RCT’s were reinforced by the development of Cochrane Effective Practice and Organization of Care (EPOC) team.

Social values and political beliefs plays an important role in the development of evidence based health policy (Kelly et al 2007). A combination of social and political determinants of evidence on health would lead to a powerful response. Social beliefs produce injustice in health amongst the different classes of people. The rich and powerful population has got easy access to health services in comparision to the poor people who die at a younger age (Kelly et al 2005). The description and measurement of social determinants of health is a complex process. The psycho social model suggests that biasness based on the social status of an individual leads to stress which in turn produces a disease because of neuroendocrine response (Karasek 1996; Siegrist and Marmot, 2004; Evans and Stoddart 2003; Goldberg et al 2003). Environmental factors, proper sanitation and pure water, balanced diet, vaccination and good housing are essential for improving health (Graham et al 2004). Apart from social values and political belief situational factors like an earthquake or draught or some epidemic are also responsible for processing and implementation of policies (Buse et al 2005).

Case Studies :

Case Study 1 :

Topic: “European union policy on smokeless tobacco : a statement in favour of evidence based regulation for public health” (Bates et al 2003).

The significant aim of tobacco control campaigning is reduction of ailment and death from malignancy, cardiovascular disease and lung disease. Bates et al (2005) case study is about the ill effects due to tobacco and substitution of tobacco by smokeless tobacco. Tobacco contains an addictive substance called nicotine and because of nicotine’s addictive property many users are not able to quit smoking. Smokeless tobacco is considered to be les injurious as compared to smoking cigarette and there was a proof from Sweden which implies that it is used as a replacement for smoking and smoking cessation. This substitution is substantial argument which depicts that Sweden has the least tobacco related diseases.

It is difficult for chain smokers to quit smoking but an alternate option to it could be meagrely dangerous forms of nicotine replacement therapies (NRT) may also reduce harm. Proofs from Sweden implies that snus can be used as a replacement against smoking and it has half mortality rate in comparision to other EU. Chewing tobacco like guthka and paan are officially forbided in the EU but is eminently lethal and Bates et al (2003) suggestion might eradicate more products from the market. In the entire Europe, Sweden ranks least smoking prevalence for male and female. Snus is 90% less injurious as compared to cigarette and the mortality rate can be declined if we use it in a limited manner.

Smokeless tobacco is also harmful but to a lesser extent as compared to tobacco. For eg, the products made of smokeless tobacco in India and USA leads to oral cancer. In india the prime reason for oral cancer is smokeless tobacco. Diseases related to deaths in Europe due to smoking includes chronic obstructive pulmonary disease (COPD) and lung disease. However, smokeless tobacco do not produce these above mentioned diseases.

A complete ban on the products that are least injurious forms of smokeless tobacco should be substituted by a regulation for all products that are smokeless instead and the products that are seriously harmful to the society should be eliminated. This policy is fair, rational, beneficial for chain smokers, self control might be developed amongst the smokers, toxicity controls would be applied and it might prove to be beneficial worldwide.

Case Study 2:

Topic: “Translating research into maternal health care policy: a qualitative case study of the use of evidence in policies for the treatment of eclampsia and pre-eclampsia in South Africa:” (Daniels et al 2008).

Deaths of pregnant women and infants due to eclampsia and pre-eclampsia is one of the prime concern of the society. A qualitative case study approach was used in South Africa for analyzing the policy procedure. This case study explores about the usage of magnesium sulphate in curing pre-eclampsia and eclampsia in South Africa from 1970 to 2005 for which RCT’s and systematic analysis were carried out. Pre-eclampsia and eclampsia are one of the prime reasons for maternal and infant morbidity and mortality universally and this is the case generally in developing countries.

South Africa did not have a national maternal care policy before 1994 and hence every institution had its own guidelines for treating eclampsia and pre-eclampsia. In the mid 1990’s the democratic government changed and various health policy reforms took place which resulted in the formation of new national policies for maternal care. These policies were evidence based and evidence was generated from RCT’s and systematic reviews. The new government identified the health of females and children as a first concern and gave greater importance to it. The new government engaged academics in policy making from local networks in the National Department of Health. The local academics had much more understanding of evidence based practice and they used their strategies for policy process. The research identifies that affiliation amidst knowledge generation and application is critical thus research in healthcare policy making is also converted into an attempt to study.

If pregnant females are suffering from hypertension it may lead to her death. Hypertension was regarded to be the main cause of death for females in 1998. Evidence was generated from research by doing two multi-center RCT’s and three systematic reviews which shows that magnesium sulphate is effective in curing eclampsia and pre-eclampsia. Garner et al elucidates that in 1995 a survey was carried out which shows that magnesium sulphate was the most promising drug in curing eclampsia. This study thus uses evidence from research for developing guidelines and policies for maternal health.

Case study 3:

Topic: “The impact of China’s retail drug price control policy on hospital

expenditures: a case study in two Shandong hospitals”(Meng et al 2005).

This is a retrospective case study which deals with the cost reduction of retail drugs and medicines in two Shandong hospitals in China. For the past two decades the pharmaceutical expenditure in China is found to be more than the overall economic growth (Wei 1999). Pharmaceuticals contributed to about 44.4% of the total health cost in 2001 in China. Hence the Chinese government adopted a systematic approach in cutting down the costs of retail drugs. In order to bring a change in the retail costs of drugs the financial data and records were viewed and analyzed. For the examination of the changes in the cost tracer condition approach was used and cerebral infarction was the health issue. About 104 and 109 cases of cerebral infarction were selected from the two hospitals prior to reform as well as after reform. The usage of drug was measured on the basis of prescribed daily dose (PDD). The usage of the drug after reform can be viewed from the literature of the hospital. But it was observed that even after implementing the pricing policy in the two hospitals the usage of drugs increased rapidly.

In the provincial hospital there was a significant decrease in drug utilization whereas in municipal hospital there was a drastic increment of 50.1% even after reform. The provincial and municipal hospitals spent about 19.5% and 46.5% of the expenditure respectively on the top 15 drugs for treating cerebral infarction whose costs have been decided by the government and this took place after reformation. Allopathic drugs accounted for about 65% and 41% in the provincial and municipal hospitals respectively, though it did not had sufficient evidence for safety and efficacy in treating cerebral infarction.

The Chinese government brought about a change in its policies for drug pricing after 2002 so that a control over the pharmaceutical expenditure could be made. In order to overcome the conflicts in pharmacy settings, countries such as Sweden approached direct salary compensation of the pharmacists. The drugs which came under the category of Urban Health Insurance Scheme were set up by the State Commission of Development and Planning.

Policy makers have made a number of efforts in order to reduce the cost of pharmaceuticals. Various initiatives taken by the policy makers include preparation of a drug list, sharing costs for various schemes on health insurance, monitoring the GDP of hospitals and marking up regulations. The drug list includes two types of drug: Part A and Part B. Central government decides the cost of drugs for Part A and Part B but Part A drugs are generally used by the retailers whereas Part B drugs are used by the provincial government.

Utilization of the drug along with the price determines the drug expenditure hence there should be rational usage of drugs and the prescribers should use various strategies for controlling drug expenditure.

Conclusion :

According to Walt (1994, p.1) since ” health policy is about power and process…. It is concerned with who influences whom in the making of policy and how that happens”. Health policy is all about decision making, consistent approach, expertise knowledge and positive action and it is emanated by senior officials, directors, ministers and government bodies. Evidence based policy stimulates a crystal clear and parallel application of evidence in health policy framework. Policy making is influenced by various social values and political belief like racial minority, holy belief, statistical features, unhealthy conditions and contagious diseases.

Evidence based healthcare movement brought about a drastic change in the 1990’s for the development of health protocols. Scientific research or RCT’s play a key role in the development of EBP making. Incorporation of the contemporary nonpareil evidence would decline the hindrance between the creation of evidence and its appliance, and there would be an increment in the bulk of patients to whom the best treatment is offered. Bates case study is more of social belief because the public should co-operate with the health professionals to quit smoking. Even though he replaced tobacco by smokeless tobacco, it is still harmful to health.

From the above mentioned case studies it can be observed that not all the health policies are implemented because of issues related to the government or the common public. Policy makers in the earlier period were not aware of the health protocols in depth as they are today and this awareness among the policy makers is brought by reformation in the public health protocols and the healthcare protocols.

The support and approval from the government is mandatory for the implementation of the policy which indicates that political support plays more important role than the social support in developing policy.