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1.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
2.  Diet and Physical Activity for the Prevention of Noncommunicable Diseases in Low- and Middle-Income Countries: A Systematic Policy Review 
PLoS Medicine  2013;10(6):e1001465.
Carl Lachat and colleagues evaluate policies in low- and middle-income countries addressing salt and fat consumption, fruit and vegetable intake, and physical activity, key risk factors for non-communicable diseases.
Please see later in the article for the Editors' Summary
Background
Diet-related noncommunicable diseases (NCDs) are increasing rapidly in low- and middle-income countries (LMICs) and constitute a leading cause of mortality. Although a call for global action has been resonating for years, the progress in national policy development in LMICs has not been assessed. This review of strategies to prevent NCDs in LMICs provides a benchmark against which policy response can be tracked over time.
Methods and Findings
We reviewed how government policies in LMICs outline actions that address salt consumption, fat consumption, fruit and vegetable intake, or physical activity. A structured content analysis of national nutrition, NCDs, and health policies published between 1 January 2004 and 1 January 2013 by 140 LMIC members of the World Health Organization (WHO) was carried out. We assessed availability of policies in 83% (116/140) of the countries. NCD strategies were found in 47% (54/116) of LMICs reviewed, but only a minority proposed actions to promote healthier diets and physical activity. The coverage of policies that specifically targeted at least one of the risk factors reviewed was lower in Africa, Europe, the Americas, and the Eastern Mediterranean compared to the other two World Health Organization regions, South-East Asia and Western Pacific. Of the countries reviewed, only 12% (14/116) proposed a policy that addressed all four risk factors, and 25% (29/116) addressed only one of the risk factors reviewed. Strategies targeting the private sector were less frequently encountered than strategies targeting the general public or policy makers.
Conclusions
This review indicates the disconnection between the burden of NCDs and national policy responses in LMICs. Policy makers urgently need to develop comprehensive and multi-stakeholder policies to improve dietary quality and physical activity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Noncommunicable diseases (NCDs)—chronic medical conditions including cardiovascular diseases (heart disease and stroke), diabetes, cancer, and chronic respiratory diseases (chronic obstructive pulmonary disease and asthma)—are responsible for two-thirds of the world's deaths. Nearly 80% of NCD deaths, close to 30 million per year, occur in low- and middle-income countries (LMICs), where they are also rising most rapidly. Diet and lifestyle (including smoking, lack of exercise, and harmful alcohol consumption) influence a person's risk of developing an NCD and of dying from it. Because they can be modified, these risk factors have been at the center of strategies to combat NCDs. In 2004, the World Health Organization (WHO) adopted the Global Strategy on Diet, Physical Activity and Health. For diet, it recommended that individuals achieve energy balance and a healthy weight; limit energy intake from total fats and shift fat consumption away from saturated fats to unsaturated fats and towards the elimination of trans-fatty acids; increase consumption of fruits, vegetables, legumes, whole grains, and nuts; limit the intake of free sugars; and limit salt consumption from all sources and ensure that salt is iodized. For physical activity, it recommended at least 30 minutes of regular, moderate-intensity physical activity on most days throughout a person's life.
Why Was This Study Done?
By signing onto the Global Strategy in 2004, WHO member countries agreed to implement it with high priority. A first step of implementation is usually the development of local policies. Consequently, one of the four objectives of the WHO Global Strategy is “to encourage the development, strengthening and implementation of global, regional, national and community policies and action plans to improve diets and increase physical activity.” Along the same lines, in 2011 the United Nations held a high-level meeting in which the need to accelerate the policy response to the NCD epidemic was emphasized. This study was done to assess the existing national policies on NCD prevention in LMICs. Specifically, the researchers examined how well those policies matched the WHO recommendations for intake of salt, fat, and fruits and vegetables, as well as the recommendations for physical activity.
What Did the Researchers Do and Find?
The researchers searched the Internet (including websites of relevant ministries and departments) for all publicly available national policies related to diet, nutrition, NCDs, and health from all 140 WHO member countries classified as LMICs by the World Bank in 2011. For countries for which the search did not turn up policies, the researchers sent e-mail requests to the relevant national authorities, to the regional WHO offices, and to personal contacts. All documents dated from 1 January 2004 to 1 January 2013 that included national objectives and guidelines for action regarding diet, physical exercise, NCD prevention, or a combination of the three, were analyzed in detail.
Most of the policies obtained were not easy to find and access. For 24 countries, particularly in the Eastern Mediterranean, the researchers eventually gave up, unable to establish whether relevant national policies existed. Of the remaining 116 countries, 29 countries had no relevant policies, and another 30 had policies that failed to mention specifically any of the diet-related risk factors included in the analysis. Fifty-four of the 116 countries had NCD policies that addressed at least one of the risk factors. Thirty-six national policy documents contained strategies to increase fruit and vegetable intake, 20 addressed dietary fat consumption, 23 aimed to limit salt intake, and 35 had specific actions to promote physical activity. Only 14 countries, including Jamaica, the Philippines, Iran, and Mongolia, had policies that addressed all four risk factors. The policies of 27 countries mentioned only one of the four risk factors.
Policies primarily targeted consumers and government agencies and failed to address the roles of the business community or civil society. Consistent with this, most were missing plans, mechanisms, and incentives to drive collaborations between the different stakeholders.
What Do These Findings Mean?
More than eight years after the WHO Global Strategy was agreed upon, only a minority of the LMICs included in this analysis have comprehensive policies in place. Developing policies and making them widely accessible is a likely early step toward specific implementation and actions to prevent NCDs. These results therefore suggest that not enough emphasis is placed on NCD prevention in these countries through actions that have been proven to reduce known risk factors. That said, the more important question is what countries are actually doing to combat NCDs, something not directly addressed by this analysis.
In richer countries, NCDs have for decades been the leading cause of sickness and death, and the fact that public health strategies need to emphasize NCD prevention is now widely recognized. LMICs not only have more limited resources, they also continue to carry a large burden from infectious diseases. It is therefore not surprising that shifting resources towards NCD prevention is a difficult process, even if the human cost of these diseases is massive and increasing. That only about 3% of global health aid is aimed at NCD prevention does not help the situation.
The authors argue that one step toward improving the situation is better sharing of best practices and what works and what doesn't in policy development. They suggest that an open-access repository like one that exists for Europe could improve the situation. They offer to organize, host, and curate such a resource under the auspices of WHO, starting with the policies retrieved for this study, and they invite submission of additional policies and updates.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001465.
This study is further discussed in a PLOS Medicine Perspective by Stuckler and Basu
The WHO website on diet and physical activity contains links to various documents, including a diet and physical activity implementation toolbox that contains links to the 2004 Global Strategy document and a Framework to Monitor and Evaluate Implementation
There is a 2011 WHO primer on NCDs entitled Prioritizing a Preventable Epidemic
A recent PLOS Medicine editorial and call for papers addressing the global disparities in the burden from NCDs
A PLOS Blogs post entitled Politics and Global HealthAre We Missing the Obvious? and associated comments discuss the state of the fight against NCDs in early 2013
The NCD Alliance was founded by the Union for International Cancer Control, the International Diabetes Federation, the World Heart Federation, and the International Union Against Tuberculosis and Lung Disease; its mission is to combat the NCD epidemic by putting health at the center of all policies
The WHO European Database on Nutrition, Obesity and Physical Activity (NOPA) contains national and subnational surveillance data, policy documents, actions to implement policy, and examples of good practice in programs and interventions for the WHO European member states
doi:10.1371/journal.pmed.1001465
PMCID: PMC3679005  PMID: 23776415
3.  An Australian childhood obesity summit: the role of data and evidence in 'public' policy making 
Background
Overweight and obesity in Australia has risen at an alarming rate over the last 20 years as in other industrialised countries around the world, yet the policy response, locally and globally, has been limited. Using a childhood obesity summit held in Australia in 2002 as a case study, this paper examines how evidence was used in setting the agenda, influencing the Summit debate and shaping the policy responses which emerged. The study used multiple methods of data collection including documentary analysis, key informant interviews, a focus group discussion and media analysis. The resulting data were content analysed to examine the types of evidence used in the Summit and how the state of the evidence base contributed to policy-making.
Results
Empirical research evidence concerning the magnitude of the problem was widely reported and largely uncontested in the media and in the Summit debates. In contrast, the evidence base for action was mostly opinion and ideas as empirical data was lacking. Opinions and ideas were generally found to be an acceptable basis for agreeing policy action coupled with thorough evaluation. However, the analysis revealed that the evidence was fiercely contested around food advertising to children and action agreed was therefore limited.
Conclusion
The Summit demonstrated that policy action will move forward in the absence of strong research evidence. Where powerful and competing groups contest possible policy options, however, the evidence base required for action needs to be substantial. As with tobacco control, obesity control efforts are likely to face ongoing challenges around the nature of the evidence and interventions proposed to tackle the problem. Overcoming the challenges in controlling obesity will be more likely if researchers and public health advocates enhance their understanding of the policy process, including the role different types of evidence can play in influencing public debate and policy decisions, the interests and tactics of the different stakeholders involved and the part that can be played by time-limited yet high profile events such as Summits.
doi:10.1186/1743-8462-2-17
PMCID: PMC1198217  PMID: 16029512
4.  The emergence of maternal health as a political priority in Madhya Pradesh, India: a qualitative study 
Background
Politics plays a critical role in agenda setting in health affairs; therefore, understanding the priorities of the political agenda in health is very important. The political priority for safe motherhood has been investigated at the national level in different countries. The objective of this study was to explore why and how maternal health became a political priority at sub-national level in the state of Madhya Pradesh in India.
Methods
This study followed a qualitative design. Data were collected by carrying out interviews and review of documents. Semi-structured interviews were carried out with twenty respondents from four stakeholder groups: government officials, development partners, civil society and academics. Data analysis was performed using thematic analysis. The analysis was guided by Kingdon’s multiple streams model.
Results
The emergence of maternal health as a political priority in Madhya Pradesh was the result of convergence in the developments in different streams: the development of problem definition, policy generation and political change. The factors which influenced this process were: emerging evidence of the high magnitude of maternal mortality, civil society’s positioning of maternal mortality as a human rights violation, increasing media coverage, supportive policy environment and launch of the National Rural Health Mission (NRHM), the availability of effective policy solutions, India’s aspiration of global leadership, international influence, maternal mortality becoming a hot debate topic and political transition at the national and state levels. Most of these factors first became important at national level which then cascaded to the state level. Currently, there is a supportive policy environment in the state for maternal health backed by greater political will and increased resources. However, malnutrition and population stabilization are the competing priorities which may push maternal health off the agenda.
Conclusions
The influence of the events and factors evolving from international and national levels significantly contributed to the development of maternal health as a priority in Madhya Pradesh. This led to several opportunities in terms of policies, guidelines and programmes for improving maternal health. These efforts were successful to some extent in improving maternal health in the state but several implementation challenges still require special attention.
doi:10.1186/1471-2393-13-181
PMCID: PMC3849759  PMID: 24079699
Maternal health; Maternal mortality; Political priority; Madhya Pradesh; India
5.  Translating research into policy: lessons learned from eclampsia treatment and malaria control in three southern African countries 
Background
Little is known about the process of knowledge translation in low- and middle-income countries. We studied policymaking processes in Mozambique, South Africa and Zimbabwe to understand the factors affecting the use of research evidence in national policy development, with a particular focus on the findings from randomized control trials (RCTs). We examined two cases: the use of magnesium sulphate (MgSO4) in the treatment of eclampsia in pregnancy (a clinical case); and the use of insecticide treated bed nets and indoor residual household spraying for malaria vector control (a public health case).
Methods
We used a qualitative case-study methodology to explore the policy making process. We carried out key informants interviews with a range of research and policy stakeholders in each country, reviewed documents and developed timelines of key events. Using an iterative approach, we undertook a thematic analysis of the data.
Findings
Prior experience of particular interventions, local champions, stakeholders and international networks, and the involvement of researchers in policy development were important in knowledge translation for both case studies. Key differences across the two case studies included the nature of the evidence, with clear evidence of efficacy for MgSO4 and ongoing debate regarding the efficacy of bed nets compared with spraying; local researcher involvement in international evidence production, which was stronger for MgSO4 than for malaria vector control; and a long-standing culture of evidence-based health care within obstetrics. Other differences were the importance of bureaucratic processes for clinical regulatory approval of MgSO4, and regional networks and political interests for malaria control. In contrast to treatment policies for eclampsia, a diverse group of stakeholders with varied interests, differing in their use and interpretation of evidence, was involved in malaria policy decisions in the three countries.
Conclusion
Translating research knowledge into policy is a complex and context sensitive process. Researchers aiming to enhance knowledge translation need to be aware of factors influencing the demand for different types of research; interact and work closely with key policy stakeholders, networks and local champions; and acknowledge the roles of important interest groups.
doi:10.1186/1478-4505-7-31
PMCID: PMC2809043  PMID: 20042117
6.  The Visible Politics of the Privatization Debate in Quebec 
Healthcare Policy  2012;8(1):67-79.
This paper analyzes the debates surrounding the privatization of health services financing in Quebec. The objective is to clarify policy-making processes with regard to this important issue and, more generally, to provide a realistic understanding of health-related policy processes in Canada. The analysis is based on a large and continuous sample of mass media and National Assembly debates on the question during the four-and-a-half years following the Chaoulli ruling of the Supreme Court of Canada. These data are used to test four hypotheses about relationships among the types of political actors involved, their policy preferences, the rhetoric they use and the anticipated policy effects they assert. The results are applied to a discussion of questions about the factors that influence the effectiveness of political communication.
PMCID: PMC3430155  PMID: 23968604
7.  Tobacco Industry Manipulation of Tobacco Excise and Tobacco Advertising Policies in the Czech Republic: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2012;9(6):e1001248.
Risako Shirane and colleagues examined the the Legacy Tobacco Documents Library and found evidence of transnational tobacco company influence over tobacco advertising and excise policy in the Czech Republic, a country with one of the poorest tobacco control records in Europe.
Background
The Czech Republic has one of the poorest tobacco control records in Europe. This paper examines transnational tobacco companies' (TTCs') efforts to influence policy there, paying particular attention to excise policies, as high taxes are one of the most effective means of reducing tobacco consumption, and tax structures are an important aspect of TTC competitiveness.
Methods and Findings
TTC documents dating from 1989 to 2004/5 were retrieved from the Legacy Tobacco Documents Library website, analysed using a socio-historical approach, and triangulated with key informant interviews and secondary data. The documents demonstrate significant industry influence over tobacco control policy. Philip Morris (PM) ignored, overturned, and weakened various attempts to restrict tobacco advertising, promoting voluntary approaches as an alternative to binding legislation. PM and British American Tobacco (BAT) lobbied separately on tobacco tax structures, each seeking to implement the structure that benefitted its own brand portfolio over that of its competitors, and enjoying success in turn. On excise levels, the different companies took a far more collaborative approach, seeking to keep tobacco taxes low and specifically to prevent any large tax increases. Collective lobbying, using a variety of arguments, was successful in delaying the tax increases required via European Union accession. Contrary to industry arguments, data show that cigarettes became more affordable post-accession and that TTCs have taken advantage of low excise duties by raising prices. Interview data suggest that TTCs enjoy high-level political support and continue to actively attempt to influence policy.
Conclusion
There is clear evidence of past and ongoing TTC influence over tobacco advertising and excise policy. We conclude that this helps explain the country's weak tobacco control record. The findings suggest there is significant scope for tobacco tax increases in the Czech Republic and that large (rather than small, incremental) increases are most effective in reducing smoking.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to 10 million by 2030. Faced with this global tobacco epidemic, national and international bodies have drawn up conventions and directives designed to control tobacco. For example, European Union (EU) Directives on tobacco control call for member states to ban tobacco advertising, promotion, and sponsorship and to adopt taxation policies (for example, high levels of tobacco excise tax) aimed at reducing tobacco consumption. Within the EU, implementation of tobacco control policies varies widely but the Czech Republic, which was formed in 1993 when Czechoslovakia split following the 1989 collapse of communism, has a particularly poor record. The Czech Republic, which joined the EU in 2004, is the only EU Member State not to have ratified the World Health Organization's Framework Convention on Tobacco Control, which entered into force in 2005, and its tobacco control policies were the fourth least effective in Europe in 2010.
Why Was This Study Done?
During the communist era, state-run tobacco monopolies controlled the supply of cigarettes and other tobacco products in Czechoslovakia. Privatization of these monopolies began in 1991 and several transnational tobacco companies (TTCs)—in particular, Philip Morris and British American Tobacco—entered the tobacco market in what was to become the Czech Republic. In this socio-historical study, which aims to improve understanding of both effective tobacco excise policy and the ways in which TTCs seek to influence policy in emerging markets, the researchers analyze publically available internal TTC documents and interview key informants to examine efforts made by TTCs to influence tobacco advertising and tobacco excise tax policies in the Czech Republic. A socio-historical study examines the interactions between individuals and groups in a historical context.
What Did the Researchers Do and Find?
The researchers analyzed 511 documents (dated 1989 onwards) in the Legacy Tobacco Documents Library website (a collection of internal tobacco industry documents released through US litigation cases) that mentioned tobacco control policies in the Czech Republic. They also analyzed information obtained from sources such as tobacco industry journals and data obtained in 2010 in interviews with key Czech informants (including a tobacco industry representative and a politician). The researchers' analysis of the industry documents indicates that Philip Morris ignored, overturned, and weakened attempts to restrict tobacco advertising and promoted voluntary approaches as an alternative to binding legislation. Importantly, while the internal documents show that Philip Morris lobbied for a specific excise tax (a fixed amount of tax per cigarette, a tax structure that favors the expensive brands that Philip Morris mainly markets), the European strategy employed at that time by British American Tobacco was to lobby for a mixed excise structure that combined an “ad valorem” tax (a tax levied as a proportion of price) and a specific tax, an approach that favors a mixed portfolio of tobacco brands. By contrast, the documents show that TTCs collaborated in trying to keep tobacco taxes low and in trying to prevent any large tax increases. This collective lobbying successfully delayed the tobacco tax increases required as a condition of the Czech Republic's accession to the EU. Finally, the interview data suggest that TTCs had high-level political support in the Czech Republic and continue actively to attempt to influence policy.
What Do These Findings Mean?
These findings provide clear evidence that Philip Morris and British American Tobacco (the two TTCs that have dominated the Czech market since privatization of the tobacco industry) have significantly influenced tobacco advertising and excise policy in the Czech Republic since 1989. The findings, which also suggest that this influence is ongoing, help to explain the Czech Republic's poor tobacco control record, which was reflected in a fall in the real price of cigarettes between 1990 and 2000. More generally, this study provides valuable insight into how TTCs might try to influence policy in other emerging markets. Improvements in global tobacco control, the researchers conclude, will be possible only if efforts are made to protect tobacco control policies from the vested interests of the tobacco industry, a principle enshrined in the WHO Framework Convention on Tobacco control, and if public and political attitudes to the industry shift.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001248.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about its Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance more information about the FCTC
Details of European Union legislation on excise duty applied to manufactured tobacco and on the manufacture, presentation and sale of tobacco products are available (in several languages)
The Legacy Tobacco Documents Library is a searchable public database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001248
PMCID: PMC3383744  PMID: 22745606
8.  Corporate Social Responsibility and Access to Policy Élites: An Analysis of Tobacco Industry Documents 
PLoS Medicine  2011;8(8):e1001076.
Gary Fooks and colleagues undertook a review of tobacco industry documents and show that policies on corporate social responsibility can enable access to and dialogue with policymakers at the highest level.
Background
Recent attempts by large tobacco companies to represent themselves as socially responsible have been widely dismissed as image management. Existing research supports such claims by pointing to the failings and misleading nature of corporate social responsibility (CSR) initiatives. However, few studies have focused in depth on what tobacco companies hoped to achieve through CSR or reflected on the extent to which these ambitions have been realised.
Methods and Findings
Iterative searching relating to CSR strategies was undertaken of internal British American Tobacco (BAT) documents, released through litigation in the US. Relevant documents (764) were indexed and qualitatively analysed. In the past decade, BAT has actively developed a wide-ranging CSR programme. Company documents indicate that one of the key aims of this programme was to help the company secure access to policymakers and, thereby, increase the company's chances of influencing policy decisions. Taking the UK as a case study, this paper demonstrates the way in which CSR can be used to renew and maintain dialogue with policymakers, even in ostensibly unreceptive political contexts. In practice, the impact of this political use of CSR is likely to be context specific; depending on factors such as policy élites' understanding of the credibility of companies as a reliable source of information.
Conclusions
The findings suggest that tobacco company CSR strategies can enable access to and dialogue with policymakers and provide opportunities for issue definition. CSR should therefore be seen as a form of corporate political activity. This underlines the need for broad implementation of Article 5.3 of the Framework Convention on Tobacco Control. Measures are needed to ensure transparency of interactions between all parts of government and the tobacco industry and for policy makers to be made more aware of what companies hope to achieve through CSR.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In the past, companies and multinational corporations were judged on the profits they made. Nowadays, though, much is made of corporate social responsibility (CSR). CSR is the commitment by business to behave ethically and to contribute to economic development while improving the quality of life of the workforce, their families, the local community, and society at large. Put simply, companies and corporations now endeavor to show that they have a positive impact on the environment, consumers, employees, and society in addition to making money for their shareholders. Large tobacco companies are no exception. British American Tobacco (BAT, the world's second largest publicly traded tobacco company), for example, began working on a wide-ranging CSR program more than a decade ago. Given that tobacco is responsible for an estimated 5.4 million deaths worldwide annually, this program was initially met with hostility and dismissed as an image management exercise. However, large parts of the investment and CSR communities now approve of BAT's CSR program, which has won numerous awards.
Why Was This Study Done?
But what do BAT and other tobacco companies actually hope to achieve through their CSR initiatives and how successful have they been in achieving these aims? Few studies have addressed these important questions. In particular, there has been little research into the extent to which tobacco companies use CSR initiatives as a form of corporate political activity that can help them gain “access” to policymakers and define the legitimate concerns and optimal alternatives of public policy (“issue definition”). Access is defined as taking place when policymakers consider the views of policy advocates such as tobacco company employees and is a crucial component of issue definition, which refers to the strategies adopted by bodies such as multinational corporations to influence the policy agenda by defining what issues public policy should concern itself with and how it should approach them. In this case study, the researchers explore whether BAT's CSR program works as a form of corporate political activity by systematically examining internal BAT documents made publicly available as a result of US litigation. Specifically, the researchers examine BAT's efforts through its CSR program to reestablish access with the UK Department of Health following the department's decision in the late 1990s to restrict contact with major tobacco companies.
What Did the Researchers Do and Find?
Using iterative searching, the researchers identified 764 documents in the Legacy Tobacco Documents Library (a large collection of internal tobacco company documents released as a result of US litigation cases) that contain information relevant to BAT's CSR strategies. Their analysis of these documents indicates that one of the key aims of the CSR program actively developed over the past decade by BAT was to help secure access to policymakers and shows how BAT used CSR to renew and maintain dialogue with policymakers at a time when contact between government and tobacco companies was extremely restricted. The documents also show that BAT employees used CSR initiatives as a means of issue definition to both optimize the probability of subsequent discussions taking place and to frame their content. Finally, the documents illustrate how BAT used its CSR program to expand the number of access points across government, thereby providing BAT with more opportunities to meet and talk to officials.
What Do These Findings Mean?
These findings suggest that CSR is a form of corporate political activity that potentially has important implications for public health given the documented impact of the political activity of tobacco companies in delaying and blocking health-related tobacco control policies. In practice, the impact of the political use of CSR is likely to be context specific and will depend on factors such as whether senior policymakers regard companies as reliable sources of information. Importantly, these findings underline the need for broad implementation of Article 5.3 of the World Health Organization's Framework Convention on Tobacco Control (FCTC), an international treaty that calls for the introduction of multiple measures to reduce tobacco consumption, including tobacco advertizing bans and relevant taxation policies. Article 5.3 aims to protect public-health policies on tobacco control from tobacco industry influence. The findings of this study indicate that implementation of Article 5.3 will require measures that ensure transparency in interactions between all parts of government and the tobacco industry and will need an increased awareness across government of what tobacco companies hope to achieve through CSR.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001076.
The Corporate Responsibility (CORE) coalition, an alliance of voluntary organizations, trade unions, and companies, maintains a Web site that contains useful material on corporate social responsibility
The European Coalition for Corporate Justice (ECCJ) promotes corporate accountability by bringing together national platforms of civil society organizations (including NGOs, trade unions, consumer advocacy groups, and academic institutions) from all over Europe
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages), details of the Framework Convention on Tobacco Control (in several languages), and guidelines for the implementation of Article 5.3 of the FCTC
The Framework Convention Alliance provides more information about the FCTC
For information about tobacco industry influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
doi:10.1371/journal.pmed.1001076
PMCID: PMC3160341  PMID: 21886485
9.  Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug 
Malaria Journal  2005;4:51.
Introduction
Research is an essential tool in facing the challenges of scaling up interventions and improving access to services. As in many other countries, the translation of research evidence into drug policy action in Tanzania is often constrained by poor communication between researchers and policy decision-makers, individual perceptions or attitudes towards the drug and hesitation by some policy decision-makers to approve change when they anticipate possible undesirable repercussions should the policy change as proposed. Internationally, literature on the role of researchers on national antimalarial drug policy change is limited.
Objectives
To describe the (a) role of researchers in producing evidence that influenced the Tanzanian government replace chloroquine (CQ) with sulfadoxine-pyrimethamine (SP) as the first-line drug and the challenges faced in convincing policy-makers, general practitioners, pharmaceutical industry and the general public on the need for change (b) challenges ahead before a new drug combination treatment policy is introduced in Tanzania.
Methods
In-depth interviews were held with national-level policy-makers, malaria control programme managers, pharmaceutical officers, general medical practitioners, medical research library and publications officers, university academicians, heads of medical research institutions and district and regional medical officers. Additional data were obtained through a review of malaria drug policy documents and participant observations were also done.
Results
In year 2001, the Tanzanian Government officially changed its malaria treatment policy guidelines whereby CQ – the first-line drug for a long time was replaced with SP. This policy decision was supported by research evidence indicating parasite resistance to CQ and clinical CQ treatment failure rates to have reached intolerable levels as compared to SP and amodiaquine (AQ). Research also indicated that since SP was also facing rising resistance trend, the need for a more effective drug was indispensable but for an interim 5–10 year period it was justifiable to recommend SP that was relatively more cost-effective than CQ and AQ. The government launched the policy change considering that studies (ethically approved by the Ministry of Health) on therapeutic efficacy and cost-effectiveness of artemisinin drug combination therapies were underway. Nevertheless, the process of communicating research results and recommendations to policy-making authorities involved critical debates between policy makers and researchers, among the researchers themselves and between the researchers and general practitioners, the speculative media reports on SP side-effects and reservations by the general public concerning the rationale for policy change, when to change, and to which drug of choice.
Conclusion
Changing national drug policy will remain a sensitive issue that cannot be done overnight. However, to ensure that research findings are recognised and the recommendations emanating from such findings are effectively utilized, a systematic involvement of all the key stakeholders (including policy-makers, drug manufacturers, media, practitioners and the general public) at all stages of research is crucial. It also matters how and when research information is communicated to the stakeholders. Professional organizations such as the East African Network on Malaria Treatment have potential to bring together malaria researchers, policy-makers and other stakeholders in the research-to-drug policy change interface.
doi:10.1186/1475-2875-4-51
PMCID: PMC1277846  PMID: 16242017
10.  Developing recommendations to improve the quality of diabetes care in Ireland: a policy analysis 
Background
In 2006, the Health Service Executive (HSE) in Ireland established an Expert Advisory Group (EAG) for Diabetes, to act as its main source of operational policy and strategic advice for this chronic condition. The process was heralded as the starting point for the development of formal chronic disease management programmes. Although recommendations were published in 2008, implementation did not proceed as expected. Our aim was to examine the development of recommendations by the EAG as an instrumental case study of the policy formulation process, in the context of a health system undergoing organisational and financial upheaval.
Methods
This study uses Kingdon’s Multiple Streams Theory to examine the evolution of the EAG recommendations. Semi-structured interviews were conducted with a purposive sample of 15 stakeholders from the advisory group. Interview data were supplemented with documentary analysis of published and unpublished documents. Thematic analysis was guided by the propositions of the Kingdon model.
Results
In the problem stream, the prioritisation of diabetes within the policy arena was a gradual process resulting from an accumulation of evidence, international comparison, and experience. The policy stream was bolstered by group consensus rather than complete agreement on the best way to manage the condition. The EAG assumed the politics stream was also on course to converge with the other streams, as the group was established by the HSE, which had the remit for policy implementation. However, the politics stream did not converge due to waning support from health service management and changes to the organisational structure and financial capacity of the health system. These changes trumped the EAG process and the policy window remained closed, stalling implementation.
Conclusions
Our results reflect the dynamic nature of the policy process and the importance of timing. The results highlight the limits of rational policy making in the face of organisational and fiscal upheaval. Diabetes care is coming on to the agenda again in Ireland under the National Clinical Care Programme. This may represent the opening of a new policy window for diabetes services, the challenge will be maintaining momentum and interest in the absence of dedicated resources.
Electronic supplementary material
The online version of this article (doi:10.1186/1478-4505-12-53) contains supplementary material, which is available to authorized users.
doi:10.1186/1478-4505-12-53
PMCID: PMC4177249  PMID: 25231603
Health care reform; Policy analysis; Quality of care; Type 2 diabetes mellitus
11.  A prospective multiple case study of the impact of emerging scientific evidence on established colorectal cancer screening programs: a study protocol 
Background
Health-policy decision making is a complex and dynamic process, for which strong evidentiary support is required. This includes scientifically produced research, as well as information that relates to the context in which the decision takes place. Unlike scientific evidence, this “contextual evidence” is highly variable and often includes information that is not scientifically produced, drawn from sources such as political judgement, program management experience and knowledge, or public values. As the policy decision-making process is variable and difficult to evaluate, it is often unclear how this heterogeneous evidence is identified and incorporated into “evidence-based policy” decisions. Population-based colorectal cancer screening poses an ideal context in which to examine these issues. In Canada, colorectal cancer screening programs have been established in several provinces over the past five years, based on the fecal occult blood test (FOBT) or the fecal immunochemical test. However, as these programs develop, new scientific evidence for screening continues to emerge. Recently published randomized controlled trials suggest that the use of flexible sigmoidoscopy for population-based screening may pose a greater reduction in mortality than the FOBT. This raises the important question of how policy makers will address this evidence, given that screening programs are being established or are already in place. This study will examine these issues prospectively and will focus on how policy makers monitor emerging scientific evidence and how both scientific and contextual evidence are identified and applied for decisions about health system improvement.
Methods
This study will employ a prospective multiple case study design, involving participants from Ontario, Alberta, Manitoba, Nova Scotia, and Quebec. In each province, data will be collected via document analysis and key informant interviews. Documents will include policy briefs, reports, meeting minutes, media releases, and correspondence. Interviews will be conducted in person with senior administrative leaders, government officials, screening experts, and high-level cancer system stakeholders.
Discussion
The proposed study comprises the third and final phase of an Emerging Team grant to address the challenges of health-policy decision making and colorectal cancer screening decisions in Canada. This study will contribute a unique prospective look at how policy makers address new, emerging scientific evidence in several different policy environments and at different stages of program planning and implementation. Findings will provide important insight into the various approaches that are or should be used to monitor emerging evidence, the relative importance of scientific versus contextual evidence for decision making, and the tools and processes that may be important to support challenging health-policy decisions.
doi:10.1186/1748-5908-7-51
PMCID: PMC3441348  PMID: 22656648
Evidence-based health policy; Policy decision making; Population-based colorectal cancer screening
12.  Searching for Truth: Internet Search Patterns as a Method of Investigating Online Responses to a Russian Illicit Drug Policy Debate 
Background
This is a methodological study investigating the online responses to a national debate over an important health and social problem in Russia. Russia is the largest Internet market in Europe, exceeding Germany in the absolute number of users. However, Russia is unusual in that the main search provider is not Google, but Yandex.
Objective
This study had two main objectives. First, to validate Yandex search patterns against those provided by Google, and second, to test this method's adequacy for investigating online interest in a 2010 national debate over Russian illicit drug policy. We hoped to learn what search patterns and specific search terms could reveal about the relative importance and geographic distribution of interest in this debate.
Methods
A national drug debate, centering on the anti-drug campaigner Egor Bychkov, was one of the main Russian domestic news events of 2010. Public interest in this episode was accompanied by increased Internet search. First, we measured the search patterns for 13 search terms related to the Bychkov episode and concurrent domestic events by extracting data from Google Insights for Search (GIFS) and Yandex WordStat (YaW). We conducted Spearman Rank Correlation of GIFS and YaW search data series. Second, we coded all 420 primary posts from Bychkov's personal blog between March 2010 and March 2012 to identify the main themes. Third, we compared GIFS and Yandex policies concerning the public release of search volume data. Finally, we established the relationship between salient drug issues and the Bychkov episode.
Results
We found a consistent pattern of strong to moderate positive correlations between Google and Yandex for the terms "Egor Bychkov" (r s = 0.88, P < .001), “Bychkov” (r s = .78, P < .001) and “Khimki”(r s = 0.92, P < .001). Peak search volumes for the Bychkov episode were comparable to other prominent domestic political events during 2010. Monthly search counts were 146,689 for “Bychkov” and 48,084 for “Egor Bychkov”, compared to 53,403 for “Khimki” in Yandex. We found Google potentially provides timely search results, whereas Yandex provides more accurate geographic localization. The correlation was moderate to strong between search terms representing the Bychkov episode and terms representing salient drug issues in Yandex–“illicit drug treatment” (r s = .90, P < .001), "illicit drugs" (r s = .76, P < .001), and "drug addiction" (r s = .74, P < .001). Google correlations were weaker or absent–"illicit drug treatment" (r s = .12, P = .58), “illicit drugs ” (r s = -0.29, P = .17), and "drug addiction" (r s = .68, P < .001).
Conclusions
This study contributes to the methodological literature on the analysis of search patterns for public health. This paper investigated the relationship between Google and Yandex, and contributed to the broader methods literature by highlighting both the potential and limitations of these two search providers. We believe that Yandex Wordstat is a potentially valuable, and underused data source for researchers working on Russian-related illicit drug policy and other public health problems. The Russian Federation, with its large, geographically dispersed, and politically engaged online population presents unique opportunities for studying the evolving influence of the Internet on politics and policy, using low cost methods resilient against potential increases in censorship.
doi:10.2196/jmir.2270
PMCID: PMC3799462  PMID: 23238600
Russia; search engine; drug dependence; policy
13.  Framing access to medicines in developing countries: an analysis of media coverage of Canada's Access to Medicines Regime 
Background
In September 2003, the Canadian government committed to developing legislation that would facilitate greater access to affordable medicines for developing countries. Over the course of eight months, the legislation, now known as Canada's Access to Medicines Regime (CAMR), went through a controversial policy development process and the newspaper media was one of the major venues in which the policy debates took place. The purpose of this study was to examine how the media framed CAMR to determine how policy goals were conceptualized, which stakeholder interests controlled the public debate and how these variables related to the public policy process.
Methods
We conducted a qualitative content analysis of newspaper coverage of the CAMR policy and implementation process from 2003-2008. The primary theoretical framework for this study was framing theory. A total of 90 articles from 11 Canadian newspapers were selected for inclusion in our analysis. A team of four researchers coded the articles for themes relating to access to medicines and which stakeholders' voice figured more prominently on each issue. Stakeholders examined included: the research-based industry, the generic industry, civil society, the Canadian government, and developing country representatives.
Results
The most frequently mentioned themes across all documents were the issues of drug affordability, intellectual property, trade agreements and obligations, and development. Issues such as human rights, pharmaceutical innovation, and economic competitiveness got little media representation. Civil society dominated the media contents, followed far behind by the Canadian government, the research-based and generic pharmaceutical industries. Developing country representatives were hardly represented in the media.
Conclusions
Media framing obscured the discussion of some of the underlying policy goals in this case and failed to highlight issues which are now significant barriers to the use of the legislation. Using the media to engage the public in more in-depth exploration of the policy issues at stake may contribute to a more informed policy development process. The media can be an effective channel for those stakeholders with a weaker voice in policy deliberations to raise public attention to particular issues; however, the political and institutional context must be taken into account as it may outweigh media framing effects.
doi:10.1186/1472-698X-10-1
PMCID: PMC2827390  PMID: 20044940
14.  Policy mapping for establishing a national emergency health policy for Nigeria 
Background
The number of potential life years lost due to accidents and injuries though poorly studied has resulted in tremendous economic and social loss to Nigeria. Numerous socio-cultural, economic and political factors including the current epidemic of ethnic and religious conflicts act in concert in predisposing to and enabling the ongoing catastrophe of accident and injuries in Nigeria.
Methods
Using the "policymaker", Microsoft-Windows® based software, the information generated on accidents and injuries and emergency health care in Nigeria from literature review, content analysis of relevant documents, expert interviewing and consensus opinion, a model National Emergency Health Policy was designed and analyzed. A major point of analysis for the policy is the current political feasibility of the policy including its opportunities and obstacles in the country.
Results
A model National Emergency Health Policy with policy goals, objectives, programs and evaluation benchmarks was generated. Critical analyses of potential policy problems, associated multiple players, diverging interests and implementation guidelines were developed.
Conclusions
"Political health modeling" a term proposed here would be invaluable to policy makers and scholars in developing countries in assessing the political feasibility of policy managing. Political modeling applied to the development of a NEHP in Nigeria would empower policy makers and the policy making process and would ensure a sustainable emergency health policy in Nigeria.
doi:10.1186/1472-698X-2-5
PMCID: PMC126243  PMID: 12181080
Nigeria; Injuries; Emergency; Health; Policy
15.  Framing health and foreign policy: lessons for global health diplomacy 
Global health financing has increased dramatically in recent years, indicative of a rise in health as a foreign policy issue. Several governments have issued specific foreign policy statements on global health and a new term, global health diplomacy, has been coined to describe the processes by which state and non-state actors engage to position health issues more prominently in foreign policy decision-making. Their ability to do so is important to advancing international cooperation in health. In this paper we review the arguments for health in foreign policy that inform global health diplomacy. These are organized into six policy frames: security, development, global public goods, trade, human rights and ethical/moral reasoning. Each of these frames has implications for how global health as a foreign policy issue is conceptualized. Differing arguments within and between these policy frames, while overlapping, can also be contradictory. This raises an important question about which arguments prevail in actual state decision-making. This question is addressed through an analysis of policy or policy-related documents and academic literature pertinent to each policy framing with some assessment of policy practice. The reference point for this analysis is the explicit goal of improving global health equity. This goal has increasing national traction within national public health discourse and decision-making and, through the Millennium Development Goals and other multilateral reports and declarations, is entering global health policy discussion. Initial findings support conventional international relations theory that most states, even when committed to health as a foreign policy goal, still make decisions primarily on the basis of the 'high politics' of national security and economic material interests. Development, human rights and ethical/moral arguments for global health assistance, the traditional 'low politics' of foreign policy, are present in discourse but do not appear to dominate practice. While political momentum for health as a foreign policy goal persists, the framing of this goal remains a contested issue. The analysis offered in this article may prove helpful to those engaged in global health diplomacy or in efforts to have global governance across a range of sectoral interests pay more attention to health equity impacts.
doi:10.1186/1744-8603-6-14
PMCID: PMC2936293  PMID: 20727211
16.  Policy initiation and political levers in health policy: lessons from Ghana’s health insurance 
BMC Public Health  2012;12(Suppl 1):S10.
Background
Understanding the health policy formulation process over the years has focused on the content of policy to the neglect of context. This had led to several policy initiatives having a still birth or ineffective policy choices with sub-optimal outcomes when implemented. Sometimes, the difficulty has been finding congruence between different values and interests of the various stakeholders. How can policy initiators leverage the various subtle mechanisms that various players draw on to leverage their interests during policy formulation. This paper attempts to conceptualise these levers of policy formulation to enhance an understanding of this field of work based on lived experience.
Methodology
This is a qualitative participant observation case study based on retrospective recollection of the policy process and political levers involved in developing the Ghana National Health Insurance Scheme. The study uses a four-concept framework which is agenda setting, symbols manipulation, constituency preservation and coalition building to capture the various issues, negotiations and nuanced approaches used in arriving at desired outcomes.
Results
Technical experts, civil society, academicians and politicians all had significant influence on setting the health insurance agenda. Each of these various stakeholders carefully engaged in ways that preserved their constituency interests through explicit manoeuvres and subtle engagements. Where proposals lend themselves to various interpretations, stakeholders were quick to latch on the contentious issues to preserve their constituency and will manipulate the symbols that arise from the proposals to their advantage. Where interests are contested and the price of losing out will leave government worse off which will favour its political opponent, it will push for divergent interests outside parliamentary politics through intense negotiations to build coalitions so a particular policy may pass.
Conclusions
This paper has examined the policy environment and the political leverages in retrospect at arriving at Ghana’s health insurance policy and design. New perspectives have been brought to the dynamics of the interactions of the 3 streams of problem, policy and politics. It provides lessons which suggest that in understanding the policy process, it is important that actors engage with the content as well as the context to understand viewpoints that may be expressed by interest groups. This will empower policy proponents to achieve easier results and limit the frustrations associated with the policy process. There are no straight and determined pathways for achieving outcomes so appreciating the evidence and basis for design, negotiation process and building coalitions along the way are skills to be mastered.
doi:10.1186/1471-2458-12-S1-S10
PMCID: PMC3381692  PMID: 22992292
17.  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 
Background
Few empirical studies of research utilisation have been conducted in low and middle income countries. This paper explores how research information, in particular findings from randomised controlled trials and systematic reviews, informed policy making and clinical guideline development for the use of magnesium sulphate in the treatment of eclampsia and pre-eclampsia in South Africa.
Methods
A qualitative case-study approach was used to examine the policy process. This included a literature review, a policy document review, a timeline of key events and the collection and analysis of 15 interviews with policy makers and academic clinicians involved in these policy processes and sampled using a purposive approach. The data was analysed thematically and explored theoretically through the literature on agenda setting and the policy making process.
Results
Prior to 1994 there was no national maternal care policy in South Africa. Consequently each tertiary level institution developed its own care guidelines and these recommended a range of approaches to the management of pre-eclampsia and eclampsia. The subsequent emergence of new national policies for maternal care, including for the treatment of pre-eclampsia and eclampsia, was informed by evidence from randomised controlled trials and systematic reviews. This outcome was influenced by a number of factors. The change to a democratic government in the mid 1990s, and the health reforms that followed, created opportunities for maternal health care policy development. The new government was open to academic involvement in policy making and recruited academics from local networks into key policy making positions in the National Department of Health. The local academic obstetric network, which placed high value on evidence-based practice, brought these values into the policy process and was also linked strongly to international evidence based medicine networks. Within this context of openness to policy development, local researchers acted as policy entrepreneurs, bringing attention to priority health issues, and to the use of research evidence in addressing these. This resulted in the new national maternity care guidelines being informed by evidence from randomised controlled trials and recommending explicitly the use of magnesium sulphate for the management of eclampsia.
Conclusion
Networks of researchers were important not only in using research information to shape policy but also in placing issues on the policy agenda. A policy context which created a window of opportunity for new research-informed policy development was also crucial.
doi:10.1186/1478-4505-6-12
PMCID: PMC2645395  PMID: 19091083
18.  Players and processes behind the national health insurance scheme: a case study of Uganda 
Background
Uganda is the last East African country to adopt a National Health Insurance Scheme (NHIS). To lessen the inequitable burden of healthcare spending, health financing reform has focused on the establishment of national health insurance. The objective of this research is to depict how stakeholders and their power and interests have shaped the process of agenda setting and policy formulation for Uganda’s proposed NHIS. The study provides a contextual analysis of the development of NHIS policy within the context of national policies and processes.
Methods
The methodology is a single case study of agenda setting and policy formulation related to the proposed NHIS in Uganda. It involves an analysis of the real-life context, the content of proposals, the process, and a retrospective stakeholder analysis in terms of policy development. Data collection comprised a literature review of published documents, technical reports, policy briefs, and memos obtained from Uganda’s Ministry of Health and other unpublished sources. Formal discussions were held with ministry staff involved in the design of the scheme and some members of the task force to obtain clarification, verify events, and gain additional information.
Results
The process of developing the NHIS has been an incremental one, characterised by small-scale, gradual changes and repeated adjustments through various stakeholder engagements during the three phases of development: from 1995 to 1999; 2000 to 2005; and 2006 to 2011. Despite political will in the government, progress with the NHIS has been slow, and it has yet to be implemented. Stakeholders, notably the private sector, played an important role in influencing the pace of the development process and the currently proposed design of the scheme.
Conclusions
This study underscores the importance of stakeholder analysis in major health reforms. Early use of stakeholder analysis combined with an ongoing review and revision of NHIS policy proposals during stakeholder discussions would be an effective strategy for avoiding potential pitfalls and obstacles in policy implementation. Given the private sector’s influence on negotiations over health insurance design in Uganda, this paper also reviews the experience of two countries with similar stakeholder dynamics.
doi:10.1186/1472-6963-13-357
PMCID: PMC3849368  PMID: 24053551
Health insurance; Stakeholder analysis; Context analysis; Policy reform; Health financing; Case study; Uganda
19.  Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control 
PLoS Medicine  2012;9(6):e1001249.
Heide Weishaar and colleagues did an analysis of internal tobacco industry documents together with other data and describe the industry's strategic response to the proposed World Health Organization Framework Convention on Tobacco Control.
Background
In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.
Methods and Findings
The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry's strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO's mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.
Conclusions
TTCs' efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die worldwide from tobacco-related causes and, if current trends continue, annual deaths from tobacco-related causes will increase to 10 million by 2030. In response to this global tobacco epidemic, the World Health Organization (WHO) has developed an international instrument for tobacco control called the Framework Convention on Tobacco Control (FCTC). Negotiations on the FCTC began in 1999, and the international treaty—the first to be negotiated under the auspices of WHO—entered into force on 27 February 2005. To date, 174 countries have become parties to the FCTC. As such, they agree to implement comprehensive bans on tobacco advertising, promotion, and sponsorship; to ban misleading and deceptive terms on cigarette packaging; to implement health warnings on tobacco packaging; to protect people from tobacco smoke exposure in public spaces and indoor workplaces; to implement taxation policies aimed at reducing tobacco consumption; and to combat illicit trade in tobacco products.
Why Was This Study Done?
Transnational tobacco corporations (TTCs) are sometimes described as “vectors” of the global tobacco epidemic because of their drive to maximize shareholder value and tobacco consumption. Just like conventional disease vectors (agents that carry or transmit infectious organisms), TTCs employ a variety of tactics to ensure the spread of tobacco consumption. For example, various studies have shown that TTCs have developed strategies that attempt to limit the impact of tobacco control measures such as the FCTC. However, to date, studies investigating the influence of TTCs on the FCTC have concentrated on specific countries or documented specific tactics. Here, the researchers undertake a comprehensive review of the diverse tactics employed by TTCs to undermine the development of the FCTC. Such a review is important because its results should facilitate the effective implementation of FCTC measures and could support the development of future tobacco control initiatives and of global initiatives designed to control alcohol-related and food-related disease and death.
What Did the Researchers Do and Find?
The researchers analyzed documents retrieved from the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) dealing with the strategies employed by TTCs to influence the FCTC alongside data from the websites of industry, consultancy, and other organizations cited in the documents; the official records of the FCTC process; and previous studies of tobacco industry efforts to influence the FCTC. Their analysis reveals that the strategic response of the major TTCs to the proposed FCTC was two-fold. First, the TTCs developed a series of arguments and “frames” (beliefs and ideas that provide a framework for thinking about an issue) to challenge the FCTC. Core frames included claiming that the FCTC would have damaging economic consequences, questioning WHO's mandate to develop a legally binding international treaty by claiming that tobacco was not a cross-border problem, and presenting corporate social responsibility (the commitment by business to affect the environment, consumers, employees, and society positively in addition to making money for shareholders) as an alternative to the FCTC. Second, the TTCs employed multiple strategies to promote and increase the impact of these arguments and frames, such as targeting FCTC delegations and enlisting the help of diverse allies including media outlets and scientists.
What Do These Findings Mean?
These findings illustrate the variety and complexity of the tobacco industry's efforts to undermine the FCTC and show the extent to which TTCs combined and coordinated tactics on a global stage that they had previously used on a national stage. Indeed, “the comprehensiveness and scale of the tobacco industry's response to the FCTC suggests that it is reasonable to speak of a ‘globalisation of tobacco industry strategy’ in combating the development of effective tobacco control policies,” write the researchers. Awareness of the strategies employed by TTCs to influence the FCTC should help guard against industry efforts to disrupt the implementation of the FCTC and should support the development of future global tobacco control initiatives. More generally, these findings should support the development of global health initiatives designed to tackle cardiovascular disease, cancer, chronic respiratory diseases and diabetes – non-communicable diseases that together account for 60% of global deaths and are partly driven by the commercial activities of food, alcohol, and tobacco corporations.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001249.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance provides more information about the FCTC
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001249
PMCID: PMC3383743  PMID: 22745607
20.  Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study 
PLoS Medicine  2014;11(10):e1001743.
Aaron Kesselheim and colleagues compared US medical students' survey responses regarding pharmaceutical company interactions with the schools' AMSA PharmFree scorecard and Institute on Medicine as a Profession's (IMAP) scores.
Please see later in the article for the Editors' Summary
Background
Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors.
Methods and Findings
Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11–0.44; marketing representative access policies, r = 0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis.
Conclusions
As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling prescription drugs and medical devices is big business. To promote their products, pharmaceutical and medical device companies build relationships with physicians by providing information on new drugs, by organizing educational meetings and sponsored events, and by giving gifts. Financial relationships begin early in physicians' careers, with companies providing textbooks and other gifts to first-year medical students. In medical school settings, manufacturers may help to inform trainees and physicians about developments in health care, but they also create the potential for harm to patients and health care systems. These interactions may, for example, reduce trainees' and trained physicians' skepticism about potentially misleading promotional claims and may encourage physicians to prescribe new medications, which are often more expensive than similar unbranded (generic) drugs and more likely to be recalled for safety reasons than older drugs. To address these and other concerns about the potential career-long effects of interactions between medical trainees and industry, many teaching hospitals and medical schools have introduced policies to limit such interactions. The development of these policies has been supported by expert professional groups and medical societies, some of which have created scales to evaluate the strength of the implemented industry interaction policies.
Why Was This Study Done?
The impact of policies designed to limit interactions between students and industry on student behavior is unclear, and it is not known which aspects of the policies are most predictive of student behavior. This information is needed to ensure that the policies are working and to identify ways to improve them. Here, the researchers investigate which medical school characteristics and which aspects of industry interaction policies are most predictive of students' reported behaviors and beliefs by comparing information collected in a national survey of US medical students with the strength of their schools' industry interaction policies measured on two scales—the American Medical Student Association (AMSA) PharmFree Scorecard and the Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database.
What Did the Researchers Do and Find?
The researchers compared information about reported gift acceptance, interactions with marketing representatives, and the perceived adequacy of faculty–industry separation collected from 1,610 medical students at 121 US medical schools with AMSA and IMAP scores for the schools evaluated a year earlier. Students at schools with the highest ranked interaction policies based on the AMSA score were 63% less likely to accept gifts as students at the lowest ranked schools. Students at the highest ranked schools based on the IMAP score were about half as likely to accept gifts as students at the lowest ranked schools, although this finding was not statistically significant (it could be a chance finding). Similarly, students at the highest ranked schools were 70% less likely to interact with sales representatives as students at the lowest ranked schools. These associations became statistically nonsignificant after controlling for the amount of research funding each school received from the US National Institutes of Health (NIH). Policies limiting gifts, meals, and being a part of speaking bureaus (where companies pay speakers to present information about the drugs for dinners and other events) were associated with students' reports of receiving no gifts and of non-interaction with sales representatives. Finally, policies regulating industry involvement in educational activities were associated with the perceived separation between faculty and industry, which was regarded as adequate by most of the students at schools with such policies.
What Do These Findings Mean?
These findings suggest that policies designed to limit industry interactions with medical students need to address multiple aspects of these interactions to achieve changes in the behavior and attitudes of trainees, but that policies limiting gifts, meals, and speaking bureaus may be particularly important. These findings also suggest that the level of NIH funding plays an important role in students' self-reported behaviors and their perceptions of industry, possibly because institutions with greater NIH funding have the resources needed to implement effective policies. The accuracy of these findings may be limited by recall bias (students may have reported their experiences inaccurately), and by the possibility that industry interaction policies may have changed in the year that elapsed between policy grading and the student survey. Nevertheless, these findings suggest that limitations on gifts should be emphasized when academic medical centers refine their policies on interactions between medical students and industry and that particular attention should be paid to the design and implementation of policies that regulate industry interactions in institutions with lower levels of NIH funding.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001743.
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice document, which describes what is required of all registered doctors in the UK
Information about the American Medical Student Association (AMSA) Just Medicine campaign (formerly the PharmFree campaign) and about the AMSA Scorecard is available
Information about the Institute on Medicine as a Profession (IMAP) and about its Conflicts of Interest Policy Database is also available
“Understanding and Responding to Pharmaceutical Promotion: A Practical Guide” is a manual prepared by Health Action International and the World Health Organization that medical schools can use to train students how to recognize and respond to pharmaceutical promotion
The US Institute of Medicine's report “Conflict of Interest in Medical Research, Education, and Practice” recommends steps to identify, limit, and manage conflicts of interest
The ALOSA Foundation provides evidence-based, non-industry-funded education about treating common conditions and using prescription drugs
doi:10.1371/journal.pmed.1001743
PMCID: PMC4196737  PMID: 25314155
21.  Science, Policy, and the Transparency of Values 
Environmental Health Perspectives  2014;122(7):647-650.
Background: Opposing groups of scientists have recently engaged in a heated dispute over a preliminary European Commission (EC) report on its regulatory policy for endocrine-disrupting chemicals. In addition to the scientific issues at stake, a central question has been how scientists can maintain their objectivity when informing policy makers.
Objectives: Drawing from current ethical, conceptual, and empirical studies of objectivity and conflicts of interest in scientific research, we propose guiding principles for communicating scientific findings in a manner that promotes objectivity, public trust, and policy relevance.
Discussion: Both conceptual and empirical studies of scientific reasoning have shown that it is unrealistic to prevent policy-relevant scientific research from being influenced by value judgments. Conceptually, the current dispute over the EC report illustrates how scientists are forced to make value judgments about appropriate standards of evidence when informing public policy. Empirical studies provide further evidence that scientists are unavoidably influenced by a variety of potentially subconscious financial, social, political, and personal interests and values.
Conclusions: When scientific evidence is inconclusive and major regulatory decisions are at stake, it is unrealistic to think that values can be excluded from scientific reasoning. Thus, efforts to suppress or hide interests or values may actually damage scientific objectivity and public trust, whereas a willingness to bring implicit interests and values into the open may be the best path to promoting good science and policy.
Citation: Elliott KC, Resnik DB. 2014. Science, policy, and the transparency of values. Environ Health Perspect 122:647–650; http://dx.doi.org/10.1289/ehp.1408107
doi:10.1289/ehp.1408107
PMCID: PMC4080531  PMID: 24667564
22.  Major Infection Events Over 5 Years: How Is Media Coverage Influencing Online Information Needs of Health Care Professionals and the Public? 
Background
The last decade witnessed turbulent events in public health. Emerging infections, increase of antimicrobial resistance, deliberately released threats and ongoing battles with common illnesses were amplified by the spread of disease through increased international travel. The Internet has dramatically changed the availability of information about outbreaks; however, little research has been done in comparing the online behavior of public and professionals around the same events and the effect of media coverage of outbreaks on information needs.
Objective
To investigate professional and public online information needs around major infection outbreaks and correlate these with media coverage. Questions include (1) How do health care professionals’ online needs for public health and infection control information differ from those of the public?, (2) Does dramatic media coverage of outbreaks contribute to the information needs among the public?, and (3) How do incidents of diseases and major policy events relate to the information needs of professionals?
Methods
We used three longitudinal time-based datasets from mid-2006 until end of 2010: (1) a unique record of professional online behavior on UK infection portals: National electronic Library of Infection and National Resource of Infection Control (NeLI/NRIC), (2) equivalent public online information needs (Google Trends), and (3) relevant media coverage (LexisNexis). Analysis of NeLI/NRIC logs identified the highest interest around six major infectious diseases: Clostridium difficile (C difficile)/Methicillin-resistant Staphylococcus aureus (MRSA), tuberculosis, meningitis, norovirus, and influenza. After pre-processing, the datasets were analyzed and triangulated with each other.
Results
Public information needs were more static, following the actual disease occurrence less than those of professionals, whose needs increase with public health events (eg, MRSA/C difficile) and the release of major national policies or important documents. Media coverage of events resulted in major public interest (eg, the 2007/2008 UK outbreak of C difficile/MRSA). An exception was norovirus, showing a seasonal pattern for both public and professionals, which matched the periodic disease occurrence. Meningitis was a clear example of a disease with heightened media coverage tending to focus on individual and celebrity cases. Influenza was a major concern during the 2009 H1N1 outbreak creating massive public interest in line with the spring and autumn peaks in cases; although in autumn 2009, there was no corresponding increase in media coverage. Online resources play an increasing role in fulfilling professionals’ and public information needs.
Conclusions
Significant factors related to a surge of professional interest around a disease were typically key publications and major policy changes. Public interests seem more static and correlate with media influence but to a lesser extent than expected. The only exception was norovirus, exhibiting online public and professional interest correlating with seasonal occurrences of the disease. Public health agencies with responsibility for risk communication of public health events, in particular during outbreaks and emergencies, need to collaborate with media in order to ensure the coverage is high quality and evidence-based, while professionals’ information needs remain mainly fulfilled by online open access to key resources.
doi:10.2196/jmir.2146
PMCID: PMC3713905  PMID: 23856364
information seeking behavior; weblogs analysis; online information needs; data mining; infectious outbreaks
23.  National policy-makers speak out: are researchers giving them what they need? 
Health Policy and Planning  2010;26(1):73-82.
The objective of this empirical study was to understand the perspectives and attitudes of policy-makers towards the use and impact of research in the health sector in low- and middle-income countries. The study used data from 83 semi-structured, in-depth interviews conducted with purposively selected policy-makers at the national level in Argentina, Egypt, Iran, Malawi, Oman and Singapore. The interviews were structured around an interview guide developed based on existing literature and in consultation with all six country investigators. Transcripts were processed using a thematic-analysis approach. Policy-makers interviewed for this study were unequivocal in their support for health research and the high value they attribute to it. However, they stated that there were structural and informal barriers to research contributing to policy processes, to the contribution research makes to knowledge generally, and to the use of research in health decision-making specifically. Major findings regarding barriers to evidence-based policy-making included poor communication and dissemination, lack of technical capacity in policy processes, as well as the influence of the political context. Policy-makers had a variable understanding of economic analysis, equity and burden of disease measures, and were vague in terms of their use in national decisions. Policy-maker recommendations regarding strategies for facilitating the uptake of research into policy included improving the technical capacity of policy-makers, better packaging of research results, use of social networks, and establishment of fora and clearinghouse functions to help assist in evidence-based policy-making.
doi:10.1093/heapol/czq020
PMCID: PMC4031573  PMID: 20547652
Research to policy; evidence-based policy; health policy; Argentina; Egypt; Iran; Malawi; Oman; Singapore
24.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
25.  National policy development for cotrimoxazole prophylaxis in Malawi, Uganda and Zambia: the relationship between Context, Evidence and Links 
Background
Several frameworks have been constructed to analyse the factors which influence and shape the uptake of evidence into policy processes in resource poor settings, yet empirical analyses of health policy making in these settings are relatively rare. National policy making for cotrimoxazole (trimethoprim-sulfamethoxazole) preventive therapy in developing countries offers a pertinent case for the application of a policy analysis lens. The provision of cotrimoxazole as a prophylaxis is an inexpensive and highly efficacious preventative intervention in HIV infected individuals, reducing both morbidity and mortality among adults and children with HIV/AIDS, yet evidence suggests that it has not been quickly or evenly scaled-up in resource poor settings.
Methods
Comparative analysis was conducted in Malawi, Uganda and Zambia, using the case study approach. We applied the ‘RAPID’ framework developed by the Overseas Development Institute (ODI), and conducted a total of 47 in-depth interviews across the three countries to examine the influence of context (including the influence of donor agencies), evidence (both local and international), and the links between researcher, policy makers and those seeking to influence the policy process.
Results
Each area of analysis was found to have an influence on the creation of national policy on cotrimoxazole preventive therapy (CPT) in all three countries. In relation to context, the following were found to be influential: government structures and their focus, donor interest and involvement, healthcare infrastructure and other uses of cotrimoxazole and related drugs in the country. In terms of the nature of the evidence, we found that how policy makers perceived the strength of evidence behind international recommendations was crucial (if evidence was considered weak then the recommendations were rejected). Further, local operational research results seem to have been taken up more quickly, while randomised controlled trials (the gold standard of clinical research) was not necessarily translated into policy so swiftly. Finally the links between different research and policy actors were of critical importance, with overlaps between researcher and policy maker networks crucial to facilitate knowledge transfer. Within these networks, in each country the policy development process relied on a powerful policy entrepreneur who helped get cotrimoxazole preventive therapy onto the policy agenda.
Conclusions
This analysis underscores the importance of considering national level variables in the explanation of the uptake of evidence into national policy settings, and recognising how local policy makers interpret international evidence. Local priorities, the ways in which evidence was interpreted, and the nature of the links between policy makers and researchers could either drive or stall the policy process. Developing the understanding of these processes enables the explanation of the use (or non-use) of evidence in policy making, and potentially may help to shape future strategies to bridge the research-policy gaps and ultimately improve the uptake of evidence in decision making.
doi:10.1186/1478-4505-9-S1-S6
PMCID: PMC3121137  PMID: 21679387

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