Can global guidelines change health policy?
M Fried*, EMM Quigley, RH Hunt, G Guyatt, BO Anderson, DJ Bjorkman, MJG Farthing, SS Fedail, R Green-Thompson, J Hampton, J Krabshuis, L Laine and R Horton About the authors
Correspondence *Division of Gastroenterology and Hepatology, University Hospital Zürich, Raemistrasse 100, CH-8091 Zürich, Switzerland
Email michael.fried@usz.ch
How can global guidelines have an impact on, support or help to change health policy? There are considerable infrastructural limitations to the provision of health care throughout the world, especially in poorer nations where health care has to compete for scarce resources with other national needs and priorities.1 Needs and priorities related to health care differ greatly throughout the world: malaria, for example, might not be a major priority in Canada but it is in many African countries.
For global guidelines to gain acceptance and influence health policy at national, regional and local levels, local involvement in their development and implementation is essential. The ability of a global guideline to have an impact on health care in a developing country will also be critically influenced by the availability of resources, by an understanding by the intended target population of the guideline-making process and a realization that benefits will accrue through their participation in the implementation of the guideline.
Although evidence-based guidelines from wealthy countries define optimal goals for resource-constrained countries, these countries commonly lack the fundamental infrastructure that is required for direct implementation. This is amply illustrated by experience with breast cancer in countries with limited resources.2
Breast cancer mortality rates are highest among economically disadvantaged countries. Low-income and middle-income countries (LMCs) typically lack the major components of health-care infrastructure and resources necessary to implement improved methods for the early detection, diagnosis and treatment of breast cancer.3 Evidence-based guidelines can define strategies by which practical, economically-achievable, incremental improvements can be sequentially introduced within the context of resource constraints to create measurable improvements in health-care administration and outcome.
Guidelines for breast health care, published in 2006 and made available in an unrestricted fashion on the internet, provide evidence-based expert consensus guidelines that specifically address issues of implementation in LMCs. The Breast Health Global Initiative (BHGI) guidelines define comprehensive pathways for LMCs to address early detection, diagnosis, treatment and health-care systems for breast health care. The BHGI guidelines stratify resources into four levels (basic, limited, enhanced and maximal), making the guidelines applicable to countries of differing economic capacities. The Institute of Medicine identifies the BHGI approach as a model for developing resource-sensitive guidelines that could be applied to other cancers or chronic diseases for which effective treatments are available.4
The development of effective global guidelines requires the early participation of all stakeholders, including health policy-makers. For a guideline to achieve acceptance, health policy-makers need to be given clear messages about its potential impact in order to help them prioritize scarce resources. These messages should include a cascade, which is a collection of related diagnostic and treatment options arranged hierarchically in terms of conditions and available resources.5
Considerable effort and resources must be assigned to the education of all those who might be involved in the implementation of guidelines, from health-care workers and their administrators to the community and patients. In relation to the latter, the inclusion of patient advocacy groups in the process of guideline construction and implementation might be of considerable value.
Opinions are divided as to whether the biomedical industry should be involved in the development and implementation of global guidelines. Reflecting widespread anxieties in regard to relationships between industry and academia in biomedical research,6 some would contend that experience has shown that the direct involvement of industry in guideline development leads to considerable skepticism of guideline recommendations. It is not enough for guideline authors to disclose relationships with industry in order to convince the public that their recommendations are unbiased. This approach might not be sufficient to inform a guideline user whether or not the participant with conflicting interests has influenced the development process in a manner that favored the pharmaceutical or device company with which that individual had a financial arrangement. Indeed, in most instances, published guidelines contain no information about financial relationships between industry and the organization that supported the guidelines, or the physicians who analyzed and summarized the data. Industry sponsorship might directly affect the credibility of those who develop the guideline and, therefore, the guideline itself. If guideline development is supported by industry then mechanisms should be put in place to guarantee complete editorial independence. The sponsorship of the guideline process by multiple and even competing industry partners would go some way towards achieving such independence. Furthermore, the medicine and biomedical science communities have already developed protocols that will facilitate a transparent interaction between medicine, science and industry.7
When considering the possible roles of industry in the support of guideline development it is also important to be mindful of some practical issues. Industry plays a vital role in discovering new drugs, manufacturing drugs and, at times, making them available to poorer populations. Indeed, few nations have the resources to develop and market medicines on the scale and to the standards that the large multinational pharmaceutical companies can achieve. These same corporations are also well-resourced and well-positioned to deal with counterfeit medicines, to ensure adequate packaging, training and monitoring. As industry is a key partner in the global health-care delivery process, their total exclusion from the guideline process would seem unreasonable. As exemplified by the work of the Novartis Foundation for Sustainable Development in the eradication of leprosy,8 industry-led projects can have a substantial impact through the provision of effective drugs.
All editorial processes involved in guideline development must be fully independent of industry sponsorship to avoid bias; however, here are many other ways that industry can provide support through, for example, translation, distribution and implementation. The resources of industry could be harnessed to the expensive process of global guideline development by inviting industry to contribute to a communal fund.
Global guidelines are not only desirable but feasible and necessary. The evidence-based approach is always preferred but its application must consider local resource constraints, values and preferences. Given the lack of an adequate evidence base for many of the health problems that confront the developing world, and the dangers of extrapolating from data from the developed world, a pragmatic approach including expert experience, opinion and synthesis will, pending definitive data, remain a key component of global guideline development.
Global medical associations should be sensitive to those guideline topics that are relevant to developing countries. These guidelines must consider regional variations in the presentation and demographics of disease and it is of key importance that different diagnostic and therapeutic options are developed for resource-constrained countries.9 Although such diagnostic and therapeutic cascades are important, it is crucial that preferred practice should always be clearly enunciated.
The costs of developing guidelines can be shared, and duplication and waste avoided, if others in the same medical disciplines share resources and experience. Local guideline panels can help to increase relevance and acceptance; similarly, centralized reviews should take account of regional databases and local values and preferences. Indeed, global medical organizations should explore how to develop and support advocacy groups in resource-constrained countries and national and regional health policy-makers should be encouraged to liaise in this process. Guidelines will not succeed if delivered by external agencies; guideline development and implementation must be an integrated process. The resources and expertise of the biomedical industry should be harnessed in a manner that does not influence the process or its outcome.
References
- Quigley EM et al. (2007) Use of evidence in WHO recommendations. Lancet 370: 824 | Article | PubMed |
- Anderson BO et al. (2006) Breast cancer in limited resources countries: health care systems and public policy. Breast J 12 (Suppl 1): S54–S69 | Article |
- Anderson BO et al. (2006) Breast cancer in limited resource countries: an overview of the Breast Health Global Initiative 2005 Guidelines. Breast J 12 (Suppl 1): S3–S15 | Article |
- Sloan FA and Gelband H (2007) Cancer Control Opportunities in Low- and Middle-Income Countries, 1–16. Washington DC: The National Academies Press.
- Winawer S et al. WGO Practice Guideline: Colorectal Cancer Screening [http://www.omge.org/globalguidelines/statement03/statement3.htm] (accessed 11 October 2007)
- Brockway LM et al. (2006) Conflicts of interest in biomedical research—the FASEB guidelines. FASEB J 20: 2435–2438 | Article | PubMed | ChemPort |
- Kaiser J (2007) Conflict of interest. Stung by controversy, biomedical groups urge consistent guidelines. Science 317: 441 | Article | PubMed | ChemPort |
- Williams PG et al. (1998) Social marketing to eliminate leprosy in Sri Lanka. Soc Mar Q 4: 27–31 | PubMed | ChemPort |
- Zotov V and Shyyan R (2003) Introduction of breast cancer screening in Chernihiv Oblast in the Ukraine: report of a PATH Breast Cancer Assistance Program experience. Breast J 9 (Suppl 2): S75–S80 | Article |
Competing interests
The authors declared no competing interests.
Contact the journal about this article
