TB diagnostics and laboratory strengthening - WHO policy
Moving research findings into new WHO policies
Today’s technologies for tuberculosis (TB) control—medicines, diagnostics, and vaccines—are decades old, and improvements in these technologies or new technologies altogether would accelerate TB control efforts worldwide. “Retooling” TB control is the process for adopting and introducing new and improved health technologies with the goal of maximizing their widespread use, while minimizing delays. A pivotal point in retooling is when a global policy is revised or created to encompass a new technology or strategy.
A primary source of global health policy is the World Health Organization (WHO). As WHO is governed by Member States, WHO policy is commonly the foundation for country-level technical decisions. The majority of countries may not take up new tools or strategies that are not endorsed by the WHO, even when they are effective. WHO strongly supports TB retooling efforts and works towards the rapid and widespread dissemination and use of new technologies to combat TB and eliminate the disease. In addition to its role in policy setting, WHO can facilitate the translation of policy into practice through its normative, technical assistance, and monitoring functions at the country level.
A widespread and common understanding of the process that WHO utilizes to move research evidence into policy is critical to ensure that all product developers or researchers have similar access to the policy-making process, and to enable countries to access objective information on all new, improved and existing technologies.
The Policy Process
- Identifying the need for a policy change: The need to formulate new or revised policies may arise from WHO’s on-going monitoring of technical developments or from interested parties submitting requests and supporting documentation for policy or guideline development. WHO receives information about a new technology or approach via many channels, with the most direct lines coming from national TB programmes and researchers themselves. To consider a global policy change, WHO must have solid evidence, including clinical trials or field evaluations in high TB prevalence settings. To request that WHO consider a new tool or strategy for global policy (to be then recommended to its Member States), send a request to email@example.com or send a cover letter and copies of supporting studies to: World Health Organization Stop TB Department 20 avenue Appia 1211 Geneva 27 Switzerland
- Reviewing the evidence: WHO may carry out or commission a review of the documentation of technology’s clinical or programmatic performance, including newly published and “grey” research or reviews, “proof of principle” reports, large-scale field trials, and demonstration projects in different resource settings. Standardized evaluation criteria have been and are being developed by the New Diagnostics, New Drugs, and New Vaccines Working Groups of the Stop TB Partnership. Evidence for new tools must conform to these criteria to be considered.
- Convening an expert panel: If the evidence base is compelling, WHO will convene an external panel of experts, excluding all original principal investigators from the studies. The panel will review the evidence and make a recommendation or propose draft policies or guidelines to WHO’s Strategic and Technical Advisory Group for Tuberculosis (STAG-TB).
- Assessing draft policies and guidelines: STAG-TB provides objective, ongoing technical and strategic advice to WHO related to TB care and control. STAG-TB’s objectives are to provide the Director-General, through the Stop TB Department, an independent evaluation of the strategic, scientific, and technical aspects of WHO’s TB activities, review progress and challenges in WHO’s TB-related core functions, review and make recommendations on committees and working groups, and make recommendations on WHO’s TB activity priorities. STAG-TB is comprised of 20 experts, representing ministries of health, national TB control programmes, academic and research institutions, civil society organizations, communities and patients affected by tuberculosis, and professional associations. WHO’s Stop TB Department serves as secretariat for STAG-TB. STAG-TB reviews the policy drafts and supporting documentation during its annual three-day meeting. STAG-TB may endorse the policy recommendation with or without revisions, request additional information and re-review the evidence in subsequent years, or reject the recommendation. On occaision, STAG-TB may work between annual meetings by setting up smaller groups which can provide ad-hoc advice to WHO.
- Formulating and disseminating policy: New WHO policies and guidelines will be disseminated through different channels to Member States, including through the World Health Assembly, WHO website, list serves, and journal publications. WHO also disseminates its recommendations to the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNITAID, the World Bank, and other agencies and donors engaged in TB control activities.