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Rare Diseases and Orphan Products
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
eBook
Policy evaluation frameworks for rare diseases: a scoping review
Background
The epidemiological burden of rare diseases positions them as a global public health challenge. Because rare disease policies are heterogeneous and complex, evaluating their effectiveness requires a systematic and structured approach. Policy evaluation frameworks provide tools to understand how policies are defined, implemented, and assessed in different health systems. These frameworks help identify gaps in policy design and support the development of mechanisms to improve rare disease management. Although several policy evaluation methods have been proposed, no study has synthesized them in a structured and comparative manner. This study aims to map existing policy evaluation frameworks for rare diseases, describe their overarching structures, and propose recommendations for improvement.
Results
This scoping review followed the Context, Population and Concept (CPC) structure to guide the search strategy. Databases and grey literature were searched from inception to 1 May 2025. Ultimately, five studies were included for extraction and evaluation. The context, population and concept of the included studies were categorized into three thematic domains: policy focus, policy problem, and stakeholder groups and collaboration.
Conclusions
The limited number of available frameworks underscores the need for further methodological development. While current approaches provide initial insights, they remain context-specific and lack a unified, transferable framework applicable to different health systems.
Journal Article
Lessons learned for other European countries from Swiss agricultural policy reforms
Learning from the experiences of other countries can support efforts to improve agricultural policies. Switzerland provides an interesting case because its policy is exceptionally targeted towards the establishment of sustainable production systems. We describe the history and the current state of Swiss agricultural policy, review evaluations of policy reforms, summarise their impact and outline the lessons learned for policy developments in other countries. We discuss four implications: i) some goals have been met, albeit at a high cost, and so, increasing efficiency of policies is key; ii) there is a need for more coherence and coordination regarding the different policy programmes (i.e. in the sense of a ‘food system policy’); iii) cross-compliance measures (i.e. minimum standards for receiving support) have an important leverage effect; and iv) policy differentiation (e.g. by spatial targeting) and increasing farmers’ discretion over how to achieve goals (e.g. by implementing results-based payments) are key for future policies.
Journal Article
The Effects of Particulate Matter Alert on Urban Park Visitation in Seoul, Korea: Using Segmented Regression
To reduce the health burden from particulate matter (PM), the Korean government implemented a nationwide PM10 (particles less than 10 µg/m3 in diameter) alert system in 2015. The policy was intended to reduce PM exposure by advising people to refrain from outdoor activities on highly polluted days. The present study aimed to estimate the effect of the PM10 alert system on people’s daily outdoor activity patterns using urban park (specifically, Children’s Grand Park) visitation data from Seoul, South Korea, from 2014–2019. Segmented regression was fitted to estimate whether the number of visitors to the park decreased on the days with PM10 alerts. PM10 concentration of 80 µg/m3, the cut-off point for a “Bad” alert, was set as a threshold, and discontinuity at the threshold and change in the relative risk after the threshold was tested. Time series regression was used to estimate the dose–response line between the ambient PM10 concentration and the daily number of park visitors. The number of park visitors decreased by 11.8% (relative risk: 0.881, 95% confidence interval: 0.808, 0.960) when a “Bad” alert was issued (PM10 level above 80 µg/m3) compared to when the alert level was “Normal” (PM10 level less than 80 µg/m3). The present study found evidence that the PM10 alert influenced people’s daily outdoor activities in Seoul, Korea. As the main purpose of the PM alert is to encourage people to refrain from outdoor activities, evaluating the relationship between PM alerts and behavior patterns can help to grasp the effectiveness of the policy. Further efforts should be made to investigate whether the observed behavioral change leads to reductions in health outcomes caused by PM.
Journal Article
Use of the GRADE approach in health policymaking and evaluation: a scoping review of nutrition and physical activity policies
Background
Nutrition and physical activity policies have the potential to influence lifestyle patterns and reduce the burden of non-communicable diseases. In the world of health-related guidelines, GRADE (Grading of Recommendations, Assessment, Development and Evaluation) is the most widely used approach for assessing the certainty of evidence and determining the strength of recommendations. Thus, it is relevant to explore its usefulness also in the process of nutrition and physical activity policymaking and evaluation.
The purpose of this scoping review was (i) to generate an exemplary overview of documents using the GRADE approach in the process of nutrition and physical activity policymaking and evaluation, (ii) to find out how the GRADE approach has been applied, and (iii) to explore which facilitators of and barriers to the use of GRADE have been described on the basis of the identified documents. The overarching aim of this work is to work towards improving the process of evidence-informed policymaking in the areas of dietary behavior, physical activity, and sedentary behavior.
Methods
A scoping review was conducted according to current reporting standards. MEDLINE via Ovid, the Cochrane Library, and Web of Science were systematically searched up until 4 July 2019. Documents describing a body of evidence which was assessed for the development or evaluation of a policy, including documents labeled as “guidelines,” or systematic reviews used to inform policymaking were included.
Results
Thirty-six documents were included. Overall, 313 GRADE certainty of evidence ratings were identified in systematic reviews and guidelines; the strength of recommendations/policies was assessed in four documents, and six documents mentioned facilitators or barriers for the use of GRADE. The major reported barrier was the initial low starting level of a body of evidence from non-randomized studies when assessing the certainty of evidence.
Conclusion
This scoping review found that the GRADE approach has been used for policy evaluations, in the evaluation of the effectiveness of policy-relevant interventions (policymaking), as well as in the development of guidelines intended to guide policymaking. Several areas for future research were identified to explore the use of GRADE in health policymaking and evaluation.
Journal Article