Quantity vs. quality: an assessment of the current pipeline for rabies.

OBJECTIVES: To gain insight in the potential of the current pipeline for rabies to decrease the burden of disease by evaluating its relevance to high-risk countries. METHODS: Rabies-related patent documents and clinical trials were retrieved from Espacenet and the WHO ICTRP, respectively. Data were cleaned, modulated and categorised into a pre-defined set of indicators those were used for (statistical) analyses on the number of patent applications, patent quality and type of stakeholders involved for different geographical areas. RESULTS: Analysis of 583 unique patent families applied for in the period 1954-2017 showed a steep growth in the yearly number of patent applications. A significant portion of new patent applications concern Chinese patents with relatively low quality that are filed by a dispersed group of applicants. Excluding these patents, the number of patent applications has been virtually stable over the years. A shift is seen in public stakeholders becoming more prolific as patent applicants. This shift is also reflected in clinical trials; key sponsors of clinical trials include public and private stakeholders originating from high-risk rabies countries. The majority of clinical trials investigate adjustments to existing vaccines that may improve accessibility. CONCLUSION: The results show a discrepancy between the quantity and quality of rabies patent applications that reflects national patent regulations rather than real progress in decreasing the burden of disease. This is in contrast to clinical trials, which focus on incremental innovations that are tested in clinical trials but may nevertheless have a potentially strong impact in high-risk countries.

OBJECTIFS: Comprendre le potentiel du pipeline actuel pour la rage pour réduire la charge de morbidité en évaluant sa pertinence pour les pays à haut risque. MÉTHODES: Les documents de brevet liés à la rage et les essais cliniques ont été récupérés auprès de réseau Espacenet et de l'OMS ICTRP, respectivement. Les données ont été triées, modulées et classées en un ensemble prédéfini d'indicateurs qui a été utilisé pour des analyses (statistiques) sur le nombre de demandes de brevet, la qualité des brevets et le type de parties prenantes impliquées pour différentes zones géographiques. RÉSULTATS: L'analyse de 583 familles de brevets uniques déposées au cours de la période 1954-2017 a montré une forte croissance du nombre annuel de demandes de brevet. Une part importante des nouvelles demandes de brevet concerne des brevets chinois de qualité relativement faible soumises par un groupe dispersé de déposants. A l'exclusion de ces brevets, le nombre de demandes de brevet est resté pratiquement stable au fil des ans. Un changement est observé dans les acteurs publics devenant plus prolifiques en tant que demandeurs de brevet. Ce changement se reflète également dans les essais cliniques; les principaux sponsors des essais cliniques comprennent des parties prenantes publiques et privées originaires de pays à haut risque pour la rage. La majorité des essais cliniques étudient les ajustements aux vaccins existants qui pourraient améliorer l'accessibilité. CONCLUSION: Les résultats montrent un écart entre la quantité et la qualité des demandes de brevet liées à la rage qui reflète les réglementations nationales en matière de brevets plutôt que de réels progrès dans la réduction de la charge de morbidité. Cela contraste avec les essais cliniques, qui se concentrent sur des innovations incrémentales qui sont testées dans des essais cliniques mais qui peuvent néanmoins avoir un impact potentiellement fort dans les pays à haut risque.

A research agenda to reinforce rabies control: A qualitative and quantitative prioritization.

BACKGROUND: Despite the existence of safe and effective vaccines, rabies disease still causes an estimated 59,000 human deaths a year in the endemic areas in Asia and Africa. These numbers reflect severe drawbacks regarding the implementation of PrEP and PEP in endemic settings, such as lack of political will and low priority given to rabies. Since these contextual factors have proven to be persistent, there is an urgency to improve current strategies or develop novel approaches in order to control rabies disease in the future. METHODS/FINDINGS: This study aimed to identify and systematically prioritize the research needs, through interviews and questionnaires with key-opinion-leaders (KOLs). A total of 46 research needs were identified and prioritized. The top research needs are considered very high priority based on both importance for rabies control and need for improvement. KOLs agree that animal rabies control remains most important for rabies control, while research on human host, agent (rabies virus) and the environment should be prioritized in terms of need for improvement. A wide variety in perceptions is observed between and within the disciplines of virology, public health and veterinary health and between KOLs with more versus those with less experience in the field. CONCLUSION/SIGNIFICANCE: The results of this study give well-defined, prioritized issues that stress the drawbacks that are experienced by KOLs in daily practice. The most important research domains are: 1) cheap and scalable production system for RIG 2) efficacy of dog mass vaccination programs and 3) cheap human vaccines. Addressing these research needs should exist next to and may reinforce current awareness and mass vaccination campaigns. The differences in perspectives between actors revealed in this study are informative for effective execution of the One Health research agenda.