DOES HUMAN MEDICINES DEVELOPMENT IN THE EUROPEAN UNION ADDRESS GLOBAL AND REGIONAL HEALTH CONCERNS?
Author(s)
Catalá-López F1, Garcia-Altés A2, Álvarez-Martín E3, Gènova-Maleras R4, Morant-Ginestar C41Spanish Medicines and Healthcare Products Agency (AEMPS), Madrid, Spain, 2King's College London, London, United Kingdom, 3Rey Juan Carlos University, Madrid, Spain, 4Regional Health Council of Madrid, Madrid, Spain
OBJECTIVES: Our aim was to investigate whether efforts to develop innovative medicines in the European Union (EU) are focusing on the most relevant conditions from a global public health perspective. METHODS: We reviewed the information on new medicinal products approved by centralised procedure (from 1995 to 2009), available for the public in the European Commission Register of medicinal products and the European Public Assessment Reports (EPAR) from the European Medicines Agency. We included morbidity-mortality data for each disease group, according to the World Health Organization Global Burden of Disease project. We evaluated the association between authorised medicinal products and burden of disease measures (disability-adjusted life years [DALYs]) in the EU and worldwide. RESULTS: We considered 520 marketing authorisations for medicinal products and 338 active ingredients. New authorisations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal products development (ρ=0.619, p=0.005) in the EU, that was moderate for middle-low income countries (ρ=0.497, p=0.030) and worldwide (ρ=0.490, p=0.033). In the EU, the most neglected conditions (related to their attributable health losses) were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions or digestive diseases, while globally they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, or digestive diseases. CONCLUSIONS: Our findings suggest that the development of new medicinal products is higher in some diseases than in others. Pharmaceutical industry and decision-makers are invited to consider the implications of this imbalance establishing work plans that allow for setting future priorities from a public health perspective.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PHP25
Topic
Epidemiology & Public Health, Health Policy & Regulatory
Topic Subcategory
Approval & Labeling, Pricing Policy & Schemes, Public Health
Disease
Multiple Diseases