Does the development of new medicinal products in the European Union address global and regional health concerns?

Abstract

Background: Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective.

Methods: We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs) in the European Union and worldwide.

Results: We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005) in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030) and worldwide (ρ = 0.490, p = 0.033). The most neglected conditions at the European level (based on their attributable health losses) were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases.

Conclusions: We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this imbalance by establishing work plans that allow for the setting of future priorities from a public health perspective.

Figure 1

Pharmaceutical output selection. Marketing authorizations granted (and active ingredients) by EU centralized procedure, 1995-2009.

Figure 2

Bubble plot representing disability-adjusted life years (DALYs) for EU-25 and active ingredients (NCEs). The areas of the bubbles are DALYs' weighted contribution of each disease condition(s) to the total burden of disease. 1: Other neoplasms; 2: Unintentional injuries (poisoning); 3: Congenital anomalies; 4: Digestive diseases; 5: Respiratory diseases; 6: Skin diseases; 7: Respiratory infections; 8: Maternal conditions; 9: Perinatal conditions.

Figure 3

Bubble plot representing disability-adjusted life years (DALYs) worldwide and active ingredients (NCEs). The areas of the bubbles are DALYs' weighted contribution of each disease condition(s) to the total burden of disease. 1: Other neoplasms; 2: Unintentional injuries (poisoning); 3: Congenital anomalies; 4: Digestive diseases; 5: Respiratory diseases; 6: Skin diseases.