Combating Non-Communicable Diseases Worldwide: What Role for Drug Research & Development?

Abstract

The share of non-communicable diseases (NCDs) is rising disproportionately fast in low-income and middle-income countries (LMIC) compared to high-income countries (HIC). At the same time, drug Research & Development (R&D) plays a key role in the fight against NCDs. However, the topic of R&D for NCDs in LMIC has received surprisingly little attention at international level. This qualitative study explores how LMIC characteristics could impact R&D of NCDs drugs; investigates how these characteristics are addressed by existing R&D strategies; and examines how system-level barriers and enablers influence this situation. Data was gathered through interviews with key informants, a literature review, and a case study on type 2 diabetes. The study finds evidence that LMIC characteristics impact R&D for NCDs for six categories: NCDs etiologic and physiological characteristics, genetic and metabolic response, patient population mix, drug delivery, drug procurement and distribution and drug adoption characteristics. For example, weaker health systems in LMIC create a need for medicines’ increased stability and simplicity and differences in genetic and metabolic responses to NCD drugs create a need for adjusted dosages. However, these characteristics are insufficiently considered in current R&D strategies. This creates a gap that leaves the potential health needs in LMIC unaddressed. System-level barriers and enablers play a role in this gap. These factors include, among others, a weak evidence base, a lack of political will, ethical issues related to clinical trials in LMIC, and the absence of international market guarantors for NCDs. At the same time, increased industry interest in emerging markets and new R&D business models could catalyze more discussion on this topic. In conclusion, this study shows the need to develop a robust policy debate on R&D for NCDs in LMIC. In order to do so, recommendations focusing on better framing this topic, in part through shared language and an improved evidence base, are proposed. R&D for NCDs in LMIC deserves more attention than this topic has received at the international level. This study is a first step. Ultimately, promoting better R&D for NCDs in LMIC could help leverage the R&D expertise of biopharmaceutical companies toward increased access to medicines.