Perspectives on Stimulating Industrial Research and Development for Neglected Infectious Diseases

Article excerpt

Voir page 740 le resume en francais. En la pagina 740 figura un resumen en espanol.

Introduction

While 50% of global health research and development (R&D) in 1992 was undertaken by private industry, less than 5% of the money was spent on diseases specific to less developed countries (1, 2). Of the 1223 new chemical entities marketed worldwide between 1975-96, only 13 were developed specifically for tropical diseases (3). Despite this, private industry has discovered several drugs for serious disease threats in less developed countries, including malaria, tuberculosis, hepatitis B, river blindness, meningitis, leprosy, sleeping sickness, and trachoma. Moreover, the development of globally applicable medicines and vaccines has led to important advances in public health in developing countries.

At the same time, every biopharmaceutical company has a limited number of R&D programmes in their portfolio, which are regularly reviewed against each other. Fundamentally, the process tends to favour those projects with a higher probability of success and which, if successful, would serve markets with a larger monetary value. Consequently, there is lower investment in diseases such as tuberculosis and malaria, despite their high global disease burden, compared with the level of investment in "industrialized-country" diseases. As a result, there is general agreement that new mechanisms and incentives are needed to encourage industrial R&D in underresourced diseases. In this paper, some recent thinking about ways to stimulate industrial R&D for neglected infectious diseases is examined, and it is argued that enlarging the value of the market for medicines and vaccines through, for example, global purchase funds, is a critical step toward stimulating R&D in these diseases.

Barriers to R&D

A joint working group of WHO and the pharmaceutical industry identified five barriers limiting industry engagement in new R&D on neglected infectious diseases (4), as described below.

The state of the science

The lack of understanding of some diseases, coupled with the complexity of the science and technology involved, makes the prospect of finding new medicines and vaccines uncertain and therefore risky. This lack of understanding limits the investment that it is prudent for industry to make. Publicly-funded basic research, often carried out by research institutions and universities, has been important in stimulating the applied work undertaken by the pharmaceutical industry, although industry is increasingly performing basic scientific research as well.

Insufficient access

Weaknesses in country-level physical, medical, financial, and political infrastructure mean that many existing products needed by people in developing countries are not being purchased by patients, health care facilities, governments, or nongovernmental organizations. There is a very real danger that even if new products are developed, they will not be purchased and made available to those who need them. While some existing products suited to developing countries are widely purchased and used, many others are not. In many cases, weaknesses in health infrastructure in developing countries mean that patients never see a health care provider and receive a diagnosis or prescription, let alone the care necessary to make effective use of some medicines. While this paper focuses exclusively on medicines and vaccines, it is often the case that other interventions are more appropriate and this fact should not be minimized.

Thus, there is the prospect that many patients with acquired immunodeficiency syndrome (AIDS) in Africa, for example, would not automatically benefit from antiretrovirals, even at dramatically lower prices. Antiretrovirals require diagnosis, monitoring, and long-term maintenance of demanding treatment regimens that are difficult to sustain without adequate infrastructure and support. …