Pharmaceutical companies have long been criticised for focusing on lucrative markets in rich nations, rather than fighting diseases of the poor. I am conducting research that reveals the true nature and magnitude of the mismatch between drug innovation and global unmet health needs
According to the World Health Organization, at least two billion people (nearly a third of the world’s population) don’t have access to the medicines they need due to lack of availability or because adequate treatments do not exist. It’s no secret the pharmaceutical industry looks for commercially attractive drug development programmes. Although the industry is highly regulated, existing incentive mechanisms, including public funding, private and public partnerships, and ultimately the way the regulatory system is designed, are driving innovation in some disease areas at the expense of many others.
There is an urgent need to tackle this mismatch between investment and health need, and to develop effective interventions to increase innovation for diseases that are currently neglected.
Our research looked at inequality in innovation by comparing R&D activity across all therapeutic and disease areas between 1990 and 2010. We discovered a mismatch between innovation levels and the burden of disease, as measured by disability-adjusted life years.
For disease areas such as cardiovascular and circulatory diseases, for which there are already numerous effective treatments on the market, industry keeps innovating in diseases with a higher burden and larger market size. These tend to be most prevalent in developed countries where the number of patients and the ability to pay makes the market financially attractive. For example, in 2010, 187 new drugs were launched for ischaemic heart disease (which accounts for 44 per cent of the cardiovascular and circulatory disease burden) and four drugs were produced for hypertensive heart diseases (which account for around five per cent of the disease burden).
We are already regulating the pharmaceutical sector, but not in a way that ensures alignment with societal objectives
For other leading causes of illness and death that already face a critical shortage of effective treatments, such as mental and behavioural disorders and neonatal disorders, innovation is disproportionately concentrated in a few low burden conditions. And these inequalities have been increasing over time. For example, in 2010, 89 new therapies were launched for the treatment of cannabis and opioid addiction, which accounted for roughly five per cent of the mental health disease burden worldwide. In contrast, just eight new therapies were produced for unipolar depressive disorders that accounted for around 34 per cent of the disease burden.
These findings paint a bleak picture of R&D inertia in tackling global health challenges.
Industry responds to incentives. We are already regulating the pharmaceutical sector, but not in a way that ensures alignment with societal objectives. Regulators set rules for drug safety, effectiveness, and price setting. However, they are failing to design incentives to foster more innovation in areas of societal need.
Resources are scarce. We need to ask ourselves which drugs we are prepared to pay for and which we are willing to forgo. As a society, we need a public discussion about which diseases lack innovation and should be prioritised from a societal perspective. Ultimately, we should be developing incentives to encourage the private sector to deliver innovation that is affordable and aligned with unmet health need.
Health technology assessment institutions such as the National Institute for Health and Care Excellence in the UK determine the value of drugs based on their impact on quality-adjusted life years relative to costs. Such policies control short term spending on drugs, but the long term consequences are not known. If regulation fails to provide the right incentives, health systems may unintentionally undermine access to expensive yet cost effective treatments. They may also reduce the incentives to invest in under-researched disease areas that could contribute to a reduction of the global burden of disease.
Looking to the future, we need an open discussion, and more research, into why there is this mismatch between drug innovation and health need, and how it can be addressed. In particular, how economic criteria and resource allocation can be incorporated into R&D decisions. Our research is the first step in that direction, but much more needs to be done.
This article is based on the following research: “Does global drug innovation correspond to burden of disease? The neglected diseases in developed and developing countries”