Through drug discovery and development, the pharmaceutical industry - for all its faults! - has helped to save or improve the lives of countless millions of people over the past century, and it continues to do so. There are very few individuals in the developed world, and increasingly in the developing world, whose lives have not been enhanced by the industry and its products

Economically, the pharmaceutical industry is a major employer of the world’s best chemists and bio-scientists, and the major companies contribute significantly to the GDP of the countries in which they are based. It is a highly competitive industry and pharmaceutical companies are subject to a wide range of competitive pressures, in particular demanding legal and regulatory requirements and the effects of rapid advances in science and technology. Current issues of note include patent expirations, falling R&D productivity and rising costs, budget constraints of health systems, personalised medicine and pharmacogenomics, e-health, disease management and evidence-based medicine, and the social and financial impact of delivering healthcare and pharmaceuticals to the third world

The future of the pharmaceutical industry depends upon its ability to discover, develop and market innovative and useful medicines in this harsh competitive climate. To compete effectively, market leaders recognise the need to monitor unmet medical needs, industry activity and competitor strategy as a regular part of doing business. Competitive intelligence is an essential cornerstone in this process

For all its faults?

The industry operates under a number of constraints, one of which is that it is composed of commercial enterprises. All companies need to make profits for their shareholders, otherwise they will simply cease to exist. In the case of research-led pharmaceutical companies this means that they have to focus on discovering, developing and manufacturing safe and effective products for which people – and healthcare systems – will pay, in order to justify the considerable costs of developing these medicines. Such medicines are therefore aimed at diseases of the developed world, especially chronic conditions such as cancer or Alzheimer’s disease. It’s the only realistic way that the research and development can be financed

Why is developing new drugs so expensive?

One reason is that drug discovery and development is very sophisticated, and requires very expensive technologies and huge numbers of scientists. Another reason is that it takes a very long time – on average 10 years - because of the safety and efficacy tests that governments insist on before a new medicine can be marketed. A recent estimate from Tufts University in the United States estimates that each new drug costs around $802 million to bring to the market 

What about the developing world and people with rare diseases?

There have been various attempts to make medicines available to countries of the developing world which cannot afford the high costs of new medicines. Individual companies have tried to develop different economic models for poorer countries and pursue charitable agendas – as an example, one company’s endeavours are described here

One general approach has been to use older medicines – i.e. those which are no longer subject to patent protection, and which can therefore be made available cheaply, often by companies other than the originators. Lists of such “essential drugs” have been composed by the World Health Organisation

Another approach has been for rich governments to pass “orphan drug” legislation which can make it worthwhile – e.g. via tax breaks - for companies to develop drugs for which there are only a small number of patients, or for diseases mainly encountered in poorer countries

Medicines for all

Recently there have been some very interesting developments relevant to addressing the needs of the developing world for medicines

At the strategic level, governments of richer countries are realising that we all really do live in the same world, and that sooner or later issues that are important to poorer countries become relevant to everyone else. Hence there are discussions ranging from writing off third world debt to relaxing pharmaceutical patent restrictions in developing countries

An exciting recent drug development initiative is the establishment of the Institute of OneWorld Health, a non-profit pharmaceutical company which aims to develop existing medicines ‘discarded’ by the pharmaceutical industry for use in developing countries

More radically still, there are new academia-based drug discovery initiatives which are beginning to emulate the commercial pharmaceutical R&D model in that they aim to validate new drug targets and test chemical compounds against diseases of importance to the developing world, such as Leishmaniasis. These include Dundee University in the UK, the Walter and Eliza Hall Institute in Melbourne, Australia and Harvard University in the USA. These centres hope to discover potential new drugs which could then reach clinical testing funded by the World bank or some commercial pharmaceutical companies