I. INTRODUCTION: HEALTH CRISES, ACCESS TO MEDICINES AND THE POOR
Many of the diseases and health conditions that account for a large part of the disease burden in low- and middle-income countries are far less common in high-income countries. These burdens are primarily associated with infectious diseases, reproductive health, and childhood illnesses. Just eight diseases and conditions account for 29 percent of all deaths in low- and middle-income countries: TB, HIV/AIDS, diarrheal diseases, vaccine-preventable diseases of childhood, malaria, respiratory infections, maternal conditions, and neonatal deaths.
Approximately 17.6 million people in low- and middle-income countries die each year from communicable diseases and maternal and neonatal conditions. Both the occurrence of and the death rates from such diseases and conditions are far lower in all high-income countries.1
Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people's lives. High-profile pandemics like HIV/ AIDS understandably attract considerable attention. Millions of people have died of this terrible disease 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively.2 As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.
The obvious reason why treatment access is such a problem is poverty. People do not have the money to buy the drugs, and governments, even those that are not corrupt or otherwise woefully dysfunctional, lack the resources and infrastructure to get them to those who need them but cannot afford them. The pharmaceutical industry certainly prefers to blame poverty and poor governance, and rejects arguments that patent rights allow them to set high prices that keep life saving drugs out of the reach of the poor.3 Up to a point, the industry is right. But to suggest this is a sufficient explanation is to be disingenuous.
High drug prices are not of course the only factor limiting patients' access to them. Access even to very cheap drugs tends to be inadequate too. Poor people often live far away from clinics and hospitals. Also, many countries are short of medical practitioners trained to prescribe drugs to patients in the appropriate combinations and dosages. Nonetheless, high prices obviously have a profound impact on the ability of cash-strapped governments and other healthcare providing organizations to deliver drugs to the poor. National pharmaceutical markets are often highly regulated, and companies are not always free to set prices entirely as they wish. Yet companies holding patent monopolies are in a strong bargaining position for as long as they can keep out the generic competition, which potentially could drive prices downwards towards the marginal cost of making the drug in question.
II. PATENTS AND PUBLIC HEALTH: STRIKING A BALANCE
Patents for inventions have their origins in Renaissance Italy. The Republic of Venice passed a patent law in 1474 whose underlying purpose was to attract "engineers" with the incentive of a 10-year monopoly right to their "invention[s]."4 The moral interest of inventors and the wider societal benefits were treated as complementary. Thus, in preventing others from building them and taking the inventor's honor away, it was believed that "more men would then apply their genius, would discover, and would build devices of great utility to our commonwealth."5 It is important to note that the public interest was also upheld by a provision allowing for government use.6
Patents are supposed to benefit society through (i) the widest possible availability of new and useful goods, services and technical information that derive from inventive activity, and (ii) the highest possible level of economic activity based on the production, circulation and further development of such goods, services and information. …