Real Clear Health

The Patent Truth: The Access to Medicines Debate

Senior Fellow Emeritus
An employee fills blister packs with capsules at the end of the production chain at the Juva Sante Laboratoires plant, on March 13, 2013 in Forbach, France. (JEAN-CHRISTOPHE VERHAEGEN/AFP/Getty Images)
An employee fills blister packs with capsules at the end of the production chain at the Juva Sante Laboratoires plant, on March 13, 2013 in Forbach, France. (JEAN-CHRISTOPHE VERHAEGEN/AFP/Getty Images)

Bill Gates and Abraham Lincoln are in agreement. Gates, whose foundation funds the development and distribution of new medicines in the developing world, said the U.S. system "is better than most other systems one can imagine.... The drug companies are turning out miracles, and we need their R&D budgets to stay strong. They need to see the opportunity." It turns out that Mr. Gates is in good company. Lincoln, the only U.S. President to hold a patent, called the IP system, "the fuel of interest which fires man's genius."

At the United Nation's General Assembly, which opened on September 13th, a group called the High Level Panel on Access to Medicines (HLP) was working hard to extinguish that source of miracles. The UN's HLP issued a report with recommendations that would disrupt medical innovation and potentially lower the health status of impoverished communities throughout the world. The report's fundamental premise is that millions of people in low and middle-income countries have been denied access to medicines because patents have increased their prices.

According to the outgoing Secretary General Ban Ki Moon, the current intellectual property (IP) system is limiting medicines that could serve the needs of the poor. The big idea on the table is to replace the current IP system with a new global drug development and approval regime, orchestrated by governments and UN agencies.

The proposed changes could cripple the current system of research and innovation that has brought us the largest gains in life expectancy and disease reduction that the world has ever known.

Beginning in 1960, at the dawn of the post-colonial world, the global population stood at three billion. Today, it is 7.3 billion, with the majority of that growth in low and middle-income countries. Through the arc of human history, a population growth of 4.3 billion in such a compressed period of time is unprecedented. It came about because billions of people had access to medicines and modern technology spurred on by the current IP system.

Medicines and medical technology were key to this success, a point disregarded by the UN's new recommendations. The incidence of polio has been reduced by 99 percent. In the 1970s, only 5 percent of the world's children had access to vaccines. Today it is 80 percent. These statistics are just a few in the dramatic reduction of disease and disability through medicines made available to people in low and middle-income countries.

The UN's HLP ignores this progress, and the evidence that innovation and its intellectual property laws can exist alongside the delivery of medicines and health services to people in need. It also ignores a number of other known factors that reduce access to medicines: underdeveloped health systems, including insufficient healthcare personnel, hospitals and clinics; excessive taxes that governments put on incoming drugs both donated and sold, corruption; and policies that inhibit economic growth and incentives to develop new technologies.

The new recommendations also ignore the parties that brought both innovation and access to medicine through the current intellectual property system. Over decades of work and cooperation, the World Health Organization, the World Intellectual Property Organization (WIPO), and others created initiatives that allowed companies to maximize their innovations while also helping generic producers manufacture safe and affordable drugs for low-and middle-income countries.

Governments need to be aware of attempts by UN agencies to put the HLP recommendations into programs, particularly during the UN budget planning process this coming December. Replacing the current system's proven accomplishments with an untested system would endanger the astounding improvement in health conditions of the poor over the past half-century. Over time, it might turn a miracle into a tragedy.