Access to lifesaving medicine is something many of us in North America take for granted. When we get sick, we drive to our doctor or nearest walk-in clinic and see a doctor, usually promptly. Following that, we head to a nearby pharmacy to fill any prescription before returning home to rest and recover.
But, what if the nearest doctor was hundreds of miles away? And if by chance you were lucky enough to make it to the doctor, what if there was no pharmacy or access to the medicine you need?
As many of us know, this scenario is a reality for millions of people living in developing nations around the world. According to a new report from the United Nations Secretary General, it’s also a stark reality for millions of middle-income people living in developed countries.
“400 million people lack health care, including access to medicines, vaccines, diagnostics and medical devices, of whom 300 million live in middle-income countries,” notes a fact sheet that accompanied the report.
What’s particularly noteworthy is that this highly-anticipated report, which was released in mid-September this year, calls for the collaboration of both big pharma and generic drug manufacturers to assist in bringing a wider level of comprehensive medical care to countries throughout the world.
“The world must take bold new approaches to both health technology innovation and ensuring access so that all people can benefit from the medical advances that have dramatically improved the lives of millions around the world in the last century,” wrote the UN Secretary-General.
The panel concluded that this can be best achieved in part through the widespread relaxing of patent claims on medicines through the introduction of a compulsory licensing program. It’s believed that a program like this would give generic drug manufacturers the ability to offer more affordable medicines in countries where the vast majority struggle to earn more than $2 a day, as well as in middle-class countries where cash-strapped citizens can’t afford prescription drugs.
Currently, there is a voluntary license protocol that allows most developing nations access to medicines for life threatening illnesses by securing voluntary licenses from pharmaceutical companies. Licenses like these permit generic manufacturers to copy the pills, while avoiding the risk of facing a potential lawsuit over intellectual property infringement.
While the voluntary program has aided millions of people in the poorest countries by providing better access to drugs, critics have been hard on the program, stating that it leaves out a large portion of the global population in need.
“With voluntary licenses the big critique is that they often exclude middle-income countries, which is where the majority of poor people live, so excluding them is very unhelpful,” said Mandeep Dhaliwal, director of health and HIV at the UN Development Programme.
The proposed U.N. compulsory program would instead see countries that are struggling to afford drugs be able to unilaterally issue compulsory licenses. These new licenses would allow a country to quickly access a generic supply without the branded pharmaceutical company’s permission.
As mentioned, the idea of a compulsory licensing program is not new. In 2003, in a landmark decision, member countries of the World Trade Organization (WTO) agreed to waive licensing provisions that were inhibiting generic drug exports to developing nations in need of medicine. Two years later, Canada became the first WTO member to act on the decision, creating a legal framework under Canada’s Access to Medicines Regime (CAMR) for generic versions of patented drugs to be shipped to nations in need. Canadian generic drug manufacturer, Apotex, was one of the first manufacturers to participate in the program. Beginning in 2005, Apotex invested more than $2 million in the research and development of a treatment for HIV using three different drugs. Three years later, Apotex’s work through CAMR’s legal framework allowed the generic manufacturer to manufacture and export 7 million doses of antiretroviral medication to Rwanda. It’s a story that should provide further weight to the compulsory program currently proposed by the UN.
In the past, many free trade agreements contained significant protection in the area of health technologies and medicines, which in turn blocked many countries from accessing these technologies. Whether some of these protections are lifted or not, the United Nations Secretary-General’s report returns a spotlight to a crucial topic: the right for a person to have adequate health care regardless of where they live.