HIV/Aids drugs will soon be priced out of reach of the poor

Seven years after an agreement at the World Trade Organisation to allow developing countries to import inexpensive copies of costly patented medicines, the compromise has failed to deliver on its promise as a pharmaceutical lifeline for the global poor.

Since the 2003 deal was reached, just a single shipment of antiretroviral drugs, the only effective treatment for HIV infection, has been delivered under its terms.

With upwards of 55 million people expected to need ARV therapy by the year 2030, health experts warn that global patent rules are contributing to a looming “time bomb” as current drugs lose their effectiveness and their newer, patented replacements are priced out of reach of all but the wealthy.

Unless the system is fixed, analysts caution, the flow of affordable lifesaving generic medicines to the world’s poorest could slow to a trickle and millions of lives — most of them African — will be lost.

The reason nearly three million Africans are now on ARV therapy is that the drugs are available for as little as $80 per patient per year, says Emi Maclean, a treatment access officer for the non-governmental Médecins sans Frontières (MSF).

This compares with an annual cost of over $10,000 when the patented treatments were first developed. The price drop, she says, was caused by fierce competition from Indian generics manufacturers who were free to copy the drugs under Indian law.

The Indian case

But that is about to change. With Indian patent laws now compliant with the WTO’s strict patent rules, she notes, it will be much harder to produce cheap generic versions of newer, more effective ARVs that are already standard in Europe and North America.

Because of serious side effects with the drugs commonly used in Africa, Ms Maclean argues that there is already an urgent need to switch to the newer formula. But that version is “two to three times more expensive.” More advanced ARV treatments can cost 27 times more.

The 2003 agreement, reached after nearly two years of hard negotiations at the WTO, was designed to create a loophole in the international rules governing medicine patents.

These rules, known as Trade Related Aspects of Intellectual Property Rights, or Trips grant patent holders a 20-year monopoly on their creations.

But they allow governments to override those protections under some circumstances through the issuance of a “compulsory licence” to a local manufacturer to make copies of patented products for domestic use without the patent owner’s permission.

The 2003 WTO exemption allowed poor countries without local drug-manufacturing industries to import generic drugs made under compulsory licences in other countries provided a number of steps were followed.

These included advance notification by the importer of the type and quantity of drugs ordered, and changes in the shape, colour or packaging of the products to distinguish them from the originals.

Many non-governmental medical groups and anti-Aids activists immediately criticised the agreement as unworkable.
They argued that the need for prior notification exposed the importing countries to political and economic pressure from donors, multinational drug companies and trading partners opposed to the use of compulsory licences.