Talks resumed this week at the World Trade Organization in Geneva on the question of renewing the pharmaceutical patent trade exemption for the world’s least developed countries. Representing those countries at the talks is Uganda alongside Nepal and Bangladesh. At issue is a U.S. government proposal to impose a ten-year limit on the exemption. Ugandan officials say that change could cost lives in the countries that need access to new low-cost generics the most.
Under current World Trade Organization guidelines, 34 of the world’s “least developed countries,” classified as LDC’s, are exempt from pharmaceutical trade patents.
Most of these countries are in Africa. The exemption means LDC’s like Uganda can import or manufacture low-cost generic versions of name-brand drugs. Whereas countries considered to be more developed, like for example France and Kenya, cannot.
In real terms, that means an LDC like Bangladesh has the right to make or import either for use or for sale to another LDC a low-cost generic version of a new medicine that may cost hundreds of dollars per pill in the United States.
However, this exemption is set to expire at the end of this year.
Uganda is pushing for its indefinite renewal for countries in the LDC bracket. U.N. AIDS, the World Health Organization, the European Union and Doctors without Borders all back this proposal.
But the United States wants to restrict the renewal to ten years.
Ugandan health officials say a decade is not enough for Uganda to develop research labs and independent manufacturing.
Moses Mulumba is executive director of the Center for Health, Human Rights and Development in Kampala.
“In the era of diseases like HIV/AIDS or tuberculosis and malaria, we really need to access the medicines. Unfortunately, the current discussion seems to be focused on more of rewarding the inventors. And for partners like United States it becomes even more sickening if they speak on one hand to provide help and on the other hand to adopt policies and laws that will be taking away medicines,” said Malumba.
If the exemption is not renewed this year, that would mean as of January 1st, LDC’s could only manufacture low-cost generics of off-patent drugs, which are typically more than 20 years old. If the U.S. proposal passes, that would be true starting in 2026.
With continued high rates of HIV in LDC’s like Uganda alongside growing global concern over antibiotic resistance, officials say limiting access to newer drugs could be catastrophic.
Nevin Bradford is chief executive officer of Cipla Quality Chemicals, one of only two W.H.O.-approved pharmaceutical manufacturing plants in East Africa.
“What will happen to the availability of newer drugs? Because HIV is a virus which mutates, develops resistance. Drugs that were very active first line treatments five years ago are not so effective and in some cases they’ve been stopped because the virus has developed resistance. And that also applies to hepatitis and other conditions of course..,so you could be in a situation in five years time where the drugs we are manufacturing and selling now are less effective. And it’s the newer drugs that will become first line,” said Bradford.
The U.S. Embassy in Kampala says while the United States recognizes the gravity of the situation, intellectual property protections for pharmaceuticals create incentives for investment in research and development of new treatments.