Washington, DC - Middle-income countries are increasingly taking measures to overcome the patents that price drugs out of reach, according to a new report released today by the international medical humanitarian organization Médecins Sans Frontières (MSF), Untangling the web of antiretroviral price reductions.

In March, India for the first time issued a ‘compulsory license’ to override a drug patent on the cancer drug sorafenib tosylate, produced by Bayer. The move sets an important precedent for access to antiretroviral (ARV) drugs that are unaffordable. China has also just confirmed its mechanism to override patents.

“Our report shows that the newest HIV drugs are now patented in India, the pharmacy of the developing world, and this blocks the production of more affordable generic versions that we need for some of our patients,” said Nathan Ford, Medical Director of MSF’s Access Campaign. “The power balance has to change as developing countries begin to make use of their rights to overcome patents when monopoly sellers price their drugs out of reach. For this reason, we fully support countries like India that are using their new patent laws to deal with monopoly abuses. If high prices prevent access to life-saving medicines, they override them.”

Unaffordable drug prices

The newest ARVs are unaffordable: a triple combination of the three drugs raltegravir, etravirine and darunavir boosted with ritonavir for people who have failed a second-line regimen, costs $2,486 per person per year in least-developed countries and sub-Saharan Africa - nearly 15 times the price of a first-line regimen. Meanwhile, middle-income countries pay many times more: MSF’s HIV and TB treatment program in India pays more than $2,147 per patient per year for just the drug raltegravir; in El Salvador the drug etravirine alone costs $6,917, while darunavir costs $8,468 per year in Georgia.

Additionally, over the last two years, lower-middle- and middle-income countries have been locked out of company discount programmes and are forced to negotiate prices on a case-by-case basis, which has led to higher prices. The Untangling report shows that the patient-friendly one-pill-a-day combination of TDF/FTC/EFV (produced by Merck/BMS/Gilead) for the last five years has remained at $1033 in lower-middle income countries, six times more than the generic first-line combination, and countries locked out of these discounts must pay many times more.  

Blocked from accessing medicines

Lower-middle-income and middle-income countries are also increasingly being blocked from accessing medicines produced under voluntary license agreements between multinational pharmaceutical companies and generic manufacturers, where the terms and conditions are largely kept secret. The report finds that there is no voluntary license agreement for ARVs that covers all developing countries.

“Multinational companies are trying to give the impression that with voluntary license agreements, all HIV drug access problems are solved, but our report shows that some countries are deliberately being left out, and there are other terms that restrict competition,” said Michelle Childs, Director of Policy/Advocacy at MSF’s Access Campaign.

Several of the newest ARVs are already priced out of reach because they have been patented in India, blocking the production of more affordable generic versions.

Until 2005, India did not grant patents on medicines which allowed free competition among generic producers. This helped drive prices down by 99 per cent for the first generation of ARVs, from more than $10,000 per person per year in 2000 to roughly $120 today.

‘Monopolies should not be handed out left and right’

While the country had to begin granting patents under World Trade Organization rules in 2005, India designed a patent law that is strict about what merits a patent. The law also allows any interested party to oppose a patent before or after it is granted. Such patent oppositions have already led to multiple ARV patents being rejected in India, such as for the drugs tenofovir and lopinavir/ritonavir.

In contrast, South Africa’s law is particularly lax about patenting, with 2,442 pharmaceutical patents having been granted in 2008 alone compared to just 278 in Brazil for the five-year period of 2003 to 2008.

“As more people need access to newer drugs that are priced out of reach, countries should take a close and hard look at their patent laws to make sure that monopolies aren’t being handed out left and right, with dire consequences,” said Childs. “The fact that countries are putting flexible mechanisms into place and are using these is a game-changer.”