As a new generation of AIDS-fighting drugs emerges, there’s fear the antiretrovirals may be too expensive for low and middle income countries. At the 19th International AIDS Conference, a medical aid group is raising concerns about prices and patents.
Doctors Without Borders, also known as MSF, treats about 220,000 people for HIV/AIDS in 23 countries. Medical Coordinator Nathan Ford said the trend for cheaper AIDS drugs has started to reverse.
“While some of the older antiretrovirals, or ARVs, have seen dramatic price reductions in the last decade, the newer medicines that are needed for patients who are failing first line therapy and second line therapy are dramatically more expensive --tenfold or even twentyfold more expensive than first line treatment,” he said
Ford said the new drugs may be widely needed in the coming years.
“There are real discussions by the World Health Organization and other expert groups about some of these newer medicines being moved earlier into the course of treatment so that patients, who are failing first line medicine already, can benefit from these newer, more powerful, less toxic drugs. So WHO and other groups are saying that these are medicines that we really want to be able to provide patients earlier in the course of treatment,” he said.
MSF reported the problem arises from new World Trade Organization agreements and patent regulations that can block the manufacture of generic drugs. A new report said middle-income countries “are increasingly taking measures to overcome the patents that price drugs out of reach.”
Patients start out on what’s called a first line regimen of medication. If for some reason that fails, or has too many side effects, they are put on a second-line and then a third line of treatment. But second and third line drugs are much more expensive.
Leena Menghaney is with Doctors Without Borders Access Campaign in India, which is a leader in the manufacture of generic drugs. However, she said there’s now a need for newer, expensive antiretrovirals – especially since more patients are co-infected with XDR-TB. That’s a strain of tuberculosis that’s become drug resistant
Leena Menghaney, MSF, Acess campaign, India (De Capua)
“We are working in Mumbai, which is the epicenter or you can say the heart of where the first few AIDS cases came out. It’s a very complex epidemic in Mumbai. You have patients with XDR, but you also have patients who have been on first line and second line and have now started to need the newer drugs. Unfortunately, for us, what has happened is that we are paying more than $2,100 for just one single drug that we’re using in the third line regimen. And ethically speaking, as doctors, we cannot turn these patients away,” he said.
For the first time India has had to use patented AIDS drugs.
She said, “It has the capacity to make those drugs. The drugs are patented. And now the World Trade Organization’s IP regime is now starting to very much hurt access to medicine in India itself.”
IP regime stands for intellectual property regime. Critics say it creates a monopoly over knowledge that stifles innovation and competition. They say while patent holders may benefit financially, social benefits may lag behind.
India signed a World Trade Agreement in 1995 and had to implement it in 2005. That agreement requires drug patents, which block generic manufacturers.
But, last March, India, for the first time, issued what’s known as a “compulsory license” to override a patent on a cancer drug. Under certain conditions, possibly a health emergency, countries can act to break patents and manufacture generics. The holder of the patent would get some sort of compensation. However, it’s not a simple process and can trigger international legal battles.
MSF said India’s move may set a precedent to gain access to new ARVs. It also says China has now established a system to override patents.
MSF Policy Advocacy Director Michelle Childs said besides compulsory licenses, countries can try to take advantage of a drug manufacturer’s discount plan. But not all countries.
Michelle Childs, MSF Director of Policy Advocacy (De Capua)
“As we showed last year, in relation to the company discounts schemes, lower-middle income and middle income countries are excluded. And that has continued this year. And we’re starting to see the effect, for example, in relation to third line drugs of what that actually means,” she said.
Other options, she said, are “voluntary licenses.”
“Pharmaceutical companies will enter into agreements with generic companies so that they can make medicines and also export them to a number of countries. The problem with voluntary licenses is twofold. Firstly, they are mostly secret. So you do not know the terms and conditions and that can have an important effect on competition. The other important thing that is clear is that there is no voluntary license that covers all developing countries,” she said.
Childs said the trend is to limit voluntary licenses to least developed countries and some areas of sub-Saharan Africa. Some NGOs have moved to block the granting of drug patents in Brazil, another leader in generic drugs.
“The middle income countries are really facing a kind of pincer movement. They are facing rising costs from patenting. They are excluded from discounts. They are excluded from voluntary licensing, which is why there has been now more of a focus on what measures they can take to remove patent barriers,” she said.
There are about 30 antiretroviral drugs now approved for HIV/AIDS. Newer drugs are needed not only because of potential drug resistance, but also toxicity. For example, MSF said some ARVs can actually disfigure a patient’s face by affecting fat deposits.
Drug makers have said they need to recoup the cost of drugs so they can invest in research and development. MSF Medical Coordinator Nathan Ford agrees. But he said they cannot recoup their investments in all countries where the drugs are used.
“We know that companies recoup their investments in developed countries. If you’re charging a price for a drug in a country [where it’s] unaffordable, you’re not making any money because nobody’s buying that drug. So they don’t recoup their investments in Malawi or Mozambique or Kenya or indeed even potentially South Africa. They recoup their investments in North America and Europe,” he said
Doctors Without Borders said there is a solution to the drug patent issue – a political one.