Affordability, Availability and Adaptability of AIDS Drugs in Developing Countries: An On-going Challenge

MSF’s Campaign for Access to Essential Medicines first published a report on AIDS drug prices in 2001, in response to the lack of transparent information available for treatment providers to be able to make informed purchasing decisions. MSF, along with others providing HIV/AIDS treatment in developing countries, continue to struggle with affordability, availability and adaptability of antiretroviral drugs (ARVs). Now in its 11th edition, ‘Untangling the Web of Antiretroviral Price Reductions’ provides a window into the evolution of ARV prices since 2001.

Karen Day, Pharmacist Coordinator for MSF’s Campaign for Access to Essential Medicines, provides an overview of some of the key issues in this years’ report:

What does treating a patient with ARVs cost these days in developing countries?

Well, the most affordable first-line antiretroviral fixed-dose combination (3TC/d4T/NVP) now costs $87 per patient per year. We’ve come a long way since 2001, when this cost more than $10,000 per year, before generic producers started making ARVs – that’s more than a 99% price reduction. But a real challenge that treatment providers, including MSF, are facing is high prices for newer ARVs.

HIV/AIDS is a disease that requires life-long treatment and people need to be able to have access to newer drugs to give them alternatives when they experience the side effects of their drugs, or when they develop drug resistance. Resistance is something that will inevitably develop, even if people take every single pill correctly. For these situations, we need access to new, more potent, and less-toxic drugs.

Can you give an example of the price increase you see for people who need to switch because of side effects? And how common are these side effects?

The drug stavudine (d4T), which is one of the components of the most commonly used ARV fixed-dose combination in developing countries, is associated with many side effects, which are quite common. In one of MSF’s AIDS projects in Rwanda, almost one in every six people on stavudine had to change their regimen due to toxicity. In 2006, the World Health Organization recommended that treatment providers move away from this drug to less-toxic regimens, based on either zidovudine (AZT) or tenofovir (TDF). But this has considerable price implications, ranging from double, at best, for AZT-based regimens, to up to 11 times for TDF-based regimens, in countries that cannot access generic versions because of patent protection. We need the prices to come down, but for this to happen, we need more manufacturers to enter the market, creating the competition that drives prices down.

And what about patients who need newer drugs because of resistance?

For patients who need a ‘second-line’ treatment regimen, the price jump is a lot greater. The increase ranges from nine-fold to up to 17-fold in some ‘middle-income’ countries where the drugs are patented and treatment providers must buy the product from the originator company. And the need for second-line regimens will continue to increase. In MSF’s longest-running AIDS project, in Khayelitsha, South Africa, 22% of patients on treatment for five years needed to be switched to a second-line drug combination. We desperately need more affordable newer medicines to be available in developing countries.

Pharmaceutical companies offer price discounts for developing countries, don’t they?

Yes, but when new drugs enter the market, the companies generally have the monopoly and can control the market by dictating which countries can access the drug and at which price. Experience has shown that the discounts these companies offer are simply not big enough to make a difference. Competition among multiple producers is the tried and tested way to bring prices down, but patents can stand in the way of allowing generic producers to enter the market. India, for example, didn’t grant pharmaceutical patents until 2005, and therefore has been one of the key countries where affordable medicines have been produced. In fact, MSF buys more than 80% of the AIDS drugs it uses from Indian manufacturers and the country has been called the ‘pharmacy of the developing world.’

So why aren’t there affordable generic versions of the newer drugs for which there is a growing need?

Because more and more of these newer drugs are being patented in India, despite the fact that the country has a very strict law in terms of what does and does not deserve a patent. So this means that generic manufacturers will no longer be able to produce affordable versions of drugs unless the company agrees to voluntary licenses with generic manufacturers, or the government decides to override a patent with a legal mechanism in patent law called a ‘compulsory license,’ which allows another entity or entities to produce the drug against the payment of a royalty. Another way around this is through pooling patents and managing patent rights collectively, such as the recent proposal the drug purchasing facility UNITAID is moving forward with. This will help bring prices for newer drugs down through increased competition, and lead to the development and production of pediatric formulations and the combination pills we need to simplify treatment for patients.

And what are the trends with AIDS drugs for children?

Unfortunately, children continue to be an afterthought when it comes to producing appropriate formulations of medicines. Of the 22 ARVs approved by the U.S. Food and Drug Administration, eight are not approved for use in children and nine do not come in any kind of pediatric formulation. And when versions for kids do exist, they are often not adapted for use in resource-limited settings, meaning they are powders requiring reconstitution with water, or syrups, both which may need refrigeration, for which access can be limited in developing countries. In addition, the bitter taste of some formulations makes dosing children quite a challenge.

Generic manufacturers have actually been at the forefront of developing and producing adapted three-in-one combination tablets for kids, and several do now exist. But it’s a sad fact that it has taken six years longer to get such a tablet combination for kids than it did for adults. There really needs to be more effort put in to addressing pediatric AIDS, but because in the West pediatric AIDS has nearly disappeared, there is not much of a market incentive for pharmaceutical companies to invest in it.

But the bottom line is that if prevention of mother-to-child transmission programs were implemented more successfully in developing countries, as they are in the West, we wouldn’t still be seeing the alarming infection rate among children anymore. There is an urgent need to address this.

And what about some of the newest AIDS drugs that have come out recently?

There have been some significant advances in the development of new drugs that attack the HIV virus in new ways. This really offers people living with HIV/AIDS many more treatment options. The trouble is, few of these newer drugs are developed to address the specific needs of patients in developing countries, such as women of childbearing age, children, and people who need to be able to take drugs for other conditions such as tuberculosis or malaria at the same time. This is a real problem, and there needs to be change much earlier in the drug development process, so we don’t have to wait years and years after such drugs become available in the West for there to be formulations that people in developing countries can use.

The companies that are producing these new drugs furthermore have not even provided prices for developing countries, which shows you how far away we still are from being able to get these drugs to people in resource-limited settings. The access gap still remains huge between people in wealthy and developing countries. And the lack of a specific research and development agenda for AIDS in the developing world is a growing problem.