Janice Lee is a pharmacist who worked with medical teams in Doctors Without Borders/Médecins Sans Frontières (MSF) projects in Liberia and Zimbabwe before starting work with MSF’s Access Campaign. Her job is, among many other things, to identify potential new sources of drugs that could be of use to MSF’s work treating patients in developing countries. She also works closely with both originator and generic drug companies to feedback on the medical needs that MSF sees in its work in the field. Here, she talks about why generic medicines are so important to our medical teams working in some of the poorest places on earth.
You worked as a pharmacist in Liberia and Zimbabwe, dealing with the drugs for our projects, how dependent are MSF medical teams on generic drugs from India to carry out their work ?
Our reliance on Indian generic drugs for treating patients with HIV/AIDS across all our programmes in MSF is particularly acute—around 80 percent of the AIDS medicines we use are generic drugs made by Indian companies. But it’s not just AIDS. In other projects too, we also routinely use Indian generic drugs to treat other diseases, such as TB, malaria, and a wide range of infectious diseases.
And it’s not just MSF that relies on the flow of generic drugs; all the major donors and leading international treatment providers, like the Global Fund, PEPFAR, UNITAID, and UNICEF, are all rely on quality affordable generic drugs for the programs they support. Right now, at a time when funding for global health programs is shrinking, it’s more important than ever to keep the flow of these affordable drugs going.
Why are so many of these generic medicines made by companies in India ?
There are several reasons. Most importantly, many of the AIDS drugs we use right now to treat people with HIV are patented in many countries. But international trade rules required India to start granting patents on pharmaceutical products only after 2005. Until that time, Indian companies were able to manufacture generic versions that competed in price not only with brand name companies but also amongst themselves to bring down the prices of AIDS drugs drastically. This is what allowed the price of treatment to drop from over US$10,000 ten years ago to less than US$80 today.
What’s more, it has been possible for them to create fixed-dose combination pills of these generic antiretrovirals—essentially two or three pills in one—that have been hugely influential in simplifying AIDS treatment and making treatment more practical in developing countries where we work. Imagine, we can offer a patient one pill once a day rather than a handful to be taken at different times of day. Some of these fixed-dose combinations don’t even exist in rich countries precisely because of the patent barriers that exist there.
In 2005, India put in place a patent law—fortunately it’s a law that supports public health objectives, so the result has been that India’s generic manufacturers have had some space to continue producing affordable and effective medicines. But the problem ahead of us is that many of the newer AIDS drugs are now patented in India and so cannot be produced by the generic manufacturers, so they will remain out of reach.
How will the current trade talks between the European Union and India make this situation worse ?
The trade talks could be another tightening of the screw. One of the main provisions that Europe wants to include in the trade deal is data exclusivity, which means more affordable generic medicines can’t be registered on the basis of data for safety and efficacy that is already out there, the generic companies will have to run their own clinical trials. If India accepts this then two options open up: generic companies will either have to wait longer (anywhere from five to ten years) before they can market their own versions of an expensive originator drug. This means it will be longer before patients can benefit from the development of an affordable generic version of the medicine. Or, in order to register their medicines, the companies will have to conduct their own clinical trials on their products, which is not only unnecessary but will also be very expensive, time-consuming and unethical. Data exclusivity won’t affect drugs that are already registered and on the market in India but would impact on the promising newest antiretroviral drugs coming along in the drug pipeline that could be our new essential treatment for AIDS patients. And what’s particularly dangerous is that it applies even where drugs are not under patent, so it acts like an alternative patent that blocks generic production.
So how much more expensive could AIDS treatment be for patients if we had to use branded or originator drugs rather than generic drugs ?
We know in the lowest income countries, a year’s treatment using the latest recommended World Health Organization recommendations containing tenofovir from an originator company costs US$613. And in some middle-income countries that price rises to over US$1000. Compare that to the price of the generic version of US$176 in a fixed dose combination pill and you can see why generics are so important, allowing us to treat many more people.
Patients who have been on antiretroviral treatment for some time develop resistance to their treatment and may have to move to newer AIDS treatments. How do branded drugs compare in price to generic drugs in that case ?
For what is called a second-line treatment, the cost of a year’s treatment using a generic combination of second-line antiretrovirals (containing boosted atazanavir) would be US$465. A branded product can cost two to three hundred dollars more.
And once a patient develops resistance to that second set of drugs, there are really no affordable options since the generic production of the newest AIDS drugs has already been stopped in India because the drugs are patented. The lowest branded product can cost over US$3,200 for a year’s treatment, which is completely out of reach for most people in developing countries.
Do generic medicines also make the treatment of children with AIDS more affordable ?
It’s a different story for children because the originator companies don’t see any commercial gain in developing and marketing fixed-dose combination treatments for children. This is essentially because in their main markets, rich countries, pediatric AIDS has almost been wiped out. So most AIDS medicine formulations for children only come from generic manufacturers in the first place. Currently the most commonly used generic fixed-dose combination for treatment of HIV/AIDS in children costs US$55 to treat a child for one year.
We also need to expand the range of options for treatment of children with HIV/AIDS and ensure that they are developed with the needs of developing countries in mind both in terms of research and development but also the formulation. For instance, most of our patients do not have a refrigerator and some remote places where we work don’t have a power supply, so drugs cannot be refrigerated. Formulations adapted for use in developing world are more likely to be developed by generic manufacturers than the big name pharmaceutical companies based in Europe and the United States.
You’ve been working for MSF in AIDS programs alongside the medical teams, what would it mean if we couldn’t get our hands on these generic drugs any more ?
Patients would die! And we would go back ten years to where we started, when treatment was too expensive to give to patients and all we could do was basically just treating the opportunistic infections that accompany HIV infection without being able to suppress the virus at all. When you remember that there is already a funding crisis today that threatens countries’ ability to put more patients on treatment, then having medicines become more expensive in the future is a very a frightening prospect.
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