Dr. Tido von Schoen-Angerer thank you for joining us today.
Can you please tell us a little about yourself and your work with Medecins Sans Frontieres (MSF)?
Answer
Hi, thank you for having me today.
I am leading the Campaign for Access to Essential Medicines of Medecins Sans Frontieres. We started this campaign because in the projects we undertake, we are increasingly facing the problem that existing medicines are too expensive and not available or that new, more effective therapies are not developed because there is no profit in diseases such as tuberculosis, kala azar, malaria etc.
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Editor
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Question
Novartis, a huge pharmaceutical company, is taking the Indian government to court regarding its patent laws.
Can you please give us a quick overview of the case please?
Answer
Novartis lost its patent application for Gleevac, a cancer drug. Now they are going to court, saying the Indian patent law is too strict.
But in fact India completely changed its patent law already in 2005 to oblige with World Trade Organization rules, so they have done what they had to do. As of now, India is providing adequate patent protection but the Indian law does not give patents to small improvements in existing medicines - this is what Novartis wants to have changed. This way, companies can extend their patent by continuing to make small changes, called "ever greening".
The case is so important because today India is the pharmacy of the developing world: more than 50% of AIDS medicines used come from India, in our own projects it is over 80%. If Novartis wins this case it will affect production of many new essential medicines.
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Donia Metwalli
- Egypt
Profession
Question
Dr:
has this scenario happened before?
I mean has there been any similar lawsuits and what was their outcome?
Thanx
Answer
Yes, a similar law suit was filed by 49 companies against the government of South Africa in 2001.
There was a huge public outcry and pharmaceutical companies finally dropped the case.
This is why it is so important that our petition for Novartis to drop its case is widely supported. I hope you and your friends will sign - see www.msf.org
It seems Novartis really wants to fight this through and we don't know if we can succeed this time.
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Zakaria Belbes
- United Kingdom
Profession
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Dear Dr:
I understand your point of view completely on the patent law changes and it's effect on people, but I would also like you to clarify your point of view regarding the fact that drug companies like Novartis do spend a vast amount of money on research?
Answer
Yes, vast amount of money is spent on research by governments and industry but today all innovation goes into diseases that are profitable, e.g. heart diseases.
Also, as long as the research costs are financed by high drug costs, poor people will not be able to afford them.
Poor countries were pushed to adopt increased patent protection with the promise that this would stimulate innovation. There is now evidence that increased patent protection is not stimulating innovation for diseases that mainly affect people in poorer countries, simply because there is no profit in those medications.
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Foudel Yousef
- Iran
Profession
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Dear Dr:
Could you give us a rough idea in numbers on the number of drugs that could be affected by the change in India's patent law and the fields they cover.
Thank You
Answer
Thousands of patent applications are currently examined by the Indian patent offices. If Novartis wins the case patenting would become easier and patenting of key medicines in all diseases fields for all the future will be affected.
For example, a key second line AIDS drug, lopinavir/ritonavir would likely be patented. The 1.7 million currently on HIV treatment worldwide will need this drug sooner or later - imagine, what this means if drug prices will not decrease because no generics from India will be possible!
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Joanne
- Australia
Profession
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Dear Doctor:
As a physicians point of view, do you think that these drugs produced by India are as effective as those produced originally by reputable drug companies?
Answer
India is so important as worldwide supplier because it has the capacity to produce high quality generic medicines.
It does not mean that all drugs produced in India are necessarily perfect but those that have been approved by the World Health Organization are identical to the originator product.
In fact there can be quality problems with originator company drugs as well sometimes. Unfortunately, pharmaceutical companies often try to put doubt on the quality of generics.
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Mandy
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You said that the Indian law doesn't give patents to small changes. I think this can be abused by the Indian government to prevent patents in order to keep their generic market booming.
What is a small change? at what stage can you say that a medication deserves a new patent? How about a small change with a huge therapeutic gain?
Answer
The Indian law tried to strike a balance between rights of patent holders and rights of patients. The generics industry is booming but so is the Indian R&D landscape - so both interests are there.
Small changes can be useless and just be there to extend the patent (ever greening) but of course there can also be follow up innovation that is useful for patients, for example an improved formulation of the medicines that is easier to use etc.
The question is: does everything need to be patentable? And should everything be patentable as easily as in Europe, US etc. Indian law really stroke a balance here between rights of patent holders and patients (for me patients should be paramount!) which is why I think they should not be pushed even further.
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Steven
- Canada
Profession
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Dear Doctor:
Could you please clarify to me what exactly does the patent law cover now? I mean are neutral addition to the drug composition accepted or must there be a chemical change in the active constituents?
Answer
the point of the Indian law is that it tries to issue one patent to the basic invention. they will only grant a second patent if the change in the molecule will bring significant improvement in efficacy.
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Hwaa
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First of all I would like to state my high regards for the work that you do. It is most valuable in these times.
The issue of patenting even the seeds we use to plant which results in market forces determining the future of biodiversity, by making it difficult for consumers, gardeners and farmers to use their favorite seeds, is a point that demonstrates the power of the corporate world over our lives without us even realizing it.
What can be done on a day-to-day basis to raise not only awareness, but people taking control over what they use as consumers?
Answer
You are right that the issues of patents in seeds and natural compounds are very similar to those that are experienced with medicines.
When signing a petition as the one we do on Novartis (www.msf.org) this is not only about awareness, it is also a way to speak out and change public opinion - which again affects the image of the company which has real monetary value.
It also influences share holders who are the real decision-makers behind the companies. In today's corporate world this is a key way for individuals to have some influence.
When it comes to the use of medicines, there is no reason to buy expensive brand name medicines if quality generic alternatives exist.
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Khalid
- Jordan
Profession
Question
Dr Tido:
But isn't this patent law a national law in India, i mean can Novartis interfere in this law being a national law?
Answer
Yes, they can file a lawsuit and indeed the case will be heard next Monday in an Indian court in Chennai.
So far, we have no idea how the court will handle this case.
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Mahir
- India
Profession
Question
Drug companies act as major corporate forces. They are driven primarily by profit. However, they always preach they care about the people
Can such a situation ever take into account the patients well-being?
Answer
It is true that we cannot expect that profit-driven companies alone will solve the problems of access to medicines for poor people.
There is need for governments to become much more active in supporting development of new medicines, tests and vaccines for diseases that disproportionally affect people in developing countries.
A process has started at the World Health Organization (WHO) where countries are discussing to set up something like a treaty on research and development because people realize that the current system does not work. I hope this will go forward - many are against.
When it comes to existing medicines there is little reason why companies need to have extensive patents and high prices in poorer countries: people in poorer nations only make up a few percent in the $600 billion drug market anyway, so this is not the place where companies make their profits.
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Maha
- United States
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Dear Dr:
But how does Novartis face the fact and the public outcry that the price of these drugs are not possible for several poor people, in fact poor countries all together?
Specially that this is a life saving drug for several increasing number of people?
Answer
Novartis apparently thinks they can handle the increasing public outcry. They also refer to the fact that they provide the drug Gleevac for free to those who need it. But this is of course not only about this one drug but will affect many other drugs. In conversations with us, Novartis has been very clear in saying that this is indeed less about Gleevec than about the principle.
Companies see big potential in the rich elite in the "emerging markets" of countries like India and this is why they are willing to fight so hard.
A few years ago Novartis said at a World Bank meeting that India is a market of 50 million people - so where are the remaining 1 billion?
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Editor
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What mechanism do you propose to satisfy drug companies who spend so much money on R&D while ensuring that the poor regain access to drugs for life-threatening diseases?
Answer
Companies recuperate their research costs in rich countries where they make most of their profit. Selling medicines at much lower prices in poorer countries (or leaving these markets to generic companies) does not take their profit away as poor people can't afford high prices anyway.
The problem is that companies will not invest substantially into new medicines for diseases where there is no profit, e.g. tuberculosis or sleeping sickness. Here even a patent system does not help and in fact much more public funding support is needed.
For example, drugs we use now for tuberculosis were developed in the 1950 - 1960's. Right now there a few organizations doing research on new medicines for tuberculosis, malaria etc - but these are underfunded and are almost entirely dependent on funding from Bill Gates - by far not enough to address the problems.
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Jack
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Money is what drives everything, including research into new drugs. If there is no money to those drug companies, then there are no new medications.
I support patents, it's their right for all the effort to discover new treatments.
Aid agencies should provide the poor with those expensive drugs, and everyone's happy. Don't you agree?
Answer
Seven years ago the price of medicines to treat HIV was 12,000 US dollars per year and almost nobody in poor countries was getting treatment. Now price has come down to 130 US dollars and we are treating 80,000 patients in MSF programs. Worldwide, 1.7 million people are on treatment. You can calculate how many we could treat with the resource we have if prices were still 12,000 US dollars.
Also, we should not forget that a big part of the research is done by universities who often discover the drugs, and then license them to pharmaceutical companies. So, it is not true that companies do all the work alone.
Many people also question that it cost 800 million dollar to develop one new drug, as companies say. Some groups say that +/- 100 million is enough - still a lot of money but much less than we are usually told.
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Maria
- United Arab Emirates
Profession
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Do you think that there is a chance that Novartis will win this lawsuit?
How do you think we could affect the outcome of this lawsuit?
Answer
It is impossible to foresee how the Indian court will handle this case. Will they come to a decision? Will they refer it to the WTO? Next week will tell us a bit more but even then a decision is unlikely to happen already.
However, it is clear that this case is not simply a technical-legal case - this is not happening in a political vacuum. If people around the world support the petition this has real impact - we are really seeing how this is increasingly being picked up and how the media is more and more interested.
I think this will remind the judges that this is not only about India. It is certainly confronting Novartis with the questions: how much more of their public image can they afford to loose if they want to continue to carry out business.
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Yousef
- Saudi Arabia
Profession
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Are there any other drug companies joining in this lawsuit or backing up Novartis? And do you think if Novartis wins this lawsuit it would open the door wide to the rest of these gigantic companies to file similar lawsuits?
Answer
Novartis is doing this alone but of course this is a battle they fight for the entire industry.
If Novartis wins it has won a battle for the entire industry and all companies will have it much easier to get various patents. If Novartis looses, other companies might file similar lawsuits. But if Novartis drops the case because it is becoming a public relations nightmare, maybe other companies will think twice before filing a similar law suit.
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Frank
- South Africa
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If Novartis wins this lawsuit, will these affect drugs that have already been certified , or only the future patents?
Answer
It will not affect drugs that have been patented in other countries before 1995.
So for example, the first line HIV drugs coming from India would not be affected. But it would affect some drugs that have recently come out as generics or are under preparation, e.g. tenofovir, lopinavir/ritonavir, valgangciclovir to mention just a few important examples - and of course all future innovations.
We already see that generic companies are getting more cautious in investing in new generics as long as the patent situation is not clear. So the insecurity alone is already causing delays.
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Zakaria Belbes
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Profession
Question
If it is as you say that the diseases such as T.B are no more researched as it is " a poor country diseases " this means that the drug market is now simply a profitable trade without any curing aims or medicinal value ?
Answer
I am afraid I can only give this simple answer: yes.
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Editor
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From your past experiences, how do you think this case will end?
Is it leaning towards a positive or negative outcome for the Indian government?
Answer
I am not at all sure about the outcome. It is a very real possibility that we will not win and poor people loosing out again.
Civil society won the case in South Africa but civil society is loosing many of the key battles: patent protection is now everywhere and it is getting harder and harder to get affordable medicines for the poor.
I hope people on this forum will support the petition on Novartis broadly.
