Interview with Dr. James Love, CPTech, Geneva.
Duration: 00:43:29; Aspect Ratio: 1.366:1; Hue: 298.429; Saturation: 0.089; Lightness: 0.282; Volume: 0.297; Words per Minute: 101.153
Summary: Tracing the story of the global struggle to make HIV/AIDS drugs more affordable and available, A Human Question raises key questions of whether private ownership of knowledge can be at the costs of human life?
access to medicine
and pricing of medicine
open source and knowledge
(Setting up; small talk)... Well, I came here for a meeting at the WIPO. There are 2 meetings this week, to look at the role of intellectual property and development. The first three are something called the WIPO development agenda. Its very- very important, it's a proposal by 14 developing countries to completely change the world intellectual property organization, to kind of return it to its original UN mission, providing creative activity and development. Its, its become really a bad UN agency, its become a agency which is kind of focusing exclusively on the rights owners and less on...well, it doesn't really focus on innovation, it doesn't focus on the interest of the public, and this meeting is to try and change that.
Well, there has been the issue of accreditation for the meetings, there has been complaints, we have complained, lots of people have complained, that WIPO has made it too difficult for civil societies to attend the meetings. I am accredited, our organization is accredited a small number of groups that work on these issues are accredited but the vast majority...
Our group is accredited, a small number of groups that work on these issues are accredited but the vast majority of organizations that come from developing countries as well as many library groups have been turned down for accreditation. I think we are going to debate that tomorrow actually. Maybe they will change their mind...
Q: what is the difference between WIPO and WTO?
Well, its an interesting question, Whereas WTO is much broader in scope, they work on issues that they really need to...agriculture, services, government procurement and all kinds of things, WIPO is just an organization that works on Intellectual property rights, it works on things like Patents, copyrights, trademarks, trade secrets...a lot of things that relate to knowledge is privatized and controlled...so the WIPO works on changing the global norms about the IP protection. If there is a sufficient consensus about what that norm is, then at some point the norm may become part of the WTO. The WTO has got the most power in terms of enforcement, but WIPO has most power in terms of raising norms that has sort of mechanisms to work directly with patent offices, and directly with copyrights offices, it is very important.
Well, I think its really a big issue for the world right now, because there is this effort to try and make the multi lateral trading system, the world trade regime work, the WTO I think, at one point was vilified by a lot of civil society groups, its sort of symbol of globalization gone wrong. You know there is some validity to all those criticisms, but what turns out to be worst than WTO are these bilateral agreements, which have been very one sided in terms of the negotiating power, so, both European commission and the American government, not to mention other trading blocks actually, now have got into this huge industry of entering into bilateral negotiations region to region, and I think that's bad for the multilateral trading system. I think its bad for developing countries because they have less power in the bilateral negotiation than they have in the multi lateral negotiation.
..your question raises a lot of different issues....you know on the one hand we have the idea that ---to try and develop a fair, multi lateral trading system and there will be enough balance in the agreements reached and the governments will have the flexibilities, to protect the weaker party, to protect the poorer, to protect the consumer interest, and you know addressing the legitimate concerns they have on the intellectual property side of making sure there is global incentives to develop new medicines as well as appropriate protections for authors for eg for works and things, so that is very difficult job all by itself. Then you have just the more brutal bilateral trading negotiations, which really just involve .. people pushing forward, the crude interest they have as exporters, importers from the industry and trying to get as much as advantage as they can, and those things tend to undermine the multilateral system. Then you have certain ideological issue-- where you have people that are in the policy leaders in India, they feel like we have to become more like the global consensus, we have to have the same policies that they have in Sweden or France or the US something like that, we have to somehow perceive to be a good trading partner, respectable player things like that. Its kind of a funny sort of a imitation of other countries. Its...its not partly ideological, I think a lot of these people are sincere, I think they believe that India has to do that in order to develop a modern industry or something like that. I think what's missing in that view is that the –big controversies in Europe and in United States are along in the intellectual property issues and its now there is quiet a bit of criticism on how wrong their model is the United States as well as Europe, so you have tremendous opposition to the Software patent in Europe. You have a strong social movements in the US, in all sorts of different areas , trying to push for more open source technologies, more user free Software, putting scientific databases into public domain, changing the business model for publishing of academic journals.
Back in the internet which is an open source model, with weak IP or no IP and lot of code protocols. So, you know there is this big open source movement in the North and its kind of ignored I think by some of the similar policy leaders, they make it sound as though there is only one way to go on these issues, which is just not true. I think if you were ask me, where things will go in next 20 years, it not be more and more IP protection, it will be people coming to grips with new ways of thinking about developing knowledge goods, where it allow you to put knowledge basically into public domain, by finding innovative ways, to stimulate investment and to provide for income to people, who create knowledge goods. And that I think where things could be at, should be at and I am hopeful, where we will be headed. For eg, lets just take medicine as an eg, there is a new bill in the US congress, house bill 417. What's this bill about, what does it do? Well, it will eliminate all monopolies on medicines in the United States, it will return every drug in the US market into its parent drug. But it would create a separate set of incentives for people to develop new drug. It would set aside 60 billions US dollars a year into something called medical innovation prize fund. So that everyone that developed a new drug, for a ten-year period may claim against this 60 billion dollar year fund. Based on the evidence of incremental health benefits of this invention came about. In a nutshell, this invention would be cheap, it would be priced like Generic drugs. But the inventor of the Product, even though may not have the monopoly, will still make a lot of money. Because they can draw money from this innovation prize fund. That's an important proposal because it shows how you come up with a entirely different and better way a stimulated investment in medicines than giving somebody a monopoly on a particular medicine.
..sure, it was kind of a rollercoaster week, I mean , there was a lot of pessimism about the patent law when I first got there and then everyday there would be some surprisingly news about some new amendment that they had been accepted in the parliament to the point were what looked like a pretty bad bill, began to look like it had not such bad piece of legislation in some areas, it wasn't as good as it should have been, but it was certainly better than what we expected. So, my own take is that India was started of with lot of compulsory licenses on mailbox paths, I think that's very important, because you will have the experience of issuing compulsory licenses, you are experiences and royalty for patent owners. those are all confidence building exercise, that actually I think very positive. the next step is how do you extend the transition CL's into the new products, I think that's what has to be done, now when I look at the act, it seems to me that the government has plenty of flexibilities to issue CL's but what you don't have is the requirement to say, issue CL for new drugs that are not yet on the market. And that depends on social movement. If you have strong social movement for access to medicine in India, the statute is pretty permissive, if you have weak social movement, then you mean you can get a CL on a new drug?? So, its up to the people who live in India that want to protect the access to medicine to engage the government how they are going to implement the new law. The new law can be pretty good or can be pretty bad, its all going to depend on implementation.
In the short term, the patent act will not make very much difference in medicine because of the amendments, when the patent law goes into affect all the drugs that are currently been manufactured and sold in India will still be available as generic products and that's going to help out quiet a bit. It will just differ a little bit longer, the real of day of reckoning of what happens to these new drugs, which are not yet in the market.
For eg there is a new vaccine in development that deals with cervical cancer, and if the tests are correct then it will be almost 100% effective against the most common cause of cervical cancer, but you have to be vaccinated, before you are sexually active. That means young women, or girls have to be vaccinated before they start having sex, so how exactly this invention is going to be priced, it seems to me that every Indian woman should be vaccinated with this vaccine because it will radically cut down on the odds of getting cervical cancer. And that's not yet in the market, but that will be an eg of a product you will see , will the government issue a compulsory license for that vaccine when that comes out.
The pharma sector is relatively bad in developing new treatments, I mean they register about 25 drugs a year that are new chemical entities, but only a small number of those are really better than the existing drugs. So, there is not that many new drugs in any given year that are very- very important. There is lot of copycat drugs that which are same as the existing drugs. But when you have a new drug, then it is important you want to access it. Like there is this drug GLIEVAC, which is quit famous for leukemia, you die without it, you live with the drug. If you have that disease, that's the drug you going to want, and if you don't have the disease then you don't care, unless you know or loves somebody that gets it, gets the disease.
Well, people care a lot about India, because India is the most important producer of the pharmaceutical drugs in the world.
(Repeats) and so, if India has patents on all these new medicines and they cannot manufacture and sell them, people are afraid that they wont be able to find anywhere where they can buy a generic drug, they are afraid nobody will know how to make a generic drug, and now India is where they are today because, because, in 1970 they eliminated pharmaceutical product patents, that allowed them to develop this really important industry, where they have lots of inexpensive medicine being manufactured, so if the patent law changes then it will depend on how the patent laws will be implemented. Its okay to have patents as long as they grant compulsory licenses on the patents. As long as the domestic firms can manufacture the new medicines competitively, in return to paying royalty to the patent owners. The TRIPS agreement says all you have to do is to pay royalty to the patent owners. You can go TRIPS plus and have monopolies if you want, but the WTO does not require that. The WTO allows you to have a compulsory licensing, and in fact I would go further and say that under the 2001 Doha declaration, on TRIPS and Public health, countries are obligated to issue CL's to expand access to medicine. Paragraph 4 says that countries should implement the patent laws in the manner that is supportive of access to medicine for all. So the monopoly leads to high prices and that cuts people of getting access then the remedy is a Compulsory license and that's what the governments have to do to protect the public from high drug prices.
Well, the WTO does tell us what to do, but the question is can you actually do what you need to do under the WTO framework. I think part of the problem in India was that the opponents of the TRIPS wasted that the last 10 years telling people how bad the TRIPS was, so when it came to implementing the law, the TRIPS law they implemented the treaty agreement finally. We had really the only kind of worst view- point is that what the agreement required. Its almost like they were painting such a bad picture that they persuaded the government we had to implement the bad law. In fact the WTO agreement is pretty flexible on some issues. So the amendments were good. So but not... still room to do some work, I mean the WTO forces you to do things, part of the problem is that it's the only paradigm that's out there to deal with how do you finance R&D, its the TRIPS agreement and the TRIPS plus bilateral trade agreements, it serve. So, we have been engaged in an exercise to develop an alternative paradigm, an alternative treaty paradigm for dealing with medicine. In fact, one of the thesis of the new trade paradigm that we are working on is to get you out of the TRIPS agreement, one of the things that you agreed to in the treaty is not sue to anyone under the WTO agreement or under any bilateral agreement for anything that involves patents on medicine or pricing on medicines, its called the medical R&D treaty. And medical R&D treaty is quiet an important proposal, its supported now by the red cross, the president of Curie institute, MSF, Oxfam, many members of the European parliament, several governments, it's a very important proposal. But what's particularly interesting about is that it is in a different paradigm for dealing with medicines and the TRIPS. Its not a different agreement, its entirely a different way of thinking about the problem. So it becomes a real threat to the TRIPS because it competes with the TRIPS for addressing the problem. It does put obligations on countries. The medical R&D treaty proposal will require India to support research and development. It will not allow you to ........ but it will allow India to do it in a way it makes sense. For eg, giving jobs to people in India to do research and development., building up the Indian Research and Development industry. It will allow India to separate the market for innovation from the market of the products. To new mechanisms like innovation prize fund, open source technologies and things like that. To do drug development. So that the prices of the drugs could be cheap. Because, you have different way of thinking about how you finance the R&D.
I was asked to present this proposal to the Indian Industry in the recent meeting in Bombay. The response was very-- very positive. It's positive because they like the fact that there was a business model to support innovation. There will be a sustainable source of funding for Indian companies that are good in doing innovations. And they understood that this new methods of financing R&D would work, I think it was very positive in presenting it in India.
Well, there is a large group of people who are involved, we have asked the WHO to study the treaty, so now we are in the process of meeting with WHO, to discuss this at the world health assembly, at the commission on the IP to continue having discussions about this. I think it will come to ahead in the executive board for the WHO, be the first major test of this proposal, it will be in January of 2006.
I think the Gates foundation, it's a pretty important situation, Here is the situation where Bill Gates made his money through really being a brutal monopolist and he is quite concerned that there is a very strong statement about intellectual property protection that protects Microsoft. At the same time, he has given away a billion dollars a year which is you know a lot of money and he is very generous about the money he gives away. I think Bill Gates, frankly is a bit crazy when it comes to IP protection. He has allowed his experience in software to cloud his judgement, when it comes to the area of medicine. He hates open source, he hates it in software and he hates it in medicine. he tries to bribe countries like Botswana, like India and other countries to avoid more open source approaches, And so he tries to give these big financial incentives.
Bill Gates now also is the primary funder of almost all of the public –private research in R&D. in area of neglected diseases
Its not healthy, I mean, its almost this one guy personally, is now controlling all the public health groups that work on diseases that affect the poor. And he is very very aggressive. I mean they bring in their own management teams, they make personnel decisions, they put people on board of directors, they write press releases, unbelievably into micro management. And its just a bizarre situation in the whole world, because is the playpen of this one guy from Seattle who made money by being a monopolist.
This is the moment in time when people are just going to decide what kind of future they want, what kind of relationship does the public want between science and public. Do they want access to knowledge or do they want privatization of knowledge and restrictive access. These are the big issues for the day. I think a lot of us talk about access to medicine as a very critical issue. And it is. It is part of a bigger way of thinking about it, which is just access to knowledge. And how we organize ourselves in the new society, so all of us have access to knowledge. How do farmers have access to seeds, how do patients have access to medicine, how does students have access to scientific publications, how do we have access to software, all of those things. So with all these areas of knowledge goods, issues about access to knowledge goods, who is going , what is the business models for all these people who are working on this, how do you get paid, its really important, and one thing you don't want to do is to back policies that are going to ,,,result in lots of monopolies, unequal outcomes, that are very bad for poor, and that will stifle innovation. You know there is a big social movement that is trying to get things right, to move towards an more enlightened policies on the knowledge economy. You don't think we are so weak, we may not have lot of money but we have a lot of smart people on our side, we have a lot of big hearts on our side, we are able to communicate through internet, so things were lot different 20 years ago, the social movement and the knowledge goods are much stronger today than10 years ago when TRIPS was negotiated.
I think it was this first wave when NGO's were fighting globalization, everything was bad, now I think people are beginning to, and I think it is because of the internet, because they think they are global citizens. I mean, If you look at who my close friends are, I would say quiet a few them don't even live in the united states, they are people I meet in India, in Kenya, South Africa, Brazil, all over the place, in France, that's because I think we all more and more see ourselves as part of the global economy. And the AIDS activists, what do they want? they want the global fund for treatment and we talk about R&D now, We talk about global R&D treaty, we talk about access to knowledge, we talk about access to knowledge treaty, climate control
Now civil societies are becoming its own instrument of globalization, let their own imagination, consider the possibilities of positive things in the globalization arena, and I think that's important, that's why there is now big debate over what is WTO?, what is WIPO, what is WHO, who really controls it, what are they talking about, what is their agenda , what is their work program? These are the things that civil society now wants to put input to, and they are having a impact, which are aiming at positive things.
What will be the outcome of this 3 days?...this is really is a step along the way, there will not be a conclusion, they can't finish in rapid speed this week. What we are trying to do is to get countries to find their voice in these issues, they are to be able to say –we have to able to protect consumer interest, consumer protection has to be part of the package, human rights has to be part of the package, we have to promote innovation and not just right owners, you protect right owners like patent owners or copy right owners,
only if in doing that you actually accomplish something good. This intellectual property is not in end in itself, it's a tool, and its not the only tool that you can use to stimulate creativity and innovation. So what we want to see come out of this week, is an appreciation that a) the job is bigger than just like, how do you reward people that innovate, you also have to protect the consumers, protect the poor, protect human rights, that's part of it, the second part is they are different ways of stimulating innovation than the patent system. Sometimes there are different ways, actually better than the patent system, you have to have a flash bone of big /
you can incorporate the best ideas, not just the ideas that benefit some people.
The US is, like everywhere else is struggling to think through these things. For most people, ideas about Intellectual property rights were so obscure, that they didn't about these things until recently. So, its only in the last 10 years that people really thought very much about IP. Since the TRIPS agreement, people really are woken up and the internet I think makes people much more aware because people read about this on the internet, which they have not heard of before. So now, you hear these stories about people getting patents on peanut butter sandwiches, or how to do a swing or things like that. Patents on genes, patents on life, you know patents on business methods in software, these are all new patent ideas for people, so in a way, we have a long ways to go. So we are trying to figure out how do you actually organize the world to support the creation of knowledge goods. And still give access to knowledge to people at the same time. And if we are smart and creative, we can figure it out and one thing is for sure, we need innovation, in a way that we stimulate innovation.
The Indian leadership at the WIPO is really been excellent. And they have done a great job at the WTO as well. One of the strongest, and we hope that continues, and India is a super power and we think they are super and its important, that they have an enlightened and progressive leadership in India, to
That would be a bad outcome for the whole world and I hope that doesn't happen.
I think there are some people in the policy league in India, they are very reactionary, conservative about IPR and they are just tuned into modern thinking about innovations, to open source, so we have to see, every country has its serve—swings back and forth, we will see how things go, but whatever happens in China, in India, in south Africa, in Brazil, those are all the important countries, because they are the strongest economies in the region. They are the most important economies and you need that sometimes as a counter balance to the European commission and the American government. We really like to change the EC and the US Government position too, I mean don't get me wrong, we have to find strategies to actually change things in the US, change things in Europe, we are trying to. The medical find prize, the US proposal, the people who will benefit is the US citizens, EC's is now debating weather or not to scale back their database directory, they think they went too far. Just because people go for certain direction doesn't mean they go in the direction forever. Now India , considering different ways they might go. Same things is true the US and Europe.
About economist...open development strategies are economically efficient and dynamic. And they have lot of advantages for developing countries.
The tension between local and global...(small talk)