Low-Cost Medical Diagnostics: Discussion with FIND.

I wish to advise witnesses that whereas Members of the Houses enjoy absolute privilege in respect of utterances made in committee, witnesses do not enjoy absolute privilege. Accordingly, caution should be exercised, particularly with regard to references of a personal nature.

The joint committee will now hold a discussion with Dr. Vinand Nantulya of the Foundation for Innovative New Diagnostics known as FIND. I welcome to the meeting Dr. Nantulya who is senior policy and implementation officer with FIND, and Ms Susan Dykes, adviser to FIND.

The Foundation for New Innovative Diagnostics is a public private partnership dedicated to seeking out and evaluating the best technology in diagnostics. FIND is based in Geneva, Switzerland, where it is developing point-of-care diagnostic tests to help fight poverty-related diseases afflicting most of the developing world.

Dr. Nantulya sees the lack of effective and low-cost diagnostics for combating infectious diseases in the developing world as an impediment to the rational use of drugs and efficient disease control. He is here to discuss the value of diagnostics as the first step in the treatment of neglected diseases.

FIND is funded by the Bill and Melinda Gates Foundation and the Dutch Government has recently agreed to become a donor, but as a public private partnership it is obliged to obtain further public funding.

Before joining FIND in February 2006, Dr. Nantulya worked for the global fund to fight AIDS, tuberculosis and malaria. He is a fellow of the Royal College of Pathologists in London. A native of Uganda, Dr. Nantulya received an MD from Dar-es-Salaam university and a PhD in immunology of infectious diseases from Nairobi university. I invite Dr. Nantulya to address the joint committee.

Dr. Vinand Nantulya

I thank the Chairman and members of the joint committee. I am acutely aware that members are busy consulting with their constituencies and I am delighted and highly honoured that you have found time to allow me to talk to you. I love coming to Dublin — this is my second visit — principally because my education has been very much linked to this city through the Mill Hill Fathers. It is a pleasure to be here.

The issue which brings me here is diagnostics. I have just a few points to leave with the committee for deliberation. The public health landscape in developing countries is changing substantially. Life saving medicines are beginning to reach people in the developing world, for tuberculosis, HIV/AIDS, malaria and other diseases. This is a tremendous achievement, but more can be done, especially in enabling the marginalised populations in rural areas who suffer a disproportionate burden of those diseases. We need to enable them to access these benefits and services.

While I thank the Government and people of Ireland for their generosity in contributing to the global fund to fight these diseases, in fact we could have greater impact if those drugs were properly utilised. A critical factor for their rational utilisation is diagnostics. Today the method of diagnosis for TB and malaria is microscopic examination of sputum or blood. It is a 100-year-old technology which was used to discover those very diseases. It is terribly inefficient but in the developing world it is the tool used for diagnosis. In the case of TB, for instance, globally we invest more than $1 billion in diagnostics, but we get a raw deal because only one quarter of patients are actually diagnosed.

Looking at the performance of microscopy, in the best case scenario under research conditions with good supervision, one would be lucky to get 50% of sputum positive patients picked up by microscopy. This used to be so before the onset of HIV/AIDS. In co-infections between TB and HIV, the sputum does not have the bacillae because they are not secreted in the sputum when patients are co-infected with HIV. They are in the blood, in the bones and elsewhere, but not in the sputum. Therefore, microscopy does not work. In children, microscopy cannot work because children do not cough out the sputum — they swallow it. We need better and easier point of care diagnostics. It is a problem to get them because the discovery has not been upfront in the case of TB to give us the right choice of protein molecules to put in the diagnostic tests. Some 50% to 80% of patients treated for malaria episodes actually do not have malaria. That is a waste of drugs because these children have other conditions.

We have to improve diagnostics, which is the case I want to make here. It is possible to improve them and that is what FIND is all about. FIND is doing so in partnership with industry and with academia in both developed and developing countries. It is working closely with the national disease control programmes of the endemic countries. The business model is a public private partnership which picks up ideas from proof of concept and drives the idea through the development of products, evaluation for efficacy trials and registration and goes a step further, which currently industry does not do. Industry will develop and register a product and that is it. We do not think that is the way to get into the public health sector. The best way to get into that sector is to introduce those products in selected national disease control programmes and generate evidence of their cost effectiveness, potential impact and ease of use in order to persuade the public health sector to utilise those technologies. That is what FIND does.

We have been assisted in doing this by the Bill and Melinda Gates Foundation. Our initial grant for TB was for $23 million, which we were supposed to spend in five years. We have spent it in three years but we achieved all the targets. We have a number of tantalising candidate diagnostic products in our pipeline and the dossier on the performance of three of them in national disease control programmes has already been submitted to the World Health Organisation. The WHO can offer guidelines to countries to use these technologies.

We have teamed up with the Clinton Global Initiative in looking at another aspect. We may have nice diagnostics but getting them used in the public sector is not a simple matter. The diagnostic services, just like the health sector infrastructure, has gone down over the last two decades and we need to address that. We are looking at methodologies and mechanisms for building the infrastructure to accept these new technologies when they arrive.

FIND is a public private partnership. Most of the funding is from the Gates foundation. We have got $23 million for TB, $10 million for malaria, $10 million for sleeping sickness. We are expecting another $50 million or so shortly as a renewal of the TB grant. We have got money from the Dutch Government, close to €8 million. It is important that we get public partners to contribute to this partnership. This is what brings me here. Part of my responsibility is to explain to donor countries, to beg — I am in charge of resource mobilisation. I have been talking to the Swiss Government, and those in the USA and Canada. It is a pleasure to address you in the same vein.

Thank you, Dr. Nantulya. I call Deputy Allen.

Dr. Nantulya is more than welcome and I thank him for his opening presentation. He stated that the true spirit of public private partnership requires greater investment by national governments and mentioned a number of countries which have indicated support. I presume he has had already had discussions with the Irish Government. In view of the fact that we have increased substantially our overseas aid, is it appropriate to ask him at what stage his negotiations are at? I accept his point about the importance of diagnostic services in countries which have serious diseases. How are services delivered within those countries? Is it through non-governmental organisations or through national governments?

I too welcome Dr.Nantulya. He made a very interesting presentation. In relation to the transfer mechanism to the receiving countries where there are high numbers of people who either have TB or are at risk of it, how is this phased if it is after the licensing and registration process? Does this mean that the diagnostic test is sourced and produced outside the country where it is applied? Dr. Nantulya refers to the transfer of capacity for the establishment of laboratories in receiving and applicant countries. How far on is that process?

The other issue refers to the pilot projects in countries at risk in different continents. How many of these pilot projects are there? How is the timescale established in terms of the roll-out? The testing of some of these diagnostic measures for TB has a timescale of three to five years. Does this mean that the test will be used universally and will be available at low cost? How is it delivered low cost? Is it by direct subsidy of the diagnostic test or is it by making the capacity to produce the test in the receiving country? They are very different things.

I welcome Dr. Nantulya. At what stage did he apply to the WHO and what response did he receive? Is there any input from the WHO to the tests he is doing? If these tests are as he claims, would they be used in the West where there is a problem, particularly in European health services?

Did Dr. Nantulya mention an analysis of protein? You are using some photo-analysis with a lamp system. That is with the tuberculosis bacillus. Can you tell us something more about that?

Dr. Nantulya

These are very interesting questions. In getting the diagnostics into use, we have got both the donor contribution and the national responsibilities. Donor contributions are in terms of making resources available to the countries and to those who are developing these tools, but the country has got a delivery system where we have a road block in some situations. That road block is influenced not only by cost but by infrastructural inability to make the products reach the patients who need them. Any model of business must address all the various elements up to the time when the product makes a difference in the life of the people who need these diagnostics.

We are employing different strategies at different levels. We have the strategy which starts from the intellectual property right and the management of that right. FIND totally subscribes to the integrity of keeping the intellectual property rights, but in getting the tools that have been devolved to the end user FIND negotiates the use of that intellectual property right this way. We get an irrevocable licence, an agreement to use the tool royalty free for developing diagnostics for the developing countries, in particular the public health and the non-public health sector. That is one element that needs to be in place before we invest money, because we do co-invest with the developer. This intellectual property is the beginning. Then there are ways we are looking at to facilitate the flow of technology.

The second element is partnerships with the WHO, which sets the norms and standards which countries follow, especially in the management of TB. We work closely with the WHO. We also work closely with the global fund because it is making resources reach countries so that they can buy the drugs. They can buy the diagnostics when they become available.

What is the mark down between the diagnostic tool being available in the West and being available in Africa? What is the percentage?

Dr. Nantulya

In terms of money?

Dr. Nantulya

Tests in the developed economy may be $25. We are negotiating for less than $2. We are basing this on the relationship between volume and price. We know there is a huge market in the public sector in the developing countries. In exchange for access to that volume, we negotiate a reduced price for that market. We do not do it by way of global subsidy. We do not think that global subsidy is the way to go. It distorts the marketplace. We think the best way is to negotiate with the producer. The market in the developed world in the case of TB, where some of the tools are already being used, is very small compared with the market in the endemic countries. We agree on a price for, say, 10 million tests a year which we can guarantee will be needed by these countries. We then negotiate a price based on that volume. We guarantee that if the test is introduced through the WHO and the public health sector, there will be access to that market. So we negotiate so that the price is closed at 10 million. We shut it at that point because we are working closely with national programmes and with the WHO. I am chairman of the task force for retooling the control of TB globally. This is how we negotiate. It is not a global subsidy because that would distort the market. Ultimately prices will go down, depending on competition in the marketplace.

It does not matter whether these products are produced in the endemic countries or in the countries where they are being developed, but as part of the process of bringing down the price we are encouraging the partners to consider alternative locations where production costs of these products would be lower. It is not absolutely essential that they should be produced in the endemic countries, but more and more manufacturers are looking at lower cost alternatives. We do not dictate that.

The rolling out of the technologies is difficult and that is why the Stop TB Partnership has created this task force for retooling TB. Looking at five or ten years down the road, we are looking at methodologies and frameworks for guiding the countries to prepare for the arrival of new tools by buying line items, on top of donor funding.

I do not know if I have answered all the questions. Please tell me if there is something I have left out.

You say that some 2 million people die each year from tuberculosis, many because the disease is detected too late or not at all. You find that the sputum smear test method is not very sensitive, especially where a person is affected by HIV/AIDS as well. You also say that you are funding the development of drug resistant TB. Is that very extensive? Do you see it as a major problem in Africa and elsewhere?

Dr. Nantulya

The problem of misdiagnosis is widespread. Of 9 million new cases a year, currently technology diagnoses only one quarter of that figure. This is because in the high endemic countries the technology is microscopic, which is not enough. There are other technologies which are more sensitive. There is the sputum culture based on liquid, a technology produced by Becton Dickinson. This is much more sensitive and gives results in 14 days, as opposed to the current culture which takes six weeks to give results. This technology of culture for 12 or 14 days is now the yardstick, but we are developing technologies which take only hours to get results. We are talking about molecular technologies.

We look at the health system as consisting of two critical levels. At the lowest level where 60% of patients go, there is no diagnosis except for symptoms and so on. At the next level is the microscope, which caters for about 40%. We want to introduce technologies at that lowest level, particularly molecular technology which produces results in 30 minutes. This technology should be going through evaluation in the next year and will be ready to go to countries for use. This is revolutionary because it will revolutionise the diagnosis of TB. Then we are looking at simple dipstick acids, like pregnancy acid tests, which can be used at the lowest level. We have been looking for antibodies and proteins of TB to be used in those tests. At present we do not have them, so we have funded a project to express the entire proteins of TB and then identify those proteins which are important.

On drug resistance, we have just started a major demonstration of two technologies in South Africa and we are moving on to Lesotho. These technologies are being tried in Peru, Russia, the Ukraine and Nepal. One is a culture technology from Becton Dickinson which gives results in ten days. There is a technology based on PCR from Hein Life Science which gives results in hours. We have developed with a small bio-technology company in the UK a technology which will give results in two days. We are looking at technology with a different company where the results will be produced in one hour. It is an incremental improvement and we have candidate technologies for all that.

That kind of work would have application in a much wider society.

Dr. Nantulya

Exactly. The TB technologies we are developing can be applied in the developed world too. When we negotiate with the manufacturer or the owner of the intellectual property, those technologies will be made available to the developed world at market price, but we negotiate different pricing for the developing world.

I am sorry I could not be here earlier. I have just returned from a trip abroad. I have already met Dr. Nantulya and I am aware of the important work he is doing. We had a long meeting and I congratulate him and wish him well. It is very important in the developing world that these diseases are at least identified. Diagnosis is the first step towards cure. I am sure my colleagues have listened attentively and we hope something productive will come from our meeting.

On behalf of the committee, I thank Dr. Nantulya for coming here today. Your work is very relevant within Africa and we can see that it could lead to much better diagnosis. Everybody needs to be aware if resistant forms of disease are developing. We would be quite happy to press the Minister and Irish Aid to work with you in this extremely important work. When we were in Kampala we met an Irish group working on research and we must update ourselves on their position. There was a lady from St. James's Hospital and a Mr. Coakley who were working with Americans and others. There was a great demand for the work they were doing and it was spreading throughout Africa. We were very impressed by their work and anxious that they should be supported.

I again thank Dr. Nantulya and wish him well in his work. I also thank Ms Dykes for bringing him here.

Sitting suspended at 3.40 p.m. and resumed at 3.42 p.m.