HC Deb 13 January 2004 vol 416 cc790-8

Motion made, and Question proposed, That this House do now adjourn.—[Joan Ryan.]

7.29 pm
Mr. Tony Colman (Putney)

Research and development into anti-malarial treatment could he thought esoteric. However, malaria kills more than 1 million people each year, and with global warming its reach will soon cover Europe and the United Kingdom. The Select Committee on Science and Technology has just commenced a major piece of work on science and UK international development policy. At its first hearing yesterday, the Department for International Development helpfully tabled a memorandum that I used for this speech.

In my Putney constituency is Ronald Ross primary school—an excellent school that is doing very good work. I particularly praise the head teacher, Gillian Baker, and Mr. Fred Shaub, who has been a teacher there for 30 years and who in May 2003 won a lifetime teaching award in London. The school is named after Sir Ronald Ross, who lived in Putney and in 1896 demonstrated the life cycle of the parasite of malaria in mosquitoes. He was awarded a Nobel prize in 1902 and his groundbreaking work is still an inspiration to the children of Putney. The Ross Institute of Tropical Diseases, where he did his work, was for many years situated at the corner of West Hill and Putney heath. He discovered that the malaria disease cycle is dependent on transmission between people by mosquitoes. A single bite from an infected mosquito can lead to malaria. Following the bite, the parasite travels to the liver within 30 minutes and starts to reproduce rapidly. The process can take five to 16 days, but some parasites lie dormant in the liver and may only become active years later. The symptoms of malaria may include fever, shivering, headaches, repeated vomiting, diarrhoea, generalised convulsions, pain of the joints and backache.

With regard to the epidemiology of malaria, approximately 40 per cent. of the world's population, mostly those living in the world's poorest countries, are at risk of the disease. High-risk areas include large parts of central and south America, Africa, the Indian sub-continent, south-east Asia, the middle east and Oceania. Worldwide, the World Health Organisation has estimated that there are between 300 million and 500 million malaria cases annually, directly causing more than 1 million deaths and contributing to a further 1.7 million. Malaria kills one child every 30 seconds, and many children who survive malaria suffer from learning impairments or brain damage. Approximately 30,000 European and north American travellers contract malaria annually. On average, for every 2,500 travellers staying in west Africa, 60 contract malaria and one person dies of the disease.

In Africa alone, malaria represents 10 per cent. of the continent's overall disease burden. When I worked in west Africa in the 1960s, I was expected to retire at 29—so ill did almost all "coasters", as those who worked on the west coast of Africa were called, become. Hundreds of millions of African children and adults are chronically infected with malaria. Between 30 per cent. and 50 per cent. of in-patient admissions and 50 per cent. of out-patient visits are attributed to malaria each year. The vast majority of malaria deaths occur in Africa, south of the Sahara.

In Africa today, malaria is understood to be both a disease of poverty and a cause of poverty. Annual economic growth in countries with high malaria transmission has historically been lower than in countries without malaria. Economists believe that malaria is responsible for a growth penalty of up to 1.3 per cent. per year in many African countries. When compounded over the years, that penalty leads to substantial differences in gross domestic product—amounting to a total of $12 billion a year—between countries with or without malaria, and it severely restrains the economic growth of the entire region. Malaria also has a direct impact on Africa's human resources. It not only results in lost life, and lost productivity as a result of illness and premature death, but hampers children's schooling and social development through absenteeism and permanent neurological and other damage associated with severe episodes of the disease.

This problem requires treatment, but at the moment the treatment of malaria in Africa is an unmet need. In many areas of the world, the recommended first-line therapy for oral treatment is chloroquine. Resistance to chloroquine is now common across most of sub-Saharan Africa. Sulfadoxine-pyramethamine, the commonly-used alternative to chloroquine, now does not work in the east and central areas of the continent. There is no vaccine for malaria and none is likely in the near future. That is why drugs are so important.

I shall mention a specific success in research and development before going on to discuss the wider situation. Since 1999, GlaxoSmithKline, DFID and other partners have developed the drug, Lapdap, which will be a valuable addition to the armamentarium of anti-malarial drugs used in sub-Saharan Africa. Lapdap was approved by the Medicines and Healthcare Products Regulatory Agency on 6 August last year—an excellent example of public-private partnership for the benefit of the world. Perhaps the Minister can update the House on progress in the production and distribution of Lapdap.

The new big development is the Medicines for Malaria Venture, which was created in 1999 by the World Health Organisation, the World Bank, bilateral donor Governments and leading foundations to replenish and sustain the global pipeline of new anti-malarial drugs. After four years, MMV has established more than 20 individual pharmaceutical discovery and development projects, now comprising the largest coordinated and managed anti-malarial research and development portfolio in history. Contractual partners in MMV's projects include 42 leading-edge research entities across the globe. In 2002, WHO described MMV as the premier public-private partnership for developing new malaria drugs. Since its inception, MMV has received pledges of more than $97 million in funding from nine philanthropic and public sector donors, conditional on performance against an agreed business plan. However, the most recent business plan for MMV predicts that an additional $80 million is needed by 2007 and if the portfolio continues to expand, even more funds will be needed. Conversely, lower funding will slow progress significantly. I pay particular tribute to the Gates Foundation, among others, which provided the largest proportion of MMV funds to date.

Although the Governments of Switzerland, the Netherlands and, I am glad to say, the United Kingdom contributed to MMV from the outset, the resurgence of malaria requires effective engagement by other bilateral agencies from significant donor nations. Will the Minister update hon. Members about the level of support from the Department for International Development and other Organisation for Economic Co-operation and Development countries to MMV?

MMV practises "virtual" research and development; it funds and manages its portfolio, but academic and pharmaceutical partners, located throughout the world, conduct the physical research and development. Current examples of success are nine projects in the pre-clinical phase that create a solid basis for at least one new drug registration for 2010. Unless there are unforeseen technical difficulties, paediatric Coartem could be registered before 2007 and the next generation of artemesinin-like peroxides could be registered before 2009. Four projects are based on combination drugs and a further nine projects involve completely new therapeutic targets. They should result in drugs with no initial selected resistance to the parasite. Perhaps the Minister can provide updated information.

Treatment costs are a major hurdle, which often inhibits prompt access to anti-malarials. MMV has therefore made developing drugs with the lowest possible intrinsic costs a priority, partly by focusing manufacture in low-cost regions such as India and China. MMV is keen for the Department for International Development to join discussions on the way forward.

That brings me to the Department's memorandum to the Select Committee on Science on Technology yesterday. It is not specific to anti-malarial research and development and I should welcome a breakdown of the figures to show the Department's efforts in that field. Members of the Select Committee expressed anxiety that untying the Department's research and development budget disadvantaged UK research foundations. Perhaps the Minister could comment on that. Of course, I welcome the Medical Research Council-DFID concordat, with a DFID contribution of £4 million.

I note that DFID has 474 professional staff acquiring and using science. How many specialise in research and development on anti-malarials? The Cochrane collaboration, which reviews existing research, has had success. Is DFID widening its scope to ensure that researchers are not reinventing the wheel?

My eminent and hon. Friend the Member for Norwich, North (Dr. Gibson), in his role as Chairman of the Science and Technology Committee, is arranging meetings with DFID and MMV next week. I look forward to hearing from him and the Minister about major new initiatives.

However, any research and development initiatives must be owned by the countries that face the scourge. Growing political commitment by African leaders to action on malaria was given a boost by the funding of the global Roll Back Malaria Partnership in 1998. Considerable progress has been made. Almost 20 African countries have reduced or eliminated taxes and tariffs on insecticide-treated nets to make them more affordable. More than half the malaria-endemic African countries, representing almost half the population at risk, have established country strategy plans to achieve the Roll Back Malaria goal and the targets that have been set.

However, given the projected resources needed by 2010, only 20 per cent. of the necessary funds will be available locally and help is needed. Is DFID planning to help?

The work is going forward under the MMV, but what is needed to ensure that proper levels of research and development are devoted to anti-malarials? The excellent work of Médecins sans Frontières, "Fatal Imbalance: the Crisis in Research and Development for Drugs for Neglected Diseases",makes the following recommendations for moving forward.

First, it states that the World Health Organisation should lead the process. A critical next step is for Governments and international organisations to establish carefully how they can contribute to dislodging the bottlenecks that currently restrict the development of new treatments.

Secondly, there is the question of legal obligations. Governments can—and do—mandate industry spending in a wide range of areas. One example of a potential mandate would be an essential research obligation. Companies would be required to reinvest a percentage of pharmaceutical sales into research and development for neglected diseases, either directly or through public R and D.

Thirdly, existing estimates about the costs of drug R and D vary widely, and remain highly controversial. To address the R and D imbalance effectively and make informed funding decisions, policy makers need objective and accurate figures on the true cost of developing drugs.

Fourthly, equitable access to medicines in developing countries should be a basic principle that guides policy initiatives from the start. If public funds are to be invested in correcting market failures in drug development, there must be guarantees that the new medicines developed can be afforded by those who need them. I welcome the Minister's comments on all those recommendations.

I started this speech by making a link with the work of Sir Ronald Ross and the Ross institute in Putney. I want to return to south-west London, as St. George's medical school is situated in Tooting, on the border of my constituency. Ross's work is continued there by Professor Sanjeev Khrishna, professor of molecular parasitology and medicine, and his colleagues. Their work on artemisinins is ground-breaking in establishing the next drugs round. I am told that we are now in the position to start anticipating how parasites will try to change to become resistant to drugs. Now that we know what to look for, this is a very exciting discovery.

I have one last concern. Putney is one of the three constituencies forming the London borough of Wandsworth. Research by Williams and others, published in "Archives of Disease in Childhood 2002", investigated all cases of childhood malaria reported at St George's hospital in Tooting. All families were interviewed, and details of the illness, and of reasons for travel, risk factors and prophylaxis, were recorded using a questionnaire.

Between 1975 and 1999, 249 children were diagnosed as having malaria. Only 41 per cent. of the children resident in the UK had taken anti-malarials and, worryingly, the overall number of symptomatic children taking no prophylaxis has increased over the past 25 years. The researchers stated: It is our experience that families that originate from endemic areas

regard their children as being 'immune' to malaria, despite them being brought up in the UK. The increasing number of cases remains of great concern. St George's hospital in Tooting—that is, just one hospital in the UK—now deals with about 100 cases of malaria a year, some of which are severe. Thus there is a worrying trend, as the research conducted over a 25-year period shows. Yet anti-malarial drugs are not paid for by the NHS. They are therefore not free at time of need to my constituents.

All too often, travellers to malaria-endemic areas take either the cheapest drugs, or none at all. They are also not as aware as they should be of the dangers. The net result is that NHS costs go up, with more cases each year that are expensive to treat. Surely not providing anti-malarials on the NHS is in the end a false economy? At the very least, a cost-benefit analysis should be done.

I believe that early diagnosis is the key. There is a need to raise awareness among the following groups of people. The first group comprises travellers, both as individuals and as travel-industry consumers. Airlines are getting better at promoting the issues, but I suspect that the travel industry in general is shy of pushing the issue, as to do so might put people off travelling to and taking holidays in malaria-endemic areas.

The second group among whom awareness should be raised is general practitioners. They should begin by providing publicity in their surgeries about malaria and its prevalence, and also pick up cases quickly from UK citizens returning from abroad. To that end, GPs must be trained recognise the symptoms.

I have ranged from Putney, gone around the world, and returned to Putney in an attempt to persuade the Minister to invest more in research and development in anti-malarials. Ultimately it is an equality issue. Infectious and parasitic diseases such as malaria account for 25 per cent. of the disease burden in low-and middle-income countries, compared to only 3 per cent. in high-income countries. According to the World Bank, eliminating communicable diseases would almost completely level the mortality gap between the richest 20 per cent. of the world's population and the poorest 20 per cent. We must close that gap, and do it permanently. We must not lose this opportunity.

7.44 pm
The Parliamentary Under-Secretary of State for International Development (Mr. Gareth Thomas)

May I take this opportunity to congratulate my hon. Friend the Member for Putney (Mr. Colman) on securing this debate. He is an assiduous member of the International Development Committee and is also assiduous in promoting the interests of his constituents and of those who serve his constituents. In that sense, I, too, want to congratulate Professor Khrishna of St. George's hospital, and the team who work with him, on their recent success in identifying how artemisinin works. Scientists have been trying to understand that since the 1970s, so the breakthrough of Professor Khrishna's team is particularly significant. As my hon. Friend mentioned, following their breakthrough, the team are now looking at how they can take forward their research to improve the treatment of malaria, to look at other drugs, and to anticipate how resistance to malaria develops.

My hon. Friend alluded to the fact that, despite more than 50 years of malaria control programmes, millions of people, particularly children, still die from it. It kills more than 3,000 children per day—more than 1 million per year—and 90 per cent. of those dying are in Africa. The millennium development goals represent a shared global ambition to address such challenges and to improve the well-being and life chances of the world's poorest citizens. My hon. Friend will know that the sixth of those millennium development goals is that by 2015 we should have halted and begun to reverse the spread of HIV/AIDS and the incidence of malaria and other major diseases. He will also know that the fourth goal contains a target to reduce the under-five mortality rate by two thirds between 1990 and 2015. Alongside the target to reduce maternal mortality, that is the one that is proving hardest to achieve.

On current trends, sub-Saharan Africa will not meet its poverty or its health millennium development goal targets, with deaths from malaria playing a huge part in that. With up to 80 per cent. resistance in some parts of Africa to chloroquine, the most widely available cheap anti-malarial drug, new approaches are needed, and they are needed fast. In addition to the wider use of insecticide-treated bed nets, new approaches to preventing death from malaria may have the single biggest impact in preventing unnecessary deaths. Other big improvements would come from routine immunisation and the introduction of new vaccines, but as my hon. Friend said, a new vaccine for malaria is still many years away. Therefore, new, good quality medicines are needed, which are accessible by poor people at affordable prices.

The Government take that challenge particularly seriously. Following the May 2001 performance and innovation unit report on tackling diseases of poverty, the Prime Minister convened a high-level working group on increasing access to essential medicines in the developing world, which was chaired by the former Secretary of State, my right hon. Friend the Member for Birmingham, Ladywood (Clare Short). Reporting in November 2002, the group recommended that the Government should consider policies to increase the level of UK research and development on essential medicines for poor people in the developing world.

To take that work further forward, my Department has established a dedicated team of officials to work on access to medicines. It is also a key priority for other staff in my Department, not least our international policy department, and crucially, given the focus of my hon. Friend's debate, our research department. Given the obvious interest of other Departments across Whitehall, we work closely on this issue with the Treasury, the Department of Health, the Department of Trade and Industry and the Patent Office.

At a global level, there have been some recent international successes—for example, at the G8 summit in Evian in 2003. As with many diseases that primarily affect poor people in developing countries, however, research and development on malaria suffers from more structural problems, as an insufficiently valuable market exists to attract private sector companies to undertake research. Although there is a so-called travellers market for anti-malarials, it is too small to offset the larger investments that are needed to bring a new drug to market: typically, we estimate that an investment of $200 million to $300 million is required to bring new drugs to market.

Clearly, that leaves a variety of public policy options for the Government to adopt to speed up the process of developing new anti-malarial treatments. They range across advocacy on the need for new and better medicines, strongly co-ordinated international strategy and policy on the need for pro-poor research investments, direct investment in research and development, and effective measures to create greater demand for the new drugs so that an incentive is created for the private sector to invest.

My Department already has a portfolio of work supporting malaria research and development. We are prioritising our research efforts as we review our strategy to address the millennium development goals in our new central research strategy, which is due to be announced in the first quarter of this year. Malaria and anti-malarial work will be a focus of that strategy.

We always seek to promote an internationally coherent approach. We were instrumental in establishing the Roll Back Malaria Partnership to secure global steerage. My Department has given the partnership some £48 million over four years, and we have inputs into its strategy in order to develop an effective relationship between the Roll Back Malaria Partnership, the global fund and the World Health Organisation, as well as the other research agencies, academia, private sector groups, foundations and so forth with which the partnership works.

We firmly believe that there should be a strong relationship between poverty-focused control activities and poverty-focused research and development strategies. My hon. Friend mentioned the link between the two.

We make direct investments in research and development that benefit malaria treatment in several ways. Each year we give some £4 million to the Medical Research Council, in a concordat that prioritises the needs of developing countries in the research selection process. Within the overall MRC portfolio, the focus on basic clinical research that can be used to identify new drug candidates includes malaria.

The Department also has experience of engaging more directly in partnerships with industry to take the kind of research produced by the MRC and turn it into drugs that can be used where they are needed most. Most recently we have formed a partnership with GlaxoSmithKline, the WHO programme on tropical diseases research and Liverpool university to develop a cheap new drug called Lapdap, which my hon. Friend mentioned. To ensure the best possible use of that drug, further research to combine it with another drug to protect against early resistance is being undertaken, managed under an umbrella organisation called the Medicines for Malaria Venture, which my hon. Friend also mentioned and which my Department supports.

MMV is an important and innovative organisation, which brings together collaborators from the public and private sectors and from foundations to solve the market failure problem that I described earlier. It adopts a new approach to drug development, which creates a virtual process of research and development, and manages intellectual property in favour of developing countries. Since its inception in 1999, it has demonstrated significant progress towards reaching its objective of two new drugs in the next two years. My hon. Friend asked about the resources that my Department is giving to MMV. I can confirm that we are committed to giving it some £5 million over five years.

I mentioned the review of our research strategy; it is worth reminding the House of that. The most expensive phase of drug development is large-scale field trials in humans—phase 3 trials. To raise public finance to support those trials the Government, led by the MRC, are a contributing partner in the new European venture called the European and Developing Countries Clinical Trials Partnership. Launched in mid-2003, the partnership brings together EU member states, developing countries, other donors and the industry. It is one of the main achievements of the European programme for action on HIV, tuberculosis and malaria, and is the largest programme of clinical trials ever targeted on Africa. I think it is a powerful example of the co-operation that can be achieved through the European Union.

Once new drugs are available, it is important to monitor their uptake in target populations. My Department has two programmes that undertake applied and operational research on malaria in African, Asian and Latin American countries. Those focus on making sure that medicines work as they are intended to in real-life situations in developing countries, as well as investigating aspects such as compliance. That is in order to turn the availability of medicines into true access and true health gain in the countries that need it most.

The Government are also using other more indirect methods to stimulate research, such as contributing to the global fund for HIV, TB and malaria. Global funds help to stimulate research by creating a "pull effect". They pull new research into being by guaranteeing larger amounts of finance to procure new medicines when they are developed.

I am sure that my hon. Friend will remember that the Government are implementing the research and development tax credits that were announced in the 2002 Budget. That special tax relief for companies developing drugs and medicines for TB, malaria and HIV/AIDS applies to all expenditure incurred on or after 22 April last year. As companies make claims when they complete their tax returns, they will have up to 12 months after the end of the accounting period in question to claim the tax credit. We are monitoring how successful the tax credit is in stimulating research and development into drugs for malaria, which obviously helps those most in need—in this case, the poorest in Africa, where malaria is most prevalent.

My hon. Friend alluded to specific issues, such as the prevention and treatment of malaria in the UK. He is right to point out that the NHS does not cover the costs of preventive anti-malarials, impregnated bed nets, sprays or drugs, because the mosquitoes that transmit the disease are not endemic in the UK. A person infected overseas is not, on return, infectious, so there is no public health risk. The NHS does cover the cost of care and treatment for those infected once they are at home. In comparison, the Department of Health pays for hepatitis A, polio, tetanus and typhoid, which are much more infectious when people return.

The Government also take action to try to make people aware of the risks of malaria by providing accurate and up-to-date travel advice. The Foreign and Commonwealth Office has a section on its website for advice "before you go", which includes travel tips and health advice. The health section advises foreign travellers to access the Department of Health website and provides a direct link to the correct site for advice on malaria. That advice provides a list of countries where malaria is endemic, offers guidance on how to protect against malaria and on the value of discussing anti-malarial measures with doctors and encourages people to seek medical attention immediately if they feel feverish while abroad or for up to three months after their return. Travel agencies in the UK are also obliged to give advice to travellers. The Association of British Travel Agents also provides a telephone hotline service. My hon. Friend is right that more needs to be done, as we cannot relax simply because we advise people to take the appropriate precautions. The debate is helpful in stimulating awareness in that respect.

I congratulate my hon. Friend once again on raising this matter. I know that he will continue to return to it in the coming months. I look forward to debating with him and discussing with other interested colleagues what further action we can take to make the treatment of malaria and prevention of its spread more achievable.

Question put and agreed to.

Adjourned accordingly at one minute to Eight o'clock.