Tuberculosis Vaccine Initiative (debate) 
President
The next item is the debate on the oral question by Louis Michel, Charles Goerens, Antonyia Parvanova, Frédérique Ries, Olle Schmidt, Maria Da Graça Carvalho, Nessa Childers, Marc Tarabella, Bart Staes and Marina Yannakoudakis on behalf of the Group of the Alliance of Liberals and Democrats for Europe, to the Commission on the Tuberculosis Vaccine Initiative -B7-0006/2011).
Charles Goerens
Madam President, I am happy to be able to lend my support to a pan-European project that is very ambitious both for the European Union and for developing countries, and which is aimed at eliminating tuberculosis by means of a vaccination programme.
Let us remember that more than 1.7 million people died from tuberculosis in 2009. The cost in terms of human life is some 4 700 people per day. Add to this the annual economic losses, which are estimated at more than USD 50 billion for Africa alone. If, based on this, we were to reduce tuberculosis to a problem typical of developing countries, we should be greatly deceiving ourselves.
In fact, the cases reported in the United Kingdom and Ireland during the summer of 2010 remind us that the disease is here in our countries, not to mention the ravages caused by the same disease in the east of our continent, particularly in Russia and Moldova. The Tuberculosis Vaccine Initiative (TBVI) is an initiative that aims to create effective vaccines with a view to protect developing countries at an affordable price. With this in mind, I should like, if I may, to make the following comments.
First, health does not have a price but it has a cost. While access to healthcare must be universal, the ability to pay remains in itself limited to the industrialised nations. That being the case, it is important to spread the costs broadly. Clearly, patients in the North, that is to say in the industrialised countries, must pay a high price, otherwise the sources of funding for research will dry up quickly enough. However, given that the financial contribution of the countries of the South is, if not non-existent, then no more than purely symbolic, our solidarity becomes indispensable to overcome this shortfall.
Second, the TBVI initiative also has a place in the EU's 2020 strategy. It is a perfect illustration of what we can achieve if we can establish our health priorities in good time.
My third, and concluding, comment is this: that this in no way excludes additional or complementary funding from the large institutional lenders, including the World Bank in particular. Other countries, such as the United States, Canada or a number of emerging countries that are affected by the problem of tuberculosis, whether directly, as it impacts on their populations, or indirectly in the context of international solidarity, should quite logically make their own contribution to this initiative too. To be specific, I am talking here about the public-private partnership model.
This new approach can be beneficial provided that solidarity is limited to those who have both medical and financial requirements. The alternative would be to protect only well-off populations.
Dacian Cioloş
In 2008, the Tuberculosis Vaccine Initiative (TBVI) was established in the form of a public-private partnership with the support of the Health Cooperation Programme within the Seventh Framework Programme for research in order to mobilise additional resources for this important area.
At the present time, the majority of recently developed new vaccine candidates are still in the preclinical development phase or beginning clinical development. A crucial point to emphasise is the fact that we do not have available clinical data to support the idea that one of the vaccine candidates under development could prove to be more effective than the vaccine currently in use, which is the Bacillus Calmette-Guérin (BCG) vaccine.
In order to come onto the market, new vaccine candidates must be capable of being more effective than BCG or of replacing it as a better vaccine. The fact is that we still do not have these important data available. The TBVI should not be considered in isolation from other initiatives for supporting clinical trials.
In order to deal with bottlenecks in the clinical development field, the European and Developing Countries Clinical Trials Partnership, or EDCTP, has been established as the first initiative taken under Article 185, in which 14 Member States, 2 Associated States and the Commission have collectively committed EUR 400 million, with EUR 200 million coming from the European Union, with the aim of promoting research in phase 2 or 3 clinical trials for AIDS, for example, malaria and tuberculosis in sub-Saharan Africa. The programme is predicted to complete all the trials currently under way, including eight trials of the anti-tuberculosis vaccine, by 2015. This alternative is therefore already in place, and it works. The Commission is also very interested in what is called 'the business model', which has been developed by the public-private partnerships, including the one presented by the TBVI.
The TBVI has, moreover, proposed a model that can potentially become a useful tool in the future. However, this requires an in-depth analysis of the commercial project as well as a risk assessment. Consequently, even if the TBVI enjoys significant financial support, its success is not guaranteed, precisely because of the fact that there is not enough information to indicate whether what is currently being trialled can yield results subsequently.
However, the Commission will continue these internal discussions and will also analyse the model with the financial institutions, thus contributing to the development of a concept so that it can form part of the practical implementation of EU 2020. From this point of view, then, this possibility could be examined.
Maria Da Graça Carvalho
Madam President, Commissioner, the incidence of tuberculosis worldwide remains a cause of great concern, despite the progress made. The increasing resistance of this disease and insufficient scientific research mean that today almost 2 million people die of it every year.
We welcome EU initiatives to combat tuberculosis through this resolution, but we call for more scientific research to be undertaken to develop new forms of vaccine against this disease. Vaccines are the public-health measure that is most effective at protecting Europeans from infectious diseases, but it is also important for healthcare to reach developing countries, so as to contribute to increasing life expectancy and combating poverty.
As I said, there has been some progress and we are on the right track, but the EU must redouble its efforts, and call for more coordinated action and integration of European research into combating poverty-related diseases. That is the only way that we will manage to alleviate the tragic situation being experienced in several developing countries.
I should like to ask the Commission how it intends to follow up on scientific research efforts in this area, to intensify these efforts, and to translate the results of this research into benefits for people in the light of the Europe 2020 strategy.
Michael Cashman
on behalf of the S&D Group. - Madam President, it is always good to see you in the chair when we are discussing issues about the plights of others. I know you share our concerns.
I want to associate myself with the words of Mr Goerens and, indeed, take the Commission a little further. It is quite right that TB is a significant global health concern and, as we know, is the second leading cause of death from infectious diseases worldwide. As we heard, 1.6 million to 2 million people die annually from the disease. EU funding has been instrumental in generating a robust pipeline of innovative TB vaccine candidates, as the Commission said enabling their early stage development by phase 1 and phase 2A clinical trials.
Unfortunately - and this is the problem - currently funding mechanisms, including the European and Developing Countries Clinical Trials Partnership, allocate very limited funding to the very costly late-stage clinical trials - phase 2B and phase 3 - which are vital to demonstrate vaccine safety. We have vaccines, but it is vital to demonstrate the safety and the efficacy necessary for licensure.
I now welcome the fact that the Commission has said that it is bringing in additional funding, but will the rules for any new EDCTP budget provisions permit funding to be directed to the development and building of clinical trial sites, including epidemiology studies? Is the Commission considering the introduction of competitive funding mechanisms for the late-stage clinical development of innovative new vaccines that address the neglected diseases, such as TB?
Angelika Werthmann
(DE) Madam President, tuberculosis is still very widespread today, particularly in poorer countries. A third of the world's population is infected and 2.5 million people die from TB each year. According to estimates by the World Health Organisation, there are 49 new cases and seven deaths per hour in Europe alone. In the industrialised nations, tuberculosis has experienced a resurgence, particularly as a secondary disease in patients with HIV and AIDS, but also as a result of migration and tourism.
Prevention, diagnosis and treatment can indeed bring the spread of this disease under control. Humans are the only host of the tuberculosis microbacterium and its eradication would be perfectly possible. However, there are concerns about the increasing number of resistant bacteria. There are new vaccinations and, according to one study, administration of vitamin D reduces the treatment time for tuberculosis. To what extent has the Commission already stepped up its activity in this area?
Filip Kaczmarek
(PL) Madam President, four years before the deadline for achieving the Millennium Development Goals, the number of new cases of tuberculosis being diagnosed throughout the world is still alarming. Tuberculosis is a treatable disease. In developing countries, unfortunately, and in particular in Asia and Sub-Saharan Africa, it remains a very serious problem. According to recent estimates, around two billion people are infected with the tubercle bacillus, or in other words one third of the world's population. Statistically speaking, one in ten of these individuals will go on to develop tuberculosis. The poorest regions of the world are at particular risk of an increase in new cases of tuberculosis, since poor nutrition and living conditions, as well as stress, create a favourable environment for development of the disease. Access to effective treatment for the disease is limited in many countries, and there is no coordination of treatment for AIDS and that for tuberculosis. This is a result of the fact that the governments of developing countries do not spend enough on health. In addition, healthcare systems in rural areas suffer from staffing shortages, and lack the means to treat such diseases. In countries with limited financial possibilities, the effects are therefore felt most severely in rural areas. Developed countries spend around 5% of GDP on public healthcare, whereas developing countries spend one half of this figure. It is therefore impossible for poorer countries to increase spending on health without external assistance, as was also noted by Mr Goerens. On top of this, tuberculosis is not only a medical problem, but also a social and economic problem, since it causes productivity to drop and has economic ramifications. All this means that we should be decisive in our response, and we really should make every effort to ensure that vaccines become more widely available.
Ricardo Cortés Lastra
(ES) Madam President, Commissioner, ladies and gentlemen, health is one of the issues that we have yet to resolve in the struggle against poverty. In the Millennium Declaration we committed, first of all, to reducing child mortality; secondly, to improving maternal health; and thirdly to combating AIDS, malaria and many other diseases, including tuberculosis.
Nonetheless, all of us here today know that it is those goals that are currently the furthest behind schedule. We must take measures: we must increase funding for health programmes in developing countries. Access to free healthcare systems should be the European Union's ultimate goal in this area.
I believe that support should be given to global initiatives such as vertical funds to aid in the struggle against AIDS, malaria and tuberculosis. However, Commissioner, it is also necessary to support countries politically and economically, so that they can develop effective healthcare systems. I am convinced that this would be the best way of ensuring the principle of appropriation and allowing the most vulnerable parts of the population access to healthcare.
Anna Záborská
- (SK) Madam President, tuberculosis, like malaria and AIDS, is one of the great pandemics which are decimating the populations of developing countries, particularly in Africa and Asia. This directly results in a deteriorating economic and social situation in these countries.
However, European countries have also failed to cope with the high incidence of tuberculosis. This disease cannot be considered simply as a medical-pharmaceutical problem, or just as a problem of human behaviour. It also involves issues of human development and integrity, and also justice, which require a global approach. People who are ill with tuberculosis in developing countries are also victims of injustice, for the treatment they receive is insufficient and not of the same quality as in the developed world.
We need further research, and a continuous flow of new medicines and vaccines capable of responding to new complications and resistant strains of various pathogens. I would like to draw your attention, however, to those simple heroes who are fighting tuberculosis, enabling us to continue treating the sick, to resist the hardships created by combined infections of tuberculosis and AIDS, and to help all countries meet the millennium challenges. We must support health workers in developing countries. Health workers are leaving for more affluent countries because health budgets are being slashed in their own countries.
I support the Tuberculosis Vaccine Initiative, but we must take a global approach to overcoming this disease. It is not enough just to support research and the pharmaceutical industry, because, apart from anything else, it will be a long time before this research bears fruit.
Miroslav Mikolášik
- (SK) Madam President, I would like to stress that tuberculosis is far from being eradicated, and we see here that nearly two million people a year are succumbing to this serious disease.
I would like to say that it is a good thing we are aware of this, and I welcome the Commission initiative for the fact that we are not talking just about the AIDS pandemic, we are also talking about tuberculosis, which takes the lives of millions of people.
I agree that there is a need to devote more resources to the development of new vaccines. As the Commission has just stated, however, we do not yet have these new vaccines, of course, as we are still in the pre-clinical stages, and we are still just testing their effectiveness when given to humans. I would like to make a call - I am about to finish, Madam President - for new funding and new resources.
Claudiu Ciprian Tănăsescu
(RO) Madam President, an annual mortality rate of between 1.6 and 2 million people makes tuberculosis one of the two major causes of death worldwide from infectious diseases. This justifies the growing concern globally of public health organisations.
In an age when medicine is making spectacular advances, we must acknowledge that the time has come for the traditional tuberculosis BCG vaccine to be replaced with a new, more modern and much more effective one. However, this cannot be achieved without, on the one hand, granting more generous EU funds for completing the research in this area and, on the other hand, finding other sources of funding by reviewing the model proposed by the TBVI for alternative, innovative funding methods.
Providing financial guarantees may make this model more attractive to the European business community, thereby ensuring its involvement and the necessary financial support.
Seán Kelly
Madam President, tuberculosis, or TB as it was known in my country, was rampant in Ireland a little over half a century ago, killing many people, young and old.
As the country grew affluent it died out, and vaccination stopped for 36 years. However, as the author has pointed out, TB has returned in recent years. Only last year in my own constituency a child in a school and a baby in a crèche contracted the disease.
Worldwide, it is a bigger problem with 2 billion affected by the bacteria and one person dying every 20 seconds. We therefore have a big task if we are to reach the target of eliminating the disease by 2050.
Research is the key, and in this area the European Union deserves great credit because, while we are behind the US and Japan in terms of research in general, we are the leaders in this field, with 60% of research taking place in the EU, and with Danish authorities and scientists in particular having developed the vaccine.
João Ferreira
(PT) Madam President, four years before the deadline for achieving the Millennium Development Goals, tuberculosis ends 2 million lives every year. Tuberculosis constitutes a flagrant example of the inequalities that riddle our world. Let us not forget that this is a disease that is not at all widespread in industrialised countries.
The problem of tuberculosis and of other diseases will not be solved without high-quality public health services accessible to the entire population, including primary healthcare. Development cooperation and aid policy plays a crucial role here, which, naturally, must involve aid to vaccination programmes; however, more is needed. We must break once and for all with mechanisms, such as those of debt and debt servicing, that drain the resources of the developing world and make it possible to keep its countries backward, dependent, subjugated and destitute.
Csanád Szegedi
(HU) Madam President, ladies and gentlemen, the number of tuberculosis cases and resultant deaths in Hungary has increased at a frightening rate over the past years. This is the result of nation-destroying liberal thinking, among other things. Here I am referring to the shameful Hungarian Healthcare Act of 2006, which was based on hospital closures and profit-oriented healthcare services. A significant factor in the development of the disease is poverty, including the increased number of homeless people and a healthcare system that is increasingly difficult to access. I believe that it is important to reinforce the healing and preventive role of healthcare, extend screenings, and not only extend improved vaccination but also make it available to everyone. These steps could result in a healthier nation, and a healthier Europe and society in the long term.
Dacian Cioloş
Madam President, I shall try to provide some answers to the points raised.
First of all, we must intensify research, as I already said in my introduction. The Commission is looking at ways in which to increase the funding for its tuberculosis programmes, and one solution could be to top up the EDCTP programme, which I spoke to you about. The programme currently operates with EUR 400 million, of which the Commission provides EUR 200 million. The Commission is also considering the possibility of creating an EDCTP 2 programme, for example. I must also stress, as I have already said to Mr Tănăsescu, that the Commission already dedicates a substantial amount of resources to the tuberculosis research programme. I can even cite you a figure: EUR 65 million have already been allocated to this programme. However, it is clear that this is not enough, and the public-private partnership must also be examined.
Having said that, if it comes down to a question of funding vaccine candidates in a clinical phase, the issue of effectiveness will have to be considered. As I told you, the information that we currently have gives us no assurance that significant funding could lead to a positive result. Vitamins are another approach currently being studied, but what we must avoid is the development of resistance. That is perhaps one avenue to be explored, but we must bear in mind the existence of that risk.
Let us now speak more generally about health systems in the European Union, as well as in the developing countries. In the European Union, health is, besides, also one of the objectives that the Commission is trying to promote in the Member States, by means of various programmes, including the Europe 2020 Agenda. In other words, it is promoting investment in health. Within the field of research, in one of the research and innovation initiatives, the Commission - and a group of Commissioners in particular - is working on this topic so as to ensure that innovation can be boosted in the Member States to intensify health-related research, in parallel with issues concerning the ageing of the population.
As far as developing countries are concerned, the European Union is already achieving a great deal in the area of health with the development fund, and this is a topic to which the Commission will continue to pay full attention in the future.
I hope that I have been able, on behalf of the Commission, to provide some answers to your questions. I can only assure you that research remains one of the Commission's main concerns.
President
To wind up the debate, four motions for resolutions have been tabled under Rule 115(5) of the Rules of Procedure.
The debate is closed.
The vote will take place tomorrow at 11:30.
Written Statements (Rule 149)
Joanna Senyszyn
As a member of the delegation to the ACP-EU Joint Parliamentary Assembly, I am in favour of the results of EU research into the development of vaccines against tuberculosis being made available to developing countries, and of helping these countries to fund treatment for those suffering from the disease. Tuberculosis is one of the three most frequently occurring infectious diseases, along with HIV and malaria. One third of the world's population is infected with the tubercle bacillus; every year, eight million people are diagnosed with the disease and it kills between 2.6 and 2.9 million. Over 95% of cases occur in developing countries. Every second, the tubercle bacillus claims another victim. Around 10% of those infected will go on to develop the disease, which can be deadly if left untreated. Most cases are diagnosed in India, China, Indonesia, South Africa, Nigeria, Bangladesh and Ethiopia. In Asia and Africa, incidence stands at 100-120 per 100 000 of population. Access to effective treatment is limited in many countries. Tuberculosis is a serious economic problem. The global fall in workforce productivity caused by the disease amounts to USD 13 billion every year. Eliminating tuberculosis is one of the Millennium Development Goals, which the EU wants to achieve by 2015. We already only have four years left. Tuberculosis is currently a fully treatable disease. We need comprehensive programmes aimed both at preventing and treating tuberculosis. An information campaign on tuberculosis and ways of avoiding and treating it should be launched as soon as possible, and a vaccination programme started.
Lívia Járóka
in writing. - Throughout the history of mankind, tuberculosis has killed more people than any other disease. This highly contagious, airborne bacterium can infect ten to fifteen other people before the symptoms are noticed.
Overcrowded housing, slumification and the lack of proper hygiene have always been a serious risk factor for tuberculosis, and therefore TB is the disease most strongly related to and partly caused by poverty.
Despite the efforts of the WHO and national authorities, the number of people dying of tuberculosis amounts to 1.5 million every year and the number is still increasing. I full-heartedly support the Tuberculosis Vaccine Initiative and sincerely hope that it can provide more vaccines for sufferers in Europe and around the world.
But it must be emphasised that the fight against TB must walk hand in hand with the fight against poverty and social exclusion. It is necessary to identify the vulnerable groups as well as to determine and eliminate the barriers preventing these groups from accessing the full range of TB prevention, diagnosis and treatment.
It would also be beneficial to modify the agenda of TB services in order to respond better to local needs and to address the widespread discriminatory practices in health systems.
Vilija Blinkevičiūt
in writing. - (LT) We must combat tuberculosis, because this disease kills nearly two million people worldwide each year, and almost a third of the world's population is infected by it. I would like to draw attention to the fact that tuberculosis is a sensitive world health issue and the second greatest cause of death among infectious diseases worldwide. Tuberculosis is heavily linked to social and economic problems, such as poverty, unemployment, alcoholism, drug addiction and HIV/AIDS, as well as the inadequate and poor state of healthcare systems in poor countries and delays in diagnosis. I am therefore pleased that the Tuberculosis Vaccine Initiative model has been drawn up, because all patients suffering from tuberculosis worldwide will be able to benefit from the results of research and work activities. Furthermore, this project would contribute towards implementing the Europe 2020 objectives and achieving the Millennium Development Goals by 2015. I would like to point out that there is insufficient funding for the fight against tuberculosis and European Union funding is very important for establishing a strong package of new potential tuberculosis vaccines. I hope that progress will be made as soon as possible to licence current potential European tuberculosis vaccines, and that they will be available to those who most need them. Furthermore, it is important to find opportunities to implement competitive funding mechanisms to carry out the final stages of clinical research into new vaccines against tuberculosis.
Elżbieta Katarzyna Łukacijewska
In the context of our debate, I would like to note that, at the start of the 21st century, tuberculosis kills around three million people every year around the world. The statistics tell us that one third of the world's population is infected with the tubercle bacillus. This problem is a cause for concern. We must ensure that only the best and most innovative vaccines are used as the fundamental tools in the fight against the disease. We must try to step up international measures and consider the funding of vaccines, particularly for developing countries. In addition, an active media campaign is needed to inform society of the problem and of the routes of infection and ways to prevent the disease, since many people believe that tuberculosis is a disease which does not affect us in the modern world. Thank you.
Artur Zasada
I am concerned at the conclusions reached by the authors of the oral question; five years before the deadline for achieving the Millennium Development Goals, there has been a slight decrease in the global incidence of tuberculosis. According to the information at my disposal, over 73% of doctors in Central and Eastern Europe admit that they do not feel adequately trained to diagnose and treat tuberculosis. The general feeling among doctors is that the situation is significantly worse; 75% of doctors believe that the number of new cases of tuberculosis is growing. What can be the reason for such a discrepancy between the official statistics and the observations of medical practitioners? The system for collecting data on new cases of tuberculosis is outdated, and healthcare institutions often neglect their duties in this respect. It should be stressed that the key weapons in fighting the disease remain prevention, education and adherence to the rules of hygiene, which makes it possible to avoid infection with the tubercle bacillus. I agree with the authors of the question that one of the solutions to this problem may be the introduction of a vaccination programme at the same time as a large-scale information campaign.
Cristian Silviu Buşoi
Although a certain amount of progress has been made, tuberculosis continues to be one of the main causes of mortality worldwide, especially in developing countries, accounting for nearly 2 million deaths a year. The situation in Romania is also worth mentioning, where 110 cases per 100 000 inhabitants are recorded, against a European average of 39 cases per 100 000.
Access to health is a universal right and it is not the financial costs of it which should concern us. An imbalance persists between the industrialised and developing countries. We must show solidarity and support using every method available the 'Stop Tuberculosis' programme launched by the World Health Organisation (WHO).
It is Europe's duty to look for viable, innovative methods to guarantee the funding for research in order to combat tuberculosis and other transmissible diseases. The Tuberculosis Vaccine Initiative (TBVI), an organisation supported by the European Union, offers a solution to the current situation by creating accessible vaccines at affordable prices, which can be supplied to the population through a structured vaccination programme. The inclusion of the TBVI in the EU 2020 strategy may be the solution enabling Europe to strengthen its strategic independence in the battle against tuberculosis and its position as a leading innovator.
