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About FP6 Funding

European Research Programme on HIV/AIDS, Malaria and Tuberculosis (2002-2006)

The genomic revolution has fuelled an unprecedented progress in our understanding of the molecular biology underlying many infectious diseases. New scientific technologies have been developed and creative applications have resulted in scientific breakthroughs, that were unimaginable a few decades ago. Few of these scientific advances are, however, translated into drugs, microbicides or vaccines that meet the real and pressing needs of people in the developing world.

Illustration

While communicable diseases are almost forgotten as a threat in affluent countries, they remain responsible for more than twothirds of the disease burden in Africa. The three major communicable diseases (HIV/AIDS, malaria and tuberculosis) alone account for over 6 million deaths per year, and new interventions to combat these overtyrelated diseases (PRDs) are therefore desperately required. In response to this global health priority, the European Commission (EC) has almost quadrupled its overall annual support to PRD research activities since 2002.

The increased funding for PRD research has mainly been provided through the Sixth Framework Programme for Research (FP6). FP6 was adopted by the EU Member States and the European Parliament in July 2002 with an indicative budget of € 400 million allocated to research into new interventions for HIV/AIDS, malaria and TB for a fouryear period. Substantial efforts have since been made to gather a critical mass of private and public partners from both developed and developing countries for a joint battle against the three diseases. To do so, different funding modalities have been applied to support various aspects of PRD research during FP6.

The largest single initiative under FP6 is the introduction of the European and Developing Countries Clinical Trials Partnership (EDCTP) by the European Parliament and Council on 16 June 2003 (OJ L 169, 8.7.2003, p.1.).

African child - Illustration

The overall goal of the EDCTP is to accelerate the development of new vaccines and drugs for the three diseases by supporting clinical trials in Africa in partnership with developing countries. The EC has allocated € 200 million to the EDCTP, which was established in autumn 2003 as a separate legal entity and is based in The Hague in the Netherlands.

The other research activities in the area of povertyrelated diseases under FP6 are mainly dedicated to establishing a stable supply line of promising new drug and vaccine candidates, which can be taken up by the EDCTP.

In areas of PRD research, where fragmentation and capacity gaps are the main obstacles, European integration and synergy has been sought through the creation of NetworksofExcellence (NoE), Coordination Actions (CA) or Specific Support Actions (SSA). In other areas of PRD research, a tight collaborative effort between scientists is required to solve welldefined scientific problems, and this has been addressed by supporting large multidisciplinary Integrated Projects (IP) and smaller Specific Targeted Research Projects (STREP).

The main aim has been to structure and integrate European research into a pipeline of projects ranging from early discovery to clinical testing of new treatments and vaccine candidates for each of the three diseases. To achieve this, the EC has supported 3 main types of research during FP6, namely discovery, translational and clinical research projects.

  1. Discovery projects are mostly small, highrisk projects with a significant degree of innovation. Individual projects have a typical duration of two to three years, and budgets of € 13 million euros. Discovery projects are mostly exploring new concepts for drug or vaccine development, or generating information about basic biological mechanisms underlying the 3 major povertyrelated diseases. Most of the discovery activities are STREP projects, but other instruments have also been used, including NoE, CA and SSA.
  2. Translational Research is undertaken by large multidisciplinary research consortia that are organised as integrated projects (IP). Each of the IPs comprise a critical mass of high level and complementary research groups that can jointly develop promising drug and vaccine candidates from discovery phases to early human testing. The average IP project comprises 10-20 research groups, and will receive an EU contribution of €10-15 million during a 5year period. This part of the pipeline consists of 11 projects and covers vaccine and drug development for all of the 3 PRDs.
  3. Clinical research in developing countries is foremost supported through the EDCTP programme, while a number of clinical research activities with relevance for Europe have been supported through collaborative research projects, including NoE, CA and SSA. The clinical research activities are mostly focused on coordination among clinical trials experts, structural support to clinical activities, and cohort studies with an aim to improve the treatment options for patients with PRD.

It is clear that a broad variety of research projects have been supported during FP6, and a vast number of research groups across Europe and beyond are now participating in EC funded research. More than 75 collaborative research projects have been launched in the area of PRD, involving more than 250 different research groups from both the public and private sector.

By the end of 2006, the EC will have committed all of its budget allocated to PRD research activities. The distribution of funding across diseases and across research types is summarised in the table below:

Discovery

Translational

Clinical

Total

Percentage

HIV infection and Aids

30,5 63,4 37 130,9 28,6%

Malaria

34,1 31,3 0 65,4 14,3%

Tuberculosis

22,4 38,7 0 61,1 13,4%

EDCTP

- - 200* 200 43,7%

Total (%)

87,0 133,4 237 457,4 100%
* EC funding commitment to the EDCTP of € 200 M.

It is obvious that product oriented research and development has been a main priority for PRD during FP6. The majority of EC funding in FP6 has thus gone to the EDCTP programme and to translational research activities carried out by IPs.

Medical solutions to efficiently cure or prevent HIV/AIDS, malaria and tuberculosis are either nonexisting or associated with major flaws. For all of the 3 diseases, a dual approach has therefore been followed during FP6, and support has been granted to the discovery and development of new treatments as well as new prophylactic vaccines. For the HIV/AIDS area, significant support has also been granted to the development of microbicides.

The total EC contribution committed to discovery and translational research activities for PRD under FP6 is more than 255M euros (not including the EC contribution to the EDCTP). Approximately 43% of this amount has been allocated to vaccine development or vaccine related research projects. Another 48% of the total EC contribution has been earmarked for development of new drugs or related treatments. The remaining 9% has been shared between HIV microbicides (6%) and research in new diagnostics (3%).

Approximate distribution of EC funding

The global epidemics of HIV/AIDS, malaria and TB have reached such proportions that coordination and partnerships between all stakeholders will be necessary in the future battle against the diseases. An important aspect of FP6 in the area of PRD has therefore been to create new and sustainable research partnerships. New partnerships have been established between the private and public sector, between developed and developing countries; and across different areas of research.

African child

A new patchwork of research partnerships has started to emerge. More than 50 industry participants, large as well as small or mediumsized enterprises (SMEs), are thus actively engaged in the EUfunded projects and collaborating with academic scientists in genuine partnerships between the public and the private sector.

It is also noteworthy that more scientists than ever before from disease endemic countries are now involved in research projects under EC funding. More than 30 different institutions from developing countries in Africa, Asia and South America are actively participating in PRD projects, thereby creating a unique opportunity for synergy between research teams from developed and developing countries.

With the 6th Framework programme coming to an end a new landscape for European research in PRD is now emerging. During the four year timeframe of FP6, the EC has made an important contribution to the fight against HIV/AIDS, malaria and TB by pooling knowledge, experience and human resources from the different stakeholders in the R&D development process. Europe is now supporting a wide range of research activities, ranging from early discovery to clinical trials and comprising an extensive pipeline of projects that may eventually result in new effective interventions for these diseases.

This book, "Combating Deadly Diseases", compiles an overview of research projects in the area of povertyrelated diseases funded by the European Commission under FP6. All projects on PRD – except those funded by the EDCTP – are presented in this catalogue together with an abstract and information about the partners. Taken together, they form the picture of a diverse and innovative European research community that is actively engaged in combating the three diseases, and thus bring hope to the many millions of sufferers around the globe.

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