[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 30.10.2008

COM(2008) 688 final

Communication from the Commission to the European Parliament and the Council

on the Progress Report on the ‘European and Developing Countries Clinical Trials Partnership’ Programme {SEC(2008)2723}{SEC(2008)2724}

Communication from the Commission to the European Parliament and the Council

on the Progress Report on the ‘European and Developing Countries Clinical Trials Partnership’ Programme

BACKGROUND

The European Commission communication of September 2000 Accelerated Action targeted at major communicable diseases within the context of poverty reduction [1] set out a broad and coherent Community response, for the period 2001-2006, to the global emergency caused by the three major infectious diseases that affect the world’s poorest populations, undermining global health: HIV/AIDS, malaria and tuberculosis.

In the same spirit, the Millennium Development Goals (MDGs) developed out of the United Nations’ Millennium Declaration[2] that same month (September 2000) aim at halving extreme poverty, halting the spread of HIV/AIDS, and providing universal primary education by 2015. Goal Number 6 aims at combating HIV/AIDS, malaria and other diseases with two specific targets: Target 7, to have halted and begun to reverse the spread of HIV/AIDS by 2015; and Target 8, to have halted and begun to reverse the incidence of malaria and other major diseases by 2015 (tuberculosis, which kills some 2 million people a year, being the third major poverty-related disease).

The Commission communication to the Council and the European Parliament Programme for action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction [3], presented in February 2001 and updated in 2005[4], set out the specific mechanisms of the EU’s response to this global emergency, which include strengthening and increasing support for research and development, capacity building in developing countries, and creating incentives for the development of specific global public goods. Among these, the creation of a European Clinical Trials Platform [later renamed the European and Developing Countries Clinical Trials Partnership] designed to remove important scientific, technological and operational hurdles to product development in developing countries.

The European and Developing Countries Clinical Trials Partnership (hereinafter referred to as "the EDCTP Programme") was established in September 2003 by Decision of the European Parliament and of the Council[5],[6] to accelerate the development of new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in the developing countries, particularly in sub-Saharan Africa, and to improve generally the quality of research in relation to these diseases. Created as the first application ever of Article 169 of the Treaty[7], the EDCTP Programme aims at coordinating and jointly implementing activities run by the Member States in partnership with developing countries.

RATIONALE

This Communication follows a recommendation in the Independent External Review (IER) report [8], also known as the Van Velzen report, that the Commission should inform the Council and the European Parliament about the current status of the EDCTP Programme, in advance of the 2008 evaluation (required by the original EDCTP Decision) due at the end of the first five years of the EDCTP.

THE NATURE OF THE CHALLENGE

The three main poverty-related diseases, HIV/AIDS, malaria and tuberculosis kill about six million people a year, mostly in sub-Saharan Africa. The lack of adequate preventive and therapeutic tools results in an increased prevalence year after year.

In addition, the most vulnerable populations lack the capacity to fight against these three infections. Research on these diseases is particularly difficult, due to a lack of trained personnel and of infrastructure, especially in sub-Saharan Africa. Without such capacity, researchers cannot properly contribute to fighting these diseases and support the local population.

While many European countries do have relevant research programmes for sub-Saharan Africa on the three diseases, they do so in bilateral North-South collaborations, and lack proper coordination with other European partners. This fragmentation hampers the development of an appropriate approach to helping African researchers and populations to combat these diseases.

Finally, European research activities in sub-Saharan Africa are conducted with no clear synergy with development aid and cooperation programmes, which invest considerable funds in public health capacity.

OBJECTIVES

The EDCTP Programme was created to tackle these challenges and, ultimately, to help alleviate poverty in Africa. The strategic objectives of EU intervention were to:

(1) Develop new interventions and products against poverty-related diseases. The fight against HIV/AIDS, malaria and tuberculosis needs both prophylactic (vaccines and microbicides) and therapeutic (drugs) tools to prevent infection and control disease progression.

(2) Build sustainable public health and research capacity in Africa, so local populations can better control the pandemic. The coordination of development aid policy and research policy should aim at a better implementation of these separate policies into a long term strategy against the three diseases.

(3) Coordinate European Member States’ research policies. While the research activities of some European Union Member States in Africa have been remarkable, they could profit from better collaboration and coordination. Coordinating European national research programmes and policies on poverty-related diseases for Africa in line with Article 169 of the Treaty will increase the impact of European interventions against these diseases.

The Early Years : THE EDCTP 2003–2006

The European and Developing Countries Clinical Trials Partnership was created as an independent organisation under the legal form of a European Economic Interest Group (EEIG), based in The Hague, The Netherlands.

The EDCTP Programme is financed with €200 million from the Sixth Framework Programme for Research and Development (2002-2006)[9] – (FP6). Moreover, participating Member States are co-funding the Programme with another €200 million. In addition, the original EDCTP Decision provided for the possibility of attracting the private sector and mobilising €200 million more from other stakeholders, including industry, foundations, public-private partnerships and other like-minded organisations.

The EDCTP initiative is unique in many ways. Firstly, it is the first use of Article 169, under which European Member States agree to coordinate their national research programmes. Secondly, it addresses poverty-related diseases in sub-Saharan Africa, where lack of local capacity is an integral part of the problem. And thirdly, it involves Member State co-funding from both development aid and research agencies, precisely to tackle the capacity-building and public health aspects of this research.

Because of this unique combination of challenges, the EDCTP Programme had a very difficult initial period. In the first three years performance was lower than expected, budget spending was abnormally low, calls for proposals were cancelled, and a 2004 report from the European Court of Auditors (PF-1828 (6046)) revealed some shortcomings. In addition, from 2003 to 2006, the EDCTP was managed by four different Executive Directors (two of them ad interim ).

In order to perform a full analysis of the Programme, in December 2006 the Commission requested an Independent Expert Review of the EDCTP, which resulted in the Van Velzen report8, delivered in July 2007.

FOLLOW-UP OF THE VAN VELZEN REPORT (EDCTP ACTIVITIES 2007-2008)

The Independent Expert Review report presented in July 2007 provided recommendations: (1) to the EDCTP Secretariat; (2) to the participating Member States; (3) to the European Commission, on future EDCTP activities; and (4) to the European Commission, on new Article 169 initiatives. The full text of the recommendations is attached as Annex 1 to the Progress Report.

1. Recommendations to the EDCTP

Since early 2007, and following the recommendations in the Van Velzen report, the EDCTP has redefined its scientific strategy (recommendation 1.1), through stakeholders’ meetings on HIV/AIDS drugs, microbicides and vaccines, malaria drugs, vaccines and malaria in pregnancy, tuberculosis drugs and vaccines, and African networks of excellence.

Participating Member States have set up an executive Steering Committee (1.2), in which the Chair and Co-chairs of the General Assembly and the EDCTP Executive Director are represented. The General Assembly Steering Committee takes decisions on behalf of the General Assembly on current issues, such as approval of projects to be funded.

Moreover, the EDCTP has introduced collaboration with public-private partnerships such as the Medicines for Malaria Venture and the Global TB Alliance, which are increasingly involved in funded projects (1.3).

The EDCTP has also published new calls for proposals (1.4) as a direct result of the different stakeholders’ meetings. In 2007, 11 calls were published, totalling approximately €180 million (€90 million from the Commission and €90 million in co-funding from EDCTP participating countries).

Finally, the EDCTP has also simplified the co-funding procedure (1.5) to allow increased participation by African researchers as Principal Investigators in EDCTP-funded projects. However, the creation of a true common pot of national funds is a long-term goal that has only just started to be implemented by EDCTP and other joint programming initiatives under the Sixth Framework Programme (FP6).

2. Recommendations to the EDCTP Member States

At the Commission’s request[10], the EDCTP Member States have renewed their commitment to the Programme (2.1), both politically, indicating their ongoing support for the Programme, and — in some cases — financially, with specific funding contributions. A common funding pot of national development aid agency funds from some Member States is now in place. The common pot for research financing has proven more difficult, since many countries claim they cannot finance foreign researchers.

Representation in the General Assembly of the chairs of all EDCTP committees has boosted African participation (2.2). In addition, the Developing Countries Coordinating Committee has new African regional representatives. On the other hand, since all Member States provide funding, however small it may be, restricting the decision making to ‘Member States that provide financial contributions’, as recommended in the report, is not relevant.

Recommendation 2.3, giving decision-making status to representatives from African countries, cannot be legally implemented, since the European Economic Interest Grouping, the legal structure of the EDCTP, does not allow non-European representation. Nevertheless, as stated, African consultative participation in the General Assembly has been significantly reinforced, involving African representatives in the decision-making process.

Member States are increasingly accepting a single central EDCTP scientific and ethics evaluation (2.4) drawing on a pool of the best experts.

Member States are indeed enforcing the Article 169 concepts on an increasingly sustainable basis (2.5), both in terms of the integration of national research programmes and in yearly financial contributions to the EDCTP, and report back each year to the EDCTP, which in turn reports to the Commission on Member States’ commitments.

3. Recommendations to the European Commission, in relation to future EDCTP activities

This report is designed to comply with the first of the group’s recommendations (3.1), i.e. reporting to the Council and Parliament about the current status of the programme in advance of the 2008 evaluation.

Commission services have engaged in a dialogue on the EDCTP (3.2) and have agreed to participate actively in its Partnership Board and General Assembly. Complementing this effort, the Commission is using the existing ‘Inter-service Group on Communicable Diseases for Poverty Reduction’ to strengthen dialogue at all levels. The latter group follows up EU policy and progress in confronting HIV/AIDS, malaria and tuberculosis through external action, while the EDCTP establishes synergies between research capacity building and training of health care workers.

The new health research strategy agreed in the Seventh Framework Programme (2007-2013) — FP7 — focuses on translational health research on the three diseases (3.3). Although the specific programme in the FP7 refers to possible further support for the EDCTP, subject to certain achievements, this strategy may have to be reformulated depending on the final evaluation of the EDCTP and the impact assessment studies planned for 2009 before any proposal for a Decision to renew the EDCTP.

The EDCTP High Representative began consultations and exchanges on its future with all stakeholders (including African governments) in 2007. The Commission is constantly working to strengthen the EDCTP’s participation in relevant international fora such as the Global Ministerial Forum on Research for Health in Bamako, Mali, on 17-19 November 2008. The involvement of African partners in the EDCTP Partnership Board has helped put the three diseases on national health research agendas. Although capacity in human resources and laboratories is being built (3.4, 3.5), more efforts are needed to ensure sustainability.

Recommendation 3.6, that a proposal for a new Decision for the continuation of the EDCTP Programme be made, will be considered in due time.

4. Recommendations to the European Commission, in relation to new Article 169 initiatives

The new Article 169 initiatives in preparation or already submitted to the Council and the European Parliament (AAL[11], BONUS-Art 169[12], EMRP[13], EUROSTARS[14]) closely follow the recommendations of the Van Velzen report, and include a specific set of preconditions to be met (4.1) before any Member State can take part in a new Article 169 initiative.

The need to ensure the pre-existence of national research programmes and that Member States are fully committed to funding (4.2) is one of the main pre-conditions set by the Commission for new Article 169 initiatives.

A common work-plan, sound governance structure, fixed national financial contributions, clear evaluation criteria and procedures, clear deliverables and solutions in case of liability (4.3) are also required for new Programmes based on Article 169.

Following the positive developments in late 2006 and early 2007, and in line with the recommendations of the Van Velzen report, in July 2007 the Commission extended the original five-year EDCTP contract by two years, i.e. up to September 2010, without additional funding. The forthcoming evaluation of the EDCTP will cover the first five years of the Programme, from September 2003 to September 2008, as required by Article 8 of the EDCTP Decision.

EDCTP PROJECT FUNDING

Since its inception, the EDCTP Programme has financed around 145 projects, including 32 clinical trials, in 122 institutions from 26 different African countries. In addition, 55 training awards and 16 Senior Fellowships were funded, allowing a number of African scientists to return to their countries to do research on poverty-related diseases.

From 2003 to December 2007, the EDCTP financed grants for €76.2 million (total funding in signed contracts, including Commission, Member State and third-party financing), 63% of these going to African researchers. Furthermore, in May 2008, partly as a result of the calls published in 2007, the EDCTP General Assembly approved the financing of 10 new projects on malaria treatment, malaria vaccine, malaria in pregnancy, and tuberculosis vaccine; 8 new projects on capacity building for African ethical committees; 3 trans-disease regional networks of excellence (East, Central and West Africa), and 6 senior fellowships, for a total of about €87 million, including 50% in co-funding from Member States and third parties. In 2008, the EDCTP expects to commit project funding of over €100 million from Community financing, as shown in Figure 1 below.

Member States’ co-funding has increased from less than €1 million in 2005 to €6 million in 2006 and €21 million in 2007. Data from January to April 2008 shows €67 million committed or pledged by Member States. Although EDCTP Member State co-funding dramatically increased in 2007, and pledges for the years 2008-2010 are increasing, so far the level of co-funding achieved is only €96 million out of a total of €200 million required from Member States by the end of 2010 (Figure 1). This means that in the next 2.5 years, participating Member States have to contribute a further €104 million. Moreover, since most of the Member States’ contributions are for their nationals participating in EDCTP-funded projects, the co-funding of African researchers is still an important issue which remains to be solved.

Since its creation, the EDCTP has also collaborated with major international stakeholders, foundations, and industries, thereby attracted more funding. Special mention should be made of the Bill and Melinda Gates Foundation, which published a joint call for proposals on HIV vaccines with the EDCTP in December 2006, and of the London School of Tropical Medicine, which is engaged in a Masters Course on Clinical Trials with the EDCTP. The EDCTP is also working closely with public-private partnerships such as the Malaria Medicine Venture on clinical trials for malaria treatment, and with the Global TB Alliance and industry in clinical trials for tuberculosis treatment. Although these collaborations have started to deliver results in 2008, as shown in Figure 1 (see third-party funding), they need to be extended even further, and should ideally reach the €200 million figure set when the EDCTP Programme was set up.

[pic] MS contribution : Member States’ annual contribution to signed projects. 2008 data include committed contribution to signed or approved projects until May 2008.

Third-party contribution : third-party annual contributions to EDCTP signed projects, if known. 2008 data include committed contribution to signed or approved projects up to May 2008.

EC funding signed grants : value of signed grants. 2008 data include the value of signed grants in the first quarter, approved grants and estimate values of future grants for the full year 2008.

Figure 1. Overview of Member State, third-party and EC total funding commitments to EDCTP projects.

The main funding problem in the current EDCTP Programme has proved to be the inability of some countries to contribute to a common co-funding pot. In fact, many participating countries only agree to fund their own national researchers, while others also finance African researchers, and some may even co-fund other European researchers. One of the main recommendations of the Van Velzen report, the achievement of a common funding pot, seems difficult to achieve if we consider only research funding from participating Member States, as most of them do not allow contributions to external scientists. Nevertheless, in the last few months, in addition to the contribution from national research agencies, the EDCTP has seen increasing financial contributions from Member States’ development aid agencies, naturally focused on activities in developing countries (where most of the EDCTP funding goes). This innovative solution greatly improves the ability of Member States to co-finance EDCTP projects.

EDCTP PERFORMANCE AND ACHIEVEMENTS

EDCTP implementation is tracked by means of performance indicators. In 2007, the EDCTP secretariat introduced key performance indicators on grants, partnerships, co-funding and governance to monitor the main activities of the Programme. These indicators, updated monthly and published on the EDCTP website (www.edctp.org) allow achievements in reaching EDCTP objectives to be measured.

The Secretariat in charge of day-to-day management of the EDCTP Programme has introduced new measures to ensure adequate administrative follow-up of EDCTP activities, and participating Member States are achieving a level of commitment and coordination not seen before.

In addition to ongoing, internal monitoring by the EDCTP’s executive management, the European Commission reports annually to the European Parliament and the Council on the EDCTP when it reports on the Framework Programme. The Commission also receives full annual reports on the EDCTP’s financial and scientific activities, and reserves the right to conduct mid-term reviews of the Programme, such as that carried out by the Van Velzen group.

Moreover, the Commission will conduct a five-year evaluation, as required in Article 8 of the original EDCTP Decision. The report on this evaluation, to be launched in 2008, will be forwarded to both the Council and Parliament and will be made public. The evaluation could be followed by an impact assessment.

Although the serious difficulties encountered between 2003 and 2006 must not be underestimated, in just under five years of existence, as noted in the June 2008 meeting of African researchers in the EDCTP Developing Countries Clinical Trials Partnership, the EDCTP has made its mark in a number of important ways, starting to fulfil the original objectives of the Programme:

the EDCTP’s ownership of the research agenda and its active participation in identifying priorities and gaps are unique;

there is an enhanced coordination of research activities and demonstrable capacity building;

African researchers have the same opportunities as their northern colleagues to develop proposals and become Principal Investigators;

the concept of networks of excellence developed by the EDCTP is increasingly attracting the attention of other funding agencies;

the EDCTP is stimulating African countries to establish national research budgets and to further contribute to the establishment of an African Fund for Health Research;

EDCTP funding gives African researchers more ownership, and provides better fora for discussion and knowledge exchange;

capacity and sites developed are fully owned by the institutions and countries, avoiding ‘scientific colonisation’;

publications stemming from EDCTP-funded projects are on the increase;

EDCTP grantees have developed new research sites by accessing funding from other sources;

EDCTP funding has been instrumental in the approval of some major policy changes, such as the development of HIV treatment in children.

Further details on the EDCTP’s performance are available in the accompanying Commission Staff Working Paper, Progress Report on the European and Developing Countries Clinical Trials Partnership (EDCTP) .

The Future of the EDCTP Programme

The present EDCTP contract will end in 2010. The EDCTP Programme was created as a ‘long-term partnership between Europe and developing countries’; its objectives cannot reasonably be achieved in seven years. The development of new drugs and vaccines can easily take 10 or more years; sustainable capacity building is, by definition, a long-term goal; and integration of European national programmes, the ultimate goal of Article 169, is an ambitious, long-term target. To progress towards these objectives, additional funding for the continuation of the EDCTP Programme beyond 2010 would be needed.

Provided that the original goals of the Programme are met, that the recommendations of the Van Velzen report are followed, and that the results of the five-year evaluation and the impact assessment are positive, the continuation of the EDCTP (2010-2015) might be envisaged, and the European Commission might duly consider a new proposal for continuation of the EDCTP Programme.

The Commission, Parliament and Council will need to reflect carefully on the legal, financial and scientific decisions entailed in renewing the EDCTP Programme. For example, they should consider the changes in EU membership that have occurred since 2004, and the fact that funding will have to be commensurate with the scientific goals and scope of the future Programme.

Conclusion

The EDCTP Programme was launched in September 2003 as the first application of Article 169 of the EC Treaty. For the first time, 14 European Member States, together with Norway and Switzerland, are building a new structure to coordinate their clinical research activities on HIV/AIDS, malaria and tuberculosis in sub-Saharan Africa. The research financed will have a direct impact on the hardest-hit populations, in terms of new drugs, vaccines and public health interventions.

As part of the European contribution to the UN’s Millennium Development Goals, the EDCTP is an important instrument in the fight against HIV/AIDS, malaria and tuberculosis. Better vaccines and treatments would help dramatically reduce the incidence of such diseases, and research is essential to developing these tools.

Despite some serious initial difficulties, the performance of the EDCTP Programme has improved in the last two years, with specific achievements in line with the original goals of the Programme and with the recommendations of the Van Velzen report. The remaining two years of the EDCTP contract until 2010 will be crucial to determining the extent of Member States’ financial and political commitment and the Secretariat’s capacity to negotiate and follow up research contracts.

The special nature of EDCTP activities — financing capacity building and research activities in developing countries — calls for collaboration on the part of development aid and research agencies. Better coordination of these funding sources will contribute to increasing the performance of both financing bodies in developing countries.

Article 169 is a powerful, ambitious instrument for coordinating national programmes and building the European Research Area. Activities conducted under this Article have a longer than average implementation phase, but come with greater potential and are able to deliver results not achievable with other instruments. As such, they should be considered long-term activities.

As learnt from the EDCTP, two of the main pre-conditions for new Article 169 initiatives are pre-existing national research programmes and a full funding commitment, in advance, from Member States.

From the outset, the EDCTP Programme was set up as a long-term initiative which could only achieve its goals of research capacity-building in Africa, halting disease progression and integrating European research in the long term. Nevertheless, progress in the medium term should be objective and measurable.

As requested by Council and Parliament in the 2003 EDCTP Decision, following the publication of this progress report the Commission will begin a five-year evaluation of the EDCTP Programme. The results obtained will be taken into account when considering a decision on renewing the EDCTP Programme for the period 2010-2015.

[1] COM(2000) 585 of 20.9.2000.

[2] United Nations General Assembly Resolution 55/2 (8 September 2000).

[3] COM(2001) 96 final.

[4] COM(2005) 179 final.

[5] Decision No 1209/2003/EC of the European Parliament and of the Council of 16 June 2003 on Community participation in a research and development programme aimed at developing new clinical interventions to combat HIV/AIDS, malaria and tuberculosis through a long-term partnership between Europe and developing countries, undertaken by several Member States (OJ L 169, 8.7.2003).

[6] The founder members of the EDCTP were Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, the United Kingdom, and Norway. Switzerland joined in 2005.

[7] Article 169 states: ‘In implementing the multiannual framework programme the Community may make provision, in agreement with the Member States concerned, for participation in research and development programmes undertaken by several Member States, including participation in the structures created for the execution of those programmes.’.

[8] Independent External Review Report: European and Developing Countries Clinical Trials Partnership (July 2007), also named after the Chair of the expert group as the Van Velzen report; see http://ec.europa.eu/research/health/poverty-diseases/doc/final_ier_report_12july2007_en.pdf.

[9] Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002.

[10] Letters from Commissioner Poto

[pic]nik to 16 Ministers of Research from EDCTP countries sament and of the Council of 27 June 2002.

[11] Letters from Commissioner Potočnik to 16 Ministers of Research from EDCTP countries sent in autumn 2007.

[12] Joint research programme on technologies for ‘Ambient Assisted Living’.

[13] Joint research programme on ‘Baltic Sea’ research.

[14] ‘European Metrology Research Programme’.

[15] Joint research programme on ‘research-performing SMEs’.