International European and Developing Countries Clinical Trials Partnership (EDCTP) Conference

EDCTP High-Level Meeting / Cape Town, 5-11-2012 — / — Your Excellencies, Distinguished Colleagues, Ladies and Gentlemen,

I am delighted to be in Cape Town to help celebrate the 15th anniversary of the signing of the Science & Technology Cooperation Agreement between South Africa and the European Union.

We have seen many successes during our 15 years of collaboration, but I think one of the best examples is the European and Developing Countries Clinical Trials Partnership, the EDCTP.

The EDCTP is a brilliant success story for EU-Africa research cooperation. Within a decade, it has become a key player in the global health arena. But much more importantly, it is a beacon of hope for millions of people across the continent.

The EDCTP was founded in 2003 in order to focus the work of the European Commission and several EU Member States around a common research agenda for the clinical testing of new medical products against HIV/AIDS, malaria and tuberculosis, in collaboration with sub-Saharan countries.

The EDCTP is also a fine example of a principle that we advocate in Europe: to open our research and innovation to worldwide collaboration. The EDCTP has proved spectacularly good at this, with projects involving 42 institutions in Europe and 156 in Africa; with 75% of funding going to African institutions and with 70% of projects led by African researchers.

Cape Town hosts the African hub of the EDCTP, and scientists in and around Cape Town have been very successful in obtaining EDCTP grants for projects such as the one led by Professor Gerhard Walzl, in Stellenbosch University on developing a point-of-care diagnostic test for TB patients.

Or the work to strengthen the capacity of the TB vaccine trials site led by Prof. Hassan Mahomed, of the University of Cape Town; or Dr Concepta Merry’s research to determine the optimal doses of anti-retroviral and anti-tuberculosis medications in TB-HIV co-infected patients.

But the EDCTP is helping to build knowledge, build research capacity and build research systems across sub-Saharan Africa. More than 300 junior and senior African scientists have been trained, and the Partnership has helped establish important institutions such as the African Vaccine Regulators Forum and the Pan-African Clinical Trial Registry.

The Partnership has also helped set up National Ethics Committees in Benin, Mozambique, Rwanda and Gabon, and eight EDCTP projects have already resulted in improved policy guidelines or recommendations for clinical practice.

This capacity building role is complemented by other European Union actions, including the training of surgeons in Malawi and Zambia, training of epidemiologists across the continent and training of midwifes in West Africa to reduce maternal and newborn mortality.

And besides its work to support capacity building and accelerate the development of new medicines, the EDCTP is an important intermediary with other stakeholders such as health providers and local manufacturers.

Overall, the EDCTP is making a big difference. It has created new momentum for the development of innovative pharmaceutical products on the African continent.

We have achieved a lot, but there is still much more to do.

Over the last century, we have largely won the war against poverty-related diseases in Europe, thanks to better hygiene, better living conditions and national vaccination campaigns.

It was a long and costly struggle, but it gave us huge reserves of knowledge and expertise – for example, an estimated two-thirds of all vaccine research is carried out in Europe, and we are the world’s biggest manufacturer of vaccines.

I am convinced that a similar public health revolution can take place in low and middle-income countries, and I believe that Europe has a moral obligation to ensure that this happens.

However, Europe cannot and should not work alone. It is essential to work together, especially in partnership with those countries that are the most affected.

The first Partnership will come to an end in 2014. We are here today to discuss future plans – EDCTP phase 2.

The European Union is currently discussing its new programme for research and innovation, Horizon 2020, that will be launched in 2014 – this programme will be the source of European Union funding for the next phase of the EDCTP.

The Horizon 2020 proposal still needs to be approved by the European Parliament and EU Member States, but I am pleased to announce that I will propose a contribution of up to 1 billion euro from Horizon 2020 to support a second phase of the EDCTP, from 2014.

The EU contribution will be requested on condition that similar amounts are committed from the participating European countries and third parties such as industry, charities and African countries.

Yes, we are calling for more money because there is much more work to do. It is not easy to ask for money when many countries in Europe are facing severe economic problems and a tight squeeze on public budgets.

So I would be failing in my duty if I did not ask “Why should Europe pay?”

Yes, the 400 million euro of public money invested in the first phase of EDCTP has been a huge commitment. But a worthwhile one when we remember that more than one billion people, including 400 million children, suffer from one or more of the target diseases. HIV/AIDS kills an estimated 2.5 million people every year, while malaria and TB together kill an estimated 2.1 million people annually.

And just last month, warning that the momentum to eradicate tuberculosis is “in real danger”, the WHO said that we are at a crossroads between eliminating TB in our lifetime and millions more TB deaths.

Behind the figures I quoted are individual people and individual stories of suffering, anguish and wasted potential. These figures represent a brake on the development of many African countries.

While Africa continues to bear the greatest human cost, the eradication of poverty-related diseases is a global challenge.

This fight is vital to all of us, not just the countries and regions where the diseases are most prevalent.

As well as appealing to altruism and the value of a shared human endeavour to reduce suffering in low and middle income countries, I can also say that closer to my home, Europe faces new or returning threats of infectious diseases. If we fight the most important sources of the infectious agents, we help safeguard public health in many parts of the world.

To taxpayers and finance Ministers, I say that the EDCTP is cost efficient, because it coordinates national and European efforts to defeat these diseases. And efficient because the contribution from the European Union and European governments acts as a magnet for co-financing from other private organizations and foundations – 80 million euro so far. But I want this private contribution to increase massively.

I will therefore strongly urge the governments of the EU Member States to make firm financial commitments.

And I say to businesses large and small, to foundations, to charities, to product development partnerships, to NGOs and any other like-minded organizations:

Join Us! Join the Partnership. Fund the Partnership. I’ve already explained why Europe takes part and why Europe pays. The same reasons may convince you.

I urge EU Member States, industry, charities and foundations to match the European Union contribution of 1 billion euro.

We are moving in the right direction – I was very pleased to hear, last night that the European Federation of Pharmaceutical Industries and Associations (EFPIA) has developed a joint clinical research fellowship programme with EDCTP.

And I would also like to mention that talks about a closer collaboration in the context of the EDCTP are ongoing between the Commission and the Bill and Melinda Gates Foundation, and I am hopeful that this will result in the signing of a joint Memorandum-of-Understanding

Your contributions will help ensure that the second phase of EDCTP builds on the successes of the first. Successes like 57 clinical trials of new treatments and vaccines, involving 100,000 patients so far, with a special focus on infants, children, pregnant women and nursing mothers.

Successes like the Kesho Bora Study of Highly Active Anti-Retroviral Therapy (HAART) during Pregnancy and breastfeeding, which showed a 43% reduction in HIV infections in infants and more than 50% cut in breastfeeding infection. These findings influenced the new guidelines on preventing mother to child HIV transmission issued by the World Health Organisation in 2010.

And successes like the Severe Malaria in Children Network, which showed that the drug Artesunate is just as effective when fewer doses are administered, thereby reducing costs and lowering the risk of incomplete treatment.

These results, and others too numerous to mention here, represent many saved lives.

The financial crisis has reminded us that resources are scarce, and working together is necessary to overcome the limits imposed by financial hardship. This is true in many walks of life, but nowhere more than for clinical testing of new products for poverty-related diseases.

Clinical trials are incredibly expensive, and few – if any – organisations, private or public, are able or willing to invest in a full clinical development programme for poverty-related products, where the return on investment may be limited.

So, I am extending a special invitation to industry to work with us in the EDCTP, and to share the financial and technological burden of developing products for the most impoverished people on Earth.

Last but not least, I am inviting the governments of African countries to join the EDCTP, both as collaborators and as contributors.

African countries and governments must make concrete financial commitments to support the EDCTP. It is only with this commitment that the EDCTP can develop into a true and balanced partnership between our continents, with knowledge and innovation flowing in both directions.

I am confident that this high-level conference will result in strong support for the vision of EDCTP-2, and that this support will be followed by concrete financial commitments.

I believe that Horizon 2020, and particularly EDCTP-2, will be a new journey that will provide even more scope for scientific collaboration between Africa and Europe.

Thank you for your attention, thank you for your commitment to the EDCTP and thank you to everyone who has worked so hard to prepare this very important conference.

I look forward to hearing the results!



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