The European and Developing Countries Clinical Trials Partnership (EDCTP) is a partnership between the

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

(EU),

Norway Norway, officially the Kingdom of Norway, is a Nordic countries, Nordic country located on the Scandinavian Peninsula in Northern Europe. The remote Arctic island of Jan Mayen and the archipelago of Svalbard also form part of the Kingdom of ...

Switzerland Switzerland, officially the Swiss Confederation, is a landlocked country located in west-central Europe. It is bordered by Italy to the south, France to the west, Germany to the north, and Austria and Liechtenstein to the east. Switzerland ...

and developing countries and other donors, as well as the

pharmaceutical industry The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing ...

, to enable

clinical trials Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

and the development of new medicines and

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...

s against

HIV/AIDS The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...

tuberculosis Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is a contagious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can al ...

, and

malaria Malaria is a Mosquito-borne disease, mosquito-borne infectious disease that affects vertebrates and ''Anopheles'' mosquitoes. Human malaria causes Signs and symptoms, symptoms that typically include fever, Fatigue (medical), fatigue, vomitin ...

br>
The need for global action against these diseases in order to promote poverty reduction has been recognised by the

United Nations The United Nations (UN) is the Earth, global intergovernmental organization established by the signing of the Charter of the United Nations, UN Charter on 26 June 1945 with the stated purpose of maintaining international peace and internationa ...

, the G8, and the

African Union The African Union (AU) is a continental union of 55 member states located on the continent of Africa. The AU was announced in the Sirte Declaration in Sirte, Libya, on 9 September 1999, calling for the establishment of the African Union. The b ...

, and the program envisioned the provision of €600 million for the period 2003–2007 in order to translate medical research results into clinical applications relevant to the needs of developing countries. The

European Council The European Council (informally EUCO) is a collegiate body (directorial system) and a symbolic collective head of state, that defines the overall political direction and general priorities of the European Union (EU). It is composed of the he ...

adopted the Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction (COM (2001)96

on 15 May 2001, following its launch by the

European Commission The European Commission (EC) is the primary Executive (government), executive arm of the European Union (EU). It operates as a cabinet government, with a number of European Commissioner, members of the Commission (directorial system, informall ...

. The Commission proposal was adopted on 16 June 2003 by the Council and the

European Parliament The European Parliament (EP) is one of the two legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it ...

br>
The Programme was to be based on three central pillars: "the impact of existing interventions, the affordability of key pharmaceuticals and trade, and the research and development of specific

global public good In traditional usage, a global public good (or global good) is a Public good (economics), public good available on a more-or-less worldwide basis. There are many challenges to the traditional definition, which have far-reaching implications in the ...

s

These aims relate specifically with the EU stance on access to

essential medicines Essential medicines, as defined by the World Health Organization (WHO), are medicines that "''satisfy the priority health care needs of the population''". Essential medicines should be accessible to people at all times, in sufficient amounts, a ...

Projects and activities

EDCTP-funded activities are based on: * North/North networking and co-ordination Partnerships among the European Union, EU and associated countries, allowing focused collaboration of national and European efforts that were not previously coordinated. * North/South networking and co-ordination Partnerships among EU and developing countries that focuses specifically on developing countries' needs, who are jointly involved in setting the research priorities. * South/South networking and co-ordination Efforts aimed at creating lasting long-term partnerships between African scientists and research institutions in Africa. * Supporting relevant clinical trials Acceleration of the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis, with a focus on phase II and III clinical trials in sub-Saharan Africa. * Capacity building Manifested as a general strengthening of clinical research capacity in Africa, including training activities, workshops and meetings, and the upgrading of

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

sites in Africa.

Funding

] The total budget of the EDCTP is €600 million for the period 2003–2007, of which one third (€200 million) is to be provided by the European Union, EU budget, an equivalent amounts from Member States' activities, and the remaining €200 million from industry, charities, and private organisations. The Partnership is intended to be a long-term initiative (10–20 years) and a separate legal entity has been created to maintain its independence and flexibility. Taken together, clinical trials based in developing countries where the diseases are endemic, capacity building, and South-South networking are expected to make up over 90% of the overall budget. (figure).

Member states and partners

Are as follows: *

Europe Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...

: European Union, EU member states, plus

and

. * Developing countries : All sub-Saharan African countries. * Industry and commercial :

Bayer Bayer AG (English: , commonly pronounced ; ) is a German multinational pharmaceutical and biotechnology company and is one of the largest pharmaceutical companies and biomedical companies in the world. Headquartered in Leverkusen, Bayer' ...

GlaxoSmithKline GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...

: Novartis Pharma :

Novo Nordisk Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsværd, with production facilities in nine countries and affiliates or offices in five. Novo Nordisk is controlled by majority shareholder Novo Holdings A/S ...

Sanofi Pasteur Sanofi Pasteur is the vaccines division of the French multinational pharmaceutical company Sanofi. Sanofi Pasteur is the largest company in the world devoted entirely to vaccines. It is one of four global producers of the yellow fever vaccin ...

Sanofi-Aventis Sanofi S.A. is a French multinational pharmaceutical and healthcare company headquartered in Paris, France. The corporation was established in 1973 and merged with Synthélabo in 1999 to form Sanofi-Synthélabo. In 2004, Sanofi-Synthélabo merg ...

. * International initiatives : The World Health Organization (WHO-TDR)

:

Drugs for Neglected Diseases initiative The Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients' needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected tropical diseases, neglected diseases, notab ...

(http://www.dndi.org) : International Aids Vaccine Initiative (IAVI) (http://www.iavi.org) : European Vaccine Initiative (EVI) (http://www.euvaccine.eu) : TB Alliance (http://www.tballiance.org) * Private non-profit organisations : Aeras Global TB Vaccine Foundation (https://web.archive.org/web/20090318151237/http://www.aeras.org/home/home.php) : The Bill and Melinda Gates Foundation (https://web.archive.org/web/20121012112446/http://www.gatesfoundation.org/Pages/home.aspx) : International Partnership for Microbicides (https://web.archive.org/web/20071008192438/http://www.ipm-microbicides.org/) : Medicines for Malaria Venture (https://web.archive.org/web/20090214212631/http://www.mmv.org/index.php) : The Wellcome Trust (http://www.wellcome.ac.uk)

References

{{Reflist

External links

European and Developing Countries Clinical Trials Partnership
(EDCTP) Clinical research International medical and health organizations National agencies for drug regulation Medical and health organisations based in the Netherlands

Projects and activities

Funding

Member states and partners

See also

References

External links