European and Developing Countries Clinical Trials Partnership
Encyclopedia
The European and Developing Countries Clinical Trials Partnership or EDCTP is a partnership between the European Union
(EU), Norway
, Switzerland
and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccine
s against HIV/AIDS
, tuberculosis
, and malaria
.http://ec.europa.eu/research/info/conferences/edctp/edctp_en.html The need for global action against these diseases in order to promote poverty reduction has been recognised by the United Nations
, the G8
, and the African Union
, 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
adopted the Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction (COM (2001)96, http://ec.europa.eu/research/info/conferences/edctp/pdf/com-2001-96_final_en.pdf) on 15 May 2001, following its launch by the European Commission
. The Commission
proposal was adopted on 16 June 2003 by the Council
and the European Parliament
.http://europa.eu/eur-lex/pri/en/oj/dat/2003/l_169/l_16920030708en00010005.pdf 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
s."http://ec.europa.eu/research/info/conferences/edctp/pdf/background_en.pdf These aims relate specifically with the EU
stance on access to essential medicines
. http://ec.europa.eu/comm/trade/issues/global/medecine/index_en.htm
Partnerships among the EU
and associated countries, allowing focused collaboration of national and European efforts that were not previously coordinated.
Partnerships among EU
and developing countries that focuses specifically on developing countries' needs, who are jointly involved in setting the research priorities.
Efforts aimed at creating lasting long-term partnerships between African scientists and research institutions in Africa.
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.
Manifested as a general strengthening of clinical research capacity in Africa, including training activities, workshops and meetings, and the upgrading of clinical trial sites in Africa.
]
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 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).
Executive director - Charles Mgone
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
(EU), Norway
Norway
Norway , officially the Kingdom of Norway, is a Nordic unitary constitutional monarchy whose territory comprises the western portion of the Scandinavian Peninsula, Jan Mayen, and the Arctic archipelago of Svalbard and Bouvet Island. Norway has a total area of and a population of about 4.9 million...
, Switzerland
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
and developing countries and other donors, as well as the pharmaceutical industry, to enable clinical trials and the development of new medicines and vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
s against HIV/AIDS
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
, tuberculosis
Tuberculosis
Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...
, and malaria
Malaria
Malaria is a mosquito-borne infectious disease of humans and other animals caused by eukaryotic protists of the genus Plasmodium. The disease results from the multiplication of Plasmodium parasites within red blood cells, causing symptoms that typically include fever and headache, in severe cases...
.http://ec.europa.eu/research/info/conferences/edctp/edctp_en.html The need for global action against these diseases in order to promote poverty reduction has been recognised by the United Nations
United Nations
The United Nations is an international organization whose stated aims are facilitating cooperation in international law, international security, economic development, social progress, human rights, and achievement of world peace...
, the G8
G8
The Group of Eight is a forum, created by France in 1975, for the governments of seven major economies: Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States. In 1997, the group added Russia, thus becoming the G8...
, and the African Union
African Union
The African Union is a union consisting of 54 African states. The only all-African state not in the AU is Morocco. Established on 9 July 2002, the AU was formed as a successor to the Organisation of African Unity...
, 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
European Council
The European Council is an institution of the European Union. It comprises the heads of state or government of the EU member states, along with the President of the European Commission and the President of the European Council, currently Herman Van Rompuy...
adopted the Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction (COM (2001)96, http://ec.europa.eu/research/info/conferences/edctp/pdf/com-2001-96_final_en.pdf) on 15 May 2001, following its launch by the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
. The Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
proposal was adopted on 16 June 2003 by the Council
European Council
The European Council is an institution of the European Union. It comprises the heads of state or government of the EU member states, along with the President of the European Commission and the President of the European Council, currently Herman Van Rompuy...
and the European Parliament
European Parliament
The European Parliament is the directly elected parliamentary institution of the European Union . Together with the Council of the European Union and the Commission, it exercises the legislative function of the EU and it has been described as one of the most powerful legislatures in the world...
.http://europa.eu/eur-lex/pri/en/oj/dat/2003/l_169/l_16920030708en00010005.pdf 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
Global public good
A global public good is a good that has the three following properties :* It is non-rivalrous. Consumption of this good by anyone does not reduce the quantity available to other agents.* It is non-excludable...
s."http://ec.europa.eu/research/info/conferences/edctp/pdf/background_en.pdf These aims relate specifically with the EU
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
stance on access to essential medicines
Essential medicines
Essential medicines, as defined by the World Health Organization are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."The WHO...
. http://ec.europa.eu/comm/trade/issues/global/medecine/index_en.htm
Projects and activities
EDCTP-funded activities are based on:- North/North networking and co-ordination
Partnerships among the EU
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
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
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
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 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 EU
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
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 http://ec.europa.eu/research/info/conferences/edctp/pdf/background_en.pdf
- EuropeEuropeEurope is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
- EUEuropean UnionThe European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
member states, plus NorwayNorwayNorway , officially the Kingdom of Norway, is a Nordic unitary constitutional monarchy whose territory comprises the western portion of the Scandinavian Peninsula, Jan Mayen, and the Arctic archipelago of Svalbard and Bouvet Island. Norway has a total area of and a population of about 4.9 million...
and SwitzerlandSwitzerlandSwitzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
.
- Developing countries
- All sub-Saharan African countries.
- Industry and commercial
- BayerBayerBayer AG is a chemical and pharmaceutical company founded in Barmen , Germany in 1863. It is headquartered in Leverkusen, North Rhine-Westphalia, Germany and well known for its original brand of aspirin.-History:...
- GlaxoSmithKlineGlaxoSmithKlineGlaxoSmithKline plc is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom...
- Novartis Pharma
- Novo NordiskNovo NordiskNovo Nordisk manufactures and markets pharmaceutical products and services. Created in 1989 through a merger of two Danish companies dating back to the 1920s, it has become one of the world's leading companies in diabetes care, where Novo Nordisk pursues research into pulmonary delivery systems;...
- Sanofi PasteurSanofi pasteurSanofi Pasteur is the vaccines division of sanofi-aventis Group. It is the largest company in the world devoted entirely to vaccines.- History :...
- Sanofi-AventisSanofi-AventisSanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
.
- International initiatives
- The World Health Organization (WHO-TDR)World Health OrganizationThe World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
(http://www.who.int/tdr/) - Drugs for Neglected Diseases initiativeDrugs for Neglected Diseases InitiativeThe Drugs for Neglected Diseases Initiative 501 is a non-profit drug research and development organization that is developing new treatments for neglected diseases....
(http://www.dndi.org) - International Aids Vaccine Initiative (IAVI) (http://www.iavi.org)
- European Vaccine Initiative (EVI) (http://www.euvaccine.eu)
- TB AllianceTB AllianceThe Global Alliance for TB Drug Development is a non-profit organization dedicated to the discovery and development of new, faster-acting and affordable tuberculosis medicines....
(http://www.tballiance.org)
- Private non-profit organisations
- Aeras Global TB Vaccine FoundationAeras Global TB Vaccine FoundationAeras is a non-profit Product Development Partnership dedicated to the development of effective tuberculosis vaccine regimens that will prevent TB infection in all age groups and will be affordable, available and adopted worldwide. Founded in 2003, Aeras is located in Rockville, Maryland,...
(http://aeras.org/home/home.php) - The Bill and Melinda Gates FoundationBill & Melinda Gates FoundationThe Bill & Melinda Gates Foundation is the largest transparently operated private foundation in the world, founded by Bill and Melinda Gates. It is "driven by the interests and passions of the Gates family"...
(http://www.gatesfoundation.org/Pages/home.aspx) - International Partnership for MicrobicidesInternational Partnership for MicrobicidesThe International Partnership for Microbicides or IPM is a non-profit product development partnership founded by Dr. Zeda Rosenberg in 2002 to prevent HIV transmission by accelerating the development and availability of a safe and effective microbicide for use by women in developing...
(http://www.ipm-microbicides.org) - Medicines for Malaria Venture (http://www.mmv.org/index.php)
- The Wellcome TrustWellcome TrustThe Wellcome Trust was established in 1936 as an independent charity funding research to improve human and animal health. With an endowment of around £13.9 billion, it is the United Kingdom's largest non-governmental source of funds for biomedical research...
(http://www.wellcome.ac.uk)
Representatives
High representative - Pascoal MocumbiPascoal Mocumbi
Pascoal Manuel Mocumbi was the Prime Minister of Mozambique from 1994 until 2004. His traditional name was Mahykete. He is the son of Manuel Mocumbi Malume, deceased, and Leta Alson Cuhle.-Education:...
Executive director - Charles Mgone
See also
- European Organisation for Research and Treatment of Cancer (EORTC)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA)