Large Research and Medical Databases in clinical and research multi-centre trials in Africa African Movement for Ethics and Bioethics JUNE 19TH, 2012 COPENHAGEN,

Large Research and Medical Databases in clinical and research

multi-centre trials in Africa

African Movement for Ethics and Bioethics

JUNE 19TH, 2012JUNE 19TH, 2012COPENHAGEN, DENMARK COPENHAGEN, DENMARK

IVth MEETING OF THE EUROPEAN COMMISSION ON INTERNATIONAL DIALOGUE ON BIOETHICS

Prof. Pierre EFFAActing President of the Pan African Congress

for Ethics and Bioethics

PRESENTATION PLAN

• I THE RELEVANT INITIATIVES

• II ETHICS PROVISION ADOPTED

• III ISSUES OF MAJOR SIGNIFICANCE OF BIOETHICS IN AFRICAN COUNTRIES

• IV CONCLUSION

African Movement for Ethics and Bioethics

THE RELEVANT INITIATIVES

• Pan African Congress for Ethics and Bioethics in charge of Bioethics

• 32nd Summit of the OAU / AU in July 1996 in Yaounde

• Designed to serve as a tool for implementation of Resolution No. AHG/Res.254 (XXXII) on Bioethics and the Development of Africa

African Movement for Ethics and Bioethics

The establishment of COPAB

COPAB Activities

• The COPAB is also a centre for advocacy, monitoring and evaluation activities related to security of life, so often neglected in research and multicentre trials conducted in Africa.

• Provide leadership and coordination of the evaluation of the ethical clearance in medical research in the member states of the African Union (AU).

African Movement for Ethics and Bioethics

COPAB Activities

• The Protocol adopted at the second COPAB 19 to 21 April 2010 in Yaounde, Cameroon was officially sent to the AU as the implementation of the Resolution of the Bioethics Summit of July 1996 in Yaounde.

• Advocates the AU to adopt a Protocol to the African Charter on Human and Peoples' Rights on Bioethics, as a reference text in this field.

• Coordinate and animate the African Platforms on Ethics and Bioethics

African Movement for Ethics and Bioethics

II ETHICS PROVISION ADOPTED

• The issues of "The governance of research and extensive medical databases and research in clinical multi-centre trials," theme of the present meeting, are addressed in the frame of historical mission of the African Movement for Ethics and Bioethics that is to implement an ethical integrated sphere throughout the African continent.

African Movement for Ethics and Bioethics

• The African Charter on Human and Peoples' Rights, adopted June 27, 1981 in Nairobi,

• The Charter of the African Cultural Renaissance adopted on January 24, 2006 Khartoum,

African Movement for Ethics and Bioethics

Roots of the Protocol to the African charter on Human and Peoples 'Rights on Bioethics

• Integrates the concerns of regulatory instruments in the field, namely: • The Oviedo Convention on Biomedicine and Human

Rights adopted April 4, 1997 in Oviedo -Spain, • the Universal Declaration on Bioethics and Human

Rights adopted by the General Assembly of UNESCO in October 2005 in Paris, France,

• the Belmont Report published April 18, 1979 in Elkridge, Maryland, USA

• as well as Law No. 2004-800 of 6 August 2004 relating to Bioethics of the Code of Health of France and

• the decree establishing the National Ethics Committee on Scientific Research, signed July 31, 2008 in Libreville, Gabon.

African Movement for Ethics and Bioethics

KEY PROVISIONS OF THE PROPOSED COPAB PROTOCOL

• Each Member State of the African Union must adopt a law for Bioethics including regulatory bodies and then establishing a national ethics committee.

• these regulatory bodies work closely with the COPAB, including establishment of databases and guidelines for assessing the ethical clearance.

African Movement for Ethics and Bioethics

III ISSUES OF MAJOR BIOETHICS SIGNIFICANCE

FOR AFRICA

• African Platforms on ethics (National, Regional and Continental)

• Coordination and animation of the African Platforms

• Forum for exchange of expertise within the AU Member states, North South and South South Collaboration

African Movement for Ethics and Bioethics

• Regular assessment of Databases and guidelines by the African Platforms for ethics which are chambers of the African Palaver for the implementation of Resolution No. AHG/Res.254 (XXXII) on Bioethics and African development.

African Movement for Ethics and Bioethics

• Scientific and Ethical standards in research for the control or eradication of priority diseases in Africa in collaboration with international partners

African Movement for Ethics and Bioethics

• Establishment of a Certification System in ethical review, in collaboration with agencies of the UN system involved in Africa, and partners in the Development of Africa.

African Movement for Ethics and Bioethics

• AU to promote enabling policies for research including international health research in all member states of the Union, to help them control / eradicate priority diseases, in compliance with the standards of the Western world ;

• Development of research programs on priority diseases in Africa, by the countries themselves, according to their priorities and emergencies.

African Movement for Ethics and Bioethics

IV CONCLUSION• Existence of political will of the African Union to

support issues on Ethics and Bioethics on the continent

• There is a need to systematically coordinate the various existing initiatives on Ethics and Bioethics on the continent

• Calls for the international community to support the continent through strategic partnerships and strengthen the instruments for advancing Bioethics in the continent (COPAB and other networks of research)

African Movement for Ethics and Bioethics

THANK YOU FORLISTENING