7 June 2016

Africa: 2nd Meeting of the Technical Team Meeting On the Establishment of the African Medicines Agency, AUC HQs, 7-8 June 2016

press release

2nd Meeting of the Technical Team Meeting on the Establishment of the African Medicines Agency, AUC HQs, 7-8 June 2016

CONCEPT NOTE

1. BACKGROUND

In response to the declarations of the African Heads of State and Government Assembly/AU/Decl.2 (XIX) as well as the decisions by the World Health Organization, WHO Regional Committee for Africa, the First African Ministers of Health Meeting jointly convened by the African Union Commission (AUC) and the World Health Organization (WHO) in Luanda, Angola, 14-17 April 2014 endorsed key milestones for the establishment of the African Medicines Agency (AMA). The milestones include: decisions by the AU Summit of Heads of State and Government, designation of host institution/ country, approval of the governing body, appointment of staff and allocation of resources and launch of the AMA (AUC/WHO/2014/Doc.2).

The Ministers of Health committed to prioritize investment for regulatory capacity development; to pursue the efforts towards convergence and harmonization of medical products regulation in Regional Economic Communities (RECs) and to allocate resources for the operationalization of the AMA. Ministers of Health also requested the AUC and WHO in collaboration with relevant stakeholders to establish a Task Team that will facilitate the implementation of the agreed milestones with due regard to regional representation and skills required to meet the mandate as noted. The ministers of health meeting also recommended that a task team be established to provide the necessary guidance and modalities for the operationalization of such an agency in Africa. The Task team was duly established and convened its first meeting in Addis Ababa, Ethiopia on 25-26 November 2014.

The outcomes of the meeting included the following:

- Review of the current situation, new interventions, therapeutics and candidate vaccines in the pipeline against Ebola Virus Disease (EVD), Regulatory pathway in the African context and harmonization approaches.

- Review of the Luanda Decision on the African Medicines Agency: Key milestones towards its establishment.

- Adoption of the Terms of Reference of the task team to facilitate the establishment of the African Medicines Agency.

- Adoption of a 4-year Plan of Action (2015-2018) for the task team.

- Endorsement of AUC, NEPAD Agency and WHO to serve as a Joint Secretariat for the Task Team.

Since the first meeting in November 2014, with the support of the joint secretariat, the Task Team has commissioned the development of a Legal and Institutional framework for AMA and the Business plan for operationalization of the AMA. These draft documents were briefly discussed at the 4th Conference of the National Medicines Regulatory Authorities Conference in Addis Ababa in December 2015. However, they need to be reviewed and validated by the Task Team. In addition, the Task Team will review the draft roadmap for accelerating implementation of key milestones towards establishment of AMA as well as the progress report on implementation of the Luanda commitment on setting milestones towards the establishment of the AMA. It is against this background that the joint secretariat is facilitating the 2nd meeting of the task team scheduled to take place in Addis Ababa, Ethiopia from 7 to 8 June 2016.

2. MEETING OBJECTIVES

2.1 General objective

To review the progress in the implementation of the task team's 4 year action plan and in the context of the commitment on the key milestones towards the establishment of the AMA agreed by the Ministers of Health at the first joint AU-WHO Ministerial Conference held in Luanda in April 2014.

2.2 Specific objectives

 To adopt the Report of the 1st AMA Task Team meeting;

 To review the draft Legal and institutional framework for AMA;

 To review the draft AMA Business plan; and

 To review the progress report on implementation of Luanda commitments on setting milestones towards the establishment of the African Medicines Agency.

3. EXPECTED OUTPUT

 Revised draft of the legal and institutional framework for AMA;

 Revised draft of the AMA business plan; and

 Revised progress report on implementation of Luanda commitments on setting milestones towards the establishment of the African Medicines Agency.

4. DATES AND VENUE

The meeting will be held in Addis Ababa, Ethiopia from 7 to 8 June 2016.

5. LANGUAGE

The meeting will be conducted in English and French with simultaneous interpretation.

6. PARTICIPANTS

The meeting will bring together members of the Task Team composed of experts from member states across the continent including experts from; 7 RECs and/or regional health organizations (RHOs) EAC, ECCAS/OCEAC, ECOWAS/WAHO, IGAD, SADC and UMEOA; NEPAD Agency, AUC, PAP, WHO and other relevant UN organizations, academia and other relevant institutions.

7. METHOD OF WORK

The meeting will be conducted in both plenary and breakout sessions moderated by individuals from among the participants. Presentations of the proposed key working documents would be made and discussed. The a joint secretariat will be charged with preparing all working documents, coordinating as well as organizing logistics related to the meeting.

8. DOCUMENTS

8.1 Working Documents:

 Report of the 1st AMA Task Team meeting;

 Draft legal and institutional framework for AMA;

 Draft AMA business plan;

 Progress report on implementation of Luanda commitments on setting milestones towards the establishment of the African Medicines Agency.

8.2 Reference Documents:

 Terms of reference of the Task Team to facilitate the establishment of the African Medicines Agency (Document AUC-WHO/TT/AMA/1/2);

 4-year action plan for the Task Team (Document AUC-WHO/TT/AMA/1/3);

 Report of the 1st AMA Task Team meeting;

 Roadmap for accelerating implementation of key milestones towards establishment of AMA, reviewed;

 Commitment on the African Medicines Agency: setting milestones towards its establishment;

 African Union Model Law on Medical Products Regulation

 AU Roadmap on Shared Responsibility and global solidarity for HIV, TB and Malaria response; and

 Strengthening the capacity for regulation of medical products in the African Region, (Document AFR/RC63/7).

9. LOGISTICS AND ADMINISTRATIVE ARRANGEMENTS

Participants sponsored by WHO will receive a round trip economy class ticket and full perdiem/daily subsistence allowance (DSA). RECs representatives will be sponsored by NEPAD Agency (and will also receive a round trip economy class ticket and full perdiem/daily subsistence allowance). An information note on local transportation, meals, medicals, security and others will be sent to all invited participants upon confirmation of their participation in the meeting. All other participants originating from countries with Ethiopian Embassy are required to obtain their visas in advance. Arrangements for Visa on arrival would be made for participants from countries without Ethiopian Embassy upon receipt of the copies of their passports by May 7, 2016.

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2nd Meeting of the Technical Team Meeting on the Establishment of the African Medicines Agency, AUC HQs, 7-8 June 2016

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