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UPDATE: Biosafety Biosecurity in Ghana

UPDATE: Biosafety Biosecurity in Ghana. William Ampofo Senior Research Fellow Noguchi Memorial Institute for Medical Research University of Ghana. Regulatory regime. Ratified Convention on Biological Diversity on Aug 29 th 1994

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UPDATE: Biosafety Biosecurity in Ghana

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  1. UPDATE: Biosafety Biosecurity in Ghana William Ampofo Senior Research Fellow Noguchi Memorial Institute for Medical Research University of Ghana

  2. Regulatory regime • Ratified Convention on Biological Diversity on Aug 29th 1994 • Adopted Cartagena Protocol on Biosafety on the 30th May 2003. • Biosafety Regulatory framework - National Biosafety Authority launched 2005 • Draft Biosafety bill to regulate biotechnology activities • Biosafety LI promulgated to circumvent the delay in the passage of the Biosafety Bill in Feb 2008 Enforcement issues are still the domain of the existing regulatory agencies

  3. Ministry of Food and Agriculture - Crops Services Directorate - PPRSD - VSD Ministry of Health - FDB Ministry of Lands, Forestry and Mines - Forestry Commission (Wildlife, Forest Products Inspection, Forest Services, and Timber Export Development Divisions) Ministry of Local Government, Rural Development & Environment - Environmental Protection Agency (EPA) - district, municipal and metropolitan assemblies

  4. Food and Drugs Board (FDB) and the Ghana Standards Board (GSB) - food safety; • Veterinary Services Directorate - animal health • Plant Protection and Regulatory Services Directorate - plant health • Environmental Protection Agency (EPA) - environmental matters; • Customs and Excise Preventive Services (CEPS) - ports and borders in collaboration with the other agencies; • District, municipal and metropolitan assemblies collaborate with regulatory agencies at the local level • Cocoa Research Institute operates independently from any other agency • The Noguchi Memorial Institute for Medical Research is under the National Council for Tertiary Education and the University of Ghana

  5. Institutional Biosafety: infectious bio-sample handling – NMIMR, Legon Packing and Transportation of specimens for international shipment Sample receipt and processing - Lab Biosafety level three facility with access control in place for authorized staff only. Establishment of Institute wide controlled access system underway for full operation by end 2010.

  6. Biosecurity • Biosecurity issues are not the responsibility of one ministry, department or agency (MDA) of state. • Several MDAs have responsibility for, or are engaged in, activities in this area

  7. Regulatory bodies with legislative responsibility for Biosecurity are: • FDB and GSB – food and related safety matters • VSD – animal health and related safety issues; • PPRSD – responsible for plant health and related safety matters • EPA – responsible for environmental regulation, including safety matters; • CEPS – responsible for ports and borders in collaboration with the other agencies • District, Municipal and Metropolitan assemblies which work with the regulatory agencies at the local levels of governance especially in monitoring and enforcement at markets.

  8. Institutional Biosecurity VSD –MOFA Workshops • Poultry farms classified into: • A - Highest bio-security practiced • B - Good • C - Average • D - Fair • E – Minimum bio-security practised

  9. DETERMINED BIOSECURITY GRADING POINTS(BASED ON PENALTY POINTS)

  10. Institutional ProgramMOH / Ghana Health Service Infection Prevention Roadmap - snapshot

  11. Institutional ProgramMOH / Ghana Health Service Infection Prevention Roadmap - snapshot

  12. Enabling Environment • In 2006, WHO TDR organized 2 meetings that highlighted the impact of advocacy on furthering research agendas • High Level Ministerial Meeting on Health Research for Disease Control and Human Development in Africa, Abuja, Nigeria, March 2006 • High Level Ministerial Meeting on Health Research, Accra, Ghana, 15-17 June 2006

  13. Enabling Environment • FIRST JOINT GHANA-SOUTH AFRICA BIENNIAL CONFERENCE ON BIOTECHNOLOGY AND MATERIALS, TECHNOLOGY April, 2008 Venue: CSIR/STEPRI and CSIR Secretariat, Accra, Ghana • Theme: Harnessing Technologies for Food Security and Materials Development • “Issues and Regulatory Mechanisms on Biotechnology” Biosafety was described as the safe use, transfer and handling of living organisms modified through modern biotechnology NMIMR CHS UG

  14. Recent News article -Biotechnology • Experts urge Ghanaians to use and apply modern biotechnology • Accra, Aug. 26, GNA - Ghanaians were urged to embrace the use and application of modern biotechnology to effectively solve food insecurity and the likely impact of climate change on farming. • Project - Safe Biotechnology Management in Sub-Saharan Africa (SABIMA) under the Forum for Agricultural Research in Africa (FARA).

  15. In response to meeting the health, science and biomedical engineering challenges of Ghana, GhanaBiomed was born and officially inaugurated in 2008. • 1st Convention August, 2008 - 70 participants • 2nd Convention Accra, August, 2008 - 125 participants • 3rd Convention Accra, August, 2008 - 100 participants • Has brought together Ghanaian and other scientists, practitioners, and students from North American, European, Ghanaian, and other African institutions.

  16. Regulations/guidelines for human subject research • No Animal IRBS • Ghana - no official national regulations/ guidelines • 4 IRBs have US Federal Wide Assurances. • All have SOPs that guide IRB members and researchers on the requirements for ethical review • 6 IRBs draw on various sources of ethical guidelines, • International Conference on Harmonisation, • WHO Operational Guidelines for Ethics Committees • Declaration of Helsinki • “CIOMS Guidelines” • US Code of Federal Regulations.

  17. Ethical review • MoH does not regulate country-wide oversight system but is concerned about the human subjects research in Ghana • MoH 3 IRBS, MoE – 2 IRBS • IRBs function independently, without oversight from any government agency • Ghana’s Food and Drugs Board has requirements for researchers conducting studies that involve drugs. • Pharmacovigilance Unit also involved in the oversight of drug trials in Ghana.

  18. Ethical Review • Significant cultural differences between North & South Ghana has implications for research • 6 boards in Ghana • HRU –GHS responsible for the ethical review of research protocols, monitors research within MoH facilities • Navrongo Health Research Centre • Noguchi Mem. Inst. for Medical Research • Sch. Med. Sc - KNUST; • Sunyani Regional Hospital IRB • Kintampo Health Research Centre IRB.

  19. Enforcement mechanisms for regulations or guidelines? • Commission on Human Rights and AdministrativeJustice is charged with safeguarding various forms of human rights, including those relating to participation in medical research. • Ghana Medical Associationfiles complaints about violations of its medical code of ethics. It is not known what sanctions that organization might impose on physicians found guilty of medical misconduct. • Ghana has expertise and capacity to perform bioassays effectively locally so it is therefore not deemed necessary to export biological samples for testing purposes.

  20. Related African/ International Events • UN SCR1540 Africa Regional Workshop, Nairobi, Kenya on February , 2010. 1540 directed towards preventing the proliferation of possible weapons of mass destruction. The Nairobi workshop focussed on biological weapons and sought to assist countries to fulfill the requirements of the resolution By enhancing laboratory biosafety and biosecurity to prevent possible breaches that can result in public health disasters • 2nd African biosafety training course - potential release of GM disease vectors Univ. Bamako, Mali. WHO TDR

  21. 1ST AFRICAN BIOLOGICAL SAFETY ASSOCIATION (AFBSA) CONFERENCE MARCH 8TH TO MARCH 12TH 2010, KEMRI Lab biosafety and biosecurity issuesDual use researchBiosecurity concerns NMIMR CHS UG

  22. Summary • Legal framework • Biosafety • Biosecurity • Advocacy for Biotechnology & Biosecurity • Ethical review • African / International

  23. References • CSIR Ghana: Ist Joint Ghana South Africa Biennial conference on Biotechnology and Materials Technology. April, 2008 • Development of National Biosafety Frameworks - Administrative Guidelines. . Alex Owusu-Biney. UNEP-GEF, NBC, MES • Workshops for the determination of biosecurity measures and grading points – MOFA / VSD. 2010 • Ghana News Agency: Feb. 2008. Ghana to use LI awaiting the passage of Biosafety Bill. Aug. 2010Experts urge Ghanaians to use and apply modern biotechnology, • Biosafety is Crucial for Ghana. Margaret Crump The ADVOCATE. May 2010 • Manteaw S.O. et al (2007) “Legal and Institutional Framework for Biosecurity in Ghana”. A Research Report. • Development of an analytical tool to assess Biosecurity legislation. FAO 2007. • African Biological Safety Association. Nairobi, Kenya www.afbsa.org • Global Research Ethics Map, GHANA - Human Subjects Administration. Harvard School of Public Health. • Infection Prevention and Control Assessment at National LevelDraft Roadmap. Gertrude Avotri. Inst. Care. Division - Ghana Health Service. Sept 2010 • Status of Biosafety and Biosecurity Efforts in Ghana. William Ampofo. CISSM Regional Biosecurity Workshop, Johannesburg, South Africa. May 2008

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