Round table discussion :Improving access to medicines through development of pharmaceutical industry in Ghana:- Presentation by Food & Drugs Board at Holiday Inn 14th July 2009.Introduction:
}Expenditure on drugs as a proportion of total health expenditure ranges from between 7% to 66% worldwide. The proportion is higher in the developing countries where it ranges from 24% to 66%.
}This huge expenditure on medicines is driven by the roles medicines can play in saving lives, restoring health, preventing diseases and stopping epidemics.
}In order to do so, medicines must be safe, efficacious and of the quality prescribed by the relevant standards.
}Expenditure on drugs as a proportion of total health expenditure ranges from between 7% to 66% worldwide. The proportion is higher in the developing countries where it ranges from 24% to 66%.
}This huge expenditure on medicines is driven by the roles medicines can play in saving lives, restoring health, preventing diseases and stopping epidemics.
}In order to do so, medicines must be safe, efficacious and of the quality prescribed by the relevant standards.
}Consequently, medicines development including clinical trials, production, importation, exportation, distribution, storage and ultimate use are subject to regulation to ensure that the standards of safety, efficacy and quality are met and maintained throughout the period of use of the product.
}To ensure access to essential medicines at all times and at affordable prices, governments (in developed countries in particular) have formulated and implemented industrial policies that include development and promotion of a vibrant pharmaceutical industry.
}These policies are reviewed to accommodate advancement in science & technology.
}To ensure access to essential medicines at all times and at affordable prices, governments (in developed countries in particular) have formulated and implemented industrial policies that include development and promotion of a vibrant pharmaceutical industry.
}These policies are reviewed to accommodate advancement in science & technology.
.The principles of effective medicine regulation demands that the MRAs develop science-based guidance and standards that help industry to efficiently comply with regulations, as well as guide them toward best practices.
}In today’s global village, harmonization of regulatory requirement and standards is the game.
}As science and technology advances, and as economic and social trends evolve, MRAs are obliged to continually evaluate the standards and guidance to ensure that they are promoting the best and most current recommendations.
}As science and technology advances, and as economic and social trends evolve, MRAs are obliged to continually evaluate the standards and guidance to ensure that they are promoting the best and most current recommendations.
Pharmaceutical Scene in ECOWAS 
}In today’s global village, harmonization of regulatory requirement and standards is the game.
}As science and technology advances, and as economic and social trends evolve, MRAs are obliged to continually evaluate the standards and guidance to ensure that they are promoting the best and most current recommendations.
}In today’s global village, harmonization of regulatory requirement and standards is the game.
}As science and technology advances, and as economic and social trends evolve, MRAs are obliged to continually evaluate the standards and guidance to ensure that they are promoting the best and most current recommendations.
•Distribution of pharmaceutical services is skewed towards the urban centres where less than 20% of the citizens live; the rural majority have limited access to pharmaceutical care relying on medicine peddlers who constitute a major conduit line for sale of fake medicines.
• Sale of medicines appear to be one of the easiest means to make a living in West Africa; thus over 80% of people involved in pharmaceutical trade are not qualified, daft illiterates to say the least. Illicit trade in pharmaceuticals is estimated to be over US$ 50 million per year.
• Public procurement of medicines in some countries are executed without adequate reference to quality standards; the lowest bidder wins the day and among the general public, affordability and not quality is the priority.
• Sale of medicines appear to be one of the easiest means to make a living in West Africa; thus over 80% of people involved in pharmaceutical trade are not qualified, daft illiterates to say the least. Illicit trade in pharmaceuticals is estimated to be over US$ 50 million per year.
• Public procurement of medicines in some countries are executed without adequate reference to quality standards; the lowest bidder wins the day and among the general public, affordability and not quality is the priority.
Medicines Regulation in ECOWAS
•Distribution of pharmaceutical services is skewed towards the urban centres where less than 20% of the citizens live; the rural majority have limited access to pharmaceutical care relying on medicine peddlers who constitute a major conduit line for sale of fake medicines.
• Sale of medicines appear to be one of the easiest means to make a living in West Africa; thus over 80% of people involved in pharmaceutical trade are not qualified, daft illiterates to say the least. Illicit trade in pharmaceuticals is estimated to be over US$ 50 million per year.
• Public procurement of medicines in some countries are executed without adequate reference to quality standards; the lowest bidder wins the day and among the general public, affordability and not quality is the priority.
•Distribution of pharmaceutical services is skewed towards the urban centres where less than 20% of the citizens live; the rural majority have limited access to pharmaceutical care relying on medicine peddlers who constitute a major conduit line for sale of fake medicines.
• Sale of medicines appear to be one of the easiest means to make a living in West Africa; thus over 80% of people involved in pharmaceutical trade are not qualified, daft illiterates to say the least. Illicit trade in pharmaceuticals is estimated to be over US$ 50 million per year.
• Public procurement of medicines in some countries are executed without adequate reference to quality standards; the lowest bidder wins the day and among the general public, affordability and not quality is the priority.
Pharmaceutical Industry Today
}There are 28 pharmaceutical manufacturing firms licensed, producing various forms of pharmaceutical products in Ghana.
}The products are mainly essential generic medicines and specialty Over-The-Counter (OTCs) drugs.
}Only two firms produce IV fluids; none produce sterile preparations for the eye/ear.
}There is only one ARV manufacturer; only one manufacturer has the facility to produce API.
}None of the manufacturers nor any of their products is WHO Pre-qualified.
}The products are mainly essential generic medicines and specialty Over-The-Counter (OTCs) drugs.
}Only two firms produce IV fluids; none produce sterile preparations for the eye/ear.
}There is only one ARV manufacturer; only one manufacturer has the facility to produce API.
}None of the manufacturers nor any of their products is WHO Pre-qualified.
}Compliance to cGMP requirements is the basis for qualification of any pharmaceutical manufacturer to produce & supply medicines.
}GMP-compliance rating of the 28 companies based on a survey undertaken by FDB 3 years ago with focus on:
Documentation, GWP, Water treatment system, personnel, plant design, raw materials, QC & QA systems, effluent management, self-audits, training, sanitation & hygiene, pest control, validation of processes, calibration & qualification of equipment, planned preventive maintenance, complaints & recalls, HVAC systems, suitability of premises;
Major findings:
}Inadequate documentation
}Lack of key personnel
}Inadequate training of staff
}Outdated equipment
}Non –validated systems
}Inadequate QC infrastructure
}Poor building design
}Insecure raw material sourcing
}Poor maintenance culture
}Inadequate sanitation & hygiene
}GMP-compliance rating of the 28 companies based on a survey undertaken by FDB 3 years ago with focus on:
Documentation, GWP, Water treatment system, personnel, plant design, raw materials, QC & QA systems, effluent management, self-audits, training, sanitation & hygiene, pest control, validation of processes, calibration & qualification of equipment, planned preventive maintenance, complaints & recalls, HVAC systems, suitability of premises;
Major findings:
}Inadequate documentation
}Lack of key personnel
}Inadequate training of staff
}Outdated equipment
}Non –validated systems
}Inadequate QC infrastructure
}Poor building design
}Insecure raw material sourcing
}Poor maintenance culture
}Inadequate sanitation & hygiene
The Needed Regulatory Intervention
}Effective regulation and enforcement of standards serve as potent tools for promotion industrial growth and development.
}Passage of the new F&D Bill into Law would provide FDB a more comprehensive authority and resources to partner industry to develop the required quality management systems.
}Having established the GMP rating for the local pharmaceutical industry, the FDB would set deadlines for each cluster group to move up the scale
}FDB, would design custom-made GMP- improvement workshops for cluster groups.
}Licensing of facilities including renewals and registration of products would be linked with industry’s willingness to meet deadlines set for quality infrastructure improvement programmes.
}By 2012, only companies with dedicated facilities for production of beta-lactam antibiotics would be granted license to produce penicillins and allied products.
}To reward commitment to improving upon quality infrastructure, FDB would qualify only quality-oriented companies to participate in MOH National Competitive Bidding to supply medicines.
}Passage of the new F&D Bill into Law would provide FDB a more comprehensive authority and resources to partner industry to develop the required quality management systems.
}Having established the GMP rating for the local pharmaceutical industry, the FDB would set deadlines for each cluster group to move up the scale
}FDB, would design custom-made GMP- improvement workshops for cluster groups.
}Licensing of facilities including renewals and registration of products would be linked with industry’s willingness to meet deadlines set for quality infrastructure improvement programmes.
}By 2012, only companies with dedicated facilities for production of beta-lactam antibiotics would be granted license to produce penicillins and allied products.
}To reward commitment to improving upon quality infrastructure, FDB would qualify only quality-oriented companies to participate in MOH National Competitive Bidding to supply medicines.
}FDB would publish regularly PMS outcomes and institute immediate recalls of products that fail quality requirements.
}The issue of qualified key or authorized persons in industry is being taken by FDB to a higher level; the competence of such persons would be assessed by the FDB annually based on criteria to be discussed with industry.
}Bioequivalence studies: comparative dissolution studies involving the originator product
}Stability testing: FDB to collaborate with WHO to organize training workshops for industry
Malaysian strategy: improving GMP compliance
}One-stop information centre for customer friendly services
}Technical guidance
}Dialogue sessions and regular training for industry personnel
}Technical Working Group on GMP, including NPCB and industry representatives
}Recommendation of sources of financial support for manufacturers seeking to improve their GMP status
}Encouragement of foreign partnerships for transfer of technology and “smart alliance” .
}The issue of qualified key or authorized persons in industry is being taken by FDB to a higher level; the competence of such persons would be assessed by the FDB annually based on criteria to be discussed with industry.
}Bioequivalence studies: comparative dissolution studies involving the originator product
}Stability testing: FDB to collaborate with WHO to organize training workshops for industry
Malaysian strategy: improving GMP compliance
}One-stop information centre for customer friendly services
}Technical guidance
}Dialogue sessions and regular training for industry personnel
}Technical Working Group on GMP, including NPCB and industry representatives
}Recommendation of sources of financial support for manufacturers seeking to improve their GMP status
}Encouragement of foreign partnerships for transfer of technology and “smart alliance” .
.When a dynamic drug regulatory infrastructure including a well resourced Regulatory Authority is in place, an enabling environment is the created for effective enforcement of appropriate manufacturing standards which leads to quality drugs; and builds up the image of the local pharmaceutical industry in the international domain. Sooner than later, products from the country attracts the international markets leading to growth in the sector with the attendant creation of more jobs and growth in the economy. Such is the role that the US FDA and the MHRA, the respective American and the British drug regulators have been funded to do in support of their pharmaceutical industry. The FDB of Ghana has the potential lift the image of the Ghanaian pharmaceutical industry if the Board id adequately funded by government
Industry/Government Response
Industry/Government Response
}Industry’s commitment to comply with regulatory notices and directives
}Investment into GMP-designed facilities in earmarked “pharmaceutical industrial zones created by government”.
}Pooled procurement of essential raw materials from accredited sources
}Out-sourcing of selected QC testing to accredited laboratories.
}Resourcing of Universities to institute courses in pharmaceutical technology and engineering to supply knowledgeable and skilled labour .
}Development of local raw material base.
}Enhanced access to calibration services, pharmaceutical consultancy services.
}Partnerships/joint ventures.
}A National Pharmaceutical Quality Award Scheme:
The drive to excel can be triggered off by many factors. In many developed countries and the Newly Industrialized Countries like Singapore and Malaysia, industry-specific quality award schemes have been used to reward deserving industries and to promote healthy competition among industry players. A National Pharmaceutical Quality Award Scheme should be considered by government-led public-private partnership incentive programme.
}Investment into GMP-designed facilities in earmarked “pharmaceutical industrial zones created by government”.
}Pooled procurement of essential raw materials from accredited sources
}Out-sourcing of selected QC testing to accredited laboratories.
}Resourcing of Universities to institute courses in pharmaceutical technology and engineering to supply knowledgeable and skilled labour .
}Development of local raw material base.
}Enhanced access to calibration services, pharmaceutical consultancy services.
}Partnerships/joint ventures.
}A National Pharmaceutical Quality Award Scheme:
The drive to excel can be triggered off by many factors. In many developed countries and the Newly Industrialized Countries like Singapore and Malaysia, industry-specific quality award schemes have been used to reward deserving industries and to promote healthy competition among industry players. A National Pharmaceutical Quality Award Scheme should be considered by government-led public-private partnership incentive programme.
Conclusion
}Not only is Ghana on the verge of drilling oil in commercial quantities, the country is also on the verge of emerging as the pharmaceutical industrial hub of ECOWAS. What is needed is an appropriate incentive package to revive existing infrastructure for pharmaceutical production, invest into new production facilities and to regulate more effectively the manufacturing processes to ensure the supply of products of the right quality and safety, both for local consumption and for export. Government initiative is required; private sector enthusiasm is needed; the will to do is demanded from both.
Presentation by :jmartey@fdbghana.pharm/0709
Presentation by :jmartey@fdbghana.pharm/0709
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