workshop 2 supply reasons
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Workshop 2 Supply reasons. Solutions for medicines shortages. What could be the solutions globally . Regulatory API Production Distribution chain Economics, Incentive Business. Regulatory . Prevention versus migitation - PowerPoint PPT PresentationTRANSCRIPT
Workshop 2 Supply reasons
Solutions for medicines shortages
What could be the solutions globally – Regulatory
– API
– Production
– Distribution chain
– Economics, Incentive Business
Regulatory 1. Prevention versus migitation
2. Harmonisation of regulation / standards between regulators and witin regulators
3. Medical essential ‘list’ 1. What2. Single manufacturer3. Single API
Regulatory - continue4. Improving quality of inspectors; ongoing
developments to improve functioning of all regulators
6. Communication transparency with the regulator
7. Do risk benefit assessment before reg action and communication
API• Need ability to share audit findings between suppliers & manufacturers
• Drug companies have obligation to ensure API meets quality standards; Regulators cannot inspect all API suppliers frequently
• Transparency & communication are key to ensuring quality between API supplier, manufacturer & regulators need systems to facilitate transparency
API - continue• Regulators & manufacturers need to focus more on helping to solver quality problems (working in collaboration with API suppliers)
• Enhance enforcement of quality standards by manufacturers & regulators
• Companies need to have more than one API supplier for a given product
• Regulators need to support manufacturers doing this.
Production
1. Better communication between inspection and approval arms
2. Once a shortage occurs, expedited reviews (onsite manufacturers)
3. Harmonized upfront helps mititagte – new products need less variability accross jurisdictions
4. Established products make more variable
Production - continue5. Price /volume commitments based on
expectation of purchase commitment
6. Production planning and commitment
7. Risk sharing – tenderer to share risk
8. Assurance of quality has a cost to it then a commitment to quality and supply need to be made if pricing is competitive
Production - continue9. Longer assurance of demand; less risk of
investments
10. Contingency/back up plans need to be in place
11. Open dialogue between procurement officials and manufacturers. Talk to the suppliers
Distribution1. Access to medicine
2. Information shared between HCPs and govt.
3. Looking at forcasting and seasonal trends /DTCA may also play a role
4. Looking at allocation, countries may consider establishing a demand planning (independent) agency
Distribution (continue)5. FIP need to report to the WHO who can lobby
to all other organisations/countries
6. Stockpiling
7. Need to be a disclosure framework e.g greater transparancy
8. Sole suppliers; double edged sword
9. Availibilty of raw materials
Distribution (continue)10. Lack of definition of necessary
medicines
11. Lean inventory WHO
12. Lack of ethical framework
13. Emergency of gray market must be no interest in gaining with medicines
14. Responsible communication about medicines shortages
Economics, incentives business - continue1. Payers negotiate reasonbale & fair price
– Reasonable profit in exchange for guarantee supply of essential drugs.
– Encourages investment in facilities
2. Guarantee of supply
3. Harmonized regulatory agency
4. Regulation of large-scale compounding business
Economics, incentives business - continue5. Incentives to generic companies to apply fro
expedited approval
6. Sharing process so be transparent