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.What 2.Single manufacturer 3.Single API

Regulatory - continue 4. 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 - continue 5. 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 - continue 9. 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

Distribution 1.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 - continue 1. 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 - continue 5.Incentives to generic companies to apply fro expedited approval 6. Sharing process so be transparent