1 / 14

Workshop 2 Supply reasons

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

gyala
Download Presentation

Workshop 2 Supply reasons

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Workshop 2 Supply reasons Solutions for medicines shortages

  2. What could be the solutions globally • Regulatory • API • Production • Distribution chain • Economics, Incentive Business

  3. Regulatory • Prevention versus migitation • Harmonisation of regulation / standards between regulators and witin regulators • Medical essential ‘list’ • What • Single manufacturer • Single API

  4. Regulatory - continue 4. Improving quality of inspectors; ongoing developmentstoimprovefunctioning of all regulators 6. Communication transparency with the regulator 7. Do risk benefit assessment before reg action and communication

  5. 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

  6. 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.

  7. Production • Better communication between inspection and approval arms • Once a shortage occurs, expedited reviews (onsite manufacturers) • Harmonized upfront helps mititagte – new products need lessvariability accross jurisdictions • Established products make more variable

  8. 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

  9. 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

  10. Distribution • Access to medicine • Information shared between HCPs and govt. • Looking at forcasting and seasonal trends /DTCA may also play a role • Looking at allocation, countries may consider establishing a demand planning (independent) agency

  11. Distribution (continue) • FIP need to report to the WHO who can lobby to all other organisations/countries • Stockpiling 7. Need to be a disclosure framework e.g greater transparancy • Sole suppliers; double edged sword 9. Availibilty of raw materials

  12. 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

  13. 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

  14. Economics, incentives business - continue • Incentives to generic companies to apply fro expedited approval 6. Sharing process so be transparent

More Related