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