1. Policy Options for Low and Middle Income Countries (LMIC)

2. Outline Outline Issues in LMIC Pricing New medications
A conversation with Thailand

3. 5 key challenges Adequate financing
‘Individual’ affordability (whoever is paying)
Assuring quality and safety
Appropriate use
‘Missing’ medications
Examples: heat-stable insulin and oxytocin, shorter treatments for latent and active TB, single-day treatments of malaria, and treatments for MDRTB.
Also pediatric formulations

4. WHO Essential Medications
Category
1. Anesthetics
11. Blood products
21. Eye preparations
2. Pain and palliative care
12. Cardiovascular products
22. Oxytocics
3. Antiallergics
13. Dermatological products
23. Dialysis solution
4. Antidotes for poisoning
14. Diagnostic agents
24. Mental and behavioral meds
5. Anti-convulsive
15. Disinfectants
25. Respiratory meds
6. Anti-infective
16. Diuretics
26. Solutions correcting water, electrolyte imbalance
7. Anti-migraine
17. GI medicines
27. Vitamins and minerals
8. Anti-neoplastic
18. Hormones, contraceptives
28. ENT meds for children
9. Anti-Parkinsonism
19. Immunologicals
29. Specific meds for neonates
10. Medicines affecting the blood
20. Muscle relaxants
30. Meds for joint diseases

5. Money
Lancet Commission: Amount needed for essential medicines in LMIC = $13-$25 per person per year
Many countries spend much less than this.
Though some low income countries spend more.
Come up with it through domestic and international sources

6. Pharma spending and total medical spending by income
Low Income
Lower Middle Income
Kyrgyzstan, Tajikistan, Uganda, Afghanistan, Myanmar
Upper Middle Income
High Income

7. Key issue 1: Purchasing at lowest price
Many LICs have difficulty negotiating low prices for medicines.
World is moving towards bulk purchasing of medicines for LICs.
Moving from a jewelry store model to a grocery store model
Medicines Patent
Pool
Clinton Health
Access Initiative

8. Key issue 2: How should prices vary with income?
Pharma’s view of the world MICs’ view of the world
Wmax
US price
Wmax
US price
Non-rich country price
Thailand price
Dollars
Dollars
Uganda price
cost
cost
Quantity
Quantity

9. The Fallback: Compulsory Licensing
Reasonably common
Often lead to negotiations
First employed for HIV/AIDS meds and now spreading to oncology
Most common countries: Brazil, Thailand, and India

10. Spread to oncology

11. Alternatives

12. Alternatives Not-for-profit research Advance market agreements
Universities are not-for-profit (though many researchers also work with industry); so are gov’t researchers (NIH)
Advance market agreements
Set a price in advance and guarantee sales if a drug is developed
Priority review vouchers (aka a prize)
If a drug is developed for some populations, get to move another drug to the front of the FDA line
Patent buyout
Buy the rights to sell the drug from the pharma company [e.g., using a tiered pricing system], and then provide the drug cheap

13. Not-for-profit research
Example: Drugs for Neglected Diseases initiative (2003-)
Partnership between countries and companies
Search existing compounds for new uses in neglected tropical diseases
Get funds to launch trials
Some successes (e.g., malaria), and some drugs moving towards trials

14. Advance Market Agreements
2007: Agreement to buy pneumococcal vaccine at no more than $3.50 / dose if developed.
Gone from no treatment to 160 million doses annually.

15. Patent Buyouts
Estimate profit from a newly approved medication. Give the firm that amount of money. Give the drug away for free (or very low cost).
None have yet been in pharmaceutical done. But the issue pops up.
- Peter Bach, MSKCC

16. Priority Review Vouchers
Manufacturers who license products for specified neglected diseases get a voucher to speed up FDA approval.
E.g., leprosy, malaria, schistosomiasis and onchocerciasis,
These can be sold (and have been, $70M - $350M)
Hasn’t worked so well so far.
Companies mostly licensing in the US products that were available elsewhere.
Doesn’t specify price or availability.

17. What is the relationship between MICs and pharmaceutical companies?

18. Our guest Somsak Chunharas, President, National Health Foundation
Former deputy minister of public health, Thailand