jiraporn limpananont - ip event
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1Dr. Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn University
IPR & Access to Medicines in Thailand
Dr. Jiraporn Limpananont
Foundation For Consumers (FFC) Drug Study Group (DSG) FTA Watch Social Pharmacy Research Unit, Faculty of Pharmaceutical Sciences, Chulalongkorn University.
2Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Scope: IPR & Access to Medicines IPR Protection: Patent Act
Raise up the innovation? High price, un-affordable Impact on the Generic Drug Manufacturing: destroy the
local generic drug manufacturer FTA and Trade Pressure: TRIPs Plus on IPR for drugs
3 Cases of consumers’ movement for Access to Drugs” Revocation: ddI case Pre-grant opposition: combid case CL implementation
5Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Event on the 6th round of Thai-US FTA negotiation
Chiamgmai, Thailand
Jan. 2005
6Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Case 1: Revocation of ddI patent ddI was invented by US NIH, licensed to BMS, and
not allowed to be patented in developing countries, BMS did not patent ddI in Thailand but patented
ddI formulation ddI formulation is not new, no inventive step, but it
was patented The price is very high
7Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Two ways of solving this problem Issue the CL since 2000
Result: no CL was issued Revoke the Patent
Result: BMS negotiated to end the case in the court by voluntary withdrew this patent
8Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
TPN+ Camp asking for CL on ddI patent
9Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Case 2: Pre-grant opposition of combid Case:
GSK filed for the formulation of AZT 300 mg + 3TC 150 mg AZT and 3TC were not patented in Thailand They were already used, not new and no inventive step The cheap generic version was sold If it was patented then GSK can monopolize the market, the price
will be very high Civil Society Movement to
Make opposition to this application Result:
The process took more than 5 years Finally GSK withdrew this patent application
Strategies: Put pressure on the unethical practice of GSK Mass media campaign and demonstration
10Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
11Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Case 3: CL of Government Use 2 ARVs:
Efavirenz commercially known as Stocrin, of MSD (on 29 November 2006)
Lopinavir/Ritonavir commercially known as Kaletra, made by Abbott (on 24 January 2007)
1 Heart disease drug Clopidogrel commercially known as Plavix, made by
Sanofi-Aventis (on 25 January 2007)
12Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Diagram to demonstrate that the Government Use of patent does not affect much on the existing market size of patented products
People paid by public budget with no or limited access to patented drugs –
“New market for drugs from Government Use”
“Public non-commercial use”
Income
% of population at each income level
62 million Thais
Social Welfare = 48.5 million
Social Security = 8.5 mil.
Civil Servant MedicalBenefit Scheme = 5 mil.
HighLowOut ofpocket
payment – “Existing market for high price patented drugs”
“Commercial use”
13Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
TRIPS flexibilities
Non Public use: Prior negotiation Voluntary licensing Compulsory licensing
Public Use: No need for prior negotiation National emergency Extreme urgency Public non-commercial use
(TRIPS 31(b): DOHA; Thai patent act section 46-52)
PermissionRoyaltyTerms of use
RoyaltyTerms of use
14Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
After negotiation for 1.5 Yr After CL Announcement
MSD- Efavirenz – Now is 770 Baht/Bottle(~ 45% price reduction)
Abbott - Strong reaction - 9 Dossier withdrew (including Kaletra film-coated tab) - Kaletra – no WHO pre-qualified pdts available (expected to be available in film-coated tab form in the next few months)
BMS- Atazanavir – No price reduction
BMS - Atazanavir (2nd line that can replace Lopinavir) – will be negotiated for price reduction and/or CL
MSD- Efavirenz – 1723 to 1401 Baht (~18.7% reduction in Baht because of the Baht appreciation: no reduction in terms of USD)
Abbott- Kaletra – 17548 to 6000 Baht (~66% reduction in Baht or ~57% reduction in USD)
Roche- Saquinavir – 4852.66 to 4601 Baht (~5% reduction in Baht or ~15% increase in USD)
Roche - Saquinavir has no patent in Thailand, but GPO is in the process of production development. - Less used in National Health Program
15Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Reaction from USTR and Abbott Under Section 301, USTR put Thailand on the PWL Abbott withdrew all applications to register its new
drugs in Thailand
16Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Reaction from Civil Society: boycott Abbott
17Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Demonstration
18Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Worldwide Boycott Abbott’s Products
19Dr. Jiraporn Limpananont, Chair, Foundation For Consumers, Thailand
Conclusion Patent in the field of pharmaceuticals:
Market driven R&D not Public Health Need driven R&D No drugs for the treatment of the Poor's diseases Patented drugs are un-affordable for the Poors
What should we do for access to medicines ?
20Dr. Jiraporn Limpananont, Faculty of Pharmaceutical Sciences, Chulalongkorn University
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