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