1. Access to Treatment: People Before Trade
Sangeeta Shashikant
Third World Network
Malaysia

2. Malaysia
first Asian country following the Doha Declaration on TRIPS & Public Health to issue a “government use” (GU) order to import generic version of patented ARVs from India
GU: safeguard that allows the government to make use of the patented product, for its use without the consent of and without the need of prior negotiations with the patent holder
initiative begun by the MOH as despite their numerous attempts to negotiate with the patent holders, the prices of ARVs was not reduced sufficiently
Nov 2002 : MOH submitted a paper to the Cabinet to import generic ARVs from India
Cabinet approved under Sec 84 of the Patents Act Government’s Rights to exploit a patent for public non-commercial use for reasons of health, emergencies or national interest

3. Conditions for the company assigned under the GU are:
Drugs Imported under Government Use Authorisation: - Didanosine 100mg tablets (patent holder: Bristol-Myers Squibb) - Didanosine 25mg tablets (patent holder: Bristol-Myers Squibb) - Zidovudine 100mg capsules (patent holder GlaxoSmithKline) - Lamivudine 150mg + Zidovudine 300mg tablet (patent holder GlaxoSmithKline)
Conditions for the company assigned under the GU are:
The imported drugs shall be supply to govt hospitals only
Every box of medicines shall be labelled with the words “MINISTRY OF HEALTH”
The brand names, shape or color of tablet or capsule shall be different from the patented products in Malaysia
The company shall keep records of sales in Poisons Wholesale Book
Compensation payment shall be paid to the patent holders within a period of two months after every time the products are imported
The permit shall be valid for two years

4. Positive Outcome
the average costs for treatment ppy dropped from US$315 to US$ 58 (81% reduction in cost)…..increasing the number of patients that could be treated from 1500 to 4000 people

5. Monthly Cost Of Treatment PPPY
2001 price patented
USD
2004 price patented
2004 Generic Price
d4T + ddI + Nevirapine
261.44
197.10
45.32
Combivir + Efavirenz
362.63
136.34
115.14

6. BMS drops prices of Didanosine
USD
2004 prices
% Drop in
price
Didanosine (100mg)
(60 tablets)
63.55
32.68
49%
Didanosine (25 mg)
44.49
8.17
82%

7. GSK drops prices again from earlier reduction in 2003
USD
2004 prices
Drop in price
Combivir (60 tabs)
286.28
57.99
80%
AZT
(100 caps)
77.58
36.08
53%
3TC
(60 tabs)
141.75
46.39
67%

8. “Adequate Remuneration”
Requirement of Art 31(h) TRIPS Agreement
MOH proposed to patent holder 4% of value of stocks actually delivered taking into account existing state practices and the UNDP Human Development Report
According to MOH officials, the patent holders “show no interest in claiming compensation”….no movement on remuneration negs. as of Feb. 2006
Possible reasons MOH have identified
- setting a precedent for future govt. use/CL
- bad publicity for the patent holder….wd seem as if accepted the practise of issuing CL
- sign of acceptance of MOH rights

9. Next Steps:
Since GU authorisation ended in Nov 2005 the MOH is considering two options:
to negotiate prices of patented products to an acceptable level
to apply for a renewal of the authorisation
It appears that the CL option will not be used for the time being….the advantage gained from the GU order will be used to negotiate lower prices

10. Challenges Opposition from patent holders
after the Cabinet decision to issue authorisation, GSK offered to drop the price of Combivir by 57%
complaints agst the Malaysian govt were lodged and meetings were held with their legal representatives where the legality of the proposed importation was questioned
one company suggested that the proposal would affect their investment decisions in Malaysia
leading to concerns being raised by other ministries regarding the TRIPS compliant nature of the proposal and the possibility of negative implications for investment prospects in the country
A law suit has been filed in the Malaysian courts by one of the patent holders although it is not activated
But MOH stood firm….strengthened by the Doha Declaration

11. TRIPS-plus provisions in US FTAs
Data Exclusivity
prevents the DRA from using the data provided by an originator company to authorise the use of an equivalent generic version of the same drug…would also apply to non-patented products
Restrictions on the grounds on which compulsory licenses can be granted
Turning DRA into patent police
DRA prevented from registering a generic version of a drug that is under patent in the country unless the patent holder gives consent
Extension of patent term
Restriction/prohibition on parallel importation
Require the grant of patent on new uses of known pharmaceutical products

12. FREE TRADE AGREEMENTS (TRIPS plus) WIPO (TRIPS plus Agendas)
requires ratification of WIPO treaties
reduces the flexibilities available in TRIPS
WIPO
(TRIPS plus Agendas)
-applicable if become member
-involved in standard setting exercises
-reflects demands/stds of developed countries
-reduces policy space
WTO (TRIPS)
-comprehensive multilateral IP minimum standards
-applicable to WTO members
Built in flexibilities
WIPO
-Paris/Berne Conv
-voluntary