NATIONAL INFLUENZA
PANDEMIC
PREPAREDNESS PLAN
MINISTRY OF HEALTH
MALAYSIA
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Influenza Pandemics in the 20th Century
1918: “Spanish Flu”
H1N1
40-50 million deaths
1957: “Asian Flu”
H2N2
1 - 4 million deaths
1968: “Hong Kong Flu”
1 - 4 million deaths
KKM / MOH
H3N2
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP)
 We are preparing for the next influenza
pandemic
NOT specifically the H5N1 Influenza.
Just happens that H5N1 appears to be the nearest
threat .
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Why are we so concerned?
•
•
•
•
•
Number of affected countries with H5N1 increasing.
Number of avian and human cases increasing.
Majority of human population has no immunity.
High case fatality rate.
Human influenza viruses are circulating in Asian
countries.
Increasing risk of human to
human transmission (pandemic)
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Prolonged outbreak of H5N1 in birds & humans, may
cause mutation of influenza virus and trigger
influenza pandemic in humans.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP)
 Preparedness activities: Surveillance – clinical & virus
 Stockpiling - anti-viral drugs, PPE,
 Vaccine
 Up-grade hospitals facilities
 Training
 Information & communication
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP) in 2005
 Preparedness activities:Oseltamivir capsule (Tamiflu) 60,000 treatment
packs (10 tabs each) has been ordered in
December 2005 –

rapid response central stockpile

stocks received in July 2006
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP)
 Preparedness activities:- Budget
Cabinet has approved budget for the following activities:
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
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
KKM / MOH
Vaccine
Personal Protection Equip
Anti-viral drugs
Lab. Surveillance
Communication
Training
Up grade hospitals
Research
Total
-
RM 4.84 mil.
RM 6.3 mil.
RM 39.75 mil.
RM 4.074 mil.
RM 0.25 mil.
RM 0.25 mil.
RM 4 mil
RM 1 mil
RM 60.464 mil per year
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP) 2006
 Type A Influenza Vaccine - purchased
220,000 doses Inj Fluarix.
Value = RM 4.8 juta.
 Distributed to front-line healthcare workers
at the ground level.
For immediate use.
Other Ministries supposed to buy their own
vaccines.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP) Stockpile 2006
 Oseltamivir capsules from Ranbaxy - to treat 2% of
population.
505,800 treatment packs (10 tabs per pack)
Total = RM 27.5 million.
Delivery to 9 stockpile sites.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
National Influenza Pandemic Preparedness
Plan (NIPPP) Stockpile 2006
Zanamivir capsules - to treat 0.5% of
population.
126,450 treatment packs (20 capsules)
Total = RM 7.2 million.
Delivery to 9 stockpile stores.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
STOCKPILE LOCATIONS
Hosp K.
Terengganu
MUSB
Miri
PBF KK
Hosp
Bukit
Mertajam
Hosp
Serdang
HSA Johor
Bharu
KKM / MOH
Hosp
Tawau
MUSN
Kuching
MUSB
Sarikei
Preparedness in the Avian Flu and HIV situation,
Release of Stockpiles
Only when a pandemic is declared in Malaysia.
WHO’s approach.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
WHO Tamiflu Stockpiles
 1.5 million treatment courses in Switzerland.
 1.5 million treatment courses in USA.
 500,000 treatment courses for ASEAN stored
in Singapore (Japan’s donation).
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
WHO Tamiflu Stockpiles
 On request from a country, WHO will fly the
stocks to the nearest international airport
(includes personal protection equipment, etc).
 Recipient country responsible for expediting
Customs clearance, transport to site of
outbreak, security, storage, distribution,
monitor adverse effects.
States with international airports to take
special note.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Eligible People
1. Rx of people hospitalized for influenza.
2. Rx of ill health-care and emergency
services workers.
3. Rx of ill high-risk persons in the community.
4. Prophylaxis of health-care workers.
5. Control outbreaks in high-risk institutions
(nursing homes/ other chronic care facilities).
6. Prophylaxis of essential services workers.
7. Prophylaxis of high-risk persons
hospitalized for illnesses other than influenza.
8. Prophylaxis of high-risk persons in the
community.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Roles and Responsibilities of Stockpile
Centres
Identify responsible officers for the stockpile and their
contact numbers.
Receive stocks from suppliers.
Maintain a list of Distribution Centers under their
responsibility.
Sort stock according to Distribution Centers.
Provide security during stockpiling.
Arrange for collection and destruction of expired
stocks.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Roles and Responsibilities of
Distribution Centres
Identify responsible officers for each Distribution
Center and their contact numbers.
Identify / Arrange for transport to collect stock from the
Stockpile Store.
Arrange for security escort.
Maintain population data for areas covered by each
Hospital / Health Clinic.
Distribute stock according to population data.
Monitor ADR.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Roles and Responsibilities of
State Health Dept.
Work with other member States of each Stockpile
Regional Store on logistics of distribution. State with
stockpile to act as leader of group.
Identify clear chains of command and contact
numbers.
States with international airport to act as recipient of
WHO stock and work out logistics of transport to site
of outbreak.
Produce a written Plan of Action.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
For 2007
•
•
•
•
Total NIPPP budget for 2007 : RM47.7 m
Budget for antivirals : RM XX.XX million.
To purchase Oseltamivir powder for syrup.
Japan to donate Cap.Tamiflu, 23,200 x 10’s
for Malaysia via ASEAN Secretariat.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Final Word
• Getting the stockpile is easy.
• Distribution is the difficult part.
• WHO Avian Influenza resource site:
http://www.who.int/csr/disease/avian_influenza/en/index.html
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
ACCESS to ARVs
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
THE PATENTS ACT 1983
Amended in 2000 and 2003
• Sec 52 – Allows the issue of a Compulsory
License for local manufacture or import.
• Sec 58 – Allows Parallel Import.
• Sec 84 – Allows the Government to exploit a
patent in a national emergency or in the public
interest eg security, nutrition, health or the
development of a vital sector as determined by
the Government.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Calling for price reductions
July 2001
• 10% reduction :
Ritonavir
• 20% - 40% reduction :
Stavudine (25% - 34%).
Didanosine (36%).
Zidovudine (30%)
Zidovudine + Lamivudine (40%)
• 60% - 70% reduction
Indinavir (65%)
Efavirenz (65%).
Nevirapine (68.5%)
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
GOVERNMENT
PROCUREMENT IN 2002
• Through public tenders
• The following originator drugs were made
available through 2-year contracts:
Stavudine tablet
Zidovudine capsule
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
ACCESS TO ARVs in 2002
• Monotherapy is free in MOH hospitals.
• Highly Active Antiretroviral Treatment (HAART)
is given free to
a) infected mothers after delivery,
b) infected children,
c) healthcare workers infected in the line of duty
d) patients infected through contaminated
products/blood transfusion.
• Other patients on HAART are given 1 free drug
and required to purchase 2 drugs. This is to ensure
commitment to treatment.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
STRATEGY FOR
INCREASING ACCESS
• Provide free HAART to 10,000 patients
• Bring prices of HIV drugs down through
negotiations with patent holders.
• Encourage local production of HIV drugs not
patented in Malaysia.
• Making use of Government’s rights under the
Patents Act 1983.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
PUTTING ON THE PRESSURE
• Nov 2002 : MOH submitted a paper to the Cabinet
to import generic ARV from India (drugs under
patent).
• Cabinet approved using Sec 84 of the Patents Act
1983.
• Sec 84 - Government’s Rights to exploit a patent
for public non-commercial use for reasons of
health, emergencies or national interest.
• Jan 2003 : MOH begins price negotiations with
Cipla’s representative and applies for
“Compulsory” Licence.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
The opposition begins
• Feb 2003 : Supplier offers to drop price of Combivir
by 57%.
• Mar 2003 : Other agencies asks MOH to reconsider.
Supplier meets Minister of Health.
• Apr 2003 : Supplier drops price of 3TC, AZT and
Combivir by 31% - 57%. MOH decides to proceed
with import of non-patented drugs first.
• May 2003 : MOH issues contract for Stavudine,
Ritonavir and Nevirapine,
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
The opposition continues
• Aug 2003 : Other agencies suggests that MOH
do not use Compulsory Licence.
• Nov 2003 : MOH obtains Compulsory Licence
from Min. of Domestic Trade for AZT, ddI and
Combivir.
• Feb 2004 : Another Ministry requests Cabinet
to reconsider its decision. Cabinet authorizes
MOH to proceed.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
SUCCESS!
• Nov 2003 : MOH announces supply of
HAART will be free once the import of
generics starts.
• Feb 2004 : MOH issues contract to import
generic Zidovudine, Combivir and
Didanosine.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Feb 2004 : Prices drop again
Combivir
(60 tabs)
AZT
(100 caps)
3TC
(60 tabs)
KKM / MOH
2001 prices 2004 prices
(RM)
(RM)
(USD)
(USD)
1103
225
(284.28)
(57.99)
301
140
(77.58)
(36.08)
550
180
(141.75)
(46.39)
Drop in
price
80%
53%
67%
Preparedness in the Avian Flu and HIV situation,
Feb 2004 : Didanosine prices drops.
2001 price
(RM)
(USD)
2004 price
(RM)
(USD)
Drop in
price
Didanosine
100mg
(60 tabs)
246.58
(63.55)
126.81
(32.68)
49%
Didanosine
25mg
(60 tabs)
172.61
(44.49)
31.70
(8.17)
82%
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
COMPENSATION
• MOH proposes 4% of contract value of
stocks actually delivered.
• Patent holders show no interest in claiming
compensation.
• Possible reasons?
• - Setting a precedent.
• - Bad publicity.
• - Acknowledgement of MOH rights.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
INCREASING ACCESS Encouraging local manufacture
of drugs not patented in Malaysia
• Stavudine
• Nevirapine
• Registered in 2003.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
DOMESTIC
MANUFACTURE
• Feb 2004 : MOH receives proposal from local
manufacturer to manufacture 3-in-1 ARV
combination.
• Oct 2004 : Local manufacturer approaches
patent owner for voluntary license.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
THE PRESENT SCENARIO
• MOH and patent holders are holding
dialogues rather than confrontation.
• First line drugs are all free.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
Lessons learnt
• Patent laws must have all the flexibilities
of TRIPS.
• Political will to make use of flexibilities.
• MOH needs to push for accessibility of
drugs as a national agenda.
KKM / MOH
Preparedness in the Avian Flu and HIV situation,
THE END
KKM / MOH
Preparedness in the Avian Flu and HIV situation,