NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN

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NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN
MINISTRY OF HEALTH MALAYSIA
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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
H3N2
1 - 4 million deaths
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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 .

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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)
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Prolonged outbreak of H5N1 in birds humans, may
cause mutation of influenza virus and trigger
influenza pandemic in humans.
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National Influenza Pandemic Preparedness Plan
(NIPPP)

• Preparedness activities-
• Surveillance clinical virus
• Stockpiling - anti-viral drugs, PPE,
• Vaccine
• Up-grade hospitals facilities
• Training
• Information communication

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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

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National Influenza Pandemic Preparedness Plan
(NIPPP)

• Preparedness activities- Budget
• Cabinet has approved budget for the following
  activities
• Vaccine - RM 4.84 mil.
• Personal Protection Equip - RM 6.3 mil.
• Anti-viral drugs - RM 39.75 mil.
• Lab. Surveillance - RM 4.074 mil.
• Communication - RM 0.25 mil.
• Training - RM 0.25 mil.
• Up grade hospitals - RM 4 mil
• Research - RM 1 mil
• Total - RM 60.464 mil per year

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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.

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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.

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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.

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STOCKPILE LOCATIONS
MUSB Miri
Hosp K. Terengganu
PBF KK
Hosp Bukit Mertajam
Hosp Serdang
Hosp Tawau
MUSB Sarikei
HSA Johor Bharu
MUSN Kuching
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Release of Stockpiles

• Only when a pandemic is declared in Malaysia.
• WHOs approach.

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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 (Japans donation).

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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.

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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.
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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.
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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.
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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.
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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 10s for
  Malaysia via ASEAN Secretariat.

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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

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ACCESS to ARVs
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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.

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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)
• .

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GOVERNMENT PROCUREMENT IN 2002

• Through public tenders
• The following originator drugs were made
  available through 2-year contracts
• Stavudine tablet
• Zidovudine capsule

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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.

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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 Governments rights under the
  Patents Act 1983.

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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 - Governments 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
  Ciplas representative and applies for
  Compulsory Licence.

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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,

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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.

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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.

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Feb 2004 Prices drop again
2001 prices (RM) (USD) 2004 prices (RM) (USD) Drop in price
Combivir (60 tabs) 1103 (284.28) 225 (57.99) 80
AZT (100 caps) 301 (77.58) 140 (36.08) 53
3TC (60 tabs) 550 (141.75) 180 (46.39) 67
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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
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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.

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INCREASING ACCESS -Encouraging local
manufacture of drugs not patented in Malaysia

• Stavudine
• Nevirapine
• Registered in 2003.

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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.

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THE PRESENT SCENARIO

• MOH and patent holders are holding dialogues
  rather than confrontation.
• First line drugs are all free.

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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.

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THE END