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NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN MINISTRY OF HEALTH MALAYSIA

This plan outlines Malaysia's preparedness for the next influenza pandemic, with a focus on the H5N1 strain. It includes surveillance, stockpiling of drugs and vaccines, hospital upgrades, training, and communication strategies.

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NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN MINISTRY OF HEALTH MALAYSIA

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  1. NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN MINISTRY OF HEALTH MALAYSIA

  2. 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

  3. We are preparing for the next influenza pandemic NOT specifically the H5N1 Influenza. Just happens that H5N1 appears to be the nearest threat . National Influenza Pandemic Preparedness Plan (NIPPP)

  4. 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. Why are we so concerned? Increasing risk of human to human transmission (pandemic)

  5. Prolonged outbreak of H5N1 in birds & humans, may cause mutation of influenza virus and trigger influenza pandemic in humans.

  6. Preparedness activities:- Surveillance – clinical & virus Stockpiling - anti-viral drugs, PPE, Vaccine Up-grade hospitals facilities Training Information & communication National Influenza Pandemic Preparedness Plan (NIPPP)

  7. 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 National Influenza Pandemic Preparedness Plan (NIPPP) in 2005

  8. 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 National Influenza Pandemic Preparedness Plan (NIPPP)

  9. 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. National Influenza Pandemic Preparedness Plan (NIPPP) 2006

  10. 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. National Influenza Pandemic Preparedness Plan (NIPPP) Stockpile 2006

  11. Zanamivir capsules - to treat 0.5% of population. 126,450 treatment packs (20 capsules) Total = RM 7.2 million. Delivery to 9 stockpile stores. National Influenza Pandemic Preparedness Plan (NIPPP) Stockpile 2006

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

  13. Only when a pandemic is declared in Malaysia. WHO’s approach. Release of Stockpiles

  14. 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). WHO Tamiflu Stockpiles

  15. 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. WHO Tamiflu Stockpiles

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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. For 2007

  21. 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 Final Word

  22. ACCESS to ARVs

  23. 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. THE PATENTS ACT 1983 Amended in 2000 and 2003

  24. 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%) . Calling for price reductions July 2001

  25. Through public tenders The following originator drugs were made available through 2-year contracts: Stavudine tablet Zidovudine capsule GOVERNMENT PROCUREMENT IN 2002

  26. 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. ACCESS TO ARVs in 2002

  27. 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. STRATEGY FOR INCREASING ACCESS

  28. 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. PUTTING ON THE PRESSURE

  29. 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, The opposition begins

  30. 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. The opposition continues

  31. 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. SUCCESS!

  32. Feb 2004 : Prices drop again

  33. Feb 2004 : Didanosine prices drops.

  34. 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. COMPENSATION

  35. Stavudine Nevirapine Registered in 2003. INCREASING ACCESS -Encouraging local manufacture of drugs not patented in Malaysia

  36. 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. DOMESTIC MANUFACTURE

  37. MOH and patent holders are holding dialogues rather than confrontation. First line drugs are all free. THE PRESENT SCENARIO

  38. 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. Lessons learnt

  39. THE END

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