NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN MINISTRY OF HEALTH

NATIONAL INFLUENZA PANDEMIC PREPAREDNESS PLAN MINISTRY OF HEALTH MALAYSIA KKM / MOH Preparedness in the Avian Flu and HIV situation,

Influenza Pandemics in the 20 th Century 1918: “Spanish Flu” H 1 N 1 40 -50 million deaths 1957: “Asian Flu” H 2 N 2 1 - 4 million deaths 1968: “Hong Kong Flu” 1 - 4 million deaths KKM / MOH H 3 N 2 Preparedness in the Avian Flu and HIV situation,

National Influenza Pandemic Preparedness Plan (NIPPP) v We are preparing for the next influenza pandemic NOT specifically the H 5 N 1 Influenza. Just happens that H 5 N 1 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 H 5 N 1 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 H 5 N 1 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) v Preparedness activities: v Surveillance – clinical & virus v Stockpiling - anti-viral drugs, PPE, v Vaccine v Up-grade hospitals facilities v Training v Information & communication KKM / MOH Preparedness in the Avian Flu and HIV situation,

National Influenza Pandemic Preparedness Plan (NIPPP) in 2005 v 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) v Preparedness activities: - Budget Cabinet has approved budget for the following activities: § § § § 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 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 v Type A Influenza Vaccine - purchased 220, 000 doses Inj Fluarix. v. Value = RM 4. 8 juta. v Distributed to front-line healthcare workers at the ground level. v. For immediate use. v. 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 v Oseltamivir capsules from Ranbaxy - to treat 2% of population. v 505, 800 treatment packs (10 tabs per pack) v. Total = RM 27. 5 million. v. Delivery to 9 stockpile sites. KKM / MOH Preparedness in the Avian Flu and HIV situation,

National Influenza Pandemic Preparedness Plan (NIPPP) Stockpile 2006 v. Zanamivir capsules - to treat 0. 5% of population. v 126, 450 treatment packs (20 capsules) v. Total = RM 7. 2 million. v. 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 v. Only when a pandemic is declared in Malaysia. v. WHO’s approach. KKM / MOH Preparedness in the Avian Flu and HIV situation,

WHO Tamiflu Stockpiles v 1. 5 million treatment courses in Switzerland. v 1. 5 million treatment courses in USA. v 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 v On request from a country, WHO will fly the stocks to the nearest international airport (includes personal protection equipment, etc). v Recipient country responsible for expediting Customs clearance, transport to site of outbreak, security, storage, distribution, monitor adverse effects. v. 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 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 : RM 47. 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 3 TC, 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, dd. I 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) 3 TC (60 tabs) KKM / MOH 2001 prices 2004 prices (RM) (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 100 mg (60 tabs) 246. 58 (63. 55) 126. 81 (32. 68) 49% Didanosine 25 mg (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,