Iha tinan 2011 Ministerio da saude sei investe barak liu iha area rekursus Umanus no kualidade servisu ninian, tanba nee orsamentu nebe propoin ba ministerio da saude ho montante U$ 37 Miloens sei investe ba ida nee.
Realidade hatudu katak Iha tinan 2011 Ministerio da saude simu estudante finalista nebe durante nee halao sira nia estudu iha Cuba reintegra ba sistema no ami sei mos prepara kondisaun hodi implementa rejime kareira especial nebe mak tenki prepara duni,” Dr. Nelson kasu lia hirak nee ba jornalista sira iha uma fukun parlamentu Nasional kinta 27 janeiru 2011.
Nunee Ministru saude mos afirma katak, prepara proporsionalidade entre infermeirus, profesionais saude ho rekursus humanus hodi servi populasaun sira nebe presija tebes assistensia nebe diak no kualidade.
Hafoin fundu dezinvolvimentu deskute makas teb-tebes Ministerio da saude prepara hodi haruka taan Doutor Geral sira ba hasai sira nia espesialidade iha rai leur no balun atu ba taan iha tinan 2011 nebe hamutuk 18 pesoas.
Dr. Martins hatutan taan katak, sei kontinua haforsa fakulidade iha siensia saude iha Universidade Nasional Timor Loro sa’e nebe kompostu husi departamentu tolu, Medisina Geral, Emfarmagen, no Parteira hodi kontinua kursu diploma DIII nunee mos ba eskola diploma I ba infermeiru, Denrista, Radiologia no farmasia.
Nunee agora dadaun problema nebe ministerio da saude sei infrenta nafatin mak fasilidade sei kurang iha 13 distritus nomos sei falta infermeiru no dotor tanba ita nia nasaun foin mak ukun aan entaun ita lao neneik mas bebeik maibe, Ministerio da saude desdu uluk ate agora ministerio da saude sempre preparadu servisu ho kondisaun saida deit. Nunee pesoal saude dedika nafatin ho espiritu nasionalizmu hadomi ita nia nasaun diak liutan, Maski ho fasilidade limitadu,” tenik Ministru saude Dr. Nelson Martins.
Tanba problema fasilidade menus nee laos ministerio da saude deit mak infrenta maibe kuaze Ministerio no intituisaun barak mak infrenta situasaun sira nee. Politika no estratejia Nasional Ministerio da saude fiar katak iha tinan 20 nia laran fiar katak, iha suku ida por/Mill populasaun sei iha infermeiru rua ho parteira ida no ambulansia ida iha postu saude hotu. Alm MS001
Friday, January 28, 2011
Thursday, January 27, 2011
Ameasa Greve PM Xanana kestiona Nasionalizmu no Profesionakizmu
Primeru Ministru Xanana Gusmao kestiona nasionalimu profesionalizmu knar nai saude sira ne’ebé ameasa halo greve konaba sira nia esjijensia ba rejime kareira nian.
Rejime kareira, ami dehan hein lai oituan neneik ba, Mak ejiji atu halo greve, Hau senti katak, Se ita ba ita rasik iha ne’e, Ita dehan, Nasionalizmu, Patriotizmu ne’e iha ne’ebé” Hateten primeru ministru Xefe Governu iha parlamentu Nasional, Kinta 27/01/2011 hafoin rona kestaun ne’e husi Deputadu FRETILIN Domingos Sarmento.
Wainhira deputadu ne’e kestiona assuntu ne’ebé refere konaba rejime kareira funsaun ba profesionais Saude hetan kedas klarifikasaun klean husi Primeru Ministru. Problema rejime kareira funsaun laos atu valorize S1 ka S2, Maibe problema iha implikasaun finanseira.
“Tanba ne’e mak ami deskuti konaba rejime kareira sira ne’e, Hamutuk ho profesores, profesionais saude Guarda prizaun no sel-seluk mos husu sira nia rejime kareira, Nune’e hau hanoin problema boot liu atu ita hare mak edukasaun, Problema edukasaun laos deit kuantidade maibe hare mos sira nia kualidade” dehan PM xanana.
PM xanana Gusmao hateten mediku iha timor leste kurang teb-tebes bainhira mak ita prepara taan mediku atu mai taan 900 ka 700 hodi la’o tan, Hare ba situasaun sira ne’e. “ Dalaruma ita hakilar ba ita nia direitu mash au husu ba deputadu sira katak, Ita la’o neneik ami hare hela subsidiu, Ida ne’ebé mak se karik hot-hotu husu ninia rejime de kareira, Ami la iha problema, Problema mai aprejenta iha orsamentu, Ninia impaktu finanseiru ba estadu,” Hateten PM xanana.
Primeru Ministru mos realsa katak governu la nega sira nia kareira especial, Maibe governo husu lao neneik oituan. Tanba sa ita hein taan oituan labele, se ita hareba komunidade iha Brimob rasik mai halo manifestasaun iha ne’e tanba deit osan simu la to’o tanba ne’e rejime kareira funsaun hein lai oituan ami sei hare ida ne’e neneik,” Katak PM Xanana.
Primeru Minitru Republika Demokratika Timor Leste apelu ba profesionais sau sira hotu katak, Tebes duni presija sira nia servisu, Maibe ho Hakraik aan hau husu atu komprende iha kontestu Global Nasaun Nian.
“ Ita mos hare dadauk ona ba sira sira rihun rua resin ne’ebé iha Edukasaun atu reforma, Ita atu halo oinsa, Ne’ebé ho hakraik aan teb-tebes ba infermeiru no Dotor inklui parteira sira, Povu doben ida ne’e presija tebes sira nia Tulun. Ita lao ho kompriende malu,” Realsa PM.
Lider rai RDTL ida ne’e Xanana Gusmao sinte triste teb-tebes kuandu profesionais sira ejije demais, kuandu timor leste sei iha problema ho IDP’s ne’ebé la iha tiha ona maibe mai nafatin, Nune’e mos komunidade Brimob tanba ne’e husu ita hotu nia komprensaun atu tane nafatin Nasionalizmu no profesinalizmu iha Nasaun Ida ne’e. Das/MS001
Rejime kareira, ami dehan hein lai oituan neneik ba, Mak ejiji atu halo greve, Hau senti katak, Se ita ba ita rasik iha ne’e, Ita dehan, Nasionalizmu, Patriotizmu ne’e iha ne’ebé” Hateten primeru ministru Xefe Governu iha parlamentu Nasional, Kinta 27/01/2011 hafoin rona kestaun ne’e husi Deputadu FRETILIN Domingos Sarmento.
Wainhira deputadu ne’e kestiona assuntu ne’ebé refere konaba rejime kareira funsaun ba profesionais Saude hetan kedas klarifikasaun klean husi Primeru Ministru. Problema rejime kareira funsaun laos atu valorize S1 ka S2, Maibe problema iha implikasaun finanseira.
“Tanba ne’e mak ami deskuti konaba rejime kareira sira ne’e, Hamutuk ho profesores, profesionais saude Guarda prizaun no sel-seluk mos husu sira nia rejime kareira, Nune’e hau hanoin problema boot liu atu ita hare mak edukasaun, Problema edukasaun laos deit kuantidade maibe hare mos sira nia kualidade” dehan PM xanana.
PM xanana Gusmao hateten mediku iha timor leste kurang teb-tebes bainhira mak ita prepara taan mediku atu mai taan 900 ka 700 hodi la’o tan, Hare ba situasaun sira ne’e. “ Dalaruma ita hakilar ba ita nia direitu mash au husu ba deputadu sira katak, Ita la’o neneik ami hare hela subsidiu, Ida ne’ebé mak se karik hot-hotu husu ninia rejime de kareira, Ami la iha problema, Problema mai aprejenta iha orsamentu, Ninia impaktu finanseiru ba estadu,” Hateten PM xanana.
Primeru Ministru mos realsa katak governu la nega sira nia kareira especial, Maibe governo husu lao neneik oituan. Tanba sa ita hein taan oituan labele, se ita hareba komunidade iha Brimob rasik mai halo manifestasaun iha ne’e tanba deit osan simu la to’o tanba ne’e rejime kareira funsaun hein lai oituan ami sei hare ida ne’e neneik,” Katak PM Xanana.
Primeru Minitru Republika Demokratika Timor Leste apelu ba profesionais sau sira hotu katak, Tebes duni presija sira nia servisu, Maibe ho Hakraik aan hau husu atu komprende iha kontestu Global Nasaun Nian.
“ Ita mos hare dadauk ona ba sira sira rihun rua resin ne’ebé iha Edukasaun atu reforma, Ita atu halo oinsa, Ne’ebé ho hakraik aan teb-tebes ba infermeiru no Dotor inklui parteira sira, Povu doben ida ne’e presija tebes sira nia Tulun. Ita lao ho kompriende malu,” Realsa PM.
Lider rai RDTL ida ne’e Xanana Gusmao sinte triste teb-tebes kuandu profesionais sira ejije demais, kuandu timor leste sei iha problema ho IDP’s ne’ebé la iha tiha ona maibe mai nafatin, Nune’e mos komunidade Brimob tanba ne’e husu ita hotu nia komprensaun atu tane nafatin Nasionalizmu no profesinalizmu iha Nasaun Ida ne’e. Das/MS001
Monday, January 17, 2011
MS PREPARA U$ 150 Mill Kombate HIV/AIDS Iha Timor-Leste
Ministerio da Saude Semanal
Dili, Saude-Semanal. Tinan 2011 ministerio da saude sei tau orsamentu montante U$ 150 dolares Norte amerikanu ba komisaun Nasional luta kombate HIV/AIDS, tanba tinan-tinan numeru nee sempre aumenta ba bei-beik. Ministru da saude Nelson Martins koalia ida nee ba Jornalista sira, segunda 17/01/2011 iha parlamentu Nasional.
Nia afirma, ministerio da saude iha tinan nee sei prepara orsamentu ho montante U$ 150 nebe tama rubrika transferensia publika hodi fob a komisaun Nasional luta hasoru moras HIV/AIDS hodi halao sira nia servisu. Nebe mak agora dadaun prepara hela finalize baze legal estatutu.
Tuir Ministru Martins katak, komisaun nasional luta kontra hasoru moras HIV/AIDS, komesa prepara nomeiasaun mebru foun hodi fo treinamentu ba membrus sira no halo estasaun servisu iha rejional hodi fo konsellu ba instituisaun estadu inklui Ministerio da Saude RDTL, hodi halo supervizaun implementa saun planu estrateziku HIV/AIDS 2010-2015 nian, no prepara apoiu implementasaun orsamentu nebe mak hetan husi global funds ba programa HIV/AIDS.
Prezidente komisaun Nasional luta kontra moras HIV/AIDS actual Ministru da Saude esplika katak, tuir data estatistika ministerio da saude nian nebe hahu tinan 2003 to’o 2010 moras HIV/AIDS iha timor leste atinji ona numeru total kuaze 200 pesoas no nain 22 mate.
Maske timor leste numeru sae, maibe ministru da saude nelson dehan timor leste sei tama nasaun nebe ho prevalensia HIV/AIDS ho pursentu 0,2 %.
Nia haklaken ministerio da saude ho komisaun Nasional luta kontra moras HIV esforsu nafatin ho parseiru sira ONG sira nebe mak dedika sira nia aan tomak ba moras HIV/SIDA inklui mos media timor leste hodi habelar informasaun ba komunidade hodi nunee sira bele iha konhesemetu klean ba moras nebe refere (HIV).
aleinde nee Antonio dos Santos suku Motael lamenta ho programa SISCa nebe oras nee dadaun lao la duun diak iha suku nebe refere, “dehan katak programa SISCa halao fulan ida dala ida maibe agora dadaun iha ami nia fatin paradu”. Hatan ba kestaun hirak nee Ministru Nelson Afirma, atu rejolve problema SISCa, rekursus Umanus mak la too hodi fo assistensia nebe klean ba komunidade maibe ho partisipasaun Komunidade tomak fiar katak programa SISCa sei lao Normal.
Dr. Nelson Haktuir katak, SISCa mos iha ninia orsamentu rasik maibe susar atu mobilize, “SISCa sei lao diak wainhira komunidade partisipa makas no lider komunitariu sira mos iha partisipasaun Masimu ba programa nee”.tenik Ministru MS.
SISCa mos tinan-tinan aloka orsamentu tuir alokasaun ba kada sentru da saude ho orsamentu montante U$ 25.00 nunee ministru Martins apela ba komunidade katak SISCa nee presija ema hotu nia kontribuisun hare ba realidade katak rekursus kurang teb-tebes.MS01 feat JNDiario
Sunday, January 16, 2011
Seitor Saúde no Edukasaun Iha Timor - Leste
Prezidente Horta : Governu tenki infeste makas
Prezidente da republika Dr. Jose Ramos Horta husu Governu tenki investe makas ba seitor Saúde no edukasaun liu-liu hatama hanesan prioridade Governu nia planu.
Ita iha nasaun kiik hanesan timor leste seitor Saúde no edukasaun importante tebes, tan ne’e hau apelu ba Nai ulun governu ezekutivu no membru poder lezislativu para hare oinsa atu it abele tau orsamentu boot liu taan ba seitor Saúde no edukasaun,” hateten nia iha tomada de posse reitor foun universidade Nasional timor Loro sa’e (UNTL) Aurelio Sergio Guterres iha sabadu 15 Janeiru 2011 iha Dili convention Center Ex Merkadu Lama Dili.
Kuandu ita la tau prioridade ba hirak ne’e mak edukasaun labele la’o no Saúde la fornesidu. Nomos iha edukasaun la klean no la iha abut entaun nasaun sei la iha ema liu-liu joven sira kualidade nune’e dezinvolvimetu sei la la’o. Tantu tenki iha konsensu no esforsu makas husi orgaun estadu no instituisaun governu hotu-hotu.
“ it abele hateten konsensu iha nasaun ne’e para nasaun la’o ba oin no moris iha globalizasaun ita tenki halo esforsu makas, liu-liu hanesan nasaun kiik investe makas iha edukasaun forma ema matenek,” tenik Horta.
Akresenta liutan katak, esforsu dezinvolvimentu kakutak ne’e tenki halo duni liu husi tau matan ba edukasaun, fo biban ba estudante sira atu bele estuda no buka matenek iha banku universidade iha rai laran no ema nia rain.
“ tuir relatoriu estudante timor oan nebe hala’o estudu iha Cuba, sira nia klasifikasaun diak liu duke estudante sira nebe mai husi Venezuela, Brazil, Vietnam no sira nebe estudu hamutuk iha ne’ebá.” Informa Horta.
Dala ida taan atu dezinvolve ema nia kakutak importante mak governu tenki kria kondisaun fo meus sosilozikus, ambiente, Sosial, tekniku nebe mak sir abele dezinvolve, katak Horta. MSo1 Feat Juliao Fernades
Prezidente da republika Dr. Jose Ramos Horta husu Governu tenki investe makas ba seitor Saúde no edukasaun liu-liu hatama hanesan prioridade Governu nia planu.
Ita iha nasaun kiik hanesan timor leste seitor Saúde no edukasaun importante tebes, tan ne’e hau apelu ba Nai ulun governu ezekutivu no membru poder lezislativu para hare oinsa atu it abele tau orsamentu boot liu taan ba seitor Saúde no edukasaun,” hateten nia iha tomada de posse reitor foun universidade Nasional timor Loro sa’e (UNTL) Aurelio Sergio Guterres iha sabadu 15 Janeiru 2011 iha Dili convention Center Ex Merkadu Lama Dili.
Kuandu ita la tau prioridade ba hirak ne’e mak edukasaun labele la’o no Saúde la fornesidu. Nomos iha edukasaun la klean no la iha abut entaun nasaun sei la iha ema liu-liu joven sira kualidade nune’e dezinvolvimetu sei la la’o. Tantu tenki iha konsensu no esforsu makas husi orgaun estadu no instituisaun governu hotu-hotu.
“ it abele hateten konsensu iha nasaun ne’e para nasaun la’o ba oin no moris iha globalizasaun ita tenki halo esforsu makas, liu-liu hanesan nasaun kiik investe makas iha edukasaun forma ema matenek,” tenik Horta.
Akresenta liutan katak, esforsu dezinvolvimentu kakutak ne’e tenki halo duni liu husi tau matan ba edukasaun, fo biban ba estudante sira atu bele estuda no buka matenek iha banku universidade iha rai laran no ema nia rain.
“ tuir relatoriu estudante timor oan nebe hala’o estudu iha Cuba, sira nia klasifikasaun diak liu duke estudante sira nebe mai husi Venezuela, Brazil, Vietnam no sira nebe estudu hamutuk iha ne’ebá.” Informa Horta.
Dala ida taan atu dezinvolve ema nia kakutak importante mak governu tenki kria kondisaun fo meus sosilozikus, ambiente, Sosial, tekniku nebe mak sir abele dezinvolve, katak Horta. MSo1 Feat Juliao Fernades
Wednesday, January 12, 2011
REJIMI BA KAREIRA FUNSAUN BA PROFESIONAIS SAUDE
MS hein Desizaun husi Komisaun Funsaun publika
Ejijensia nebe hatoo husi AETL ( asosiasaun Imfermeiru Timor leste) katak iha tinan 2011 tenki implementa rejime de kareira especial ba profesionais saude “oras nee hau seidauk hetan karta husi Komisaun funsaun publika tenik Dr. Nelson Martins iha uma fukun parlamentu nasional kuarta 12 de Janeiru 2011.
Rejime kareira professional hanesan subsidiu ba mediku, imfermeirus, parteiras, no sel-selutan hodi nunee sira bele fo asistensia diak ba komunidade.
Dr. Nelson haktuir ejijensias nebe AETL hatoo nee laos problema ema ida rua nian deit maibe ba professional saude tomak nebe fo ona sira kontribuisaun diak ba nasaun ida nee.
Draft husi Direktor Geral no rekursus Umanus Ministerio da saude hatoo tiha ona ba KFP no agora dadaun ita hot-hotu hein hela desizaun final husi KFP, sorin seluk rejolusaun nebe refere sei iha Prezidente KFP nia liman sei hatoo ba parlamentu nasional hodi halo diskusaun maibe ita sei hein took desizaun ikus husi Parlamentu Nasional.
Atu esplika klean liutan katak agora dadaun Ministerio da saude liu husi Dr. Nelson Martins hein nafatin karta legal husi KFP konaba assuntu nebe refere.
Dr. Nelson hatutan rejime kareira especial ami halo tiha ona diskusaun dala tolu iha konsellu Ministru maibe ita tenki hetan klires husi KFP.
Ministru saude Dr. Nelson Martins apela ba profesionais saude sira hotu nebe namkari iha timor laran tomak katak, ita hotu iha direitu atu halo protesta maibe ita tenki kumpri ita nia dever katak tenki protesta ho ulun malirin lalika halo mogok problema nebe refere agora dadaun iha ona funsaun publika nia liman.MS001
Ejijensia nebe hatoo husi AETL ( asosiasaun Imfermeiru Timor leste) katak iha tinan 2011 tenki implementa rejime de kareira especial ba profesionais saude “oras nee hau seidauk hetan karta husi Komisaun funsaun publika tenik Dr. Nelson Martins iha uma fukun parlamentu nasional kuarta 12 de Janeiru 2011.
Rejime kareira professional hanesan subsidiu ba mediku, imfermeirus, parteiras, no sel-selutan hodi nunee sira bele fo asistensia diak ba komunidade.
Dr. Nelson haktuir ejijensias nebe AETL hatoo nee laos problema ema ida rua nian deit maibe ba professional saude tomak nebe fo ona sira kontribuisaun diak ba nasaun ida nee.
Draft husi Direktor Geral no rekursus Umanus Ministerio da saude hatoo tiha ona ba KFP no agora dadaun ita hot-hotu hein hela desizaun final husi KFP, sorin seluk rejolusaun nebe refere sei iha Prezidente KFP nia liman sei hatoo ba parlamentu nasional hodi halo diskusaun maibe ita sei hein took desizaun ikus husi Parlamentu Nasional.
Atu esplika klean liutan katak agora dadaun Ministerio da saude liu husi Dr. Nelson Martins hein nafatin karta legal husi KFP konaba assuntu nebe refere.
Dr. Nelson hatutan rejime kareira especial ami halo tiha ona diskusaun dala tolu iha konsellu Ministru maibe ita tenki hetan klires husi KFP.
Ministru saude Dr. Nelson Martins apela ba profesionais saude sira hotu nebe namkari iha timor laran tomak katak, ita hotu iha direitu atu halo protesta maibe ita tenki kumpri ita nia dever katak tenki protesta ho ulun malirin lalika halo mogok problema nebe refere agora dadaun iha ona funsaun publika nia liman.MS001
KONSTRUSAUN MORTUARIU HNGV ATINJI ONA 30%
Kontrusaun Mortuariu forensic Ospital Nasional guido nebe halao iha fulan Dezembru 2010 no sei remata iha fulan jullu 2011, Agora dadaun atinji ona 30%.
Kompanhia cruz li nebe manan projetu obra konstrusaun mortuariu nebe refere ba Jornalista sira hateten sira garante sei halo hotu obra nee iha jullu 2011.
Iha sorin seluk rui Manuel Gagu Exposto Adminisrador HNGV ba saude semanal tersa 11 de Janeiru 2011 hateten orsamentu nebe alokadu ba obra konstrusaun nee mak U$ 1.2 miloens no ba moru halaeu ho montante U$ 300 mil.
Konstrusaun mortuariu ho medidas 12/17 no kontrusaun nee bele rai mate isin hamutuk 30. Iha parte seluk moru nebe agora dadaun haleu Mortuario nee manan husi kompanhia Ailora Enterprises, Lda ho osan ba obra nee montante U$ 300 $ nunee tuir planu sei remata iha fulan marsu 2011. Aleinde nee Rui Gagu mos imforma katak Governu Novazelandia mos fo sira nia kontribuisaun liu husi hari klinika matan ba HNGV maibe la inklui husi OGE agora dadaun atinje ona % 80. Garantia katak sei halo hotu iha tinan ida nee nia laran.MS001
Kompanhia cruz li nebe manan projetu obra konstrusaun mortuariu nebe refere ba Jornalista sira hateten sira garante sei halo hotu obra nee iha jullu 2011.
Iha sorin seluk rui Manuel Gagu Exposto Adminisrador HNGV ba saude semanal tersa 11 de Janeiru 2011 hateten orsamentu nebe alokadu ba obra konstrusaun nee mak U$ 1.2 miloens no ba moru halaeu ho montante U$ 300 mil.
Konstrusaun mortuariu ho medidas 12/17 no kontrusaun nee bele rai mate isin hamutuk 30. Iha parte seluk moru nebe agora dadaun haleu Mortuario nee manan husi kompanhia Ailora Enterprises, Lda ho osan ba obra nee montante U$ 300 $ nunee tuir planu sei remata iha fulan marsu 2011. Aleinde nee Rui Gagu mos imforma katak Governu Novazelandia mos fo sira nia kontribuisaun liu husi hari klinika matan ba HNGV maibe la inklui husi OGE agora dadaun atinje ona % 80. Garantia katak sei halo hotu iha tinan ida nee nia laran.MS001
Pasientes iha CHC Bairo Formoza Dili (centru)
Saude-semanal
Dili Saude-semanal, Iha 2010 nia laran centru formoza simu pasiente moras hanesan Ispa 28.580, Malaria 685, diarea 4.680 dermatitis (isin katar) 3.809 pnemonia 1.965 (matan mean) 1.141 no malnutrisaun ka labarik sira nebe krekas liu 522 nunee total pasientes hamutuk 449.853. informsaun hirak nee Saude semanal asesu liu husi notisia diariu Timor Post edisaun kuarta feira 12 Janeiru 2011.
Hatan ba prekupasaun konaba labarik sira nebe isin krekas ka malnutrisaun hamutu 522 ne’e Mario Moreira dos Reis Unidade seguransa Alimentar Ministerio da saude ba saude semanal hateten, Durante nee centru Saude formoza implementa ona programa tratamentu externa ba labarik sira nebe hetan malnutrisaun nebe krekas maran ho LKL (liman kabun Leten) menus husi 11,5cm mai kraik. Nunee kuandu iha komplikasaun mak refere ba Ospital Nasional.
Pakote HTM (hahan tramentu ba malnutrisaun) ba pasientes nebe identifika moras malnutrisaun simu HTM fulan ida dala rua. Nunee ba hahan suplementu sira hanesan Timor-Vita desde inisiu iha ona planu atu distribui ba neba maibe fatin ka armajen hodi tau fatin nee mak la iha.
Mario realsa liutan katak ministerio saude kontinua servisu makas atu hadia Jestaun malnutrisaun tanba nee minterio saude liu husi Departamentu Nutrisaun kontinua esforsu aan makas hodi asegura hahan ba moras malnutrisaun.MS001
Dili Saude-semanal, Iha 2010 nia laran centru formoza simu pasiente moras hanesan Ispa 28.580, Malaria 685, diarea 4.680 dermatitis (isin katar) 3.809 pnemonia 1.965 (matan mean) 1.141 no malnutrisaun ka labarik sira nebe krekas liu 522 nunee total pasientes hamutuk 449.853. informsaun hirak nee Saude semanal asesu liu husi notisia diariu Timor Post edisaun kuarta feira 12 Janeiru 2011.
Hatan ba prekupasaun konaba labarik sira nebe isin krekas ka malnutrisaun hamutu 522 ne’e Mario Moreira dos Reis Unidade seguransa Alimentar Ministerio da saude ba saude semanal hateten, Durante nee centru Saude formoza implementa ona programa tratamentu externa ba labarik sira nebe hetan malnutrisaun nebe krekas maran ho LKL (liman kabun Leten) menus husi 11,5cm mai kraik. Nunee kuandu iha komplikasaun mak refere ba Ospital Nasional.
Pakote HTM (hahan tramentu ba malnutrisaun) ba pasientes nebe identifika moras malnutrisaun simu HTM fulan ida dala rua. Nunee ba hahan suplementu sira hanesan Timor-Vita desde inisiu iha ona planu atu distribui ba neba maibe fatin ka armajen hodi tau fatin nee mak la iha.
Mario realsa liutan katak ministerio saude kontinua servisu makas atu hadia Jestaun malnutrisaun tanba nee minterio saude liu husi Departamentu Nutrisaun kontinua esforsu aan makas hodi asegura hahan ba moras malnutrisaun.MS001
Politika Stratejia Nutrisaun iha Timor Leste
Wainhira koalia kona ba nutrisaun outomatikamente koalia kona ba aihan nebe lor-loron ita han, ho mos oinsa aihan ne’e bele benefisia ba ita nia isin no resulta ba status saude no nutrisaun nebe signifikadu bele hamosu kondisaun isin fakru tamba moras no mos tamba insufisienti konsumu aihan maka bele, hamosu kurang nutrisaun nebe hanaran malnutrisaun ho nia nivel status hanesan; status normal, moderadu no grave.
Malnutrisaun hanesan problema publiku nebe kompleksu teb-tebes nebe fo kontribuisaun ba morbidade no mortalidade ba saude ema hotu-hotu nian, liu-liu ba labarik no inan sira. Malnutrisaun fo impaktu kresimentu, dezenvolvimentu fiziku, mental no kualidade rekursus humanus nian. Atu resolve ne’e laos deit aproximasaun husi asistensia saude nian deit, maibe problema malnutrisaun mosu tanba problema multifaktor, tamba ne’e presiza aproximasaun ida nebe invole sertores relevantes hotu-hotu.
Bazeia ba peskiza no Estudu Demografia Saude nebe halao iha Timor Leste, hatudu katak malnutrisaun sei as nafatin, ida ne’e ita bele hare katak, sempre ida husi labarik nain rua iha Timor leste maka sofre husi malnutrisaun kroniku, nebe hare husi sira nia altura no idade , maka resulta ba rakitiku /raes /badak (stunting), mais ke sira ne’e, ita hare hanesan normal, sempre iha mos ida husi labarik nain nen maka krekas los (wasting ) no mos sempre hat husi nain sanulu maka todan menus.
Problema nutrisaun sempre iha relasaun ho problema insufisienti aihan, nia intervensaun laos tenki atu hasae deit produsaun no fornesimentu aihan, maibe presiza konsidera no hare mos ba problemas sira hanesan situasaun krize ( iha bailoro raimaran, dezastre naturais, konflitu sosilial , politiku, no krize ekonomiku ect), maibe problema nutrisaun mosu tamba insiguransa alimentar iha nivel uma kain, ida nebe fo impaktu ba uma kain atu asesu aihan ba membru hotu nebe hela iha uma kain ida. Hare ba ida ne’e, maka atu hasae status nutrisaun komunidade nian, presiza stratejia ida atu asegura komunidade bele asesu ba aihan ho adekuadu no mos husi nia kuantidade no kualidad nebe diak. Iha kontestu ida ne’e, ita bele dehan katak problema nutrisuan talves laos deit problema saude, maibe mos problema mukit hamosu hamala, atetude no portunidade atu hetan servisu.
Saida maka sai hanesan problema ?
Problema nutrisaun iha Timor-Leste no mos nasaun dezenvolvidu sira, em geral sei dominasi ho problema defisiensia ba makronutrienti maka rezulta ba Kuran Energia Proteina, nebe hamosu malnutrisaun ho tipu hanesan krekas aguda, badak, no todan menus, no mos defisiensia ba mikronutriente maka resulta ba defisiensia vitamina no mineral hanesan anemia ferru, kakorok bot, (defisinesia Iodo)defisiensia A , ect.
Saida maka sai hanesan kazu malnutrisaun iha Timor Leste?
Malnutrisaun hanesan resultadu ida husi faktores oi-oin nebe nia impaktu resulta ba status nutrisaun no mos fo kontribuisaun ba mortalidade no morbidade, liu ba saude maternu infantil. Nutrisaun menus mosu husi kauza multiplikadu. Hahan importante ba ema nia moris hanesan nesesidades bazika esencial. Availabilidade aihan laos deit faktor nebe fo influensa ba status nutrisional ema ida nian, maibe iha mos faktores seluk nebe influensia ba status nutrisional
Kazu imidiata nebe afeta deretamente mosu malnutrisaun maka inadekuadu aihan iha nivel uma kain no mos moras. Exemplu labarik nebe hetan hahan sufisiente maibe moras bebeik finalidade sei hetan malnutrisaun nunemos labarik sira nebe la hetan hahan sufisiente maka sira nia resistensia isin sei fraku no fasil atu hetan moras, maka halo ema labele buras ( kresimentu no dezenvolvimentu fizika mental).
Kazu indereta maka; Reflekta liu ba moris iha level uma kain: ho faktores sira hanesan: 1.Insufisienti asessu ba hahan uma laran fo impaktu ba konsumu individual iha uma kain no han aihan nebe la adekuadu (kuantidade no kualidade). nebe relasaun ho siguransa alimentar inklui avalailabilidade, asesibilidade no utilizasaun ba pratika fornesimentu no preparasaun aihan nebe nutrivu
2.Koidadu nebe la adekuadu ba pratika koidadus inan ba oan, liu-liu ba maneira fo hahan ba labarik, fo tempu no atensaun no suporta atu labarik sira krese no dezenvolve físika,mental no social ho diak.
3.Asistensia saude no ambiente nebe la adekuadu katak asistensia saude tenki fornese pakote servisu bazika nebe seguru, be’e mos no sanitasaun nebe asesu ba familia hotu . Faktores hirak nebe iha leten ne’e, relasiona ho level edukasaun, koinhesimentu, no hahalok nebe limitadu, wainhira ema nia nivel edukasaun as maka koinhensimentu no hahalok sei diak liu ,nunemos atensaun nebe diak maka ema sei uza asistensia saude ho diak. Kauza Bazika iha level sosiedade: maka rekursus humanus,rekrusus ekonomiku,Strutrura organizasoin,Política no lei,Kultura,envairomentu, Geografika no infrastrutura nebe la seguru.
Atu hasae nutrisaun komunitaria ne laos pasu no solusaun ida deit, maibe koperasaun, komitmentu no esforsu husi difrentes sektores. Atu responde situasaun hira ne’e Governu tenki iha stratejia ida atu hamenus malnutrisaun maka tenki garante ba inan hotu-hotu atu fo susuben inan esklusivu, involvimentu ba aspetu sosial, politika ,ekonomia, ideologia no kultura. Relasiona ho ida ne’e presiza halo aproximasaun programa intergadu ho sektor relevantes nivel nasional no distrital.
Oinsa komitmentu Ministerio da Saude hodi hare resolve situasaun ne’e?
Ministerio da Saude nia komitmentu hodi hasae status nutrisaun iha Timor Leste maka Ministerio da saude iha Direção Naciona Saude Comunitaria no iha Departamentu nutrisaun atu garante programa intervensoins iha komponente de servisu hanesan: Programa Nutrisaun komitaria e edukasaun e promusaun , Programa Siguransa alimentar, Programa Mikronutriente, programa nutrisaun kliniku, monitorizasaun no supervizaun hodi responde intervensaun direta no inderata ida asistensia servisu pakote baziku.
Intervensaun saida maka Departamentu Nutrisaun Implementa hodi asegura situasaun ne’e?
Intervensaun nebe Ministerio halo halao bazeia ba situasaun aktual nebe iha rai laran, Ministerio da saude fornese intervensaun bazeia ba servisu pakote basiku iha koidadus primerio. Asistensia nutrisaun fornese tratamentu no preventiva bazeia ba sikus moris hahu husi adolsentes to tinan lima mai kraik. Tipu de intervensoin nebe halao maka hanesan:
· Halao prevensaun: promove promusaun kona ba susuben inan ho optimu, komplementaria hahan nebe apropriadu liu husi( pratika fo hahan ba labarik kiik nebe optimu/ Infant young Child Feeding (IYCF), halo edukasaun nutrisaun liu husi SISCa, suplementu vitamina A feru folate ba inan gravida sira no suplementaria hahan ba inan grafidas, laktantes no labarik sira hotu nebe iha idade fulan 6 to fulan 59. nebe asistensia hirak fornese iha SISCa, Postu Postu Sanitario, Centru da Saude Komunitaria, Hospitais de Referensia no Nasional
· Halo tratamentu: iha programa Jestaun Malnutrisaun Aguda iha Komunidade (JMAK) nebe responde ba tratamentu interna, tratamentu extrena, suplementaria hahan ba labarik malnutrisaun moderadu
· Mobilizasaun komunidade; atu hasae asistensia servisu saude no nutrisaun maka persiza informasaun ba intervensaun nebe iha ba se no iha nebe atu hetan asistensia nebe diak, hodi haburas partisipasaun komunidade, identifikasaun sedu liu-liu ba labarik ho inan sira nebe ho kondisaun malnutrisaun, hasae kobertura programa no garante ba komunidade katak iha asistensia saude
· Reforsa streategia ba muda hahalok ba moris saude no nutrisaun saudavel liu husi edukasaun formal no non formal, hametin vijilansia nutrisaun hodi asegura intervensaun nutrisaun ba doensa kontajiozas no nao kontajiozas.
Hametin kordenasaun no servisu intergradu ho sektores revelantes hodi asegura no grante asistensia programa nutrisaun (Dirce Maria Soares Araujo, SKM) # MS01#
Malnutrisaun hanesan problema publiku nebe kompleksu teb-tebes nebe fo kontribuisaun ba morbidade no mortalidade ba saude ema hotu-hotu nian, liu-liu ba labarik no inan sira. Malnutrisaun fo impaktu kresimentu, dezenvolvimentu fiziku, mental no kualidade rekursus humanus nian. Atu resolve ne’e laos deit aproximasaun husi asistensia saude nian deit, maibe problema malnutrisaun mosu tanba problema multifaktor, tamba ne’e presiza aproximasaun ida nebe invole sertores relevantes hotu-hotu.
Bazeia ba peskiza no Estudu Demografia Saude nebe halao iha Timor Leste, hatudu katak malnutrisaun sei as nafatin, ida ne’e ita bele hare katak, sempre ida husi labarik nain rua iha Timor leste maka sofre husi malnutrisaun kroniku, nebe hare husi sira nia altura no idade , maka resulta ba rakitiku /raes /badak (stunting), mais ke sira ne’e, ita hare hanesan normal, sempre iha mos ida husi labarik nain nen maka krekas los (wasting ) no mos sempre hat husi nain sanulu maka todan menus.
Problema nutrisaun sempre iha relasaun ho problema insufisienti aihan, nia intervensaun laos tenki atu hasae deit produsaun no fornesimentu aihan, maibe presiza konsidera no hare mos ba problemas sira hanesan situasaun krize ( iha bailoro raimaran, dezastre naturais, konflitu sosilial , politiku, no krize ekonomiku ect), maibe problema nutrisaun mosu tamba insiguransa alimentar iha nivel uma kain, ida nebe fo impaktu ba uma kain atu asesu aihan ba membru hotu nebe hela iha uma kain ida. Hare ba ida ne’e, maka atu hasae status nutrisaun komunidade nian, presiza stratejia ida atu asegura komunidade bele asesu ba aihan ho adekuadu no mos husi nia kuantidade no kualidad nebe diak. Iha kontestu ida ne’e, ita bele dehan katak problema nutrisuan talves laos deit problema saude, maibe mos problema mukit hamosu hamala, atetude no portunidade atu hetan servisu.
Saida maka sai hanesan problema ?
Problema nutrisaun iha Timor-Leste no mos nasaun dezenvolvidu sira, em geral sei dominasi ho problema defisiensia ba makronutrienti maka rezulta ba Kuran Energia Proteina, nebe hamosu malnutrisaun ho tipu hanesan krekas aguda, badak, no todan menus, no mos defisiensia ba mikronutriente maka resulta ba defisiensia vitamina no mineral hanesan anemia ferru, kakorok bot, (defisinesia Iodo)defisiensia A , ect.
Saida maka sai hanesan kazu malnutrisaun iha Timor Leste?
Malnutrisaun hanesan resultadu ida husi faktores oi-oin nebe nia impaktu resulta ba status nutrisaun no mos fo kontribuisaun ba mortalidade no morbidade, liu ba saude maternu infantil. Nutrisaun menus mosu husi kauza multiplikadu. Hahan importante ba ema nia moris hanesan nesesidades bazika esencial. Availabilidade aihan laos deit faktor nebe fo influensa ba status nutrisional ema ida nian, maibe iha mos faktores seluk nebe influensia ba status nutrisional
Kazu imidiata nebe afeta deretamente mosu malnutrisaun maka inadekuadu aihan iha nivel uma kain no mos moras. Exemplu labarik nebe hetan hahan sufisiente maibe moras bebeik finalidade sei hetan malnutrisaun nunemos labarik sira nebe la hetan hahan sufisiente maka sira nia resistensia isin sei fraku no fasil atu hetan moras, maka halo ema labele buras ( kresimentu no dezenvolvimentu fizika mental).
Kazu indereta maka; Reflekta liu ba moris iha level uma kain: ho faktores sira hanesan: 1.Insufisienti asessu ba hahan uma laran fo impaktu ba konsumu individual iha uma kain no han aihan nebe la adekuadu (kuantidade no kualidade). nebe relasaun ho siguransa alimentar inklui avalailabilidade, asesibilidade no utilizasaun ba pratika fornesimentu no preparasaun aihan nebe nutrivu
2.Koidadu nebe la adekuadu ba pratika koidadus inan ba oan, liu-liu ba maneira fo hahan ba labarik, fo tempu no atensaun no suporta atu labarik sira krese no dezenvolve físika,mental no social ho diak.
3.Asistensia saude no ambiente nebe la adekuadu katak asistensia saude tenki fornese pakote servisu bazika nebe seguru, be’e mos no sanitasaun nebe asesu ba familia hotu . Faktores hirak nebe iha leten ne’e, relasiona ho level edukasaun, koinhesimentu, no hahalok nebe limitadu, wainhira ema nia nivel edukasaun as maka koinhensimentu no hahalok sei diak liu ,nunemos atensaun nebe diak maka ema sei uza asistensia saude ho diak. Kauza Bazika iha level sosiedade: maka rekursus humanus,rekrusus ekonomiku,Strutrura organizasoin,Política no lei,Kultura,envairomentu, Geografika no infrastrutura nebe la seguru.
Atu hasae nutrisaun komunitaria ne laos pasu no solusaun ida deit, maibe koperasaun, komitmentu no esforsu husi difrentes sektores. Atu responde situasaun hira ne’e Governu tenki iha stratejia ida atu hamenus malnutrisaun maka tenki garante ba inan hotu-hotu atu fo susuben inan esklusivu, involvimentu ba aspetu sosial, politika ,ekonomia, ideologia no kultura. Relasiona ho ida ne’e presiza halo aproximasaun programa intergadu ho sektor relevantes nivel nasional no distrital.
Oinsa komitmentu Ministerio da Saude hodi hare resolve situasaun ne’e?
Ministerio da Saude nia komitmentu hodi hasae status nutrisaun iha Timor Leste maka Ministerio da saude iha Direção Naciona Saude Comunitaria no iha Departamentu nutrisaun atu garante programa intervensoins iha komponente de servisu hanesan: Programa Nutrisaun komitaria e edukasaun e promusaun , Programa Siguransa alimentar, Programa Mikronutriente, programa nutrisaun kliniku, monitorizasaun no supervizaun hodi responde intervensaun direta no inderata ida asistensia servisu pakote baziku.
Intervensaun saida maka Departamentu Nutrisaun Implementa hodi asegura situasaun ne’e?
Intervensaun nebe Ministerio halo halao bazeia ba situasaun aktual nebe iha rai laran, Ministerio da saude fornese intervensaun bazeia ba servisu pakote basiku iha koidadus primerio. Asistensia nutrisaun fornese tratamentu no preventiva bazeia ba sikus moris hahu husi adolsentes to tinan lima mai kraik. Tipu de intervensoin nebe halao maka hanesan:
· Halao prevensaun: promove promusaun kona ba susuben inan ho optimu, komplementaria hahan nebe apropriadu liu husi( pratika fo hahan ba labarik kiik nebe optimu/ Infant young Child Feeding (IYCF), halo edukasaun nutrisaun liu husi SISCa, suplementu vitamina A feru folate ba inan gravida sira no suplementaria hahan ba inan grafidas, laktantes no labarik sira hotu nebe iha idade fulan 6 to fulan 59. nebe asistensia hirak fornese iha SISCa, Postu Postu Sanitario, Centru da Saude Komunitaria, Hospitais de Referensia no Nasional
· Halo tratamentu: iha programa Jestaun Malnutrisaun Aguda iha Komunidade (JMAK) nebe responde ba tratamentu interna, tratamentu extrena, suplementaria hahan ba labarik malnutrisaun moderadu
· Mobilizasaun komunidade; atu hasae asistensia servisu saude no nutrisaun maka persiza informasaun ba intervensaun nebe iha ba se no iha nebe atu hetan asistensia nebe diak, hodi haburas partisipasaun komunidade, identifikasaun sedu liu-liu ba labarik ho inan sira nebe ho kondisaun malnutrisaun, hasae kobertura programa no garante ba komunidade katak iha asistensia saude
· Reforsa streategia ba muda hahalok ba moris saude no nutrisaun saudavel liu husi edukasaun formal no non formal, hametin vijilansia nutrisaun hodi asegura intervensaun nutrisaun ba doensa kontajiozas no nao kontajiozas.
Hametin kordenasaun no servisu intergradu ho sektores revelantes hodi asegura no grante asistensia programa nutrisaun (Dirce Maria Soares Araujo, SKM) # MS01#
Sunday, January 09, 2011
East Timor: Rains threaten food shortage and disease
By Janet Gunter
This year East Timor has not experienced a normal dry season. Much of the country has had rain all year, apparently a result of La Nia (related to the El Nio weather phenomenon). The capital Dili has repeatedly flash flooded. Local news outlets have reported both crops destroyed by rains, and even more worryingly that farmers have not planted this year in many places, as they are not used to preparing fields in the rain.
East Timor at the best of times is a net food importer, not able to produce surpluses to support city dwellers, and with a hungry season between crops. But this year, the situation is quite dire.
Mercy Corps aid worker Jim Jarvie explains
Normally, families prepare for up to two months of limited food in January and February between harvests, but this year the exceptional weather has meant they have already been suffering from lack of food for several months, with the next harvest still four months away if they are lucky. []
To exacerbate the problem, the roads that link these vulnerable communities with the capital city, Dili, are crumbling down the steep slopes as excessive water slides the roads. sometimes down hundreds of feet, into gullies. There is little to no support for these weakening families in increasing isolation. And they have little voice.
Blogger The Dili Insider provides a simple photographic reminder that for the past years in this season, East Timor has found itself in this situation, waiting for ships with imported rice to arrive.
Since 2006, the government has been importing and subsidizing rice. In previous years, there have been scandals related to these rice contracts (see Global Voices' 2009 coverage of The Ricegate scandal). It is not clear how much of the imported rice has ever reached these isolated rural communities with food deficits - most appears to have gone to town and city dwellers.
And given the serious situation facing Timorese farmers, the issue of food imports and access to imported food has taken center stage once again.
Opposition blogger Tatoli continues to criticize the ruling coalition [Tet] on its rice importation policy:
Maib foos mak tama iha Timor-Leste tonelada ba tonelada ms Povu Timor-Leste barak mak la hetan foos ne'e nia oin. Povu Timor-Leste kiak tiha ona, foos ms folin karun tan fila fali, enkuantu Sr. Germano da Silva Lobato (ministra Lucia Lobato nia la'en) sa'e karreta Hummer b-mai hodi soe rai-rahun ba Povu ki'ik-kiak.
But the rice that comes to Timor, ton after ton, many Timorese people never even see it. The Timorese people are already poor, the rice prices go up again, while Mr. Germano da Silva Lobato [Minister of Justice Lucia Lobato's husband who got rice importation contracts] goes around in a Hummer kicking up dust all over the meek, poor people.
Economist blogger Professor Almeida Serra believes that inflation in recent months is linked to the availability of subsidized, imported rice. He wrote in late October [pt]
Para a subida da taxa de inflao ter contribudo, nomeadamente, o quase desaparecimento do mercado do arroz do MTCI, subsidiado, sendo substituido por arroz importado comercialmente. Por exemplo, a taxa homloga de inflao dos cereais, razes e seus produtos onde se inclui o arroz e que representa 13,1% do cabaz do IPC foi, nos meses de Junho a Setembro, respectivamente de 14,1%, 16%, 11,1% e 11,3%.
The near disappearance from the market of the subsidized MTCI [Ministry of the Tourism, Commerce and Industry] rice, substituted by commercially imported rice, has contributed to increased inflation. For example, the rate of inflation for cereals, tubers and their products - where rice is counted, representing a 13.1% of the basic needs basket - was from the months of June to September respectively 14.1%, 16%, 11.1% e 11.3%
Bloggers report changes in the government's approach to rice. Lita at Notisia Negosio (Business News) writes [Tet]
Iha fulan Outubru 2010 MTCI sei hamenus intervensaun foos iha merkado, tamba fo hikas ona knar ba empresarios sira hodi nunee MTCI sei hare deit ba assuntos emergencia no sei atende deit iha fatin nebee deficil acesso ba mercado ( areas remotas ou rurais)
In the month of October the Ministry of the Tourism, Commerce and Industry [MTCI] will reduce its intervention in the rice market, because it has given this back to businesspeople so that the MTCI can focus on emergency matters and attend to those who live in places with poor access to markets (remote and rural areas).
One thing is clear: there will be little margin of error in food supply in East Timor over the coming months.
Mosquito-borne illness
Another potential impact of the rain is an increase in diseases transmitted by mosquitoes like malaria and dengue. The local media reported an upsurge in children being hospitalized in the month of October[Tet], with both patients and hospital officials citing the unceasing rains as a possible factor.
The World Health Organization's regional tracking of dengue revealed that as of September in East Timor, more than two times as many cases had been reported than in all of the previous year. Their briefing states:
The exact reason for the apparent upsurge in reported cases in different countries is not completely clear, but weather patterns, especially relative increases in rainfall are very likely to be an important feature.
The Timorese Ministry of Health has set up a team called Kondemal to look at the extraordinary prevalence [of disease] or outbreaks that can happen in the rainy season. The Ministry announces on its blog [Tet]
Ekipa Kondemal sei foti asaun seriu ba kazu extraordinaria nebe mosu iha tenpu udan. Liu husi servisu konjunta entre Ministeriu Sade liu husi Sade Distrito, Ho autoridades local hodi hatun no halakon moras nee liu husi atendementu hanesan Fogin (Rega susuk), Abatisasi no intervensaun seluk mak hanesan liu husi atendementu SISCA neeb hatoo husi Meja 4.
The Kondemal team will take serious measures against extraordinary cases that arise in the rainy season, through joint work between the central Ministry of Health and District Health institutions, with local authorities to reduce and get rid of these diseases through services like fumigation, abatisasi [use of abate powder in stagnant water], and other interventions like those treatment through the SISCA [mobile health clinics].
Robin Taudevin's 2006 photos of malaria and dengue patients at Bairro Pite Clinic are a dramatic reminder of what an impact these diseases have, particularly on children.
This year East Timor has not experienced a normal dry season. Much of the country has had rain all year, apparently a result of La Nia (related to the El Nio weather phenomenon). The capital Dili has repeatedly flash flooded. Local news outlets have reported both crops destroyed by rains, and even more worryingly that farmers have not planted this year in many places, as they are not used to preparing fields in the rain.
East Timor at the best of times is a net food importer, not able to produce surpluses to support city dwellers, and with a hungry season between crops. But this year, the situation is quite dire.
Mercy Corps aid worker Jim Jarvie explains
Normally, families prepare for up to two months of limited food in January and February between harvests, but this year the exceptional weather has meant they have already been suffering from lack of food for several months, with the next harvest still four months away if they are lucky. []
To exacerbate the problem, the roads that link these vulnerable communities with the capital city, Dili, are crumbling down the steep slopes as excessive water slides the roads. sometimes down hundreds of feet, into gullies. There is little to no support for these weakening families in increasing isolation. And they have little voice.
Blogger The Dili Insider provides a simple photographic reminder that for the past years in this season, East Timor has found itself in this situation, waiting for ships with imported rice to arrive.
Since 2006, the government has been importing and subsidizing rice. In previous years, there have been scandals related to these rice contracts (see Global Voices' 2009 coverage of The Ricegate scandal). It is not clear how much of the imported rice has ever reached these isolated rural communities with food deficits - most appears to have gone to town and city dwellers.
And given the serious situation facing Timorese farmers, the issue of food imports and access to imported food has taken center stage once again.
Opposition blogger Tatoli continues to criticize the ruling coalition [Tet] on its rice importation policy:
Maib foos mak tama iha Timor-Leste tonelada ba tonelada ms Povu Timor-Leste barak mak la hetan foos ne'e nia oin. Povu Timor-Leste kiak tiha ona, foos ms folin karun tan fila fali, enkuantu Sr. Germano da Silva Lobato (ministra Lucia Lobato nia la'en) sa'e karreta Hummer b-mai hodi soe rai-rahun ba Povu ki'ik-kiak.
But the rice that comes to Timor, ton after ton, many Timorese people never even see it. The Timorese people are already poor, the rice prices go up again, while Mr. Germano da Silva Lobato [Minister of Justice Lucia Lobato's husband who got rice importation contracts] goes around in a Hummer kicking up dust all over the meek, poor people.
Economist blogger Professor Almeida Serra believes that inflation in recent months is linked to the availability of subsidized, imported rice. He wrote in late October [pt]
Para a subida da taxa de inflao ter contribudo, nomeadamente, o quase desaparecimento do mercado do arroz do MTCI, subsidiado, sendo substituido por arroz importado comercialmente. Por exemplo, a taxa homloga de inflao dos cereais, razes e seus produtos onde se inclui o arroz e que representa 13,1% do cabaz do IPC foi, nos meses de Junho a Setembro, respectivamente de 14,1%, 16%, 11,1% e 11,3%.
The near disappearance from the market of the subsidized MTCI [Ministry of the Tourism, Commerce and Industry] rice, substituted by commercially imported rice, has contributed to increased inflation. For example, the rate of inflation for cereals, tubers and their products - where rice is counted, representing a 13.1% of the basic needs basket - was from the months of June to September respectively 14.1%, 16%, 11.1% e 11.3%
Bloggers report changes in the government's approach to rice. Lita at Notisia Negosio (Business News) writes [Tet]
Iha fulan Outubru 2010 MTCI sei hamenus intervensaun foos iha merkado, tamba fo hikas ona knar ba empresarios sira hodi nunee MTCI sei hare deit ba assuntos emergencia no sei atende deit iha fatin nebee deficil acesso ba mercado ( areas remotas ou rurais)
In the month of October the Ministry of the Tourism, Commerce and Industry [MTCI] will reduce its intervention in the rice market, because it has given this back to businesspeople so that the MTCI can focus on emergency matters and attend to those who live in places with poor access to markets (remote and rural areas).
One thing is clear: there will be little margin of error in food supply in East Timor over the coming months.
Mosquito-borne illness
Another potential impact of the rain is an increase in diseases transmitted by mosquitoes like malaria and dengue. The local media reported an upsurge in children being hospitalized in the month of October[Tet], with both patients and hospital officials citing the unceasing rains as a possible factor.
The World Health Organization's regional tracking of dengue revealed that as of September in East Timor, more than two times as many cases had been reported than in all of the previous year. Their briefing states:
The exact reason for the apparent upsurge in reported cases in different countries is not completely clear, but weather patterns, especially relative increases in rainfall are very likely to be an important feature.
The Timorese Ministry of Health has set up a team called Kondemal to look at the extraordinary prevalence [of disease] or outbreaks that can happen in the rainy season. The Ministry announces on its blog [Tet]
Ekipa Kondemal sei foti asaun seriu ba kazu extraordinaria nebe mosu iha tenpu udan. Liu husi servisu konjunta entre Ministeriu Sade liu husi Sade Distrito, Ho autoridades local hodi hatun no halakon moras nee liu husi atendementu hanesan Fogin (Rega susuk), Abatisasi no intervensaun seluk mak hanesan liu husi atendementu SISCA neeb hatoo husi Meja 4.
The Kondemal team will take serious measures against extraordinary cases that arise in the rainy season, through joint work between the central Ministry of Health and District Health institutions, with local authorities to reduce and get rid of these diseases through services like fumigation, abatisasi [use of abate powder in stagnant water], and other interventions like those treatment through the SISCA [mobile health clinics].
Robin Taudevin's 2006 photos of malaria and dengue patients at Bairro Pite Clinic are a dramatic reminder of what an impact these diseases have, particularly on children.
Wednesday, January 05, 2011
National Drugs and Medicines Policy
REPÚBLICA DEMOCRÁTICA DE TIMOR LESTE
MINISTÉRIO DA SAÚDE
Ministry of Health
Table of Contents
Introduction 4
Goals set in the National Drug- and Medicine Policy 9
Objectives 10
Priority areas to be strengthened, as defined by the Policy. 13
Specific objective
1. Updated Law and Regulations 15
2. Medicine / Drug Registration 16
3. Importer, Wholesaler, Pharmacy Licenses 17
4. Standards, Monitoring and Supervision 18
5. Control of pharmaceutical advertisement 18
6. Post-marketing surveillance. 19
7. Antibiotic resistance 19
8. Safe Prescribing Practices. 19
9. Access To Medicines 20
10. Selection of Medicines 20
11. Essential Medicines 21
12. Generic Medicine (Multisource products) 21
13. Procurement of medicines. 21
14. Distribution of medicines 22
15. Stakeholder involvement 23
16. Quality Assurance and Quality Control 23
17. Rational and Safe Use of Medicines 24
18. Drug and Medicine Information 26
19. Human Resources Development 27
20. Calculation of drug quantity needs 28
21. Production of medicines 29
22. Research 29
23. Control of Traditional Medicine 31
24. Monitoring and Evaluation 32
25. Regional / International Collaboration 32
26. Policy Implementation, Enforcement 34
Definitions 34
Introduction
The National Drug Policy (synonyms also used; National Medicine, or; National Pharmaceutical policy for Timor Leste) deals with the development, provision and use of medicines within both the public and the private sector. The overarching goal is to secure safety and protect the individual patient and the public. The National Drugs and Medicines pharmaceuticals Policy aims to contribute to improved health and wellbeing of all people in Timor Leste.
This National Medicine Policy document aims for uninterrupted supply of safe, effective and good quality Essential Medicines, and promoting the rational and safe use of medicines both in public and private sectors throughout the country. For the National Medicine Policy to have impact, it must be owned by all stake holders and implemented through updated legislation and regulations, through a National Drug Administration as central Authority in line with WHO recommendations.
The National Drug Policy embraces all aspects of supply, quality, use and management of pharmaceuticals/medicines/drugs. The Policy addresses all drugs, both branded and generic, as well as biological products derived from living sources such as blood, blood products and vaccines as well as medicines of chemical composition, and products which are classified as so called traditional medicines or traditional health products.
A Drug, a Pharmaceutical or Medicine/Medicinal product is defined by its intended use, if it is intended for diagnostic, preventive, curative or palliative care for human use. Also products used for diagnostic, preventive of curative use in animals are classified as medicines.
This is addressed by development of legislative norms and acts, action plans, guidelines and programs that improves the health status of the people and prevents and reduce drug-related harm. This is achieved through optimal availability and use of essential pharmaceuticals in prevention, diagnosis and treatment of illness and disease. An important objective is to strive towards equity and efficiency in access to medicines of reliable quality for all citizens and/or visiting people in country, regardless of social vulnerability, poverty or any form of social marginalization.
The Pharmaceutical policy thus promotes both efficiency and efficacy of healthcare service delivery.
The National Drug Policy recognizes that medicines constitute an integral and vital part of healthcare, in diagnosis, prevention, curative treatment, palliative care and control of disease.
Medicines are defined in the Law of Timor Leste, in line with international praxis; A Medicine or Pharmaceutical product is any product or substance(s) which is used for the purpose to prevent, diagnose or treat conditions and diseases in humans. The same definition also applies, when products are used with the purpose to prevent, diagnose and/or treat conditions in animals.
All medicines fall under the requirement of formal requirement of registration approval, before they can be allowed to be imported or allowed to be sold or used in Timor Leste. The objective with this requirement is to protect the population from harm, and to secure that only medicines with reliable quality are made available in Timor Leste.
Timor Leste is therefore updating and implementing a new Law for the Pharmaceutical sector. This new Law also includes rules for the storage, prescribing, dispensing and use of medicines in all sectors of medical practice, private and public, and this Law also defines clear requirements for import, export, production, stock holding, wholesale and retail, prescribing, use and handling of all medicines (Synonyme terminology also used, Drugs, Pharmaceuticals or Medicinal products).
The Government is committed to a vision of ensuring safe, effective, reliable quality, essential medicines to be available at affordable cost at all times to the entire population of Timor Leste. This commitment is emphasized in this Drug Policy as amendment to the National Health Policy and Streategy. Moreover access to essential medicines is also formulated in line with the national commitments to reach the Millennium Development Goals.
While assessing challenges and problems, the National Drug Policy also recognizes that many practical factors still hamper availability of medicines at various levels of health care. The situation of limited resources is always present in all national healthcare systems, and Timor Leste is no exception in this regard.
The National Drug Policy therefore recognizes that Priorities must be made in terms of selecting drugs for supply, to meet the most important needs of the healthcare system, solving the most important health problems of the population.
The National Drug Policy therefore promotes the Essential Drugs concept and mechanism, and also promotes Standard Treatment Guidelines. Priority is given to supply of vital Essential drugs, as an important mechanism to reach key Goals of the National Drug Policy.
An important goal in the National Drug Policy is therefore also, to build good public sector including work with defining needs specifications for supply of Essential Drugs for hospitals and primary care.
The National Drug Policy also require Goverment Licinsing to private and public sector healthcareproviders and institutions, before they are allowed to deliver healthcare services and/or to import, sale, distribute or prescribe and dispense Medeicines and Pharmaceuticals.
The benefit to a private sector in healthcare and pharmaceutical service delivery has been establised. However the establishment of private pharmacies and private clinics has not yet been matched with adequate regulatory control. The National Drug Policy therefore addresses this gap. The new Drug Policy and new Drug Law is aiming to address the needs to control both the public and the private sector, with the overarching aim to safeguard peoples health.
Legal and regulatory demands are defined with the aim to protect the people against the risk of unsafe and poor quality medicines and pharmaceutical products, a risk which has been reported to occur in many other countries World-wide and in the region.
New clear standards, guidelines and technical regulations are launched, to set requirements for registration of medicines, setting requirements for Good Pharmaceutical Practices, Good Distribution Practices, Good in-hospital Pharmaceutical Management, and Good Pharmaceutical Management in Primary Care.
The National Drug Policy therefore launch new standards, guidelines and technical regulations for the control of the private and public sectors alike, as defined in a new Pharmaceutical Law.
Specific new guidelines are defined to ensure compliance with retail only of medicines registered and approved by the National Drug Regulatory Authority, and to ensure that unsafe sale of medicines without prescription is reduced. Professional performance benchmarks are also launched for both private and public pharmacy practice, including to ensure necessary education and information to patients, always ensuring that patients are well informed about dosages and how to safely use the prescribed medicines.
The new Pharmacy Law also set clear regulatory requirements about the importation of medicines.
The legal requirements connect closely to the WHO Certification scheme to combat and prevent unsafe, counterfeit and substandard quality drugs from being imported into Timor Leste.
The Drug Policy and legislation recognizes that the present number of qualified pharmaceutical personnel, both in the public and private sector is inadequate. This shortage must be met to develop pharmaceutical services.
The National Drug Policy recognizes that there is a need to strengthen the quality assurance and quality control mechanisms for medicines.
This entails both in-country adherence to Good Distribution Practices, Good Pharmacy Practices and requirements in regard to procurement and importation. Formal requirements are therefore set in the Law for Quality Assurance and Quality Control during procurement and importation of medicines, only allowing medicines produced under certified Good Manufacturing Practice (GMP) and controlled under the umbrella of WHO Certification scheme. The Quality assurance requirement also addresses the need to set-up collaboration with an internationally certified drug quality control laboratory for quality-testing of samples taken during inspections of Pharmacies in Timor Leste.
The National Drug Policy is clearly stating the objective to promote the essential medicine concept and promote adherence to standard treatment guidelines to guide rational and safe clinical drug use in Timor Leste. The National Drug Policy recognizes that a Code of Quality of Care is needed along with establishment of hospital Therapy committees, to promote adherence to rational use of drugs, as well as to establish safe prescribing and safe medicine dispensing practices.
The Government of Timor Leste has established a national wholesaler, the “SAMES” as a centralized procurement, wholesale and supply system. The Public Health objectives for the operation of the SAMES need to be further defined, with clearly objectives, goals Guidelines and Standard Operating Procedures.
This is essential both to optimize public health protection and to economize and minimize cost expenditure on medicines and thereby ensuring availability and supply of medicines to all levels of health care in a predictable manner. A well functioning mechanism for quantification of drug quantity requirements shall be established, based on patient case load and case mix statistics, and based on Standard treatment guidelines, to present a reliable estimate of needs as base for budget planning and allocation of adequate financial resources for drug procurement and supply.
In order to fill the gaps between needs and current practice, there is an urgent need to establish a National Drug Regulatory Authority in Timor Leste, matching WHO recommendations many policies and functions which need to be established at national level.
The organization, authority and responsibilities and organization set-up of the National Drug Regulatory Authority (National Drug Administration) is outlined in the updated Drug Law.
Goals set in the National Drug- and Medicine Policy
Three main Goals are defined in the Policy;
(i) To ensure that all medicines which are imported or locally manufactured, distributed, sold and used in the Timor Leste are effective, safe and of good reliable quality. This objective shall be ensured through the effective function and operation of a National Drug Regulatory system, spearheaded by the key institution, the National Drug Regulatory Authority (synonymous terms: National Drug Administration, currently the Pharmacy department of the Ministry of Health).
(ii) To ensure that adequate quantities of quality Essential Medicines are determined correctly, based on the needs of the population and based on the patient case load and case mix in primary care and hospitals. Needed essential drugs shall be made available at affordable costs at all times, to meet the need of the entire population, and especially protecting the needs of the most poor and vulnerable.
(iii) To promote rational, safe and cost-effective use of medicines: The use of medicines shall be guided and controlled, both to reduce risk for harm, and to optimize the curative effect of used medicines, while also reducing cost, thereby optimizing the ability to reach and cover the whole population with effective and safe treatment, within available budget frame. Key mechanisms shall be established, including active implementation of standard treatment guidelines, in-hospital therapeutic committees, active provision of consumer independent drug-information and activities to raise awareness and prevent avoidable adverse and side effects of drugs.
Objectives
In order to achieve set Goals and to reduce and solve problems in the pharmaceutical sector, the following objectives are set:
To ensure reliable supply of essential drugs of good and reliable quality and quantity
To ensure rational selection, procurement, and storage and distribution of medicines according to procedures to maintain quality, in both public and private sectors to ensure availability of Essential Medicines throughout the country.
To establish key functions and services of a National Drug Administration (National Drug Regulatory Authority), and within this institution establish key functions, including a well functioning medicine registration system, and a system for Licensing and Pharmaceutical Market surveillance and control.
To establish a range of quality assurance mechanisms including efficient inspection system, with which to monitor wholesalers, retail pharmacies and other distribution outlets including public and private hospitals and clinics with pharmacies throughout the country. This quality assurance system shall both function as a regulatory control and enforcement mechanism, to ensure complicance with laws and regulations, and; provide supportive services to strengthen Good Pharmacy Practices in private and public sector pharmaceutical sector operators alike.
To optimize the curative and preventive result of drug treatment by promotiong rational and safe use of drugs, and reduce the risk for harm caused by unsafe and irrational drug-use; Healthcare professionals shall be provided with updated standard treatment guidelines matching the reality in Timor Leste, and matching in-service supervvision and training. A drug-use audit and survey sustem ahall be established along with the establishment and set-up of Drug and Therapy Committees in all hospitals.
To promote safe prescribing and safe procedures in dispensing, thereby preventing medication mistakes and errors.
To strengthen the prescribing and monitoring of narcotic and psychotropic drugs and substances, while also promoting the needed availability and appropriate and rational use of pain control and mental health drugs for all patients in need.
To establish a national repository depot of key antidotes and emergency drugs, and a poisoning information service.
To Establish mechanisms for adverticing control and provision of producer-independent drug information to prescribers and pharmacists in Timor Leste.
To establish a consensus and participatory mechanism and organization for revision, development and implementation of standard treatment guidelines, matching evidence based medicine and matching the reality situation in Timor Leste.
For Special pharmaceutical products, blood, serum, vaccines, special requirements shall be defined and implemented for quality and safety, especially for blood-products, any products containing biological materials and especially materials from human origin, vaccines and other biological products to esure safety from perspective of viral and bacterial contamination.
To develop and strengthen adequate technical, human resources in the field of pharmacy and medicine management by appropriate training and continuing education,
To establish a prospective planning and budgeting mechanism, with which to allocate adequate resources, especially for implementing and monitoring the National Medicines Policy, print and disseminate Standard Treatment Guidelines, Essential Drug Lists and the updated Pharmacy Law, to be available widely in all facilities and institutions.
To establish a prospective planning and budgeting mechanism, with which to calculate needed budget resources for the procurement of drugs, matching the patient case-mix and case-load in hospitals and primary care of the public health system in Timor Leste.
To establish twinning and exchange with other National Drug Regulatory Authorities / Drug Administrations in the ASEAN region and in wider International cooperation with international and regional agencies, in areas such as training of staff, exchange of information and exchange of technical methods.
To establish a partnership between the government of Timor Leste and its National Drug Administrationm and the private providers in the pharmaceutical sector.
To establish collaboration with the Ministry of Agriculture, regarding the regulatory issues pertaining to veterinary drugs.
Priority areas to be strengthened, as defined by the Policy.
The National Drug Policy aim gives priority to key outputs and aim to strengthen the following areas:
Set-up and establish a National Drug Administration (synonym terminology: National Drug Regulatory Authority), in line with WHO recommendations for National Drug Regulatory Authorities in small countries with limited resources. Including key functions such as Drug registration, market regulation, surveillance and control, and control of drug use in all segments of healthcare, public and private.
Updating of Laws, Legislation and Regulations for the Pharmaceutical sector and for the control of prescribing and use of medicines in all sectors of healthcare, both public and private.
Implementation of Regulatory, administrative and quality standards in the Pharmaceutical sector and for handling and use of medicines in all segments of healthcare, public and private.
Establishment of Medicine registration services, as a key function of National Drug Regulatory Authority, with the establishment of a national Drug registration database, and establishment of well-functional drug registration mechanism. This drug registration mechanism shall ensure that only reliable medicines with available documentation about efficacy, available documentation about safe/risk profile and with reliable quality are allowed into Timor Leste.
Pharmaceutical inspection and enforcement services for implementing and ensuring adherence to regulations and procedures in practical pharmacy work, strengthened
Quality assurance and quality control services established, through collaboration with internationally certified QC laboratory and market surveillance.
Supply of essential medicines to all levels of health care.
Medicine and poison information services established
Advertising control mechanisms established
License database for pharmacies and clinics using and storing, prescribing and dispensing medicines, established
Licensing database for all pharmaceutical personnel, and database over all authorized personnel with prescribing rights established
Monitoring and supervision to promote rational use of medicines, by updating and implementation of Standard Treatment Guidelines and Essential Drugs
Antibiotic resistance surveillance and measures to prevent, stop further spread and limit the negative health and cost impact of antibiotic resistance infections.
Supervision of pharmaceutical practices and supervision of safe prescribing and dispensing practices in hospitals, and in clinics, public and private
A comprehensive National Medicine Policy has hereby been formulated addressing a set of listed priorities. National Strategies shall be drawn up, with specific action plans as needed to address each component of the National Drug Policy.
Specific objective
1. Updated Law and Regulations
An updated Law of the Republic of Timor-Leste shall form the legal basis and framework for regulatory control of the pharmaceutical sector, matching set goals, objectives and priorities defined in the National Drug Policy.
The updated Law shall incorporate elements of existing rules and regulations which are in line with this policy. The updated Law shall also harmonize requirements in Timor Leste with international praxis, paving the way for safe trade and safe importation of reliable pharmaceutical products of good quality and ensuring best possible safety for patients and people in Timor Leste.
For enactment of the Law by the relevant bodies, detailed regulations governing standards and key procedures shall be defined in Guidleines to carry out the provisions of the Law. A set of necessary Guidelines, for Good Pharmacy Practice, Good Distribution practice and guidleines for drug management in healthcare facilities and institutions shall therefore be formulated and issued.
The updated Law and updated regulatory framework shall include solutions and norms to enable:
The updated Law shall pave the way for the establishment of a National Drug Administration syn. National Drug Regulatory Authority, in the organization of the Ministry of Health.
Enforcement of the Drug Law, with technical regulations for authority and authority.
The operation of the National Drug Administration as focal point for implementation of the National Drug Policy.
The National Drug Administration support with help of a Advisory body. (hereinafter called Advisory Board)
2. Medicine / Drug Registration
A functional Drug Registration shall be established. Approval by Drug Registration shall be required with definition of approved purpose(s) (indications) for any pharmaceutical, drug or medicine, before any pharmaceutical, drug or medicine can be imported, sold or used in Timor Leste. Only products with adequate and documentation about its efficacy and its safety/risk profile in use for the suggested indication(s) can be approved by registration. Import license and marketing authorization from the Drug Administration shall also be required before any pharmaceutical product (medicine, drug) is allowed on the market in Timor Leste. Regulations for issuing or denying marketing authorizations shall be clearly defined in the updated Pharmacy Law, and shall be based on evaluation of safety, efficacy, quality and medically defined need.
Marketing Authorization shall be valid for a specified period of time as defined in the updated Pharmacy Law. A review shall be required for renewal of all Drug registrations.
A registration fee shall be charged for registration, marketing authorization and for import License for all pharmaceutical products and Medicines and other products as determined by the Ministry of Health.
A database for registration and monitoring imports of pharmaceutical products shall be developed and established.
3. Importer, Wholesaler, Pharmacy Licenses
The Ministry of Trade and Development is responsible for issuing a general trade license for any corporation. Once such a License has been obtained, the corporation must also apply to the Drug Administration of the Ministry of Health for License to operate as medicine importer, wholesaler or as retail pharmacy.
Legislation requirements shall be defined in the updated Pharmacy Law, for all importers, wholesalers, pharmacies and other retail outlets. Basic requirements shall include the demands:
To be Licensed by the National Drug Regulatory Authority in Ministry of Health (syn Drug Administration), and
Before License can be issued, the appying institution or corporation must fulfill a defined set of quality requirementsdefined by the Ministry of Health. These requirements includes both the demant to keep and maintain suitable premises and quality procedures, appropriate storage conditions for medicines to preserve quality in line with Good Distribution Practices. Requirements also include demands for available personnel with pharmaceutical competence, to endure good pharmacy practices.
Licenses shall be issued to all Pharmaceutical personnel, and to all Healthcare personnel with the right to dispense and prescribe. All such personnel shall be licensed by the National Drug Regulatory Authority (Drug Administration).
Data about all personnel with License shall be kept in an annually updated License-database in the National Drug Regulatory Authority (Drug Administration). Updated printed records over licensed prescribers, shall be provided to all pharmacies 2 times per year.
4. Standards, Monitoring and Supervision
It shall be the responsibility of the National Drug Administration to monitor, supervise and enforce that the medicine / pharmaceutical regulatory requirements and quality standards are properly followed by importers, wholesalers and pharmacies during procurement, distribution storage, sale and prescribing and dispensing of all pharmaceuticals in the country.
National Drug Administration will conduct regular Supervision and Monitoring, of stock holding and procedures in all public hospitals and clinics, and in all private pharmacies, whiolesalers and all private clinics with sale and dispensing of medicines.
5. Control of pharmaceutical advertisement
Advertisement and medicine promotion through the mass media shall require prior approval.
The content and distribution of medicine information provided by pharmaceutical companies and/or their representatives to health care professionals and the public shall be subject to monitoring and control and conform to the WHO Ethical criteria for promotion of Medicinal products.
6. post-marketing surveillance.
All marketed medicines shall be under vigilance to ensure constant conformity with the conditions and terms of the marketing authorization and safety
7. Antibiotic resistance
The National Drug Administration shall lead and establish a national surveillance of antibiotic resistance, in collaboration with the National Laboratory. Data from antibiotic resistance surveillance shall be shared with the WHO regional collaboration, and data from surveillance in Timor, and data from the regional collaboration, shall be used to revise national standard treatment guidelines, as well as to design and implement activities to reduce irrational and unsafe prescribing, use and irrational and unsafe sale of antibiotics in Timor Leste.
Every effort shall be made through appropriate regulations, to reduce the further spread of drug resistant infections, including the problem of drug resistant Tuberculosis, drug resistant Malaria and drug resistant infections such as occur in primary care and hospitals in Timor Leste.
8. Safe Prescribing Practices.
Prescribing authority will be limited to registered and licensed health professionals, as defined in annually updated database over licensed personnel. A Database shall be established in the National Drug Administration, annually updating all healthcare personnel who are licensed and authorized to prescribe medicine.
Regulations will define clearly which medicines require prescription and which can be sold without prescription, as Over-the-Counter OTC medicines.
Clear regulations and legal requirements shall be available about which medicines are controlled substances, (Narcotic and psychotropic drugs), with clear instructions and guidelines about prescribing, dispensing and record keeping requirements. National Drug Administration and Ministry of Health Inspectorate will conduct special Monitoring, supervision and audits to all institutions, to control compliance with the specific legal requirements.
In addition, the national Drug Law defined which medicines are Controlled substances, narcotics and psychotropic medicines, for which extra stringent prescribing and recording practices are required.
9. Access To Medicines
A centralized procurement and supply system has been established, the SAMES with the aim to ensure availability and supply of medicines to all levels of health care in a predictable manner. The Public Health objectives of the SAMES system shall be defined in the new Drug Law of Timor Leste.
10. Selection of Medicines
Medicines for procurement and importation shall only be selected from the list of products which have a valid Registration approval and a valid marketing authorization.
Medicines for procurement shall also only be selected from a list of medicines supplied from pre-qualified sources, based on quality performance, based on the WHO Certification scheme, and based on international exchange of information about reliable product supply.
Selection of medicines shall be done by the National Drug Administration, defining Essential Medicines List and through international tender procedures managed by the wholesaler, under control of the regulatory requirements set by the National Drug Administration and national Drug Law.
11. Essential Medicines
A National Essential Medicine List that shall be reviewed annually, to be based on medical needs defined by morbidity, mortality and evidence based medicine and to be used as a guide for procurement and prescribing at all levels of health care.
Adequate stock level of Essential Medicines must be maintained at all levels of health care.
Quantity needed shall be calculated, based on Case-load and case-mix in primary care and hospitals, matching drug selection defined in standard treatment guidelines and matching the Essential drug list.
Provisions shall be made for supply of medicines for exceptional needs, which are not registered or not on the National Essential Medicines List
12. Generic Medicine (Multisource products)
The government encourages import and use of generic medicine nomenclature in all aspects, ensuring multisource products of assured quality and safety.
13. Procurement of medicines.
The National Medicine Policy promotes the purchase of essential medicines through the SAMES governmental wholesaler. The position of SAMES as Governmental Wholesaler, includes Public Health objectives, basing drug procurement on medical priorities, and not only on commercial objectives of meeting high volume requests for “popular medicines”. This means, that the budget allocated to drug procurement by SAMES shall give first priority to essential medicines of vital importance for treating serious and important medical conditions.
A mechanism shall also be provided for procurement of additional medicine supply from private importers.
Under both cases, importation is controlled under the regulations of the National Drug Law and National Drug Administration guidelines.
14. Distribution of medicines
The government will organize sufficient and appropriate logistic facilities to ensure a systematic and reliable distribution. Hereby, adequate supplies of Essential Medicines shall be made available at all times to the all levels of health care, even in remote locations.
District warehouses shall be established, with staff, logistic support resources and warehouse management IT systems in place.
The organization of distribution system and its management shall match the wider healthcare system organization, if per district or per future regional organization.
Supply depots shall be established both at central and district levels, with buffer stock and with task to reduce overstock and stock-out differences between primary care facilities within a district or region.
Hospital and health center pharmacies are required to promote the concept of Essential Medicines and rational and safe prescribing and rational and safe dispensing.
Community participation to set-up and operate pharmacies on self sustainable basis shall be encouraged and supported.
Regulations shall be revised to allow for clinicians and nurse practitioners to dispense in locations with low population.
All parties involved in procurement import, and distribution of medicines of medicines shall follow WHO Certification scheme and WHO based guidelines on good distribution and storage practices and good pharmacy practice procedures.
15. Stakeholder involvement
Activities of all sectors should complement each other and aim towards effective medicines distribution, availability and rational medicine use throughout the country.
Every effort shall be made to minimize wastage of medicines at all levels.
The role of the active players in the pharmaceutical sector in the emergency response and preparedness to national disasters shall be stipulated.
All agencies donating medicines must ensure compliance to WHO Medicine Donation Guidelines and with the national Essential Medicines List and with the National Drug Law.
16. Quality Assurance and Quality Control
Quality assurance of medicines shall be achieved through a comprehensive medicine registration system, testing of marketed medicines, inspection at ports of entry and at points of distribution and retail
As part of the product registration system, the WHO Certification Scheme and Prequalification Scheme shall continue to be adopted as a means of ensuring quality of medicines imported in to the country
Medicines storage facilities and outlets at both public and private institutions shall be inspected regularly.
Regulations and practices shall be put in place to ensure that quality is maintained during transport and handling
The government National Drug Administration will take action and confiscate and destroy any medicines found with unacceptable quality, or any medicine found imported without valid importation license, without valid registration or without valid marketing approval or without valid quality certificate.
17. Rational and Safe Use of Medicines
The National Medicine Policy aims at promoting rational use of medicines in all aspects and areas of prescribing, dispensing, and also in private pharmacy operation and self-medication.
A system for promotion of rational and safe use of drugs will be based on standard treatment guidelines (STGs), developed with a strong base in international best practice, and connected to the reality of currently available resources in Timor Leste.
Standard treatment guidelines define the place in diagnosis, therapy, prevention and palliative care for pharmaceutical products. The STGs will be developed with active involvement of the prescribers who later also shall use the guidelines, building consensus with support from a Clinical Pharmacology Adviser. Development and revision of standard treatment guidelines shall also build up a panel of national reference committees for STG revision in key therapeutic areas.
These committees shall involve both specialists and non-specialist prescribers, and link with drug and therapy committees in district and national referral hospitals.
The standard treatment guidelines will be used as base for assessing drug needs, and also for clinical audits and for training to promote Quality of Care.
Standard treatment guidelines will also be used as base for Continuous Medical Education and Continuous Professional Development. A national system for development and revision of treatment guidelines will be formed with strong national and international collaboration as fundament. In additional to the Standard Treatment Guidelines, Timor Leste will also distribute the WHO Model Formulary, as an objective and producer independent handbook for rational use of drugs for prescribers.
To promote the rational use of medicines at all levels, the government shall:
Provide and up-date the National Essential Medicine List to be used as a guide for procurement, prescribing and dispensing.
Encourage prescribing medicines in their generic (non-proprietary) names.
Update and regularly make available to the prescribers, pharmacists, public, and the pharmaceutical sector the list of marketed medicines.
Develop and revise standard treatment guidelines for primary care and hospital care.
Provide continuing education programs and refresher courses for health care professionals on rational use of medicines, matching standard treatment guidelines.
Develop, implement and monitor adherence to national Standard Treatment Guidelines and Formularies.
Create public awareness on the rational use of medicinal medicines using mass media and other means of communication in local language.
Strengthen prescription monitoring system to improve prescribing habits.
Ensure correct dispensing, labeling and patient counseling procedures.
Ensure disposal of expired and banned medicines environment friendly in accordance with regulations.
18. Drug and Medicine Information
Mechanisms shall be developed to provide current and objective information on medicines for health care professionals and prescribers to promote rational use of medicines.
A medicine and poison information unit shall be established at central level for health professionals and consumers
All medicines approved for importation, sale and use in Timor Leste, must include written information about dosage and risks, written in the language of Tetun, Portuguese, Bahasa or English.
Information dissemination mechanisms shall be developed.
Reliable and producer-independent information about all medicines registered in Timor Leste, shall be made widely available to all prescribers and all pharmacists.
This information shall include information about documented risks, including risk for adverse reactions and side effects, risks associated with use of drugs during pregnancy and breast feeding, and risks associated with pathological conditions such as allergy, or risks due to reduced kidney or liver function of the patients.
Objective information about the correct use and correct dosage shall be available to all prescribers.
A clear system shall be set-up, with database recording import license for all medicines which have been given approval and which have been imported. The database shall include information about each imported batch registration. This shall allow the National Drug Administration to launch recalls in the event that information is made available about substandard quality or any aspect of defective medicine products.
Health care professionals and, the public shall be informed about risks and safety problems that are observed on marketed medicines. Awareness shall be raised especially about the risk of self-medication, specifically targeting unsafe self-medication and irrational sale of antibiotics, aiming to reduce risks for adverse effects as well as to reduce the risks for further spread of antibiotic resistance in Timor Leste.
A procedure for product recall, shall be in place for all marketed products
19. Human Resources Development
For effective implementation of various elements of the National Medicine Policy:
Training of technical, administrative and health care personnel who are required for organizing and operating at different levels of implementing the National Medicine Policy shall be facilitated.
Pharmacists and other professionals needed for inspection, enforcement, and regulatory activities shall be trained.
Pharmacy education shall be up-graded to a diploma level.
Funds and loans shall be allocated for pharmacy education
Regulatory incentives shall be provided to encourage more locals to enter into the pharmacy profession.
More students shall be sent for training abroad in the field of pharmacy, to meet the country's need for pharmacists in the areas of hospital pharmacy, regulatory activities, as well as medicine supply and management.
Pharmaceutical and health care professionals shall be provided regular education and training on Essential Medicines concept, Rational Medicine Use and Management of Supplies.
The National Drug Administration shall establish a collaboration network with pharmaceutical and medical advisers, to assist in setting up and delivering / providing postgraduate and Continuous education for medical and pharmaceutical professionals, promoting rational and safe use of drugs.
20. Calculation of drug quantity needs
The National Drug Administration shall provide estimates of needed drug requirements, based on case-mix and case-load, and based on standard treatment guidleines for major diseases, to be used to calculate adequate annual financial resources to procure and supply availability of essential medicines throughout the country by the public health services.
The National Health Information system shall provide monthly updates to the National Drug Administration, about the case-load and case mix and bed days, for main diseases treated in hospitals and primary care throughout the country.
Reliable drug quantity estimates shall be provided as base to calculate adequate financial resources to procure medicines.
Special funding provisions shall be made for the low-income and especially vulnerable groups of the population who are unable to pay for their treatment.
Special funding provisions must also be made for providing treatment priority diseases and conditions, including Tuberculosis, Malaria, Antenatal care and as defined in amendment to the National Drug Law by annual decree by Ministry of Health. These diseases and conditions shall be decided at national level based on prevalence, mortality and chronic nature.
21. Production of medicines
For domestic production of medicines, standards, technology and personnel required for pharmaceutical production shall confirm to international standards of Good Manufacturing Practice (GMP). ASEAN level GMP is the first required level tier in the quality requirements for medicine GMP.
For non-pharmaceutical “traditional medicines” local standards and best practices shall be developed. ASEAN level GMP is the first tier, in the quality requirements in all production.
22. Research
Human rights of the patients shall always be safeguarded and protected, following WHO – WMA Guidelines and the Helsinki declaration of human rights of the patient.
Research shall be carried out to find practical solutions and solve operational problems such as medicine selection, procurement and distribution. The aim is to enable to achieve the goals and objectives of the National Drug Policy. It will focus particularly on the following areas:
Health systems research to measure the impact of the National Medicines Policy.
Point prevalence prescribing studied, in hospitals and primary care to assess adherence to Essential medicines and standard treatment guidleines at different levels of the health systems.
Medicine stock-out survey and supply utilisation.
Practice survey, on record keeping, record writing, prescribing records and safe dispensing procedures
Social and cultural aspects of medicines use.
Self medication, and attitudes of medicine consumers.
Antibiotic use and assessment of the spread of antibiotic resistance and planning and assessment of impact of interventions to limit and contain antibiotic resistance
Assessment of adverse drug reactions and side effects, aiming to identify how to limit the extent of drug-related harm and iatrogenicity
Surveys shall be conducted to ensure that no research is conducted without compliance to international standards, for human rights of the patient, as defined in the Helsinki declaration and in the WHA Ethical guidelines for clinical research (No clinical research is allowed, without appropriate approval of research ethical committee in Timor Leste and in the country of origin of the donor, in line with provisions of the WMA and Helsinki declaration)
23. Control of Traditional Medicine
For all Traditional medicine, the Government shall:
Develop clear regulations within the frame of an updated Drug Law.
Standardization and quality control requirements shall be enforced for all components, products and raw materials.
Any traditional medicines sold, with claimed therapeutic, diagnostic or preventive effect, is breaking the ruules, since it then in fact meets the definitions of a Medicine or Pharmaceutical product.
It can therefore only be allowed if it is evaluated and given a full registration approval as Medicine / Pharmaceutical product.
As an example; Consequently, herbals claiming effect against Malaria can not be allowed as traditional medicine. Such products, claiming a therapeutic effect defines the product as a medicine.
As stated, all medicines must undergo a full registration assessment before they can be issued or rejected approval. Only medicines which get registration apprpval can be allowed to be imported and to be allowed to be prescribed, used and sold in Timor Leste.
A key requirement is, that a pharmaceutical product (medicine, drug) can only be approved for registration, if there is full documentation available, proving both clinical efficacy and documenting clinical safety/risk profile.
Any traditional medicine sold with claimed preventive, diagnostic or curative effect, and any pharaceutical product lacking such documentation, is forbidden. The reason for this, is to match international praxis, in protecting patients and protecting the people from unjustified dangers, risks and harm.
Only traditional medicines with PROVEN safety and harmless ability can be allowed in Timor Leste, in line with international standard procedures and international praxis.
Develop a system to provide marketing authorization for traditional medicine prescribers and launch of an audit system to monitor their practices.
Protect the community from danger and consequences of using unknown ingredient products or which are fraudulent or do not meet required quality and standards.
24. Monitoring and Evaluation
The Ministry of Health in close collaboration with relevant national bodies will form a committee and set indicators for monitoring and evaluating the implementation of the National Medicine Policy and achievement of its objectives.
The implementation status of the national medicine policy shall be reviewed every five years.
Problems and constraints encountered in the process of implementation shall be discussed and appropriate solutions shall be sought.
25. Regional / International Collaboration
Coordination mechanisms for collaboration between Ministries and the Pharmaceutical sector shall be strengthened.
Links with Medicine Regulatory Authorities of countries within and outside the region shall be strengthened, with priority given to collaboration and exchange of information within ASEAN.
All opportunities to transfer technology, to build national capacity shall be explored
International assistance shall be sought to train more Pharmacists abroad and up-grade the pharmacy curricula at Timor Leste College of Higher Education, Faculty of Health Sciences.
Collaborate in the implementation of international conventions on narcotics and psychotropic substances, which the country is signatory to.
The Ministry of Health will co-ordinate with Ministry of Trade and Development and other government sectors, to ensure that public health interests are taken into account in negotiations and implementation of international and regional trade agreements by Timor Leste. The government recognizes the potential impact of TRIPS and other international trade agreements on access to medicines and will exercise maximum rights including enacting relevant legislation to offset any adverse impact
26. Policy Implementation, Enforcement
Following approval of the proposed policy by the Government, relevant laws, rules and regulations shall be instituted to enforce this policy. An operational plan (Strategy) for implementing the National Drug Policy shall be developed.
Definitions
Medicine; A "medicine" is defined as any substance which is used with intent to prevent, diagnose, cure or modify or explore the physiological state or conditions in a human or animal.
Synonymous terms used includes “pharmaceutical” or “pharmaceutical product”, or the term “drug” for human or veterinary use. The definition is based on intended use: Intention to use with the aim to prevent, diagnose or treat conditions or disease, modify or explore physiological systems or pathological states.
(Note that this definition is broad and includes blood products, vaccines, diagnostic materials, essential consumables and devices)
National Drug Administration synonyme: National Drug- or Medicines Regulatory Authority
A national body that administers the full spectrum of medicine regulatory activities, including at least all of the following functions:
Registration, marketing authorisation of new products and variation of existing products;
Revision and development of standard treatment guidelines
Development and implementation of practice guidelines and standards for drug management and drug-use in all sectors of healthcare, public and private.
Quality assurance and Quality Control. Collaboration with international licensed QC Laboratory for quality control laboratory testing of samples of medicines taken from the market (taken at point of import or from retail or healthcare facility pharmacy).
Drug information to healthcare providers and adverse medicine events monitoring.
Provision of medicine information and promotion of rational medicine use;
Setting standards for Good Distribution Practice, Good Manufacturing Practice (GMP), Good Pharmacy Practice and standards for Inspections and Licensing of prescribers, licensing of pharmacists, Licensing of manufacturers, wholesalers, pharmacies.
Monitoring of medicine utilisation.
Essential Medicines
"Essential Medicines" are medicines with available documentation about efficacy and safety/risk profile, which are needed based on evidence based medicine for health care of the disease ocurring in the population
Registsred Approved Medicines
These are Pharmaceutical products (medicines) which have been granted formal Registration approval and marketing authorization, for a specified medical purpose, e.g for defined indication(s).
Marketing Authorization
An official document issued by the national medicine regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality.
It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using International Non-proprietary Names or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics.
It specifies the information on which authorization is based. It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization.
Once a product has been given marketing authorization, it is included on a list of authorized products - the register - and is often said to be registered or to have registration. Marketing authorization may occasionally also be referred to as product license.
MINISTÉRIO DA SAÚDE
Ministry of Health
Table of Contents
Introduction 4
Goals set in the National Drug- and Medicine Policy 9
Objectives 10
Priority areas to be strengthened, as defined by the Policy. 13
Specific objective
1. Updated Law and Regulations 15
2. Medicine / Drug Registration 16
3. Importer, Wholesaler, Pharmacy Licenses 17
4. Standards, Monitoring and Supervision 18
5. Control of pharmaceutical advertisement 18
6. Post-marketing surveillance. 19
7. Antibiotic resistance 19
8. Safe Prescribing Practices. 19
9. Access To Medicines 20
10. Selection of Medicines 20
11. Essential Medicines 21
12. Generic Medicine (Multisource products) 21
13. Procurement of medicines. 21
14. Distribution of medicines 22
15. Stakeholder involvement 23
16. Quality Assurance and Quality Control 23
17. Rational and Safe Use of Medicines 24
18. Drug and Medicine Information 26
19. Human Resources Development 27
20. Calculation of drug quantity needs 28
21. Production of medicines 29
22. Research 29
23. Control of Traditional Medicine 31
24. Monitoring and Evaluation 32
25. Regional / International Collaboration 32
26. Policy Implementation, Enforcement 34
Definitions 34
Introduction
The National Drug Policy (synonyms also used; National Medicine, or; National Pharmaceutical policy for Timor Leste) deals with the development, provision and use of medicines within both the public and the private sector. The overarching goal is to secure safety and protect the individual patient and the public. The National Drugs and Medicines pharmaceuticals Policy aims to contribute to improved health and wellbeing of all people in Timor Leste.
This National Medicine Policy document aims for uninterrupted supply of safe, effective and good quality Essential Medicines, and promoting the rational and safe use of medicines both in public and private sectors throughout the country. For the National Medicine Policy to have impact, it must be owned by all stake holders and implemented through updated legislation and regulations, through a National Drug Administration as central Authority in line with WHO recommendations.
The National Drug Policy embraces all aspects of supply, quality, use and management of pharmaceuticals/medicines/drugs. The Policy addresses all drugs, both branded and generic, as well as biological products derived from living sources such as blood, blood products and vaccines as well as medicines of chemical composition, and products which are classified as so called traditional medicines or traditional health products.
A Drug, a Pharmaceutical or Medicine/Medicinal product is defined by its intended use, if it is intended for diagnostic, preventive, curative or palliative care for human use. Also products used for diagnostic, preventive of curative use in animals are classified as medicines.
This is addressed by development of legislative norms and acts, action plans, guidelines and programs that improves the health status of the people and prevents and reduce drug-related harm. This is achieved through optimal availability and use of essential pharmaceuticals in prevention, diagnosis and treatment of illness and disease. An important objective is to strive towards equity and efficiency in access to medicines of reliable quality for all citizens and/or visiting people in country, regardless of social vulnerability, poverty or any form of social marginalization.
The Pharmaceutical policy thus promotes both efficiency and efficacy of healthcare service delivery.
The National Drug Policy recognizes that medicines constitute an integral and vital part of healthcare, in diagnosis, prevention, curative treatment, palliative care and control of disease.
Medicines are defined in the Law of Timor Leste, in line with international praxis; A Medicine or Pharmaceutical product is any product or substance(s) which is used for the purpose to prevent, diagnose or treat conditions and diseases in humans. The same definition also applies, when products are used with the purpose to prevent, diagnose and/or treat conditions in animals.
All medicines fall under the requirement of formal requirement of registration approval, before they can be allowed to be imported or allowed to be sold or used in Timor Leste. The objective with this requirement is to protect the population from harm, and to secure that only medicines with reliable quality are made available in Timor Leste.
Timor Leste is therefore updating and implementing a new Law for the Pharmaceutical sector. This new Law also includes rules for the storage, prescribing, dispensing and use of medicines in all sectors of medical practice, private and public, and this Law also defines clear requirements for import, export, production, stock holding, wholesale and retail, prescribing, use and handling of all medicines (Synonyme terminology also used, Drugs, Pharmaceuticals or Medicinal products).
The Government is committed to a vision of ensuring safe, effective, reliable quality, essential medicines to be available at affordable cost at all times to the entire population of Timor Leste. This commitment is emphasized in this Drug Policy as amendment to the National Health Policy and Streategy. Moreover access to essential medicines is also formulated in line with the national commitments to reach the Millennium Development Goals.
While assessing challenges and problems, the National Drug Policy also recognizes that many practical factors still hamper availability of medicines at various levels of health care. The situation of limited resources is always present in all national healthcare systems, and Timor Leste is no exception in this regard.
The National Drug Policy therefore recognizes that Priorities must be made in terms of selecting drugs for supply, to meet the most important needs of the healthcare system, solving the most important health problems of the population.
The National Drug Policy therefore promotes the Essential Drugs concept and mechanism, and also promotes Standard Treatment Guidelines. Priority is given to supply of vital Essential drugs, as an important mechanism to reach key Goals of the National Drug Policy.
An important goal in the National Drug Policy is therefore also, to build good public sector including work with defining needs specifications for supply of Essential Drugs for hospitals and primary care.
The National Drug Policy also require Goverment Licinsing to private and public sector healthcareproviders and institutions, before they are allowed to deliver healthcare services and/or to import, sale, distribute or prescribe and dispense Medeicines and Pharmaceuticals.
The benefit to a private sector in healthcare and pharmaceutical service delivery has been establised. However the establishment of private pharmacies and private clinics has not yet been matched with adequate regulatory control. The National Drug Policy therefore addresses this gap. The new Drug Policy and new Drug Law is aiming to address the needs to control both the public and the private sector, with the overarching aim to safeguard peoples health.
Legal and regulatory demands are defined with the aim to protect the people against the risk of unsafe and poor quality medicines and pharmaceutical products, a risk which has been reported to occur in many other countries World-wide and in the region.
New clear standards, guidelines and technical regulations are launched, to set requirements for registration of medicines, setting requirements for Good Pharmaceutical Practices, Good Distribution Practices, Good in-hospital Pharmaceutical Management, and Good Pharmaceutical Management in Primary Care.
The National Drug Policy therefore launch new standards, guidelines and technical regulations for the control of the private and public sectors alike, as defined in a new Pharmaceutical Law.
Specific new guidelines are defined to ensure compliance with retail only of medicines registered and approved by the National Drug Regulatory Authority, and to ensure that unsafe sale of medicines without prescription is reduced. Professional performance benchmarks are also launched for both private and public pharmacy practice, including to ensure necessary education and information to patients, always ensuring that patients are well informed about dosages and how to safely use the prescribed medicines.
The new Pharmacy Law also set clear regulatory requirements about the importation of medicines.
The legal requirements connect closely to the WHO Certification scheme to combat and prevent unsafe, counterfeit and substandard quality drugs from being imported into Timor Leste.
The Drug Policy and legislation recognizes that the present number of qualified pharmaceutical personnel, both in the public and private sector is inadequate. This shortage must be met to develop pharmaceutical services.
The National Drug Policy recognizes that there is a need to strengthen the quality assurance and quality control mechanisms for medicines.
This entails both in-country adherence to Good Distribution Practices, Good Pharmacy Practices and requirements in regard to procurement and importation. Formal requirements are therefore set in the Law for Quality Assurance and Quality Control during procurement and importation of medicines, only allowing medicines produced under certified Good Manufacturing Practice (GMP) and controlled under the umbrella of WHO Certification scheme. The Quality assurance requirement also addresses the need to set-up collaboration with an internationally certified drug quality control laboratory for quality-testing of samples taken during inspections of Pharmacies in Timor Leste.
The National Drug Policy is clearly stating the objective to promote the essential medicine concept and promote adherence to standard treatment guidelines to guide rational and safe clinical drug use in Timor Leste. The National Drug Policy recognizes that a Code of Quality of Care is needed along with establishment of hospital Therapy committees, to promote adherence to rational use of drugs, as well as to establish safe prescribing and safe medicine dispensing practices.
The Government of Timor Leste has established a national wholesaler, the “SAMES” as a centralized procurement, wholesale and supply system. The Public Health objectives for the operation of the SAMES need to be further defined, with clearly objectives, goals Guidelines and Standard Operating Procedures.
This is essential both to optimize public health protection and to economize and minimize cost expenditure on medicines and thereby ensuring availability and supply of medicines to all levels of health care in a predictable manner. A well functioning mechanism for quantification of drug quantity requirements shall be established, based on patient case load and case mix statistics, and based on Standard treatment guidelines, to present a reliable estimate of needs as base for budget planning and allocation of adequate financial resources for drug procurement and supply.
In order to fill the gaps between needs and current practice, there is an urgent need to establish a National Drug Regulatory Authority in Timor Leste, matching WHO recommendations many policies and functions which need to be established at national level.
The organization, authority and responsibilities and organization set-up of the National Drug Regulatory Authority (National Drug Administration) is outlined in the updated Drug Law.
Goals set in the National Drug- and Medicine Policy
Three main Goals are defined in the Policy;
(i) To ensure that all medicines which are imported or locally manufactured, distributed, sold and used in the Timor Leste are effective, safe and of good reliable quality. This objective shall be ensured through the effective function and operation of a National Drug Regulatory system, spearheaded by the key institution, the National Drug Regulatory Authority (synonymous terms: National Drug Administration, currently the Pharmacy department of the Ministry of Health).
(ii) To ensure that adequate quantities of quality Essential Medicines are determined correctly, based on the needs of the population and based on the patient case load and case mix in primary care and hospitals. Needed essential drugs shall be made available at affordable costs at all times, to meet the need of the entire population, and especially protecting the needs of the most poor and vulnerable.
(iii) To promote rational, safe and cost-effective use of medicines: The use of medicines shall be guided and controlled, both to reduce risk for harm, and to optimize the curative effect of used medicines, while also reducing cost, thereby optimizing the ability to reach and cover the whole population with effective and safe treatment, within available budget frame. Key mechanisms shall be established, including active implementation of standard treatment guidelines, in-hospital therapeutic committees, active provision of consumer independent drug-information and activities to raise awareness and prevent avoidable adverse and side effects of drugs.
Objectives
In order to achieve set Goals and to reduce and solve problems in the pharmaceutical sector, the following objectives are set:
To ensure reliable supply of essential drugs of good and reliable quality and quantity
To ensure rational selection, procurement, and storage and distribution of medicines according to procedures to maintain quality, in both public and private sectors to ensure availability of Essential Medicines throughout the country.
To establish key functions and services of a National Drug Administration (National Drug Regulatory Authority), and within this institution establish key functions, including a well functioning medicine registration system, and a system for Licensing and Pharmaceutical Market surveillance and control.
To establish a range of quality assurance mechanisms including efficient inspection system, with which to monitor wholesalers, retail pharmacies and other distribution outlets including public and private hospitals and clinics with pharmacies throughout the country. This quality assurance system shall both function as a regulatory control and enforcement mechanism, to ensure complicance with laws and regulations, and; provide supportive services to strengthen Good Pharmacy Practices in private and public sector pharmaceutical sector operators alike.
To optimize the curative and preventive result of drug treatment by promotiong rational and safe use of drugs, and reduce the risk for harm caused by unsafe and irrational drug-use; Healthcare professionals shall be provided with updated standard treatment guidelines matching the reality in Timor Leste, and matching in-service supervvision and training. A drug-use audit and survey sustem ahall be established along with the establishment and set-up of Drug and Therapy Committees in all hospitals.
To promote safe prescribing and safe procedures in dispensing, thereby preventing medication mistakes and errors.
To strengthen the prescribing and monitoring of narcotic and psychotropic drugs and substances, while also promoting the needed availability and appropriate and rational use of pain control and mental health drugs for all patients in need.
To establish a national repository depot of key antidotes and emergency drugs, and a poisoning information service.
To Establish mechanisms for adverticing control and provision of producer-independent drug information to prescribers and pharmacists in Timor Leste.
To establish a consensus and participatory mechanism and organization for revision, development and implementation of standard treatment guidelines, matching evidence based medicine and matching the reality situation in Timor Leste.
For Special pharmaceutical products, blood, serum, vaccines, special requirements shall be defined and implemented for quality and safety, especially for blood-products, any products containing biological materials and especially materials from human origin, vaccines and other biological products to esure safety from perspective of viral and bacterial contamination.
To develop and strengthen adequate technical, human resources in the field of pharmacy and medicine management by appropriate training and continuing education,
To establish a prospective planning and budgeting mechanism, with which to allocate adequate resources, especially for implementing and monitoring the National Medicines Policy, print and disseminate Standard Treatment Guidelines, Essential Drug Lists and the updated Pharmacy Law, to be available widely in all facilities and institutions.
To establish a prospective planning and budgeting mechanism, with which to calculate needed budget resources for the procurement of drugs, matching the patient case-mix and case-load in hospitals and primary care of the public health system in Timor Leste.
To establish twinning and exchange with other National Drug Regulatory Authorities / Drug Administrations in the ASEAN region and in wider International cooperation with international and regional agencies, in areas such as training of staff, exchange of information and exchange of technical methods.
To establish a partnership between the government of Timor Leste and its National Drug Administrationm and the private providers in the pharmaceutical sector.
To establish collaboration with the Ministry of Agriculture, regarding the regulatory issues pertaining to veterinary drugs.
Priority areas to be strengthened, as defined by the Policy.
The National Drug Policy aim gives priority to key outputs and aim to strengthen the following areas:
Set-up and establish a National Drug Administration (synonym terminology: National Drug Regulatory Authority), in line with WHO recommendations for National Drug Regulatory Authorities in small countries with limited resources. Including key functions such as Drug registration, market regulation, surveillance and control, and control of drug use in all segments of healthcare, public and private.
Updating of Laws, Legislation and Regulations for the Pharmaceutical sector and for the control of prescribing and use of medicines in all sectors of healthcare, both public and private.
Implementation of Regulatory, administrative and quality standards in the Pharmaceutical sector and for handling and use of medicines in all segments of healthcare, public and private.
Establishment of Medicine registration services, as a key function of National Drug Regulatory Authority, with the establishment of a national Drug registration database, and establishment of well-functional drug registration mechanism. This drug registration mechanism shall ensure that only reliable medicines with available documentation about efficacy, available documentation about safe/risk profile and with reliable quality are allowed into Timor Leste.
Pharmaceutical inspection and enforcement services for implementing and ensuring adherence to regulations and procedures in practical pharmacy work, strengthened
Quality assurance and quality control services established, through collaboration with internationally certified QC laboratory and market surveillance.
Supply of essential medicines to all levels of health care.
Medicine and poison information services established
Advertising control mechanisms established
License database for pharmacies and clinics using and storing, prescribing and dispensing medicines, established
Licensing database for all pharmaceutical personnel, and database over all authorized personnel with prescribing rights established
Monitoring and supervision to promote rational use of medicines, by updating and implementation of Standard Treatment Guidelines and Essential Drugs
Antibiotic resistance surveillance and measures to prevent, stop further spread and limit the negative health and cost impact of antibiotic resistance infections.
Supervision of pharmaceutical practices and supervision of safe prescribing and dispensing practices in hospitals, and in clinics, public and private
A comprehensive National Medicine Policy has hereby been formulated addressing a set of listed priorities. National Strategies shall be drawn up, with specific action plans as needed to address each component of the National Drug Policy.
Specific objective
1. Updated Law and Regulations
An updated Law of the Republic of Timor-Leste shall form the legal basis and framework for regulatory control of the pharmaceutical sector, matching set goals, objectives and priorities defined in the National Drug Policy.
The updated Law shall incorporate elements of existing rules and regulations which are in line with this policy. The updated Law shall also harmonize requirements in Timor Leste with international praxis, paving the way for safe trade and safe importation of reliable pharmaceutical products of good quality and ensuring best possible safety for patients and people in Timor Leste.
For enactment of the Law by the relevant bodies, detailed regulations governing standards and key procedures shall be defined in Guidleines to carry out the provisions of the Law. A set of necessary Guidelines, for Good Pharmacy Practice, Good Distribution practice and guidleines for drug management in healthcare facilities and institutions shall therefore be formulated and issued.
The updated Law and updated regulatory framework shall include solutions and norms to enable:
The updated Law shall pave the way for the establishment of a National Drug Administration syn. National Drug Regulatory Authority, in the organization of the Ministry of Health.
Enforcement of the Drug Law, with technical regulations for authority and authority.
The operation of the National Drug Administration as focal point for implementation of the National Drug Policy.
The National Drug Administration support with help of a Advisory body. (hereinafter called Advisory Board)
2. Medicine / Drug Registration
A functional Drug Registration shall be established. Approval by Drug Registration shall be required with definition of approved purpose(s) (indications) for any pharmaceutical, drug or medicine, before any pharmaceutical, drug or medicine can be imported, sold or used in Timor Leste. Only products with adequate and documentation about its efficacy and its safety/risk profile in use for the suggested indication(s) can be approved by registration. Import license and marketing authorization from the Drug Administration shall also be required before any pharmaceutical product (medicine, drug) is allowed on the market in Timor Leste. Regulations for issuing or denying marketing authorizations shall be clearly defined in the updated Pharmacy Law, and shall be based on evaluation of safety, efficacy, quality and medically defined need.
Marketing Authorization shall be valid for a specified period of time as defined in the updated Pharmacy Law. A review shall be required for renewal of all Drug registrations.
A registration fee shall be charged for registration, marketing authorization and for import License for all pharmaceutical products and Medicines and other products as determined by the Ministry of Health.
A database for registration and monitoring imports of pharmaceutical products shall be developed and established.
3. Importer, Wholesaler, Pharmacy Licenses
The Ministry of Trade and Development is responsible for issuing a general trade license for any corporation. Once such a License has been obtained, the corporation must also apply to the Drug Administration of the Ministry of Health for License to operate as medicine importer, wholesaler or as retail pharmacy.
Legislation requirements shall be defined in the updated Pharmacy Law, for all importers, wholesalers, pharmacies and other retail outlets. Basic requirements shall include the demands:
To be Licensed by the National Drug Regulatory Authority in Ministry of Health (syn Drug Administration), and
Before License can be issued, the appying institution or corporation must fulfill a defined set of quality requirementsdefined by the Ministry of Health. These requirements includes both the demant to keep and maintain suitable premises and quality procedures, appropriate storage conditions for medicines to preserve quality in line with Good Distribution Practices. Requirements also include demands for available personnel with pharmaceutical competence, to endure good pharmacy practices.
Licenses shall be issued to all Pharmaceutical personnel, and to all Healthcare personnel with the right to dispense and prescribe. All such personnel shall be licensed by the National Drug Regulatory Authority (Drug Administration).
Data about all personnel with License shall be kept in an annually updated License-database in the National Drug Regulatory Authority (Drug Administration). Updated printed records over licensed prescribers, shall be provided to all pharmacies 2 times per year.
4. Standards, Monitoring and Supervision
It shall be the responsibility of the National Drug Administration to monitor, supervise and enforce that the medicine / pharmaceutical regulatory requirements and quality standards are properly followed by importers, wholesalers and pharmacies during procurement, distribution storage, sale and prescribing and dispensing of all pharmaceuticals in the country.
National Drug Administration will conduct regular Supervision and Monitoring, of stock holding and procedures in all public hospitals and clinics, and in all private pharmacies, whiolesalers and all private clinics with sale and dispensing of medicines.
5. Control of pharmaceutical advertisement
Advertisement and medicine promotion through the mass media shall require prior approval.
The content and distribution of medicine information provided by pharmaceutical companies and/or their representatives to health care professionals and the public shall be subject to monitoring and control and conform to the WHO Ethical criteria for promotion of Medicinal products.
6. post-marketing surveillance.
All marketed medicines shall be under vigilance to ensure constant conformity with the conditions and terms of the marketing authorization and safety
7. Antibiotic resistance
The National Drug Administration shall lead and establish a national surveillance of antibiotic resistance, in collaboration with the National Laboratory. Data from antibiotic resistance surveillance shall be shared with the WHO regional collaboration, and data from surveillance in Timor, and data from the regional collaboration, shall be used to revise national standard treatment guidelines, as well as to design and implement activities to reduce irrational and unsafe prescribing, use and irrational and unsafe sale of antibiotics in Timor Leste.
Every effort shall be made through appropriate regulations, to reduce the further spread of drug resistant infections, including the problem of drug resistant Tuberculosis, drug resistant Malaria and drug resistant infections such as occur in primary care and hospitals in Timor Leste.
8. Safe Prescribing Practices.
Prescribing authority will be limited to registered and licensed health professionals, as defined in annually updated database over licensed personnel. A Database shall be established in the National Drug Administration, annually updating all healthcare personnel who are licensed and authorized to prescribe medicine.
Regulations will define clearly which medicines require prescription and which can be sold without prescription, as Over-the-Counter OTC medicines.
Clear regulations and legal requirements shall be available about which medicines are controlled substances, (Narcotic and psychotropic drugs), with clear instructions and guidelines about prescribing, dispensing and record keeping requirements. National Drug Administration and Ministry of Health Inspectorate will conduct special Monitoring, supervision and audits to all institutions, to control compliance with the specific legal requirements.
In addition, the national Drug Law defined which medicines are Controlled substances, narcotics and psychotropic medicines, for which extra stringent prescribing and recording practices are required.
9. Access To Medicines
A centralized procurement and supply system has been established, the SAMES with the aim to ensure availability and supply of medicines to all levels of health care in a predictable manner. The Public Health objectives of the SAMES system shall be defined in the new Drug Law of Timor Leste.
10. Selection of Medicines
Medicines for procurement and importation shall only be selected from the list of products which have a valid Registration approval and a valid marketing authorization.
Medicines for procurement shall also only be selected from a list of medicines supplied from pre-qualified sources, based on quality performance, based on the WHO Certification scheme, and based on international exchange of information about reliable product supply.
Selection of medicines shall be done by the National Drug Administration, defining Essential Medicines List and through international tender procedures managed by the wholesaler, under control of the regulatory requirements set by the National Drug Administration and national Drug Law.
11. Essential Medicines
A National Essential Medicine List that shall be reviewed annually, to be based on medical needs defined by morbidity, mortality and evidence based medicine and to be used as a guide for procurement and prescribing at all levels of health care.
Adequate stock level of Essential Medicines must be maintained at all levels of health care.
Quantity needed shall be calculated, based on Case-load and case-mix in primary care and hospitals, matching drug selection defined in standard treatment guidelines and matching the Essential drug list.
Provisions shall be made for supply of medicines for exceptional needs, which are not registered or not on the National Essential Medicines List
12. Generic Medicine (Multisource products)
The government encourages import and use of generic medicine nomenclature in all aspects, ensuring multisource products of assured quality and safety.
13. Procurement of medicines.
The National Medicine Policy promotes the purchase of essential medicines through the SAMES governmental wholesaler. The position of SAMES as Governmental Wholesaler, includes Public Health objectives, basing drug procurement on medical priorities, and not only on commercial objectives of meeting high volume requests for “popular medicines”. This means, that the budget allocated to drug procurement by SAMES shall give first priority to essential medicines of vital importance for treating serious and important medical conditions.
A mechanism shall also be provided for procurement of additional medicine supply from private importers.
Under both cases, importation is controlled under the regulations of the National Drug Law and National Drug Administration guidelines.
14. Distribution of medicines
The government will organize sufficient and appropriate logistic facilities to ensure a systematic and reliable distribution. Hereby, adequate supplies of Essential Medicines shall be made available at all times to the all levels of health care, even in remote locations.
District warehouses shall be established, with staff, logistic support resources and warehouse management IT systems in place.
The organization of distribution system and its management shall match the wider healthcare system organization, if per district or per future regional organization.
Supply depots shall be established both at central and district levels, with buffer stock and with task to reduce overstock and stock-out differences between primary care facilities within a district or region.
Hospital and health center pharmacies are required to promote the concept of Essential Medicines and rational and safe prescribing and rational and safe dispensing.
Community participation to set-up and operate pharmacies on self sustainable basis shall be encouraged and supported.
Regulations shall be revised to allow for clinicians and nurse practitioners to dispense in locations with low population.
All parties involved in procurement import, and distribution of medicines of medicines shall follow WHO Certification scheme and WHO based guidelines on good distribution and storage practices and good pharmacy practice procedures.
15. Stakeholder involvement
Activities of all sectors should complement each other and aim towards effective medicines distribution, availability and rational medicine use throughout the country.
Every effort shall be made to minimize wastage of medicines at all levels.
The role of the active players in the pharmaceutical sector in the emergency response and preparedness to national disasters shall be stipulated.
All agencies donating medicines must ensure compliance to WHO Medicine Donation Guidelines and with the national Essential Medicines List and with the National Drug Law.
16. Quality Assurance and Quality Control
Quality assurance of medicines shall be achieved through a comprehensive medicine registration system, testing of marketed medicines, inspection at ports of entry and at points of distribution and retail
As part of the product registration system, the WHO Certification Scheme and Prequalification Scheme shall continue to be adopted as a means of ensuring quality of medicines imported in to the country
Medicines storage facilities and outlets at both public and private institutions shall be inspected regularly.
Regulations and practices shall be put in place to ensure that quality is maintained during transport and handling
The government National Drug Administration will take action and confiscate and destroy any medicines found with unacceptable quality, or any medicine found imported without valid importation license, without valid registration or without valid marketing approval or without valid quality certificate.
17. Rational and Safe Use of Medicines
The National Medicine Policy aims at promoting rational use of medicines in all aspects and areas of prescribing, dispensing, and also in private pharmacy operation and self-medication.
A system for promotion of rational and safe use of drugs will be based on standard treatment guidelines (STGs), developed with a strong base in international best practice, and connected to the reality of currently available resources in Timor Leste.
Standard treatment guidelines define the place in diagnosis, therapy, prevention and palliative care for pharmaceutical products. The STGs will be developed with active involvement of the prescribers who later also shall use the guidelines, building consensus with support from a Clinical Pharmacology Adviser. Development and revision of standard treatment guidelines shall also build up a panel of national reference committees for STG revision in key therapeutic areas.
These committees shall involve both specialists and non-specialist prescribers, and link with drug and therapy committees in district and national referral hospitals.
The standard treatment guidelines will be used as base for assessing drug needs, and also for clinical audits and for training to promote Quality of Care.
Standard treatment guidelines will also be used as base for Continuous Medical Education and Continuous Professional Development. A national system for development and revision of treatment guidelines will be formed with strong national and international collaboration as fundament. In additional to the Standard Treatment Guidelines, Timor Leste will also distribute the WHO Model Formulary, as an objective and producer independent handbook for rational use of drugs for prescribers.
To promote the rational use of medicines at all levels, the government shall:
Provide and up-date the National Essential Medicine List to be used as a guide for procurement, prescribing and dispensing.
Encourage prescribing medicines in their generic (non-proprietary) names.
Update and regularly make available to the prescribers, pharmacists, public, and the pharmaceutical sector the list of marketed medicines.
Develop and revise standard treatment guidelines for primary care and hospital care.
Provide continuing education programs and refresher courses for health care professionals on rational use of medicines, matching standard treatment guidelines.
Develop, implement and monitor adherence to national Standard Treatment Guidelines and Formularies.
Create public awareness on the rational use of medicinal medicines using mass media and other means of communication in local language.
Strengthen prescription monitoring system to improve prescribing habits.
Ensure correct dispensing, labeling and patient counseling procedures.
Ensure disposal of expired and banned medicines environment friendly in accordance with regulations.
18. Drug and Medicine Information
Mechanisms shall be developed to provide current and objective information on medicines for health care professionals and prescribers to promote rational use of medicines.
A medicine and poison information unit shall be established at central level for health professionals and consumers
All medicines approved for importation, sale and use in Timor Leste, must include written information about dosage and risks, written in the language of Tetun, Portuguese, Bahasa or English.
Information dissemination mechanisms shall be developed.
Reliable and producer-independent information about all medicines registered in Timor Leste, shall be made widely available to all prescribers and all pharmacists.
This information shall include information about documented risks, including risk for adverse reactions and side effects, risks associated with use of drugs during pregnancy and breast feeding, and risks associated with pathological conditions such as allergy, or risks due to reduced kidney or liver function of the patients.
Objective information about the correct use and correct dosage shall be available to all prescribers.
A clear system shall be set-up, with database recording import license for all medicines which have been given approval and which have been imported. The database shall include information about each imported batch registration. This shall allow the National Drug Administration to launch recalls in the event that information is made available about substandard quality or any aspect of defective medicine products.
Health care professionals and, the public shall be informed about risks and safety problems that are observed on marketed medicines. Awareness shall be raised especially about the risk of self-medication, specifically targeting unsafe self-medication and irrational sale of antibiotics, aiming to reduce risks for adverse effects as well as to reduce the risks for further spread of antibiotic resistance in Timor Leste.
A procedure for product recall, shall be in place for all marketed products
19. Human Resources Development
For effective implementation of various elements of the National Medicine Policy:
Training of technical, administrative and health care personnel who are required for organizing and operating at different levels of implementing the National Medicine Policy shall be facilitated.
Pharmacists and other professionals needed for inspection, enforcement, and regulatory activities shall be trained.
Pharmacy education shall be up-graded to a diploma level.
Funds and loans shall be allocated for pharmacy education
Regulatory incentives shall be provided to encourage more locals to enter into the pharmacy profession.
More students shall be sent for training abroad in the field of pharmacy, to meet the country's need for pharmacists in the areas of hospital pharmacy, regulatory activities, as well as medicine supply and management.
Pharmaceutical and health care professionals shall be provided regular education and training on Essential Medicines concept, Rational Medicine Use and Management of Supplies.
The National Drug Administration shall establish a collaboration network with pharmaceutical and medical advisers, to assist in setting up and delivering / providing postgraduate and Continuous education for medical and pharmaceutical professionals, promoting rational and safe use of drugs.
20. Calculation of drug quantity needs
The National Drug Administration shall provide estimates of needed drug requirements, based on case-mix and case-load, and based on standard treatment guidleines for major diseases, to be used to calculate adequate annual financial resources to procure and supply availability of essential medicines throughout the country by the public health services.
The National Health Information system shall provide monthly updates to the National Drug Administration, about the case-load and case mix and bed days, for main diseases treated in hospitals and primary care throughout the country.
Reliable drug quantity estimates shall be provided as base to calculate adequate financial resources to procure medicines.
Special funding provisions shall be made for the low-income and especially vulnerable groups of the population who are unable to pay for their treatment.
Special funding provisions must also be made for providing treatment priority diseases and conditions, including Tuberculosis, Malaria, Antenatal care and as defined in amendment to the National Drug Law by annual decree by Ministry of Health. These diseases and conditions shall be decided at national level based on prevalence, mortality and chronic nature.
21. Production of medicines
For domestic production of medicines, standards, technology and personnel required for pharmaceutical production shall confirm to international standards of Good Manufacturing Practice (GMP). ASEAN level GMP is the first required level tier in the quality requirements for medicine GMP.
For non-pharmaceutical “traditional medicines” local standards and best practices shall be developed. ASEAN level GMP is the first tier, in the quality requirements in all production.
22. Research
Human rights of the patients shall always be safeguarded and protected, following WHO – WMA Guidelines and the Helsinki declaration of human rights of the patient.
Research shall be carried out to find practical solutions and solve operational problems such as medicine selection, procurement and distribution. The aim is to enable to achieve the goals and objectives of the National Drug Policy. It will focus particularly on the following areas:
Health systems research to measure the impact of the National Medicines Policy.
Point prevalence prescribing studied, in hospitals and primary care to assess adherence to Essential medicines and standard treatment guidleines at different levels of the health systems.
Medicine stock-out survey and supply utilisation.
Practice survey, on record keeping, record writing, prescribing records and safe dispensing procedures
Social and cultural aspects of medicines use.
Self medication, and attitudes of medicine consumers.
Antibiotic use and assessment of the spread of antibiotic resistance and planning and assessment of impact of interventions to limit and contain antibiotic resistance
Assessment of adverse drug reactions and side effects, aiming to identify how to limit the extent of drug-related harm and iatrogenicity
Surveys shall be conducted to ensure that no research is conducted without compliance to international standards, for human rights of the patient, as defined in the Helsinki declaration and in the WHA Ethical guidelines for clinical research (No clinical research is allowed, without appropriate approval of research ethical committee in Timor Leste and in the country of origin of the donor, in line with provisions of the WMA and Helsinki declaration)
23. Control of Traditional Medicine
For all Traditional medicine, the Government shall:
Develop clear regulations within the frame of an updated Drug Law.
Standardization and quality control requirements shall be enforced for all components, products and raw materials.
Any traditional medicines sold, with claimed therapeutic, diagnostic or preventive effect, is breaking the ruules, since it then in fact meets the definitions of a Medicine or Pharmaceutical product.
It can therefore only be allowed if it is evaluated and given a full registration approval as Medicine / Pharmaceutical product.
As an example; Consequently, herbals claiming effect against Malaria can not be allowed as traditional medicine. Such products, claiming a therapeutic effect defines the product as a medicine.
As stated, all medicines must undergo a full registration assessment before they can be issued or rejected approval. Only medicines which get registration apprpval can be allowed to be imported and to be allowed to be prescribed, used and sold in Timor Leste.
A key requirement is, that a pharmaceutical product (medicine, drug) can only be approved for registration, if there is full documentation available, proving both clinical efficacy and documenting clinical safety/risk profile.
Any traditional medicine sold with claimed preventive, diagnostic or curative effect, and any pharaceutical product lacking such documentation, is forbidden. The reason for this, is to match international praxis, in protecting patients and protecting the people from unjustified dangers, risks and harm.
Only traditional medicines with PROVEN safety and harmless ability can be allowed in Timor Leste, in line with international standard procedures and international praxis.
Develop a system to provide marketing authorization for traditional medicine prescribers and launch of an audit system to monitor their practices.
Protect the community from danger and consequences of using unknown ingredient products or which are fraudulent or do not meet required quality and standards.
24. Monitoring and Evaluation
The Ministry of Health in close collaboration with relevant national bodies will form a committee and set indicators for monitoring and evaluating the implementation of the National Medicine Policy and achievement of its objectives.
The implementation status of the national medicine policy shall be reviewed every five years.
Problems and constraints encountered in the process of implementation shall be discussed and appropriate solutions shall be sought.
25. Regional / International Collaboration
Coordination mechanisms for collaboration between Ministries and the Pharmaceutical sector shall be strengthened.
Links with Medicine Regulatory Authorities of countries within and outside the region shall be strengthened, with priority given to collaboration and exchange of information within ASEAN.
All opportunities to transfer technology, to build national capacity shall be explored
International assistance shall be sought to train more Pharmacists abroad and up-grade the pharmacy curricula at Timor Leste College of Higher Education, Faculty of Health Sciences.
Collaborate in the implementation of international conventions on narcotics and psychotropic substances, which the country is signatory to.
The Ministry of Health will co-ordinate with Ministry of Trade and Development and other government sectors, to ensure that public health interests are taken into account in negotiations and implementation of international and regional trade agreements by Timor Leste. The government recognizes the potential impact of TRIPS and other international trade agreements on access to medicines and will exercise maximum rights including enacting relevant legislation to offset any adverse impact
26. Policy Implementation, Enforcement
Following approval of the proposed policy by the Government, relevant laws, rules and regulations shall be instituted to enforce this policy. An operational plan (Strategy) for implementing the National Drug Policy shall be developed.
Definitions
Medicine; A "medicine" is defined as any substance which is used with intent to prevent, diagnose, cure or modify or explore the physiological state or conditions in a human or animal.
Synonymous terms used includes “pharmaceutical” or “pharmaceutical product”, or the term “drug” for human or veterinary use. The definition is based on intended use: Intention to use with the aim to prevent, diagnose or treat conditions or disease, modify or explore physiological systems or pathological states.
(Note that this definition is broad and includes blood products, vaccines, diagnostic materials, essential consumables and devices)
National Drug Administration synonyme: National Drug- or Medicines Regulatory Authority
A national body that administers the full spectrum of medicine regulatory activities, including at least all of the following functions:
Registration, marketing authorisation of new products and variation of existing products;
Revision and development of standard treatment guidelines
Development and implementation of practice guidelines and standards for drug management and drug-use in all sectors of healthcare, public and private.
Quality assurance and Quality Control. Collaboration with international licensed QC Laboratory for quality control laboratory testing of samples of medicines taken from the market (taken at point of import or from retail or healthcare facility pharmacy).
Drug information to healthcare providers and adverse medicine events monitoring.
Provision of medicine information and promotion of rational medicine use;
Setting standards for Good Distribution Practice, Good Manufacturing Practice (GMP), Good Pharmacy Practice and standards for Inspections and Licensing of prescribers, licensing of pharmacists, Licensing of manufacturers, wholesalers, pharmacies.
Monitoring of medicine utilisation.
Essential Medicines
"Essential Medicines" are medicines with available documentation about efficacy and safety/risk profile, which are needed based on evidence based medicine for health care of the disease ocurring in the population
Registsred Approved Medicines
These are Pharmaceutical products (medicines) which have been granted formal Registration approval and marketing authorization, for a specified medical purpose, e.g for defined indication(s).
Marketing Authorization
An official document issued by the national medicine regulatory authority for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy and quality.
It must set out, inter alia, the name of the product, the pharmaceutical dosage form, the quantitative formula (including excipients) per unit dose (using International Non-proprietary Names or national generic names where they exist), the shelf-life and storage conditions, and packaging characteristics.
It specifies the information on which authorization is based. It also contains the product information approved for health professionals and the public, the sales category, the name and address of the holder of the authorization, and the period of validity of the authorization.
Once a product has been given marketing authorization, it is included on a list of authorized products - the register - and is often said to be registered or to have registration. Marketing authorization may occasionally also be referred to as product license.
Steady progress made towards treating TB in Timor-Leste
By Citizen News Service
Dili: A greater number of new positive Tuberculosis (TB) cases are being detected now in Timor-Leste compared to nine years ago. Of these new cases, about 85% are being successfully treated. Timor Leste’s TB burden was first recorded in 1995 and averaged 707 cases per 100,000 of its population. Today it stands at 378 cases per 100,000 of its population. Read more
“Timor-Leste is on track to meeting the MDG goal of halving the number of TB cases in the country by 2015. However this disease still posses a heavy burden in our country,” says Dr Nelson Martins, Minister of Health.
Tuberculosis is a disease caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. If not treated properly, TB disease can be fatal.
“I particularly want to stress the importance of our Timorese doctors who have returned from Cuba to be sensitized to the TB programme’s needs and receive training on standard diagnostic and treatment protocol of the National TB Control Programme (NTP),” stressed Dr Martins, who was the founding manager of the NTP when the proagmme was established in 2000 by Caritas.
The country’s National TB Control Programme next five year strategy is an ambitious one. From now till 2015, it aims to further improve access to TB diagnostic services with a focus on reaching the marginalized and vulnerable groups and strengthen the recording and reporting of data as part of its immediate action.
The National TB Control Programme is integrated within the Ministry of Health. It receives funding from the Global Fund and technical support from the World Health Organization. Various partners including South Australia Pathology, the Catholic Clinic network supported by CARITAS, Clinic Café Timor and the Bairo Pite Clinic in the capital Dili are integral in the success of the programme to date.
“The firm and dedicated support from both our national and international partners have been significant in the control of TB in Timor-Leste. I’m extremely grateful for this and look forward to our continued partnership,” stressed Dr Martins at the launch of the country’s Stop TB Strategy for 2011-2015.
Dili: A greater number of new positive Tuberculosis (TB) cases are being detected now in Timor-Leste compared to nine years ago. Of these new cases, about 85% are being successfully treated. Timor Leste’s TB burden was first recorded in 1995 and averaged 707 cases per 100,000 of its population. Today it stands at 378 cases per 100,000 of its population. Read more
“Timor-Leste is on track to meeting the MDG goal of halving the number of TB cases in the country by 2015. However this disease still posses a heavy burden in our country,” says Dr Nelson Martins, Minister of Health.
Tuberculosis is a disease caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. If not treated properly, TB disease can be fatal.
“I particularly want to stress the importance of our Timorese doctors who have returned from Cuba to be sensitized to the TB programme’s needs and receive training on standard diagnostic and treatment protocol of the National TB Control Programme (NTP),” stressed Dr Martins, who was the founding manager of the NTP when the proagmme was established in 2000 by Caritas.
The country’s National TB Control Programme next five year strategy is an ambitious one. From now till 2015, it aims to further improve access to TB diagnostic services with a focus on reaching the marginalized and vulnerable groups and strengthen the recording and reporting of data as part of its immediate action.
The National TB Control Programme is integrated within the Ministry of Health. It receives funding from the Global Fund and technical support from the World Health Organization. Various partners including South Australia Pathology, the Catholic Clinic network supported by CARITAS, Clinic Café Timor and the Bairo Pite Clinic in the capital Dili are integral in the success of the programme to date.
“The firm and dedicated support from both our national and international partners have been significant in the control of TB in Timor-Leste. I’m extremely grateful for this and look forward to our continued partnership,” stressed Dr Martins at the launch of the country’s Stop TB Strategy for 2011-2015.
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