NATIONAL POLICY

This house believes that Indonesia should place limits on internal

rural urban migration
ENVIRONMENT
This house would stop REDD's Benefit Sharing program
INTERNATIONAL POLITICS
This house believes that there should be an international
framework to regulate space exploration
THAILAND
This house believes that Thailand should stop the "direct payment
to farmers" scheme
HEALTH
This house would waive patent rights for vaccines & anti-retroviral
drugs in underdeveloped countries

Program PBB untuk Pengurangan Emisi dari Deforestasi dan Degradasi Hutan (atau
Program UN-REDD) adalah inisiatif kolaboratif di negara berkembang, diciptakan
dalam menanggapi keputusan UNFCCC mengenai REDD di COP 13 dan Bali Action
Plan. Ini didasarkan pada peran mengadakan dan keahlian teknis dari Organisasi
Pangan dan Pertanian Perserikatan Bangsa-Bangsa (FAO), United Nations
Development Programme (UNDP) dan United Nations Environment Programme
(UNEP). [1]
Program UN-REDD mendukung nasional-dipimpin proses REDD + dan
mempromosikan keterlibatan informasi dan bermakna dari semua pemangku
kepentingan, termasuk masyarakat adat dan masyarakat yang bergantung pada
hutan lainnya, di tingkat nasional dan internasional REDD + implementasi. Program
ini juga bekerja untuk membangun kesadaran internasional dan konsensus tentang
pentingnya termasuk mekanisme REDD + dalam perjanjian perubahan iklim di
masa depan.
Program REDD PBB bukanlah satu-satunya inisiatif negara-negara yang ingin
terlibat dalam kegiatan REDD + membantu. Inisiatif lain termasuk Karbon Hutan
Fasilitas Bank Dunia Kemitraan, International Iklim Norwegia dan Inisiatif Hutan,
Global Environment Facility, Australia Inisiatif Karbon Hutan Internasional dan
Kemitraan Kolaboratif Hutan.
Pada bulan Maret 2012, Program UN-REDD dirilis Tahun tahunan dalam laporan
Ulasan untuk 2011, [2] yang tersedia di website program. [3]
Program ini saat ini memiliki 47 negara mitra yang mencakup Afrika, Asia - Pasifik
dan Amerika Latin dan Karibia . Enam belas negara-negara yang menerima
dukungan langsung kepada Program Nasional. Ini adalah 16 negara : Bolivia ,
Kamboja , Republik Demokratik Kongo ( DRC ) , Ekuador , Indonesia , Nigeria ,
Panama , Papua Nugini , Paraguay , Filipina , Republik Kongo , Kepulauan Solomon ,
Sri Lanka , Tanzania , Vietnam dan Zambia . Konflik telah muncul antara masyarakat
adat Panama dan Program UN-REDD , yang telah menyebabkan penghentian
sementara kegiatan di negara tersebut pada bulan Maret 2013. [ Rujukan? ] Todate , [ kapan? ] Program REDD PBB Dewan kebijakan telah menyetujui total US $
67.800.000 untuk Program Nasional dalam 16 negara mitra . Dana ini membantu
untuk mendukung pengembangan dan pelaksanaan strategi REDD + nasional.
Negara Program UN-REDD tidak menerima dukungan langsung kepada program
nasional terlibat dengan Program dalam berbagai cara , termasuk sebagai
pengamat Dewan Kebijakan Program , dan melalui partisipasi dalam lokakarya
regional dan berbagi pengetahuan , difasilitasi oleh kerja online interaktif Program
itu . Negara-negara ini adalah: Argentina , Bangladesh , Benin , Bhutan , Kamerun ,

Republik Afrika Tengah , Chili , Kolombia , Kosta Rika , Pantai Gading , Ethiopia ,
Gabon , Ghana , Guatemala , Guyana , Honduras , Kenya , Laos , Malaysia, Meksiko ,
Mongolia , Maroko , Myanmar , Nepal , Pakistan , Peru , Sudan Selatan , Sudan ,
Suriname , Tunisia dan Uganda . [ 4 ]
Kegiatan program global
Pada tingkat internasional , Program REDD PBB berusaha untuk membangun
konsensus dan pengetahuan tentang REDD + dan meningkatkan kesadaran tentang
pentingnya termasuk mekanisme REDD + dalam perjanjian perubahan iklim pasca
2012 . Hal ini juga memberikan kesempatan bagi dialog antara pemerintah ,
organisasi masyarakat sipil dan para ahli teknis , untuk memastikan bahwa upayaupaya REDD + didasarkan pada ilmu pengetahuan dan memperhitungkan
pandangan dan kebutuhan semua pemangku kepentingan .
Program REDD PBB menyatukan tim teknis dari seluruh dunia untuk
mengembangkan pendekatan umum , analisis dan pedoman tentang isu-isu seperti
pengukuran , pelaporan dan verifikasi ( MRV ) dari emisi karbon dan arus ,
penginderaan jauh , dan persediaan gas rumah kaca . Ini memberikan panduan
tentang cara terbaik untuk merancang dan mengimplementasikan REDD + , untuk
memastikan bahwa hutan terus memberikan beberapa keuntungan bagi
penghidupan dan keanekaragaman hayati untuk masyarakat saat menyimpan
karbon pada saat yang sama . Program ini juga sangat berkomitmen untuk
mendukung keterlibatan masyarakat adat dan organisasi Masyarakat Sipil dalam
desain dan implementasi strategi REDD + .
Organisasi dan tata kelola
Kebijakan Dewan Program REDD PBB mengadakan dua kali setahun untuk
memutuskan orientasi strategis dan alokasi anggaran dari Program . Pertemuan
yang diketuai oleh perwakilan dari negara mitra Program REDD - PBB dan
perwakilan baik dari FAO , UNDP atau UNEP

Mungkin bagi sebagian orang ada yang pernah mendengar apa itu REDD, REDD+ maupun
REDD++ tapi sebagian orang juga mungkin ada saja yang baru mendengar akan eksistensi
REDD pada saat tulisan ini dipublish. REDD adalah Reducing Emission from Deforestation and
Forest Degradation merupakan sebuah program yang membahana di kalangan rimbawan,
NGO, dan masyarakat yang peduli akan kondisi bumi yang semakin kritis.
Apa itu REDD?

sesuai namanya, REDD merupakan pengembangan dari apa yang telah dibicarakan dari Kyoto
Protocol dalam rangka menindaklanjuti issue terkait dengan perubahan iklim global dengan
mengurangi kegiatan deforestasi (ex: Illegal Logging) dan Degradasi Hutan.
Kapan, dimana, dan bagaimana REDD?
REDD muncul pada COP ke-13 di Bali pada tahun 2007 yang pada mulanya dicetuskan oleh
negara pemilik hutan tropis terbesar ke-1 yaitu Brazil dalam rangka menghadapi akan adanya isu
Carbon Trade dan trend yang berkembang pada pasar Eropa yaitu sertifikasi pengelolaan hutan
lestari. Memang kerangka dasar baik REDD maupun sertifikasi sangat bagus dalam menyokong
sifat conservationist namun dampaknya bagi negara berkembang akan lumayan menyentil.
Penulis tekankan disini menyentil dikarenakan negara berkembang belum mempunyai pondasi
dalam berekonomi yang cukup kuat apalagi ditambah dengan adanya kebijakan tentang REDD
yang seakan-akan Indonesia dilarang menebang hutan. Penulis disini terlihat sebagai orang yang
mendukung Indonesia untuk menebang hutannya, YA penulis memang mendukung Indonesia
yang menebang hutannya sendiri, bukan oknum-oknum di bidang kehutanan yang entah siapa
dirinya hingga sektor Kehutanan hanya memberikan sedikit terhadap GNP Indonesia yang
seharusnya Indonesia sebagai Negara pemilik Hutan Tropis terbesar ketiga di dunia dapat
menjadikan Kehutanan sebagai sektor utama pendapatan negara ini. Belum dapat memanfaatkan
hutan secara optimal tapi Indonesia sudah ditekan dengan REDD, ditambah dengan sumbangan 1
Milyar Dollar dari Norwegia agar dilakukannya moratorium sehingga Indonesia semakin dirantai
dalam memanfaatkan hutannya sendiri.
Lalu mengapa REDD?
Pada tahun 2000 Departemen Kehutanan telah membuat kerangka regulasi untuk menghadapi
tantangan deforestasi dan degradasi hutan di indonesia yang memiliki lima kebijakan pokok dan
delapan kebijakan prioritas di dalamnya yang ternyata dalam REDD yang dimulai pada tahun
berikutnya yaitu tahun 2007 memiliki garis besar yang sama dengan apa yang dicetuskan dari
Departemen Kehutanan. Timbul lah pertanyaan disini, mengapa REDD? Jadi untuk apa REDD?
REDD disini seperti sebuah cara Departemen Kehutanan dalam membuat penelitian dengan
cuma-cuma, karena dalam membuat sebuah pilot-project cenderung membutuhkan dana yang
cukup besar sedangkan di Indonesia sekarang Kehutanan diharapkan sebagai sumber pendapatan
negara sehingga muncul dua kutub paradoksal akan pengelolaan hutan yang ada di Indonesia.
Di sisi lain akan adanya Carbon Trading yang menarik negara-negara maju untuk memberikan
sedikit uangnya untuk mengatur kondisi hutan di Indonesia juga terlihat mempunyai pandangan
yang berbeda, mereka memandang bahwa jika mereka telah menyumbangkan sejumlah uang
untuk mendukung adanya reforestasi di Indonesia maka mereka memiliki Right to Pollute,

Industri mereka akan semakin maju dan Indonesia akan semakin miskin karena hutannya
dilarang untuk ditebang.

Tanya Jawab Mengenai REDD+

Apakah REDD+ itu?
Reducing Emissions from Deforestation and Forest Degradation (REDD) adalah langkahlangkah yang didesain untuk menggunakan insentif keuangan untuk mengurangi emisi dari gas
rumah
kaca
dari
deforestasi
dan
degradasi
hutan.
REDD+ tidak hanya mencakup pengurangan gas rumah kaca tetapi juga mencantumkan peran
dari konservasi, manajemen hutan yang berkepanjangan, dan peningkatan stok hutan karbon.
Skema ini akan membantu menurunkan tingkat kemiskinan dan mencapai pertumbuhan ekonomi
berkelanjutan.
Proses penerapan REDD+ menitikberatkan pada keterlibatan para pemangku kepentingan. Suara
dari masyarakat, penduduk asli dan komunitas tradisional harus dijadikan pertimbangan untuk
memastikan hak mereka yang tinggal di dalam dan sekitar hutan akan terjamin.

REDD+ di Indonesia
Pada Oktober 2009, Presiden Susilo Bambang Yudhoyono berkomitmen untuk mengurangi emisi
CO2 Indonesia sampai 26%, dibandingkan skenari business as usual pada tahun 2020, hal ini
merupakan komitmen terbesar yang diberikan oleh kekuatan ekonomi yang sedang meningkat.
Dengan adanya dukungan keuangan internasional, Presiden Yudhoyono juga berkomitmen untuk
mengurangi emisi gas rumah kaca sampai 41%.
Pemerintah Norway menyambut baik komitmen ini dan menyetujui penandatanganan Surat Niat
(Letter of Intent atau LoI) pada 26 Mei 2010. Norway akan memberikan kontribusi kepada
Indonesia berdasarkan pengurangan emisi yang terverifikasi yang sejalan dengan skema
REDD+.
Pada bulan September 2010, Presiden Yudhoyono mendirikan Satuan Tugas REDD+ untuk
memastikan bahwa implementasi REDD+ berjalan dengan baik melalui Keputusan Presiden
No.19/2010. Dr. Kuntoro Mangkusubroto dipilih sebagai Ketua dari satuan tugas lintas sektoral
ini, dan Kalimantan Selatan dipilih oleh Presiden sebagai provinsi percontohan dari program
REDD+ di Indonesia pada bulan Desember 2010.

Pelaksanaan Strategi REDD+

Strategi REDD+ di Indonesia bertujuan untuk mengatur sumber daya alam secara berkelanjutan
sebagai asset nasional demi kesejahteraan bangsa. Tujuan tersebut dapat tercapai melalui
implementasi di lima area fungsional pembangunan institusi dan proses yang menjamin

peningkatan tata kelola hutan dan lahan gambut, pengkajian ulang dan peningkatan kerangka
peraturan, meluncurkan program strategis untuk manajemen lansekap, merubah paradigma lama
dan melibatkan pemangku kepentingan utama secara bersamaan.
Sebagai provinsi percontohan, Kalimantan Tengah akan menjadi laboratorium untuk uji coba
penerapan dari lima area fungsional di atas. Provinsi lainnya di Indonesia akan menerapkan
strategi REDD+ sesuai dengan kepentingan masing-masing provinsi.
Untuk pelaksanaan di tingkat provinsi dan pusat, Satgas REDD+ akan membentuk institusi untuk
memonitor, mengkoordinasi, dan mengimplementasi kegiatan REDD+; serta institusi untuk
memonotir, melaporkan, dan meverifikasi. Sejalan dengan itu, instrumen pendanaan akan
ditetapkan untuk memastikan ketersediaan dana.

Apa yang akan terjadi selama moratorium dua tahun ini?

Pemerintah Indonesia berkomitmen untuk menjalankan suspensi dua tahun bagi pelepasan ijin
baru bagi hutan primer dan lahan gambut, yang dikenal juga sebagai moratorium. Jeda dua tahun
ini diatur oleh Presiden dalam Instruksi Presiden No 10/2011, dan akan memberikan kesempatan
bagi Indonesia untuk mengkaji pertumbuhan ekonomi dan implikasinya terhadap sumber daya
alam. Selama jeda ini, Indonesia akan mengupayakan agar implikasi tersebut semakin berkurang
dan turut mencari jalan keluar, terlepas dari skema bisnis seperti biasa, menuju jejak langkah
pembangunan yang baru.
Inpres tersebut memberikan kesempatan bagi peningkatan tata kelola hutan dengan mengkaji
ulang dan menyempurnakan kerangka peraturan untuk ijin tata kelola lahan dan membentuk
sistem data utama yang mencakup informasi yang menyeluruh tentang lahan kritis, yang dapat
meningkatkan perencanaan spasial serta mempermudah penentuan lahan untuk pembangunan,
serta mendukung perusahaan yang akan beroperasi pada lahan kritis.
Suspensi dua tahun ini akan memberikan kesempatan untuk peningkatan produktivitas pertanian,
penyelesaian permasalahan ijin tanah yang berbenturan dengan ijin konsesi serta hak para
masyarakat lokal, penguatan praktek penebangan dan penambangan yang berkelanjutan,
mengurangi pembalakkan liar dan menguragi pembebasan lahan yang menggunakan
pembakaran.
Pemerintah Indonesia berada dalam proses untuk menyediakan akses sebesar 30 juta ha lahan
kritis untuk pertumbuhan ekonomi dan ekspansi sebagai alternatif dari penggunaan hutan
sekunder dan lahan gambut.

Berapa banyak karbon yang dihasilkan dari deforestasi dan degradasi hutan?
UN IPCC (United Nations Intergovernmental Panel on Climate Change / Panel Perubahan Iklim
antar Pemerintah Perserikatan Bangsa-Bangsa) telah memperkirakan bahwa deforestasi dan
degradasi hutan memberikan kontribusi global hingga mencapai 17 persen dari seluruh emisi gas
rumah kaca yang berarti melebihi sektor transportasi dan peringkat ketiga setelah energi global

(26%) dan sektor-sektor industri (19%). Lebih dari 60% dari emisi karbon di Indonesia
dihasilkan dari deforestasi dan lahan gambut.

Apa itu REDD?

REDD adalah suatu mekanisme global untuk menciptakan suatu insentif bagi negara-negara
berkembang untuk melindungi dan mengelola sumber daya hutannya dengan lebih baik dan
bijaksana, dan memberikan kontribusi terhadap perjuangan global melawan perubahan iklim.
Strategi-strategi REDD bertujuan untuk membuat hutan lebih bernilai dari pada ketika hutan
tersebut ditebang, dengan menciptakan suatu nilai finansial terhadap karbon yang tersimpan di
dalam pepohonan. Jika karbon ini dinilai dan dihitung, tahap terakhir dari REDD adalah negaranegara maju membayarkan carbon offset kepada negara berkembang, atas tegakan hutan yang
mereka miliki.

Apa itu REDD+?

REDD+ tidak hanya terbatas pada pengurangan gas rumah kaca, namun juga memperhitungkan
peranan konservasi, manajemen hutan berkelanjutan dan peningkatan stok karbon. Pengurangan
Emisi dari Deforestasi dan Degradasi Hutan (REDD+) merupakan suatu mekanisme global yang
memberikan suatu kesempatan unik bagi negara berkembang seperti Indonesia, yang memiliki
wilayah hutan yang luas dan sedang menghadapi ancaman deforestasi.

Bagaimana Program REDD+ bisa menjamin bahwa masyarakat yang

bergantung pada hutan dan para pemelihara hutan di negara-negara
berkembang akan memperoleh manfaat dari REDD+?
Desain strategi REDD+ yang sah harus menyertakan pedoman dan pengamanan yang
memastikan bahwa manfaat REDD+ akan menyentuh masyarakat yang menjaga dan melindungi
hutan dan keragaman hayati. Program UN-REDD bekerja sangat dekat dengan berbagai negara
untuk melibatkan para pihak dan pemelihara hutan di segala tahapan desain dan implementasi
program, sehingga mereka merupakan pihak-pihak yang memperoleh manfaat dengan
melindungi hutan.

Selain menerima carbon offsets melalui suatu mekanisme REDD+, apa

keuntungan lain yang bisa dinikmati negara-negara berkembang dan
masyarakat lokal dari mengurangi deforestasi dan melindungi hutan?
Selain perannya sebagai penyimpan karbon, hutan memberikan berbagai layanan ekosistem bagi
masyarakat. Sifat dari layanan-layanan ini bervariasi di berbagai tempat, dan meliputi pengaturan
air, perlindungan tanah, produk-produk hutan selain kayu dan serat, pengaturan iklim dan
keragaman hayati.

Apakah peran hutan di negara berkembang?

Lebih dari tiga perempat air bersih di dunia berasal dari daerah resapan air di wilayah berhutan.
Kualitas air berkurang dengan menurunnya kondisi dan tutupan hutan, dan bencana alam seperti
banjir, longsor dan erosi tanah semakin menimbulkan dampak yang lebih besar. Hutan setiap
tahunnya menghasilkan lebih dari 3,3 milyar kubik meter kayu (termasuk 1,8 milyar kubik meter
kayu bakar dan arang), juga berbagai produk-produk hutan non kayu yang memainkan peranan
yang signifikan dalam perekonomian ratusan juta penduduk.

Apakah yang dilakukan oleh Indonesia untuk melindungi hutan dan lahan
gambutnya?
Sebagai suatu langkah pertama yang signifikan, Presiden menandatangani Instruksi Presiden
No.10/2011 pada tanggal 20 Mei 2011, yang mengikat Indonesia untuk melakukan penundaan
penerbitan izin baru selama dua tahun untuk penggunaan hutan alam primer dan lahan gambut.

Bagaimana Moratorium akan membantu REDD+?

Penundaan memberikan suatu kesempatan untuk meningkatkan tata kelola hutan dengan
menciptakan jeda untuk meningkatkan tata kelola hutan dengan mengkaji dan memperbaiki
kerangka peraturan untuk ijin penggunaan lahan dan menciptakan suatu sistem database dengan
informasi yang mendalam terkait lahan kritis sehingga memperkuat tata ruang, secara jelas
menetapkan lahan untuk pembangunan, dan mendukung perusahaan-perusahaan yang berpindah
ke lahan kritis. Penundaan selama dua-tahun akan memungkinkan untuk memulai dengan
lembaran yang bersih, dan mengembangkan sistem penggunaan lahan yang baru yang
memaksimalkan manfaat ekonomi dari penggunaan sumber daya alam di Indonesia dan
mengurangi emisi gas rumah kaca sesuai dengan komitmen internasional.

Over the past decade activist pressure, the emergence of competition from generic
manufacturers, and direct negotiation with pharmaceutical companies have all contributed to a
dramatic drop in the price of certain drugs to treat HIV and AIDS in developing countries.
The availability of cheap antiretroviral drugs has been instrumental in treatment scale-up for
resource-poor settings hard hit by the AIDS epidemic. Around 8 million people in low- and
middle-income countries are currently receiving drugs to treat HIV/AIDS.1 This would simply
not have been possible without a reduction in the price of antiretrovirals drugs (ARVs).
Despite significant advances, a number of problems related to the price of HIV drugs remain.
Not all drugs to treat HIV and AIDS are available at a suitably cheap price for poor countries,
meaning that many of the newer, more effective drugs are only available in the West. This page
looks at how the initial price reductions were achieved and the problems that many developing
countries still face in accessing cheap, appropriate antiretrovirals.

Reducing the price of HIV/AIDS treatment

Access to antiretroviral (ARV) treatment in Botswana
In 1996, HAART - an effective combination therapy that delays the onset of AIDS - became
available to those living with HIV in rich countries.2 Within four years, death rates for people
with HIV/AIDS in developed countries had dropped by 84 percent.3
At a cost of US$10,000-15,000 per person per year, these antiretroviral drugs were far too
expensive for the majority of people infected with HIV in resource poor countries. Five years
after HAART was introduced in the West, only 2 percent of people in developing countries were
receiving the life-saving drugs.4 In order for treatment to reach people living with HIV in the
developing world, the price of the drugs clearly needed to come down to an affordable level.
At the beginning of the new millennium there was a breakthrough in treatment provision for
resource poor areas when an Indian pharmaceutical company started to produce generic
antiretrovirals that were exactly the same as those made by large pharmaceutical companies, but
significantly cheaper. This sparked a price war between branded and generic drug makers, which
forced the large pharmaceutical companies to lower the price of their AIDS drugs. This
competition, coupled with pressure from activists, organisations - such as the Clinton Foundation
- and governments of poor countries with severe AIDS epidemics, dramatically reduced the price

of ARVs for developing countries. By the middle of 2001, triple combination therapy was
available from Indian generic manufacturers for as little as $295 per person per year.5
The price of antiretrovirals for low- and middle-income countries has continued to fall. Between
2004 and 2008, first-line antiretroviral regimens in lower- and middle-income countries declined
by 30-68 percent. The most widely used drug combination, stavudine (d4T)+lamivudine (3TC)
+nevirapine (NVP), is available for $US 64 per person per year.6 However, WHO recommends
that countries phase out the use of stavudine (or d4T), due to the severe side effects associated
with this drug.7
The role that generic drug production and price negotiations with multinational pharmaceutical
companies played in lowering the price of antiretrovirals is discussed in more detail below.

Generic drugs
Stop AIDS Campaign protest to raise awareness of the importance of affordable generic
medicines produced in India.
A generic drug is an identical copy (bioequivalent) of a brand name (or proprietary) drug.
Generics are exactly the same as their branded counterparts in dosage form, safety, strength,
route of administration, quality, performance characteristics and intended use. The notable
difference between the two is the price.
Generic drug manufacturers incur fewer costs in creating the generic drug, as they do not have to
cover the expense of drug discovery, or lengthy safety and efficacy trials. Instead generic makers
reverse-engineer known drug compounds. This means that generic manufacturers are able to
maintain profitability while offering the drug at a much lower cost.
This is problematic for pharmaceutical companies who argue that generic copying reduces their
profits and decreases the amount of money they can spend on researching and developing new
antiretroviral drugs. In order for the proprietary drug makers to recoup the money they spent on
drug creation, they are granted a patent (an intellectual property right), which is an exclusive
right that prevents others from making, using, selling, offering to sell, or importing their drug.
The patent typically lasts for twenty years.
Legislation in favour of the pharmaceutical industries right to patent their drugs - TRIPS - was
introduced in 1995. TRIPS - The Agreement on Trade Related Aspects of Intellectual Property
Rights introduced intellectual property law into the international trading system for the first
time and applies to all members of the World Trade Organization (WTO). Because the
implementation of TRIPS was to have a huge impact on generic drug production, the majority of
developing countries were given a ten-year transition period in which to comply. This means that
developing countries (such as India) were able to continue developing generic drugs until 2005,
whilst least developed countries have until 2016.

Generic drugs, FDCs and AIDS

In 2001, Indian generic drug manufacturer, Cipla, announced that it would sell a generic copy of
a triple-therapy antiretroviral for US$350 per patient per year. This had an incredible impact as
the competition this generated dramatically drove down the price of HIV drugs for developing
countries, thereby increasing the range of affordable options for national treatment programmes.
The graph below illustrates the effect of generic competition on proprietary drug prices between
2000 and 2001. It shows the lowest world price per patient per year of triple combination therapy
made up of stavudine (d4T)+lamivudine (3TC)+nevirapine (NVP).8

India is the largest supplier of generic ARVs to low- and middle- income countries, providing 80
percent of donor-funded ARVs to low- and middle-income countries.9 Brazil, Thailand and South
Africa also produce a significant amount of generic drugs and a number of African nations - such
as Zambia, Ghana, Tanzania, Uganda, Zimbabwe and Kenya - have developed local HIV drug
manufacturing facilities.10 11 12 13 14 In 2008 UNAIDS reported that national governments of 94
percent of countries with generalised epidemics, and 61 percent of countries with concentrated
epidemics, had national policies for using generics to promote antiretroviral access.15
The manufacture and export of generic drugs was not only a turning point in terms of the price of
ARVs, but also helped to revolutionise treatment for resource-poor settings by simplifying
HIV/AIDS treatment. In 2001, an Indian generic manufacturer produced a combination of three
antiretrovirals (patented by different pharmaceutical companies) into a single pill, known as a
fixed dose combination (FDC). This was only possible because India did not have to abide by
TRIPS legislation at this time and was therefore able to ignore the patents on the drugs.
FDCs were a significant innovation as they reduce the number of pills taken each day. Because
FDCs are easier to manage for both patients and health workers they increase adherence,
thereby reducing the incidence of drug resistance. The drugs were also available in heat resistant

forms, which proved extremely valuable for use in the developing world, where often there is
scarce access to refrigeration facilities.
Generic antiretrovirals are now widely used to treat HIV/AIDS in the developing world. They
have been integrated into many treatment programmes including PEPFAR - the President's
Emergency Plan for AIDS Relief. PEPFAR, the single greatest supporter of treatment provision
for HIV and AIDS in the developing world, began to distribute generic drugs through its
programmes in 2004-5. Generics now account for 98 percent of the drugs procured and supplied
through PEPFAR's Supply Chain Management System (SCMS), which provides antiretroviral
drugs to sixteen PEPFAR supported countries.16 From 2005-2008, generic ARVs allowed
PEPFAR to significantly scale up its procurement of ARV drugs, without a commensurate
increase in its spending on ARVs. Over this period, the increase in the proportion spent on
generics by PEPFAR from 9.2 percent to 76.4 percent resulted in more than $300 million in cost
savings.17
The role that the production of generic drugs had on the distribution of treatment for developing
countries cannot be underestimated. Quite simply, as Stephen Lewis, former UN Special Envoy
for AIDS in Africa, has said:
"we wouldnt have this extraordinary run of treatment in Africa now if it werent for the
generic drugs." 18

Pressure and negotiation with Big Pharma

In the early 2000s, large pharmaceutical companies (sometimes referred to as Big Pharma)
manufacturing drugs to treat HIV/AIDS were subject to intense pressure to lower their prices.
Organisations such as the Clinton foundation, Mdecins Sans Frontires and (later) UNITAID,
alongside AIDS activists and a number of national governments, all worked to achieve price
reductions.
In May 2000, five pharmaceutical companies offered to negotiate steep cuts in the price of HIV
and AIDS drugs for regions severely affected by the AIDS epidemic. Dr. Rolf Krebs, vice
chairman of Boehringer Ingelheim recognised that this was '' The first time that both the public
and private sector are joining forces to implement a major change in the care of HIV/AIDS in the
developing world.'' Although significant price reductions were achieved, the drugs remained
prohibitively expensive for many poor countries. Dr. Peter Piot, at the time Executive Director of
UNAIDS, called the negotiations ''A promising step in a long-term process'', whilst Mdecins
Sans Frontires called the negotiations ''A victory, but a small one, much like an elephant
giving birth to a mouse''.19
Around the same time, the Clinton administration issued an executive order which promised that
the US government would not interfere with African countries that violate American patent law
to obtain cheaper antiretroviral drugs.
South African AIDS activists

In 2001 Bill Clinton - following the end of his second term as US president - confirmed his
commitment to HIV/AIDS drug provision when he established the William J. Clinton
Foundation, containing an HIV/AIDS programme. Using the former Presidents contacts and
knowledge, the foundation has continually worked to increase access to HIV treatment by
negotiating pricing deals with drug manufacturers and working to improve health care services in
developing countries.20 Mdecins Sans Frontires does similar advocacy work and runs a major
'Campaign for Access to Essential Medicines'.21
Another significant event in drug price reduction also came in 2001 following an attempt by
thirty-nine major pharmaceutical companies to prosecute the South African government for
passing a law that allowed easy production and importation of generics. Big Pharma was
eventually forced to back down and drop the case following a tremendous outcry from the
international community including the South African government, the European Parliament and
300,000 people from over 130 countries who signed a petition against the action. One of the
pharmaceutical companies involved in the case, GlaxoSmithKline, even granted permission
(called a voluntary licence) to major South African generics producer Aspen, to share the rights
to their drugs AZT, 3TC and the combination Combivir without charge.22 This was a significant
case as it brought access to medicines for poor countries into the public consciousness.
In 2006 UNITAID - an international drug purchase facility - was established to ensure a stable
source of funding for drugs to treat HIV/AIDS, malaria and tuberculosis. UNITAID has
partnered with the Clinton Foundation's Clinton Health Access Initiative (CHAI) since 2006,
negotiating with manufacturers, including generic producers, to continually lower the price of
HIV drugs and supply them in over 70 developing countries. In 2009, they announced they had
reduced the price of a convenient once-daily pill (combining generic drugs tenofovir, lamivudine
and efavirenz) by 30 percent compared to the price they had negotiated in 2008.23 In partnership
with drug manufacturers Pfizer and Mylan, they also brought the price of a second-line therapy
regimen to below $500 dollars for the first time.24 25 Overall, they estimated that they managed to
reduce the price of leading child HIV treatment regimens by 64 percent and the price of leading
adult regimens by 43 percent in lower-income countries from 2006 to 2009. In 2011, UNITAID
and CHAI and the United Kingdom's Department for International Development (DFID)
announced another set of negotiations had led to further reductions in pricing for a tenofovir
based regimen (down to $159 per person per year, a 60 percent reduction on 2008) as well as a
WHO-recommended second line drug regimen (reduced to $410 per person per year).26 The price
reductions secured by the partnership since 2008 are projected to save $600 million from 2011 to
2014. Through their work, UNITAID and the Clinton Foundation have encouraged more
suppliers to enter into the paediatric and second-line therapy markets which have not been seen
by manufacturers as lucrative markets due to constraints on patent, lower demand, and more
complex production techniques.27
Negotiations with Big Pharma have led to a system of tiered pricing. Tiered pricing means that
the price at which the big pharmaceutical companies sell their drugs is calculated using formulas
based on average income per head, leading to lower prices in poor countries.28
"Preferential pricing is the only way how we can meet both conflicting needs in the fight against
AIDS. We can refinance our high research and development costs for innovative, new treatments

by the established price system in industrialised countries and can offer affordable medicines to
patients in poor countries who otherwise cannot afford antiretroviral medication"Alessandro
Banchi, chairman of Boehringer29
Although this system is beneficial to the large pharmaceutical companies, there are concerns that
the system is overcomplicated and overdependent on the goodwill of the large pharmaceutical
companies.
Sometimes, a country will simply override patent applications by drug manufacturers. In 2009,
India rejected patent applications on two antiretroviral drugs, tenofovir and darunavir. A
generically-produced version of the former drug could cost over five times less than a branded
version.30 The ruling also allows other countries that have rejected patents on these drugs to
import generic versions from India. A representative from Mdecins Sans Frontires said:
This is a really important day for HIV patients in developing countries. The rejection of the
patents on tenofovir opens up the market for new generic competitors to drive down the price of
this key HIV/AIDS drug.31
Later, in 2012, Indonesia's government issued compulsory licenses for a number of antiretroviral
drugs, allowing local drug companies to legally bypass drug patents and make their own, cheaper
versions for the treatment of HIV and Hepatitis.32
Another initiative to achieve optimal pricing is The Global Price Reporting Mechanism (GPRM).
Launched by the AIDS Medicines and Diagnostics Service (AMDS) in April 2005, the
mechanism provides information on transaction prices and quantities of antiretroviral drugs in
low- and middle-income countries.33 This web-based database assists countries in selecting the
most affordable drug and supplier. Formed from the information of numerous organisations the
GPRM allows a national and international market price comparison. Improving the access
countries have to market information widens their options whilst placing more pressure on
pharmaceutical companies to reduce their pricing.
A study of this database monitored ARV transactions in over 100 countries between 2002 and
2008.34 The review indicated significant differences in the prices paid for ARVs and a clear
decrease in the price of ARVs over this time period, particularly for generic ARVs. This fall is
believed to be associated with, among other reasons, producers of branded ARVs continuing to
waiver patents and lower their prices for low income countries as well as ongoing policy
formation to address market imperfections.35 However, vast differences in price still exist and
pressure to lower the prices of some drugs, notably protease inhibitors (PI), is still needed particularly as the demand for second-line therapy increases.

back to top AIDS, TRIPS and second-line therapy

Demonstrators protesting GlaxoSmithKline's policies regarding generic AIDS drugs in Africa
Since 2005, developing countries that are members of the WTO (such as India, Thailand and
Brazil) have been required by TRIPS to issue patents. Obliging developing countries to comply

with patent legislation has complicated the provision of HIV treatment. This is because although
patents have expired on a number of first-line AIDS drugs (making them available cheaply from
generic makers), patents still exist on most new and second-line medicines.
This is problematic as newer antiretroviral drugs are generally less toxic, easier to take and more
effective at fighting HIV. They are often needed when a patient has to change their antiretroviral
regime due to toxicity or resistance. Drugs used to combat resistance are called second-line drugs
and although the number of people in need of second-line drugs is expected to increase, these
drugs remain on average six times more expensive than drugs commonly used for first line
regimens.36
TRIPS has stifled the generic competition that drove the price of first generation antiretrovirals
down, causing huge disparities in the price of first- and second-line ARVs. In 2009 the median
cost of the most commonly used second-line regime (lamivudine+tenofovir+ritonavir-boosted
lopinavir) was US$554 in low-income countries, US$692 in lower-middle-income countries, and
US$601 in upper-middle-income countries per person per year.37 The vastly more expensive
second-line drugs mean that, despite very few people taking them, they still account for a large
proportion of the overall drug expenditure. In Brazil, for example, the Ministry of Health
currently spends 80 percent of its budget on imported patented drugs, even though they represent
only a small proportion of drugs used.38
The consequence of TRIPS is that the new, better drugs are only available in countries that have
the capacity to cover the high cost. Poor countries are forced to wait until their patent expires or
the proprietary prices are forced down. The access gap between people in wealthy and
developing countries has angered many, who feel that TRIPS further exacerbates difficulties in
supplying antiretroviral drugs to poor countries and puts the profit margins of the large
pharmaceuticals before public health. It is felt that if the capacity to provide generic effective, yet
cheap anti-HIV treatment to the developing world exists, then it is immoral not to allow the
production of drugs that will save millions of lives.
"We're starting from zero again by the time generic competition kicks in for the newer drugs,
millions of people will have died unnecessarily. MSF campaign for access to essential
medicines39
In light of these concerns, the WTO proposed two means by which generic versions of drugs
under patents may be produced.
We're starting from zero againby the time generic competition kicks in for the newer drugs,
millions of people will have died unnecessarily.
MSF campaign for access to essential medicines40
The first is called voluntary licensing. A government, an individual, or an organisation can
request a voluntary license from a patent holder (usually a large pharmaceutical company) to
allow generic drugs to be supplied during a public health emergency, either through imports or
by local production. A number of voluntary licenses have been granted to date including a

licence granted by Merck for South African generic producer Aspen Pharmacare to produce
efavirenz.41 The drawback of voluntary licenses is that they depend on the goodwill of the patent
holder, and can be lengthy to negotiate.
The second option, compulsory licensing, is discussed below.

Compulsory licensing
Legally a country can get around TRIPS patent enforcement by issuing a compulsory licence. A
compulsory licence is a government licence that enables someone other than the patent holder to
copy patented products and processes without fear of prosecution. Governments can issue them
if a patent owner abuses their rights by, for example, failing to offer their product on the market,
or offering it at a price that is too high for potential buyers to afford. Normally, to copy drugs for
this reason, the generic company has to negotiate with the original manufacturer to agree
royalties (money paid to the patent holder to make up for the loss of profit exclusivity).
However, following the 2001 Doha agreement a country can issue a compulsory licence for a
drug that treats a disease causing a severe health emergency in that country without royalties
being paid.42
Although in theory compulsory licensing offers a legal solution to patent protection for
HIV/AIDS treatment, in practice it is difficult to exploit for the following reasons:

Generic manufacturers are limited to producing only the quantities predefined in each
compulsory licence. This curbs the large-scale production that is required to deliver drugs
cheaply.

Certain large pharmaceutical companies have demonstrated that countries that issue
compulsory licences may face repercussions (see below).

It was ruled that licences should be granted predominantly to supply the domestic
market, making it difficult for poor countries lacking technological capabilities to access
generic drugs manufactured abroad.

This final point was a particular point of contention for those concerned with providing ARVs to
the developing world as it was felt that this effectively penalised the worlds poorest countries
that were already struggling to roll out HIV treatment.
The World Trade Organization (WTO) therefore issued the so-called paragraph 6 waiver which
allows members who are unable to produce pharmaceuticals at home and are suffering a serious
health crisis to import generics from other nations under compulsory licences (providing
exported drugs are not part of a commercial or industrial policy of the exporting country).43
Despite endorsement by the WTO, because of its complicated nature, compulsory licensing has
been used very little by low- and middle-income countries. In fact, to date Thailand provides an
excellent example of why other countries have been reluctant to follow suit.

Thailand has issued a number of compulsory licences for antiretroviral drugs including Merck &
Co.s Sustiva (efavirenz) in 2006 and Abbotts Kaletra (a combination of lopinavir &
ritonavir) in 2007.44 45 Abbott which is the tenth largest pharmaceutical company in the world was angered that Thailand had ignor[ed] the patent system and retaliated by announcing that it
would not be applying for licences to sell seven of its newest products in Thailand (one of which
was a new once-a-day heat resistant form of Kaletra which would have been extremely useful
in the hot Thai climate).46 Thailand has since been repeatedly placed on a US Trade
Representative 'priority watch list' of countries seen to be committing intellectual property
piracy.47 48 Although this has been detrimental for Thailand, it has helped to reduce the price of
Kaletra by half in many developing countries.49 In August 2010, the Thai government extended
compulsory licensing for Efavirenz and Kaletra until their patents expire (January 2012 for
Efavirenz and December 2016 for Kaletra).50
Brazil issued a compulsory license to produce a lower-cost, generic version of Merck's
antiretroviral Efavirenz in 2007. Recognising the repercussions that Brazil may face, President
Luiz Inacio Lula da Silva said:
Between our trade and our health, we have chosen to look after our health."51
Despite the WTO permitting production of certain ARVs under some conditions, there remain
other barriers to their manufacture and distribution. In February 2009 a shipment of second-line
generic ARV drugs was confiscated by Dutch customs authorities. The 49kg of abacavir sulfate
tablets produced by an Indian company, Aurobindo, were bound for a treatment programme in
Nigeria. The tablets were later released but the seizure highlighted tensions between the
European Unions rules on intellectual property rights and World Trade Organization rules
concerning the production of generic medicines.52

back to top The way forward

For the moment, most people that need antiretrovirals in the developing world are on first-line
therapy. However, as treatment becomes more widespread, people stay on treatment for longer
and resistance increases, the high price of second-line drugs is becoming a major issue.
Addressing this issue will become increasingly important to ensure the most cost-effective use of
available resources and the sustainability of treatment programmes.
Some countries, such as Thailand, Brazil and India have found innovative ways of securing
cheaper second-line drugs. But the problem is that these options are limited to countries with
political clout and financial stability and autonomy. As is all too often the case, it is the poorest
countries already struggling to manage their HIV epidemics that are the least likely to benefit
from the current system.
This video shows the problems that are preventing people from getting the HIV drugs they need.
Some have suggested that the only way forward is to abolish the TRIPS system for medicines
altogether, and replace it with an alternative form of remuneration and reward for innovative
research and development. However as this is unlikely, an alternative solution needs to be found.

One initiative created by UNITAID in 2009 is the patent pool".53 The objective of the pool is to
hold licences on various patented medicines, which generic companies can then produce at a
lower cost for poor countries.54 The production of generic versions of antiretrovirals can then be
more easily negotiated and therefore faster and more efficient. The first patent holder to license
an ARV drug to the patent pool was the National Institutes of Health for the drug darunavir.55
Then in July 2011, the pharmaceutical giant Gilead agreed to license four separate antiretroviral
drugs and one combination drug to the pool.56 Three of these were 'pipeline products', meaning
they are still in clinical development. However, their inclusion in the license agreement means
that they will be far more widely available when they come onto the market than they would
have been if they had not been included. In response to Gilead's decision, the chair of UNITAID
stated..."This is an historic day and a good day for people living with HIV/AIDS in developing
countries."57 Although a promising step, the Medicines Patent Pool will require the voluntary
participation of other large pharmaceuticals as well to have sustained impact.
In October 2011, Aurobindo Pharma and MedChem, became the first producers of generic
antiretroviral drugs to join the Medecines Patent Pool. Under the new agreement, the
pharmaceutical companies are licensed to produce a number of generic antiretroviral drugs,
which should lead to these antiretrovirals becoming cheaper and easier to access.58 Then, in early
2013, in a move that will go a long way towards improving access to treatment among children,
ViiV Healthcare, added a paediatric formulation of the antiretroviral drug abacavir to the patent
pool, with negotiations around further licenses on the horizon.59
Prices of ARVs have been driven down substantially over the years, allowing millions of people
to live with the virus. However, greater effort, cooperation and innovation is needed to achieve
universal access to affordable life saving HIV treatment.