NGOs laud ministry’s efforts as a win for public health

  • Tuesday, 20 Mar 2018

PETALING JAYA: NGOs are happy that patients can now be cured of Hepatitis C after the Government issued a compulsory licence to gain access to the effective drug.

Third World Network (TWN) programmes director Chee Yoke Ling said it welcomed this long-awaited day when Malaysians who needed affordable Hepatitis C treatment could finally be cured.

She said the great efforts of the Health Ministry over several years had achieved a victory for public health.

“Malaysia is now able to buy generic sofosbuvir at one of the lowest prices in the world.

TWN also urged the authorities to expand the availability of treatment to university hospitals under the Education Ministry.

Drugs for Neglected Diseases initiative (DNDi) South-East Asia regional office head Jean-Michel Piedagnel said no other country in the world went as far in providing life-saving Hepatitis C treatment to all.

“It shows that public political leadership is essential in promoting access to healthcare. Proud to be part of the team,” he said.

DNDi is an international non-profit drug research and development organisation, of which the Health Ministry is a founding member.

Malaysian Medical Association president Dr Ravindran R. Naidu said the free Hepatitis C treatment was a step in the right direction.

“However, at present, treatment is only in government hospitals and the patients have to be carefully selected,” he said, adding that the free treatment would initially be available only in 18 government hospitals nationwide.

Positive Malaysian Treatment and Advocacy Group director Edward Low also agreed that the move to make Hepatitis C treatment free was a good start.

“We hope this treatment programme is able to expand to the primary healthcare centres like district clinics because the oral medicines are easy to monitor by trained physicians,” said Low when contacted.

Read more at https://www.thestar.com.my/news/nation/2018/03/20/ngos-laud-ministrys-efforts-as-a-win-for-public-health/#tfgRlsvqjxppt2P8.99

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Rawatan Hepatitis C percuma di 18 hospital kerajaan

MENTERI Kesihatan, Datuk Seri Dr S Subramaniam berbual dengan seorang pesakit pada lawatan rasmi di Hospital Selayang hari ini. Turut hadir Ketua Pengarah Kesihatan, Datuk Dr Noor Hisham Abdullah. – Foto Aizuddin Saad

SELAYANG : Seramai 2,000 pesakit kronik Hepatitis C bakal menikmati rawatan antiviral secara percuma di 18 hospital kerajaan seluruh negara.

Menteri Kesihatan, Datuk Seri Dr S Subramaniam, berkata ada 23,000 pesakit Hepatitis C yang sudah berdaftar dengan kementerian untuk mendapatkan rawatan itu.

Katanya, rawatan yang dimulakan sejak dua minggu lalu disasar dapat memberi manfaat kepada seramai lebih 400,000 pesakit Hepatitis C di seluruh negara mengikut anggaran Pertubuhan Kesihatan Sedunia (WHO), dengan sebilangan besar masyarakat belum tahu mereka menghidap penyakit itu.

“Rawatan berkenaan adalah pencapaian terbaik negara kerana menjadi negara pertama dunia menggunakan compulsory licence (CL) untuk rawatan hepatitis C.

“Ubat generik ini memberi makna besar kepada negara dan pesakit kerana ia boleh membunuh virus, pada masa sama menghalang ia daripada menjangkiti orang lain,” katanya.

Beliau berkata demikian pada Majlis Inisiasi Ubatan Direct Acting Antiviral (DAA) untuk rawatan Hepatitis C di Hospital Selayang di sini hari ini.

Yang turut hadir Ketua Pengarah Kesihatan, Datuk Dr Noor Hisham Abdullah; Pengarah Biro Kawalan Farmaseutikal Kebangsaan, Bahagian Perkhidmatan Farmasi Kementerian Kesihatan, Dr Salmah Bahri dan Pengarah Hospital Selayang, Dr Siti Zaleha Mohd Salleh.

Beliau turut meluangkan masa melakukan lawatan ke wad Hepatologi di situ.

Katanya, hepatitis C atau penyakit berkaitan hati adalah adalah antara isu kesihatan awam yang besar.

Pesakit yang tidak dirawat berpotensi untuk mengidap penyakit lain berkaitan hati, termasuk kemungkinan mendapat barah hati.

Ia boleh berjangkit menerusi transfusi darah.

Dr Subramaniam, berkata DAA yang diimport dari Mesir dianggap sebagai kos efektif malah diyakini berupaya menyembuhkan penyakit hingga 95 peratus.

“Dulu untuk seorang pesakit kita menanggung kos hingga RM50,000 untuk 12 kali rawatan seorang, tetapi dengan ubat ini, kita berupaya mengurangkan hingga RM1,000 saja untuk seorang pesakit,” katanya.

Dalam usaha menangani Hepatitis C, Kementerian giat menjalankan pemeriksaan darah bagi mengenal pasti individu dijangkiti supaya mereka mendapat rawatan sewajarnya.

Sementara itu mengulas mengenai insiden kebakaran di Hospital Kuala Lumpur (HKL) baru-baru ini, beliau berkata pihaknya sedang menunggu laporan forensik bomba.

Katanya, dalam langkah keselamatan, pihaknya turut melakukan audit pada semua hospital yang berusia lebih 20 tahun sejak tahun lalu.

“Kita turut memperkasakan kakitangan mengenai aspek keselamatan termasuk kebakaran dan ia dijalankan secara berterusan.

“Antara langkah kita selalu tekankan kepada kakitangan, ialah memadamkan sumber oksigen dan hentikan bekalan elektrik bagi mengelakkan risiko lebih teruk daripada berlaku,” katanya.

Kebakaran berlaku Sabtu lalu didakwa disebabkan oleh litar pintas dan merebak dengan cepat kerana stor tempat berlaku kebakaran, turut digunakan untuk menyimpan banyak peralatan perubatan daripada plastik.

https://www.bharian.com.my/berita/nasional/2018/03/401248/rawatan-hepatitis-c-percuma-di-18-hospital-kerajaan

Putting lives above profits for Hepatitis C treatment

A HIGHLY effective drug which can cure Hepatitis C hit the market in 2013 but five years later, over 70 million people around the world are still not getting the needed treatment.

In Malaysia, that was initially the fate of an estimated 400,000 pa­­tients for this disease, amid intense debates whe­ther the cheaper generic version of drugs should be made available to more people.

One major reason for the untreated millions of people was the prohibitive price.

When the direct acting anti-viral medicine (DAA) sofosbuvir was first introduced in the United States, it cost US$84,000 (RM324,000) for a full 12-week treatment course.

Last year, The Star reported that Malaysia was not given special pricing for the drug by pharmaceutical companies because it is considered a middle-income country, even though the disease is a major public health threat.

Negotiations with the drug company failed after it gave its last offer at RM50,000 for a 12-week full-course treatment, said Health Mi­­nis­ter Datuk Seri Dr S. Subrama­niam recently.

The Government then defied the odds and became the first in the world to gain access to the generic version of sofosbuvir through compulsory licence (CL), an authorisation that allows access to generic products at a much lower cost while the patent is still underway.

It is part of the flexibility provided under the World Trade Organi­sation’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. It brought the cost down to RM1,000 for the full-course treatment in combination with daclatasvir.

This led to the wrath of big pharmaceutical companies which pressured Malaysia to retract its position, saying that the decision discouraged innovation. They even got the US government to intervene.

Meanwhile, in developed countries, governments could only provide a limited number of treatments a year due to the high cost.

In the United States, 18 lawmakers wrote in February to the Department of Health and Human Services to consider issuing CL for expensive Hepatitis C treatments.

They argued that rationing current treatment only to those with advanced forms of the disease is harming public health in the country.

The number of people worldwide who have not been treated is a staggering 71 million, according to the latest World Health Organisation (WHO) 2018 progress report on access to Hepatitis C treatment.

The number of those who initiated DAA-based treatment for Hepa­ti­tis C was negligible, with an increase from about one million in 2015 to 1.5 million in 2016, it said.

This is despite the fact that 95% of people with Hepatitis C can be completely cured within two or three months.

While pharmaceutical companies want their intellectual property rights to be recognised, governments and civil society are asking if astronomical pricing of drugs is justified.

It is important to recognise that it is costly to develop drugs, including the cost of clinical trials. Pharma­ceutical companies also have to answer to shareholders. But how much profit is too much and what is the value of human lives?

Gilead Sciences’ representative said it does not wish to comment for now.

However, the US Senate investigation of Gilead Sciences revealed that Pharmasset had initially considered a price of US$36,000 (RM138,900) for sofosbuvir.

But Gilead Sciences, which had acquired Pharmasset, set the market price at US$84,000 (RM324,000), according to The BMJ journal report.

The report, “Betting on Hepatitis C: How Financial Speculation in Drug Development Influences Access to Medicines” on July 27, 2016, said the price was set “after internal deliberation over multiple factors, including an evaluation of the high prices of previous drugs and how much health systems could bear”.

“The resulting cycle of profit accumulation, speculation, and higher prices deepens the problem of affordable access to medicines,” it said.

It also said that by the first quarter of 2016, Gilead had accumulated over US$35bil in global revenue from Hepatitis C medicines since its launch in December 2013.

The revenue was more than triple the cost of the initial acquisition of Pharmasset and nearly 40 times the cost of Gilead and Pharmasset’s combined reported costs for developing sofosbuvir-based medicines, it said.

It brings into question the purpose of a new discovery or innovation. It is supposed to bring progress and better health to mankind. But what purpose does it serve when millions are unable to afford it?

A lot of rethinking is needed if the world is to achieve better health outcomes with Hepatitis C.

The WHO report urged governments to scale up treatments by procuring the more affordable generic DAAs, which have become available through voluntary licensing or local production.

Drugs for Neglected Diseases initiative (DNDi) South-East Asia regional office head Jean-Michel Piedagnel said pharmaceutical companies should cover their R&D cost and make some profit but they should also base their profit on volume rather than a small market to enable the disease to be tackled from a public health approach.

“When cost is prohibitive, only a limited number of people will be treated and Hepatitis C infection will still be transmitted.

“Malaysia using CL in making drugs affordable and tackling Hepatitis C through public health approach is a game changer.

“The approach could eliminate Hepatitis C,” he said.

Third World Network programmes director Chee Yoke Ling said the misuse of patents includes the issue of “ever greening” – the use of various strategies to file many patents around a medicine which can increase the market mono­­poly beyond the normal term of 20 years for the first patent.

In Malaysia, patients in public hospitals started receiving DAAs treatment last month following the CL move.

The move had also led to Gilead Sciences announcing on Aug 24 to include Malaysia in the Hepatitis C generic licensing agreement with several Indian manufacturers.

The granting of a sofosbuvir voluntary licence (VL) meant that it will be possible for lower-cost gene­ric versions of the drug to be made available. The price before the VL was US$30,000 (RM128,115) per person.

While WHO has called on countries to step up its fight against He­­patitis C, pharmaceutical companies too need to be more conscionable and introduce a business mo­­del that provides the support needed for nations, instead of purely maximising profit.

Read more at https://www.thestar.com.my/news/nation/2018/04/07/putting-lives-above-profits-for-hepatitis-c-treatment/#YfT6Hc1rzY5Wc7P8.99

Health D-G: New Hepatitis C treatment has 97% cure rate

KUALA LUMPUR: A new affordable Hepatitis C treatment – with Malaysian involvement in clinical trials – has shown a 97% cure rate and is able to treat the most severe form of the disease.

The treatment, which uses the drug ravidasvir in combination with a generic version of sofosbuvir, has been shown to be safe and effective, with extremely high cure rates for patients including hard-to-treat cases, according to interim trial results.

The results were presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.

“As hepatitis C has become a major public health concern in Malaysia, it is crucial to increase access to treatment for the benefit of the nation,” said Health director-general Datuk Dr Noor Hisham Abdullah (pic) in a press release issued by the DNDi on Thursday (April 12).

In September 2017, The Star reported that the Government announced it had issued a “government-use” license on sofosbuvir to allow 400,000 Hepatitis C patients in Malaysia to access generic version of the drug in public hospitals.

Tthe new combination drug announced by DNDi will be able to treat Genotype 3, which is the most severe form of Hepatitis C.

Read more at https://www.thestar.com.my/news/nation/2018/04/12/health-d-g-new-hepatitis-c-treatment-has-97-cure-rate/#hcSxVsgvHiloKIPr.99

Rawatan kombinasi hepatitis C mampu bayar yang baharu menunjukkan 97% kadar kesembuhan

Paris, 12 April 2018

Hasil keputusan menyokong pendekatan kesihatan awam terhadap hepatitis C

Satu rawatan kombinasi hepatitis C mampu bayar yang melibatkan calon ubat terbaharu, ravidasvir telah dibuktikan selamat dan berkesan, dengan kadar kesembuhan yang sangat tinggi kepada pesakit, termasuk kes-kes yang sukar dirawat. Ini ialah hasil keputusan interim ujian percubaan Fasa II/III STORM-C-1 yang dibentangkan oleh pertubuhan penyelidikan dan pembangunan bukan berasaskan keuntungan iaitu inisiatif bagi Ubat untuk Penyakit Yang Diabaikan (DNDi) di Persidangan Hati Antarabangsa di Paris.

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Healthcare worker examines liver of hepatitis C patient in Thailand

Keputusan menunjukkan bahawa kombinasi sofosbuvir/ravidasvir adalah setanding dengan terapi terbaik untuk hepatitis C yang terdapat hari ini tetapi dijual pada harga mampu bayar dan boleh menjadi pilihan alternatif di negara-negara yang dikecualikan daripada program akses kepada syarikat farmaseutikal,” kata Dr Bernard Pécoul, Pengarah Eksekutif DNDi.

Ujian percubaan menggunakan ubat yang dikeluarkan oleh pengeluar ubat Mesir, Pharco Pharmaceuticals ini telah dijalankan oleh DNDi dan ditaja bersama oleh Kementerian Kesihatan Malaysia, di sepuluh tapak di Malaysia dan Thailand. Perjanjian-perjanjian yang telah ditandatangani pada 2016 dan 2017 membolehkan ujian-ujian percubaan dan peningkatan pesakit di Malaysia memulakan harga sasaran US$300 untuk rawatan selama 12 minggu, hampir 100% pengurangan daripada harga rawatan sedia ada di Malaysia.

Memandangkan hepatitis C telah menjadi salah satu masalah kesihatan awam utama di Malaysia, adalah penting untuk meningkatkan akses kepada rawatan demi manfaat negara,” kata Datuk Dr Noor Hisham Abdullah, Ketua Pengarah Kesihatan, Kementerian Kesihatan Malaysia. Pada September 2017, kerajaan Malaysia telah mengeluarkan lesen “kegunaan kerajaan” ke atas paten-paten sofosbuvir bagi membenarkan 400,000 pesakit hepatitis C di Malaysia mendapat akses kepada rejimen HCV generik di hospital-hospital awam.

DNDi menjalankan ujian percubaan label terbuka STORM-C-1 untuk menilai keberkesanan, keselamatan, toleran dan farmakokinetik calon ubat ravidasvir yang digabungkan dengan sofosbuvir. 301 pesakit dewasa dengan jangkitan teruk telah dirawat dengan kombinasi ravidasvir/sofosbuvir selama 12 minggu untuk pesakit tanpa sirosis hati dan 24 minggu untuk pesakit dengan sirosis terkompensasi. Selaras dengan piawaian antarabangsa yang menakrifkan kesembuhan bagi rawatan HCV, 12 minggu selepas tamat tempoh rawatan, 97% daripada mereka yang terlibat telah sembuh (95% CI: 94.4-98.6). Kadar kesembuhan adalah sangat tinggi walaupun bagi pesakit yang paling sukar dirawat: pesakit dengan sirosis hati (96% sembuh), pesakit yang menghidap HIV menggunakan rawatan biasa mereka (97%), pesakit yang dijangkiti dengan genotip 3 (97%) termasuk mereka dengan sirosis (96%) dan pesakit yang telah diberikan rawatan HCV sebelum ini (96%). Yang penting, pesakit yang mengalami kombinasi beberapa daripada faktor-faktor risiko ini telah sembuh dan tiada isyarat keselamatan luar jangka telah dikesan.

Figure: STORM-C-1 : SVR12 rates overall and per pre-defined sub groups-Intend to treat analysis
Analisa kadar keseluruhan STORM-C-1 : SVR12 dan bagi setiap kumpulan kecil pra-takrif yang dicadang untuk dirawat

Dari perspektif penyedia rawatan, ini ialah perkembangan yang sangat menarik kerana kita telah lama menantikan satu rawatan yang mudah, mampu bayar dan kuat yang boleh diterima oleh semua kumpulan pesakit termasuk mereka yang hasil rawatannya pada masa ini adalah yang lebih kurang baik, seperti pesakit yang menerima terapi antiretroviral,” kata Pierre Mendiharat, Timbalan Pengarah Operasi untuk Médecins Sans Frontières / Doktor Tanpa Sempadan (MSF). “Ini penting untuk memperluaskan rawatan kepada pesakit dalam kategori paling lemah di negara-negara sedang membangun.” MSF dan DNDi bekerjasama untuk meningkatkan akses kepada penjagaan dan rawatan untuk pesakit-pesakit HCV di negara-negara berpendapatan rendah dan pertengahan yang utama, melalui projek STORM-C yang dibiayai oleh inisiatif Keupayaan Pelaburan Transformasi (TIC) MSF.

Lebih 71 juta orang menghidap hepatitis C di seluruh dunia, sejenis penyakit yang telah menyebabkan 400,000 kematian setiap tahun. Walaupun rawatan yang sangat berkesan telah wujud selama beberapa tahun, kurang daripada tiga juta orang menerima rawatan tersebut, sedangkan lebih ramai orang yang dijangkiti setiap tahun berbanding jumlah yang diberikan rawatan. Pertubuhan Kesihatan Sedunia menyasarkan 80% pesakit yang didiagnosis dengan HCV mendapat rawatan menjelang 2030.

Ravidasvir ialah perencat NS5A oral yang dilesenkan kepada DNDi oleh Presidio Pharmaceuticals. Kebanyakan pesakit yang terlibat dalam ujian percubaan DNDi di Malaysia dan Thailand mempunyai genotip 1 (42% daripada peserta) atau genotip 3 (53%), dengan itu mengesahkan keberkesanan kombinasi tersebut untuk kedua-dua genotip tambahan ini. Ujian-ujian percubaan lanjut dirancang untuk mendokumenkan keberkesanan dan keselamatan kombinasi tersebut kepada pesakit yang dijangkiti dengan genotip HCV yang lain, terutamanya kepada kumpulan-kumpulan yang lemah, bagi memungkinkan pendekatan kesihatan awam kepada rawatan hepatitis C.

Pharco berasa bangga dapat membolehkan pendekatan kesihatan awam kepada rawatan hepatitis C dengan menyediakan rawatan mampu bayar. Kami berharap akan dapat meneruskan kolaborasi ini pada masa hadapan dalam ujian percubaan klinikal tambahan bagi mengesahkan keberkesanan dan keselamatan ravidasvir,” kata Dr. Sherine Helmy, CEO, Pharco.

 

RCEP trade round: Singapore host privileges business over people’s rights

3 May 2018

RCEP trade round: Singapore host privileges business over people’s rights

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Singapore: Trade officials from 16 countries that are negotiating the Regional Comprehensive Economic Partnership (RCEP) are meeting in Singapore this week to advance this ambitious mega-Free Trade Agreement (FTA), however civil society has been shut out.

Civil society has worked hard to gain access and a voice in previous rounds, although not nearly enough. At the negotiating rounds in the Philippines, Indonesia, Japan, South Korea and India, key representatives of civil society were at least invited to share their concerns.

The Singapore government has gone backwards. Today, it hosted Transnational Corporations (TNCs) and other local business groups at a Business Dialogue to identify their interests and concerns. Trade unions, farmers and civil society organisations who will be adversely affected by RCEP were excluded.

The negotiations to further open up and deregulate sectors such as agriculture, public services, manufacturing and the digital economy are taking place under complete secrecy and no text has been made public, despite that the negotiations have been on-going for the past six years.

“ASEAN governments have been asserting ASEAN centrality throughout these RCEP talks. Meaningful consultations are important to voice the concerns of people. The consultation in Singapore has effectively shut out peoples’ voices and instead provided privileged access once again to business. This exposes further the democratic deficit in the RCEP process”, said Joseph Purugganan, of Focus on the Global South and convenor of Trade Justice Pilipinas .

“People living with HIV across the world have benefited from generic competition from India, which dramatically increased access to affordable medicines. We are extremely worried that Japan and South Korea continue to attack this lifeline by pushing for harmful IP provisions in RCEP negotiations. At this negotiating round in Singapore, it is disheartening to note that while multinational corporations find place at the stakeholders meeting and are being consulted, HIV positive people — whose lives are at stake — in the IP negotiations of this trade agreement are being kept in the dark,” said Paul Lhungdim, from Delhi Network of Positive People.

“The Governments and TNCs gathered in Singapore are deciding the rules for tomorrow’s digitised economy. It defies logic that workers, whose fundamental rights will be directly affected by these new rules, have been completely shut out of this process. Meaningful engagement with workers and other affected communities from across the region is a necessary precursor for workers to exercise their democratic rights; what we have seen here makes a mockery of these rights.” said Building and Wood Workers International (BWI) Regional Representative Apolinar Tolentino. BWI represents close to 4 million workers in the Asia-Pacific region, with affiliate unions in thirteen of the sixteen RCEP countries.

Civil society members are also gathered in Singapore for their own meeting on RCEP reminded their governments that it is their collective responsibility to ensure that, as a minimum, inclusive and comprehensive stakeholder consultations are held as recognised inputs into each round of negotiations. Country representatives cannot hide behind the lack of political will of the host country and need to ensure that minimum standards for enabling meaningful and inclusive stakeholder input is set for future rounds of RCEP negotiations.

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Fire In The Blood

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An intricate tale of ‘medicine, monopoly, and malice’, Fire in the Blood tells the story of how Western pharmaceutical companies and governments aggressively blocked access to low-cost AIDS drugs for the countries of Africa and the global south in the years after 1996 – causing ten million or more unnecessary deaths – and the improbable group of people who decided to fight back.

Shot on four continents and including contributions from global figures such Bill Clinton, Desmond Tutu and Joseph Stiglitz, Fire in the Blood is the never-before-told true story of the remarkable coalition which came together to stop ‘the Crime of the Century’ and save millions of lives in the process.

As the film makes clear, however, this story is by no means over. With dramatic past victories having given way to serious setbacks engineered far from public view, the real fight for access to the life-saving medicine is almost certainly just beginning.

“The untold story of how an unlikely group of people took on giant pharmaceutical companies and major Western governments to stop ‘the Crime of the Century’ and save millions of lives.”

You are specially invited for the virgin screening in Malaysia of this acclaim Sundance Film Festival’s

Official Selection 2013 documentary movie on ‘medicine, monopoly, and malice’, Fire in the Blood (FITB), which is joined by its writer/director/producer Mr Dylan Mohan Gray.

There will be an hour of panel discussion right immediately after the 1 and half hour documentary movie screening, led by a panel of distinguished members of the parliament, the Ministry of Health,
Patent Office, and the Program Director of the Third World Network of Malaysia.

Kindly RSVP your attendance by/before 12:00noon on 25 May 2018 (Friday) as there is limited spaces available, and there will be a light refreshment given out by ticket only at the end of the movie screening session in conjunction with Ramadhan open fasting period.

 

RCEP and Health: This Kind of ‘Progress’ is Not What India and the World Need

Concerns remain over the impact of RCEP negotiations on public health and access to medicines

The availability of affordable drugs should not be compromised in the rush to negotiate a new regional trade deal. Credit: Flickr/rakka CC 2.0

Negotiators from 16 countries are meeting in Kobe, Japan on Monday to begin the 17th round of negotiations of the Regional Comprehensive Economic Partnership (RCEP) agreement. Launched in 2012, the RCEP negotiations are taking place between the Association of South East Asian Nations (ASEAN) which comprises 10 countries (Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam) and six countries with which the ASEAN bloc has pre-existing trade agreements – India, Australia, China, Japan, New Zealand and South Korea.

Since the recent demise of the Trans Pacific Partnership (TPP) agreement, all eyes have turned to the RCEP negotiations that now carry, in the opinion of some, the heavy burden of rescuing the international free trade regime from the growing tendency to protectionism. Unfortunately, the RCEP negotiations suffer the same flaws as the TPP, particularly in the context of public health. As with the TPP and most other free trade negotiations, RCEP too is being negotiated behind closed doors, with limited access for public interest and health groups, and the only negotiating texts available in the public domain coming from regular online leaks. An analysis of these leaked texts shows that Japan and South Korea are proposing intellectual property (IP) provisions referred to as TRIPS-plus, in that they go far beyond the obligations under the World Trade Organisation’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Such provisions are a cause for great concern among public health groups over their potential adverse impact on access to affordable medicines.

High priced patented medicines in Asia-Pacific countries

All developing countries in the RCEP negotiations are now implementing the TRIPS Agreement and granting 20 year patents on pharmaceutical products; the impact of the resulting high priced patented medicines is being felt directly by patients and government programmes. Around 2.1 million people living with HIV in the Asia–Pacific region had access to antiretroviral therapy in 2015, which accounts for approximately one in three people living with HIV. Scaling up of HIV treatment across the region remains slow. For developing countries in the region, categorised as middle income countries by the World Bank, their access to international aid, particularly from the Global Fund, is decreasing while at the same time multinational pharmaceutical companies are withdrawing lower prices for their medicines and excluding several of these countries from voluntary licenses with generic companies. A 2014 WHO report found widely varying prices for HIV medicines in middle income countries impacted by their patent status and licensing deals. According to information provided by the Positive Malaysian Treatment Access and Advocacy Group (MTAAG) the second line combination of tenofovir+emtricitabine+lopinavir/ritonavir costs US$ 3204 per year in Malaysia; generic prices for these drugs could total as low as US$ 307 per year.

For people living with hepatitis C, access to directly acting antivirals (DAAs) like sofosbuvir, ledipasvir and daclatasvir, has also been severely hampered by high prices and restrictive voluntary licensing by patent holders. In the case of sofosbuvir and ledipasvir, Gilead has issued voluntary licenses to generic companies to produce low cost versions that exclude China, Malaysia, and Thailand among the developing countries in the RCEP negotiations. In the case of daclatasvir, BMS and the Medicines Patent Pool have issued voluntary licenses to generic companies that exclude China, Malaysia, and Thailand. For the countries excluded, Gilead and BMS are negotiating extremely high prices; according to MTAAG, patients in Malaysia are paying US$40,667 for a 12 week course of Gilead’s version of the sofosbuvir/ledipavir combination. Meanwhile community groups in India are procuring 12 week courses of sofosbuvir for US$324; of daclatasvir for US$153; and of sofosbuvir and ledipasvir fixed dose combination for US$507.

Like much of the developing world, the Asia-Pacific region is also witnessing a rise in the incidence of non-communicable diseases (NCDs).. The cost of oncology drugs, particularly for biologics, remains unaffordable in developing countries. As pointed out by Dr. Margaret Chan, executive director, WHO, “Developing countries now account for around 70% of all cancer deaths. Many of these people die without treatment, not even pain relief. Estimates for 2010 indicate that cancer cost the world economy nearly $1.2 trillion.”

Global leaders in use of TRIPS flexibilities

To deal with the high prices of patented medicines, several developing countries in the Asia-Pacific region are using TRIPS flexibilities to ensure access to affordable generic medicines. The right of all WTO members to use these flexibilities was reiterated in 2001 in the Doha Declaration on TRIPS and Public Health which stated that “the (TRIPS) agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”.

Among the RCEP negotiating countries, Malaysia (2003), Indonesia (2004, 2007 and 2012), Thailand (2006 and 2008) and India (2012) have issued compulsory licenses to ensure generic competition for medicines for HIV, heart disease and cancer. India and the Philippines have included statutory provisions in their laws that incorporate strict patentability criteria including a prohibition on evergreening – the practice of patent holders extending monopolies on medicines by filing successive and overlapping patents on new forms and new uses of old medicines. As a result of the use of this and other provisions in India, first and second line AIDS drugs remain off-patent in India. The patent laws of most RCEP developing countries include several other TRIPS-flexibilities as well, such as parallel imports, early working, research and experimental exceptions among others.

TRIPS-plus provisions: What’s on the RCEP table?

Despite being strong proponents and users of TRIPS flexibilities, developing countries in the region now find themselves in the midst of trade negotiations that could severely restrict their ability to use these flexibilities. According to the leaked IP chapter of the RCEP negotiations, several TRIPS-plus provisions appear to be on the table that could adversely impact public health and access to medicines including:

  • Data Exclusivity that prevents governments from relying on clinical trial data to register generic versions of medicines even if they are off-patent, their patents have expired or are revoked & complicates the issuance of compulsory licences;
  • Patent Term Extensions that extend patent life beyond 20 years and further delay generic entry;
  • Weakened Patentability Criteria that could put restrictions in terms of the time period and content of material that the patent office can take into consideration in determining whether a medicine is actually new or inventive (see provisions on grace periods and worldwide novelty);
  • Accelerated Patent Examination that may create undue pressure on already burdened patent offices in developing countries with limited human and financial resources to take hurried decisions on pharmaceutical patent applications that require close, detailed scrutiny;
  • Technical Assistance measures that may result in the indirect introduction of the lower patentability standards of developed countries into developing country patent offices through patent examiner trainings and increasing reliance on patent examination reports and conclusions of developed countries;
  • Weakened Patent Exceptions that may impose restrictions on how developing countries in the Asia-Pacific region employ and define research and experimental exceptions to patent rights;
  • Border Measures that may deny medicines to patients in other developing countries with custom officials seizing generic medicines that are being imported or exported;
  • Injunctions and Damages that could undermine the independence of the judiciary in issuing orders relating to the enforcement of patents, particularly in a manner that prioritises the right to health of patients;
  • Other IP Enforcement Measures that could put third parties like treatment providers at risk of court cases and draw the whole manufacturing, distribution & supply chain for generic medicines into litigation;
  • WTO-Plus Dispute Settlement On TRIPS by including TRIPS compliance in the RCEP negotiations, RCEP countries could sue each other for alleged TRIPS violations outside of the WTO Dispute Settlement Body

The RCEP region consists of the ASEAN countries plus India, Australia, New Zealand, Japan and South Korea

At the insistence of India and the ASEAN bloc, a provision reciting and re-affirming the commitment of RCEP countries to the Doha Declaration has been included. This is an important indication that the impact of these negotiations on public health is certainly obvious to at least some of the negotiating countries. Unfortunately, this alone may be insufficient to address public health concerns. Some commentators cast doubts on the impact of such an inclusion, referring to it as “usual – and usually ineffective” – as a reference to the Doha Declaration in such negotiations is largely self-contradictory. The Doha Declaration reaffirms flexibilities in the TRIPS Agreement. The TRIPS-plus demands of developed countries in the RCEP negotiations require governments to give up or greatly limit these flexibilities, making the reference to the Doha Declaration little more than lip service. Certainly an argument could be made that the reaffirmation of Doha in RCEP could strengthen the hands of developing countries in their use of TRIPS flexibilities left untouched by RCEP, notably in the issuance of compulsory licenses. If this is the thinking, the reference to Doha comes at a heavy price when critical flexibilities are being sacrificed in the rest of the IP chapter.

A specific provision for Least Developed Countries (LDCs) in the RCEP negotiations i.e. Cambodia, Laos and Myanmar, is also being discussed based on the leaked text. Under the TRIPS Agreement, LDCs presently enjoy a transition period to implement the TRIPS agreement till 2021 and to enforce patents and data protection on pharmaceuticals till 2033. The leaked text includes a very limited recognition of only one of the transition periods stating that LDCs would be exempt from some obligations under the RCEP chapter related to pharmaceuticals till 2021. Again, this indicates a clear recognition on the part of the some of the negotiating countries of the importance of shielding LDCs from the effects of a stronger IP regime at a point when their ability to absorb the impact of TRIPS itself is in doubt. Clearly the text also needs to take into account the full exemption that LDCs have till 2021 and include the 2033 transition period as well. However, addressing LDC concerns in negotiating TRIPS-plus provisions in RCEP is not as simple or straightforward as the mere inclusion of the both LDC transition periods in the text. In effect the inclusion of LDCs in the IP chapter would mean that at the end of the TRIPS transition periods, LDCs would be required to implement TRIPS-plus provisions rather than TRIPS. The RCEP negotiations may end up creating a direct path for LDCs to TRIPS-plus provisions –  bypassing completely or greatly limiting the period where they comply with TRIPS and enjoy to the fullest extent, the flexibilities available in the TRIPS Agreement. To avoid this situation, LDCs must be exempt from the IP chapter entirely not just as long as they enjoy the TRIPS transition periods.

To be fair, it is apparent from the leaked text that India, ASEAN and to some extent China are pushing back against the worst of the TRIPS-plus demands being backed by several of the developed countries in the negotiations. India announced its success in rebuffing moves to overturn the restrictions in its patent law on evergreening i.e. Section 3(d) of the Patents Act, and an official reportedly expressed optimism  that the rush to complete RCEP in light of the failure of the TPP may decrease some of the pressure on India to commit to TRIPS-plus provisions. If push comes to shove, the exceptions and exemptions in the name of public health may offer some relief and room for manoeuvre to developing and least developed countries but the reality is they will only create more legal complications and difficulties in their attempts to fulfil the right to health in the long term. With clear evidence that just TRIPS compliance alone is resulting in high prices and reduced availability of medicines, the only viable pro-health approach to the RCEP negotiations requires that these TRIPS-plus provisions be taken off the table entirely.

The IP chapter, while the most prominent threat to public health and access to safe, effective and affordable generic medicines, is not the only one problematic part of the draft. RCEP countries have put forward several proposals for a chapter on investment protection and all include provisions for investor to state dispute settlement (ISDS) mechanisms. ISDS provisions allow corporations to take governments into private international arbitration over a plethora of national laws, policies and judicial decisions including those related to health. Given increasing concerns over the ISDS system, some countries are proposing health related exceptions, though the extent and effectiveness of these remain to be seen. In particular, countries must preserve their policy space related to compulsory licences, patent revocations or refusals, public interest exceptions in IP enforcement, health safeguards in patent laws, price controls, negotiations and reimbursement measures as well as their ability to promote local production or require technology transfer from foreign investors.

Undermining international health commitments

The adverse impact that TRIPS-plus provisions can have on public health and access to medicines is well recorded and has led to advice from UN agencies to developing countries not to sign up to such provisions in trade negotiations. These provisions being negotiated in RCEP and indeed several other trade deals are in conflict with the increasing global commitments on health that these same countries are signing up to.

In December 2012, all RCEP countries were part of the historic General Assembly resolution that, “recognises the responsibility of governments to urgently and significantly scale up efforts to accelerate the transition towards universal access to affordable and quality health-care services…” In 2015, all RCEP negotiating countries also committed to achieving the Sustainable Development Goals (SDGs). In particular Goal 3b includes a commitment to:

“Support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all.”

The full use of TRIPS flexibilities is also central to the WHO’s Global Action Plan for the Prevention and Control of Non-Communicable Diseases and its Global Health Sector Strategy on Viral Hepatitis, both of which have been endorsed by WHO member governments.

The apparent conflict between trade and health commitments was highlighted in the report of the UN Secretary General’s High Level Panel on Access to Medicines which was released in September 2016 which recommended that, “governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health.” Not only did the panel find that governments are duty bound to “protect the rights of their citizens by using TRIPS flexibilities,” but further in relation to TRIPS-plus provisions in FTAs that the, “failure to conduct robust impact assessments before concluding such agreements is tantamount to a neglect of state duties to safeguard the right to health.” By taking these recommendations on board, RCEP countries can chart a new and sensible approach to trade negotiations that does not place the health and well being of people at the mercy of the pharmaceutical industry.

A positive agenda

Indeed, a genuine commitment to the Doha Declaration from the RCEP negotiating countries should lead them to focus their negotiations on a positive agenda on issues related to intellectual property, research and development, increasing access to safe, effective and affordable generic medicines and prioritising the right to health. This would require a clear rejection of any TRIPS-plus provisions in the intellectual property chapter as well as any investment protection provisions that would allow companies to take governments into arbitration over domestic health policies. in terms of process, RCEP negotiating countries should immediately adopt a transparent approach to the negotiations, release the text on intellectual property and investment and hold broad based public consultations on the text to ensure that these do not undermine public health and access to medicines.

RCEP countries should commit to the inclusion of the full extent of TRIPS flexibilities in their domestic laws. The reality is that over 15 years after the Doha Declaration, most countries have yet to include the full extent of these flexibilities in their national legislation. Where they have, using these provisions also requires the support and assistance from regional partner countries – including in fending off undue pressure from developed countries. For LDCs who have till 2021 to implement TRIPS and till 2033 to grant or enforce pharmaceutical patents, RCEP countries should commit to supporting technology transfer and local production of generic medicines in LDCs.

Finally, RCEP countries should commit to negotiating and implementing a new paradigm on research and development that prioritises research in the diseases and health needs of developing and least developed countries in the Asia-Pacific region.

RCEP governments must recall their international, regional and national commitments to respect, protect and fulfill the right to health including the right to access affordable medicines. In their quest for greater economic integration, RCEP negotiating countries must not put the lives and health of millions of people in the Asia-Pacific region at risk. In the words of WHO DG Margaret Chan, “Some Member States have expressed concern that trade agreements currently under negotiation could significantly reduce access to affordable generic medicines. If these agreements open trade yet close access to affordable medicines, we have to ask: Is this really progress at all, especially with the costs of care soaring everywhere?

 


Shiba Phurailatpam is the Regional Coordinator of the Asia-Pacific Network of People Living with HIV/AIDS;