Letter to Mayor Changsha, Hunan, China

Date : 22nd Aug 2019

Mr. HU Zhongxiong
Mayor
Changsha City
Hunan Province
People’s Republic of China

Dear Mr. HU,

We write to share our urgent concerns about the human rights of three prominent anti-discrimination activists who have been detained by Changsha Municipal state security agents and facing possible state subversion charges. Cheng Yuan, Liu Yongze and Xiao Wu of Changsha Funeng have done important work to end discrimination against people living with HIV and people with hepatitis, and to advance the right to health and rights of persons with disabilities in China. As the supervisor of Changsha Municipal State Security Bureau, you should ensure they uphold the legal rights of these three activists.

Cheng Yuan has led over a decade of ground-breaking impact litigation on health rights — first at Tianxiagong, and later as co-founder of Changsha Funeng. Two of his landmark cases, in 2013 and 2016, won damages for teachers who lost their jobs due to their HIV status. Cheng Yuan has also led work on hepatitis B discrimination litigation, advocated forcefully for the rights of persons with disabilities and for an end to China’s One Child Policy, and worked to promote freedom of information and rule of law.

On Monday, 22 July, Cheng and two colleagues, Liu Yongze and Xiao Wu, disappeared. Cheng Yuan’s wife, Shi Minglei, has nothing to do with his NGO, but she has been placed under residential surveillance under suspicion of subverting state power. Cheng Yuan’s brother has also been questioned by police because of his vocal concerns about the case. So far, their lawyers have not been able to meet with any of the three activists.

As a UN member state, China committed to the 2030 Agenda for Sustainable Development in 2015, and in doing so committed to ending HIV by 2030, to combating hepatitis, to promoting peaceful and inclusive societies for sustainable development, and to achieving “zero discrimination” against people living with HIV. To achieve this, UNAIDS recommends countries finance and support HIV-related legal services to reduce stigma and discrimination, and the Global Fund has committed to scaling up this work in numerous countries — it is exactly the kind of work in which Changsha Funeng has expertise.

China has ratified the International Covenant on Economic, Social and Cultural Rights, which upholds the right to health, as well as the Convention Against Torture, and has committed to many other human rights standards. China has signed but not ratified the International Covenant on Civil and Political Rights.

China must not only uphold, but set a positive example to the world of promoting UN commitments to end HIV and end discrimination, as well as international human rights law. The Changsha Three live and work in Changsha. We urge the mayor of Changsha to commend Changsha Three instead of detaining them, and we urge you to directly address the harassment by Changsha state security police of Cheng Yuan’s family members.

Sincerely,

Edward Low
Director
Positive Malaysian Treatment Access & Advocacy Group

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Ubat – Sofosbuvir/Daclatasvir

Matlamat rawatan virus hepatis C (HCV) adalah penyembuhan (apabila tiada lagi HCV dalam sistem darah seseorang pada minggu ke 12 selepas rawatan tamat).
Apa itu sofosbuvir/daclatasvir? Sofosbuvir/daclatasvir adalah satu kombinasi dos tetap bagi dua ubat melawan HCV (sofosbuvir dan daclatasvir).

Nama dagang bagi sofosbuvir ialah Sovaldi; nama dagang bagi daclatasvir ialah Daklinza.Kombinasi kedua-dua ubat mungkin juga dijual dengan nama Darvoni atau Sovodak. Pertubuhan Kesihatan Sedunia (WHO) telah meluluskan ubat-ubatan ini bagi mereka yang mempunyai semua jenis genotip hepatitis C (1 – 6) yang berumur 18 tahun dan ke atas.

Bagaimana sofosbuvir dan daclatasvir diambil? Sofosbuvir dan daclatasvir diambil sekali sehari, sebelum atau selepas makan, selama 12 minggu. Rejimen rawatan bebas Ribavarin adalah digalakkan bagi bagi pesakit yang belum pernah
dirawat sebelum ini. Mereka yang mempunyai sirosis (kekerasan organ hati) terkompensasi (sirosis tanpa simptom penyakit hati), mungkin perlu melalui rejimen rawatan lebih lama atau dengan mengambil ubat, ribavarin, jika mereka belum pernah dirawat sebelum ini. Walau bagaimanapun, tempoh optimal penggunaan sofosbuvir dan daclatasvir bagi pesakit dengan sirosis belum lagi ditetapkan. Keberkesanan rawatan bergantung kepada sama ada seseorang mempunyai sirosis, genotip virus mereka, dan sejarah rawatan HCV mereka yang lalu.
Jangkamasa Rawatan yang dicadangkan WHO dan Kadar Penyembuhan dalam Percubaan
Klinikal1,2,*,**

Genotip 1 dan 2, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu**: 93%
Genotip 3, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu**: 79-82%
24 minggu: 90%
Genotip 4, tiada sirosis + sirosis terkompensasi
12 minggu: 92% 12 minggu: 98%
Genotip 5, tiada sirosis + sirosis terkompensasi2
12 minggu: 100% 12 minggu: 100%
Genotip 6, tiada sirosis2 + sirosis terkompensasi2
12 minggu: 98% 12 minggu**: 90%

1. Lihat juga Treatment Action Group. Ribavarin Fact Sheet. 2015 December. Boleh didapati di:http://www.treatmentactiongroup.org/hcv/ factsheets/ribavirin (Diakses pada 1 Februari 2019).

2. Iwamoto M, Sonderup MW, Sann K et al. Real-world effectiveness and safety of Daclatasvir/Sofosbuvir with or without Ribavirin among genotype 5 and 6 Hepatitis C Virus patients. Poster session presented at: the 68th Annual Meeting ofAmerican Association for the Study of Liver Diseases; 2017 October 20-24; Washington, D.C.

*Kadar penyembuhan dalam percubaan klinikal adalah lebih tinggi berbanding dalam populasi umum kerana pesakit dalam percubaan selalunya lebih sihat dan menerima lebih pantauan dan sokongan **Hanya disyorkan di negara-negara yang distribusi genotipnya diketahui dan prevalens bagi genotip 3 adalah <5%.

Apa yang paling penting boleh dilakukan oleh seseorang untuk sembuh adalah mengambil ubat-ubatan HCV anda – apa yang dipanggil pematuhan. Ini akan mengurangkan risiko virus untuk membina rintangan terhadap rawatan.
Apa itu rintangan ubat? Setiap hari, HCV membiak menjadi berbilion salinan dirinya. Sebahagian salinan tidak sama dengan virus asal. Ia mungkin berubah-ubah (dipanggil mutasi) yang boleh menyebabkan ubat hepatitis C berhenti berfungsi.

Jika pesakit tertinggal dos rawatan, HCV berpeluang untung membiak–dan sebahagian salinan mungkin dapat menentang rawatan HCV. Sebahagian orang mempunyai rintangan terhadap ubat walaupun mereka tidak pernah mendapat rawatan hepatitis C, tetapi ramai yang tetap dapat disembuhkan. Kebanyakan mereka yang tidak sembuh mempunyai rintangan terhadap satu atau banyak ubat HCV yang diambil. Rintangan terhadap ubat-ubatan hepatitis C boleh hilang dalam beberapa bulan, tetapi ia juga boleh bertahan bertahun-tahun dan mungkin dapat menghadkan peluang-peluang rawatan semula.

Sofosbuvir/daclatasvir dan umur, gender, dan bangsa/etnisiti: Dalam percubaan klinikal, kadar penyembuhan tidak berbeza mengikut umur (lebih 65 tahun versus bawah 65 tahun), gender, atau bangsa. Kesan-kesan sampingan sofosbuvir/daclatasvir: Berbincanglah dengan doktor anda tentang kesan-kesan sampingan yang mungkin ada dan bagaimana ia boleh diuruskan. Dalam percubaan-percubaan klinikal sofosbuvir/daclatasvir, kesan-kesan sampingan yang paling biasa ialah pening kepala, keletihan, dan loya, selalunya ringan.

Dapatkah sofosbuvir/daclatasvir berfungsi dengan ubat-ubatan HIV? Sofosbuvir/daclatasvir boleh digunakan dengan ubat-ubatan HIV tertentu, tetapi dosnya mungkin perlu diselaraskan daripada dos dewasa 60 mg/hari yang
standard. Berbincanglah dengan doktor anda sebelum mengambil sofosbuvir/daclatasvir mengenai tindakbalas ubat yang mungkin ada.
Sofosbuvir/daclatasvir dan ubat-ubatan lain: Sofosbuvir/daclatasvir boleh digunakan bersama ubat-ubatan pengganti opiate (e.g., buprenorphine atau methadone) tanpa perlu penyelaran dos. Menggabungkan ubat-ubatan
dapat meningkatkan atau mengurangkan tahap ubat (dipanggil interaksi ubat-ubatan). Peningkatan tahap ubat mungkin akan mengakibatkan kesan sampingan menjadi lebih teruk, sementara pengurangan tahap ubat mungkin akan menyebabkan ubat kurang berfungsi, memberi risiko rintangan atau tidak dapat sembuh daripada sakit hepatitis C.

Sofosbuvir/daclatasvir tidak patut diambil oleh mereka yang mengambil ubat-ubatan rentak jantung amiodarone kerana kombinasi sofosbuvir dengan amiodarone dapat mengakibatkan masalah jantung yang boleh mengancam nyawa. Jangan ambil suplemen herba St. John’s wort dengan sofosbuvir/daclatasvir dan beritahu doktor anda jika anda mengambil ubat untuk kholesterol atau ubat-ubatan bagi kanser, sawan, jangkitan bakteria, atau pedih ulu hati/refluks asid.

Berbincanglah dengan doktor anda sebelum memulakan atau menghentikan sebarang ubat-ubatan, suplemen,atau ubat-ubatan herba.Sofosbuvir/Daclatasvir dan Rawatan-rawatan HIV (Antiretroviral)Penghalang protease HIV (HIV protease inhibitors)
Atazanavir/ritonavir atau atazanavir/cobicistat Reyataz)

Kurangkan daclatasvir kepada 30 mg.

Penghalang integrase HIV (HIV integrase inhibitors)
Kombinasi dos tetap elvitegravir, cobicistat,
emtricitabine, dan tenofovir DF (Stribild)

Kurangkan daclatasvir kepada 30 mg.

Penghalang transkriptase berbalik bukan analog nukleosida HIV (HIV non-nucleoside reverse transcriptase
inhibitors)
Efavirenz (Sustiva, Atripla) Tambah daclatasvir kepada 90 mg.
Etravirine atau nevirapine (Intelence, Viramune)

Tidak disyorkan dengan penggunaan
sofosbuvir/daclatasvir.

Tenofovir DF (Viread, Truvada, Atripla, Complera,
Stribild) Tidak perlu penyelarasan dos. Tiada isu yang diketahui

dengan TDF dan daclatasvir.

Penyimpanan sofosbuvir/daclatasvir: Simpan sofosbuvir dan daclatasvir pada suhu bilik (di bawah 30°C [86°F]). Sofosbuvir/daclatasvir bagi pesakit buah pinggang: Sofosbuvir/daclatasvir tidak disyorkan bagi pesakit dengan kerosakan buah pinggang yang teruk (kegagalan buah pinggang Gred 4 dan 5).

Sofosbuvir/daclatasvir bagi pesakit dengan sirosis: Garis panduan rawatan HCV mencadangkan pesakit hati yang parah (Child-Pugh Kelas B atau C) untuk dirawat oleh pakar. Penggunaan sofosbuvir/daclatasvir telah terbukti secara amnya adalah selamat bagi mereka dengan sirosis (terkompensasi dan dekompensasi), tetapi
tempoh rawatan mungkin perlu diselaraskan dengan genotip hepatitis C. Sebagai tambahan, ribavirin mungkin perlu ditambah dalam rejimen rawatan.

Sofosbuvir/daclatasvir semasa hamil atau menyusukan anak dan bagi kanak-kanak: Tidak diketahui sama ada sofosbuvir/ daclatasvir dapat membahayakan bayi yang belum lahir atau menyusukan anak. Jika anda sedang hamil atau menyusukan anak, atau merancang untuk salah satunya, berbincanglah dengan doktor anda tentang risiko dan kelebihan rawatan HCV. Dalam kajian haiwan berkaitan kehamilan tikus dan arnab, dos sofosbuvir/daclatasvir yang amat tinggi menyebabkan kecacatan kelahiran, keguguran, dan kematian ibu. Pada dos yang lebih rendah, tiada bahaya dapat dilihat.

Sofosbuvir/daclatasvir ketika ini sedang diuji bagi kanak-kanak berumur kurang daripada 18 tahun, tetapi belum lagi disyorkan bagi kumpulan umur ini.

Helaian fakta ini adalah terkini pada bulan Mei 2019. Dinasihatkan untuk sentiasa semak maklumat yang terkini.

Strengthening Advocacy for Hepatitis C Diagnostics: Malaysia Workshop Summary Report

1-3 March 2019, Penang, Malaysia

Positive Malaysian Treatment Access and Advocacy Group (MTAAG+), with partners Treatment Action Group and the Foundation for Innovative New Diagnostics, convened the first advocacy workshop on hepatitis C virus (HCV) diagnostics. The workshop presented the latest developments in HCV treatment and diagnostics and prepared community members to participate and raise advocacy concerns at the 4th National Hepatitis Conference (held later on 7-8 March in Kuala Lumpur). A total of 41 participants attended, including family medicine providers and other specialists, technical resource people, and community leaders working with or representing people living with HIV and/or HCV (PLHIV and/or PLHCV), people who use drugs, men who have sex with men, transgender people, incarcerated people, and sex workers.

Workshop goals:

  • Strengthen treatment, harm reduction, and other healthcare advocates’ capacity and technical knowledge on HCV diagnostics
  • Foster advocates’ leadership skills and prepare their meaningful community engagement in high-level national decision-making processes associated with timely regulatory approval, guidance development, and scale up of diagnostic technologies.

In addition, the workshop aimed for participants to exchange experiences from different districts and clinical settings, while ensuring the presence of medical expertise and breaking down the silos between medical professionals, advocates, and community members in order to build a coalescent yet diverse and active coalition.

Several strategies and themes emerged to scale up diagnoses, based on the Status Report on Availability and Accessibility of Hepatitis C Diagnosis in Malaysia:

  • Increase awareness among people at risk (key populations) to encourage them to go for testing
  • Increase decentralization of HCV health services outside hospital settings
  • Improve surveillance and collect more comprehensive HCV-specific data
  • Strengthen and escalate advocacy for treatment availability

To take concrete steps to address these strategies, advocates developed action plans and a comprehensive list of recommendations, which were presented to Malaysian health authorities in a civil society dialogue at the National Hepatitis Conference. Overall, the key outcomes of the workshop were a clearer overview of the hepatitis C situation in Malaysia and basic understanding of challenges related to HCV diagnostics and treatment among advocates. Furthermore, there was a renewed sense of solidarity and confidence in being advocates on hepatitis C, with a focus to ensure that there will always be civil society representation and input moving forward in national elimination planning.

Download the report below.


ATTACHED DOCUMENTS

Report HCV Diagnostics Advocacy Workshop_Malaysia

PDF – 5.7 Mb

Status Paper – Availability and Accessibility of Hepatitis C Diagnosis in Malaysia

Status paper on availability & accessibility of diagnosis and follow up with MoH to remediate to the issues highlighted in the paper.

Availability and accessibility of Hepatitis C diagnosis in Malaysia

The Malaysian Government, particularly the Ministry of Health, has shown a strong commitment to hepatitis C (HCV), in particular, with the availability of effective, all oral direct-acting antiviral (DAA) hepatitis C treatment earlier this year. It is estimated that 380,000 Malaysians are living with Hepatitis C, yet a minority or only less than 10 % have been detected. Therefore, a key factor still outstanding is to find the missing thousands of individuals in Malaysia who are currently infected with hepatitis C but not diagnosed. Early detection of those infected is crucial as successful HCV therapy improves liver disease, reduces the risk of death and liver cancer.

The Foundation for Innovative New Diagnostics (FIND) and the Drugs for Neglected Diseases initiative (DNDi) had recently announced their collaboration with the Ministry of Health (MOH), Malaysia to scale up of hepatitis C (HCV) diagnosis and treatment. The initial diagnostic step that will be taken is decentralized HCV screening at MOH health clinics using pre-qualified rapid diagnostic tests:  HCV positive cases will subsequently undergo HCV confirmation to enable them to be linked to HCV treatment as part of a DNDi clinical trial or in government hospitals (https://www.dndi.org/2018/media-centre/press-releases/find-dndi-malaysianmoh-efforts-hepatitisc-screening-treatment/).

The objective of this report is to

  1. assess availability and accessibility of HCV diagnostic tools in Malaysia
  2. identify strategies to improve access to HCV testing and improve linkage to care and therefore, support, strengthen and complement Ministry of Health’s existing efforts to scale up of HCV diagnosis and treatment

Key observations

Figure 1 shows the HCV Care Cascade, not only focusing on the major gap in those diagnosed and aware, but also the possible gaps all along after HCV diagnosis.

HCV screenings

The initial step for HCV diagnosis in all hospitals and health centres where mandatory or opportunistic HCV screening done is testing for the presence of Hepatitis C antibodies using laboratory-based assay. Rapid diagnostic test (RDT) for HCV is currently mainly performed by non-governmental organisations such as Positive Malaysian Treatment Access & Advocacy Group and Hepatitis Free Malaysia/Hepatitis Free Pahang.

HCV Confirmation

As the presence of Hepatitis C antibodies implies either current or past or infection, a confirmation step is crucial as only those with HCV viraemia will be considered for HCV treatment. Confirmation of HCV viraemia can be done using either HCV RNA test or HCV Core Ag as recommended by all major international guidelines on HCV management.

In public hospital setting, HCV confirmatory tests can only be done in very few MOH hospitals in Malaysia (Hospital Kuala Lumpur, Hospital Sungai Buloh, Hospital Selayang, Hospital Sultanah Bahiyah, Hospital Umum Sarawak and Hospital Melaka), University Malaya Medical Centre (UMMC) and University Kebangsaan Malaysia Medical Centre (UKMMC). Currently, HCV confirmatory tests are not yet accessible to primary care physicians.

Until recently, HCV RNA testing is limited to HCV RNA quantitative test, which costs at least three times higher compared to the HCV RNA  qualitative test. WHO and EASL guidelines recommended using either quantitative or quantitative HCV RNA tests as both tests are equally sensitive assays with a lower limit of detection of ≤15 IU/ml.

In the public hospital setting, HCV RNA qualitative testing was only available in UMMC until recently, where its now available at Hospital Kuala Lumpur and Hospital Umum Sarawak. The test is also available in the Institute for Medical Research (IMR).

In hospitals where HIV RNA tests is done, testing for HCV RNA can also be made available on the same platform in Hospital Pulau Pinang and Hospital Raja Perempuan Zainab II, Kota Bharu.

Although HCV core antigen assays is slightly less sensitive than HCV RNA, a WHO commissioned systematic review which included 44 studies, has provided a high level of evidence that HCV core antigen is good alternative to HCV RNA detection and is strongly recommended both by WHO and EASL guidelines for HCV confirmation. Awareness of HCV core antigen as a confirmatory test for HCV is still lacking, although there is increasing access to this test in 7 MOH hospitals (Hospital Kuala Lumpur, Hospital Ampang, Hospital Selayang, Hospital Sultanah Bahiyah,  Hospital Raja Perempuan Zainab, Hospital Sultanah Aminah and Hospital Queen Elizabeth)

Liver disease assessment

The main reason to assess the stage of liver disease is not to miss cirrhosis. Fibroscan is a reliable non-invasive test, but its only available in UMMC and 3 MOH hospitals (Hospital Selayang, Hospital Sultanah Bahiyah, Hospital Raja Perempuan Zainab). Serum biomarkers of fibrosis such as APRI and FIB-4 can be used and have been shown to have a good negative predictive value to rule out cirrhosis.

HCV Genotyping

There is no role for HCV genotyping in the 2018 WHO guidelines as only pangenotypic regimens are recommended. However, as Genotype 3 is the in predominant HCV genotype in Malaysia, accounting for 63% of all HCV in Malaysia, HCV genotyping is still required for cirrhotic patients as the duration of treatment and the need for ribavirin differ according to genotype and treatment experience for certain pangenotypic regimen (eg Daclatasvir/Sofosbuvir)

In the public hospital setting, HCV genotyping is only available in UMMC and Hospital Kuala Lumpur. The test is also available in Institute for Medical Research (IMR).

Assessment of cure and monitoring

HCV RNA test is only required once if used for HCV confirmation and 12 weeks post treatment to assess cure/SVR. For those with cirrhosis, surveillance for HCC is required for life with US +/- AFP measurement, and these are only done at tertiary centres.

If available, HCV RNA quantitative test should be used to assess cure/SVR to save costs.

Strategies to improve access to HCV testing and improve linkage to care

Lack of access to HCV Diagnostic is undoubtedly a major barrier in the HCV care continuum. As recently highlighted, this is fuelled by quasi-monopolies on HCV diagnostics, and the lack of competition has kept prices of reagents at a high price

  • Increase public awareness to identify those at risk of HCV

Engagement with family medicine specialists to facilitate identification of those at high risk for HCV had started since 2014 which have been shown to result in an increase detection and notification of new HCV cases in 2016. These should be strengthened further with the use of rapid diagnostic tests (RDT) for HCV screening of those at high risk of HCV.

In addition, the quest to “Find the Missing Thousands” living with hepatitis C who have not been detected should involve many stakeholders, including NGOs and those living with hepatitis C, to make  testing more accessible and remove barriers for testing amongst them. There is a need to increase public awareness programmes to identify those at risk of HCV and the use of rapid diagnostic tests for HCV screening is recommended in these settings

  • Decentralizing HCV confirmation tests and liver disease assessment

For those tested HCV positive with the initial HCV screening/RDT, reflex HCV confirmatory tests is recommended at the same sitting so these patients are not lost to follow-up.

Nearly 60% of HCV in Malaysia were transmitted amongst people who use drug (PWUD). Mandatory HCV screenings have been conducted in patients with opioid use disorder who are being followed at primary care facilities and medication-assisted treatment (MAT) clinics, with approximately 64% of the 3000 registered patient at government MAT setting annually with slightly higher number of cumulative registered patients at private MAT clinics who are HCV-infected. HCV testing in these settings is limited to anti-HCV test, therefore a large proportion of patients who were tested positive for HCV antibody have not undergone confirmatory HCV testing and liver disease assessment, so these tests should be prioritized at primary care facilities and (MAT) clinics

  • Providing simple HCV diagnostic and treatment algorithm

The recently updated WHO guidelines provides a simple algorithm for HCV diagnosis, treatment and monitoring, which can definitely increase the understanding on the steps needed to achieve HCV cure and monitoring thereafter.

  • Increase access to DAAs and increase treatment sites

Access to generic DAA is only available at 22 MOH hospitals. To reach the goal of HCV elimination by 2030, the government needs to expand HCV diagnosis and treatment services. To achieve this will require moving beyond hospital settings and necessitate the greater involvement of a broad range of health professionals, especially primary-care providers.

  • Efficient procurement and supply management of diagnostics (and DAAs)

Centralised or bulk procurement system or negotiation of cost of HCV diagnostics and DAAs at a national level can translate to more efficiency and lower cost of procurement of reagent and drugs for the government.

The use of using open diagnostic platforms for HCV platforms has been suggested as the way forward to introduce competition and can potentially be very efficient and decrease prices of reagents in the near future. In addition, a nationwide access to generic DAA therapy is urgently needed so that the burden of HCV diagnosis and care management is shared by both the public (including university hospitals) and private sectors.

References

  1. McDonald SA, Azzeri A, Shabaruddin FH, Dahlui M, Tan SS, Kamarulzaman A, Mohamed R. Projections of the Healthcare Costs and Disease Burden due to Hepatitis C Infection under Different Treatment Policies in Malaysia, 2018–2040. Appl Health Econ Health Policy. 2018 Aug 25. doi: 10.1007/s40258-018-0425-3
  2. Ho SH, Ng KP, Kaur H, Goh KL. Genotype 3 is the predominant hepatitis C genotype in a multi-ethnic Asian population in Malaysia. Hepatobiliary Pancreat Dis Int. 2015;14(3):281–6. 5
  3. Freiman JMTran TMSchumacher SG, et al. Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis. Ann Intern Med.2016 Sep 6;165(5):345-55. doi: 10.7326/M16-0065
  4. World Health Organization. Global health sector strategy on viral hepatitis 2016–2021. 2016.
  5. Fatiha S, et al. Estimated 3-year acquisition cost of direct acting antiviral (DAA) for the treatment of Hepatitis C in Malaysia in 2018 to 2020. APASL 2018 Delhi
  6. Near-Monopolies On HCV Diagnostics Curb Competition, Keep Prices High, Research Finds

http://www.ip-watch.org/2018/10/24/near-monopolies-hcv-diagnostics-curb-competition-keep-prices-high-research-finds/Accessed 25 October 2018.

  1. Ministry of Health Malaysia. Press Statement Minister of Health 20th September 2017 – Implementation of the Rights of Government for Sofosbuvir Tablet to Increase Access for Hepatitis C Treatment in Malaysia. 2017.
  2. World Health Organization. Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection. 2018.
  3. AASLD/IDSA. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. September 2017 Retrieved from https://www. hcvguidelines.org/Treatment-Naive. Accessed 4 September 2018.

Appendix 1

Study Profile

Number of interviews: 15

The interview was conducted throughout Malaysia from the period of end of July 2018 to early October 2018, covering non-medical personals and doctors from the government clinics and hospitals.

Below are the summary of our interviewees profile.

Question 1
Non-Medical Personnel 2
FMS 3
Hepatologist 3
Gastro 1
Total 9

 

Question 2
Microbiologist 2
Patologist 4
Non-Medical Personnel 2
Total 8

 

Notes :

The non-medical personals answered both questions one and two thus we recorded their presence in both column on question 1 and question 2.

Appendix 2

HCV Diagnostic Survey, Malaysia – July 2018 – Summary Report

ACCESS TO DIAGNOSTIC TESTING

Question 1. Please note the availability of the following tests and their prices in the public sector.

Add rows as needed.

Test (Diagnosis) Available in public sector? Length of result Total price (per test) Price paid out-of-pocket by patient Length of result  

Venue of lab & name.

HCV Rapid Test Kit X On the spot        
HCV antibody (HCV Ab or anti-HCV) X Ranges from 1 – 3 days to

1 – 2 weeks

RM20 Nil   HKL
HCV core antigen X Ranges from 2 – 3 days to 1 week or more. RM80 Nil    
HCV RNA PCR X 1 – 8 weeks RM400 Nil   Sungei Buloh
HCV Genotype X 4 – 8 weeks       HKL / IMR
Fibroscan X   Depends on opportunities as 3 years ago was immediately     Selayang

 

Main issues captures from all the interviews are listed below :

  1. Budget allocation in government hospital.
  2.  Not maximising use of the existing Gene Expert Machine.
  3. The length of result available is too long.
  4. HCV RNA PCR, HCV Genotype can not be ordered directly from KK and has to be referred to the hospital specialist.
  5. Not aware about the existing Gene Expert Machine available.
  6. Need to refer patients to hospital for confirmation test (HCV RNA PCR).
  7. Budget constrain especially for HCV RNA PCR is very expensive test.
  8. Further (HCV RNA PCR) testings are based on criteria (selective criteria such as patients who are planned for treatment, co-infection cases) at cost constraint.

Recommendations :

  1. More budget allocation as some may not be repeated cases.
  2. Need integration with TB department.
  3. Government subsidize cost for reagent.

 

Usage of Diagnostic   

Manufacturer

Price procured for the machine.

RM

Cost per reagent /cartridge Number of test requested

per day

Number of test was used per day Number of free testing. Number of out source testing.
HCV Rapid Test Kit SD Bioline/ Others            
HCV antibody (HCV Ab or anti-HCV) Abbott     23 – 40 tests

per day

  40 test  
HCV core antigen  

 

          Available at HKL only
HCV RNA PCR

(for TB usage)*

Abbott/Cobas/

Cepheid

(Gene Xpert)

RM34K – RM80K

per unit

RM70 – RM80

per unit

 

> 50 tests/day 50 tests/day   Malaysia Liver Foundation
HCV RNA PCR

(for IMR)

Cobas   RM200 – RM300   10 – 20 tests per week    
HCV Genotype Abbott/Cobas

 

          30 tests and mostly available at HKL only
HCV Genotype

(for IMR)

Cobas   RM300 – RM400   1 – 5 tests per week (New)    
Fibroscan

 

  RM200K – RM700K   10 cartridges 25 cartridges per week All free No.

* Note:  Gene Expert IV – existing 19 units for TB usage in MoH hospitals, and propose 14 units for HIV/HCV usage, and most of them are on reagent rental contract. Prices are based on procurement through reagent rental. This would also depends on workload such as number of tests performed per year basis. Obviously analyser as an asset would offer lower prices.

 

Hepatitis elimination by 2030 in doubt as countries fail to scale up diagnosis and treatment

Keith Alcorn
Published:
24 April 2019
 

Most countries will struggle to eliminate hepatitis C by 2030 due to lack of investment and political will, missing an internationally agreed target set by the World Health Organization, The International Liver Congress in Vienna heard earlier this month.

“Despite the progress we’ve seen, we’re clearly not going to make it,” said Gottfried Hirnschall, Director of HIV and Hepatitis at the World Health Organization (WHO), speaking at a symposium on elimination of viral hepatitis organised by WHO.

The World Health Assembly agreed ambitious targets for elimination of viral hepatitis in 2016. Countries pledged to scale up prevention, diagnosis and treatment so that deaths caused by viral hepatitis would be cut by 65% and new infections cut by 90%

Although 124 countries now have national plans for viral hepatitis elimination, 42% of plans have no domestic funding, Mark Bulterys, head of WHO’s hepatitis team told the symposium.

Furthermore, although 5 million people had been treated with direct-acting antivirals (DAAs) by the end of 2017, most of these treatments occurred in ten ‘champion countries’ which have scaled up treatment quickly, including Egypt, Brazil and Australia.

Even in higher-income countries, hepatitis C elimination may only be achieved by a handful of countries by 2030, the Center for Disease Analysis estimates. Nine countries – Australia, France, Iceland, Italy, Japan, South Korea, Spain, Switzerland and the United Kingdom – will achieve elimination by 2030 at current rates of diagnosis and treatment.

Elimination may not occur before 2050 in Canada, the United States and smaller European countries, the modelling exercise found. Two-thirds of higher-income countries are seriously off-track, the Center for Disease Analysis reported.

Despite dramatic reductions in the prices of generic versions of DAAs to less than $100 per cure, some lower-income countries are still paying substantially higher prices although they are eligible for low-price drugs under voluntary licensing agreements. Sixty-two per cent of people with hepatitis C live in countries covered by these agreements, which allow generic versions of DAAs manufactured under voluntary licence from the originator company to be imported from countries such as India or Egypt.

WHO has calculated how much it will cost to eliminate hepatitis C by 2030. Its model, developed by Dr Melikha Toy of Stanford University, estimates that it will cost $58.8 billion to achieve elimination of viral hepatitis by 2030, slightly higher than the estimate presented by Professor Margaret Hellard of the Burnet Institute, Melbourne, on the opening day of the conference.

But Dr Toy said that the cost of elimination could be considerably lower if drug prices fall rapidly, if countries use voluntary licensing arrangements to obtain low-cost drugs, and if the cost of diagnostics falls, especially hepatitis B DNA testing. A large part of the cost of elimination will be the cost of HBV DNA monitoring, and much of the cost of elimination will be concentrated in the Western Pacific region and Africa due to the high burden of hepatitis B in those regions, she said.

The cost of elimination would add 1.5% to the total budget for universal health coverage proposed by WHO in 2017. The budget set out how much it would cost to achieve the Sustainable Development Goals for health by 2030 through universal health coverage in 67 lower- and middle-income countries. Hepatitis diagnosis and treatment was not included in that costing.

“If you look at data, and ask, ‘what is hepatitis achieving in the context of universal health coverage’, it’s just about getting off the ground,” Dr Gottfried Hirnschall told infohep in an interview.

“We hear about Egypt, Mongolia, Georgia, China, Brazil, but there are many other countries that are not moving yet. There are whole continents that are falling behind, Africa when it comes to hepatitis B, and for hepatitis C some of the larger high burden countries are not moving sufficiently – Russia for example, and China still has a long way to go despite some positive momentum that has been building up.”

“A movement has been created, the momentum has been sparked, the feasibility has been demonstrated in some countries but too many others are still looking across the fence and finding easy excuses for not doing it.”

To maintain a positive trajectory and accelerate it, advocacy will still be needed. We must not give the impression that HIV is almost done, and we must encourage countries to factor those services into a broader health financing approach, and we see that in some countries, such as Thailand.

“In hepatitis, we have to demystify that management is highly complex and can only be done by hepatologists – we are here at a hepatology conference and we need to convince them, ‘it’s not just your job, it can be done by any general practitioner’ and in some low-income settings it could be simplified further, which is what we’ve seen in HIV.”

Read more at : http://www.infohep.org/page/3478324/?utm_source=NAM-Email-Promotion&utm_medium=conference-bulletin&utm_campaign=English&fbclid=IwAR3cidqV0T8sSNjm2w_TeW9IA904gmGI5DJopHfsobf1xqogHcrQOxJEFsQ

Reaching people who inject drugs and people in prisons – a must for hepatitis C elimination

1 May 2019, PORTO – The World Health Organization (WHO) is calling for greater commitments to scale up hepatitis C virus (HCV) testing and treatment services to people who inject drugs (PWID) and people in prisons (PIP).

Group of young men sitting and discussing

Médecins du Monde

Around 71 million people are infected with chronic HCV worldwide with PWID being disproportionately affected. They account for the highest proportion of new infections – 23% of the 1.75 million infections that occur every year. As for PIP, up to 1 in 4 can be HCV positive. The elimination targets set by WHO aim to diagnose 90% and treat 80% of all eligible persons by 2030.

Today at the Harm Reduction International Conference (HR19), WHO is releasing a new policy brief “Access to hepatitis C testing and treatment for PWID and people in prisons – a global perspective”. The policy brief looks at the global landscape of national hepatitis plans and country experiences, showcasing some of the gains and gaps in reaching PWID and PIP with HCV services.

New findings

The policy brief outlines the following analysis.

  • More countries have developed national hepatitis plans as at February 2019, but many of these plans overlooked the needs of PWID and PIP.
  • Of the 81 national plans and treatment guidelines reviewed by April 2019, 51 (63%) included services for PWID, and 37 (46%) did so in full alignment with the WHO “Global health sector strategy on viral hepatitis, 2016–2021”.
  • 28 (35%) plans and guidelines included services for PIP, and 23 (28%) did so in full alignment with the WHO “Global health sector strategy on viral hepatitis, 2016–2021”.
  • 11 (14%) plans and guidelines specified restrictive requirements such as drug use abstinence (commonly for a period of 6 months or longer) for PWID to be eligible for HCV testing and treatment.
  • Many national plans and guidelines also specify requirements for health insurance coverage, which presents a barrier for PWID and PIP in some countries.

Country snapshots

The policy brief also provides select country experiences:

  • Australia recently published its fifth national strategy (2018–2022) on the path to hepatitis elimination by 2030. The country used a simplified approach to service delivery, integrating hepatitis testing, treatment and harm reduction for PWID at decentralized sites, and engaging peer workers and general doctors. Concerted implementation of HCV testing and treatment in several prisons shows elimination in these settings is possible.
  • China is undertaking development of a national hepatitis plan, which references PWID as a priority population for HCV testing and treatment. The government and health insurance providers are in the process of negotiating lower prices for DAAs – the results of these negotiations will be key to the strategy’s success.
  • India launched a national action plan to combat viral hepatitis in February 2019, targeting PWID as a priority population, aiming to provide 1 000 000 DAA treatment courses annually over the next 3 years.
  • The Islamic Republic of Iran has a 3-year national hepatitis plan that proposes interventions for PWID and PIP. DAAs can be obtained for as little as US $81, but only for people with health insurance. Many PWID and PIP without insurance face a higher cost of US$ 2200.
  • Ukraine is developing a national strategy to contain tuberculosis, HIV and viral hepatitis. Generic DAAs are now available for less than US$ 100. Effective collaboration with the Ministry of Justice enabled HCV testing for 1 000 PIP living with HIV in 2018. Of these people, 50 were treated with DAAs, achieving a 98% completion rate.
  • The United States of America also has a viral hepatitis action plan and policies that target PWID and PIP. But high costs for DAAs (between US$ 15 000 and US$ 94 000) are a major implementation barrier.

Steps for HCV elimination among PWID and PIP

The WHO policy brief calls for greater political will to improve testing and treatment access for these marginalized populations. HCV treatment prices also need to drop further. Reaching PIP with public health services is feasible– and can help achieving HCV elimination within this specific population group.

Reaching PWID and PIP with HCV testing and treatment services as part of a comprehensive harm reduction approach is an essential element of hepatitis elimination efforts and embodies the principles of the Universal Health Coverage (UHC) agenda to ensure that no one is left behind.

Reflecting voices of PWID and PIP and other key and at-risk populations in shaping hepatitis elimination and UHC efforts is a critical step as well. This week, WHO is supporting the participation of 7 key population scholars in multi-stakeholder consultations, in preparation for the UN High-Level Meeting on UHC to take place in September 2019.

Read more at : https://www.who.int/hepatitis/news-events/pwid-prison-hcv-access-story/en/?fbclid=IwAR3Sx303t71KP2WdlNubSzaGAsa6wD5E7DIVLbhleW1BSfieML7Zy7c8JPU

Aku Janji Ubati Hep C

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Malaysian AIDS Council

Salam #Ramadan dan Selamat Berpuasa. Nama saya Basri, saya bertugas sebagai rakan sokong bantu bagi program TAPS (Treatment and Adherence Peer Support) bersama NGO Persatuan Perantaraan Pesakit Kelantan. Saya juga seorang PLHCV (people living with #hepatitis C), saya telah ketahui status saya sejak tahun 2007. Saya mengetahui mengenai rawatan baru DAA #HCV apabila mengikuti workshop bersama MTAAG+. Saya mengalakkan komuniti PWID/PWUD (people who inject drugs/people who use drugs) di Kelantan untuk menjalani saringan dan mendapatkan rawatan HCV yang percuma di fasiliti kesihatan kerajaan. #akujanjiubatiHepC

Ending Viral Hepatitis

To end viral hepatitis by 2030, communities are key. We have effective treatments and harm reduction measures, but less than 5% of 71 million people living with hepatitis C have been treated.
“For the community, by the community, with the community”
Join us in our fight: www.coalitionplus.org
https://www.youtube.com/watch?v=Tq9OT-CQG14
UNITAID Malaysian AIDS Council KEMENTERIAN KESIHATAN MALAYSIACoalition PLUS

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To end viral hepatitis by 2030, communities are key. We have effective treatments and harm reduction…

World IP Day

What’s wrong with IP rights? Protecting medicines from competition can be costly

Gram for gram a HIV medicine costs more than gold.
What makes drugs so costly?
Is it research and development, or have the prices of essential, life-saving drugs been ramped up by a lack of transparency and abuse of a system intended to reward innovation?

Estimated read: 7 minutes

26 April 2019 is World Intellectual Property Day. Intellectual Property. IP. Must be important, to have its own day? So, what do you know about it?

It’s something to do with rights, right? Along the lines of if you invent something, something that you’ve invested time, money and more than a sprinkling of ‘genius’ in, then you can patent your invention for 20 years. That ensures that someone else can’t just come along, copy your idea and make a quick million bucks off the back of your hard work. Sounds fair enough?

A lot of people think of an inventor in a shed, or state-of-the-art tech when you say ‘IP’. But what about when it’s medicines being patented? You can choose whether or not to buy a swanky new gadget, but you don’t choose to get sick, and you don’t choose to need a medicine that gram for gram costs more than gold.

That’s why some people think medicines shouldn’t be owed by anyone, that they are for the good of the people and shouldn’t be monetised at all. Like Jonas Salk, inventor of the polio vaccine, who when asked ‘who owns the patent?’, famously said: “The people, I would say. There is no patent. Could you patent the sun?”

On the other hand, many would argue, discovering new medicines takes time. Lots of it, decades of development and testing, depending on which accounts you read. Plus, after rigorous testing for efficacy and safety, the majority of drugs don’t make it to market (unless you lie about it of course), and who’s supposed to foot the bill for that?

If (and we’ll come back to this word shortly) companies, rather than governments, invest all this time and skill, then there’s got to be an incentive, right? After all, pharmaceutical companies aren’t in it simply for the good of their health, they are a profit-making industry and don’t feign otherwise.

The flow of invest-reward-invest-reward is supposedly what keeps the cogs turning; new medicines being invented; sick people made better.

Then why do pharmaceutical companies seem to get so much flack these days? After all, it sounds like they are just protecting their hard work. Why do treatment activists and pharmaceutical companies who, on the face of it, should be on the same side, have such a bad reaction towards each other? Let’s examine the hotly contested research and development (R&D) argument.

‘Monopolies are necessary in order to recoup the investment and put more money into developing new drugs.’  This, or phrases along these lines, are Big Pharma’s favourite tropes. The industry has repeated this for years. But is it true?

Let’s break it down. To assess the argument’s merit we need to discover who invests in R&D, whether the amount being recouped is fair, and whether that actually leads to more innovation.

R&D: It’s NOT a solo venture

Billions go into biomedical research and development every year. Each year it fluctuates from country to country, and it is generally a combination of public money and industry investment. 

The current trend is for the majority of investment to come from industry. It’s to be expected, as the whole point of the present system is for those that invest to get a return. No-one’s begrudging a fair profit, after all that was the idea: invest-reward-invest-reward. 

The pharmaceutical industry is the third most profitable in the world, so there are pretty healthy returns, and it’s a strong indicator that profits have gone way beyond a point of merely recouping costs.

The pharmaceutical industry is the third most profitable in the world.

Add to that that not all investment comes from industry, it varies from country to country, but a decent percentage comes from government. Take the USA as an example, in 2017 67% of medical investment came from industry, but 22%, not an insignificant proportion, was funded by the government. 

Presumably that would mean that around 1 in 4 medical patents in the USA are owned by the government, and can be priced fairly for the good of citizens, based on the proportion of investment. They don’t. So where is that return on the government’s investment going?

Who’s paying for patents?

Only last month, a Washington Post headline ran: An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions.

The drug is Truvada for PrEP, the company is Gilead.

The New York Times also ran a piece on the same example. In it the columnists, co-founders of PrEP4All, explain how the price for generic Truvada costs less than $6 per month in other countries, “but Gilead charges Americans, on average, more than $1,600, a markup from the generic of 25,000 percent.”

It continues: “Infuriatingly, American taxpayers and private charities — not Gilead — paid for almost all of the clinical research used to develop Truvada as PrEP.” 

This is not uncommon. Often drugs initially developed in the public sector are bought, not invented, by pharma companies, which then complete the development and file the patent.

In this case surely the argument, that such high prices are necessary to recoup costs from years of investment, has to be thrown out of the window. 

Gilead has earned $36.2 billion on Truvada since 2004 according to its annual reports. The total funding needed to get the HIV response back on track has been estimated at $26 billion annually.

Why is the USA government paying for a drug that it largely funded, and allowing an unfair profit to be made by a private company when there’s a shortfall in HIV funding?

Treatment activists have been wondering whether it’s the “cosy relationship” between government and Gilead that prevents the government taking a stand on a patent that by rights shouldn’t belong to a pharmaceutical company. 

Not only is the pharmaceutical industry is the world’s third most profitable industry, it’s also THE largest lobbying power in the USA.

Why is the USA government paying for a drug that it largely funded when there’s a shortfall in HIV funding? And why the need for such heavyweight lobbying?

Say Truvada for PrEP was the exception and not the norm. If the system was fair and therefore it was patently obvious that countries must pay for the price of investment, then why the need for such heavyweight lobbying?

Industry’s influence on, or in, government 

As THE largest lobbying power in the USA, pharmaceutical companies effectively have a seat at the government’s table, and not just figuratively speaking.

Pharmaceutical companies have a seat at the USA Government’s table, and not just figuratively.

Alex Azar is a lawyer, pharmaceutical lobbyist and former drug company executive. He’s also the current Secretary of Health and Human Services. Let’s repeat that. A pharmaceutical lobbyist holds the USA’s most senior health role.

In ‘NO is not enough’ Naomi Klein describes what’s happening in Washington since Trump’s election as a “naked corporate takeover”. Klein writes: “Apparently, all that wining and dining of elected officials, all that cajoling and legalised bribery, insulted their sense of divine entitlement. So now they’re cutting out the middlemen – those needy politicians who are supposed to protect the public interest – and doing what top dogs do when they want something done right: they are doing it for themselves.”

Who else who sits on Trump’s cabinet? Sitting alongside Azar is a millionaire investor who lied about his net worth. He’s the Secretary of Commerce. An investment banker and previous hedge fund manager is Secretary of the Treasury. Exxon-Mobile, General Dynamics, Boeing, and Goldman Sachs alumni and board members have also sat round the table in Washington in official roles. This shows that Azar is not the only one holding a position with a glaring conflict of interest. “Trump’s cabinet of billionaires and multimillionaires tells us a great deal about the administration’s underlying goals,” writes Klein.

When you think of it it beggars belief, you couldn’t make it up, and yet it’s true. How about numbers though, can you make those up?

How much does drug development cost?

Unfortunately the one thing numbers can’t add up to is agreement.

Estimates for the cost of a medicine, “from invention to pharmacy shelves” varies from $30.3 million to $2.7 billion. This guys argues, in Forbes, that it’s the upper limit. In his words: “What really drives up costs is the fact that 90% of medicines that start being tested in people don’t reach the market because they are unsafe or ineffective. The $2.7 billion figure includes the cost not only of these failures, but also of not putting the money spent on them into something that would give a more reliable return.”

The high-end figures come from industry-funded studies, and as an MSF report states, they chose to include “arbitrarily inflated” costs yet don’t account for the public support.

Big Pharma is notoriously un-transparent about R&D costs. While that remains the case we’ll never know the true costs, but even if you take the low end of the calculations it begs the question, ‘how much profit is enough?’.

How much profit is enough? Blockbuster Drugs

Take a ‘Blockbuster Drug’, two words that, for many, sit together uncomfortably. The pharmaceutical industry defines a blockbuster drug as one that meets the “$1 billion USD annualsales milestone”.

Let’s do a quick calculation: $1 billion per year (minimum) x 20 years standard monopoly = $20 billion (minimum). 

That was easy. However, it might take a blockbuster drug up to four years to reach its potential. Let’s knock off $4 billion – of course they don’t earn nothing in the first four years, but just for ease, plus let’s also minus the top-level, industry-funded estimate ($2.7 billion) that a company invested.

That’s now ‘dwindled’ down to $13.3 billion. Of course, not every drug is grossing $13 billion plus, but we also know not every, if any, drug costs $2.7 billion to create either. To provide some context, Avatar is the most expensive movie ever made. The costs were over $478 million and it grossed over $3 billion worldwide. At least $10billion less than a blockbuster drug.

The most expensive movie ever made grossed $10 billion less than a ‘Blockbuster Drug’.

A less dramatic way to look at it would be to take each drug on the World Health Organization’s (WHO) list of essential medicines and compare the cost and price of all the drugs on it. That’s what researchers at the University of Liverpool did. The research looked at cost of production, which included manufacturing, formulation, packaging, taxation and a 10% profit margin. It found a significant gap between the cost and price of the majority of medicines on the list.

Still though: Innovation, innovation, innovation

So prices for patented medicines are excessive. However, perhaps even for those uncomfortable with such steep profits being attached to medicines, maybe the incentive of earning billions is OK if it achieves an end goal of discovering more effective drugs, and more breakthroughs and cures?

After all, once the 20 year patent period has expired we should expect that competition gets introduced, prices drop massively, and pharma companies race to find new, effective (and profitable) drugs.

But wait. A patent doesn’t always end after 20 years. There’s a common practice called evergreening. This is when companies effectively extend their monopolies by applying for multiple, overlapping patents, with small changes, on the same drug.

A monopoly often doesn’t end after 20 years.

Take Thailand. During an 11 year period (1999-2010) 82% of patent applications were examples of evergreening, and 72% of patents granted also fell into that category. In one example there were six patents and a total monopoly period of 31 years on one drug.

Even in cases of genuine innovation, it means nothing if you, or your government, can’t afford the drug that’s needed to save your life15.2 million of the 36.9 million people living with HIV do not have access to treatment.

Investing in drugs, or patents?

Instead of incentivising innovation, the practice of evergreening patents actually stifles innovation, leading to less medical breakthroughs. If you can continue to make millions or billions on an existing product it removes much of the profit motivation to develop new products. 

Paediatric drugs have particularly suffered due to this practice, due to a ‘limited market’. It seems that sick children just aren’t profitable enough. 

“We are not markets, we are people” – Lorena Di Giano, Executive Director, Fundación GEP.

A country can refuse to grant an unmerited patent, including evergreening patents, while an application is pending, or, when a patent is granted issue what’s called a compulsory license, which effectively overrides the monopoly if there is a public health need. The classic case for the latter is when a government can’t afford to treat all people in need at the prices charged, and to prevent or tackle a public health crisis, it uses its legitimate right to source more affordable, trusted, generic versions.

This is all laid out in a multilateral agreement know as TRIPS (Trade Related Aspects of Intellectual Property Rights Agreeement) and the Doha Declaration (Declaration on the TRIPS agreement and public health. The problem is that often when governments legitimately push back pharmaceutical companies use their legal and financial muscle to push back harder. 

Examples of how that ‘push back’ has manifested in the past include threatening an impact on trade, or refusing to register new drugs in a country. One reason countries may decide not use the ‘flexibilities’ entitled to them under the TRIPS Agreement is the fear of these types of consequences. Another theory as to why these rights aren’t enacted in the first place is because if industry is within governments or at least influencing them, then governments are less likely to act, as they’d effectively be pushing back against their own interests.

The current system, connected to the enigma of R&D costs, keeps prices and profits unfairly high, and there’s little or no recourse. One proposed solution is de-linkage. The argument is that R&D funding should not be tied to the price of the product. Monopolies and high prices would be replaced with alternative incentives based upon cash rewards, and expanded funding for research, drug development, and clinical trials through a combination of grants, contracts, tax credits, and other subsidies.

The R&D argument is unmerited

The current system, and the arguments made by pharma that prop it up, amounts to a lot of profit but not much else.

There are many more examples of IP abuse that can be cited here, and so for an industry built on medicines, there’s an unhealthy amount of controversy.

If you wnat more convincing, consider these salaries: Among the recent top 10 highest paid pharma bosses was the Gilead CEO taking home $13.9 million a year; the AbbVie chief exec securing a $18.8 million salary (that’s the company that pulled all new drugs when a country enacted its rights), and the Bayer boss earning $25.27 million.

That’s per year, just take that in. In just one year, 110,000 children died of HIV-related illnesses$25 million, ONE person’s salary, could be enough to provide 416,000 children with life-saving HIV treatment for a year. Now that’s got to make you sick.

read more at : http://makemedicinesaffordable.org/en/whats-wrong-with-ip-rights-protecting-medicines-from-competition-can-be-costly/?fbclid=IwAR2HJTweUSAGILrpJFiy73SDq_AXxB2jlmPkIfLtKHp1x13fD85IcR0uRbM