Fix The Patent Laws

Patent law reform will benefit both people with cancer and HIV

Posted on | October 31, 2012 | 1 Comment

People in South Africa currently pay much higher prices for key cancer medicines than do people in India

By Catherine Tomlinson

 This article was originally published on 29 October on www.Quackdown.info

When TAC and MSF marched to parliament to support India in its legal battle against Novartis the Cancer Alliance released a statement criticising the action.[1]The Cancer Alliance is a recently formed group representing several cancer organisations.

The march for which TAC and MSF were criticised was in support of India’s use of flexibilities allowed under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).[2] TAC and MSF are currently running the Fix the Patent Laws campaign to call on the South African government to adopt similar flexibilities into our national laws to improve access to medicines.[3]

The amendments we are calling for are in line with current international law. In the TAC and MSF campaign, we are not trying to dismantle the patent system. We are arguing that South Africa should make use of available legal mechanisms that will help restore some balance between the rights of patients and the needs of pharmaceutical companies.

The criticism by the Cancer Alliance is baffling. Particularly, as the objective of TAC and MSF’s campaign is to bring down the prices of numerous cancer medicines. Many critical cancer medicines are not provided in the public sector, or included under prescribed minimum benefits, because of their high cost.

According to Mediscor’s annual Medicine Review, cystostatics (cancer medicines) are the second highest cost to South African medical schemes.[4] Additionally, in a recent Mail&Guardian article, Discovery stated that the cost of oncology treatment in South Africa has grown 11% every year since 2008 and that the increase was mainly because of speciality drugs.[5]

Currently, there are a number of barriers to accessing cheaper generic versions of cancer medicines in South Africa. These barriers include the slow registration of medicines by the Medicines Control Council (MCC), the difficulty in developing and registering generic versions of biological medicines, and South Africa’s strict patent protection and failure to use flexibilities allowed under TRIPS to protect health.

TAC and partners faced the same challenges of patent barriers and slow registration by the MCC in accessing cheaper, generic antiretroviral medicines. The critical antiretroviral medicine tenofovir was registered by the US Food and Drug Administration in 2001, whereas registration in South Africa was delayed by the Medicines Control Council until 2007. But, despite challenges, today affordable ARVs are widely available and about 2 million people are accessing these medicines in South Africa. The cost per person of first line ARVs per year has dropped to R689 today, from over R35,000 in 2000.[5a]

The massive drop in the price of ARVs was in large part due to the work of HIV activists globally, including TAC and MSF. Activists fought against patent barriers on these critical medicines to secure low-cost, generic ARVs throughout the developing world. To access these medicines, TAC organised numerous public demonstrations, complained to the Competition Commission, and even went as far as importing generic medicines from Thailand and Brazil in defiance of patents.

In the Fix the Patent Laws campaign, TAC and MSF are now looking beyond simply securing access to medicines for people living with HIV. In this campaign we are calling for amendments to our laws that will improve access to medicines for all diseases.

We have looked closely at the Indian example. India has adopted into their national legislation many of the flexibilities allowed under the TRIPS agreement to protect medicine access. South Africa has failed to follow suit. As a result a number of medicines in India are far cheaper than in South Africa. The table below demonstrates the difference in price, in India versus South Africa, of a number of cancer medicines. The flexibilities used by India in the examples below include, using the extension period prior to 2005, granting a compulsory license and rejecting patents on new formulations of existing medicines.

Examples of cancer medicine prices in the South African private and public sectors versus prices available in India
Medicine South African private sector price South African public sector price Indian generic price
Imanitib mesylate R863 per 400 mg tablet N/A R46.20 per 400 mg tablet
Sorafenib R203.50 per 200 mg table N/A R8.55 per 200 mg tablet
Bortezomib R11,548.70 per 3.5 mg vial N/A R2,980 per 3.5 mg vial 
Oxaliplatin R2,331.79 per 50mg/10ml injectionR4,663.53 per 100mg/20ml injection

 

R702 for 50 mg injection for infusionR1,405.34 for 100 mg injection for infusion 50 mg price not sourced 

R585 per 100 mg vial for injection

Rituximab R2,789.50 per 10mg/ml infusionR13,947 per 500 mg injection R1,589.99 for 100 mg injectionR 7,950.01 for 500mg injection R1,542 per 100 mg vial 

R6,173 per 500 mg vial

Temozolomide R958.73 per 100 mg tablet R903.44 per 100 mg tablet R273.79 per 100 mg tablet(Note: Cipla has announced it will reduce the price to R74 per tablet)

N/A means the medicines is not procured in the public sector. More detailed information is available in the table below.

Cancer is not a disease to which TAC is a stranger. TAC leadership, as well as TAC members have been affected by the disease. People living with HIV are at a much higher risk of developing some types of cancer than the general population

The opposition of the Cancer Alliance to our campaign calls into question the extent to which this group represents the interests of people living with cancer. It is notable that a member of the Alliance, Breastsens, released a statement in support of the work of TAC and SECTION27 to secure access to generic cancer medicines.

It seems that the close relationship between many members of the Cancer Alliance and the pharmaceutical industry is the cause of its opposition to our campaign. For instance, Campaigning for Cancer (C4C), one of the more vocal groups of the Alliance, has many ties to the pharmaceutical industry. The Chairperson, Neil Kirby, works with Werkmans Attorneys, who according to their website, carry out litigation on behalf of multinational corporations to protect their patents and other intellectual property rights.[6] Additionally, a number of board members have previously worked for multinational pharmaceutical companies and one board member is even described as ‘the architect of pharmaceutical and biotech industry efforts to protect intellectual property laws’.[7]  Further, many members of the Cancer Alliance receive part of their funding from pharmaceutical companies.

C4C and the Cancer Alliance undoubtedly do essential and important work in many other areas that improves access to cancer care in South Africa. Yet the Alliance is failing to take a stand on behalf of patients against abusive practices of pharmaceutical companies and the outrageous prices of many medicines. We hope that the Alliance will reconsider its position against South Africa using flexibilities allowed under international law to protect health and join TAC and MSF in our campaign to improve access to medicines for all people living in South Africa.

 

 

 


Annexure: Detailed analysis of availability of 6 cancer medicines in South Africa’s private and public sectors with SA versus India cost comparisons

Unless information is explicitly references then:

–          All public sector prices are calculated from the current government tender

–          All private sector prices were sourced from Medprax on 30 July 2012

–          Indian generic prices were supplied by MSF India during September and converted to Rands on 26 September 2012

–          Data on prescribed minimum benefit status was sourced from the Council for Medical Schemes (CMS)

–          Data on patent status was sourced from the Companies and Intellectual Property Commission’s online patent database. However companies are not required to submit applications under the name of the product to which the patent application is subject. Therefore some patents on these medicines may not be included in the table below.

–          Data on private sector expenditure was sourced from Mediscor’s 2011 Medicine Review

 

Example 1.

Imanitib mesylate

Brand names: Gleevec/ Glivec

Imanitib mesylate has received approval to treat 10 cancers, including chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors. Numerous studies have demonstrated the efficacy of Gleevec, and improved survival rates for CML patients (from 42 – 65% between 1983 and 2000 to 87% from 2001 onwards) since the introduction of this medicine.[8]

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R863 per 400 mg tablet(Novartis)

 

In 2011, the SEP for Gleevec was R360 000 per patient per annum

Not procured for use in the public sector. R46.20 per 400 mg tablet(Cipla)

 

R53.18 per 400 mg tablet

(Natco)

 

India rejected the patent application on Imanitib mesylate because it is a new formulation of an existing molecule.

 

SA PRIVATE SECTOR USAGE AND PMB STATUS

SA PUBLIC SECTOR USAGE/ NEED

In 2010 and 2011 the private sector spent more on Gleevec than any other cancer medicine. 

CML is a prescribed minimum benefit. According to the CMS, 233 medical scheme users suffered from CML in 2011. However, according to the CMS, ‘Although Gleevec is effective [in treating CML], it is not considered PMB level of care due to [un]affordability.’

 

 

The incidence of CML is cited at 2/100 000/year; however local South African incidence and prevalence data are lacking.[9] 

According to the CMS, 233 medical scheme users suffered from CML in 2011. However, only roughly 16% of the population is covered by medical schemes. The rest of the population receives care from the public sector. The public sector does not procure Gleevec but receives some free through Novartis’s free assistance programme. Novartis has provided Gleevec to 553 patients in the public sector (it is not clear whether this figure is for current patients or total patients over the last decade).[10]

Patent status:Imanitib mesylate is under patent in South Africa and therefore can only be purchased from the patent holder, Novartis. In South Africa there are a total of seven patents containing the word ‘imatinib’ of which three are accepted and four granted. The expiration dates rank from 2025 to 2029.

 

Example 2.

Sorafenib

Brand name: Nexavar

Sorafenib is used to treat kidney and liver cancers, mainly hepatocellular carcinoma and renal cell carcinoma. Clinical trials have shown that sorafenib extend survival by three months in patients with advanced heptocellular carcinoma.[11] When used in renal cell carcinoma, a planned analysis of overall survival at this time demonstrated a 28% reduction in the risk of death among patients receiving sorafenib, as compared with those receiving placebo.[12] Following demonstration of progression free survival with Sorafenib, patients receiving placebo were switched to sorafenib. The final analysis did not demonstrate an improvement of overall survival between the two groups, but the authors suggested that this may have been confounded by the cross-over of patients from placebo to sorafenib.[13] 

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R203.50 per 200 mg tablet(Bayer)

 

A cycle costs R240 000, total treatment costs exceed R1 million

Not procured for use in the public sector. 

 

R8.55 per 200 mg tablet[14](Cipla)

 

R11.00 per 200 mg tablet

(Natco)

 

India granted a compulsory licence on sorafenib in 2012, allowing generic production and sale of the medicine.

 

 

PMB STATUS

Renal cell carcinoma is a PMB. However sorafenib is not considered a PMB for the condition because according to CMS, ‘it is costly and may not be cost effective’ given limited benefit the patient. 
Patent status:Three patent applications on the ‘antitumor combination including AVE0862 and sorafenib’, ‘the process for the preparation of sorafenib tosylate’ and ‘sorafenib dimethyl sulphoxide solvate’ are currently pending.

 

Example 3.

Bortezomib

Brand name: Velcade

Bortezomib is used to treat multiple myeloma and in second line treatment for patients with mantle cell lymphoma. A study published in 2010 showed that the addition of Bortezomib, with other medicines used to treat multiple myeloma, reduced the risk of death by 35%.[15] 

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R11,548.70 per 3.5 mg vial(Janssen Pharmaceuticals)

 

 

Not procured for use in the public sector. 

 

R2,980 per 3.5 mg vial(Intas Biopharmaceuticals)

 

R2,849 per 3.5 mg vial

(Natco)

The molecule was developed before 1995 and therefore the medicine was not patented. (India’s patent laws changed after that.) Additionally, unlike SA, India does not grant new use or new formulation patents.

 

SA PRIVATE SECTOR USAGE AND PMB STATUS
Bortezomib ranked 5thaccording to overall expenditure on cystostatics in the private sector. 

According to the CMS this medicine is not a PMB because it is unaffordable.

Patent status:In South Africa a patent on the ‘lipsomal formulation of bortezomib’ was granted in 2007 and a process patent application is currently pending.

 

Example 4.

Oxaliplatin

Brand name: Eloxatin

Oxaliplatin is used in advanced colorectal cancer and stage III colon cancer.  A trial demonstrated that the addition of oxaliplatin to a regimen of 5FU and leucovorin improved the probability of disease-free survival at three years from 72.9 to 78.2% (P=0.002).[16]

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R2,331.79 per 50mg/10ml injection(Sanofi-Aventis)

 

R4,663.53 per 100mg/20ml injection

(Sanofi-Aventis)

R702 for 50 mg injection for infusion(Winthrope Pharmaceuticals – a member of the Sanofi-Aventis group)

 

R1,405.34 for 100 mg injection for infusion

(Winthrope Pharmaceuticals)

 

 

 

R585 per 100 mg vial(Cipla)

 

R705.24 per 100 mg vial

(Glenmark Pharmaceuticals)

 

R1,518.29 per 100 mg vial

(Dr Reddy)

 

The molecule was developed before 1995 and therefore the medicine was not patented. Additionally, unlike SA, India does not grant new use or new formulation patents.

 

SA PRIVATE SECTOR USAGE AND PMB STATUS

SA PUBLIC SECTOR USAGE

Oxaliplatin ranks 6thin terms of overall expenditure on cancer medicines in the private sector. 

The medicine is included as a PMB for patients with colon cancer.

2,100 50 mg injections and 4,4000 100 mg injections were purchased in the 2012/14 tender.
Patent status:A patent on ‘oxaliplatin solution formulations and the method of use thereof’ was granted in 1999. A patent on ‘pharmaceutically stable oxaliplatin preparation for parental administration’ was granted in 2002. And a patent for ‘treatment with oxaliplatin and an egfe-inhibitor’ was granted in 2006.

 

Example 5.

Rituximab

Brand names: Rituxan and MabThera

Rituximab is used to treat non-Hodgkin lymphoma and chronic lymphocytic leukemia. A number of studies have found that Rituximab, in addition to chemotherapy, improves overall survival in comparison to patients receiving chemo alone statistical significant better overall survival in the R-chemo group compared with the chemotherapy-alone group (RR, 1.09, 95% CI: 1.06–1.12, p <0.0000).[17] Additionally, trials have shown that the addition of Rituximab to chemotherapy with fludarabine and cyclophosphamide, improved outcomes. In two trials complete response (the disappearance of all signs of cancer) was almost doubled in patients receiving rituximab.[18]

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R2,789.50 per 10mg/ml infusion(Roche)

 

R13,947 per 500 mg injection

(Roche)

 

R1,589.99 for 100 mg injection, 10 ml vial for infusion(Roche)

 

R 7,950.01 for 500mg injection, 50ml vial for infusion

(Roche)

 

R1,542 per 100 mg vial(Dr Reddy)

 

R6,173 per 500 mg vial

(Dr Reddy)

 

The molecule was developed before 1995 and therefore the medicine was not patented. Additionally, unlike SA, India does not grant new use or new formulation patents.

SA PRIVATE SECTOR USAGE

SA PUBLIC SECTOR USAGE

Rituximab ranks 3rd, in terms of total expenditure on cancer medicines by medical schemes. 2,700 100 mg injections and 2,100 500 mg injections were purchased in the 2012/14 tender.
Patent status:In South Africa, a patent was granted for the ‘intrathecal administration of rituximab for the treatment of central nervous system lymphomas”, which will expire in 2022 and for ‘antineoplastic combinations of CCI-779 and Rituximab’ which will expire in 2026.

 

Example 6.

Temozolomide

Brand names: Temodar/ Temodal/Temcad

Temozolomide is used to treat, melanoma (a form of skin cancer), as well as, aggressive brain tumors. A study found that temozolomide reduced the size of brain tumors in 53% of the study’s participants.[19]

SA PRIVATE SECTOR PRICE

SA PUBLIC SECTOR PRICE

GENERICS AVAILABLE IN INDIA

R2,397.50 per 250 mg capsuleR958.73 per 100 mg capsule

R191 per 20 mg capsule

R48 per 5 mg capsule

(MSD)

R903.44 per 100 mg tablet(MSD)

 

R273.79 per 100 mg tablet(Cipla)

 

R305.53 per 100 mg tablet

(Dr Reddy)

 

Cipla has announced that it will market the medicine at even lower prices:[20]

R154 per 250 mg tablet

R74 per 100 mg tablet

R14.80 per 20 mg tablet

 

The molecule was developed before 1995 and therefore the medicine was not patented. Additionally, unlike SA, India does not grant new use or new formulation patents

SA PRIVATE SECTOR USAGE

SA PUBLIC SECTOR USAGE

The medicines is not a PMB for the treatment of brain glioma, because according the the CMS it is not cost effective and it does not provide better results than Carmustine. 5,500 capsules were ordered in the 2012/14 tender 
Patent status:In South Africa, 10 patents containing the word ‘Temozolomide’ were granted between 1994 and 2009.

 

 

 


[1] http://www.link2media.co.za/index.php?option=com_content&task=view&id=16569&Itemid=12

[2] http://www.fixthepatentlaws.org/?p=355

[3] http://www.fixthepatentlaws.org/?p=79

[4] According to the Mediscor Review, anti-hypertensive medicines accounted for the top expenditure by medical scheme on a medicine group in 2011

[5] Ibid.

[5a] In 2000, a common first line antiretroviral regimen containing stavudine(d4T), lamivudine (3TC) and nevirapine (NVP) cost R35,753 (ex VAT) per patient per year in South Africa. These medicines were not provided in the public sector and could only be purchased through the private sector. With the entry of generic medicines there has been a massive drop in the price of these medicines and they are now widely available through the public sector. Today government purchases d4T, 3TC and NVP for R689.28 (ex VAT) per patient per year. With the entry of generic versions of better antiretroviral medicines, most public sector patients now access a regimen containing tenofovir (TDF), 3TC and efavirenz (EFV). The cost to government per patient per year for this regimen is R1,436.88. Reference: The medicines prices were compiled by Beth Vale a former Master’s student with the UCT’s AIDS Society and Research Unit and current DPhil Candidate in Evidence-based Social Intervention at the University of Oxford.

[6] http://www.werksmans.co.za/legal-services/intellectual-property/

[7] This description is no longer on C4C’s website, but can still be found on the individual’s blog at http://cambattley1.wordpress.com/about/

[8] H Kantarjian et a. Imrpover survival in chronic myeloid leukemia since the introduction of imanitb therapy: a single-institution historical experience. Blood: Journal of the American Society of Haemotology. January 2012 0.1182/blood-2011-08-358135

[9] V J Louw et al., Recommendations for the management of adult chronic myeloid leukaemia in South Africa. November 2011, Vol. 101, No. 11 SAMJ

[10] This figure was accessed through email communication with Novartis on 8 October. Novartis has failed to respond to follow up queries as to whether this is the total number of patients that have received Gleevec since GiPAP began in 2002, or if this is current patients.

[11] J M Llovet et al. Sorafenib in Advanced Hepatocellular Carcinoma. N Engl J Med 2008; 359:378-390

[12] B Escudie et al. Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma.  N Engl J Med 2007; 356:125-134

[13] B Escudier et al. Sorafenib for Treatment of Renal Cell Carcinoma: Final Efficacy and Safety Results of the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. JCO July 10, 2009 vol. 27 no. 20 3312-3318

[14] Price converted from Rs on 25 July

[15] Mateos M-V et al. Bortezomib Plus Melphalan and Prednisone Compared With Melphalan and Prednisone in Previously Untreated Multiple Myeloma: Updated Follow-Up and Impact of Subsequent Therapy in the Phase III VISTA Trial. Journal of Clinical Oncology. Volume 28, Number 13, May 2010. Available at http://jco.ascopubs.org/content/28/13/2259.full.pdf

[16] Andre. T, Boni. C, Mounedji-Boudiaf. L et al. Oxaliplatin, Fluorouracil, Leucovorin as adjuvant treatment for colon cancer. NEJM 2004;350:2343-51

[17] G Gao. A systematic review and meta-analysis of immunochemotherapy with rituximab for B-cell non-Hodgkin’s lymphoma. Informa Healthcare.  January 2010, Vol. 49, No. 1 ,

[18] National Cancer Institute. Rituximab Improves Outcomes for Patients With Chronic Lymphocytic Leukemia. Posted: 01/14/2009

[19] American Academy of Neurology. Chemotherapy drug shrinks brain tumors. MAY 21, 2007. Available at http://www.aan.com/press/index.cfm?fuseaction=release.view&release=509

[20] http://www.thehindubusinessline.com/companies/article3379501.ece?homepage=true . (Prices converted to Rands on 27 September)

Comments

One Response to “Patent law reform will benefit both people with cancer and HIV”

  1. webmaster
    November 1st, 2012 @ 11:35 am

    Please note that there was an error in the original article. The South Africa private sector price for Bayer’s Nexavar was listed at R381 per 200 mg tablet. The price per tablet has now been reduced to R203.50.

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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign of the Treatment Action Campaign (TAC). TAC is a non-profit organisation that seeks to ensure that every person living with HIV has access to quality, comprehensive prevention and treatment services to live a healthy life. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

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