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GSIPA2M, Plenary 2, The role of civil society - Lotti Rutter
- 1. Patent Law Reform & the Struggle for Access to Medicines in South Africa
- 2. Early law reform efforts South Africa took a progressive step forward in 1997 Medicines and Related Substances Control Amendment Act. The amendments to the Act included: - requirements that doctors offer patients generic medicines when available; - allowing for international tendering in order to secure lower priced medicine in other countries; and - parallel importation provisions.
- 3. Pharmaceutical Manufacturing Association (PMA) case • Despite being signed into law, in 1998, 39 multinational drug companies attempted to stop the implementation of the Act by going to court against the South African government. • TAC fought on the side of government, offering legal support, educating our members about pharmaceutical greed, and organising demonstrations worldwide. • Following worldwide outrage the case was dropped in 2001.
- 4. Case by case struggles… • Fluconazole defiance campaign (2000) • Hazel Tau case (2002) • Competition Commission case on excessive price efavirenz (2007) • While we won the battle on 1st line ARV pricing in South Africa, the drug companies won the war for most other medicines. Why?
- 7. Of identical applications, South Africa grants 40% more patents than US & European Patent Offices.
- 8. Use of patent examinations & oppositions to stop evergreening & allow early generic entry Source: WHY SOUTH AFRICA SHOULD EXAMINE PHARMACEUTICAL PATENTS, Research and Information System for Developing Countries (RIS), Briefing document, 2012. * The graph shows the year in which the patents would have expired if they had been granted
- 10. What does this mean for the cost of specific medicines?
- 11. 0 200 400 600 800 1000 1200 1400 1600 1st line (TDF / FTC / EFV) 2nd line (AZT / 3TC / LPR/r) 3rd line (DRV / RAL / ETR) Monthly Cost of Standard ARV Regimens in Public Sector - (ZAR prices per person per month)
- 12. Cancer meds: patent status • 92 secondary patents found on 24 cancer medicines. • 74 were active secondary patents & potentially competition-blocking in South Africa. • Of the 92 - 39 had been rejected or withdrawn in at least one other jurisdiction.
- 14. Cancer meds: affordability • Of the 24 medicines, 15 are available in India for less than half of the price offered to the South African private sector.
- 16. Cancer meds: availability • Of the 24 case study medicines, 21 are available in the private sector in South Africa and only 7 are available in the public sector. • The lack of public sector availability of these drugs is driven mainly by high prices which, in turn, are caused by the proliferation of poor quality patents.
- 17. Lenalidomide • Treatment of multiple myeloma • Derivative of thalidomide - more effective / fewer side-effects • Not available in public sector • 8 secondary patents on thalidomide & lenalidomide • Could prevent use up to 2026 – 71 years after initial thalidomide patent & 31 years after original lenalidomide patent in other jurisdictions • 1 year’s supply of lenalidomide is priced at ZAR 882,000 (USD 71,410) in South Africa and less than ZAR 32,000 (USD 2,591) in India. • Once registered in SA, all Section 21 applications for import of generic lenalidomide was no longer allowed – although this is being challenged
- 18. Rituximab • Rituximab recommended by the WHO as an essential treatment for diffuse large B-cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma • In 2016, rituximab was the 7th highest driver of medicine expenditure by medical insurers in SA. • A single 500mg vial costs ZAR 16,822 (USD 1,364) in the private sector – and ZAR 7,950 (USD 644) per 500mg vial in public sector. • Primary patent on rituximab expired in 2004, but it will be protected by five secondary patents until at least 2030 – 42 years after first patent granted in SA. Pending patent applications if granted could extend a further 6 years. • Patents granted, upheld and pending on rituxumab in SA have been withdrawn in Europe and the Philippines and refused in South Korea.
- 19. Sorafenib • Sorafenib indicated for treatment of advanced renal cell carcinoma and advanced inoperable hepatocellular carcinoma. • Only Bayer’s originator version of sorafenib is available in SA, sold under brand name Nexavar. • Not available in the public sector - can only be accessed in the private sector. • 1 year of sorafenib treatment in SA costs approx. ZAR 334,720 (USD 27,105) – compared to ZAR 21,900 (USD 1773) in India. • 3 secondary patents may prevent use of generics until 2027 – 26 years after the earliest identified patent was granted.
- 20. Trastuzumab • Herceptin is sold in SA private sector for ZAR 23,562 (USD 1,910) per 440mg vial, or ZAR 471,240 (USD 38,210) for a full treatment course • In 2016 Herceptin was the third highest driver of medicine expenditure by private medical aid schemes in SA. • Roche’s clone product Herclon sold at ZAR 10,596 (USD 859) – or ZAR 211,920 (USD 17,184) for a full treatment course (undercut biosimilar price). • SA DOH currently negotiating with Roche for a lower price to allow for broad public sector access. • Six secondary patents could inhibit broad use of biosimilar trastuzumab and trastuzumab emtansine products in SA until 2036 – 44 years after the primary patent granted in US / EU and 36 years after the initial patent was granted in South Africa.
- 22. Hepatitis B • Entecavir chronic medicine for people who don’t tolerate tenofovir or have kidney impairment. • Not available in public sector, or paid for by private medical schemes. • Initial patent expired 2011 in SA. Three secondary patents were granted, one still in force (expires 2022). • ZAR 2 755 – ZAR 5 510 (USD 202 – USD 404) per month in SA depending on dose. • In India, generics cost around ZAR 480 – ZAR 896 (USD 35 - USD 65) per month. • Data from Andrew Hill - with economies of scale entecavir could be produced for as little as ZAR 41 (USD 3) per month.
- 25. Reform & other access processes.. • Sept 2013: Draft National Policy on Intellectual Property released by DTI (submission TAC/SECTION27/MSF October 2013) • July 2016: IP Consultative Framework released as way forward to finalise policy (submission FTPL September 2016) • Aug 2017: After Cabinet approval, DTI publish Draft Intellectual Property Policy of the Republic of South Africa, Phase I, 2017 for comment (submission FTPL October 2017).
- 26. #PharmaGate • Leaked documents by Mail & Guardian in SA revealed ZAR 6 million (USD 440 000) international pharmaceutical industry plot to delay intellectual property reforms in South Africa. Leads to national and international outrage. • Minister of Health Dr Aaron Motsoaledi said: "I am not using strong words; I am using appropriate words. This is genocide," in response to a plan he described as a conspiracy of "satanic magnitude" – a plan he called on all South Africans to fight "to the last drop of their blood".
Editor's Notes
- DOCTORS MUST INFORM ABOUT GENERICS. INTERNATIONAL TENDERING CL PROVISIONS TAC FOUGHT ON THE SIDE OF GOVT IN COURT
- DOCTORS MUST INFORM ABOUT GENERICS. INTERNATIONAL TENDERING CL PROVISIONS TAC FOUGHT ON THE SIDE OF GOVT IN COURT
- Fluconazole defiance campaign (2000) - TAC imported and distributed over 100 000 pills from Thailand (at ZAR 1.78 – USD 0.13) to South Africa (where they cost ZAR 29 (USD 2.12) per capsule in public sector) Hazel Tau case (2002) - complaints at Competition Commission against GSK and Boehringher-Ingleheim over excessive AZT & NVP prices (over R2000 per person per month). Competition Commission found prices excessive and referred to Competition Tribunal. Lead to VLs - current pricing 1st lines at R110 pppm 2007: TAC launched case at Competition Commission against Merck for excessive price of EFV, & lack of license for FDC. Merck backed down and lead to 80% price drop.
- There are patent examiners now – but they are yet to start rejecting frivilous and secondary patents… Depository system South Africa traditionally had a depository patent system – without any substantive search or examination in place
- stat: Ref: C Correa. Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing. Research paper 41, South Centre, 2011.
- Not only are all patents granted, but none are even pending in South Africa—very short amount of time to receive a patent Data in the table above was compiled by Bhaven Sampat, Amy Kapczynski, Professor at Yale Law School and Chan Park, General Counsel and Interim Executive Director for the Medicine Patent Pool. The table compares identical patent applications that were filed in South African Patent Office (CIPC), the U.S. Patent and Trademark Office (USPTO) and the European Patent Office (EPO) via the Patent Cooperation Treaty (PCT).
- EVERGREENING PLUS NO OPPOSITION SYSTEM IN SA EITHER 24 years additional of monopoly Third lines, R1500 --- 15x more than 1st line drugs But it doesn’t even begin to compare with how expensive it is across the world The impact of strict patent standards on monopolies and prices of medicines can be dramatic. The slide above shows graphs from a study comparing the patent systems of India and South Africa. While India applies strict patent standards and prohibits evergreening, in South Africa patents are granted without examination. Accordingly, “Countries like South Africa that have a registration system for patents are therefore more likely to grant multiple patents on a single medicine, and to allow evergreening to occur. Figure 2 provides an illustration of this in relation to darunavir, the antiretroviral medicine to treat HIV. Although the patent on the base compound (1993) was never filed in South Africa, a number of patents have been granted on different versions of this drug that do not expire till 20281.” See: http://www.ris.org.in/sites/default/files/pdf/Policy%20Brief-60.pdf
- If SA examined all its current patents based on it existing patentability criteria – 80% would have been rejected. E.g Reserve IP incentive for new compounds i.e. active ingredients that represent a fresh contribution to the stock of products available for medicinal use But not all patent applications relate to new compounds. Majority are for existing drugs (new use, new forms and new formulations) These can be rejected as such inventions that are common knowledge and practice in the pharmaceutical field
- R111,93 R244.38 R1614.14 Additional costs to the DOH as patients shift 16.9% of patients in South Africa need to be switched from 1st lines after 5 years due to virological failure Money being shifted from wider health system Dolutegravir – low dosage, less side effects, less API, low manufacturing costs, treatment naïve and advanced.
- Additionally, if South Africa reforms its processes for granting compulsory licenses, then compulsory licensing could be used as an expedited mechanism to access more affordable generic sorafenib in South Africa – as was done in India.
- Currently the cost of biosimilar trastuzumab products in India are similar to the cost of Herclon in South Africa – although it can be anticipated that the cost of biosimilar trastuzumab products will decline as their use increases globally as biosimilar products receive pre-qualification by the WHO64 and registration approval by stringent regulatory authorities. Secondary patents granted and upheld in South Africa include patents that were withdrawn in India, South Korea and Europe, as well as a patent refused in South Korea. In 2017 Roche granted a global license that will allow for use of Mylan’s biosimilar trastuzumab in South Africa following its registration.71 The license was granted as part of a settlement agreement in which Mylan agreed to withdraw its legal challenges against two trastuzumab products in the US.72 While the license will allow for introduction of Mylan’s biosimilar trastuzumab in South Africa following its registration, it is unlikely that the introduction of this product will lead to significant price reductions if patents remain a barrier to the entry of other competitor products.
- Hepatitis B chronic infection affects approximately 8% of the population in Sub-Saharan Africa. BMS 6 Hill A et al. Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries. Journal of Virus Eradication 01/2015; 1:103-110 One of my current patients, for instance, who could benefit from entecavir is a 38-year-old HIV-Hepatitis B co-infected lady with chronic hepatitis B-associated kidney disease. Ordinarily, joint use of lamivudine- and tenofovir-based ART would be excellent therapy for her hepatitis B, but this cannot be used: she developed lamivudine resistance after three years, with rising hepatitis B levels, and the tenofovir may further damage her kidneys, causing kidney failure. She would then need kidney dialysis to stay alive; however, this is a scarce resource and there is no guarantee she will access this treatment. Furthermore, with uncontrolled hepatitis B, she is not a kidney transplant candidate. Her only hope is to add entecavir to her treatment, but at more than ZAR 4 500 a month for entecavir, this is not accessible to her, or many other patients that could benefit from it. Generic entecavir at a fraction of the cost is available outside of South Africa. It seems a paradox that a young woman may die with a fully treated and suppressed HIV viral load but untreated hepatitis B.
- joint coalition of 36 patient groups, including: AmaBele Belles’ Project Flamingo, Breast Course 4 Nurses, Breast Health Foundation (BHF), Cancer Association of South Africa (CANSA), Can-Sir, CanSurvive Cancer Support, Cape Mental Health (CMH), Childhood Cancer Foundation of South Africa (CHOC), DiabetesSA, Doctors without Borders (MSF), EpilepsySA, Hospice Palliative Care Association (HPCA), Igazi Foundation, Lymphoedema Association of South Africa (LAOSA), Look Good Feel Better, Marie Stopes South Africa, Men’s Foundation, National Council Against Smoking, Oncology Nursing Association of SA, Pancreatic Cancer Network of SA, People Living With Cancer (PLWC), Pink Trees for Pauline, Pocket Cancer Support, Rainbows and Smiles, Reach for Recovery, Schizophrenia and Bipolar Disorders Alliance (SABDA), SECTION27, South African Depression and Anxiety Group (SADAG), South African Federation of Mental Health (SAFMH), South African Non-Communicable Diseases Alliance (SANCD Alliance), Stop Stock Outs Project (SSP), The Pink Parasol Project, The Sunflower Fund, Treatment Action Campaign (TAC), Vrede Foundation, and Wings of Hope.
- Although big wins… we are still fighting today. Aims to have Department of Trade and Industry include pro-public health language in national IP policy in order to take advantage of TRIPS flexibilities in national laws.
- $450 000 plot “Patents do not impede access to medicines…” “We do NOT want a debate over individual drug prices to become the focal point” “South Africa is now ground zero for the debate on the value of strong IP protection. If the battle is lost here, the effects will resonate.” “Proposed IP Policy Hurts the South African Economy… innovation will stall” … as we have seen these arguments are misconceptions…
- Finished training Were 20 now 18 or 17 left Focus on pharma – not all Now they cant actually examine until the policy is finalised….. Doing practice examinations