29 October 2015
Dear Honourable Minister Davies
RE: Request for urgent update on the status of the IP Policy and introduction of a bill to fully incorporate TRIPS safeguards to protect health into the Patents Act 57 of 1978
October 2015 marks the two year anniversary of the close of the public comment period on the Draft National Policy on Intellectual Property (IP). The draft policy – released by the DTI in September 2013 – committed to reforming South Africa’s patent laws to fully adopt safeguards to protect health and access to medicines allowed under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). To date no finalised policy has been released, despite multiple promises and commitments by the DTI to do so over the past two years. See Annex 3
We are concerned by the lack of transparency surrounding the policymaking process. In addition to missing self-imposed deadlines for finalising the IP Policy, the DTI has not responded to multiple requests for clarity from Fix the Patent Laws (FTPL) coalition members on when the finalised policy will be released, and bills to amend the Patents Act and related legislation will be brought before Parliament, in order to fully adopt TRIPS health safeguards. FTPL coalition members have not received a substantive response to any of the correspondence sent to Minister Davies since the release of the policy, including:
- An open letter to the Department of Trade and Industry from 130 organisations and experts on 17 October 2013 calling for the full adoption of TRIPS flexibilities into South Africa’s laws to protect health [http://tinyurl.com/q5gz47t].
- An open letter to Minister Davies from the FTPL coalition and international partners, endorsed by 59 organisations and 31 individuals and sent on 17 October 2014, requesting urgent clarification of when the IP Policy will be finalised and a bill to reform the Patents Act will be brought before Parliament. [https://www.fixthepatentlaws.org/?p=959 ]
- A letter to Minister Davies from the Treatment Action Campaign sent on 25 June 2015 requesting urgent clarification regarding IP-related concessions made by the DTI in the AGOA agreement and clarification on when the finalised IP Policy will be released. [https://www.fixthepatentlaws.org/?p=1013]
- A letter to Minister Davies from Doctors Without Borders sent on 16 September 2015 requesting South Africa’s support for an unconditional extension of the transition period under Article 66.1 of the TRIPS Agreement regarding certain obligations with respect to pharmaceutical products, as well as a waiver from Articles 70.8 and 70.9 of TRIPS for as long as countries remain least developed countries. The letter also requested urgent clarification of when the finalised IP Policy would be released. [http://bit.ly/1RBjgN9]
The FTPL coalition seeks urgent clarification from Minister Davies on when the finalised policy will be released and a bill to reform the Patents Act and related legislation will be brought before Parliament.
Further, the coalition requests an in-person meeting with Minister Davies and other senior officials in the DTI and the Companies and Intellectual Property Commission to discuss next steps for finalising the IP Policy, and reforming and implementing the Patents Act and related legislation.
Since its launch in 2011, the FTPL coalition has grown to include 18 patient groups and health organisations in South Africa working in the fields of cancer, diabetes, epilepsy, mental health, other non-communicable diseases, sexual and reproductive health, tuberculosis and HIV. Coalition members of the Fix the Patent Laws campaign represent patients and constituencies who need access to affordable medicines to treat a wide range of conditions that are life threatening, or result in significantly reduced quality of life if untreated.
FTPL coalition members have witnessed first-hand how South Africa’s laws and procedures for protecting intellectual property negatively impact on people’s lives by blocking access to much needed affordable versions of medicines and medical technologies. We find delays in undertaking pro-public health reform deeply concerning.
Table 1 in Annex 1 provides examples of medicines used to treat a wide range of conditions, for which patent monopolies granted in South Africa block access to more affordable generic and biosimilar versions and/or more stable supplies. Multiple manufacturers supply these medicines in other countries where patent monopolies have expired, where patent applications have not met national patentability criteria, or where patents were overturned on public health grounds.
Of the 13 medicines listed in Table 1, only four[1] are procured by the National Department of Health for use in the public sector—though other factors, including cost, may limit their availability. The rest are not available in the public sector, or are only available under extremely limited circumstances given their high costs. In the private sector, medical schemes exclude on cost-effectiveness grounds many of these medicines from their medicine formularies and treatment protocols for the treatment of prescribed minimum benefits conditions (PMBs) – conditions for which a medical scheme must pay for treatment in full regardless of a medical scheme member’s benefit option.
More affordable generic and biosimilar versions of these medicines are available in other parts of the world, while only originator products are available in South Africa – largely due to shortcomings in South Africa’s laws and procedures for granting and protecting patents. Annex 2 provides narrative case studies for four of these medicines, outlining the extent to which South Africa’s laws have cost and/or access implications. Case studies 1 – 3 highlight how private sector patients and medical schemes in South Africa could save as much as R191 million per annum, if the prices of just three medicines included in table 1 reached levels on par with India and Canada. Access to lower prices could also facilitate national procurement through the public sector.
In addition to limiting access to more affordable medicines, South Africa’s patent laws can compromise the security of medicine supply in the country, as highlighted in Case Study 4. Since April 2015, health facilities across South Africa have reported shortages of the key antiretroviral combination medicine Lopinavir/ritonavir to a civil society consortium monitoring stock outs of essential medicines. The patent holder, AbbVie, has been unable to deliver adequate supply, while patent monopolies have blocked the use of quality-assured, generic products registered in South Africa, which could increase available supplies and reduce stock outs.[2]
To reduce morbidity and mortality in South Africa, there is urgent need to enhance competition among pharmaceutical manufacturers, facilitate access to more affordable generic and biosimilar versions of medicines, and better ensure security of medicine supply. An important step toward achieving these objectives requires South Africa to fully adopt TRIPS health safeguards[3] into its national laws. The DTI’s present failure to finalise a national IP policy that lays the foundation for such reform compromises the realisation of the constitutional right of people living in South Africa to have access to health care services, and is unacceptable to this coalition.
The coalition requests an urgent response to the following:
- A date for the release of a finalised IP Policy; and
- A date for a meeting.
We look forward to your response. Please cc catherine.tomlinson@joburg.msf.org and lotti.rutter@tac.org.za in communications with the FTPL coalition.
Regards,
Anele Yawa, General Secretary, Treatment Action Campaign, Anele.yawa@tac.org.za, cc. lotti.rutter@tac.org.za
Julia Hill, Deputy Head of Mission, Doctors Without Borders (MSF), julia.hill@joburg.msf.org, cc. catherine.tomlinson@joburg.org
Umunyana Rugege, Attorney, SECTION27, rugege@section27.org.za, cc. khan@section27.org.za
Lillian Dube, Cancer survivor and celebrity, Lillian09@telkomsa.net
Cassey Chambers, Operations Director, South African Depression and Anxiety Group, office@anxiety.org.za
Vicki Pinkney-Atkinson, Strategic Development Manager, SA NCD Alliance, vicki@phango.org.za
Charlene Sunkel, Program Manager: Advocacy & Development, SA Federation for Mental Health, charlene@safmh.org
Chanelle Albertyn, PR and Communications Manager, Cape Mental Health, chanelle@cmh.org.za
Bella Hwang, Project Manager, Stop the Stock Outs Project, msfocb-capetown-mhealth@brussels.msf.org
Ronald Creasy, Chairman, Schizophrenia and Bipolar Disorder Alliance, creasy@iburst.co.z, sabda@iburst.co.za
Karen Robinson, National Social Development Manager, Epilepsy South Africa, socdev.no@epilepsy.org.za
Keegan Hall, Marketing Coordinator, DiabetesSA, marketing@diabetessa.org.za
Andrea Thompson, Advocacy and Engagement Manager, Marie Stopes, andrea.thompson@mariestopes.org.za
Cancer Alliance, Liz Gwyther, Executive Council Member, info@canceralliance.co.za
Linda Greeff, Director, People Living With Cancer (PLWC), linda.greeff@cancercare.co.za
Salomé Meyer, Project Manager, Advocates for Breast Cancer, meyernaude@telkomsa.net
Magdalene Seguin, Head of Advocacy, Cancer Association of South Africa, mseguin@cansa.org.za
Carl Queiros, Chief Executive Officer, CHOC Childhood Cancer Foundation South Africa, carl@choc.org.za, cc. Adri.Ludick@choc.org.za
Bernice Lass, Co-Founder , CanSurvive, bernicelass@outlook.com
Annex 1
TABLE 1. Selected medicines for which South Africa’s failure to scrutinize patent applications have allowed for ever-greening of patent monopolies, blocking access to generic and biosimilar products available in other countries
| Disease group | Generic name | Originator Brand name | Patent monopolies upheld in SA may block generics and biosimilars until *
|
Countries where generics/ biosimilars already known to be available (non-exhaustive list) |
| Cancer | Trastuzumab | Herceptin | 2033 | India, South Korea |
| Bortezomib | Velcade | 2035 | Canada, India | |
| Sorafenib | Nexavar | 2021/2032 ** | India | |
| Pain | Pregabalin | Lyrica | 2028 | Canada, UK, Russia, India |
| Celecoxib | Celebrex | 2020 | US, Canada, India | |
| Oxycodone | Oxycontin | 2031 | US, Canada, India | |
| Mental health | Aripiprazole | Abilify | 2033 | US, India |
| Sexual and reproductive health | Misoprostol | Cytotec | 2016 | US, Canada, South Korea, India |
| Drospirenone and ethinyl estradiol | Yasmin, Yaz | 2024 | US, parts of Europe | |
| Hepatitis | Entecavir | Baraclude | 2026 | US, India |
| Ribavirin | Ribatol, Copegus | 2018/2024** | US, Japan, India | |
| HIV and opportunistic infections
|
Lopinavir/ritonavir | Aluvia | 2026 | Mozambique, Zimbabwe |
| Valganciclovir | Valcyte | 2030 | India |
* if no additional patents blocking generic entry are granted
** These two dates are the dates of expiry of patents held in South Africa. It is unclear if generics will be able to be sold under the earlier date listed, or if the latter patent will continue to block generic use until expiry.
Annex 2. Narrative case studies highlighting how South Africa’s patent laws impact negatively on medicine access
| CASE STUDY 1: TRASTUZUMAB |
| Trastuzumab is used to treat HER2 positive breast cancer and some types of stomach cancer. Trastuzumab is recommended as an essential medicine by the World Health Organisation as a medicine with a “relevant survival benefit” for a cancer with a high incidence[4]. Yet in South Africa, originator company Roche is the sole supplier of trastuzumab which is sold under the brand name Herceptin. In South Africa, trastuzumab medicine is not provided in the public sector[5] and is excluded from prescribed minimum benefits due to its high cost.[6]
In India, biosimilar versions of trastuzumab are available at prices 70% lower than those charged for Roche’s originator version in South Africa. Patent barriers held by Genetech (which provides exclusive marketing rights to Roche for trastuzumab) could block the use of registered biosimilars in South Africa until 2033.[7] During 2013, Roche earned over R100 million on sales of Herceptin in South Africa[8], yet many women that could have benefited from this drug were unable to access it at current prices. If biosimilar products were available in South Africa at the same prices charged in India, private sector patients and medical schemes could realise potential cost savings of R70 million per annum. |
| CASE STUDY 2: ARIPIPRAZOLE |
| Aripiprazole is used to treat major depressive disorder, schizophrenia and bipolar disorder. Aripiprazole is more tolerable for patients and has fewer side-effects than other typical antipsychotic medicines.[9] While generic versions of aripiprazole are already available in India and the US, patent monopolies held by Bristol-Myers Squibb (BMS) and Otsuka (who jointly market with BMS) could block their use in South Africa until 2033.[10] In South Africa BMS markets aripiprazole under the brand name Abilify.
Given its cost, aripiprazole is not procured nationally for use in the public sector[11] and only limited public sector access is available under narrow circumstances. In the private sector, the medicine is only covered as a prescribed minimum benefit for patients that have previously failed on other first line treatments.[12] In the private sector, the monthly cost of Abilify ranges between R1,089.60 (10mg per day) to R2,408.10 (30mg per day). In India generic equivalents are available at significantly lower monthly costs of R35.40 (10mg per day) to R84.60 (30mg per day). During 2013, BMS earned more than R30 million on the sale of Abilify in South Africa’s private sector. If generic versions were available in South Africa at prices charged in India, then private sector patients and medical schemes could realise potential cost savings of R28 million per annum. |
| CASE STUDY 3: CELECOXIB |
| Celecoxib is used to treat pain in patients with rheumatoid arthritis and osteoarthritis. Generic versions of celecoxib are already available in the US, Canada, India and other countries. In South Africa patents held by G.D. Searle (owned by Pfizer) may continue to block availability of generics until 2020.[13] Generics in Canada are available at prices 58% lower than that of originator celecoxib in South Africa.[14]
During 2013, Pfizer earned more than R160 million from sale of its originator version of celecoxib in South Africa’s private sector.[15] If generic versions were available in South Africa at the same prices charged in Canada, patients could realise potential cost savings of approximately R93 million per annum. |
| CASE STUDY 4: LOPINAVIR/RITONAVIR |
| Lopinavir/ritonavir (LPV/r) is an antiretroviral combination medicine that is used in second line HIV treatment for adults and adolescents and first line HIV treatment of children under 3 years of age. In South Africa, AbbVie is the sole supplier of LPV/r and holds multiple patents on the medicine.[16]
Since April 2015, AbbVie has been unable to provide adequate supply of LPV/r in South Africa and other countries – resulting in country wide stock outs of this medicine and treatment interruptions for thousands of patients.[17] Treatment interruptions significantly increase patients’ risks of immunological failure, or opportunistic infections, and can result in development of further resistance, requiring considerably more costly treatments. To date, AbbVie’s patent monopolies on LPV/r – lasting at least until 2026[18] – have blocked the use of generic lopinavir/ritonavir products that are pre-qualified by the World Health Organisation and registered in South Africa, limiting the ability of government to increase available supply and reduce stock outs.[19] |
Annex 3.
A Timeline of Intellectual Property Reform in South Africa
1994 – 2015
April 1994: The Bill of Rights comes into force in South Africa outlining the new democratic government’s constitutional obligations. The Bill of Rights states that “the state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of [the right to have access to health care services].” Source: http://www.justice.gov.za/legislation/constitution/SAConstitution-web-eng-02.pdf
April 1994: As a member of the World Trade Organisation (WTO), South Africa signs the international agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), agreeing to provide 20-years of patent protection on products and processes that are new, innovative and capable to industrial application. The agreement contains safeguards to allow countries to protect health over patents. Source: https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
September 1997: South Africa amends its Patents Act 57 of 1978 to provide 20 years of patent protection in line with its TRIPS obligations, failing to fully utilise extension periods provided to developing countries in implementing their TRIPS obligations, or fully adopt safeguards allowed under TRIPS to protect health over patents. Prior to the 1997 amendments, South Africa provided 16 years of monopoly protection on patents. Source: https://www.fixthepatentlaws.org/?p=79
November 1997: President Nelson Mandela signs amendments to South Africa’s Medicines Act 90 of 1997 into law. The amendments include provisions to allow for parallel importation (a safeguard allowed under TRIPS to protect health), and encouraging generic substitution of off-patent medicines. While these provisions were important steps towards improving medicine access, they did not go far enough – failing to adopt many of the safeguards allowed under TRIPS to protect health. Source: http://www.ldd.org.za/images/stories/Ready_for_publication/V5-2_Debunking_Conglomo-talk.pdf
February 1998: The Pharmaceutical Manufacturers Association (PMA) representing 37 international pharmaceutical companies initiates legal action against the introduction of Medicines Act amendments in South Africa to promote use of generic medicines and allow parallel importation to improve access to affordable medicines. Source: http://www.ldd.org.za/images/stories/Ready_for_publication/V5-2_Debunking_Conglomo-talk.pdf
1998: Following the ratification of amendments to the Medicines Act to promote use of generic medicines and allow for generic substitution, the United States Trade Representative places South Africa on the 301 Watch List. Inclusion on this list signifies that the U.S. perceived South Africa had created trade barriers for the U.S. and could therefore be subject to trade sanctions. Sources: http://www.ldd.org.za/images/stories/Ready_for_publication/V5-2_Debunking_Conglomo-talk.pdf; https://en.wikipedia.org/wiki/Special_301_Report
November 2000: Litigation between the South African government and PMA commences over Medicine Act amendments to promote the use of generic medicines and allow parallel importation. Source: http://www.ldd.org.za/images/stories/Ready_for_publication/V5-2_Debunking_Conglomo-talk.pdf
April 2001: The case against the South African government is dropped by the Pharmaceutical Manufacturing Association following massive, international outcry. Following the court case, the PMA split into 2 organisations – one retaining the name PMA and the other re-branding itself as Innovative Medicines South Africa (IMSA) Sources: http://www.ldd.org.za/images/stories/Ready_for_publication/V5-2_Debunking_Conglomo-talk.pdf; http://www.edoc.co.za/modules.php?name=News&file=article&sid=4633; http://crm.bhfglobal.com/new-pharmaceutical-body-tackle-drug-registration-delay
November 2001: The Doha Declaration on the TRIPS Agreement and Public Health (“the Doha Declaration”) is signed by members of the WTO, re-affirming countries’ rights to utilise safeguards in the TRIPS agreement to protect health.
Source: https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
September 2002: TAC files a complaint with the Competition Commission concerning the conduct and excessive pricing of essential ARV medicines by multi-national pharmaceutical giants Boehringer Ingelheim and GlaxoSmith Kline. The Competition Commission refers the case to the Competition Tribunal for adjudication. Sources: http://www.section27.org.za/wp-content/uploads/2010/04/journal-HR-practice-heywood.pdf; http://www.tac.org.za/newsletter/2003/ns10_12_2003.htm
December 2003: Following referral of TAC’s Competition Commission complaint to the Competition Tribunal, Boehringer Ingelheim and GlaxoSmithKline grant licenses for generic manufacture and sale of the antiretroviral medicines lamivudine and zidovudine in South Africa. The availability of generic medicines paves the way for massive price reductions and scaled up access. Source: http://www.tac.org.za/newsletter/2003/ns10_12_2003.htm
October 2005: As a member of the African Union, South Africa commits to making full use of TRIPS flexibilities in the Declaration on A Roadmap Towards Universal Access to Prevention, Treatment and Care. Source: http://www1.chr.up.ac.za/undp/regional/docs/audeclaration7.pdf
November 2007: TAC launches Competition Commission complaint against MSD (the South African subsidiary of multinational drug company Merck) for unlawfully refusing to grant licenses to allow for generic production of and affordable access to generic efavirenz. Sources: http://www.tac.org.za/community/node/2329; http://www.tac.org.za/community/node/2127
June 2008: Following TAC’s Competition Commission complaint, MSD grants voluntary licenses for production and use in South Africa of generic versions on antiretroviral medicine efavirenz, leading to massive price reductions. Source: http://www.tac.org.za/community/node/2329; http://www.tac.org.za/community/node/2998
June 2009: South Africa’s Department of Trade and Industry (DTI) initiates the process of reforming intellectual property (IP) laws on its own accord. The DTI announces plans to release a policy document for reform of South Africa’s intellectual property legislation during 2009. Source: https://pmg.org.za/committee-meeting/10470/; http://bit.ly/1MTv6P8
September 2009: Competition Commission ruling allows for manufacture and use of generic versions of antiretroviral medicine abacavir following TAC’s submission on the merger between GlaxoSmithKline and Aspen Pharmacare. Generic competition results in large prices reductions. Sources: http://www.tac.org.za/community/node/2744; http://www.tac.org.za/community/node/2998
July 2011: Health Ministers of BRICS countries (Brazil, Russia, India, China, South Africa) sign the Beijing Declaration, stating their support for TRIPS safeguards, and commitment to preserving and promoting, to the full, the provisions contained in the Doha Declaration. Source: http://www.brics5.co.za/about-brics/sectorial-declaration/health-ministers-meeting/beijing-declaration/
August 2011: Jodi Scholtz, group COO of the DTI states that: “The Department of Trade and Industry (DTI) intends to submit the Intellectual Property (IP) draft policy to Cabinet next month to secure approval to undertake wider public consultation.” Source: http://www.tac.org.za/community/node/3250
September 2011: Research published by Prof Carlos Correa, Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law at the University of Buenos Aires demonstrates that South Africa grants significantly more pharmaceutical patents than other countries of similar socio-economic backgrounds. South Africa granted 2,442 pharmaceutical patents in 2008 alone, while Brazil only granted 278 pharmaceutical patents between 2003 and 2008. Source: http://apps.who.int/medicinedocs/documents/s21395en/s21395en.pdf
September 2011: In response to a letter sent by the Treatment Action Campaign to DTI Minister Rob Davies, civil society is informed by Minister Davies that: “The Government is developing an Intellectual Property Policy (IP Policy) which will also address access to medicines and public health issues… The IP Policy will also establish a framework for legislative reform across all areas of IP policy to ensure a consistent approach that contributes positively to the economic and social interest of South Africa… The Policy will provide clarity as to which sections of the Patents Act 57 of 1978 and the Medicines Control and Related Substances Act 101 of 1965 require amendment to ensure that the flexibilities relating to access to medicine and health are incorporated into national legislation.” Source: https://www.fixthepatentlaws.org/?p=79
October 2011: President Jacob Zuma signs a joint declaration with Presidents of India and Brazil, recognising that the impact of intellectual property on health, access to drugs and prices can best be tackled by enabling the scaled-up production of generic medicines through the full use of flexibilities provided by the TRIPS agreement, in accordance with the Doha Declaration. Source: http://www.thepresidency.gov.za/pebble.asp?relid=5053
November 2011: Research published by academics from the University of Pretoria’s Graduate School of Technology Management and Institute for Technological Innovation exposes that 80% of patents upheld in South Africa do not meet the country’s patentability criteria. The researchers conclude: “We found that the current intellectual property rights regime not only fails to support the objectives of the national innovation system but also that it facilitates exploitation by foreign interests and creates substantial social costs.” Sources: http://reference.sabinet.co.za/document/EJC97100; http://www.sanedi.org.za/archived/wp-content/uploads/2012/02/ee/Patents%20and%20economic%20develoment%20SAJS%2097-2003-named.pdf
November 2011: TAC, MSF and SECTION27 jointly launch the Fix the Patent Laws campaign on the 10 year anniversary of the Doha Declaration. The Doha Declaration was important because it clarified the rights of members to use flexibilities contained in the TRIPS agreement to protect health and states that the TRIPS agreement “should not prevent Members from taking measures to protect public health… and should be interpreted in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicine for all.” Source: https://www.fixthepatentlaws.org/?p=79
May 2012: Representatives of MSF meet with the DTI and are informed the IP policy will be released for public comment in June/July 2012. The policy is not forthcoming. A leaked version of the draft policy is obtained by civil society groups. The document features comments from the multinational pharmaceutical industry associations, Innovative Medicines South Africa (IMSA) and the Pharmaceutical Industry Association of South Africa (PIASA) which outline their opposition to proposed reforms promoting access to medicines. Sources: https://www.fixthepatentlaws.org/?p=646; https://www.fixthepatentlaws.org/?p=559 ; http://bit.ly/1ka1aHm
July 2012: South Africa’s Supreme Court of Appeal affirms that the broader public interest, and not only the financial interests of litigating parties, must be taken into account when settling cases of purported patent infringement. This implies that courts must consider the availability and affordability (or lack thereof) of medicines to which patents apply. Source: http://www.justice.gov.za/sca/judgments/sca_2012/sca2012-108.pdf
August 2012: DTI spokesperson says that “concerns raised by the TAC were being addressed by the draft policy on intellectual property, which is awaiting approval by Trade and Industry Minister Rob Davies and the Cabinet.” Source: http://www.bdlive.co.za/articles/2011/11/17/sa-s-tight-patent-protection-drives-high-drug-prices
October 2012: Intellectual property experts: Amy Kapczynski, Professor at Yale Law School; Bhaven Sampat, Professor at Columbia School of Public Health and Chan Park, General Counsel and Interim Executive Director at the Medicines Patent Pool, present research demonstrating that South Africa grants 66% more patents that the United States and European Union on identical applications. Source: https://www.fixthepatentlaws.org/?p=459
October 2012: DTI representatives inform civil society during TAC and MSF-hosted meeting that the IP policy will be submitted to Cabinet on 5 December 2012, and finalised in March/April 2013. No draft policy is forthcoming until September 2013. Source: https://www.fixthepatentlaws.org/?p=459
December 2012: No IP policy is submitted to Cabinet. DTI representative says policy will be presented to Cabinet in January 2013. It is not forthcoming. Source: https://www.fixthepatentlaws.org/?p=523
January 2013: No IP policy is submitted to Cabinet. Civil society is informed it will be submitted in early February 2013. It is not forthcoming. Source: https://www.fixthepatentlaws.org/?p=526
February 2013: At the Africa IP Forum in Midrand, DTI Minister Davies responds to activist concerns, noting that the draft policy is in its final stages, and will be released soon. He comments that the policy should balance “the rights of innovators and the rights of humanity… There needs to be both incentives for innovation as well as ensuring public health and access to medicine”. The Minister repeatedly highlighted the role of generic medicines in fighting disease in South Africa and was clear that “generics are not counterfeits”. Source: https://www.fixthepatentlaws.org/?p=540
April 23, 2013: Reuters article quotes DTI representative as saying the overhaul of IP legislation would improve access to medicines by making it more difficult for pharmaceutical companies to obtain patents and keep prices high, suggesting the Ministry was making progress in developing its policy position. Source: http://www.reuters.com/article/2013/04/22/us-safrica-medicines-idUSBRE93L0M420130422
April 24, 2013: Days later, the DTI reneges on IP policy commitments, with DTI Minister Davies stating that South Africa’s new IP policy would not be released for public comment any time soon. Source: https://www.fixthepatentlaws.org/?p=583
May 2013: Two industry groups representing originator-producing pharmaceutical companies in South Africa – the Pharmaceutical Industry Association of South Africa (PIASA) and the Innovative Medicines South Africa (IMSA) – merge to from the Innovative Pharmaceutical Association of SA (IPASA). Source: http://crm.bhfglobal.com/new-pharmaceutical-body-tackle-drug-registration-delay
August 2013: DTI Chief Director of Policy and Legislation, Macdonald Netshitenzhe, confirms that the draft IP policy has been submitted to Cabinet. He says that the policy proposes to improve access to medicines, and introduce patent examination to stop pharmaceutical companies from “evergreening” their patents. Sources: http://www.bdlive.co.za/national/health/2013/08/08/state-hopes-big-changes-to-patent-rules-will-cut-drug-costs https://www.msf.org.za/msf-publications/bush-radio-msf-and-tac-discuss-sas-patent-laws
September 2013: DTI releases draft IP policy, inviting public comment. The draft policy outlines principles and proposals that promise to increase competition in the pharmaceutical sector and lower the prices of medicines in South Africa. Source: https://www.fixthepatentlaws.org/?p=657
October 2013: Public comment period closes on draft IP Policy. Over 100 submissions are submitted to the DTI. Source: http://www.ip-watch.org/2013/11/18/comments-received-to-south-africas-process-for-new-ip-policy/
October 2013: The United Nations Development Programme releases a detailed analysis of South Africa’s intellectual property laws, recommending the adoption of TRIPS flexibilities to improve access to medicine. Source: http://www.undp.org/content/dam/undp/library/hivaids/English/using_law_to_accelerate_treatment_access_in_south_africa_undp_2013.pdf
November 2013: The DTI releases a statement that an upcoming conference will allow for consultation with stakeholders on the draft IP policy. This conference does not go forward. Source: https://www.fixthepatentlaws.org/?p=814)
November 2013: At the “Creating and Leveraging Intellectual Property in Developing Countries” conference (CLIPDC), Minister Davies notes recommendation of draft IP policy to introduce substantive examination of patents. He encourages partnership and collaboration with other developing countries, in order for South Africa to arrive at approaches that best address their developmental objectives. Source: http://www.clipdc.co.za/wp-content/uploads/2013/08/Minister-Davies-Speach.pdf
January 2014: Pharmagate scandal hits South African media—25 pharmaceutical companies under the umbrella organisation IPASA are revealed to be plotting the finance of a scheme to delay the finalisation of the IP policy. Minister of Health calls the plot tantamount to “genocide”, and South African and other country statements at the Executive Board meeting of the World Health Organisation reiterate that IP reform in South Africa “will promote competition and ensure the levelling of the playing field.” One week after the Pharmagate scandal, pharmaceutical companies Roche quits, and Novo Nordisk temporarily leaves the association. Sources: http://mg.co.za/article/2014-01-16-motsoaledi-big-pharmas-satanic-plot-is-genocide; https://www.fixthepatentlaws.org/?p=847; http://sciencespeaksblog.org/2014/02/11/follows-on-pharmagate-plot-south-africa-activists-picket-merck-office-while-two-drug-companies-leave-pharmaceutical-association/
February 2014: The DTI promises that a finalised policy will be tabled in April 2014, and the DTI will meet and consult with all Ministries affected by the IP policy. The final policy is not forthcoming. Source: https://www.msf.org.za/msf-publications/new-age-mps-set-to-tackle-vital-patent-legislation-on-medicines
March 2014: Marches are held by civil society organisations in Cape Town and Pretoria. Memorandums calling for a final IP policy before national elections are delivered to the DTI Minister, and Parliament. The DTI says that the policy will be finalised after elections, because “parliamentary processes…need to be followed.” Sources: https://www.msf.org.za/msf-publications/pretoria-news-activists-tackle-department-on-patent-laws; https://www.msf.org.za/msf-publications/new-age-health-activists-urge-patent-law-finality-may-7; https://www.msf.org.za/msf-publications/cabinet-mps-save-your-voters-lives-push-final-ip-policy-elections
October 2014: At an IP Summit hosted by the Treatment Action Campaign, nearly 50,000 signatories sign petitions and an open letter to encourage the finalisation of the IP policy. The DTI announces that it will implement a substantive search and examination system. They also noted that they have appointed a consultant, Genesis Analytics, to conduct a Regulatory Impact Assessment on the draft IP policy, to facilitate its eventual approval by Cabinet. They announce that a final policy will be released by the end of 2014, with Bills introduced in Parliament in February 2015. Neither the final policy nor the bills are forthcoming. Source: https://www.fixthepatentlaws.org/?p=953 https://www.fixthepatentlaws.org/?p=959
November 2014: The Mail & Guardian posts on sourceafrica.net all the submissions to the DTI on the draft IP policy, as well as a 600-page summary of all submissions by the DTI. Source: https://sourceafrica.net/public/search/Draft%20IP%20policy
March 2015: DTI Director General Lionel October’s presentation to Trade and Industry Portfolio Committee in Parliament announces the DTI has developed eight Bills to amend IP legislation in South Africa in relation to the policy, and undertaken regulatory impact assessments for each of these Bills. Source: https://pmg.org.za/committee-meeting/20514/
April 2015: Commissioner Astrid Ludin of the Companies and Intellectual Property Commission notes in her presentation to Parliament’s Committee on Health that South Africa will introduce substantive examination of patents. Source: https://www.thedti.gov.za/parliament/2015/CIPC_strat_app.pdf
June 2015: Twelve leading health and patient support organisations join the Fix the Patent Laws campaign in calling for progressive patent law reform. These organisations are: People Living With Cancer (PLWC), the South African Depression and Anxiety Group (SADAG), DiabetesSA, CanSurvive, the SA Federation for Mental Health (SAFMH), Stop Stock Outs, the Cancer Association of South Africa (CANSA), the Schizophrenia and Bipolar Disorder Alliance (SABDA), the South African Non-Communicable Diseases Alliance (SANCD Alliance), Marie Stopes South Africa, Epilepsy South Africa and Cape Mental Health. Source: https://www.fixthepatentlaws.org/?p=973
July 2015: The South African Catholic Bishops Conference (SACBC) joins the campaign for affordable medicines, calling on the DTI to urgently release the finalised policy. Source: https://www.fixthepatentlaws.org/?p=986
July 2015: Cabinet approves publication of the Copyright Amendment Bill 2015 in the Government Gazette for wider consultation. This is one of the eight bills linked to the final IP policy, but the policy is not forthcoming. Source: http://www.gcis.gov.za/newsroom/media-releases/statement-cabinet-meeting-24-june-2015
July 2015: Doctors Without Borders respond to leaked submission made by the European Union to the DTI calling for South Africa to abandon reform of IP laws to protect health and scale up protection of intellectual property. Source: https://www.fixthepatentlaws.org/?p=980
August 2015: The American Chamber of Commerce in South Africa—whose members include companies involved in the Pharmagate scandal— makes a submission to the Office of the United States Trade Representative requesting that South Africa’s eligibility for ongoing inclusion in the African Growth and Opportunities Act (AGOA) be dependent on South Africa abandoning IP reforms to protect health. TAC, MSF, SECTION27 and Stop Stock Outs make a submission to counter such efforts. Source: https://www.fixthepatentlaws.org/?p=1013
April 2015: TAC sends a letter to Trade and Industry Minister, Rob Davies, requesting clarification on any IP concessions made in negotiations with the US for South Africa’s ongoing inclusion in AGOA, and for an urgent update of when the finalised IP policy will be released. No response is received. Source: https://www.fixthepatentlaws.org/?p=1013
August 2015: CIPC announces it is hiring “Patent Searchers” for the eventual implementation of a patent examination system. Source: http://www.cipc.co.za/files/3414/3895/2521/Patent_Searcher_External.pdf
September 2015: Members of the Fix the Patent Laws Coalition make submissions to the Portfolio Committee on Trade and Industry on the Copyright Amendment Bill. The submissions discuss areas related to access to medicines, as well as user-rights for people with disabilities. Source: https://www.fixthepatentlaws.org/?p=1027
September 2015: Doctors Without Borders sends a letter to Trade and Industry Minister, Rob Davies, requesting South Africa’s support for an unconditional extension of the transition period under Article 66.1 of the TRIPS Agreement regarding certain obligations with respect to pharmaceutical products, as well as a waiver from Articles 70.8 and 70.9 of TRIPS for as long as countries remain least developed countries. The letter also requests urgent clarification of when the finalised IP Policy will be released. No response is received. Source: http://bit.ly/1RBjgN9
October 2015: The Cancer Alliance, CHOC Childhood Cancer Foundation South Africa and Advocates for Breast Cancer join the Fix the Patent Laws Campaign.
Members of the Fix the Patent Laws Coalition send a letter to Trade and Industry Minister Rob Davies, calling for clarification on the DTI timelines for finalising the IP policy, and introducing a bill to Parliament to amend the Patents Act. Patents on medicines continue to be granted without substantive examination of applications, and thousands of people in South Africa remain unable to access affordable versions of the medicines that they need.
References:
[1] Misoprostol (sexual and reproductive health), ribavirin (hepatitis), lopinavir/ritonavir (HIV), valganciclovir (HIV related opportunist infections)
[2] http://tinyurl.com/o8ulder
[3] Specifically, the Fix the Patent Laws Coalition is advocating for 1) substantive search and examination of pharmaceutical patent applications; 2) the adoption of more workable and expedited procedures for granting compulsory licenses; 3) the adoption of patent opposition procedures; and 4) stricter patentability criteria.
[4] World Health Organisation – News release. WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers. 8 May 2015 http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/
[5] 21 August 2015 NDoH Master Procurement Catalogue
[6] Communication with the Council for Medical Schemes September – October 2015
[7] Data on patents in South Africa was collected from the Companies and Intellectual Property Commission’s (CIPC) online patent database
[8] Data on pharmaceutical companies’ earnings on medicines during 2013 was sourced from IMS Health. Available via request from http://www.imshealth.com/portal/site/imshealth
[9] http://www.cochrane.org/CD006617/SCHIZ_aripiprazole-versus-typical-antipsychotic-drugs-for-schizophrenia
[10] Data on patents in South Africa was collected from the Companies and Intellectual Property Commission’s (CIPC) online patent database
[11] 21 August 2015 NDoH Master Procurement Catalogue
[12] Communication with the Council for Medical Schemes September – October 2015
[13] Data on patents in South Africa was collected from the Companies and Intellectual Property Commission’s (CIPC) online patent database
[14] https://www.healthinfo.moh.gov.on.ca/formulary/SearchServlet
[15] Data on pharmaceutical companies’ earnings on medicines during 2013 was sourced from IMS Health. Available via request from http://www.imshealth.com/portal/site/imshealth
[16] http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs
[17] http://stockouts.org/uploads/3/3/1/1/3311088/stockouts_2014_final_online.pdf
[18] http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs
[19] https://www.msf.org.za/msf-publications/south-africa-should-override-patent-on-key-hiv-medicine-after-widespread-stock-out