Fix The Patent Laws

A Timeline of Intellectual Property Reform in South Africa 1994 – 2015

Posted on | October 29, 2015 | No Comments

See brief timeline at: FTPL timeline web infographic

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:http://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:http://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: http://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: http://www.fixthepatentlaws.org/?p=646;http://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: http://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: http://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: http://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: http://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: http://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:http://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: http://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:http://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-genocidehttp://www.fixthepatentlaws.org/?p=847http://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-lawshttps://www.msf.org.za/msf-publications/new-age-health-activists-urge-patent-law-finality-may-7https://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: http://www.fixthepatentlaws.org/?p=953http://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: http://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: http://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: http://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:http://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: http://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:http://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.

 

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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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