Australian Centre for Health Law Research
QUT Faculty of Business and Law
The Gibson Room, Level 10, Z Block, Gardens Point, QUT
Friday, the 8th December 2023
Overview
The Australian Centre for Health Law Research is hosting a one-day, in-person, symposium on intellectual property and public health at the Gibson Room at Gardens Point, QUT, on Friday the 8th of December 2023.
This event is intended to explore the multi-dimensional topic of intellectual property and public health in the wake of the COVID-19 crisis. It will cover the fields of trade mark law, consumer protection, patent law, trade secrets, and data protection. The event will focus on high-profile public health issues in this field — including tobacco control; e-cigarette regulation; health and food labelling; greenwashing; access to essential medicines; and biotechnology patents. It will examine the role of intellectual property in the promotion of public health, nutrition, and sustainable development. This event will consider how intellectual property impacts upon health professionals — such as doctors, surgeons, and nurses — and their patients.
The Albanese Government has introduced new tobacco control measures, with the Public Health (Tobacco and Other Products) Bill 2023 (Cth) and accompanying regulations. The Health Minister Mark Butler has observed: ‘The Government’s Reignite The Fight Against Tobacco Addiction reforms will bring together all of Australia’s current tobacco measures — along with 11 new measures — into a single streamlined and effective Act of Parliament that will re-ignite the fight against tobacco and nicotine addiction.’ He has maintained: ‘Australia needs to reclaim its position as a world leader on tobacco control.’ This event will explore Australia’s ambitions for a tobacco endgame, and the legal response of the tobacco industry. There has also been policy action in respect of e-cigarettes — with the Federal Government and the States promising to work together on regulation and law enforcement.
There has also been interest in parallel issues in respect of other forms of health labelling — with food and nutrition labelling; environmental labelling; and alcohol labelling and gambling warnings. There has been ongoing debate about food and nutrition labelling and advertising, and the efficacy of measures such as the Healthy Star Rating system. Likewise, there has been debate about whether there should be greater regulation of alcohol labelling (with discussions in Ireland as to whether there should be standardised packaging for alcohol). The Australian Parliament has also been anxious about the public health impact of gambling advertising in the mass media and online. The Australian Senate is currently investigating the problem of greenwashing — in which there are misleading and deceptive representations about the environment and sustainability being made by companies in the course of trade and commerce. Across these fields of regulation, there have been tensions between the trade mark system, and the objectives of the public health system.
During the COVID-19 crisis, intellectual property rights have come to the fore in discussions over access to essential medicines, vaccines, diagnostics, therapeutics, and other health equipment. The TRIPS Waiver was put forward by South Africa and India to allow nation states to suspend intellectual property rights while dealing with the COVID-19 crisis. However, Switzerland, the United Kingdom, and some members of the European Union opposed such an agreement. The Ministerial Council Decision has been much more limited in its operation — allowing for compulsory licensing of vaccines for export in limited circumstances. There has been a discussion as to whether a proposed Pandemic Treaty should deal with the topic of intellectual property and access to essential medicines.
In the field of patent law, there have been new challenges to the limits and boundaries of patentable subject matter, with the emergence of new fields in the life sciences. The Myriad decisions on patent law and genetic testing laid down some new parameters for the definition of patentable inventions. In the United States, Senators Chris Coons and Thom Tillis have introduced the Patent Eligibility Restoration Act. The bill aims to overturn recent precedents by the Supreme Court of the United States on patent eligibility. There has also been heated patent litigation over CRISPR gene-editing technologies.
Trade secrets, confidential information, and data protection are also increasingly playing an important role in the regulation of medicine, biotechnology, and healthcare.
Schedule
9:30 am — 11:00 am
Session 1 — Tobacco Control and e-Cigarette Regulation
Chair:
Professor Tina Cockburn, Director, Australian Centre for Health Law Research, QUT
1. Strengthening WHO FCTC Implementation in Australia and Beyond: Where to Next?
Hayley Jones, McCabe Centre for Law and Cancer
2. The Tobacco Endgame: Intellectual Property, Human Rights, and Sustainable Development
Professor Matthew Rimmer, QUT
3. e-Cigarette Litigation and Regulation
Professor Matthew Rimmer, QUT
11:00 am — 11:30 am
Morning Tea
11:30 am -1:00 pm
Session 2 — Healthy Labelling
Chair:
Associate Professor Deborah Gleeson, LaTrobe University
4. Food Standards, Food Regulation, Food Law, Health Star Regulation
Associate Professor Helen Vidgen, QUT
5. Controlling the Information Environment for Alcohol: The Regulation of Alcohol Labelling, Packaging and Advertising
Professor Paula O’Brien, University of Melbourne
6. Ireland’s Proposed Alcohol Health Warning Labels: Arguments at the WTO
Associate Professor Deborah Gleeson, La Trobe University
Professor Paula O’Brien, University of Melbourne
7. The Australian Greenwashing Inquiry
Professor Matthew Rimmer, QUT
1:00 pm — 1:30 pm
Lunch
1:30 pm — 3:00 pm
Session 3 — Access to Essential Medicines
Chair:
Hayley Jones, Director, McCabe Centre of Law and Cancer
8. The WHO Pandemic Prevention, Preparedness and Response Accord: Proposals for Advancing Equitable Access to Pandemic-related Products and their Prospects for Success
Associate Professor Deborah Gleeson, La Trobe University
9. Access to Medicines: Data Exclusivity and Patent Monopoly Extension
Dr Teddy Henriksen, University of the Sunshine Coast
10. Equitable Access to Medicines and Vaccines from a South Centre Perspective
Professor Carlos Correa, Executive Director of the South Centre (video)
With Dr Muhammad Zaheer Abbas, QUT, as in person discussant
11. African Regionalism and the use of TRIPS Flexibilities to Promote Access to Medicines
Dr Olasupo Owoeye, University of Augsburg (video)
3:00 pm — 3:30 pm
Afternoon Tea
3:30 pm — 5:00 pm
Session 4 — Intellectual Property and Biotechnology
Chair:
Professor Matthew Rimmer, QUT
12. Intellectual Property Commercialisation
Dr Erin Rayment, Executive Director, Industry Engagement, QUT
13. CRISPR Patent Dispute: Impact on Future Innovation and Dissemination
Dr Muhammad Zaheer Abbas, QUT
14. ‘The Genome Defense’ — Gene Patents, Civil Rights and Access to Health
Professor Jorge Contreras, University of Utah (video)
Afterword
15. The Inequity of Using a ‘Pathogen Access and Benefit-Sharing System’ to Operationalise Equity in the Pandemic Treaty
Dr Michelle Rourke, Griffith University (video)
Abstracts and Biographies (Order by Programme Order)
1. Strengthening WHO FCTC Implementation in Australia and Beyond: Where to Next?
Hayley Jones, McCabe Centre for Law & Cancer
Abstract
Recent Australian government announcements have shown an ambition to reinstate Australia as a world leader in tobacco control. Reforms proposed include streamlining Australian tobacco control measures and introducing new measures to strengthen implementation of the WHO Framework Convention on Tobacco Control (WHO FCTC). The growing challenge of e-cigarettes is also being targeted, with further restrictions announced to limit sales and advertising and entrench the prescription model. Current data showing increases in Australian youth smoking and e-cigarette usage, suggests that these reforms are timely.
Against a backdrop of continuing tobacco industry interference and ever-evolving new nicotine products, there has been insufficient progress globally on implementing the WHO FCTC and in delivering the target of a 30% reduction in smoking prevalence by 2030. While implementation is particularly poor in some countries, other countries, such as New Zealand and Malaysia, are taking a new approach and looking to phase out sales of tobacco altogether for younger generations. This presentation will look at the new Australian tobacco control reforms in context of global efforts to accelerate reductions in tobacco consumption, and will draw on reflections from the Tenth Session of Conference of the Parties to the WHO FCTC in November 2023.
Biography
Hayley Jones is Director of the McCabe Centre for Law & Cancer, a joint initiative of Cancer Council Victoria, the Union for International Cancer Control and Cancer Council Australia. Hayley leads the McCabe Centre team based in Australia, Fiji, Kenya, New Zealand and the Philippines. Through world-leading research and training programs, the McCabe Centre empowers individuals, organisations and governments to use law to prevent cancer and other noncommunicable diseases, and to advance equitable health care for all people. Hayley leads the McCabe Centre’s work as the WHO Framework Convention on Tobacco Control Knowledge Hub on Legal Challenges. She is Director of the WHO Collaborating Centre of Law and Noncommunicable Disease and Co-Chair of the Executive Committee for the Australian Network of WHO Collaborating Centres. Dual-qualified as a lawyer in Australia and England, Hayley’s background includes legal initiatives supporting access to justice, health and education for children, migrants and people living in poverty, focused on ensuring no one is left behind.
2. The Tobacco Endgame: Intellectual Property, Human Rights, and Sustainable Development
Professor Matthew Rimmer, QUT
Abstract
This presentation explores the relationship between intellectual property and sustainable development in the context of the public health efforts to address the global tobacco epidemic. It provides an account of the role of Gro Harlem Brundtland in both shaping the discourse of sustainable development, and building the institution of the World Health Organization, and establishing the WHO Framework Convention on Tobacco Control 2003. This presentation considers the legal conflicts over intellectual property and sustainable development. Big Tobacco has launched legal actions in superior courts, questioning the introduction of pioneering public health measures, such as graphic health warnings and plain packaging of tobacco products. There has also been disputes in investment tribunals and trade panels as to whether public health tobacco control measures are compatible with trade and investment laws. It examines the development of the United Nations Sustainable Development Goals, and its treatment of tobacco control as a key target of the third goal focused upon public health. This presentation explores the relevance of other key United Nations Sustainable Development Goals to the topic of tobacco control. In particular, it highlights questions around decent work and child labor. It examines the impact of tobacco production and use on the land and the environment. This presentation finally examines the efforts of tobacco companies to depict themselves as sustainable. It is argued that there is a need to take remedial enforcement action against tobacco companies engaged in greenwashing, which are making false and misleading claims about the environment, the climate, and sustainable development.
Biography
Dr Matthew Rimmer is a Professor in Intellectual Property and Innovation Law at the Faculty of Business and Law, at the Queensland University of Technology (QUT). He has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, plain packaging of tobacco products, intellectual property and climate change, Indigenous Intellectual Property, intellectual property and trade, and 3D printing regulation. He is undertaking research on intellectual property and sustainable development (including the debate over the right to repair); greenwashing; intellectual property, access to essential medicines, and public health (particularly looking at the COVID-19 crisis), and tobacco endgame policies. His work is archived at QUT ePrints, SSRN Abstracts, Bepress Selected Works, and Open Science Framework.
3. e-Cigarette Litigation and Regulation
Professor Matthew Rimmer, QUT
Abstract
This presentation considers the inquiry of the Health and Environment Committee in the Queensland Parliament on vaping and reducing rates of e-cigarette use in Queensland. This talk highlights Australia’s National Tobacco Strategy 2023–2030 and its application to the regulation of e-cigarettes and vaping. This presentation provides an analysis of how Federal, State, and Territory Governments in Australia are responding to the regulation of e-cigarettes and vaping. It highlights enforcement action in respect of e-cigarettes and vaping. As a Queensland case study, it considers the 2023 matter heard in Holland Park Magistrate’s Court, Police v. M&R Trading Pty Ltd. Furthermore, this presentation offers a comparative study of how the United States, the United Kingdom, and New Zealand are dealing with the regulation of e-cigarettes and vaping. Finally, the talk considers the advice of the World Health Organization in dealing with the regulation of e-cigarettes and vaping.
Biography
Dr Matthew Rimmer is a Professor in Intellectual Property and Innovation Law at the Faculty of Business and Law, at the Queensland University of Technology (QUT). He has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, plain packaging of tobacco products, intellectual property and climate change, Indigenous Intellectual Property, intellectual property and trade, and 3D printing regulation. He is undertaking research on intellectual property and sustainable development (including the debate over the right to repair); greenwashing; intellectual property, access to essential medicines, and public health (particularly looking at the COVID-19 crisis), and tobacco endgame policies. His work is archived at QUT ePrints, SSRN Abstracts, Bepress Selected Works, and Open Science Framework.
4. Food Standards, Food Regulation, Food Law, Health Star Regulation
Associate Professor Helen Vidgen, QUT
Abstract
Our contemporary global industrialised food system is a key contributor to climate change and the burden of disease. Regulatory approaches are part of a suite of strategies used by health professionals to address these issues. This presentation will describe opportunities for regulation across the food system and critique current approaches used in Australia with respect to their effectiveness in addressing diet related disease and keeping pace with social, cultural, economic and biological developments in food and nutrition. The presentation will position Australia internationally with regard to this public health nutrition strategy area. It will describe current food, nutrition and health policy frameworks in Queensland and Australia which provide opportunities for food system reform through regulation.
Biography
Associate Professor Helen Vidgen is a public health leader with extensive experience in policy, practice, research, and education across government, civil society and higher education sectors. She is a global leader in the area of food literacy. Her definition and conceptualisation of the term is the most cited internationally and has advanced the concept in research, policy and practice across settings and sectors in low, middle and high income countries, including being adopted by the UN Food and Agriculture Organisation. Vidgen’s other research interests include the social dimensions of food and eating, public health nutrition policy, translation and implementation including planning, evaluation, workforce and capacity. She was the chief investigator of Queensland’s largest trial of a universal childhood obesity management program, wrote the evaluation framework for the State’s largest chronic disease prevention program, and conducted Queensland’s only published audits of the community and public health nutrition workforce. She enjoys the complexity of implementation. Helen’s public health nutrition research is informed by her extensive practice and civil society experience. This includes 12 years working in the Queensland Department of Health including a period as Director of Public Health Nutrition and five years as convenor of the Public Health Association of Australia Food and Nutrition group during which time she represented the organisation on the Australian Government Healthy Food Partnership and the Food Regulation Standing Committee.
5. Controlling the Information Environment for Alcohol: The Regulation of Alcohol Labelling, Packaging and Advertising
Professor Paula O’Brien, University of Melbourne
Abstract
The concern about harms from alcohol is leading some governments, NGOs, and the WHO to explore new policy measures in the form of regulation of alcohol labelling, packaging and advertising. However, these measures are intensely opposed by commercial interests, because of their potential to change individual consumption-related behaviours and to reshape social understandings and norms around alcohol. This paper reviews the current debates about these measures in Australia, the proposals for reform, domestic hurdles to change, the likely regulatory trajectory of these proposals, and the international context.
Biography
Dr Paula O’Brien is Associate Professor at Melbourne Law School. She is the co-director of Melbourne Law School’s Health Law and Ethics Network. She specialises in public and global health law, researching the regulation of the commercial determinants of health, access to health care, and public health emergencies. Her work on the commercial determinants of health has focussed on alcohol, with related projects on gambling, unhealthy food, cannabis, and tobacco. She works with the World Health Organization and state and federal governments on the design of health-enhancing regulation and policy.
6. Ireland’s Proposed Alcohol Health Warning Labels: Arguments at the WTO
Associate Professor Deborah Gleeson, La Trobe University
Professor Paula O’Brien, University of Melbourne
Abstract
This paper considers Ireland’s proposed alcohol health warning labels, and possibilities in respect of a challenge to the regime in the WTO.
Biographies
Deborah Gleeson is an Associate Professor in the School of Psychology and Public Health at La Trobe University where she leads the discipline of Health Practice and Management and teaches postgraduate subjects in health policy and health law. She holds a PhD in Health Policy, a Master of Public Health, Graduate Diploma in Health Promotion and Bachelor of Applied Science (Medical Laboratory Science). Deborah’s research focuses on public health policy, particularly at national and international levels, and the interface between these levels. Her primary interest area is the implications of international trade agreements for public health, including access to medicines. Her 2020 book with Professor Ronald Labonte, Trade Agreements and Public Health, provides an introduction to the topic for health policy makers, researchers and advocates. Deborah’s scholarly publications include over 70 peer-reviewed journal articles, one first-authored book, five book chapters and five other journal articles. Forty-four of her peer-reviewed publications focus on trade agreements and 33 on access to medicines. She has had over 35 invited national and international speaking engagements, including scholarly workshops and conferences and events organized by governments and intergovernmental organizations. Deborah holds the honorary role of Co-convenor of the Political Economy of Health Special Interest Group of the Public Health Association of Australia (PHAA), and plays a key role in PHAA’s advocacy for healthy trade agreements. She received a PHAA President’s Award in 2015 for public health leadership, engagement and commitment on the impact of international trade issues on public health.
Dr Paula O’Brien is Associate Professor at Melbourne Law School. She is the co-director of Melbourne Law School’s Health Law and Ethics Network. She specialises in public and global health law, researching the regulation of the commercial determinants of health, access to health care, and public health emergencies. Her work on the commercial determinants of health has focussed on alcohol, with related projects on gambling, unhealthy food, cannabis, and tobacco. She works with the World Health Organization and state and federal governments on the design of health-enhancing regulation and policy.
7. The Australian Greenwashing Inquiry
Professor Matthew Rimmer, QUT
Abstract
The Australian Senate has established ‘an inquiry into greenwashing, particularly claims made by companies, the impact of these claims on consumers, regulatory examples, advertising standards, and legislative options to protect consumers.’ The terms of reference observe that the inquiry on greenwashing will focus on (a) the environmental and sustainability claims made by companies in industries including energy, vehicles, household products and appliances, food and drink packaging, cosmetics, clothing and footwear; (b) the impact of misleading environmental and sustainability claims on consumers; © domestic and international examples of regulating companies’ environmental and sustainability claims; (d) advertising standards in relation to environmental and sustainability claims; (e) legislative options to protect consumers from green washing in Australia; and (f) any other related matters. The Australian Senate Environment and Communications Reference Committee is investigating the topic of greenwashing — with a view to publishing a report in 2024.
This presentation will consider a variety of regulatory regimes, which have been deployed to regulate greenwashing — looking at misleading and deceptive representations about the environment, sustainability, and climate change in a variety of fields. This work traverses a variety of legal disciplines — including advertising regulation, consumer law, competition policy, corporations law, environmental and climate litigation, intellectual property law, Internet regulation, and freedom of speech (in terms of constitutional law and human rights law). This research is also comparative — and has looked at the position of Australia, alongside that of the United States, Canada, the United Kingdom, the European Union, and Nordic states such as Norway, Sweden, Finland, and Denmark. This presentation makes a number of recommendations and suggestions as to how to modernise Australia’s legal regimes, so that they are better equipped to deal with the risks, problems and challenges of greenwashing. It also provides advice in respect of legal enforcement by key regulators in respect of the problem of greenwashing. The presentation highlights the need for stronger international frameworks to better deal with the risks of greenwashing.
Biography
Dr Matthew Rimmer is a Professor in Intellectual Property and Innovation Law at the Faculty of Business and Law, at the Queensland University of Technology (QUT). He has published widely on copyright law and information technology, patent law and biotechnology, access to medicines, plain packaging of tobacco products, intellectual property and climate change, Indigenous Intellectual Property, intellectual property and trade, and 3D printing regulation. He is undertaking research on intellectual property and sustainable development (including the debate over the right to repair); greenwashing; intellectual property, access to essential medicines, and public health (particularly looking at the COVID-19 crisis), and tobacco endgame policies. His work is archived at QUT ePrints, SSRN Abstracts, Bepress Selected Works, and Open Science Framework.
8. The WHO Pandemic Prevention, Preparedness and Response Accord: Proposals for Advancing Equitable Access to Pandemic-related Products and their Prospects for Success
Associate Professor Deborah Gleeson, La Trobe University
Abstract
Global inequities in access to COVID-19 vaccines, therapeutics, diagnostics and medical equipment have proved both catastrophic and intractable, and efforts to address these inequities have largely failed. The Access to COVID-19 Tools Accelerator and its vaccines arm, COVAX, were undermined by the rampant nationalism of high-income countries. Neither the COVID-19 Technology Access Pool set up to enable voluntary sharing of intellectual property (IP) and technology nor the mRNA vaccine technology transfer hub established in South Africa received timely support. Negotiations over a temporary waiver of obligations in the Agreement on Trade-Related Aspects of Intellectual Property Rights for COVID-19 products (the ‘TRIPS waiver’) produced a disappointing outcome that remains unused to date. In light of these failures, civil society groups and developing countries have turned their attention to negotiations by World Health Organization (WHO) Member States over a new Pandemic Prevention, Preparedness and Response Accord (‘pandemic treaty’), in the hope that it can strengthen global governance and solidarity to deal more effectively with the systemic barriers to equitable access to pandemic countermeasures. A Zero Draft included proposed provisions aiming to, inter alia, promote technology transfer to manufacturers in developing countries, commit parties to support time-bound waivers of IP rights, affirm parties’ rights to apply TRIPS flexibilities to the full, increase the transparency associated with public funding for research and development, and ensure a subset of pandemic-related products are reserved for distribution by WHO to developing countries during future pandemics. However, the politics surrounding the negotiations mean these controversial proposals — already largely couched in aspirational rather than enforceable language — risk being progressively watered down. This paper examines the provisions of the pandemic treaty that have been proposed for advancing equitable access to pandemic-related products and evaluates their prospects for success.
Biography
Deborah Gleeson is an Associate Professor in the School of Psychology and Public Health at La Trobe University where she leads the discipline of Health Practice and Management and teaches postgraduate subjects in health policy and health law. She holds a PhD in Health Policy, a Master of Public Health, Graduate Diploma in Health Promotion and Bachelor of Applied Science (Medical Laboratory Science). Deborah’s research focuses on public health policy, particularly at national and international levels, and the interface between these levels. Her primary interest area is the implications of international trade agreements for public health, including access to medicines. Her 2020 book with Professor Ronald Labonte, Trade Agreements and Public Health, provides an introduction to the topic for health policy makers, researchers and advocates. Deborah’s scholarly publications include over 70 peer-reviewed journal articles, one first-authored book, five book chapters and five other journal articles. Forty-four of her peer-reviewed publications focus on trade agreements and 33 on access to medicines. She has had over 35 invited national and international speaking engagements, including scholarly workshops and conferences and events organized by governments and intergovernmental organizations. Deborah holds the honorary role of Co-convenor of the Political Economy of Health Special Interest Group of the Public Health Association of Australia (PHAA), and plays a key role in PHAA’s advocacy for healthy trade agreements. She received a PHAA President’s Award in 2015 for public health leadership, engagement and commitment on the impact of international trade issues on public health.
9. Access to Medicines: Data Exclusivity and Patent Monopoly Extension
Dr. Teddy Henriksen (University of the Sunshine Coast)
Abstract
Data exclusivity and patents are important to the pharmaceutical industry, and both these regimes coexist in the pharmaceutical landscape. The interplay and interactions between these two regimes are important considerations in overall market exclusivity periods and hence access to medicines. It is well established that stronger incentives for innovation through monopolies can have a detrimental effect on access to the innovation through higher costs to consumers. Both data exclusivity and patents provide market exclusivity through monopoly periods. Because data exclusivity and patents can protect the same pharmaceutical, beginning at different times in the pharmaceutical lifecycle and having different durations, these terms may not coincide, and each can extend the effective market exclusivity period of the other. For example, when data exclusivity persists beyond patent expiry for a pharmaceutical, subsequent entrant access to the market is restricted and the period during which originators can charge high prices is extended. I propose a method whereby data exclusivity and pharmaceutical product patents expire simultaneously.
Biography
Teddy Henriksen is a Lecturer in Law in the School of Law and Society at UniSC. Teddy holds a Doctorate in Law, Bachelor of Laws (Hons) and a Bachelor of Pharmacy and has completed a Graduate Diploma of Legal Practice. Teddy is admitted to the legal profession in the Supreme Court of Queensland, is registered to practice as a pharmacist with the Australian Health Practitioner Regulation Agency and is a member of the Pharmaceutical Society of Australia.
Teddy has been tutoring and lecturing in a number of branches of law at UniSC since 2018 including Patent Law, Tort Law, Foundations of Australian Law, Criminal Law and Corporations Law. Before commencing teaching and researching at UniSC Teddy practiced as a pharmacist and has extensive experience in owning and managing community pharmacy practices over the past thirty-five years. Teddy maintains his pharmacy registration by working as a locum pharmacist on the Sunshine Coast.
Teddy’s research interests revolve around pharmaceuticals and the law and intellectual property. In recent times Teddy has focused on biosimilars and the information exchange associated with biosimilars in intellectual property arrangements. Teddy’s research outputs in this area have been published in peer-reviewed journals in Australia and internationally and led to conference presentations through the Australian Centre for Health Law Research at QUT.
More recently Teddy has begun to focus on access to medicines and how the law, including intellectual property law, affects the ability of people to gain timely, affordable access to the medicines they need.
10. Equitable Access to Medicines and Vaccines from a South Centre Perspective
Professor Carlos Correa, Executive Director of the South Centre
Abstract
A proposal for a temporary waiver of several sections of the TRIPS Agreement was submitted by India and South Africa and co-sponsored by other 65 WTO Member States. The proposal received the support of more than 100 WTO member States, as well as a large number of civil society organizations and of many scholars both in developed and in developing countries. It aimed at suspending the obligations under the TRIPS Agreement in relation to health products and technologies for the prevention, treatment or containment of COVID-19. The main purpose of the requested waiver was to allow for an expansion of the manufacturing capacity to rapidly overcome the dramatic asymmetry in their supply to developing countries. However, it took almost two years to reach an agreement amongst WTO member states to adopt, at the 12th WTO Ministerial Conference held in Geneva in June 2022, a belated and narrow ‘Ministerial Decision on the TRIPS Agreement’ (hereinafter ‘the Decision’) with a waiver of limited scope and some clarifications of existing flexibilities under the TRIPS Agreement. While a possible extension of the waiver beyond vaccines was to be negotiated within six months of the Decision’s approval, it has not been agreed upon so far. This is the second time since the adoption of the TRIPS Agreement that a waiver needs to be negotiated with regard to paragraph f) of article 31 of the TRIPS Agreement. The interpretation of the Decision raises interesting issues that are relevant for the use of the waiver if it were ever invoked by a WTO member.
Biography
Dr. Carlos M. Correa is the Executive Director of the South Centre. Previously, he was the Special Advisor on Trade and Intellectual Property of the South Centre. Dr. Correa is a renowned international authority on intellectual property, international trade, plant biodiversity and technology issues. Dr. Correa has worked with the Argentine government and has been the Director of the Center for Interdisciplinary Studies on Industrial Property and Economics (CEIDIE) at the Law Faculty of the University of Buenos Aires. He has been a member of the Scientific Council of the Deutsch-Argentinisches Hochschulzentrum (DAHZ-CUAA), of the UK Commission on Intellectual Property, of international expert commissions convened by the World Health Organization and of the FAO Panel of Eminent Experts on Ethics in Food and Agriculture. He has been a visiting professor in post-graduate courses of several universities, as well as consultant to various regional and international organizations, including FAO, UNCTAD, UNDP, UNIDO and the World Bank. He is the author of several books (the most recent published by Oxford University Press, Kluwer Law and Edward Elgar) and of numerous articles. He is a lawyer and economist and holds a PhD in Law from the University of Buenos Aires.
11. African Regionalism and the use of TRIPS Flexibilities to Promote Access to Medicines
Dr Olasupo Owoeye, University of Augsburg
Abstract
Despite the global gains in the management and treatment of HIV/AIDS, Tuberculosis and Malaria, these diseases remain on the list of the 10 causes of death in low-income countries. Access to medicines continues to be one of the measures necessary to stall the spread of communicable diseases, particularly in low-income countries. Access to medicines is generally recognised as an essential component of the right to health. Since the entry into force of the Agreement Establishing the World Trade Organization in 1995 with its suite of agreements including the Agreement on Trade Related Aspects of Intellectual Property Rights, there have been a lot of discussions on the implications of intellectual property protection for public health. This paper discusses some of the flexibilities available under the TRIPS Agreement for facilitating access to medicines and the extent to which African regional collaboration may enhance the use of those flexibilities. The presentation examines how the African Continental Trade Area may provide a viable platform for promoting access to medicines in the region through local manufacturing, exhaustion of rights and compulsory licensing.
Biography
Dr Olasupo Owoeye is a law academic with expertise in International Intellectual Property Law. He holds a Bachelor of Laws (Honours) degree from the University of Ibadan and a PhD in Law from the University of Tasmania. He is admitted to the legal profession in Nigeria, New Zealand and Australia. Dr Owoeye practised as a counsel at Punuka Attorneys and Solicitors, a top tier Lagos law firm, before he became a law academic. He has taught at both undergraduate and postgraduate levels at the University of Tasmania; the University of South Australia, Adelaide; RMIT University, Melbourne and Central Queensland University. He is a Research Fellow at the University of Augsburg, Germany and a Law Professor at Lead City University, Nigeria. He is the author of Intellectual Property and Access to Medicines in Africa: A Regional Framework for Access (Routledge, Oxfordshire; 2019). He has also been a resource person for different institutions and inter-governmental organisations including the World Health Organization, the World Intellectual Property Organization, and the African Regional Intellectual Property Organisation.
12. Intellectual Property Commercialisation
Dr Erin Rayment, Executive Director, Industry Engagement, QUT
Abstract
IP commercialisation is known by several different titles. Research commercialisation, technology transfer and knowledge exchange are all ways of describing the process of transferring intellectual property developed within research organisations into the hands of third parties to make it useful. For many, this means creating a profit through the development of deep technology products, such as novel pharmaceutical compounds, advanced materials, or autonomous robots, to name just a few. For others, this might be in the creation of a service, the development and implementation of evidence-based policy or supporting not-for-profits to create a difference in their chosen field. This presentation will cover some of the challenges and opportunities in IP commercialisation across Australia, plus share recent commercialisation survey results and accompanying recommendations for improvement.
Biography
Dr Erin Rayment is a leader in commercialisation, passionate about creating impact with research and is currently the Executive Director, Industry Engagement at the Queensland University of Technology. Erin has led and executed multiple research commercialisation deals across several universities. Prior to joining QUT, Erin has led industry engagement and research development for several universities and has worked across Australia and the United Kingdom. She has a PhD in tissue engineering, is a Graduate of the Australian Institute of Company Directors, is a Registered Technology Transfer Professional and a Superstar of STEM.
Erin contributes to the commercialisation policy discussion through her role as Director of Knowledge Commercialisation Australasia and participation in several government working groups. She is currently Chair of QUT Bluebox, which manages a portfolio of 35+ early stage technology companies across multiple industry sectors and has seen significant growth in the portfolio since her involvement, along with tangible value realisation. Erin holds Director roles with the Translational Research Institute, the Reef Restoration and Adaptation Program and CelluAir, an early-stage technology company.
13. CRISPR Patent Dispute: Impact on Future Innovation and Dissemination
Dr. Muhammad Zaheer Abbas (QUT)
Abstract
CRISPR is an abbreviation for clustered regularly interspaced short palindromic repeats. There are certain special genes in addition to the CRISPR non-repetitive sequences. These special genes — called CRISPR-associated and abbreviated as Cas — are only present in CRISPR-containing prokaryotes. Collectively, this genome editing technology, based on CRISPR and the DNA-cutting enzyme Cas, is called the CRISPR-Cas system. CRISPR-Cas is a powerful genome editing tool because of its ease of use, superior speed, enhanced accuracy and cost-effectiveness as compared to other biotechnological tools. Patent law and policy are at the core of how this technology develops and impacts the global community. The issue of who first invented the CRISPR-Cas genome editing tool has been the subject of a heated dispute between two high-profile research teams — one led by molecular biologist Feng Zhang and the other led by biochemist Jennifer Doudna and microbiologist Emmanuelle Charpentier. There are little signs of this dispute ending any time soon. Rather it is likely to become even more complex as the patent protection around CRISPR-Cas is growing and different countries are reaching different decisions about who first invented what. This study considers how this dispute complicates patent landscape around CRISPR-Cas and negatively impacts both future innovation and broader access to fruits of innovation.
Biography
Dr. Muhammad Zaheer Abbas is a Lecturer in the School of Law at the Queensland University of Technology (QUT), Brisbane, Australia. He focuses his research on intellectual property law and policy, with a special interest in patent law and public health. He has written over 30 articles on topics covering various public interest dimensions of intellectual property laws, with a key focus on pharmaceutical patents and access to medicines and vaccines. His work has appeared in the Journal of Law and the Biosciences, Global Public Health, Journal of World Intellectual Property, Journal of Intellectual Property Law and Practice, and Intellectual Property Journal, among several others. He is a frequent speaker on intellectual property dimensions of public health and has delivered over 40 conference presentations worldwide.
14. ‘The Genome Defense’ — Gene Patents, Civil Rights and Access to Health
Professor Jorge L. Contreras, University of Utah
Abstract
In 2013, the US Supreme Court held that naturally occurring genetic sequences may not be patented, instantly invalidating hundreds, if not thousands, of existing patents and opening the market to genetic screens for cancer and other hereditary diseases. The case, Association for Molecular Pathology v. Myriad Genetics, was remarkable in many ways, not least because it was prosecuted on behalf of twenty plaintiffs — researchers, professional associations, medical practitioners and individual patients — by the American Civil Liberties Union and the Public Patent Foundation as a case centered on individual civil rights rather than a technical interpretation of the U.S. Patent Act. In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (Hachette/Algonquin, 2021), Professor Jorge Contreras brings this important and unique case to life. Through nearly 100 interviews with attorneys, advocates, judges, patients and government officials, Contreras peels back the layers of this remarkable episode in American legal history and explains not only what happened, but why and how, and what its implications are for the future of medical science, particularly in view of recent legislative proposals to overturn the decade-old decision.
Biography
Jorge L. Contreras is the James T. Jensen Endowed Professor for Transactional Law and Director of the Program on Intellectual Property and Technology Law at the University of Utah S.J. Quinney College of Law, with a secondary appointment in the Department of Human Genetics, University of Utah School of Medicine. Professor Contreras’s research focuses on intellectual property, technical standards, antitrust law and science policy. He is the editor or author of twelve books and more than 150 scholarly articles and chapters. During his career he has served on advisory committees of the US National Institutes of Health, the National Academies of Science, and as Co-Chair of the National Conference of Lawyers and Scientists. Professor Contreras’s award-winning book, The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (NY: Hachette/Algonquin, 2021), which has received praise from media outlets from the New York Times and Wall St. Journal to Nature and Law360, describes the landmark civil rights litigation that ended gene patenting in America. He is a graduate of Harvard Law School (JD) and Rice University (BSEE, BA), and an elected member of the American Law Institute.
15. The Inequity of Using a ‘Pathogen Access and Benefit-Sharing System’ to Operationalise Equity in the Pandemic Treaty
Dr Michelle Rourke, Griffith University (via video)
Abstract
The World Health Organisation’s (WHO) International Negotiating Body (INB) has until May 2024 to deliver a “convention, agreement or other international instrument on pandemic prevention, preparedness and response” (“Pandemic Treaty”). With developing countries unlikely to get any concessions on intellectual property, their negotiating efforts are now directed towards a pathogen access and benefit-sharing system. Access and benefit-sharing (ABS) was designed in the late 1980s to incentivise biodiversity conservation and sustainable development. These are very different problems to those that a proposed pathogen ABS system seeks to address:
- Under the current iteration of the International Health Regulations (2005), there is no obligation for WHO Member States to share pathogen samples or associated genetic sequence data with the global scientific community. Low and middle-income countries (LMICs) are at the highest risk for pathogen emergence. High-income countries (HICs) require samples and sequence data to track the spread of pathogens, and to develop and test medical countermeasures like diagnostics and vaccines.
- LMICs did not get adequate access to medical countermeasures during the COVID-19 pandemic, with HICs hoarding more vaccine doses than required to protect their populations.
Proponents of a pathogen ABS system state that it would secure access to pathogen samples for HICs and deliver a fairer share of medical countermeasures for LMICs. The reasoning goes: pathogens are a type of genetic resource and countries have sovereign rights over genetic resources under the United Nations’ Convention on Biological Diversity (CBD; 1992). Under the CBD, countries should facilitate access to their sovereign genetic resources in exchange for a share of the benefits associated with their use in R&D. Therefore, when countries share their pathogens with the international scientific community they should get a share of the diagnostics, vaccines, medications and/or profits (benefits) that are generated using those pathogen samples. Thus, proponents argue that a specialised multilateral pathogen ABS system under the WHO’s Pandemic Treaty would help to realise the Treaty’s overarching goal of equity.
At first blush, this quid pro quo may seem like a fair (if convoluted) mechanism to ensure that LMICs provide their pathogen samples and secure much-needed medical countermeasures in the event of a pandemic. But this transactional way of thinking jettisons the argument that people have a human right to health and makes access to essential medicines contingent on the States’ provision of sovereign genetic resources. The ABS mechanism has proven incapable of generating tangible benefits for environmental conservation and sustainable development over the last thirty years. Instead, proponents cite the success of the only pathogen-specific ABS instrument, the WHO’s Pandemic Influenza Preparedness (PIP) Framework (2011). This instrument may be successful in securing influenza virus samples from LMICs, but it cannot induce vaccine-producing States to share vaccines with LMICs during a pandemic. Replicating this ABS model keeps LMICs in the role of the early warning system for HICs (canaries in the pandemic coalmine) and entrenches LMICs’ dependence on HICs for access to medical countermeasures (rather than building regional manufacturing capacity for LMICs). Yet LMICs will fight hard for this “better than nothing” pathogen ABS system, knowing that genuine concessions on IP, capacity building, and technology transfer will never be on the negotiating table.
Biography
Michelle Rourke is a Postdoctoral Research Fellow at the Law Futures Centre, Griffith University. She spent ten years as a Scientific Officer in the Royal Australian Army Medical Corps where she researched mosquito-transmitted viruses of importance to the Australian Defence Force. She completed her doctoral studies in international law at Griffith University and as a Fulbright Scholar at the O’Neill Institute for National and Global Health Law at Georgetown University. Her PhD thesis examined how international access and benefit-sharing (ABS) laws under the United Nations’ Convention on Biological Diversity and its Nagoya Protocol impact access to pathogen samples and associated information, including genetic sequence data. Michelle is a member of the Digital Sequence Information (DSI) Scientific Network, the Global Health Law Consortium and a non-resident Affiliate of the Center for Global Health Science and Security at Georgetown University.
References
1. Hayley Jones, McCabe Centre for Law and Cancer, ‘Strengthening WHO FCTC Implementation in Australia and Beyond: Where to Next?’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/1n0kj4hMcoU?si=-C5oKLwHZn6KWb6X
2. Professor Matthew Rimmer, QUT, ‘The Tobacco Endgame: Intellectual Property, Human Rights, and Sustainable Development’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/zTR-VB8N0ms?si=Aa_1F62KWnjB-6MQ
3. Professor Matthew Rimmer, QUT, ‘e-Cigarette Litigation and Regulation’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/Z1c3jZrIUHA?si=pjorLlP_TysYK–u
4. Associate Professor Helen Vidgen, QUT, ‘Food Standards, Food Regulation, Food Law, Health Star Regulation’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/PZ_6CgDiaLQ?si=2cY-1sV1_8F5l8Rz
5. Professor Paula O’Brien, University of Melbourne, ‘Controlling the Information Environment for Alcohol: The Regulation of Alcohol Labelling, Packaging and Advertising’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/mJU_MYLG-jk?si=8LdoS9O6cWO1HWot
6. Associate Professor Deborah Gleeson, La Trobe University, and Professor Paula O’Brien, University of Melbourne, ‘Ireland’s Proposed Alcohol Health Warning Labels: Arguments at the WTO’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/DsDH9fHfTHQ?si=stdWdlSwXY3Ff9GH
7. Professor Matthew Rimmer, QUT, ‘The Australian Greenwashing Inquiry’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/kStFNUEPnKM?si=kgr1UL4NCienqwx3
8. Associate Professor Deborah Gleeson, La Trobe University, ‘The WHO Pandemic Prevention, Preparedness and Response Accord: Proposals for Advancing Equitable Access to Pandemic-related Products and their Prospects for Success’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/sv1bmzO5NhI?si=8SCrbHt760Bm9DTT
9. Dr Teddy Henriksen, University of the Sunshine Coast, ‘Access to Medicines: Data Exclusivity and Patent Monopoly Extension’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/SFsB4W1oKb8?si=phna7aE18NrdgBlA
10. Professor Carlos Correa, Executive Director of the South Centre, Equitable Access to Medicines and Vaccines from a South Centre Perspective’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023. https://youtu.be/ZT375dMSNtg?si=FBqAeDycfgSX3Drc
11. Dr Olasupo Owoeye, University of Augsburg, ‘African Regionalism and the use of TRIPS Flexibilities to Promote Access to Medicines’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/WznFmZaYPQQ?si=_gCQqFNjJZHE49b_
12. Dr Erin Rayment, Executive Director, Industry Engagement, QUT, ‘Intellectual Property Commercialisation’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/ubX9lRjA5TI?si=5_-HS-JkFzS2JRQd
13. Dr Muhammad Zaheer Abbas, QUT, ‘CRISPR Patent Dispute: Impact on Future Innovation and Dissemination’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/GFWkCj6MM6g?si=qygDvBfGZTuhQqdc
14. Professor Jorge Contreras, University of Utah, ‘“The Genome Defense” — Gene Patents, Civil Rights and Access to Health’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/JMulkkQ-QSc?si=PA7gQ_IDIww25kPV
15. Dr Michelle Rourke, Griffith University, ‘The Inequity of Using a “Pathogen Access and Benefit-Sharing System” to Operationalise Equity in the Pandemic Treaty’, Intellectual Property and Public Health Symposium, Australian Centre for Health Law Research, QUT Faculty of Business and Law, 8 December 2023, https://youtu.be/sa8TS2LIIgY?si=PH2fSfqvKSEbJtDC
