- Pamela Andanda, LLB, LLM (Public Law), PhD is a Professor of Law at the University of the Witwatersrand, Johannesburg... morePamela Andanda, LLB, LLM (Public Law), PhD is a Professor of Law at the University of the Witwatersrand, Johannesburg where she coordinates and lectures Intellectual Property Law and Research Methodology courses. She previously lectured biotechnology and the law, Special Contracts and Commercial Law. Prior to joining the School of Law, Professor Andanda practised as a commercial litigation advocate, conveyancer and was a policy research and analysis consultant. She is rated by the South African National Research Foundation as an internationally acclaimed researcher. Her academic background is in Law and Bioethics. Her research interests are in the areas of intellectual property, biotechnology, health law, bioethics, policy analysis, governance of research, privacy and data protection.
Professor Andanda was a member of the European Commission’s Expert Group on Global Governance of Science. She has worked as an independent expert of ethics at the European Commission by performing tasks such as ethics review, ethics screening, and follow-up of projects under the Seventh Framework Programme for Research and Technological Development and currently in the HORIZON 2020 Programme. She has also collaborated in an NIH funded project (Harmonizing Privacy Laws to Enable International Biobank Research) and was a consortium member of the TRUST project (Creating and enhancing Trustworthy, responsible and equitable partnerships in international research), a 2.66 million Euros grant from the European Commission’s HORIZON 2020 funding programme.
Pamela is currently a member of the following international, regional and national committees:
UNESCO’s International Bioethics Committee;
The African Academy of Sciences - Data and Biospecimen Governance Committee;
Academy of Science of South Africa (ASSAf) Standing Committee on Biosafety and Biosecurity; the Ethics Advisory Council of the International COVID-19 Data Alliance (ICODA);
Strathmore University’s institutional ethics review committee and
The Data and Biospecimen Access Committee of the Human Heredity and Health in Africa (H3Africa).
She chairs Wits University’s advisory committee on ethics, has acted as an expert for the World Intellectual Property Organization’s Standing Committee on the Law of Patents (WIPO/SCP) and was an external expert reviewer of the World Health Organization’s Guidance document on the Ethics and governance of artificial intelligence for health, 2021.edit
Public engagement (PE), commonly understood as the inclusion of citizens in governing science, is one of the keys to responsible research and innovation (RRI) framework that has been developed by the European Commission for purposes of... more
Public engagement (PE), commonly understood as the inclusion of citizens in governing science, is one of the keys to responsible research and innovation (RRI) framework that has been developed by the European Commission for purposes of ensuring the participation of all societal actors in the research and innovation process. Ensuring inclusive innovation (Taebi et al., 2014), which meets the needs of marginalised communities, is at the heart of PE. While PE is mostly viewed as an element of deliberative democracy (Elam & Bertilsson 2003) and a tool for RRI, concerns have been raised that a predominantly top-down approach is used in PE (Wynne 2005). Accordingly, there is a need to shift the focus of PE from creating awareness to effectively engaging with and even collaborating with the public in the innovation process.
This chapter examines the extent to which the policies and practices that are currently used to foster PE in the biotechnology sector in Low and Middle Income Countries (LMICs) sufficiently address the inclusion, demands and needs of those at the Bottom-of-the-Pyramid. Using two countries from Africa as case studies, it discusses the extent to which PE strategies in Kenya and South Africa have engaged the public in a manner that meets the envisaged attributes of PE as an RRI tool. An assessment of the two countries’ strategies is undertaken by considering the following fundamental questions: Is engagement used in a manner that allows contestation thus avoiding a top-down approach where scientists and policy makers lead the process? Does engagement effectively consider and incorporate the public’s contributions in the deliberative process thus leading to inclusive innovation? By delving into these questions, the chapter considers the suitability or otherwise of PE as an RRI tool for ensuring inclusive governance approach to biotechnology innovation in LMICs based on lessons that are drawn from the two countries.
This chapter examines the extent to which the policies and practices that are currently used to foster PE in the biotechnology sector in Low and Middle Income Countries (LMICs) sufficiently address the inclusion, demands and needs of those at the Bottom-of-the-Pyramid. Using two countries from Africa as case studies, it discusses the extent to which PE strategies in Kenya and South Africa have engaged the public in a manner that meets the envisaged attributes of PE as an RRI tool. An assessment of the two countries’ strategies is undertaken by considering the following fundamental questions: Is engagement used in a manner that allows contestation thus avoiding a top-down approach where scientists and policy makers lead the process? Does engagement effectively consider and incorporate the public’s contributions in the deliberative process thus leading to inclusive innovation? By delving into these questions, the chapter considers the suitability or otherwise of PE as an RRI tool for ensuring inclusive governance approach to biotechnology innovation in LMICs based on lessons that are drawn from the two countries.
Research Interests:
This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or... more
This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone (Legal and ethical regulation of biomedical research in developing countries p. 134, 2016). The wording of the current version of the Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ (LMICs) health research ethics committees (RECs) in order to ensure that research participants who enroll in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs.
Research Interests:
Advances in information and communication technologies have enabled health care users and providers to share health information online thus generating contents, which may be used for health-related research. In addition, the data may be... more
Advances in information and communication technologies have enabled health care users and providers to share health information online thus generating contents, which may be used for health-related research. In addition, the data may be used for health care decision-making thus blurring the boundaries between health care and research particularly with the repurposing of data for other uses. This paper discusses the ethical and legal concerns that emerge from using digital data from user-generated online health content for health-related research. It analyses the nature of digital health data from user-generated online content and considers the extent to which its use can be governed through the current regulatory and ethical frameworks. It then highlights the strengths and weaknesses of these frameworks and proposes strategies that can be used to protect data subjects’ privacy while facilitating research in an ethical manner.
Research Interests:
Big data is revolutionising the health care sector by making it easier to analyse large volumes of data. This enables health care providers to monitor individuals or systems in real time. However, the main concern with regard to big data... more
Big data is revolutionising the health care sector by making it easier to analyse large volumes of data. This enables health care providers to monitor individuals or systems in real time. However, the main concern with regard to big data in biomedicine is how to overcome the barriers to using such data for health-related research. The landscape of big data is still evolving and the law has not developed suitable principles for governing access to big data. This paper sketches the fuzzy contours of data ownership and related intellectual property rights to demonstrate that ownership is a concept that is ill-suited for governing rights in big data. The dawn of big data calls for an alternative normative framework. This framework must be capable of reconciling competing societal, individual and industries' interests in the data with a view to ensuring fair access while minimising legal and ethical risks. Ultimately, the paper proposes a paradigm shift from ownership to custodianship in the governance of access and use of big data, particularly in international health-related research.
Research Interests:
The application of exceptions to copyright infringement in online news articles has become contentious with the widespread practice of aggregation. The specific concern is whether reproducing or adapting news articles that are published... more
The application of exceptions to copyright infringement in online news articles has become contentious with the widespread practice of aggregation. The specific concern is whether reproducing or adapting news articles that are published on competitors’ websites without permission falls within the scope of the exceptions to copyright infringement in respect of news articles or, alternatively, such conduct is protected by fair use.
This paper provides a South African perspective on the above concern by comparing the USA case of Meltwater with the South African case of Moneyweb, which has attempted to provide clarity on copyright in the context of online journalism. The paper first analyses the complexities of the rapid rise of online news, which raise questions such as whether hyperlinking is sufficient attribution and the difference between ‘scraping’ and aggregation, as well as the effects of these practices on competing media. It then considers whether the doctrine of fair use, which should arguably be flexible enough to adapt to the changing obligations in the context of new technologies, is capable of providing clear guidance on reasonable online media practice beyond South Africa. The central argument is that the doctrine of fair use should foster online innovation and the sharing of public information while ensuring respect of copyright.
This paper provides a South African perspective on the above concern by comparing the USA case of Meltwater with the South African case of Moneyweb, which has attempted to provide clarity on copyright in the context of online journalism. The paper first analyses the complexities of the rapid rise of online news, which raise questions such as whether hyperlinking is sufficient attribution and the difference between ‘scraping’ and aggregation, as well as the effects of these practices on competing media. It then considers whether the doctrine of fair use, which should arguably be flexible enough to adapt to the changing obligations in the context of new technologies, is capable of providing clear guidance on reasonable online media practice beyond South Africa. The central argument is that the doctrine of fair use should foster online innovation and the sharing of public information while ensuring respect of copyright.
Research Interests:
Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times... more
Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times inadequate and of great concern to the stakeholders involved in such research. The challenges for law as a regulatory mechanism in this regard are twofold: the complexity of issues related to HIV-vaccine research, and the apparent disconnection between the legal and ethical frameworks that are applied in the regulation of these issues. This article analyses the extent to which these challenges have been addressed in South Africa and Kenya. Especially, it highlights the lessons that can be drawn from the two countries in establishing a suitable ethical-legal framework for HIV-vaccine research.
Research Interests:
Bioethics would also like to thank the following individuals who most generously agreed to referee manuscripts for us between June 2003 and May 2004. Whilst every effort has been made to include everyone, we apologise for any... more
Bioethics would also like to thank the following individuals who most generously agreed to referee manuscripts for us between June 2003 and May 2004. Whilst every effort has been made to include everyone, we apologise for any oversights–please do let us know if we have missed you so that we can update our records.
Research Interests:
Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times... more
Law is an important regulatory mechanism, particularly for creating an enabling research environment. However, the manner in which law addresses issues related to medical research, and HIV-vaccine research in particular, is at times inadequate and of great concern to the stakeholders involved in such research. The challenges for law as a regulatory mechanism in this regard are twofold: the complexity of issues related to HIV-vaccine research, and the apparent disconnection between the legal and ethical frameworks that are applied in the regulation of these issues. This article analyses the extent to which these challenges have been addressed in South Africa and Kenya. Especially, it highlights the lessons that can be drawn from the two countries in establishing a suitable ethical-legal framework for HIV-vaccine research.
Research Interests:
Trade in counterfeit medicines raises serious public health concerns. However, efforts geared towards combating trade in counterfeit medicines tend to focus more on the protection of trademarks, which may not necessarily protect the... more
Trade in counterfeit medicines raises serious public health concerns. However, efforts geared towards combating trade in counterfeit medicines tend to focus more on the protection of trademarks, which may not necessarily protect the public from the adverse consequences of using counterfeit medicines. This arises from differences in the meaning of " counterfeit " in the intellectual property and public health contexts. This article analyses the extent to which the anti-counterfeiting legislation and institutions in two African countries, Kenya and South Africa, are capable of combating trade in counterfeit medicines in a manner that protects both the public and brand name owners. The article examines the anti-counterfeiting legislation and institutions that ensure compliance with the standards for marketing medicines that are in place in these countries, in order to draw lessons on how they can be used to balance the protection of public health interests and trademarks.
Researchers from the Universities of Oxford, Nairobi, and Manitoba are collaborating on a project to develop an HIV vaccine based on the immunological protection mechanisms found in commercial sex workers from the Majengo slum in Nairobi.... more
Researchers from the Universities of Oxford, Nairobi, and Manitoba are collaborating on a project to develop an HIV vaccine based on the immunological protection mechanisms found in commercial sex workers from the Majengo slum in Nairobi. This group consists of educationally and economically disadvantaged women who resort to commercial sex work for a living. A clinic was established in the slum to study sexually transmitted diseases, which now includes HIV/ AIDS. The clinic serves as a research facility for the collaborating researchers who have been using the women's blood, cervical, vaginal, and saliva samples for the ongoing studies. The clinic runs two HIV-integrated activities: HIV research and HIV care and treatment. For HIV negative participants, samples are collected and used for research and care after they give informed consent. HIV positive participants are involved in research, HIV antiretroviral treatment (ART), and the receipt of care support services after giving informed consent. No more than four blood samples (20 ml each) are collected per year. Notably, the timing of research samples' collection is usually planned to coincide with ART and care monitoring to minimize costs. This article asks what makes these women vulnerable as research participants. The first part contextualizes the definition of vulnerability. The indicators of vulnerability are discussed in the second part, focusing in particular on informed consent and access to the benefits of research. The discussions in this article are based on information obtained from interviews with Kenyan stakeholders and current literature on ethical issues related to vulnerability. 1