An exploratory assessment of the legislative framework for combating counterfeit medicines in South Africa

Background Substandard and Falsified (SF) medical products are a growing global concern. They harm the individual patient, the healthcare system and the economy. The World Health Organisation (WHO) has highlighted contributing factors globally: insufficient national medicine regulation, poor enforcement of existing legislation, weak stakeholder collaboration and the rise of novel viruses, such as the COVID-19. The study aimed to assess the legislative and policy framework and institutional relationships governing pharmaceuticals and anti-counterfeiting strategies. Methods The study was explorative and consisted of two phases. The first phase was between 2016 and 2017. It looked at document analysis (annual reports and press releases from 2011 to 2016) from government institutions involved in medicines regulation and law enforcement for SF seizure reports between 2004 and 2017. The second phase was between 2016 and 2018 through in-depth semi-structured interviews (seven in total) with selected stakeholders. Results First Phase—the data collected and reported by various departments was sporadic and did not always correlate for the same periods indicating, a lack of a central reporting system and stakeholder collaboration. In South Africa, counterfeiting of medicines mainly involves the smuggling of non-registered goods. The most common counterfeit items were painkillers, herbal teas, herbal ointments, while some were medical devices. Furthermore, Customs identified South Africa as a transhipment point for SF infiltration to neighbouring countries with less robust regulatory systems. Second phase—interview transcripts were analysed by thematic coding. These were identified as the adequacy of legislation, institutional capacity, enforcement and post-market surveillance, stakeholder collaboration and information sharing, and public education and awareness. Conclusion Document analysis and interviews indicate that South Africa already has a national drug policy and legislative framework consistent with international law. However, there is no specific pharmaceutical legislation addressing the counterfeiting of medicines. Law enforcement has also been complicated by poor stakeholder engagement and information sharing.

Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution?

The pace of scientific progress over the past several decades within the biological, drug development, and the digital realm has been remarkable. The’omics revolution has enabled a better understanding of the biological basis of disease, unlocking the possibility of new products such as gene and cell therapies which offer novel patient centric solutions. Innovative approaches to clinical trial designs promise greater efficiency, and in recent years, scientific collaborations, and consortia have been developing novel approaches to leverage new sources of evidence such as real-world data, patient experience data, and biomarker data. Alongside this there have been great strides in digital innovation. Cloud computing has become mainstream and the internet of things and blockchain technology have become a reality. These examples of transformation stand in sharp contrast to the current inefficient approach for regulatory submission, review, and approval of medicinal products. This process has not fundamentally changed since the beginning of medicine regulation in the late 1960s. Fortunately, progressive initiatives are emerging that will enrich and streamline regulatory decision making and deliver patient centric therapies, if they are successful in transforming the current transactional construct and harnessing scientific and technological advances. Such a radical transformation will not be simple for both regulatory authorities and company sponsors, nor will progress be linear. We examine the shortcomings of the current system with its entrenched and variable business processes, offer examples of progress as catalysts for change, and make the case for a new cloud based model. To optimize navigation toward this reality we identify implications and regulatory design questions which must be addressed. We conclude that a new model is possible and is slowly emerging through cumulative change initiatives that question, challenge, and redesign best practices, roles, and responsibilities, and that this must be combined with adaptation of behaviors and acquisition of new skills.

When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries

The recent growth of medicine sales online represents a major disruption to pharmacy markets, with COVID-19 encouraging this trend further. While e-pharmacy businesses were initially the preserve of high-income countries, in the past decade they have been growing rapidly in low-income and middle-income countries (LMICs). Public health concerns associated with e-pharmacy include the sale of prescription-only medicines without a prescription and the sale of substandard and falsified medicines. There are also non-health-related risks such as consumer fraud and lack of data privacy. However, e-pharmacy may also have the potential to improve access to medicines. Drawing on existing literature and a set of key informant interviews in Kenya, Nigeria and India, we examine the e-pharmacy regulatory systems in LMICs. None of the study countries had yet enacted a regulatory framework specific to e-pharmacy. Key regulatory challenges included the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders and risks of over-regulation. However, e-pharmacy also presents opportunities to enhance medicine regulation—through consolidation in the sector, and the traceability and transparency that online records offer. The regulatory process needs to be adapted to keep pace with this dynamic landscape and exploit these possibilities. This will require exploration of a range of innovative regulatory options, collaboration with larger, more compliant businesses, and engagement with global regulatory bodies. A key first step must be ensuring that national regulators are equipped with the necessary awareness and technical expertise to actively oversee this e-pharmacy activity.

Dark pools and data markets: an exploration of the regulatory challenges

Regulating the data market is shaping up to be one of the major challenges of the twenty-first century. In order to think about regulating this market, however, we first need to make its dimensions and dynamics more accessible to research. In this paper we explore what the state of the sociological and legal research on markets can tell us about the market for data: what kind of market it is, the practices and configurations of actors that constitute it, and what kinds of data are traded there. We start from the subjective opacity of this market to researchers interested in regulation, using ‘dark pools’ as a point of reference for the challenges of understanding how data are traded and channelled. We explore comparisons from food and medicine regulation to understand how these markets have been shaped and the different aims that have been taken into account in doing so, and discuss the implications of these explorations for the future regulation of data markets.

Shaping stem cell therapies in Argentina: regulation, risk management and innovation policies

This paper aims to analyze innovation pathways for stem cell technology in Argentina. Firstly, we present a theoretical perspective on the co-construction of regulation and technology development, positing four main tensions that underlie regulatory building and the shaping of national strategies for regenerative medicine. Regulation is understood as a negotiated process among interests, values, benefits, rewards, and different understandings of safety, efficacy, access and availability. The framework is useful to explore how actors and their visions of desired futures shape the creation of standards and, in turn, how they configure the way these emerging technologies are produced, accessed and used. Secondly, we discuss in detail the Argentine case. We focus on (a) the deployment of state actions on capacity and regulatory building, (b) the creation of new businesses in response to patient expectations, particularly umbilical cord stem cell banks and the supply of experimental treatments, and (c) state-led actions to build a specific regulatory framework (still in the making). Ambiguities and gaps in the current legislation as well as scarce enforcement capabilities configure a legal “grey area” for for-profit experimental treatments. Building a specific regulatory framework is understood to be a part of Science, Technology and Innovation (STI) state agencies’ struggle to govern technology development in terms of national envisaged innovation strategies. Lastly, we show how STI authorities and scientists managed to align a broad coalition of actors that encourage international harmonization strategies, following the pharmaceutical model of drug evaluation based on the multi-phase trial system.