Africa

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).

Background to AMA and medicines regulation in Africa

Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).

Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency

Last week, Ethiopia hosted the 2nd regional African Forum on Business and Human Rights. This year’s Forum focused on local perspectives and solutions to implementing the UN Guiding Principles on Business and Human Rights (UNGPs), including in the context of operationalising the African Continental Free Trade Area (AfCFTA). Participants included a range of stakeholders including business enterprises and associations, governments, civil society, Indigenous Peoples groups, labour organisations, international and regional organizations and national human rights institutions. Dialogue touched on critical issues including the intersection between environmental and social impacts and the importance of developing and implementing business and human rights (BHR) frameworks that are appropriate for Africa.

In this post, we distil several considerations for businesses operating in Africa:

  1. Stakeholders are committed to establishing BHR frameworks tailored to Africa

An underlying theme of the Forum — “For Africa, From Africa” — was the implementation of the UNGPs through African perspectives. Participants discussed the extra-territorial reach of the EU’s proposed Corporate Sustainability Due Diligence Directive (CSDDD), through which the EU seeks to play a critical role in global standard setting on human rights due diligence. There was a clear recognition that the CSDDD and a plethora of other EU ESG laws are likely to apply directly or indirectly to businesses and significantly impact many businesses in the region. The EU is currently piloting projects in several African states to develop frameworks to assist states and businesses in preparing for CSDDD implementation and mitigate the risk of the law negatively impacting value chains. Despite this, there was some criticism regarding a perceived limited engagement with stakeholders in the Global South in the CSDDD drafting process and the potential risks and implications that could flow from that, including for example, a concern that costs of meeting due diligence standards could ultimately be pushed down to small-holding farmers and SMEs within the value chain.Continue Reading 2023 African Forum on Business and Human Rights: What do companies need to know?

At the beginning of a new year, we are looking ahead to five key technology trends in the EMEA region that are likely to impact businesses in 2023.

1. Technology Regulations across EMEA

European Union

If 2022 was the year that the EU reached political agreement on a series of landmark legislation regulating the technology sector, 2023 will be the year that some of this legislation starts to bite:

  • The Digital Services Act (DSA): By 17 February 2023, online platforms and online search engines need to publish the number of monthly average users in the EU. Providers that are designated as “very large online platforms” and “very large search engines” will need to start complying with the DSA in 2023, and we may start to see Commission investigations kicking off later in the year too.
  • The Digital Markets Act (DMA): The DMA starts applying from 2 May 2023. By 3 July 2023, gatekeepers need to notify their “core platform services” to the Commission.
  • The Data Governance Act (DGA): The DGA becomes applicable from 24 September 2023.

Also this year, proposals published under the European Data Strategy—such as the Data Act and European Health Data Space—and EU legislation targeting artificial intelligence (AI) systems—including the AI ActAI Liability Directive and revised Product Liability Directive—will continue making their way through the EU’s legislative process. These legislative developments will have a significant impact on the way that businesses ingest, use and share data and develop and deploy AI systems. In addition, the new liability rules will create potentially significant new litigation exposure for software and AI innovators.Continue Reading Top Five EMEA Technology Trends to Watch in 2023

When he was running to win the White House, President Joe Biden’s campaign committed to implement a “bold strategy” toward Africa, and one that would be based on a “mutually respectful engagement” and a reinvigorated diplomacy, if elected. Indeed, the campaign was the first-ever to outline how it would promote the interests of the African

There has been a substantial increase in the use of the Internet across the African continent, aided by ongoing investment into local digital infrastructure, reduction in the associated costs, and improved user access. This has allowed both individuals, and private and public entities, the ability to access, collect, process and/or disseminate personal data more easily,

The African Growth and Opportunity Act (AGOA) has served as the cornerstone of the U.S.-Africa commercial relationship for more than two decades but it is set to expire on September 30, 2025. While the legislation’s unilateral trade preferences have provided economic benefits for countries across sub-Saharan Africa, AGOA as a whole remains underutilized. To ensure

If there is a silver lining to most crises, the accelerated move toward digitized commerce globally and in Africa may be one positive outcome of the COVID-enforced lockdown. It is welcome news there that the South African Minister of Communications and Digital Technologies (“Minister”) published the Draft National Data and Cloud Policy (in Government Gazette

Our Africa Anti-Corruption Practice has previously outlined key considerations for handling internal investigations and remediation of compliance issues in Africa.  Here, we take a closer look at a particular aspect of remediation, the root cause analysis.  After the dust settles on an investigation identifying misconduct, a root cause analysis can serve as the most effective