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Mosa Mkhize

Mosa Mkhize is a policy advisor in the firm’s Africa Practice Group through which she provides strategic policy and regulatory advice to clients doing business with and across Africa.

Ms. Mkhize, a non-lawyer, has over a decade of experience in international trade and public policy. During this time, she has supported senior policymakers and private sector companies on a broad range of issues including policymaking and development, negotiating complex international trade deals, and advocating for policies and regulations related to science and technology. In addition to this, Ms. Mkhize’s capabilities include building strategic relationships and coalitions in support of smart technologies. Furthermore, she is currently working with government officials, private corporations, academia, and the general public on facilitating policies in the smart technology space.

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?

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,

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

On June 17, 2020 South African President Cyril Ramaphosa announced government’s intention to further ease the lockdown restrictions imposed due to COVID-19, allowing more industries to re-open fully under stringent health and safety protocols. This announcement comes two weeks after the government de-escalated the country from Alert Level 4 to Alert Level 3 pursuant to