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ENSafrica www.ENSafrica.com [email protected] Credible difference With over 600 specialist practitioners, ENSafrica is Africa’s largest law firm and…
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ENSafrica | South Africa | 4 Aug 2021

Cosmetic or medicine? The distinction could be in the claim

The courts have held that if a person says that a product is used for the purpose of treating or preventing disease, it will fall within the definition of a "medicine" under the Medicines and Related Substances Act 101 1965. In a recent decision, the Directorate of the Advertising Regulatory Board was asked to determine the boundary between medicinal and cosmetic claims. Although this......
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ENSafrica | Global | 9 Jun 2021

Would a TRIPS waiver improve access to COVID-19 vaccines?

A recent proposal calls for a waiver for all World Trade Organisation members of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in relation to the "prevention, containment or treatment" of COVID-19. However, without the voluntary cooperation of vaccine originator companies, a significant or rapid increase in the production of vaccines by......
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ENSafrica | South Africa | 28 Apr 2021

Biosimilar regulation FAQs

A biosimilar is a biological medicine that is manufactured to be similar, but – unlike a generic pharmaceutical medicine – not necessarily identical, to its reference medicine. The South African Health Product Regulatory Authority has published several guidelines to assist applicants which wish to register biological and biosimilar medicines. This article answers FAQs about the registration......
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ENSafrica | South Africa, USA | 3 Mar 2021

Telemedicine: time for an upgrade?

The COVID-19 pandemic has led to a significant increase in the use of electronic platforms to provide access to health services. These platforms seemingly push the legal boundaries of telemedicine. Looking beyond the COVID-19 pandemic, it is hoped that the Health Professions Council of South Africa considers patients' best interests and takes decisive action to incorporate national and......
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ENSafrica | Africa | 9 Dec 2020

Current pharmaceutical invention patent restrictions

A number of African World Trade Organisation members have supported a proposal to waive certain provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for the prevention, containment and treatment of COVID-19. It appears that this is an opportune time for many least-developed countries (LDCs) to extend the TRIPS exemptions beyond the COVID-19 pandemic to......
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ENSafrica | South Africa | 11 Nov 2020

Battling COVID-19: mechanisms for access to antiviral products and diagnostics

While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries. What mechanisms are available at present to provide for access to medicines and diagnostics?
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ENSafrica | South Africa | 21 Oct 2020

Genetic information: a new resource to be mined?

Given that humankind originated in Africa, Africans (and South Africans in particular) have significant genetic diversity. As such, there is a potential wealth of genetic information available to be mined. Unfortunately, without effective regulation, the collection and use of African genetic information could result in the unfair exploitation of the donors of this information. Due to the......
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ENSafrica | South Africa | 17 Sep 2020

Is the 2020 Cannabis Bill a flower among weeds or a weed among flowers?

The 2020 Cannabis Bill outlines the regulations under which adults may legally cultivate, possess and use cannabis for private use and recreational purposes. The bill also groups cannabis-related offences into four categories, which each carry different penalties. Even though South African adults can legally possess significantly more grams of cannabis than adults in various other countries,......
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ENSafrica | Africa | 5 Aug 2020

African Union publishes COVID-19 vaccine strategy

The African Union (AU) recently published a COVID-19 vaccine strategy. The strategy was announced in a communique issued by the AU ministers of health and heads of delegation following a virtual conference on 24 and 25 June 2020. Access to medicine in Africa is a recurring concern and it may be an opportune moment to use the response to the COVID-19 pandemic as a blueprint to secure future......
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ENSafrica | South Africa | 22 Jul 2020

Q&A on ABS compliance in South Africa

There has been much debate in recent years as to the effectiveness of access and benefit sharing provisions relating to indigenous biological and genetic resources (IBGRs) and traditional knowledge or indigenous knowledge (IK) as set out in the Convention on Biological Diversity and adapted into local legislation of member countries. This article explores the situation in South Africa, one of......
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