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12 November 2019 | Story Leonie Bolleurs | Photo Leonie Bolleurs
Farmovs
At a first for South Africa, the SACRA clinical trials capacity-building workshop with government, research institutions, and industry, were from the left: Dr Nathaniel Mofolo, Dr Rita Nathan, Dr Mojalefa Maseloa (Head: Clinical Services in the Clinical Unit at the Universitas Hospital) and Sue Baily (Site Management Head at IQVIA).
Whether it is to treat the flu or a more serious illness, all medicines go through a very costly and lengthy research process before being approved for prescription to patients. The cumulative time from the beginning of trials to marketing approval has increased over the past ten years. 

According to Dr Vathi Papu-Zamxaka from the South African Clinical Research Association (SACRA), South Africans would not have had access to safe and effective medicines, had it not been for the intensive research conducted on new medicines. 

On 7 November 2019, a group of 115 delegates representing the Free State Department of Health, the UFS, private research sites, and the pharmaceutical industry met at FARMOVS on the Bloemfontein Campus of the University of the Free State (UFS) for the SACRA clinical trials capacity-building workshop.

2,1 billion dollars to develop one successful drug

Dr Michelle Middle, Chief Medical Officer at FARMOVS, provided some interesting stats on the process for drugs to hit the shelves: “One out of 10 drugs entering human research will be approved. The cost of development of one successful drug is approximately 2,1 billion dollars. And the time to develop a drug, from submission of the Investigational New Drug Application (IND) to approval by the Food and Drug Administration (FDA), is between 12 and 15 years.”

Dr Middle stated that drug development is one of the most regulated processes, with ethics and patient safety governing the undertaking. “With SAHPRA (South African Health Products Regulatory Agency) having some of the strictest regulations in the world, South Africa has a good history of running trials.  In addition, fast growth is expected for the pharmaceutical market on the African continent, necessitating the need for increased clinical trials on this continent,” she said. 

Very few clinical trials hosted in South Africa 

Although Africa has the broadest genetic variability of all human populations and carries 17% of the global population, very few clinical trials are hosted on the continent. Globally, there are currently approximately 322 000 clinical trials being actively conducted, of which only 1 700 are conducted in Africa, i.e. less than 3%.  Even worse, only 304 of the 1 700 trials running in Africa are conducted in South Africa.  There is thus a critical need for South Africa as a country to market itself as a clinical trial destination and to attract more trials to the country.

South Africa’s competitive edge lies in being known for its ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)-compliant top-quality research, racial and genetic diverse trial participants, good medical infrastructure and expertise, and the good reputation of the regulator (SAHPRA). “There are, however, a need for transformation and capacity building in clinical research in the country,” said Dr Middle. 

Dr Rita Nathan, Head of Clinical Services in the Clinical Department at the Universitas Hospital, who was representing government at the workshop, is looking to strengthen clinical trials across government and industry by focusing on, among others, funding models, operations management, and service delivery. 

From the UFS Faculty of Health Sciences, Dr Nathaniel Mofolo, Head of the School of Clinical Medicine, said collaboration between stakeholders is important. “This initiative is giving direction to the UFS vision of being a research-led university.” 

Other topics discussed at the workshop include the clinical trials landscape, how clinical trials work, the patient factor, ethics in clinical trials, and the economic aspect of clinical trials. 

News Archive

UFS law experts publish unique translation
2006-06-21

Attending the launch of the publication were from the left:  Prof Boelie Wessels (senior lecturer at the UFS Faculty of Law), Prof Frederick Fourie (Rector and Vice-Chancellor of the UFS), Prof Johan Henning (Dean: UFS Faculty of Law) and Adv Jaco de Bruin (senior lecturer at the UFS Faculty of Law). Prof Wessels translated the treatise from corrupted medieval lawyer Latin into English, Prof Henning is the leading author and initiator of the publication and Adv de Bruin assisted with the proofreading and editing. Photo: Stephen Collett

UFS law experts publish unique translation of neglected source of partnership law

The Centre for Business Law at the University of the Free State (UFS) has translated a unique long neglected Roman-Dutch source of the law of partnership law from Latin into English.  This source dates back to 1666. 

The book, called Tractatus de Societate (A Treatise on the Law of Partnership), by Felicius and Boxelius is published as Volume 40 in the research series Mededelings van die Sentrum vir Ondernemingsreg/Transactions of the Centre for Business Law.  It is the first translation of this Roman-Dutch source into English and comprises of a comprehensive discussion of the South African common law of partnerships.  

“Apart from various brief provisions dealing on a peace meal and an ad hoc basis with diverse matters such as insolvency, there is no comprehensive Partnership Act in South Africa.  The law of partnership in South Africa consists of South African common-law, which is mainly derived from Roman-Dutch law,” said Prof Johan Henning, Dean of the Faculty of Law at the UFS.  Prof Henning is also the leading author and initiator of this comprehensive publication.

“Countries such as America, England, Ireland and The Netherlands have drafted or are in the process of establishing new modern partnership laws in line with new international guidelines, practices and commercial usages,” said Prof Henning.

“However, in South Africa the most recent policy document released by the Department of Trade and Industry explicitly excludes partnership law from its present company law reform programme and clearly regards this as an issue for another day,” said Prof Henning.

“Unless there is a political will to allocate the necessary resources to a comprehensive partnership law revision program, it is a practical reality that South Africa will not have a modern Partnership Act in the foreseeable future,” said Prof Henning. 

According to Prof Henning South African courts have been using the Roman-Dutch partnership law sources as authority.  “The English Partnership Act of 1890 is not binding and the English text books should therefore be approached with caution,” said Prof Henning.

“A treatise on the law of partnership that has been regarded by South African courts as an important common law authority is that of  a Frenchman by the name of Pothier.  This treatise was translated into English and was regarded as an au­thority of significance in The Netherlands towards the end of the eighteenth century,” said Prof Henning. 

“Pothier’s opinions are however not valid throughout in the Roman-Dutch partnership law as it did not apply to the Dutch province of The Netherlands and it sometimes also rely on local French customs for authority,” said Prof Henning.

For this reason the Centre for Business Law at the UFS decided to focus its attention again on the significance of the comprehensive treatise of Felicius and Boxelius on the Roman-Dutch partnership law.  Felicius was an Italian lawyer and Boxelius a Dutch lawyer.

This long neglected source of partnership law was published in 1666 in Gorkum in The Netherlands.  "A significant amount of Roman-Dutch sources of authoritive writers trusted this treatise and referred to it,” said Prof Henning.

The translation of the treatise from corrupted medieval lawyer Latin into English  was done by Prof Boelie Wessels, a very well-known expert on Roman Law and senior lecturer at the UFS Faculty of Law.  Prof Wessels, who  has 15 degrees, spent almost ten years translating the treatise.  The proofreading and editing of the translation was done by Prof Henning and Adv Jaco de Bruin, a senior lecturer at the UFS Faculty of Law.

“We want the South African courts to use Volume 40 in the research series Mededelings van die Sentrum vir Ondernemingsreg/Transactions of the Centre for Business Law as the primary source of reference when cases where Roman-Dutch Law partnership law principles are involved, are ruled on,” said Prof Henning.

The first part of the publication comprises of selected perspectives on the historical significance of the work as well as a translation of selected passages. “The intention is to follow this up expeditiously with the publication of a very limited edition of a complete translation of the work,” said Prof Henning.

A total of 400 copies of the publication will be distributed to all courts, the Appeal Court and the Supreme Court.

Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
21 June 2006

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