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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

Twenty years of the constitution of South Africa – cause for celebration and reflection
2016-05-11

Description: Judge Azar Cachalia Tags: Judge Azar Cachalia

Judge Azar Cachalia

The University of the Free State’s Centre for Human Rights and the Faculty of Law held the celebration of the twentieth anniversary of the adoption of the South African Constitution on 11 May 2016 on the Bloemfontein Campus.  Students and faculty members celebrated and reflected on not only the achievements of the constitution but also on perspectives regarding its relevance in modern society, and to what extent it has upheld the human rights of all citizens of South Africa.

The panel discussion started with a presentation on the pre-1996 perspective by Judge Azar Cachalia of the Supreme Court of Appeal.  Judge Cachalia reflected on his role in the realisation and upholding of the constitution, from his days as a student activist, then as an attorney representing detainees during political turmoil, and currently as a judge: “My role as an attorney was to defend people arrested for public violence. My role as a judge today is to uphold the constitution.”  He stressed the importance of the constitution today, and the responsibility institutions such as the police service have in upholding human rights.  Judge Cachalia played a significant role in drafting the new Police Act around 1990, an Act which was to ensure that the offences perpetrated by the police during apartheid did not continue in the current democratic era. Further, he pointed out that societal turmoil has the potential to make society forget about the hard work that was put into structures upholding human rights. “Constitutions are drafted in moments of calm.  It is a living document, and we hope it is not torn up when we go through social conflict, such as we are experiencing at present.”

Thobeka Dywili, a Law student at the UFS, presented her views from the new generation’s perspective.  She relayed her experience as a student teaching human rights at schools in disadvantaged communities. She realised that, although the youth are quite aware of their basic human rights, after so many years of democracy, “women and children are still seen as previously disadvantaged when they should be equal”. She pointed out that, with the changing times, the constitution needs to be looked at with a new set of eyes, suggesting more robust youth engagement on topics that affect them, using technology to facilitate discussions. She said with the help of social media, it is possible for a simple discussion to become a revolution; #feesmustfall was a case in point.

Critical perspectives on the constitution were presented by Tsepo Madlingozi of University of Pretoria and University of London. In his view, the constitution has not affected policy to the extent that it should, with great disparities in our society and glaring issues, such as lack of housing for the majority of the poor.  “Celebration of the constitution should be muted, as the constitution is based on a decolonisation approach, and does not directly address the needs of the poor. The Constitutional Court is not pro-poor.”  He posed the question of whether twenty years on, the present government has crafted a new society successfully.  “We have moved from apartheid to neo-apartheid, as black elites assimilate into the white world, and the two worlds that exist have not been able to stand together as a reflection of what the constitution stands for.”

Prof Caroline Nicholson, Dean of the Faculty of Law, encouraged more open discussions, saying such dialogues are exactly what was intended by the Centre for Human Rights. She emphasised the importance of exchanging ideas, of allowing people to speak freely, and of sharing perspectives on important issues such as the constitution and human rights.

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