Clinical Trials: A friend or foe

11 Jun 2020 1:07 pm by Mpho Khoele

Liability insurance in clinical trials is an indemnity covering the liability of an applicant for injury attributable to participation in the clinical trial. The loss covered includes that for medical treatment, and financial or other assistance necessary to adequately compensate participants for resultant impairment disability or handicap. When applying for a clinical trial to be approved, the applicant, the manufacturer, must submit evidence of comprehensive no-fault insurance. It seems that this measure is an adequate filter to avoid any company that may have nefarious intentions.

Whether the choice for clinical trial participants envisaged for the COVID-19 virus is appropriate or not, one cannot say. However, should the trials go ahead, participants would be covered for any eventuality.

Written by Mpho Khoele, Advocate of the High Court of the Republic of South Africa, for LexisNexis South Africa.

[Durban, 25 May 2020]

Introduction

Before a drug company can introduce a drug to the market, it first has to test its efficacy and potential adverse effects it may have on the populace.

Recently, a group of French Doctors was captured on video discussing the possibility of conducting clinical trials in Africa, to test the efficacy of a new vaccine for the Covid-19 virus[1].

During a debate on a TV Channel LCI Jean-Paul Mira, head of intensive care at Cochin hospital in Paris, said:

If I can be provocative, shouldn't we be doing this study in Africa, where there are no masks, no treatments, no resuscitation?”

A bit like as it is done elsewhere for some studies on Aids. In prostitutes, we try things because we know that they are highly exposed and that they do not protect themselves.”

Also, Bill Gates, a tech-giant, philanthropist, and founder of the Bill Gates Foundation seemingly added to that sentiment. On Saturday 4 April 2020, News24 published an article titled "Bill Gates confident a potential coronavirus vaccine will work in Africa, but Twitter does not think so"

Later the information and comments contained in the article were established as fake news and News24[2] withdrew the article and apologized to the Bill and Melinda Gates Foundation.

In a follow-up piece that contained an apology for the false information (see Apology to the Bill and Melinda Gates Foundation for 'Africa vaccine' story), News24 acknowledged:

“Nowhere in the interview does Gates mention testing a vaccine in Africa. In his tweet, Ramaphosa stated the businessman will support South Africa with testing kits and research”[3]

But the media storm that these stories had created was tremendous and the damage was done. Many people in the African nations were outraged at these misleading suggestions, and rightfully so, considering the various gross human rights violations previously visited upon the African continent in the name of advancing medical research. An example of these gross violations is where African children were treated for spinal meningitis in Kano, Nigeria, with an experimental drug without the parent’s knowledge that the drug was experimental[4].

The argument put forward is that it is common practice that trials are not only conducted in Africa but everywhere in the world where there is a vulnerable community of people that can be exploited.

So, the questions that come to my mind in these times of uncertainty are:

  1. In what why are participants in clinical trials protected in the process?
  2. And should there be any human rights violations, is there any type of recourse that the participants have?

These questions will be considered briefly below.

The Role of the South African Good Clinical Practice Guidelines

The South African Good Clinical Practice Guidelines[5] (SA GCP) is a framework that provides researchers and other interested parties with clear guidelines of how to conduct clinical research in the South African context to ensure that clinical trials involving human participants are designed and conducted according to local requirements as well as scientific and ethical standards.

These guidelines include the provision that before a clinical trial is conducted a risk-benefit analysis must take place and the suitability of the study population examined. Where a vulnerable group is included in the study it must be analyzed if the study is justified and if there are sufficient measures in place to protect their interests.

So, it is quite apparent that where vulnerable groups are involved, the balance of power is skewed between them and the drug corporations, so extra vigilance is a must to protect the interests of all parties.

The Potential for Human Rights Violations

The right to dignity and bodily integrity are fundamental in the current human rights dispensation of South Africa. Even more so where those rights affect vulnerable communities that often do not have the clout to go against the tyranny of big multi-national corporations.

But seemingly, there is recourse available to aggrieved participants which includes:

  1. Various non-binding ethical guidelines used in the protection of clinical research participants.
  2. Human rights documents such as the South African Constitution, the African Charter, and the African Union resolutions and declarations
  3. International human rights law, in the form of binding treaties and conventions.
  4. Liability insurance having been taken out by pharmaceutical companies and manufacturers for clinical trial participants.

Unfortunately for many, the recourse mentioned in points one to three above may be out of reach due to various reasons such as financial constraints. And so, this is where liability insurance steps into that gap as the most viable option that will not adversely affect the participant’s pocket.

Liability insurance in clinical trials is an indemnity covering the liability of the applicant for injury attributable to participation in the clinical trial. The loss covered includes that for medical treatment, financial or other assistance to adequately compensate participants for resultant impairment disability or handicap. When applying for a clinical trial to be approved, the applicant, the manufacturer, must submit evidence of comprehensive no-fault insurance. And so, it seems this measure is an adequate filter to avoid any company that may have nefarious intentions.

Whether the choice for clinical trial participants envisaged for the Covid-19 virus is appropriate or not, one cannot say. However, should the trials go ahead, the participants would be covered for any eventuality.

[1] https://www.bbc.com/news/world-europe-52151722 (viewed 16 May 2020)

[2] https://www.news24.com/Analysis/fact-check-how-a-lie-about-bill-gates-and-a-vaccine-for-the-coronavirus-exploded-on-twitter-20200407 (viewed 16 May 2020)

[3] https://www.news24.com/SouthAfrica/News/apology-to-the-bill-and-melinda-gates-foundation-for-africa-vaccine-story-20200405 (viewed 16 May 2020)

[4] https://www.theguardian.com/world/2011/aug/11/pfizer-nigeria-meningitis-drug-compensation (viewed 16 May 2020)

[5] https://www.sahpra.org.za/clinical-trials/ (viewed 16 May 2020)


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