Jegede Ademola Oluborode
29 May 2008
opinion
Jegede Ademola Oluborode looks at the Protocol on the Rights of Women in relation to medical or scientific experiments and argues that ethical and scientific standards are lowered when it comes to African women and informed consent may not be enough to protect vulnerable African women.
This article is a reflection on the provision of article 4(2)(h) of the Protocol to the African Charter on Human and Peoples' Rights on the Rights of Women in Africa( Protocol on the Rights of Women) which seeks to prohibit all medical and scientific experiments on women without their informed consent. The article argues that the prohibition of all medical or scientific experiments on women without their informed consent, without more, falls short of other ethical requirements for safety in scientific and medical experimentation. This in itself is an expression of the regrettable gap which over the years has existed in major international human rights instruments, to which most African States are signatory. To this end therefore, the article suggests that along with the requirement of consent, there is a need to legally prescribe appropriate human rights standard on the performance of medical and scientific experiments. The article concludes that a re-draft of article 4 (2)(h) of the Protocol on the Rights of Women is imperative to ensure maximum legal protection for women, who by virtue of their role in the society are most vulnerable to medical and scientific exploitation.
INJUSTICES IN MEDICAL OR SCIENTIFIC EXPERIMENTS AND WOMEN [1]
Examples of where women have been victims to medical and scientific exploitation under the pretext of research are not new. Grave atrocities were committed in the process of medical experiments carried out during the Second World War on non-consenting women and children prisoners of Nazi concentration camps [2]. During the same period in history, African women from the German South West Africa, now Namibia, were part of sterilization programmes instituted by Germany without their consent [3]. In more recent times, evidence from Nigeria implicated Pfizer International Incorporated (PII) of fraud and criminal breach of trust of its controversial drug test, popularly known as Trovan Clinical Trials, which it carried out on Nigerian citizens in Kano in 1996, which had fatal results [4].
The burden of disease, generally, including malaria, sickle cell anaemia, tuberculosis and HIV/AIDS, weighs heavily on Africa, where these illnesses are most prevalent. In more ways than one, the impact of these diseases has been disproportionately borne by women. While medical and scientific trials and research involving women, holds great prospects for the solution of these problems, researches and pharmaceutical companies who engage in trials can not always be trusted to function with due consideration for ethical requirements, when such requirements are not well specified and projected in the African human rights system.
It is noteworthy that due to low level of literacy in Africa, very few women who are research participants are sufficiently educated to really understand the details of studies and trials in which they are engaged [5]. The poverty and powerlessness of women often lead to their participation in clinical and scientific researches merely for inexpensive inducements, and largely due to less understanding of study risks, or for the pregnant women, under the mistaken belief that such studies will result in care for their unborn children. There are for instance, controversies which have surrounded microbicide trials carried out on women in South Africa which revealed that women in the study developed higher risk of HIV infection [6]. In 2007, the US-based reproductive health research organisation, CONRAD, also announced the premature end of trials of a cellulose sulphate-based microbicide in Nigeria, Benin and Uganda after the data safety and monitoring committee found a higher number of infections in the active group compared to the placebo group [7].
The New England Journal of Medicine carried a comment on 15 on-going clinical trials testing cheaper drug regimens to prevent maternal-foetal transmission of HIV in Africa. Some 16,000 pregnant, HIV-positive women were enrolled in the placebo-controlled trials. The problem with these trials was that it began after Zidovudine (AZT) had been found to prevent such transmission by 50% or more, and is recommended to all HIV-positive pregnant women in western countries. In other words, it was reported that, thousands of women in the trials were getting sugar pills to test the efficacy of the new regimens whereas if they had been enrolled in trials in Europe, they would have received a standard course of AZT [8]. This further underscores the point that the truth in Africa, is that very few women do enjoy the benefits of the research in which they participate.
The survival of women therefore raises the question as to whether international human rights have done enough to protect women in terms of medical and scientific experimentation and if not, whether there is the need for the African human right system to review existing legal framework with the view of addressing such gap.
INTERNATIONAL AND REGIONAL HUMAN RIGHTS INSTRUMENTS ON MEDICAL/ SCIENTIFIC EXPERIMENTS
When international human rights instruments have discussed access to health services, it has been silent on medical and scientific experimentation. This was the case with the Universal Declaration of Human Rights which only guarantees in its Article 25(1) the right of everyone to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care. Similarly, subsequent notable instrument such as the International Covenant on Economic, Social and Cultural Rights (ICESCR) in Article 12(2)(d) only urges the States to take steps to achieve full realization of the right to health by creating conditions which would assure to all medical service and medical attention in the event of sickness [9]. Article 5 (d)(iv) of the Convention on the Elimination of All Forms of Racial Discrimination is no different when it provides for the right to public health, medical care, social security and social services [10].
Although, the need to take urgent steps to address the inequality as it affects women on a number of issues led to the adoption of the Convention on Elimination of Discrimination Against Women (CEDAW), [11] the Convention fails to sufficiently address the issues of human rights around medical and scientific experiments in its copious provisions in Article 11(f), 12(1) and 14(2) (b) regarding improvement of access of women to health care services. This is also lacking in the 1999 General Comment of the Committee on the Elimination of Discrimination against Women, which interpreted the right to health under Article 12 of CEDAW as the right of women to be fully informed, by properly trained personnel, of their options in agreeing to treatment or research, including likely benefits and potential adverse effects of proposed procedures and available alternatives [12].
Article 4(2)(h) of the Protocol on the Rights of Women provides that States parties shall take appropriate and effective measures to prohibit all medical or scientific experiments on women without their informed consent. This appears progressive for Africa, considering that, with the exception to South African Constitution which has similar provision; hardly does any other African constitution have a similar provision with such safeguard [13].The Protocol is however merely re-stating article 7 of the International Covenant on Civil and Political Rights (ICCPR) which provides that 'no one shall be subject without his free consent to medical or scientific experimentation [14]. The inherent weakness in the foregoing efforts is that the requirement of consent, without more excludes certain elements of ethics which are fundamental in medical and scientific experiments and in so doing, deprives them of being legally determinable.
ELEMENTS AS IMPORTANT AS 'INFORMED CONSENT' IN MEDICAL AND SCIENTIFIC EXPERIMENTS
The medical misdeeds at the Second World War led to the Nuremberg code in 1947, a set of principles devised to protect human subjects from unethical experimentation [15]. The Nuremberg code was a part of the judgment delivered in the so-called Doctors' Trial at Nuremberg following World War II. The principles of the code were based upon the criteria for ethical research that were elucidated by the two expert medical witnesses at the trial if human experimentation was to be justified. These are: informed consent; Results must be for the good of society; and the experiment must be conducted only by scientifically qualified persons [16].
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