Date: 24/04/2006
Source: Department of Health
Title: Tshabalala-Msimang: Opening of Scientific Session of Microbicides 2006


  Keynote address by Minister Manto Tshabalala-Msimang at the opening of the Scientific Session of the Microbicides 2006 conference

Chairperson,
Members of the conference organising committee,
Honourable Ministers and MECs present,
Director General,
Heads of departments and senior officials representatives of various multinational organisations,
Researcher and academics,
Members of civil society,
Distinguished guests,
Ladies and gentlemen,

I wish to welcome you all to the opening of the scientific session of this very important conference in Cape Town, one of the many beautiful areas of South Africa.

I would like to invite our visitors particularly those from abroad to take time to see a little more of our country in between and after this conference. I must assure you South Africa has a lot to offer. I can guarantee you that once you have seen South Africa and its people you will definitely visit us again.

We are pleased that the conference on Microbicides has come to our country. This year South Africa observes the 50th anniversary of the heroic action of women who marched on the Union Buildings in Pretoria during the height of apartheid in 1956, thus placing women of our country in the forefront of our struggle for national liberation.

We have made great progress in the empowerment of women since the advent of democracy in 1994. In addition to improved representation of women in decision making positions there has been a great deal of effort to ensure that policies and programmes particularly of government are sensitive to the needs and aspirations of women.

We begin this conference with the hope that it will contribute to protecting and promoting the interest of women and to empower them to take charge of their sexual and reproductive health.

I trust that this conference will discuss microbicides not only as products used to prevent infections among women but also as tools for promoting women's health and empowering women. We believe that the development and marketing of effective microbicides will have a great impact on the well being of women and consequently on their children.

The invention of an effective microbicide will ensure that the health of women in relation to sexually transmitted infections will no longer depend on their ability to negotiate safer sex and the balance of power in their relationships with men.

As you know while condoms remain an effective intervention in the prevention of sexually transmitted infections and unwanted pregnancies, their effective use remains very much dependent on the cooperation of men. Therefore, microbicides represent empowerment for many women who need to protect themselves from the risks associated with unprotected sex.

You may be aware that African Ministers of Health declared 2006 as the year of accelerated prevention of HIV and AIDS at last year's World Health Organisation/AFRO (WHO/AFRO) meeting. We are aware that intensifying prevention interventions includes the challenge of looking for additional tools that can be added to the existing set of interventions to deal with the spread of HIV infection and the impact of AIDS. It is encouraging that this conference is focused on research that seeks to strengthen prevention of infections including the prevention of HIV infection.

We are aware that several potential microbicides are being tested globally with five out of six products that are in advanced stages being tested in South Africa and elsewhere in the world. I understand that their mechanism of action is different from non-oxynol nine otherwise referred to as N9.

I am particularly pleased that there will be a dialogue around the N9 microbicide during this conference. When I first heard about the results of the N9 study conducted in South Africa I was very concerned.

One of the issues that this conference needs to address is ethical recruitment of candidates for clinical trials. In a community that is poor, providing financial compensation could prove to be perverse incentives. As we know the poor may become desperate to receive these incentives despite the risk. Therefore, informed consent becomes even more critical in this context.

We need to ensure that research participants receive the necessary care for the management of conditions that they may be exposed to. One of the key issues that this conference needs to address is what happens when there are complications from a clinical trial. From an ethical point of view we need to answer how we compensate patients who suffer such complications and ensure that they have adequate insurance.

The type of insurance that is available for research participants in developed countries should be extended to participants in developing countries. It is unethical that participants in one multi-country study should have unequal levels of protection.

We would like you as researchers skilled in the areas of clinical trials and ethics to make necessary recommendations to these complex issues. As a Health Minister, it is my responsibility to ensure that the health of citizens of our country particularly women is not adversely affected in the process of research. Let us reflect on the lessons learned in the N9 study and plan future studies with these lessons in mind to avoid similar problems.

We are all aware of the possibility that the outcome of a clinical trial may not be as positive as expected during the planning stage. It is of critical importance that we ensure that our methods, procedures and planning are impeccable. I hope that during this conference we will discuss methods and procedures that will make clinical trials safer for those who participate in them.

I am informed that your deliberations over the next three days will focus not only on clinical science but you will also extensively discuss issues around informed consent, community responses and participation in clinical trials.

The former advantaged areas of our country have good infrastructure, skilled researchers and well equipped research institutions comparable to many developed countries while the rest of the population is affected by the burden of diseases common to many developing countries particularly in sub-Saharan Africa.

These features of our country have attracted many international institutions to choose South Africa as a site for research. As you know, increasing research activity, competition and an attractive research environment may sometimes result in unethical practices.

As we utilise the opportunities presented by this environment we need to ensure that we protect human rights particularly of research participants as entrenched in our constitution and the National Health Act. This should become standard practice in all developing countries.

With respect to the South African context the National Health Act provides for the establishment of the National Health Research Ethics Council which must:

* Register and audit health research ethics committees;
* Set norms and standards for conducting research on humans and animals, including norms and standards for conducting clinical trials; and
* Adjudicate complaints and institute disciplinary action if ethics have been contravened.

The establishment of the Ethics Council is one of the most important steps we have taken to maintain ethical conduct in research and protect the rights of research participants. Let me take this opportunity to also announce that in line with the international requirement for the registration of clinical trials, South Africa has recently established a nailing this conference. When I first tonal clinical trial register. The register will not only inform the Department of Health of ongoing trials but will also enable trial participants to obtain more information about trials.

I have scanned through some of the topics of presentation. I must say that it is clear that although the developing countries are used as testing sites research capacity to conduct these trials does not exist in many of these countries. Let us ensure that the issue of strengthening research capacity in Africa and other developing regions is fully addressed - African scientists must more and more become the lead researchers in studies conducted on Africans, in Africa. We have to develop a strong research culture on problems that are of greatest concern for Africa.

I am encouraged to learn that for the first time in the history of this conference there is a track dedicated to advocacy and community issues. We need to hear the voices of the people we are researching and their families.

Let us not forget our commitment to improve the lives of the ordinary people and this should guide us in our deliberations during this conference. I look forward to participating in some of the sessions and hearing the outcome of the conference.

Let us strive to ensure that this conference contribute significantly to improving health including reproductive health of our populations.

Delegates, ladies and gentlemen it is a pleasure for me to declare this conference open.

Issued by: Department of Health
24 April 2006