18-19 February 2008
Programme Director,
Representatives of the AU Commission,
Distinguished Experts from the African Region
Representatives of World Intellectual Property Organization (WIPO),
African Regional Industrial Property Organisation (ARIPO),
Our Partners the WHO and UN
Fellow South Africans
Good Morning,
As the World celebrates 30 years of the Alma Ata Declaration that launched the Primary Health as the Pillar of Quality services, there is greater need for all of us to improve access to affordable medicines. Even in rich countries, access to affordable medicines cannot be guaranteed. Of course, the problems are much greater in many developing countries, with insufficient or no manufacturing capacities in the pharmaceutical sector.
This brings me to the purpose of this meeting this morning, which is to review the implementation of The Africa Health Strategy on enhancing local manufacturing of pharmaceuticals to reduce reliance on outside countries and defray costs, We also seek international expertise and advice before embarking on manufacturing – with particular emphasis on African traditional medicine not excluding innovation.
Access to healthcare is a constitutional right for all citizens of this continent. Pharmaceuticals play a significant role in attaining this goal. MDG 8 Target 17, specifically states“: In cooperation with pharmaceutical companies, provide access to affordable drugs in developing countries”. Whilst we are not advocating medicalisation of healthcare, we cannot hope to meet the goal of MDG4 of reducing child mortality, without reliable and sustainable access to medicines and vaccines.
We are however too reliant on other countries to provide essential medicines for us. This is not strategic and correct, as we cannot guarantee availability of appropriate technologies that truly respond to our current and emerging needs. We have seen that diseases that disproportionately affect us have been neglected in the technology development agenda.
A classical example is tuberculosis, for which no new medicines have been developed over the last forty years. The Consequent development of new highly resistant strains of TB put extreme pressure in the affected countries and communities who are force to use older drugs, which have significant side effects.
We also need to pay attention to, and continually evaluate the appropriateness of existing formulations and delivery methods in our environment.
The limited availability of appropriate paediatric medicines is another concern. It is immoral to continue to treat children as “little adults” in terms of dosages and formulations, knowing fully well that the bioavailability of medicines in children is quite different from adults as their fat deposition and metabolism are not the same. This has implications for safety and efficacy of medicines in children.
Secondly, many paediatric formulations require refrigeration, are bulky and are therefore difficult to manage in our setting.
Whilst we acknowledge that it is difficult to conduct clinical trials in children, thus leading to inability to license paediatric medicines we should not relax in our efforts to find more appropriate paediatric formulations.
I believe we have to devise and implement strategies that encourage a conducive environment to research and development of paediatric medicines. We must however ensure that clinical trials conducted in developing paediatric medicines are ethical and respond to our needs and disease burden.
While we unashamedly advocate the need to ensure availability of commodities that address conditions that disproportionately address developing countries, we are mindful of the fact that the landscape for our disease burden has changed and is increasingly including non-communicable conditions like diabetes, heart diseases, hypertension and cancers.
As you deliberate on local production I urge you not to lose sight of these developing trends.
Local manufacturing of pharmaceuticals will not attain the desired outcomes if affordability, effective and efficient distribution channels and quality are not addressed. This implies that our medicines and related technologies regulatory capacity must be strengthened. Counterfeits mainly coming from outside our borders are a concern. I hope you will cover these areas in your deliberations.
I hope you will also deliberate on African traditional medicines. African traditional medicines have, through generations proved to be accessible, affordable and acceptable to communities. It is therefore imperative that African traditional medicine is afforded recognition as part of a broader public health element just as it happens in other continents.
The number of truly innovative chemical molecules is shrinking. We are also seeing more reports of safety concerns with regard to some of the newer chemical entities. This could be a function of the safety profile of the molecules or increasing ability to detect areas of concern.
The trend seems to be moving to biotechnologies and traditional medicines, which could play a more significant role in this regard. It is a well-known fact that natural products have been sources of leads to synthetically produced molecules that are developed as allopathic medicines. Some natural products however seem to be more efficacious in their native state, the reason often being the stability of the molecule.
Research and development of natural products is absolutely critical. This will not only lead to possibilities of innovation but also lead to understanding issues around the efficacy of these medicines. The study of the physiological and molecular effects of natural products with immune modulating properties could provide clues as to the basis of immune protection in HIV and AIDS for example, thus assisting in HIV vaccine development.
The same strategy has been used with a cancer drug (Paclitaxel) that led to the screening of other drugs with a similar mechanism of action. Another example is the antimalarial drug artemisinin that is derived from the herb Artemisia annua used to treat malaria for ages in China. Artemisinin’s methyl ether derivative, artemether in combination with another molecule (lumefantrine) is the drug of choice for chloroquine - resistant malaria. Organ transplantation was transformed by the introduction of immunosuppressant drugs of natural origin e.g. cyclosporin A, sirolimus (rapamycin), tacrolimus etc.
Finally, I hope that local production will not only focus on domestic use but also look at the possibility of exports. This could have a positive impact on poverty alleviation. I hope that in the context of implementing the Africa Health Strategy your committee will come out with recommendations on how the local production could be pursued in the continent in and equitable, cost effective and sustainable way. Your recommendations will help the Ministers of Health in Africa to decide on which steps to consider before embarking on local manufacturing.
I wish you very robust and fruitful deliberations.
Vuka uzenzele!