Delivering good, affordable drugs to those in need

Prof. Umberto D’Alessandro (5th from the left), Prof. Bruno Gryseels (2nd from the right) and their team
2009
Prof. Bruno Gryseels & Prof. Umberto D’Alessandro, ITM, Belgium

Established in 1906, the Institute of Tropical Medicine (ITM), Antwerp, Belgium, provides postgraduate training for medical doctors and paramedics – a number of whom are headed for central Africa. ITM carries out a range of research on a number of tropical diseases. In terms of bibliometric impact, ITM ranks among the top-15 academic institutes in Europe.

 

1. Where do the challenges for clinical research in antimalarials lie in the context of sponsorship, multi-country trials and capacity building?

One of the main hurdles to running clinical trials in Africa lies in the absence of “legal sponsorship”, which is essential for correct scientific conduct, especially in multi-country trials. Few scientific institutes or NGOs, aside from MMV, are capable or willing to take on the responsibilities of legal sponsorship and provide oversight to clinical trials. In the absence of African regulations, trials are conducted according to European or American standards. Organizations such as the European & Developing Countries Clinical Trials Partnership (EDCTP) and MMV impose GCP guidelines and sponsorship to international standards.

2. How do you think we can overcome these challenges?

The ultimate solution is for African countries to establish competent and reliable regulatory agencies, not only for drug registration but also for clinical trials. Drug approval by a national regulatory agency to strict legal standards, is critical. As a first step, several countries are making good progress by creating formal ethical committees, but this is not enough. Such agencies need to link up on a regional or continental basis to ensure harmonization and coordination of multi-country trials. Finally all parties need to be more aware and proactive regarding these issues.

Patients cannot wait, however, until these institutions have been established for new drugs. In the interim, we strongly plead for a set of clinical trial guidelines established by African investigators and institutions. All foreign clinical investigators, institutions and agencies should obviously follow these guidelines or, if unavailable, the standards applied in their own country.

3. How could you work with MMV to achieve the goals of malarial elimination and eradication?

Collaboration between MMV and ITM must and will continue to focus on the development and trial of new antimalarials. We are very pleased that MMV is also engaging in the field of delivery and access. Licensing new drugs is of little help if people cannot find affordable quality care in their neighbourhood, or are at the mercy of the unregulated free market, flooded with counterfeit and sub-standard drugs.

Working towards elimination or eradication is a worthy goal, but our immediate priority remains to deliver good, affordable drugs and prevention tools where needed, in a timely manner. At this time the socio-economic or political conditions to go beyond control simply do not exist in the countries that are hardest hit. Funding aside, malaria control and elimination is mainly a matter of political will, good governance and relatively strong health systems, as demonstrated by Morocco and Thailand. Eradication on the other hand, must be tackled on a country-by-country basis, via a multi-pronged approach adapted to local epidemiology and resources.

While the international community has an important role to play with financial, political and scientific support, national experts and leaders know best how to fulfil the objective of elimination and when to switch emphasis from morbidity to transmission control.

4. Besides funding, how have you and your team benefited from working with MMV as a partner?

MMV has been a highly competent partner in pre-clinical and clinical drug development, in which academic institutions, such as ITM, usually cannot venture. MMV has also been of enormous help in the development of our own capacities and most of all the support of our partners in Africa. In our sometimes bitter fight against “poor drugs for poor people”, many of which originate from Europe, MMV has been firmly at our side with expert advice and moral support. In short, MMV is a true institutional friend.


Prof. Bruno Gryseels has been the Director of ITM since 1995. He has worked in Africa for many years and served as an advisor to several international scientific committees and organizations, and national schistosomiasis control programmes. Bruno is a strong advocate of the universal right to comprehensive health care and the integration of disease control into health systems.

Prof. Umberto D’Alessandro has been involved in malaria research since 1990 and is ITM’s main malaria trialist. Umberto has worked for many years in Africa, initially as a clinician. His current field of research is the epidemiology and control of malaria. He and his ITM team have worked closely with MMV on clinical trials for DHA-Piperaquine.