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Project to Develop Guidelines for Health Research in Africa Launched

Monday, March 24, 2008

The “Clinical Trials Roundtable” attracted more than 70 participants during the “Science with Africa” conference organized by the United Nations Economic Commission for Africa and the African Union, which is an international organization that promotes cooperation among the independent nations of Africa. The conference was held in Addis Ababa, Ethiopia, and attended by more than 600 representatives, including representatives from health and science ministries, universities, non-governmental organizations and international organizations from Africa, Europe and North America.

Two representatives from industry were also in attendance—Dr. Richard C. Hubbard, senior director, External Medical Affairs, International, Office of the Chief Medical Officer, Pfizer, and a representative from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents the global research-based pharmaceutical industry.

Much of the Clinical Trials Roundtable, chaired by Mrs. Avril Doyle, member of European Parliament, focused on identifying the needs of African countries for guidelines in clinical trials and other areas of health research. It also provided an opportunity for leading African and international partners to develop a consensus position on the organization of the project to develop guidelines for health research in Africa.

Francis Crawley, executive director of Brussels, Belgium-based Good Clinical Practice (GCP) Alliance, which he founded in 2005, was approached by organizers of “Science with Africa” in October to participate. Crawley has extensive experience in creating GCP guidelines and model bioethics laws in Eastern European, Asian and African countries. He was also asked to speak briefly at a meeting in the European Parliament in December and subsequently to write an abstract for the roundtable.

More than 70 attended the Clinical Trials Roundtable, which ran for four hours. About 80% of participants were from Africa and the rest were from Europe, the U.S. and Canada, according to Crawley. The industry representatives also participated. At a pre-meeting to the roundtable, African participants made it clear that, despite the existence of many international guidelines, Africa needed its own.

Crawley said, “They need to feel a sense of ownership. They want a sense that these are guidelines that we did for ourselves and also that these are guidelines that are appropriate to the African situation.”

But Crawley stressed that the project to develop guidelines for health research in Africa cannot be counted as a success unless the guidelines are implemented.

“The real thing that we need to accomplish is to have these guidelines implemented into national policy so that we have regulatory agencies in Africa that have standards for health research and that these standards are also in line with healthcare and public objectives.”

Crawley alluded to the importance of getting big pharma to the table when it comes to the topic of guidelines for health research in Africa.

“We want the pharmaceutical industry to be at the table here, to be saying, ‘These are the kinds of considerations we have with our clinical trials. This is what is important and what we need. This is what we expect from guidelines. These are the kinds of situations where we felt uncomfortable in the past with regard to human subject protections and these are the areas where we would like to see more developed. We need to have the pharmaceutical industry there in a really committed way because Africa—with the somewhat exception of South Africa—really lacks an industry presence and it needs that. We have seen the difference that this makes in places like India, Singapore, Korea, Thailand and China. And Africa needs to be there too.”

The project has two secretariats, the Cameroon Bioethics Society in Africa and the GCP Alliance in Europe, to support and develop management for it. A team of African and international collaborators is being built and from within that team a steering committee will be formed, followed by working parties for individual guidelines or model laws to be drafted. The plan is to develop and implement the following guidelines: Good Clinical Practice Guidelines; Pediatric Research Guidelines; Genetics, Tissues, and Data Guidance; Intellectual Property and Sharing Health Resources; and Guidance on Ethics in African Health Research. The group plans to create a database of existing guidelines in Africa as a resource.

Crawley plans to have drafts of guidelines and model laws to discuss with the ethicists, health experts, scientists, policymakers and politicians who will attend the 1st Pan-African Bioethics Congress to be held May 28-30 in Yaoundé, Cameroon.

He said, “I think we should get where we’re going. I’m fairly confident at the moment, but it’s a long, long road. We’re near the beginning.”

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