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Joint Statement of University of Nairobi, Medical Research Council and IAVI

October 20, 2000

NAIROBI, Kenya, 20 October 2000—The University of Nairobi, the Medical Research Council (MRC) of the UK and the International AIDS Vaccine Initiative (IAVI) reaffirm their commitment to jointly continue their work on AIDS vaccine development.

We have just concluded two days of fruitful discussion and are in full agreement about the need to move forward as expeditiously as possible with the initiation of Phase I linical trial in Kenya. We come before you as a united team: three not-for-profit institutions dedicated to improving world health and the welfare of humankind. We are and always have been equal partners in this endeavor. Our partnership is based on mutual respect and our recognition of our different strengths as institutions.

At the outset, it is important to recognize that this partnership has made extraordinary progress in the short time since it was created in November of 1998 and now serves as a model for other international AIDS vaccine development partnerships. In less than two years, both components of the innovative immunization regimen have been manufactured, undergone toxicology testing, and been put into vials; both components have been approved for use in clinical trials in the U.K; and a clinical trial of the subtype A DNA vaccine candidate has been initiated in Oxford. In addition, significant preparations have been made for the launch of clinical trials in Kenya, for which we await regulatory approvals.

The project's rapid scientific progress has highlighted shortfalls in the current Memorandum of Understanding between the University of Nairobi and the Medical Research Council.

Therefore, the three partners have agreed to revise the Memorandum, and to include the International AIDS Vaccine Initiative as a signatory. The revised Memorandum will address a number of key issues not addressed in the current Memorandum. These issues include intellectual property rights and the benefits that will accrue to Kenya, and to individuals who have participated in this research, should this endeavor yield a successful vaccine.

The revised Memorandum will continue to be guided by a principle we all share, that is, that scientific credit for work conducted by members of the partnership be apportioned fairly and equitably.

In that spirit, we state today that the rationale for the vaccine approach the partnership is pursuing brings together about 25 years of basic immunology research, and 17 years of HIV research data generated among cohorts that include exposed but uninfected individuals. We further state that recent advances in molecular biology facilitated the creation of the vaccine constructs and that animal models were employed for pre-clinical testing.

It is important to note that credit for scientific advances is principally determined through scientific publications, and in this arena the Kenyan group has distinguished itself. The Kenyan scientists in this partnership enjoy a strong international reputation through the publication of more than 200 articles in leading scientific journals.

There has been considerable discussion in the media in recent days about a patent in filed in December, 1999, by the Medical Research Council of the U.K. Patent law and intellectual property rights are highly technical subjects. Therefore, the three partners have agreed to establish a technical task force consisting of patent and intellectual property experts. Members will be drawn from the three institutions. The task force will establish mechanisms to address current and future patent and intellectual property issues.

The task force will be guided by the principle of fairness, the need to equitably apportion credit and any revenues that may accrue from this project, and international patent law. The task force will also be guided by the principle that any successful vaccine that results from this collaboration should be affordable and accessible to all who need it around the world.

Without prejudging the deliberations of the task force, it is important to note that this patent was filed in good faith to protect the candidate DNA vaccine from unauthorized third-party exploitation. The patent will help enable the partners to fulfill our commitment and moral obligation to make a successful vaccine available at minimal cost in developing countries, where more than 95% of new HIV infections occur.

We expect that there will be a number of improvements to the vaccine concept as a result of the ongoing work, and that all parties involved in that work will be recognized appropriately in any new patents. It is the intention of the partners to share any revenues generated by current and future patents.

But it is important to stress that this partnership is about ending the worst public health crisis in the history of humankind, not money. More than 500 Kenyans are infected with HIV every day, and more than 15,000 people are infected every day around the world. It is time to get back to the science and to deliver on our vision of a world without AIDS.