by Michael Lytton
Bill Gates is a man people love to hate. His persistent critics include competitors who have been left in the dust, government antitrust authorities seeking to change Microsoft's business practices, and high-end clothing stores bemoaning his lifetime aversion to appropriate attire. Mr. Gates is, unfortunately, an easy target.
Hence the combination of disinterest and skepticism that greeted his announcement that the Bill & Melinda Gates Foundation would add $6 billion to its $11 billion fund for global health care. This lack of attention to Gates' initiative is personally unfair and ignorant from a public health care standpoint.
The focus of the foundation is to broaden access significantly to provide greater amounts and types of vaccines in developing countries. The foundation will purchase large quantities of vaccines from for-profit vaccine companies, as well as funding their research and development activities to discover new vaccines.
The plan is to eliminate significant business risks that have discouraged manufacturers from developing vaccines with a principal application for diseases in developing countries, as well as to encourage the vaccine companies to make these products available at lower prices in developing countries.
An interesting analogy can be drawn between vaccines and software. Both require large initial investments in development costs, but they are then relatively inexpensive to make in high volumes.
In the past, the high upfront cost of developing new vaccines has discouraged U.S. and other manufacturers from making vaccines for diseases useful to limited markets (that is, mainly in developing countries). The markets are usually too small or the potential customers may lack the funds to pay.
There are also significant disincentives for a company to market an existing vaccine in developing countries, due to the higher costs of distributing the vaccine (relative to developed countries), combined with the inability to price the vaccine at the level charged in developed countries. Historically, it has taken 15 or more years from the time a vaccine is first available in the United States before it becomes available to persons in developing countries.
The $17 billion Gates pledged makes his foundation one of the largest medical charities in the world. Gates' efforts are not a solitary escapade; for example, the foundation's funds will be made available through the United Nations Children's Fund (UNICEF). In addition, the Gates Foundation is one of the conveners of the newly formed Global Alliance for Vaccines, which includes (in addition to UNICEF) the World Bank, representatives of the vaccine industry, and public health organizations in multiple countries.
Depressing industry statistics underscore the importance of this effort. The cost of developing a vaccine averages about $250 million. Vaccine companies typically expect a market size of at least $500 million after successful launch of a new vaccine. In contrast, many diseases prevalent in developing countries constitute far less lucrative commercial opportunities.
Diseases such as cholera, malaria, tuberculosis, and AIDS will be at the top of the list of diseases which will be targeted. Of course, AIDS is a major problem in the United States, but 95 percent of the world's HIV carriers reside in developing countries.
Ironically, this historic lack of interest in diseases afflicting developing countries (until Gates' recent arrival on the scene) is accompanied by a recent, unrelated development: Controversial proposals were put forward last week to change the Helsinki Declaration, which lays down ethical procedures for clinical trials.
The changes are aimed at the growing practice of testing new drugs in developing countries. Promoting the interests of pharmaceutical economics, the proposed changes (applicable principally to developing countries) would weaken the requirement of obtaining informed consent from a person participating in a clinical trial, expand the use of placebos in clinical trials (even where there may be a better alternative available outside the developing country), and, most importantly, limit access to alternative treatments for clinical trial participants in developing countries to the best treatment available locally, rather than the best practices worldwide (the former standard).
So, clinical trials are likely to increase significantly in developing countries, putting participants at much greater risk without - absent Gates - offering the benefit of ultimate access to a new therapy. We may begin to have a double standard of care in clinical research, with the rights of the patient being subordinated to considerations of cost, convenience and efficiency in developing countries.
Fortunately, this amendment to the Helsinki Declaration is only proposed and it has attracted a great deal of controversy.
Gates' foundation and its new approach to vaccine development are timely. While it may be ap
Reprinted with permission. All rights reserved. Mass High Tech 1999.
The content of this article is general in nature and is not intended as legal advice related to individual situations. Counsel should be consulted for specific legal planning and advice.