Patents and Vaccines and Ethics

In my last post I reviewed A Patent Lie by Paul Goldstein. The book is a legal thriller involving a court case over the alleged infringement of a patent for an AIDS vaccine.

Within the book was a discussion about the cost that such should be paid for treatments of a vaccine. Hundreds of millions of dollars are spent in the research and testing of the vaccine.

Drug companies could simply work out a worldwide price recouping their costs and make a profit. However, the ability to pay of patients needing the treatment varies immensely by country. Within the book there is debate on how much to charge for the product in wealthy America versus how much to charge in poor southern Africa.

Proposals involved charges of hundreds of dollars for American AIDS patients against $45 in Africa. It was recognized that even $45 is beyond the reach of many Africans.

These 21^st Century issues over this AIDS vaccine product reminded me of issues raised in the hearings of the Canadian Royal Commission of Inquiry into the Canadian Blood System during the 1990’s.

The Commission was investigating how and why Canadian hemophiliacs and blood transfused were infected with AIDS and Hepatitis C from tainted blood during the 1980’s. I represented a group of hemophiliacs who did not want representation by the Canadian Hemophilia Society.

There was information on efforts to develop an AIDS vaccine. A difficult issue involved clinical trials. While there was no product being tested at the time there was a challenging ethical question.

Was there a way to ethically run trials in which only half of the people received the vaccine? You would be putting the other half of the cohort at a risk for being infected with AIDS which had no treatment until the mid-1990’s. At the same time, if the potential vaccine, were effective potentially millions around the world were being denied a product that could prevent them from being infected with AIDS.

It was doubtful an appropriate protocol could be drafted for North America. There was discussion on whether trials could be conducted in Third World countries where having the chance of being in the group getting the vaccine was better than any other they would have to avoid infection. Should a protocol be undertaken in a Third World country that could not take place in North America?

A more current discussion can be found on the vaccineethics.org website at http://www.vaccineethics.org/issue_briefs/HIV_clinical_trials.php.

The premise of the book also brought to mind a situation that took place in litigation following the completion of the hearing of evidence in the Inquiry.

In the book Michael Seeley is called from Buffalo to San Francisco to take over as lead counsel this huge patent infringement case but 2 weeks before trial. I might have thought the scenario implausible but for what happened in judicial review proceedings involving the Inquiry.

Several parties to the Inquiry sought to have the Commissioner restrained in his ability to assess responsibility in his report. At the Federal Court Trial Division the application was denied. The decision was appealed to the Court of Appeal.

Approximately 2 weeks before the hearing of the appeal the lead counsel for the Commissioner fell sick and needed surgery. No one wanted an adjournment because of the time involved to re-schedule the appeal. Dozens of lawyers were involved.

A new lawyer stepped in on behalf of the Commissioner to argue the appeal. It was a tremendous challenge. He did his best.

I was one of several lawyers appearing for groups of victims at the appeal. We all had intervener status. All of us supported the Commissioner. We sought to assist the new lawyer by dividing the issues to be argued and adding specific submissions. The appeal was denied as I hoped.

Ultimately the Supreme Court of Canada decided the Commissioner could write his report unhindered. It can be found at http://epe.lac-bac.gc.ca/100/200/301/hcan-scan/commission_blood_final_rep-e/index.html. What happened in the Canadian blood system is a long and sad story.