HPV Vaccine for All, for Cheap

Each year nearly half a million women are diagnosed with cervical cancer, and more than 260,000 — most of whom live in the developing world — die of the disease. And while a new vaccine shows promise, the world’s poorest women likely won’t benefit. At $360, the three-shot vaccination that targets the human papillomavirus (HPV) — which is linked to the development of cancerous cervical lesions — is far beyond their means, says Kevin Outterson, a School of Law associate professor.

Outterson says he and colleague Aaron Kesselheim, a lawyer and instructor in medicine at the Harvard School of Public Health, have come up with a way to streamline licensing of such medical innovations to allow patented products to become more readily available in developing countries while allowing manufacturers to generate reasonable revenues from them. They have been researching models of vaccine costs and are proposing what they call a generic open license. Details of the proposal were published in the January/February edition of Health Affairs.

Outterson explains to BU Today how it would work.

BU Today: Why did you focus your research on HPV vaccines?
Outterson: More so than any other cancer, cervical cancer is a disease of the poor, and it bothered me that a vaccine for a disease of the poor was also the most expensive vaccine in history. Worldwide, 93 percent of mortality occurs in low- and middle-income countries, and some of the largest spots where this occurs are countries such as India, where there’s a huge population and a very poor system of routine cervical screening. The death rate in the United States is also largely clustered around people who have inadequate access to health care, and it is disproportionate among minority communities and people without health insurance. It’s a slow-growing cancer, and if you receive routine screening and treatment, you won’t die from it. The wealthy rarely die of cervical cancer.

What is the problem with the HPV vaccine?
It’s the most expensive vaccine in history. It costs $360 in Western Europe, the United States, and Australia, and that’s just the factory price. You have to pay more for the doctor to inject it. The average annual health spending averages in the entire rest of the world — the lower-income countries — is under $96 per person. So if you look at the models of vaccine costs, for most of the women who really need this, the vaccine needs to be free or nearly free — at most, 50 cents. Next year, 250,000 women will die of cervical cancer in developing countries, and the vaccines won’t save many lives unless they’re delivered to the poorest women at an affordable price.

What’s preventing the cost from coming down?
I’ve done a fair amount of related work in the area of AIDS. The only reason the price of the AIDS drugs went down so dramatically is, at that time, certain Indian pharmaceutical companies were not subject to patents, and they were able to produce these drugs generically and reduce the cost from $10,000 to $150 or less per patient per year. Since that happened, the World Trade Organization’s agreement on intellectual property has forced India and every country in the world to adopt U.S.-style patent laws. So that one-time success is unlikely to ever be replicated, particularly in new areas, unless we think of a better way to balance the issues of providing innovation and access to the drugs.

What is the solution?
Aaron Kesselheim and I have proposed something called a generic open license, where a patented drug or vaccine becomes automatically open to generic production by interested manufacturers for use exclusively in low- and middle-income countries. We can’t very well ask pharmaceutical companies such as Merck — a for-profit business — to donate these vaccines to two or three billion women. Merck has promised to donate a million courses, or three million shots, and that will treat one million women, but it leaves most women without treatment. So the idea of the generic open license is that Merck will make all of its money in the richer countries. Most people in the United States, Western Europe, Australia, and Japan can afford a $360 vaccine, and only 7 percent of the deaths occur there. It’s worked before. The annual dosage price for the AIDS drug was well over $10,000, and now it costs around $125 per year. This is a much more likely solution than some sort of structured donation program or government-enforced giveaway-type thing. After all, we have to give Merck and Glaxo-SmithKline a return on investment for what they’ve done.

Why do patents limit the distribution of vaccines?
A patent gives drug companies exclusive marketing rights — no one else can produce, sell, or market the vaccine without their permission. Also, the FDA won’t even approve the vaccine for use domestically without the approval of the patent holder. If someone did do it, the patent holder could sue. And that’s true in every country in the world.

When will the proposal become a reality?
That will depend on the drug companies. We haven’t asked the government to force the companies to do this. We’re hoping that the companies will understand that this proposal does not hurt them at all, that it’s a tremendous benefit to global health, and that it will be great publicity for them. It’s also what the scientists want. They don’t want the vaccine only going to middle-class women in the suburbs. They want it to go to the women who are dying of cervical cancer; they want to help prevent a generation of deaths. So, we’re hoping the companies will see that it’s in their own self-interest to be flexible in this way.

Vicky Waltz can be reached at vwaltz@bu.edu.