Solving the vaccine affordability problem

We've discussed the problem of an affordable vaccine for the developing world several times (here, here, here). We advocate ten to a dozen regional international vaccine institutes to make influenza vaccine at cost, license and patent free. Another suggestion has come from Dr. Carl Nathan from Cornell Medical College in a Commentary published in Nature Medicine and summarized at the Cornell news site:

Weill Cornell Medical College scientist Dr. Carl Nathan has issued a bold call for reforming the pharmaceutical development and patent systems in order to increase the number of vaccines and drugs available to combat neglected diseases that are ravaging the world's poor.

Dr. Nathan, in a commentary published in the March issue of the scientific journal Nature Medicine, proposes a two-pronged reform: first, to create "open access drug companies," where researchers can collaborate on developing drugs based on need rather than profit; and second, to establish an additional patent track that rewards innovation in proportion to its impact on global health.

"Industry has little financial incentive to develop products for diseases that mainly afflict the poor, and the poor cannot afford products that industry develops for wealthier customers," Dr. Nathan notes. "A fundamental solution to these problems requires aligning three basic processes ? innovation, incentive and access -- so that they become mutually reinforcing." (News release)

His idea is to establish fee-for-service divisions within existing drug companies, funded by users and government. These divisions would be venues of collaboration between industry and academic scientists, presumably as a way to meld the special expertise of each.

Dr. Nathan's proposed reform would also allow open access to new chemical libraries to be assembled at one or more pharmaceutical companies, designed for their particular promise for solutions to infectious disease. These libraries would feature natural products from under-explored sources, such as marine actinomycetes, plants and uncultured organisms from which operons are cloned for expression in recombinant bacteria. The libraries would also include privately held compounds donated to promote discovery of new uses.

Those using the libraries could patent their own novel derivatives of the compounds in the screening collection, but not the open source compounds themselves. Dr. Nathan points to a current example in which Pfizer is sharing 12,000 compounds with scientists affiliated with the WHO's Special Program for Research and Training in Tropical Diseases (TDR).

In addition, Nathan suggests a new type of patent, rewarding those who address the most serious diseases affecting the most people. The idea seems to be that instead of using a patent as a monopoly device to sell to those most able to afford a drug at far above research, development and production costs, this would spur innovation to develop drugs for the neediest.

I am not optimistic this is the solution, however. There is nothing to prevent an enterprising company from doing just what Dr. Nathan wants them to do. The reason Big Pharma isn't doing it is fairly simple. It's not that it isn't profitable. It's that it isn't obscenely profitable. It isn't a patent issue, specifically. Big Pharma responds to the market but the market doesn't work for this problem and we shouldn't either try to make it work by distorting it or believing we can make it work when we can't. The solution is to go outside the market and establish vaccine research, development and production as an essential service, like surveillance or other key public health services.

Meanwhile I'm glad this is being talked about more widely and new ideas put forth, especially ideas that suggest reforming disgraceful intellectual property laws that reward the greediest and inhibit innovation. Too bad it didn't happen earlier and is happening too slowly now. But we'll take what we can get and hope it isn't too late.

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There certainly are advantages to including the pharmaceutical companies' infrastructure in all of theis. OTOH, the best thing might be to set-up a non-profit to do the work, funded by major donors. PhARMA could get tax write-offs for contributing. There are successful examples of this (e.g., the original March of Dimes). This would need to be on a big scale, otherwise, the entity might wind up spending valuable resources advocating for more corporate welfare for PhARMA which is what has happened with IAVI, the HIV vaccine non-profit.

I like the idea to reward useful research by international
organizations while the products are patent-free then.
I suggested that earlier for computer-software.

What's "obscenely" profitable ?
If it's non-obscenely profitable, why not quickly
make your own pharma-company and benefit ?
Even 3rd world could do it.

Good topic. Forgive if my understanding is naive, however I suspect that doctors are too immersed in medical ethics to consider the following solution.

The huge cost in discovering & bringing a new drug to market (hundreds of $millions as I understand it) is the process of certifying a drug as safe & efficacious. That process ostensibly protects big pharma from lawsuits, and also gives big pharma a virtual monopoly on new drugs.

Meanwhile people are at risk of dying. They are desperate for anything that might work.

The issue breaks into two parts. (1)Finding new drugs that are not harmful below a known dosage. (2)Finding a use for those drugs.

Why is it not a workable solution to provide on a central registry a graduated scale of the safe dosages of different drugs? e.g. "There is a 99% probability that in dosages of less than x mg/Kg this drug will not permanently harm people". It then becomes a separate process by other medical scientists to establish a use for the drug.

Desperate patients would be prepared to take risky drugs. Those less desperate (headache cure?) would take less risky drugs. Having signed off on the known risk level, a patient's lawsuit would likely fail.

Revere: could you please edit the funny symbols above to be quote (") marks? My editor is not 100% compatible with yours :(.

Why not retrieve all the vaccine that is discarded at 28 days after opening in spite of the manufacturer and CDC saying it is good until the manufacturer's expiration date. USP made the rule and JCAHO is enforcing it. I can very easily see a very small DoD clinic somewhere in the middle of no where discarding 9 doses of the HPV vaccine because only one woman came in that month for a shot.