The Atlantic has a story out on delinkage, an alternative model for recovering R&D costs in drugs & devices. Delinkage relies on prizes and grants instead of patent-protected sales above marginal cost. For the definitive background on prize-based alternatives to intellectual property rights, see Jamie Love’s page.

For many goods and services, relying on patents and market prices might be a great outcome. For prescription drugs, however, the “market” rarely sets prices, at least in countries with government-funded reimbursement systems. Access is another salient issue. We might be fine with patents raising the price of an iPhone 5 to be beyond the reach of the lowest income quartile (for example), but that result seems unacceptable when the drug is lifesaving and is priced beyond the reach of several billion people. Differential pricing theoretically addresses some of these concerns, but has been very challenging in practice.

One delinkage proposal is the R&D Treat proposal floated at WHO during the last few years, coming from the CEWG process. The Atlantic article describes the strident opposition to the proposal from the Obama Administration, which seems surprising. Some major pharmaceutical companies (such as GSK) publicly support delinkage, while most do not.

Several other delinkage proposals were discussed in late February at an FDA conference at the Brookings Institute, all focused on antibiotics. As I’ve written with Aaron Kesselheim (in Health Affairs and the Yale JHPLE), antibiotics might be a particularly apt drug class to test the delinkage concept. One model (with Thomas Pogge & Aidan Hollis) is the antibiotic health impact fund, paying annual prizes to the patent holder over 10 years for the actual health impact of the drug around the world. For the first time, companies would have a financial incentive to get the drug to the sickest people able to benefit the most at an affordable price instead of overmarketing a precious exhaustible resource. Another model is the Strategic Antimicrobial Reserve, paying a company NOT to market a particularly valuable antibiotic, saving it for a time of greater need. A third might be to modify antibiotic reimbursement away from unit sales (which drive resistance) through payer-based models.

Prior TIE posts on antibiotics here.


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