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Medicines Patent Pool Gets Big Wins in Accessing Breakthrough COVID-19 Drugs for the Third World

November 17, 2021

By Noel Courage 

We have previously written about the benefits of licensing as a way to get the drug remdesivir quickly deployed during the COVID-19 pandemic. The drug maker, Gilead, signed many licensing agreements to enable generic manufacturers to make the product widely accessible. As it turns out, the drug’s uptake for use against covid has been limited due to a narrow window of efficacy (hospitalized patients) and prohibitive cost. The benefits of remdesivir remained uncertain.

Pfizer is now preparing to come onstream with a drug that shows much more promise and broad applicability in treating COVID-19 and preventing hospitalization and death. The drug PF-07321332, is administered in combination with a low dose of ritonavir, which is a repurposed HIV antiviral drug. The Pfizer drug is still in clinical trials, so these results are still considered preliminary until regulators confirm that it is safe and effective enough for emergency use approval (expected in the USA first). 

Pfizer has just signed on with the UN-supported Medicines Patent Pool (MPP) to grant non-exclusive sublicenses for the new drug to certain generic manufacturers. This step was done voluntarily by Pfizer.  It follows on the heels of a similar deal back in October 2021, between Merck and MPP, which entails the licensing of Merck’s COVID-19 antiviral drug, molnupiravir (see the licence here). The Pfizer-MPP deal will make the drug available in 95 countries, covering 53% of the world’s population.  Using the Medicines Patent Pool makes sense for Pfizer and Merck, since it will allow regional generic drug manufacturers to apply for a licence to produce the drug as soon as it is approved. These regional drug manufacturers may also have better distribution channels in some countries than Pfizer and Merck, making the drugs more accessible to patients. 

The Medicines Patent Pool has had access to other COVID-19 drugs for sublicensing, none of which had the potential up-side of the Pfizer and Merck drugs. Often, innovative drug manufacturers are hesitant to grant rights to a patent pool due to the risk of gray marketing (also called parallel imports). This means that the drugs will be redirected from the intended permitted markets for sale into unlicensed world markets, undercutting the innovative company’s sales and profit. The terms of the sublicence prohibit sale other than in the intended country, but a contractual condition is not enough to stop violation of the licence terms where there is money at stake.  The urgency of the pandemic, and the public relations heat that Pfizer took after vaccine shortages, were likely key factors leading to Pfizer’s decision to accept this gray marketing risk. 

Pfizer and Merck will not be taking royalties back from drug sales for as long as COVID-19 is classified as a Public Health Emergency of International Concern by the World Health Organization. This is a great step for ensuring access to medicine, and hopefully a trend that can be continued in case of future epidemics.

 

 

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Author(s):

Noel Courage Noel Courage
B.Sc. (Biochem.), LL.B.
Partner
416.957.1655  email Noel Courage