Droves of House De­moc­rats in Wash­ing­ton and mem­bers of the Eu­ro­pean Par­lia­ment have now glommed on­to a ma­jor push by In­dia and South Africa at the WTO to abol­ish all IP around Covid-19 vac­cines.

At first blush, waiv­ing this IP sounds like an easy win: More Covid-19 vac­cines made lo­cal­ly for more peo­ple means more lives saved. Sim­ple enough, es­pe­cial­ly as low-in­come coun­tries have re­ceived just a tiny frac­tion of the world’s vac­cine al­lot­ment so far.

But when you be­gin to con­sid­er how this is sup­posed to play out in the re­al world, how the tech trans­fer will take time and en­er­gy and en­gage­ment from the very com­pa­nies that would lose their IP, how the le­gal chal­lenges and lo­gis­tics will com­pli­cate every­thing fur­ther, and how the man­u­fac­tur­ing site num­bers don’t re­al­ly make sense, it’s easy to won­der why there’s such a big push for this.

Take, for in­stance, Mod­er­na. Back in Oc­to­ber 2020, Mod­er­na an­nounced that it would not en­force its Covid-19 re­lat­ed patents against those mak­ing vac­cines in­tend­ed to com­bat the pan­dem­ic, even say­ing it would li­cense its IP.

Tahir Amin

Sounds great, but no one has come call­ing.

Some have not­ed that Mod­er­na doesn’t own every patent used in its vac­cine. Tahir Amin, an IP lawyer at the fore­front of push­ing for the waiv­er, al­so has ex­plained at length how man­u­fac­tur­ers need more than just the patents, say­ing oth­er vac­cine man­u­fac­tur­ers could scale up in about 6 to 8 months.

But where? What oth­er man­u­fac­tur­ers? Even Pfiz­er and Mod­era took longer than 6 to 8 months to re­al­ly ramp up.

The pub­li­ca­tion The In­ter­cept pro­posed to an­swer that ques­tion re­cent­ly in an ar­ti­cle ti­tled, “Fac­to­ry Own­ers Around the World Stand Ready to Man­u­fac­ture Covid-19 Vac­cines.” But the on­ly ex­am­ple pro­vid­ed is On­tario-based Bi­ol­yse Phar­ma, which said it can make 20 mil­lion vac­cines per year, and an­oth­er fill-fin­ish fa­cil­i­ty in Bangladesh that says it has ca­pac­i­ty.

So we’re go­ing to dis­rupt Pfiz­er and Mod­er­na, which to­geth­er are pro­duc­ing al­most 10 bil­lion dos­es of Covid-19 vac­cines over the next two years in fa­cil­i­ties that have been cleared by the top reg­u­la­tors in the world, so Bi­ol­yse can make 20 mil­lion dos­es in a year?

Even if there are hun­dreds of oth­er man­u­fac­tur­ing sites like Bi­ol­yse (which, by the way, was shut down by Health Cana­da in 2014) around the world, who’s go­ing to man­date the tech trans­fer, and who’s go­ing to en­sure the sites are built and per­form­ing prop­er­ly?

The US FDA isn’t cur­rent­ly con­duct­ing on­site for­eign in­spec­tions, and many low-in­come coun­tries don’t even have drug reg­u­la­tors. Cut­ting cor­ners on vac­cine man­u­fac­tur­ing can lead to se­ri­ous health is­sues, as we’ve seen with con­trac­tor Emer­gent’s site in Bal­ti­more, which is es­pe­cial­ly im­por­tant as these vac­cines are go­ing to healthy peo­ple.

Pres­i­dent Biden said Tues­day af­ter­noon that by Ju­ly 4, the US will do­nate 10% of its Covid-19 vac­cine stock­pile to the rest of the world. And ear­li­er this week, Mod­er­na pledged 500 mil­lion dos­es for low-in­come coun­tries. Biden’s chief med­ical ad­vis­er Tony Fau­ci told the Fi­nan­cial Times this week that while he’s ag­nos­tic on the waiv­er, he warned it could back­fire in­to a long le­gal bat­tle.

Right now, the cam­paign­ing for the IP waiv­er in the US seems to be a lot more about bash­ing Big Phar­ma than try­ing to ac­tu­al­ly in­crease vac­cine dos­es for the need­i­est. A long le­gal bat­tle with com­pa­nies like Pfiz­er and Mod­er­na isn’t go­ing to help bring the world more Covid-19 vac­cine dos­es.

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

So here’s how Blackstone is spending its $4.6 billion biopharma pot.

The private equity firm announced Tuesday they were teaming with the CRISPR biotech Intellia and the little-known German CAR-T startup GEMoaB to launch a new — and so far unnamed — CAR-T company. Blackstone, the sole investor, will pour $250 million into the joint venture and take a third ownership. Intellia and Cellex, GEMoaB’s parent company, will each take another third.

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.