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.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”