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--:-- Sean Rameswaram: Support for Today Explained comes from Saks Fifth Avenue. Fall is here. Might be time to find some nice new pieces you can wear again and again.
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--:-- Sean Rameswaram: This product may contain up to 0.3% THC.
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--:-- Kieran Stacey: India today reported a world record in new coronavirus cases. The number was 414,188 new cases, probably an undercount.
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--:-- Kieran Stacey: And at the same time, vaccinations in India are down.
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--:-- Kieran Stacey: They're the world's biggest vaccine manufacturer, but there's a shortage of shots.
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--:-- Kieran Stacey: Just over 2% of the country is fully vaccinated.
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--:-- Kieran Stacey: On the other side of the world, COVID is surging in South America, Colombia, Peru, Argentina, and Brazil are all hitting record numbers of cases, and none of them have even 10% of their populations fully vaccinated.
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--:-- Kieran Stacey: All the while, in the United States, we're blowing past vaccination goals and breaking out the short shorts to head into a sort of maybe normal summer.
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--:-- Kieran Stacey: Which helps you understand why people have been clamoring for Western leaders to make their vaccines more accessible to the world.
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--:-- Kieran Stacey: And vaccine patents are seen as one of the biggest barriers.
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--:-- Kieran Stacey: So for months, countries, mostly low-income ones, have said, lift the patents and let the generic vaccines flow out of every pharmaceutical factory possible on the planet.
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--:-- Kieran Stacey: Which was why Biden's announcement this week was such a big deal.
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--:-- Kieran Stacey: The announcement is that the Biden administration has carried out what is essentially a 180 degree turn in U.S. policy, and it is now going to back a suggestion at the World Trade Organization that there should be a complete waiver for intellectual property rights on COVID vaccines.
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--:-- Kieran Stacey: So this means all these companies that have been working for the last year developing and manufacturing vaccines could be faced with not being able to prosecute anybody who tries to then make a cheap knockoff and sell it elsewhere in the world.
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--:-- Kieran Stacey: Now, intellectual property is absolutely vital for the pharmaceutical industry.
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--:-- Kieran Stacey: That's how they make their money.
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--:-- Kieran Stacey: They make sure that other people don't copy their ideas as soon as they generate them.
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--:-- Kieran Stacey: So this is a really big deal for some of the biggest pharma companies in the US and elsewhere.
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--:-- Kieran Stacey: Well, let's talk about how we got here, because I know this decision has been sort of bandied back and forth all week.
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--:-- Kieran Stacey: Where does this story begin?
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--:-- Kieran Stacey: Well, the story begins months ago.
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--:-- Kieran Stacey: South Africa and India are leading a movement to suspend the World Trade Organization's agreement on intellectual property rights for COVID-19 vaccines.
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--:-- Kieran Stacey: All kinds of COVID drugs, actually.
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--:-- Kieran Stacey: The original suggestion by the two countries was that it would apply to any kind of medicine used to treat or prevent COVID.
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--:-- Kieran Stacey: So a huge range of drugs were envisioned in that original proposal.
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--:-- Kieran Stacey: That was immediately opposed, as I think the two countries expected by most of the West, by countries that have large international drug makers.
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--:-- Kieran Stacey: Europe opposed it.
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--:-- Kieran Stacey: The US opposed it.
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--:-- Kieran Stacey: Plenty of other places did too.
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--:-- Kieran Stacey: They say waiving the patents would put off private investors and slow down scientific innovation.
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--:-- Kieran Stacey: Then on the campaign trail, Joe Biden, when asked about it, would say that he did support the suggestion that companies should waive their intellectual property rights, particularly to COVID vaccines.
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--:-- Kieran Stacey: Absolutely, positively.
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--:-- Kieran Stacey: This is the only humane thing in the world to do.
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--:-- Kieran Stacey: People didn't pay that much attention because there was so much else going on during that crazy campaign.
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--:-- Kieran Stacey: But when it became a policy issue in the last few months, there has been this week a World Trade Organization meeting, and people knew this was up for discussion.
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--:-- Kieran Stacey: For a while, it was assumed that the US would just stick to their previous position, which was, by the way, not only that they didn't support this suggestion, but they didn't even support discussion of it.
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--:-- Kieran Stacey: But it started to become clearer.
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--:-- Kieran Stacey: Catherine Tai, the US trade ambassador, was having a bunch of meetings with anybody she could think of, drug companies, lobbyists, also progressive activists, it was clear that she was thinking this over.
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--:-- Kieran Stacey: And so when it got to this week, when this meeting was due to take place, it seemed that we were at a crunch point.
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--:-- Kieran Stacey: Now, I actually thought on Monday, I spoke to Dr. Tony Fauci, who many of your listeners will know as the chief medical advisor.
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--:-- Kieran Stacey: Friend of the show.
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--:-- Kieran Stacey: Friend of the show. Friend of many shows.
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--:-- Kieran Stacey: That's what we love about Tony Fauci.
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--:-- Kieran Stacey: Wait, we're not special.
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--:-- Kieran Stacey: I'm so sorry.
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--:-- Kieran Stacey: I'm so sorry.
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--:-- Kieran Stacey: I'd love to say he was a friend of the FT, but it turns out he speaks to other people as well.
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--:-- Kieran Stacey: But he actually called me and he said, he laid out a bunch of reasons why this might not be such a great idea.
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--:-- Kieran Stacey: Principle of which was it could end up just getting involved in litigation and taking too long to get the vaccines where they're needed.
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--:-- Kieran Stacey: One of the complicating issues of the so-called waiving the patents is that by the time you then get set up to get the technology transferred to other countries to be able to do it, you may be going into the end of 2022, the beginning of 2023, at which point a lot of people will have died.
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--:-- Kieran Stacey: So I'm not against transferring technology and I'm agnostic about the TRIPS waiver.
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--:-- Kieran Stacey: Waiver.
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--:-- Kieran Stacey: So I put down the phone to Tony Fauci on Monday thinking, okay, the administration's probably going to stick with the status quo.
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--:-- Kieran Stacey: And then on Tuesday, there was a meeting in the White House.
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--:-- Kieran Stacey: Now, Tony Fauci wasn't at that meeting.
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--:-- Kieran Stacey: Catherine Tai, the trade ambassador, was the person who presented her materials to the president and a few of his foreign policy and domestic policy advisors and said that she did back companies being forced to waive their intellectual property rights as far as COVID vaccines go.
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--:-- Kieran Stacey: We're just finding out a little bit more about what happened during that meeting, but from what the White House has been telling me this week, the president always intended to stick to the promise that he made during the campaign to actually force the companies to give up their intellectual property rights on this absolutely vital piece of pharmaceutical genius.
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--:-- Kieran Stacey: Fauci was wrong.
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--:-- Kieran Stacey: Look what he told me was he was agnostic about whether or not to do it but then he gave me a bunch of reasons why it was a bad idea.
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--:-- Kieran Stacey: As far as I know, he still thinks those things.
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--:-- Kieran Stacey: He is, of course, not the only voice within the administration.
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--:-- Kieran Stacey: So I think what has happened is simply that the people arguing the other side of this have won out.
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--:-- Kieran Stacey: And one of the reasons that the other side of this has won out, by the way, is that it's going to take a long time for this to actually come to anything.
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--:-- Kieran Stacey: These negotiations have to happen over the next few months at the World Trade Organization, and every single country there has to sign up.
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--:-- Kieran Stacey: Now, as I'm speaking to you, we are Thursday lunchtime.
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--:-- Kieran Stacey: I have literally just seen an alert suggesting that Angela Merkel is refusing to back what's known as a TRIPS waiver, the intellectual property waiver.
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--:-- Kieran Stacey: Now, if she stays to that position, it's dead in the water.
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--:-- Kieran Stacey: It needs unanimous consent.
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--:-- Kieran Stacey: So the entire World Trade Organization, all the member nations need to sign on.
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--:-- Kieran Stacey: That's right.
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--:-- Kieran Stacey: Everybody needs to agree to this.
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--:-- Kieran Stacey: Now, the US changing its mind is a huge deal.
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--:-- Kieran Stacey: If the US does, its allies tend to do the same.
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--:-- Kieran Stacey: But Angela Merkel says this would be a problem for our domestic manufacturers.
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--:-- Kieran Stacey: And of course, they have BioNTech as a German company.
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--:-- Kieran Stacey: That is the company who developed the vaccine that Pfizer has been rolling out everywhere in the US.
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--:-- Kieran Stacey: So it might be that this ends up coming to nothing.
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--:-- Kieran Stacey: But what the Biden administration has done very cleverly, is look like a friend to the developing world, look like a friend to those countries that are really suffering from major COVID surges right now.
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--:-- Kieran Stacey: And I think that's one of the reasons that the arguments of the progressives who've been pushing for this within the White House, I think that's one of the reasons they won, is simply because they said to the skeptics, look, it's going to take some time.
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--:-- Kieran Stacey: We're going to have input into this.
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--:-- Kieran Stacey: We can make sure that the exact policy is tailored to what we want.
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--:-- Kieran Stacey: But it's not going to happen tomorrow.
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--:-- Kieran Stacey: Don't worry, this isn't going to suddenly undermine the U.S. vaccine rollout.
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--:-- Kieran Stacey: We can take our time over this and make sure we get it right.
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--:-- Sean Rameswaram: What are the pharmaceutical companies themselves saying?
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--:-- Sean Rameswaram: I know we can assume that Merkel is acting on their behalf, but have they come out and publicly said, no, we don't want to help the poorest countries in the world.
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--:-- Sean Rameswaram: We don't want our technology getting out there.
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--:-- Sean Rameswaram: Well, they have said that they oppose it.
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--:-- Sean Rameswaram: Absolutely, they've said they oppose it.
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--:-- Sean Rameswaram: Funnily enough, they don't couch it in terms of we don't want to help the poorest countries in the world.
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--:-- Sean Rameswaram: Weird.
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--:-- Sean Rameswaram: Funny that.
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--:-- Sean Rameswaram: What they say is two things, really.
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--:-- Sean Rameswaram: One, it doesn't make a difference.
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--:-- Sean Rameswaram: And actually on this, they have a point.
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--:-- Sean Rameswaram: They say that the major constraint to getting vaccines to the developing world is not intellectual property, especially because Moderna has already said that it will not pursue its intellectual property rights if somebody else chooses to make a cheaper version of their vaccine.
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--:-- Sean Rameswaram: They say the major problem with getting vaccines to other parts of the world is supplies.
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--:-- Sean Rameswaram: mRNA vaccines in particular, these are the vaccines made by Moderna and by Pfizer, are very difficult to make.
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--:-- Sean Rameswaram: And they're very new things.
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--:-- Sean Rameswaram: And we're just starting to build up the supply chains to them.
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--:-- Sean Rameswaram: So you need all kinds of specialist equipment and specialist supplies to be able to make them.
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--:-- Sean Rameswaram: And they say those supplies are in constraint.
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--:-- Sean Rameswaram: That's why we can't get as many vaccines as we want instantly.
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--:-- Sean Rameswaram: Simply allowing other companies to set up and try and make them is not going to help.
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--:-- Sean Rameswaram: We just need more supplies.
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--:-- Sean Rameswaram: So that's their number one argument.
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--:-- Sean Rameswaram: The number two argument is that intellectual property in general matters.
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--:-- Sean Rameswaram: It's their incentive to try and develop these immensely expensive, immensely risky drugs in the first place.
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--:-- Sean Rameswaram: And that has been true for almost every drug ever produced.
--:-- [Sound effects: gentle background chatter]
--:-- Sean Rameswaram: But on this occasion, actually, the government took a bunch of risk.
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--:-- Sean Rameswaram: The US government very early on pledged billions of dollars trying to get these vaccines off the ground and said to the vaccine manufacturers, we will buy these vaccines, we will pay you for these vaccines, even if they don't work, and even if we don't end up approving them.
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--:-- Sean Rameswaram: So there is an argument here where the US government can turn around and say, you haven't taken all the financial risk yourself on this one.
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--:-- Sean Rameswaram: We've put in a bunch of money, and we think it's right that this is how it should be used.
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--:-- Sean Rameswaram: President Biden's decision isn't going to change the world tomorrow, but it's a historic stance against big pharma.
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--:-- Sean Rameswaram: More in a minute on Today Explained.
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--:-- Sean Rameswaram: Nobody owns us or tells us what we can and can't say, so we're free to report the whole picture.
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--:-- Sean Rameswaram: We connect what's happening in Washington to the rest of the globe, expose corruption wherever we find it, and give fresh perspective on everything, from wellness and soccer to culture, the climate, and more.
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--:-- Sean Rameswaram: Read, watch, and listen to The Guardian for free at theguardian.com.
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--:-- Sean Rameswaram: All right, we're back.
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--:-- Sean Rameswaram: Biden made some big news this week when he came out in favor of waiving intellectual property protections for COVID-19 vaccines.
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--:-- Sean Rameswaram: That doesn't mean it's going to happen just yet, but it's a historic shift in thinking that's been the norm for decades.
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--:-- Sean Rameswaram: We asked medical ethicist Harriet Washington to take us back to when things got really cozy between the government and big pharma.
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--:-- Harriet Washington: I trace it to the year 1980.
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--:-- Harriet Washington: In that year, the Bay-Dole Act became law, and essentially it was sponsored by Bob Dole.
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--:-- Bob Dole: I'm Senator Bob Dole.
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--:-- Bob Dole: Some describe me as tough.
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--:-- Bob Dole: Well, I've known tough times, and I've made many tough decisions.
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--:-- Bob Dole: And that's what it takes to get the job done in Washington.
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--:-- Harriet Washington: The argument by industry was universities were generating all these new medications and all these potentially useful things but they were not being developed.
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--:-- Harriet Washington: They were laying fallow.
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--:-- Harriet Washington: No one was making them into medications.
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--:-- Harriet Washington: Industry said let us do that.
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--:-- Harriet Washington: It be better for the American people.
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--:-- Harriet Washington: We generate more and better drugs.
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--:-- Harriet Washington: It sounded like a good argument, and the law was passed.
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--:-- Harriet Washington: And ultimately, I think it has become a disaster.
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--:-- Harriet Washington: Because as a result of the law, the decision about which medications become developed and how much they cost has passed wholly into the hands of corporations.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: And they're guided by a fealty to the bottom line, not to the welfare of American patients.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: They're looking for drugs that will affect many, many, many people so they can sell many, many, many drugs, but they may not be the most important problems.
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--:-- Harriet Washington: I used to make love to my wife.
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--:-- Harriet Washington: Whenever we wanted.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: It was wonderful.
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--:-- Harriet Washington: So when I couldn't, I tried to avoid it.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: I tried to avoid it, but then I made a call.
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--:-- Harriet Washington: And now we're back.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: If you or your partner isn't living life to the fullest because of erectile difficulties, there's something you can do.
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--:-- Harriet Washington: Erectile dysfunction.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: We now have, what, many, many, many drugs for erectile dysfunction and only one new drug for malaria.
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--:-- Harriet Washington: Clearly, it's not the medical needs of people but the bottom line that is driving them.
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--:-- Harriet Washington: And, you know, the thing is, that's the role of industry.
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--:-- Harriet Washington: We're a capitalist society.
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--:-- Harriet Washington: We're here to make money.
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--:-- Harriet Washington: I don't indict industry as much as I indict the government because it's the government that is supposed to watch out for our welfare and our health.
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--:-- Harriet Washington: And I think the government should be reigning in industry more as it is now.
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--:-- Sean Rameswaram: And you're saying it was this Bayh-Dole Act that led to this set of circumstances we find ourselves in now, where this pharmaceutical drug culture in America is sort of driven by profit?
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--:-- Harriet Washington: Exactly.
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--:-- Harriet Washington: In transferring these molecules, these developments to industry, we gave industry the power to decide which ones would become drugs, which ones would not, which ones would be developed.
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--:-- Harriet Washington: And the industry began determining what new drugs would be needed.
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--:-- Harriet Washington: And when they made that determination, they based it upon what was going to make the most money for them and their stockholders.
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--:-- Harriet Washington: So now, in one sense of the word, it's industry that has control over the medical research agenda, and not incidentally, over medication pricing.
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--:-- Harriet Washington: The pricing issue is huge, and that's completely dependent on patents.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: If there were not patent protections for industry, they could not charge whatever they wanted for a drug.
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--:-- Harriet Washington: And it's no accident that the most expensive drugs are those for the most deadly, usually fatal diseases.
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--:-- Harriet Washington: Cancer drugs that cost a million dollars a year, for example.
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--:-- Harriet Washington: They're paying what people are able and willing to pay to stay alive.
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--:-- Harriet Washington: That's what they're charging.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: It's not really predicated on what the drug costs them to provide, which is what you often hear.
--:-- [Sound effects: gentle background chatter]
--:-- Harriet Washington: No, it's predicated on what people are able to pay.
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--:-- Harriet Washington: And that's why in the West, prices are very high.
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--:-- Harriet Washington: The patents allow the companies to not have any competition.
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--:-- Harriet Washington: And so where you have patents for drugs, these are monopolies.
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--:-- Harriet Washington: You have someone who can set the price without interference from the outside.
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--:-- Sean Rameswaram: You mentioned this passed in 1980, just before the HIV-AIDS crisis hit.
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--:-- Harriet Washington: How did this impact how accessible AIDS drugs were?
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--:-- Harriet Washington: It had an impact on how drugs were priced.
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--:-- Harriet Washington: In the early 1990s, AIDS drugs were not at all affordable.
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--:-- Harriet Washington: They cost $19,000, $20,000 a year, and not everybody could afford them.
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--:-- Harriet Washington: So you had people who were able to buy the drugs or had insurance that covered the drugs, and these were people who were medicated.
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--:-- Harriet Washington: Then you had people who couldn't afford them, who were not insured, and they simply didn't have access to the drugs, and they died.
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--:-- Harriet Washington: Now, the government did step in and create the ADAP program.
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--:-- Harriet Washington: Congress created ADAP in 1990 as part of the Ryan White program.
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--:-- Harriet Washington: Which was meant to provide monies for these drugs so people couldn't afford them.
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--:-- Harriet Washington: The ADAP has helped me to get the same drugs which would cost you an arm and a leg in most cases if you're not insured.
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--:-- Harriet Washington: But the program was administered by states in different ways and the country became like this crazy quilt of risk.
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--:-- Harriet Washington: If you lived in one state, ADAP would cover you, but in many states, ADAP ran out of money very quickly, leaving people with no way to pay for these drugs.
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--:-- Harriet Washington: And the drugs prices begin to come down, which is something that typically happens because the patents have a time limit.
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--:-- Harriet Washington: Right, though it takes decades.
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--:-- Harriet Washington: And this is surely having an impact on the rest of the world in the meantime?
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--:-- Harriet Washington: The patenting of drugs enabled by the Baydoll Act does indeed have an effect on the rest of the world and how it prices drugs.
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--:-- Harriet Washington: In the developing world, you have situations where the average income of people is so low, they simply cannot afford the drugs at Western prices.
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--:-- Harriet Washington: Well, one country that for a very long time supplied drugs to a good part of the developing world at low prices was India.
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--:-- Harriet Washington: This is what's known as the medicine market, a very visual reminder of India's status as world leader in low-cost drugs, made locally, sold all over the world.
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--:-- Harriet Washington: It did it for a long time.
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--:-- Harriet Washington: It did it very well.
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--:-- Harriet Washington: And it did it partly because the patent system in India is different.
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--:-- Harriet Washington: In India, patents were predicated on the manufacturing process.
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--:-- Harriet Washington: In the U.S., patents were predicated on the formulations.
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--:-- Harriet Washington: So under Indian law, they could take a drug, reverse engineer it, and produce it and then sell it at cost if they wanted, or sell it at a low enough price that they would still make a profit, but not the huge profits of the pharmaceutical companies.
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--:-- Harriet Washington: Here they produce exact copies of branded medication with the same standards as those in the West, but at a fraction of the cost.
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--:-- Harriet Washington: Different types of anti-calcine drugs are being manufactured and marketed in the domestic market as well as some of the export market.
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--:-- Harriet Washington: So India did a very good job until the World Trade Organization.
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--:-- Harriet Washington: The members got together and decided to put an end to it.
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--:-- Harriet Washington: They decided to enact what they call a TRIPS Trade-Related Intellectual Property Act, which suddenly forced India and all other developing countries to adhere to Western patent laws.
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--:-- Harriet Washington: Slogans that have been perfected in recent months among the protesters' patients who owe their lives to generic medication calling on pharmaceutical giant Novartis to drop its case against the Indian government.
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--:-- Harriet Washington: So they bullied India into adhering to the Western way?
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--:-- Harriet Washington: Right.
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--:-- Harriet Washington: India was a chief way that people in these countries got their drugs.
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--:-- Harriet Washington: Sipla is one of the most important Indian manufacturers of generics to treat HIV AIDS.
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--:-- Harriet Washington: It is now producing second generation HIV AIDS drugs which are mostly sold abroad.
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--:-- Harriet Washington: Other companies were able to bypass the law or even as they did in Thailand and Brazil and Nigeria they were able to use a loophole in patent law to force the companies to surrender their patents and give it to a company that would promise to divide the drug at low price.
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--:-- Harriet Washington: And so, but when they did that, the U.S. was one of the prime actors stepping up to say, it's intellectual property theft.
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--:-- Harriet Washington: You can't do that.
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--:-- Harriet Washington: It wasn't legally wrong, but the U.S. was opposed to it.
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--:-- Harriet Washington: So there are other ways of getting around law, but they were quashed by this World Trade Organization, TRIPS Law, that said that now all these companies had to adhere, had to recognize and honor Western patents.
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--:-- Harriet Washington: What was the result of that?
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--:-- Harriet Washington: I mean, did that mean that poor countries couldn't supply their people with the drugs they needed?
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--:-- Harriet Washington: Yes.
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--:-- Harriet Washington: And it meant that India could not provide their own cheaper versions of the drugs.
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--:-- Harriet Washington: But there was a lot of furor over that.
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--:-- Harriet Washington: Nelson Mandela had denounced it.
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--:-- Harriet Washington: Is this acceptable?
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--:-- Harriet Washington: We know that there are treatments available which restore the immune system, which stop the opportunistic infections, especially TB, and which return AIDS sufferers to good health for several years at least.
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--:-- Harriet Washington: Is it acceptable that these dying parents had no hope of access to treatment?
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--:-- Harriet Washington: Many prominent people were concerned about the fact that you had these fantastically wealthy Western companies bullying dying people in the third world who were just trying to keep themselves alive.
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--:-- Harriet Washington: And as a result, there was a compromise.
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--:-- Harriet Washington: There was a meeting in Doha.
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--:-- Harriet Washington: The meeting in Doha provided for certain loopholes so that these companies could indeed obtain and pursue cheaper versions of drugs.
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--:-- Harriet Washington: Everyone agreed to it, but when the time came to actually sign the agreement, the U.S. refused to sign, and it wasn't the only country.
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--:-- Harriet Washington: Several wealthy Western countries would not sign the agreement, leaving these countries in legal limbo.
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--:-- Harriet Washington: