Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Friday, August 13, 2021

China's Drug War: Coming Soon to a Taiwanese Hospital Near You

                    

Hey look it's an accurate cover photo and you know it. 


If you're wondering where I've been these past few weeks, it's still the same old thing: moving all of my work online means I'm in front of a computer all day, and I just get tired of it. I want to read a paper book or look at something that's not a screen.

I've also been working on that longer project with Brendan comparing every general history book about Taiwan available in English. It took some time, but look for it to be coming out soon.

But, as usual, something got stuck in my head that won't get out. So here we are. 

About two weeks ago, the Taipei Times published this piece on China snapping up the Taiwan distribution rights to almost a third of all new pharmaceuticals. It was a good article, and important warning -- and seems to have been largely overlooked: 

In a report dated Monday, the Legislative Yuan’s Judiciary and Organic Laws and Statutes Bureau decried the arrangement as unreasonable.

“Requiring South Korea to purchase vaccines through a North Korean distributor or Israel to go through a Palestinian firm would be preposterous,” the report said.

Granting exclusive distribution rights in a nation to its political and military adversary is ethically problematic, it said.

Due to the antagonism and mutual distrust between the two nations, it is highly unlikely that they would complete a contract and instead use it as a tool for political manipulation, it added.

This would further hinder transactions and jeopardize the right to healthcare of the “represented country,” the report added.

I would switch Israel and Palestine in that analogy, personally, but the point holds. This is terrifying, and you should be terrified. It is not crisis-mongering. It's an actual crisis in the making. 

Imagine a future in Taiwan where about a third of new drugs on the market are difficult to get or simply not available because China holds the distribution rights, but it would be political suicide to buy from China (not to mention playing directly into CCP hands).

Now, expand that thought: not just you at the doctor's office unable to get the drugs you need. Imagine millions in that same position, and how angry they'd be. Imagine the political crisis that would create: we already saw it with the BNT vaccines. Visualize that, but with a huge percentage of all new drugs on the market. 

Consider as well the opportunities for malicious actors and disinformation purveyors, populists riling up the people who are rightfully mad because they can't get medicine, sharpening that public anger into a poison spear and throwing it at exactly the wrong target. Not China, whose fault this is, or even those in Taiwan who insist China can be dealt with reasonably and warmer relations are possible without undermining one's own position. Rather, the protests would be directed at those trying to protect Taiwan from Chinese interference and annexationism -- the people who best understand that Taiwan needs to stand up for itself. 

Think of the destabilization: a KMT that wins, and caves in to buying medicine through Chinese channels, whose own supporters voted them in so that they could do this, and a furious opposition. Or DPP in power, but furious KMT voters who blame the DPP, not China, for the existence of the problem. Imagine a DPP who cannot cave (it would be political suicide with their own base) but has trouble withstanding that kind of pressure. It's not hard to imagine, because that's already what they do! 

With a segment of the population -- albeit a shrinking one -- who still does not understand that it is impossible for Taiwan to deal with China without China trying to undermine the country, it would be...well, a crisis. It would be difficult to have a functioning democracy in a country who can't access a huge portion of the latest medicines.

Let me make it worse. Consider as well that there are always two players in these games. China's gonna China, that's how the CCP rolls. Subjugation-happy assholes to the last. But those pharmaceutical companies agreed to those terms. They didn't see anything wrong with selling the rights to the Taiwan market to Taiwan's biggest existential threat. 

Taiwan watchers have been talking a lot recently about the good press and stronger support Taiwan has been getting. I admit, I've been glad to see it too. But while we've been celebrating, entire vital sectors of the economy have been quietly turned against Taiwan by the CCP. And those international entities let it happen. 

You might not be mad about the airlines caving to China. Perhaps you're not mad about the major language proficiency tests doing it (still, fuck IELTS). Maybe you couldn't work up sufficient anger over exclusion from international organizations, "Chinese Taipei", the end of actual Taiwanese representation in the Taiwanese representative office in Hong Kong or the BNT fiasco. In a lot of cases, it's a name change, purely aesthetic, or it's one medication. Those international organizations are pretty useless sometimes, it seems.

But all of those slights, all of those insults, all of those successful attempts to undermine Taiwan: they were always leading up to bigger, bolder plans for forced subjugation. 

That's what this is. 

I hope you were mad before. If not, I hope you're furious now. 

This proves without a doubt that the Shanghai Fosun deal with BNT (Shanghai Fosun, as a large company in China, is ultimately beholden to the CCP) was not an unfortunate accident, an oversight, a one-off. It was a direct attempt to harm Taiwan, and BNT let it happen. They agreed to it. Everyone who said it wasn't a big deal, that the DPP were wrong for declining to consider working with Shanghai Fosun, that the distribution rights were above board and negotiated in good faith, not an attack on Taiwan...you were wrong. Your opinion was bad and you should feel bad. 

I've said it before and I'll say it again: the weird workaround of letting Terry Guo, TSMC and Tzu Chi buy the doses was not some odd accidental outcome. I have thoughts about TSMC's role that I won't share, and not much of an opinion on Tzu Chi (though I dislike religious organizations generally), but I stand firm on this: Terry Gou is a gamepiece. Perhaps he knows it to some degree, but I'm not sure if he realizes the extent to which is is a CCP pawn.

It also proves that the only way to deal with China is to refuse to play. If Taiwan bends over and accepts drugs through Chinese distribution channels -- as the torch-and-pitchfork types are likely to scream that the country should do -- then it'll be more drugs next time. Then something else. And another thing. And soon the CCP plan to get its claws inextricably into Taiwan will actually have worked. 

There is no way to talk to China, no way to negotiate, no way to warm up relations. They will always try this. They will never come honestly to the table. They will always try to undermine you. It's like trying to have an honest relationship with a narcissist, abuser or compulsive liar. It's not possible. If you take this punch, if you let that comment slide, if you try to placate them, they only escalate. It never works. 

The only way to win is not to play. 

Finally, this proves that a basic understanding of Taiwan among the general international community actually does matter. I've heard people say that only policymakers matter, only politicians, only officials. There's no point in trying to reach a wider audience of people who are not in a position to effect change, because, well, they can't do anything. 

That attitude is wrong. 

You know who's sitting in that "general audience" section? Businesspeople. Talent that Taiwan might recruit. Several million people who might intentionally choose a Taiwan-made product over a Chinese one. Writers and newscasters who don't focus on Taiwan normally but at the Olympics, might take a stand and just call Taiwan by its name, rather than Chinese Taipei. Creators who might re-think what peddling their products in China will ultimately cost them, and ask if it's worth the market access. 

And, of course, another important segment of that audience: pharmaceutical executives

Not the people who are considered particularly important in Taiwan discourse. And yet, looking at those numbers, I sure do wish more international pharma execs were more knowledgeable about Taiwan. I wish we'd tried harder to reach people like that: not just in the drug industry, but all industries. Because today it's medicine, tomorrow it'll be something else. It always is.

Perhaps it wouldn't make a difference. Perhaps they'd have signed away Taiwan's distribution rights to its biggest enemy regardless. Perhaps there is nothing one can do to make them care. 

But perhaps not. Perhaps actually knowing what one is doing might cause one to choose a different option.

You honestly never know.

This is a great reason to sign my petition for Last Week Tonight to do a show about Taiwan, by the way. The whole point is to reach a general audience. Now available in Mandarin!

Tuesday, May 25, 2021

Vaccines, Sovereignty and the Hanging Thread

Untitled


In my last post, I explored how Taiwan safeguarding its sovereignty was a major reason why it could not simply accept vaccines from Shanghai Fosun, a Chinese company. Something about that storyline has continued to bug me, though: 

The other thing this article doesn't mention: according to Chen Shih-chung, the Taiwanese government hasn't received any official application to sell these vaccines in Taiwan. How can the government agree to offer a product if the company that wants to provide it hasn't even asked the Ministry of Health and Welfare if they can do so?


It's a bit of a loose thread. Why haven't they applied?

They say they've been "promoting these vaccines since last year" for Taiwan, but this is the first we've heard of them. I find it very hard to believe that this due to the Taiwanese media and government keeping quiet. What is there to keep quiet if Fosun never went through the proper channels to offer the doses here in the first place?

Although anyone with a healthy distrust of the CCP -- which ought to be everyone -- might be tempted to automatically reject any notion that vaccines of any kind from China are acceptable, it bears at least asking: should Taiwan accept this offer of vaccines given the very real threat facing the country?

This is a legitimate question, especially as the vaccines in question are not the ineffective Sinovac/Sinopharm vaccines, but the highly-regarded Pfizer/BioNTech ones. 

After considering that question -- not dismissing it out of hand -- I still believe we should not play China's game.

So let's start with the application that the Taiwanese government said it never received. Couldn't this all simply be fixed if Fosun were to go through the process as it's meant to be done? Why didn't they?

A partial answer is contained in a post I came across while writing my last piece, from an executive at Pfizer (it doesn't say that in his Facebook bio but it's easy enough to find out.) I didn't think about it much until today, but perhaps I should have: 

其實复星從德國進口的BNT162b2,可以循正常管道向台灣TFDA申請BNT162b2在台EUA,复星已經花錢買了輝瑞half-ownership 的data ,為查驗登記用的,不過一旦送了,复星和中國處心積慮吃台灣豆腐的政治操弄,一個中國的泡泡就會被吹破⋯⋯因為台灣「另一個國家」和港澳「地區」不同,所以biologic license submissions (BLA)   送案的程級不一樣,复星幾乎可以在港澳,經過較簡單的流程,很快直接送上市。但在台灣必須有各種疫苗(生物製劑)進口審查規範。基本上:复星BLA送案等同「外商」。 也就是說:中國复星=外商 ⋯⋯面對台灣是一個國家,獨立自主審查,那复星和中國辛辛苦苦經營吃台灣豆腐(一中泡泡)的目的就被吹破了!

不知道复星背後的大人態度如何?不過如果台灣要買,复星就得送。但是送了,「一個中國」泡泡就破了,所以复星不知道敢不敢送? 



Note: the original post has since been deleted (it probably got too popular for a pharma exec's comfort zone) but I think the snippet is useful, so I'm keeping it here.

I don't think I'm quite capable of a good translation so let me summarize the key relevant point. Basically, according to the contractual relationship between BioNTech and Fosun, the vaccine is an imported product from Germany, not a domestically-produced drug, so getting government approval requires the contracting company to purchase global research data that it can include in its application.

So far, China hasn't actually approved it for use in their own "mainland" even though Fosun has (presumably?) paid for this data already. However, it was a relatively simple process to offer it in Macau and Hong Kong, as those are territories of China. So, the licensing agreements and approval processes are at the regional/territorial level. 

Taiwan, on the other hand, has its own application procedures, which Fosun would have to go through to get it approved and distributed here. In addition, as Taiwan is a country, the licensing level -- the level of approval needed for biologics -- is different from Hong Kong and Macau. From Taiwan's perspective, not only is the vaccine itself an imported product, but Fosun is a foreign business, and has to go through the approval process as a foreign entity, not a domestic one.

Even if the BioNTech vaccine itself had already been approved, this particular batch would need to be tested as we can't be 100% sure it's not defective, and distributors need to be approved as well. This is why importing 'in parallel' (importing a real drug that has been approved, but not through an approved distribution channel) is considered the same as selling counterfeit drugs, even if the product itself is 'real'. 

Obviously Taiwan thinks this application procedure is quite normal, but to China, it might well be unacceptable.

If Fosun actually applied in good faith through the regular channels, it would be tantamount to admitting that they recognize that Taiwan is a nation with its own licensing and approval procedures, as evidenced by the level of submission required. There would be no way to do this while still pushing a "one China" narrative. 

That isn't great for China, which allegedly blocked the initial Taiwan/BioNTech deal, almost certainly so that it could then push BioNTech to include Taiwan in the deal it made with Fosun regarding Hong Kong, Macau and China. 

Taiwan never had any say in this deal, so as far as the Taiwanese government is concerned, it's meaningless. 

So rather than apply through regular channels to distribute these doses in Taiwan, China has chosen to kick up a media and disinformation firestorm to make the current government look bad.

Put another way, Fosun claims to be the distributor for Taiwan, yet never applied to distribute this drug in Taiwan. And yet the CCP is pushing the media and KMT to make a big stink about Taiwan not 'accepting' it.

It's convincing, too.  You're too passive! Don't Taiwanese deserve the best vaccines? Why should we settle for second-rate AZ doses? This is all political, you just don't want to buy from China! are all extremely persuasive arguments in a time when people are anxious and stressed out. 

Much better to not apply, wait until the expiration dates are near to create a sense of anxiety -- you know, hurry now or you'll lose this hot deal! Your window of opportunity is closing fast! -- then get your media and KMT muppets in Taiwan to kick up a fuss that precious time is being wasted and Fosun has been "promoting" these doses "since last year", even though nobody in Taiwan has heard anything (?) about them until recently. 

That's highly suspicious. Would you trust doses offered to Taiwan under those conditions? Because although I do speak from a place of privilege (I've had my first dose of AZ), I wouldn't. 

Why, then, doesn't Taiwan reach out to Fosun and invite them to apply? Then we could test the product here and decide if it's safe. 

There are a few reasons why that's not a good idea: 

First, regarding vaccines, Taiwan doesn't approach brokers (I also believe this is a general rule, but don't take my word for it). They approach original manufacturers such as BioNTech. 

These processes aren't particularly fast, and they're difficult to expedite. The laws are quite clear (I've spent enough time with pharma people in Taiwan to know that, and that the Taiwan FDA does not play around with drug approvals.) Approvals take months, not weeks; companies celebrate if they can shave such approvals down even by a fairly small margin, and doing so takes a very convincing case. 

With rumors flying that these particular doses are defective -- again, I can't verify this so please don't take my word for it -- there's no convincing reason to expedite approval. In fact, there's a very good case for applying extra caution. 

In other words, ignoring all of China and Fosun's political games, by the time those doses could possibly get approved, they'll be expired.  The only way to avoid that is to circumvent the approval process completely. 

This is exactly what China wants, because China's approved them in Hong Kong and Macau -- their territories. Allowing that approval to include Taiwan (which I believe is what the China-negotiated contract with Fosun says) without Taiwan doing its own legwork is functionally the same as allowing China to treat Taiwan as a region or territory under its control. 

What's more, by the time they get approved, all of the other vaccines Taiwan has coming its way will already be here. The sense of urgency to get these particular shipments is fabricated. Yes, we need vaccines as soon as possible, but we were never going to get these particular ones faster.

In other words, if you believe Taiwan should do everything in its power to get those doses, congratulations, you've just sold out Taiwan's sovereignty.

It also raises the question of whether approval now would allow Fosun to sell this vaccine in Taiwan long-term; short-term approvals do not exist as far as I know. With Fosun claiming it intends to manufacture this drug in China at some point, it's worth considering whether we want to take the risk that a China-produced vaccine could end up in Taiwanese arms.

And this is leaving aside the fact that this is only an issue because China decided to make it one. Taiwan had a deal with BioNTech, and China wrecked it just so it could pull this stunt. Even if we ignore that playing China's game means letting China win, you can't ignore the very clear national-level processes that make this deal a non-starter. 

Another reason not to trust these doses is that accepting "one time only" that China can push Taiwan around opens the door for them to do it again. China believes this is the way it should be; they won't treat it as a special circumstance. They'll go back to all their international business partners and point out that they've successfully negotiated for Taiwan before -- which would be true if we allowed this -- and convince them it's acceptable to do again. International businesses are already quite happy to bend over for China, so this won't be difficult. There is absolutely no way to win this: the only way to win is not to play. 

The final reason is quite simple: Taiwan has its own vaccines coming, either domestically or through foreign agreements.

The Fosun/BioNTech doses were never going to make it here in time, and other options will be available soon. This was never anything more than a chimaera, a disinformation attack. Don't fall for it. 

So, again, here's what I think is going on: 

China doesn't care whether Taiwan gets them or not. If Taiwan accepts them on China's terms, then China wins. If Taiwan rejects them and the outbreak rages, China still wins.  They waited for an opportune moment to make it seem like China is trying to "help" Taiwan, and allow the media to again attack Taiwan for obstinately refusing this "help" with an issue that only exists because China helped create it. 

If China did genuinely intend for Taiwan to receive vaccines, rather than playing politics, it should have just applied to do so properly. Or it could have simply not stood in the way of Taiwan acquiring vaccines on its own.

China didn't do either of those things, and that tells you all you need to know. It's playing with smoke and mirrors, not making a genuine offer. 

This is all a media stunt -- block Taiwan's own vaccine acquisition efforts, and then allow the media to do what it does best, and blame Taiwan for problems China foisted on it.

I don't think China intentionally let a stockpile of vaccines near their expiration date as some sort of deep-level conspiracy to smear Taiwan's reputation. Rather, I think some of the more competent hatemongers in the CCP saw an opportunity and ran with it: Taiwan's outbreak, its currently rather low supply of unpopular vaccines and the fact that more vaccines might not arrive until later this summer at the earliest all provided them with a window to attack Taiwan right when it was weakest, and use something it already had on hand -- expiring doses that Hong Kongers don't want -- to make the government look bad. 

In other words, China and their various allied sellouts in Taiwan are making it look like Taiwan is faced with a closing window of opportunity -- act fast or these vaccines will be GONE GONE GONE! -- when in fact China's the one with the closing window. 

Anyone in marketing knows this game: the false sense of urgency created to get you to ACT NOW! is actually fulfilling a need on the creator's part, not the customer's. 

Taiwan will get this outbreak under control, and it will gain access to vaccines, either domestically or through other foreign partnerships. The only time China could have possibly acted was now, and they did. This opportunity will soon disappear, and they know it. 

China is also foisting the "playing politics" smear on Taiwan to cover for its own actions. China's attempts to block Taiwan's own vaccine acquisition programs not only endanger Taiwanese and international public health, they are intensely political. They're using any leverage they can find to try and discredit the Taiwanese government. When the government pushes back and refuses to budge on critical issues of drug safety and national sovereignty, the CCP and their associated mouthpieces (including the KMT) use that to accuse Taiwan of being the one to "play politics". 

But of course, it is precisely the opposite. It's gaslighting to the utmost degree. They make it sound like Taiwan is playing with people's lives, when China's the one doing that.

To sum up, the question of whether these Fosun vaccines should be acquired by Taiwan is legitimate. It deserves some inquiry.

But ultimately, I strongly believe the answer is "no". In fact, I don't even believe it would be possible to do so if we wanted to. 

All that's left, then, is the media stunt. The attack on Taiwan's government, to make it look "passive". 

In short, and highlighted for emphasis:

I'm highlighting this for emphasis:

China created the problem by blocking BioNTech's deal with Taiwan. It then allowed a Chinese company to negotiate with BioNTech for "rights" to Taiwan distribution, without asking Taiwan.

Then China stepped in to offer a solution to the problem it created: allow us to treat you just like Hong Kong and Macau and circumvent your own government's regulations and approval processes, and you can have these vaccines which we blocked you from obtaining independently.


Then China created an extra sense of urgency, got their political and media puppets in Taiwan to scream at the government over it, and put all the blame on Tsai and the CECC.

It was always a game. Don't fall for it. 

Friday, June 8, 2012

Big Pharma

Cyanide and Happiness, a daily webcomic
Cyanide & Happiness @ Explosm.net


Back in the USA I hated Big Pharma.

Now I work (in part) for them.

My reasons back home were due to, well, events like those discussed in this article - affording drugs is a problem around the world, and a two-pronged issue. On one side you've got areas so poor that even low-priced drugs cost too much, and on the other you've got the USA, where people generally have more money, yet drugs are so astronomically expensive that many still can't afford them despite their exponentially better overall standard of living.

From people I know in Big Pharma back home, I can say that the argument does ring true: drugs are sold in the USA at exorbitant prices, and at far lower prices elsewhere, because companies both want to recoup clinical testing costs and make a tidy profit (a little too tidy if you ask me), and feel that the USA is the market to milk, because we can apparently "afford it". Except we can't.

It also bothers me that they throw so much money behind lobbying the government in their own interests, which mostly counter the interests of the American people, but pretty much all industries do that.

Working at a lot of pharmaceutical companies in Taiwan, though, makes me dislike the whole industry a lot less. I wouldn't go so far as to say "like" or "trust", so I'll stick with "dislike less".

I think it has a lot to do with regulation. I know the health system in Taiwan is imperfect, but it's about ten kachillion times better than the travesty of a "system" in the USA. Don't even bother arguing with me on this, I have a mother who is facing cancer that is not going to go away, and the possibility of losing her company-backed health insurance and very few options after that, so seriously, do not even start. I will tear you to shreds.

Here, we have our imperfect-but-wonderful national health insurance, and a heavy hand in regulating drug prices. I don't agree with some of the laws: the idea that doctors are forced to give certain medications first and others can only be tried later, and that some can't be tried until certain symptoms or issues occur or criteria are met, ties doctors' hands unfairly: it takes away from them what should be their expert judgment regarding what would be best for the patient and puts it in the hands of people who can't necessarily make that call: either because they're bureaucrats, not doctors, or because even if they are doctors, they're not there with that individual patient assessing that patient's needs.

The price regulations, however, I support completely. A dearth of price regulation in the USA has brought unconscionable drug prices for things people need - seriously, it's not like you have a choice sometimes, so supply and demand doesn't apply - prices people can't afford and insurance companies don't want to pay. Regulations in Taiwan have kept most prices for the same drugs at reasonable levels.

You can argue this hurts the company, and many who work in pharmaceuticals in Taiwan would agree, but the fact is that those companies are still in Taiwan, still making a profit and still see being in the Taiwanese market as something worth doing. The price controls haven't scared them away. If it were truly unbearable, companies would pull their products and shutter their offices and Taiwan would be SOL. That hasn't happened.

Those same people in the industry, while they might tell you that the price controls are an issue, would generally not argue that there shouldn't be any regulation or any cost control. In my experience (and I have a lot of experience talking to people in many different firms), while they'd like more freedom, they'd agree that keeping drugs affordable is important, and that wouldn't be lip service: they mean it. They wouldn't say it the way a PR schlub for Big Pharma back home would rattle it off a press release and then look the other way as "reasonable prices" became "$1000+ for what should be a $30 compound".

Even if they would - business is business & all - the regulations are there, and it keeps things reasonable. Not perfect, but reasonable. People get their medicine, companies make a profit, and it becomes an industry that does not inspire so much hatred and animosity. Everybody wins.

So what is all this anti-regulation hullaballoo back home? Phooey.