Hey everyone, welcome back to My Weird Prompts. I am Corn, and I am sitting here in a very sunny Jerusalem living room with my brother. It is February fifth, twenty twenty six, and honestly, after that cold snap we had last week, this sun feels like a gift from the heavens.
Herman Poppleberry, present and accounted for. And yeah, it is a beautiful day, though I have been cooped up inside all morning reading through some pretty dense regulatory filings from the Ministry of Health. I know, I know, I am a barrel of laughs, but someone has to keep track of the fine print.
Well, that is actually perfect timing because our housemate Daniel sent us a voice note this morning that is right up your alley. He was asking about something that has been a recurring theme in our house lately, especially with all the talk about the cost of living in Israel and the big reforms we saw go into effect last year.
You mean the What Is Good For Europe Is Good For Israel reform? The one that finally let us import refrigerators and cosmetics without a separate Israeli standard?
Exactly. Daniel was specifically looking at drug approvals. He was wondering why that same logic does not seem to apply to medicine. If the Food and Drug Administration in the United States or the European Medicines Agency says a drug is safe and effective, why does a small country like Israel need its own group of people to look at it all over again? Is it just a lack of trust, or is there something more structural going on? And how do other small countries handle this? Do they all have their own version of the F D A, or are some of them more, let us say, trusting of international bodies?
This is a huge topic because it sits right at the intersection of national sovereignty, public health, and economics. And you are right, we have touched on this in different ways before. I remember back in episode one hundred two, we talked about the A D H D medication maze and how bureaucracy can really mess with brain health. This is like the macro version of that. It is the question of why we insist on being an economic island when it comes to the things that literally keep us alive.
So let us start with the basics. When a pharmaceutical company develops a new drug, they usually go to the big players first, right? The F D A in the States or the E M A in Europe.
Exactly. Those are the gold standards. If you get through them, you have access to the biggest markets in the world. Now, most people assume that once the F D A says yes, it is just a matter of translating the label and putting it on the shelf in Israel. But in reality, there is a two step process here that people often conflate. There is registration, which is the legal permission to sell the drug, and then there is reimbursement, which in Israel is the Sal Briut, or the national health basket.
And that is a crucial distinction. Daniel mentioned the Sal Briut specifically. Just because a doctor can technically prescribe something does not mean the average person can afford it if the government is not subsidizing it.
Exactly. But even before you get to the money, you have the registration. And to Daniel's point, why does Israel have its own registration process at all? Well, the first reason is actually legal and jurisdictional. A country is responsible for the health of its own citizens. If a drug causes a massive unforeseen side effect in Israel, the Israeli Ministry of Health cannot just point at the F D A and say, well, they said it was fine. They have a legal and ethical duty to perform their own due diligence. In legal terms, it is about the tort of negligence. If the state does not do its own check, it could be held liable.
But is that due diligence actually a new study? Are they running new clinical trials in Israel?
Almost never. For a country our size, that would be impossible. What they are doing is a regulatory review of the data that has already been submitted elsewhere. But here is where it gets interesting. They are looking at that data through a local lens. For example, does this drug interact with other medications that are common in the Israeli population? Or, and this is a big one, does the local population have genetic variations that might change how the drug is metabolized?
That is a good point. We are a very diverse population here, but we also have specific genetic markers that are more prevalent in certain communities, like Ashkenazi Jewish populations or specific Arab communities. I can see why a regulator would want to make sure the dosage recommendations from a study done in, say, Ohio, actually apply here.
Precisely. Think about things like G six P D deficiency, which is quite common in certain Jewish and Arab populations in the Middle East. If a drug has a known risk for people with that deficiency, an Israeli regulator is going to be much more sensitive to that than someone in Washington. Or take Familial Mediterranean Fever. We have a high prevalence of that here. A drug that might be fine for the general European population could have different implications for someone with a pre existing inflammatory condition that is common locally.
Okay, I can buy the genetic argument. What about the environment? You mentioned environmental factors earlier.
Right. We live in a hot, Mediterranean climate. In the world of pharmaceutical stability, there are different zones. Most of Europe is in Zone one or two. Israel is in Zone four B, which is hot and humid. The stability data for a drug stored in a warehouse in Sweden might look very different from a drug sitting in a pharmacy in Eilat in August. The Israeli regulator needs to ensure that the packaging and storage requirements are appropriate for our specific environment. If a pill degrades faster in thirty five degree heat, that is a safety issue.
Okay, I can buy the environmental and genetic arguments to a point, but surely there is a way to streamline this? If we are talking about a standard blood pressure medication that has been used by millions of people in Europe for five years, does the Ministry of Health really need to sit on it for another eighteen months?
That is where the friction is. And you hit on a word there, streamline. There is actually a lot of movement in this space globally. Many small countries are moving toward what we call reliance pathways. And actually, Israel just launched a major reform on this in March of twenty twenty five. They created what they call the Reliance Tracks.
Wait, so we are actually doing it? Why haven't I heard more about this?
Because it is still in the pilot phase for twenty twenty five and twenty twenty six. But the numbers are actually quite impressive. Under Reliance Track A, if a drug has been approved by at least two major international agencies like the F D A and the E M A within the last three years, the Israeli Ministry of Health commits to a seventy day registration process. Seventy days! That is a massive jump from the years it used to take.
Seventy days sounds like a dream. What about drugs that only have one approval?
That is Track B. If it has one major approval from a recognized authority like the F D A, the E M A, or even the M H R A in the United Kingdom, they aim for one hundred twenty days. And they have a similar track for generic medicines. So, on paper, the registration bottleneck is finally being addressed.
So if the registration is getting faster, why is Daniel still frustrated? Why does it still feel like we are waiting forever for new treatments?
Because registration is only half the battle. This brings us back to the Sal Briut, the health basket. Even if a drug is registered in seventy days, it still has to wait for the annual committee meeting to decide if the state will pay for it. And that is where the real gatekeeping happens.
Right, the money. I saw the news that the twenty twenty six Health Basket Committee was just appointed in November. What is the budget looking like this year?
It is sitting at six hundred fifty million shekels. Now, to you and me, six hundred fifty million sounds like a fortune. But when you look at the applications, it is a drop in the bucket. For the twenty twenty five basket, they had requests totaling over four billion shekels. They could only approve about one third of the drugs submitted. So you have this situation where a drug is legally registered and available in Israel, but it costs ten thousand dollars a month, so for ninety nine percent of people, it might as well not exist.
That is the heartbreaking part. You see the headline that a new cancer drug is approved, but then you find out it is not in the basket.
Exactly. And this is where Daniel's question about trust comes back in. It is not just about trusting the science of the F D A; it is about the economic reality of a small nation. If we automatically accepted every drug the F D A approved, our healthcare budget would collapse overnight. The F D A does not consider cost when they approve a drug. They only look at safety and efficacy. But a small country with universal healthcare has to look at the price tag.
So the independent regulator acts as a sort of speed bump for the budget?
In a way, yes. It is a cynical view, but it is a reality. If you slow down the registration, you delay the moment when the public starts screaming for the drug to be added to the basket. It is a pressure valve for the national budget.
That is heavy. But Daniel also asked about other small countries. How do they handle this? Are we the only ones with this two step dance?
Not at all, but some are definitely more efficient. Take Singapore. Their Health Sciences Authority, or H S A, is the gold standard for this. They have a verification evaluation route. If a drug is approved by two of their reference agencies, they can approve it in sixty working days. They basically say, look, the heavy lifting has been done. We are going to verify the data, check the local labeling, and get it to the patients. They are very transparent about it.
Sixty days! And who are their reference agencies?
They look at the F D A, the E M A, Health Canada, the T G A in Australia, Swissmedic in Switzerland, and the M H R A in the United Kingdom. It is a very specific list of high trust partners.
And what about Switzerland? They are a small country too, but they have a huge pharma industry.
Switzerland is the exception that proves the rule. They have Swissmedic, which is considered a peer to the F D A. Because they have giants like Roche and Novartis based there, they have the expertise to do full, independent reviews. They do not rely on others; others often look to them. But for a country like Israel, which has a great medical community but not that level of regulatory scale, trying to act like Swissmedic is where we get into trouble.
So why don't we just join a club? Is there a club for small but smart regulators?
There actually is! It is called the Access Consortium. It is a group of medium sized, like minded regulators. It includes Australia, Canada, Singapore, Switzerland, and the United Kingdom. In fact, the U K's M H R A is actually chairing the consortium for twenty twenty six. They work together to share the workload. Instead of each country reading the same ten thousand page report, they divvy it up. One country looks at the clinical data, another looks at the manufacturing quality, and they share their findings.
That sounds incredibly logical. Is Israel part of that?
Not yet. There have been calls for Israel to join for years. It would make perfect sense. We share the same values regarding clinical evidence, and we have the scientific talent to contribute to the group. Joining would give us the best of both worlds: we keep our independent voice for those local genetic or environmental factors, but we benefit from the collective labor of other world class regulators.
So what is the hold up? Is it just the usual bureaucratic inertia?
Part of it is inertia. Part of it is that our Ministry of Health has its own very specific way of doing things. But the biggest hurdle is that link to the Sal Briut. If we join an international consortium and start approving drugs twice as fast, the demand for funding those drugs will double. The system as it is currently funded cannot handle that speed. It is a feature of the system, not a bug.
It is that economic island effect again. We are isolated not just by geography but by these unique regulatory hurdles that keep the budget manageable but also keep prices high and choices limited.
Exactly. And it is not just the drugs themselves. It is the clinical trials. If it is too hard to get a drug registered here, pharmaceutical companies might be less likely to run clinical trials in Israeli hospitals. That means Israeli patients lose out on early access to experimental treatments. It is a cascading effect that impacts the entire medical ecosystem.
You know, it is interesting you mentioned the U K being the chair of the Access Consortium this year. Since Brexit, they have had to rebuild a lot of their own regulatory capacity, but they have been very smart about using these international partnerships. They realized they could not go it alone.
That is a great point. The M H R A has been very innovative. They created something called the I L A P, the Innovative Licensing and Access Pathway. It brings together the regulator, the budget people, and the National Health Service right from the start. They work with the drug company to map out the entire journey from the lab to the patient. It is a unified pathway instead of a series of hurdles.
See, that is the kind of forward thinking we need here. Instead of having these separate silos where the registration people do not talk to the budget people, you create a unified process. But that requires a level of inter agency cooperation that is, shall we say, not always the hallmark of Israeli governance.
True. We are more of a last minute scramble at three a m kind of culture. Which works great for software patches, but not so great for pharmaceutical regulation where people's lives are on the line.
So, looking ahead, do you see things changing? We have the twenty twenty five reform pilot running right now. Does medicine ever get included in the broader standardization push?
There is a push. There was a recent amendment proposed in the Knesset that would require the Ministry of Health to justify why they are deviating from international standards for certain medical devices. It is a small step, but it is the first time we have seen that burden of proof shift from the company to the regulator. If that succeeds, I could see it eventually moving toward pharmaceuticals.
That would be a huge shift. Making the regulator explain why they are saying no, rather than making the company beg for a yes.
It would change the entire dynamic. But there will be massive pushback. The bureaucracy sees itself as the thin white line protecting the public from unsafe foreign influence. It is a deeply ingrained culture of self reliance. And look, sometimes we are unique! Our experience with trauma care and emergency response is world leading. But we have to be humble enough to know when we are not the experts. When it comes to the molecular stability of a new monoclonal antibody, we should probably trust the collective wisdom of the global scientific community.
I think that is a perfect place to start wrapping this up. It is about that balance of humility and sovereignty. Daniel, I hope that answers the question. It is not just about trust; it is about a complex web of legal duties, genetic nuances, environmental factors, and, perhaps most importantly, the invisible hand of the national budget.
And if you want to see how this same kind of bureaucracy plays out in other areas, definitely check out episode three hundred one where we talked about how A I is being used at the borders to scan parcels. It is the same tension: how do you move things fast without compromising on safety?
Or episode one hundred two for more on the A D H D med maze. It is a recurring theme for us because it affects so many people's daily lives. We have over four hundred eighty episodes in the archive now, and you can search them all at myweirdprompts dot com.
Truly. And hey, if you are listening to this and you have your own thoughts on the Sal Briut or the Ministry of Health, or maybe you have worked in one of these agencies and want to tell us why we are wrong, get in touch! We love hearing from experts who can pull back the curtain even further.
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Mostly the coffee. Alright, I think that is it for today. Thanks for joining us on My Weird Prompts. I am Corn.
And I am Herman Poppleberry. We will see you in the next one.
Bye everyone.
Shalom.
