You knew they’d say this, didn’t you?

Alima Batchelor, head of policy at PDA said: “Whilst these shortages cannot be ascribed to Brexit, they do show the need for concerted action to ensure that leaving the EU will not exacerbate an already unacceptable level of drug shortages.”

What’s the problem?

Pharmacists have warned of shortages of every major type of medicine – including HRT, antidepressants and blood pressure pills.

Drugs for diabetes, epilepsy and skin problems are among the treatments in short supply, along with common contraceptives, a survey suggests.

So, being inside the EU system allows these problems to happen. But we must be careful about leaving because these problems?

Isn’t it actually an argument that we want to leave the current regulatory system?

33 thoughts on “You knew they’d say this, didn’t you?”

  1. I saw this on telly. There is a major shortage of all these drugs in Germany – docttors and chemists are having to ration their prescripttions.
    I don’t think that they mentioned contraceptives though…

  2. ”Isn’t it actually an argument that we want to leave the current regulatory system?”

    Oh, we wish! The medicines supply chain at pharmacy level is highly efficient – out of stock drugs at the pharmacy can be replenished multiple times daily from wholesalers. Further up the chain lies the problem; increasing regulatory demands on electronic traceability of medicines throughout the supply chain down to the individual patient level, ostensibly for fighting counterfeit products, but in reality, the result of ‘idle hands’ in the Commission creating ‘much work’ is causing huge issues for manufactures. Add to that the outsourcing by manufacturers of drug substance and finished product supply to China / India for cost savings, and the under resourcing of regulatory agency auditing capacity to match this invariably leads to supply issues when elements of the product realisation process deviate from the responsible manufacture’s validated and defined processes. And it’s not just drugs: From May 2020, the EU’s ‘hammer to crack a nut’ approach to regulation of medical devices comes into force. The eye watering complexity of the new devices regulation has led to the loss of much of the E.U. wide Notified Body (NB) capacity – they audit and certify manufacturers under EN 13485 and the device regulation, and many have just thrown in the towel due to the complexity and resultant costs, leaving many manufacturers high and dry unable to find a new NB due to the remaining NBs lack of resource. And of course, you won’t be surprised to learn that there is precisely zero interest in the U.K. civil service to extract us from the regulatory ‘Medusa’ that is medicines and medical devices regulation. Better plan your hip or other prosthetic replacement before May next year!

  3. In addition to prioritising ethnic purity over growth prosperity business and Western security we will now have to put up with the long years of “Its nothing to do with Brexit” which will be based on the mid numbingly dim witted truism that nothing is ever entirely due to anything .
    So companies with existing difficulty will go under but “Its nothing to do with Brexit , they had existing difficulties”.
    Problems that are already a head ache will be worse but”Its nothing to do with Brexit” they were already problems

    I cannot wait

  4. So in the month after the Summer shut down, inventories have run down and refilling the supply chain is taking its usual time.

  5. @Newmania

    I spent 25 years (1976 to 2001) working for a non-European company importing pharmaceuticals and devices into the EEC begat the EU.

    It clearly is a surprise to some that you do not have to be in the EU to trade with it.

    There were lots of problems: regulatory, exchange rates, protectionism, manufacturing, supply, pricing, transportation, strikes, etc as there are in the course of trade, but nothing to do with my company not being in the EEC/EU and of course nothing to do with Brexit, because, well, that excuse was not available back then.

  6. John B

    This has been a crisis in Germany since at least March and has probably been on the cards for years.

  7. Currently in Portugal where much is blamed on the 1755 earthquake. Will the blame on Brexit last as long?

  8. Kring,

    Pharmacists can’t ration prescriptions in Germany, they can either supply or refuse (send you elsewhere). To undersupply they have to send you back to your doc for a smaller prescription. Antihypertensives and metrformin are issues because patients are largely on stable, chronic treatment, and the N3 packs run out first.

    German pricing policies mean the country is one of the first in line to lose distribution when there are global shortages. That’s the flip-side to negotiating huge discounts.

    There are two major drug shortages currently, valsartan (with knock-on effects for other ARBs) and several patch HRTs. Both are due to manufacturing issues, not regulatory. Except you could say valsartan is regulatory because the Indian and Chinese-manufactured products were pulled for having too many carcinogens in them. Boo hiss nasty regulators, jolly good that plucky Britain will be out from under that jackboot soon!

  9. BiG – thanks, interesting knowledge-drop.

    Except you could say valsartan is regulatory because the Indian and Chinese-manufactured products were pulled for having too many carcinogens in them

    Literally dunno. Obviously we don’t want to give people cancer, otoh the modern approach to regulation involves fretting like a feeble old woman and possibly creating bigger problems through an overabundance of caution.

    Would the Manhattan Project or the Apollo missions be possible under a latter-day regulatory regime? I don’t bloody think elfin safety allows it. But we’ll never achieve anything great whilst obsessively covering our arses as if at a Michael Barrymore pool party.

    See also: mongs trying to ban fracking on the grounds that pensioners dying of fuel poverty is somehow less risky than the tiny, infinitesimally remote chance that drilling might wake Cthulhu in his tentacley wrath.

    So mebbe Indian cancer pills are a risk worth taking (doesn’t literally everything have carcinogens in it?), mebbe not, but the general EU approach doesn’t inspire much confidence, tho of course Brexit is not a magic solution to the problem of unreasonable bureaucratic CYAttitude.

    Re: trade-offs, absolutely. I keep telling my American friends the NHS is actually OK for most people, most of the time, and not the evil socialist nightmare they think it is. Otoh, if I had cancer, I’d probably prefer US healthcare even though it’d likely bankrupt me, because “free” ain’t much use to a dead man.

  10. Steve,

    The valsartan thing is going to develop into a major scandal. Almost every product on the market was recalled simultaneously. We may even hear eventually that lessons have been learned – could be that serious.

    You are quite right that the risk from short term exposure to the quantities involved is pretty marginal. In fact the advice to patients was “keep taking your medicines and go to your doc to sort out a suitable replacement”. Suddenly stopping taking those things would potentially do more harm than the trivial risk. But the big problem with ARBs is that peopole take them pretty much for life. And many hundreds of millions of people, that is. So you do, really, have to get the level of nasties in them down as low as reasonably achievable or you are actually going to be killing rather a lot of them.

    The nasty-concentration went up because someone changed a manufacturing procedure. To cut costs.

    We had, I think in one of the vanished threads (I see a different version of this site every time I log on) someone boo hissing the evil EU for saying that consumer white goods should be more easily repairable. Boo hiss evil EU making things more expensive. Except as, there really are many things where more expensive is cheaper in the long run.

    Still, Britain will soon be able to taste the sweet taste of freedom, and enjoy those cheap Chinese and Indian cancer pills once more. Off to the sunlit, unicorn-infested uplands where there are no regulations, no more little Hitlers from the council enforcing Brussels directives, no home-grown overweening legislation to replace it, and no distant unaccountable unelected upper chamber interfering with the British way of life.

  11. I sneeze in threes

    “We may even hear eventually that lessons have been learned – could be that serious.“ BIG, you win the internet!

  12. “The nasty-concentration went up because someone changed a manufacturing procedure.”

    A change that was signed off by the European regulator we are supposed to be grateful for.

  13. Some (most) of current drug shortages are due to parallel importing, or as Tim would say the market operating normally.
    Prices for the same drug differ across the EU (and indeed the globe) consequently plenty of scope sometimes for arbitrage. i.e. if Viagra sells for $10/pack in Portugal but $20/pack in UK it makes sense for the wholesaler to export from Portugal to Uk and make a nice little profit (and of course vice versa)

  14. Would the Manhattan Project or the Apollo missions be possible under a latter-day regulatory regime? I don’t bloody think elfin safety allows it.

    I work in a factory belonging to a large multi-national European aircraft manufacturer, who shall remain nameless to save them embarrassment.
    Their latest Elfin Safety decree is that everyone using a staircase holds onto the handrail. This is MANDATORY. And senior management will pull you up on it if they see you gasp not holding the handrail.
    In case you aren’t a competent adult who can successfully do things like walk… :eyeroll:

    Land on the moon? Don’t make me f’in laugh…

  15. “Still, Britain will soon be able to taste the sweet taste of freedom, and enjoy those cheap Chinese and Indian cancer pills once more. Off to the sunlit, unicorn-infested uplands where there are no regulations, no more little Hitlers from the council enforcing Brussels directives, no home-grown overweening legislation to replace it, and no distant unaccountable unelected upper chamber interfering with the British way of life.”

    And how good were the SEC when some people tipped them off that Bernie Madoff was likely doing something illegal? Utterly useless. How good were the FSA at regulating our banks? Utterly useless. Did the regulators spot VW’s emission trick? No, it was a non-profit doing real-world tests. Did the NHS spot that Harold Shipman was bumping people off? No, it was a funeral director who thought she was seeing Shipman rather too often. Who then went to the police and the NHS who did nothing (despite the statistical data showing he was way above the norm).

    I worked for a drug testing company and we were told the story of another company where a doctor was forging results. The trial subjects didn’t exist. The company turned a blind eye. The drug passed and went into production, and only then did people find there were side effects and start digging.

    The thing with regulators is if you really want to get past them, you can, because they’re bureaucrats. They do what the book says. The only people they stop from delivering a new drug or selling a car are decent people.

  16. C D.

    Their latest Elfin Safety decree is that everyone using a staircase holds onto the handrail. This is MANDATORY

    LOL. I work for a large, multi-national, European confectionery company. We have the same rules. All the handrails have brightly coloured stickers every 6 inches urging you to hold the hand rail.
    Oh, and we have to take the lift between floors if we are carrying a coffee. Can’t risk hot drinks on the stairs…

  17. “The thing with regulators is if you really want to get past them, you can, because they’re bureaucrats. They do what the book says. The only people they stop from delivering a new drug or selling a car are decent people.”

    I work for a notified body that does both testing and certification for CE marking of safety equipment. It’s amazing how easy it would be to cheat it. There’s fuck all market surveillance so anyone could send a ‘golden sample’ for testing and then switch materials/procedures in production. The only way they would get caught is if the product failed resulting in injury/death.

  18. If the diabetes drug in question is metformin then grow your own. It’s found in goat’s rue.

    (A doctor once told me that it came from feverfew but WKPD claims not.)


  19. Their latest Elfin Safety decree is that everyone using a staircase holds onto the handrail. This is MANDATORY

    I work for a large, multi-national, European telecom company. We have the same rule. Trouble is, in our main HQ, the staircases do not have handrails. None.
    If taken to task on this, for non-compliance, I will ask for a demonstration of correct use of the (virtual) handrail.

  20. I mentioned this to the wife this morning. She experienced a shortage of a particular drug, urgently had to get a fresh prescription at a much higher dose of another drug that wasn’t as effective for the situation.

    This was in 2012. She had a similar problem in 2003 – ongoing drug that suddenly was unavailable and had to switch to higher dose of another antibiotic.

    So yes does happen. May not come across it regularly unless working in a pharmacy but its not news.

  21. C D – I use 2 walking sticks normally. My problem is such that if I have to take the stairs I have to use both sticks in left hand and walk down holding right side handrail. That’s the handrail everyone else holds in their left hand to go up the stairs.
    Very disruptive but no other way for me to safely use stairs.

    Much to the annoyance of H&S people.

  22. Is this the argument?

    Massive creeping Regulationism is the bestest EVAH thing even though

    a) there are signs that the people who do the checking are either unwilling or unable to keep up with the flow of crap emanating from the mental pygmies of Brussels (Will above)

    b) there is growing evidence that corporations are gaming the system – eg Dieselgate and https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60334-6/fulltext

    c) the regulators get things wrong – eg “The nasty-concentration went up because someone changed a manufacturing procedure. To cut costs”

    d) the regulators are corrupt – the phasing out of incandescent lightbulbs for fluorescent ones so that Philips could make more money

    e) they just don’t work – all the regulations in Brussels did not prevent that listeria outbreak a few years ago

    because it saves stupid morons like me from having to think about the pros and cons of whether to buy a mega-expensive appliance or a cheap and cheerful one

  23. Is it just round here, or is there a shortage of generic ibuprofen in the supermarkets?

    Is this Brexit, or the BMA removing a hangover remedy to try to stop us drinking?

  24. Rules about handrails always sound hilarious but:

    – the biggest source of accidents in the workplace is ‘slips, trips and falls’
    – the difference bewteen a fatal accident and a non-fatal accident is luck. If you trip and fall on a staircase because you aren’t holding the hand rail the consequence may simply be a loss of dignity, or lifetime paralysis due to a broken neck or death due to a fractured skull.

  25. – the difference bewteen a fatal accident and a non-fatal accident is luck. If you trip and fall on a staircase because you aren’t holding the hand rail the consequence may simply be a loss of dignity, or lifetime paralysis due to a broken neck or death due to a fractured skull

    Things like this are always going to happen. That’s life, it sucks like that.
    Policies like instructing people that they MUST hold a handrail are patronising and insulting. At some point, the individual has to take responsibility for themselves and decide whether to use a handrail or not.

    All that happens with decrees like this is that Elfin Safety gets thought of as an annoyance and a department full of little dictators. This means they are more likely to be ignored on the whole, which can result in people ignoring the instructions when they really shouldn’t

    I don’t know whether to be glad that it isn’t just where I work that has this insanity… or to weep.
    To think, only a couple of generations ago, our forebears were storming beaches and dying horribly to save us from tyranny and give us freedom.
    What have we done? Created a system where how to go up and down stairs is prescribed by diktat.

    Freedom my arse.

  26. @Arthur Dent October 3, 2019 at 7:38 pm

    Which means installing handrails on every sloped pavement, every hill & mountain… exoskeleton for everyone

    Accidents happen, live with it.

  27. Of course accidents happen and if you fall down a staircase in your home and kill yourself I don’t care. But if you fall down a staircase in my business premises and bruise your finger, your quite likely these days to sue me for compensation especially if I haven’t warned you about the advisability of using the fricking handrail.

    Most of the complaints about intrusive elf and safety are actually due to a combination of grasping individuals with no sense of responsibility and ambulance chasing lawyers

  28. @Arthur Dent

    Rebel: install sign “Use at your own risk”

    An office joker could add a pic of dummy in mouth and bum on stair green tick

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