Comment

Comment on NHS hit by ‘severe drug shortages’ due to Brexit red tape

You need a UK gov licence to import drugs into the UK. As we now need our own customs rather then the EU. This means the company doing so has to prove they meet all the UK standards. While those standards are currently the same as the EU. The licence still requires all the documentation to be provided separately. And translated. So def a bit more then a form.

The population of the EU is approx 448m (jan 1 23) the UK 67.7+m (23 no date) so the simple fact is where companies have a choice to sell. They have 6.5x the potential customers for exactly the same amount of documentation as the UK. Add the US 334m china 1425m india also 1425m (slightly more then china this year). And while we are far from the smallest nation of drug buyers. We are hugely down the list when it comes to actual money made by the drug companies dealing with us.

Our only advantage over the bigger nations is single payer. But that still in no way effects the work to make drugs legal in this nation. It actually makes it harder because other nations do not consider cost. They allow the insurance companies or paitent to make that choice. Our NHS via MHRA and NICE is forced to consider the cost per outcome when approving drugs for use in the UK. Meaning once a import licence is issued. The pharmacy companies importing and selling to the NHS are still limited in their ability to bid from suppliers.

UK should up it’s manufacturing

Def do not disagree. But their is limits to what we can make. Legally we need to licence drugs protected by patent law. And the drug companies will only do that if its profitable for them. The NHS already uses lots of generics when those patients have expired. Way more then the US from my own experience (so admittedly anecdotal). But many of the drugs used are still under patent. Many providing huge life style and length changes over older generic treatments available.

Drug patents are a strong system to break. Backed by international support. IE if we ignored our own laws on this. or changed them to disadvantage the drug companies. Other nation (mainly the US and EU) would be forced to sanction sales to the UK. Yes it sounds like a cartel. It really is though.

You may guess I used to work in the industry (long long before brexit). I worked writing the software system used by many drug companies to collect test data from lab trials. Used to submit to orgs like the FDA EMA and I assume now MHRA.

I agree Brexit is not everything. Heck so dose the article if you assume the tittle isd part click bait. NHS funding and Covid would be an issue without it.

But I can say that issues were happening with pharmacies i the UK having trouble competing on drug purchases just before COVID. Back in 2020 for the first 3 months while COVID was just rummers from china. I was hearing from old contacts that pharmacies were failing to fill many medications. Nice was publishing online reports n possible alternatives (often less effective) for docs to RX. Cancer treatments for chemo and ED injections were the huge ones that became 0 supply for a couple of weeks. But safety margin delays were happening throughout the drug catalogue. COVID hitting during that just made it harder.

Opinion. While NHS funding and tory attitudes to cost saving is the cause. The increased workload in supply to a relatively small market buy international standards. Is why many in demand drugs became easier to sell for more elsewhere. Not having to submit extra documentation to sell o one nation when 26 others were also looking for supplies has forced UK pharmaceutical to compete harder. And the fact that the UK MHRA requirements are identical to EMA means trying to buiy outside the EU means even more work for the suppliers.

source

Sort:hotnew top

bernieecclestoned@sh.itjust.works ⁨1⁩ ⁨year⁩ ago

The population of the EU is approx 448m (jan 1 23) the UK 67.7+m (23 no date) so the simple fact is where companies have a choice to sell. They have 6.5x the potential customers for exactly the same amount of documentation as the UK.

It’s not that simple though, the supposed panacea that is the single market is just that

In Germany, around 90% of medicines that obtain marketing authorisation from the European Medicines Agency (EMA) are available to citizens while in Lithuania, for example, it is only 20% of the approved drugs.

Another major problem is the length of time it takes for a drug to appear on the national market after EU registration.

Germany is again the leader in this respect, with a waiting time of around 100 days. At the other end of the spectrum is Romania, where the procedure can take up to 900 days, or 2.5 years. In the Czech Republic, the average time for the whole process is around 1.5 years.

euractiv.com/…/a-single-market-for-medicines-woul…

source
- HumanPenguin@feddit.uk ⁨1⁩ ⁨year⁩ ago
  And we are not on the high side. Nice dramatically restricts drugs available to the NHS. If you have ever had to fight to get Nice approval you will understand I fave hence my retirement at 50.
  
  But you are still forgetting the main point. EMA allows the nations under it to move drugs around. If ou need a drug in one nation. That your helth service dosent want to provide. You can buy it yourself and import from another EU nation. As we could in 2019. Now you cabnnot unless MHRA also covers it. So any drug created since 2020. Requires 2x the paperwork to even give you the option to buy.
  
  just so you know back in 2000 that was multiple simi trucks of paperwork because at that point FDA and EMA would not take digital records.
  
  It is still 100s f gigabytes of data for each drug. Needing to be formated for each agency.
  
  As I said single payer is our only advantage, As even most EU nations have universal not single payer healthcare. But sales is still a relatively small part of the cost. Certification represents a huge part of all drug costsP Grooving it dose what you say and that the side effects are within reason at multiple levels haveing to interpret the results as each agency wants. And answer seperate questions from each agency before they will certify your drug as suitible for theie citizery. Is by far the largest cost after actual testing on animal subjects. independent of data analysis and presentation human subject testing is actually cheaper when it happens.
  
  source
  - bernieecclestoned@sh.itjust.works ⁨1⁩ ⁨year⁩ ago
    
    But you are still forgetting the main point. EMA allows the nations under it to move drugs around
    
    Not during shortages, the Single Market doesn’t force anyone to share anything
    
    If ou need a drug in one nation. That your helth service dosent want to provide. You can buy it yourself and import from another EU nation. As we could in 2019.
    
    Without a prescription?
    
    Now you cabnnot unless MHRA also covers it. So any drug created since 2020. Requires 2x the paperwork to even give you the option to buy.
    
    The MHRA did the vast majority of the certification for the EMA…
    
    source
    HumanPenguin@feddit.uk ⁨1⁩ ⁨year⁩ ago
    PS you know cross border prescriptions were legal in the EU. Doctors in the UK could write me an RX and I could take it to Germany to fill. Was a common thing for many who often had to work cross borders. For thing the NHS covered it was easy and needed for my insulin etc. But for things not covered under NICE. Most NHS GPs will be happy to schedule a private appointment and write a non NHS rx. It really was not that uncommon pre brexit. With pre 2020 medication it can still be done. As most Chemists in the world recognise the need for travel (UK tends to require london as our chemists are often tied to NHS supply lines). The issue now is. It is illegal for me to bring medications back in any supply. Such checks did not exist pre brexit.
    
    source
    -> View More Comments
    HumanPenguin@feddit.uk ⁨1⁩ ⁨year⁩ ago
    Nor dose the UK. But your argument is not shortage drugs it was that germany helth agency supplies more then others. If you go to germany and buy drugs. No one can legally stop you crossing the French border. If you pay a priv doc in germany you can buy what ever is available to sell.
    
    I can tell you right now. Brexit fucked that up for me and many others. And has given us fuck all in return.
    
    But again its a invalid argumnt anyway. Because the issue is. The NHS germany and every health care agency in the world. Rarely if ever buys drugas directly from astrazenica or phizer GSK etc. (covid was a unique exception) They buy them from huge drug import companies that then sell them to local pharmacies. Who order what they need based on customer load and expectations. The warehouses in the EU are not selling to the warehouses in the UK. Because the paperwork and licencing to do so is a fuck sight more then just a form. It is staff who understand the drugs filling in that form. Who are simply not needed to sell to 26 other countries.
    
    It really is not complicated to understand why that cost has become higher due to brexit. As I say other things are included. But the brexit extra paperwork is the big reason companies want more money to sell to the UK then to just ship to an other health agency in the EU.
    
    While at the same time we gain no ability to buy from out of EU nations that we did not have before brexit. Because they need even more paperwork. Because every single drug they sell needs to prove it meets MHRA standards rather then just the post 2019 ones. Meaning more staff who now have to be trained in filling even more UK specific forms that tgese ware houses have no need for when selling in their own demain. Add to that how fucking expensive for both ends it is if that import licence gets filled in wrong. (as we saw happen over covid multiple times).
    
    And it really only take very minimal understanding of market economics to see why the NHS is having issues and having to ask the gov to authorise higher payments for popular drugs.
    
    As I keep saying. Brexit is a cause not the only one. The way our NHS is funded (underfunded compared to most other nations) has a huge hit. But the extra work of filling forms and providing data evidence to support those forms is something that has to come from somewhere. And why should pharmacutical warehouses in the EU fund it just because a tiny % over 50% of the UK had fuck all idea how this all worked when they voted.
    
    Those who voted for it have to accept the cost of their choice.
    
    source
    -> View More Comments