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Coronavirus update - NO MORE RESTRICTIONS
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Re: Coronavirus update
Don't worry, they can pay for it out of taxing nurses to take covid tests. I sometimes wonder if the NHS did too good a job looking after some people.Originally posted by Jordi Culé View Posthttps://www.theguardian.com/politics...ut-open-tender
Good to see Boris, Gove, Cummings & co cutting out the bureaucracy of the civil service in order to combat Covid19.
Nothing to see here.

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Re: Coronavirus update
Well I ran the commercial side of the UK division of a large Pharma company and maybe I got it wrong for 30 yearsOriginally posted by Rjk View Postthat's simply not true, every project I've ever worked on the launch markets have been EU or USA or both. any smaller markets no matter how easy their regulatory approvals always follow on after the biggest markets are launched.
next in priority would be Japan, China, Brazil etc.
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Re: Coronavirus update
Me too. Especially as I had Boris in our ‘Celebrity Dead Pool’ syndicate. I would’ve won the pot.Originally posted by CCFCC3PO View PostDon't worry, they can pay for it out of taxing nurses to take covid tests. I sometimes wonder if the NHS did too good a job looking after some people.
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Re: Coronavirus update
I'm just speaking from my experience, if the regulatory route for the UK diverges from the EU then it is more likely that it will delay launches here rather than accelerating them.Originally posted by lisvaneblue View PostWell I ran the commercial side of the UK division of a large Pharma company and maybe I got it wrong for 30 years
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Re: Coronavirus update
Where did you get this from?Originally posted by xsnaggle View PostPubs in Wales not permitted to open until 08 August at the earliest. He is determined to destroy the hospitality industry completely.
Parochial methodist minded reactionary!!!!
Its the 13th outdoors. 3rd August indoors isnt it.
Good decision not to open 6am on a Saturday as well.
Saying that only a complete bufoon would do that.
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Re: Coronavirus update
Ok, but Im not sure your experience relates to new research based prescription medicines. They are generally not launched on an EU wide basis. Currently the EMA approves such medicines for EU. However, that is just the first hurdle.Originally posted by Rjk View PostI'm just speaking from my experience, if the regulatory route for the UK diverges from the EU then it is more likely that it will delay launches here rather than accelerating them.
The medicines then have to be authorised for use by individual countries.. in our case in UK by NICE. Other countries have their own methods of putting products on an approved list. Then there is the matter of pricing. Unlike non prescription medicines each EU country can set an acceptable price for prescription medicines through negotiation with the manufacturer. In UK this is done via a system agreed between Pharma industry and government.
There are a lot of other variables that I won't go into now. Suffice to say that there is currently free movement of prescription medicines across EU but not free pricing, and this can lead to supply issues as traders move goods from a lower price country to a higher price one.
So, in my experience prescription medicines are launched to each individual EU country at variable times. From discovery the patent clock is ticking and Pharma does not wait, as you implied, in order to launch in bigger markets first. So you are wrong in thinking we would delay launch in UK because EU is a bigger market
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Re: Coronavirus update
you are just talking about the commercial agreements, whereas I was talking about regulatory approvals which is where the biggest impact will be of divergence from Europe.Originally posted by lisvaneblue View PostOk, but Im not sure your experience relates to new research based prescription medicines. They are generally not launched on an EU wide basis. Currently the EMA approves such medicines for EU. However, that is just the first hurdle.
The medicines then have to be authorised for use by individual countries.. in our case in UK by NICE. Other countries have their own methods of putting products on an approved list. Then there is the matter of pricing. Unlike non prescription medicines each EU country can set an acceptable price for prescription medicines through negotiation with the manufacturer. In UK this is done via a system agreed between Pharma industry and government.
There are a lot of other variables that I won't go into now. Suffice to say that there is currently free movement of prescription medicines across EU but not free pricing, and this can lead to supply issues as traders move goods from a lower price country to a higher price one.
So, in my experience prescription medicines are launched to each individual EU country at variable times. From discovery the patent clock is ticking and Pharma does not wait, as you implied, in order to launch in bigger markets first. So you are wrong in thinking we would delay launch in UK because EU is a bigger market
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Re: Coronavirus update
No I'm not. Im talking about getting individual country approvals following regulatory approvals. Commercial agreements are the next level down from country approvals and often there are no commercial agreements beyond the list price.Originally posted by Rjk View Postyou are just talking about the commercial agreements, whereas I was talking about regulatory approvals which is where the biggest impact will be of divergence from Europe.
Have you really had experience at launching prescription medicines??
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Re: Coronavirus update
some yes, more so in medical devices. it's the just the "first hurdle" bit that's the most important for me.Originally posted by lisvaneblue View PostNo I'm not. Im talking about getting individual country approvals following regulatory approvals. Commercial agreements are the next level down from country approvals and often there are no commercial agreements beyond the list price.
Have you really had experience at launching prescription medicines??
I'm sure. you're absolutely right that once regulatory approval is obtained for a new drug then country approvals will be pursued in many countries all at once.
if the UK has different regulatory requirements then there is a real risk that the EU and USA will be considered first and the UK amongst the follow up countries.
Happy to agree to disagree though.
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Re: Coronavirus update
Originally posted by Rjk View Postsome yes, more so in medical devices. it's the just the "first hurdle" bit that's the most important for me.
I'm sure. you're absolutely right that once regulatory approval is obtained for a new drug then country approvals will be pursued in many countries all at once.
if the UK has different regulatory requirements then there is a real risk that the EU and USA will be considered first and the UK amongst the follow up countries.
Happy to agree to disagree though.
Rjk....this business was my bread and butter for many years, and I have to tell you that you are wrong.
Lets leave it at that otherwise we'll be discussing forever, and currently I'm more interested in tonight's match against Fulham
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