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[lisvaneblue]

that'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.

Well I ran the commercial side of the UK division of a large Pharma company and maybe I got it wrong for 30 years

[Rjk]

Well I ran the commercial side of the UK division of a large Pharma company and maybe I got it wrong for 30 years

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.

[lisvaneblue]

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.

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.

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

[Rjk]

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.

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

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.

[lisvaneblue]

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.

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.

Have you really had experience at launching prescription medicines??

[Rjk]

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.

Have you really had experience at launching prescription medicines??

some 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.

[lisvaneblue]

some 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