Coronavirus update - NO MORE RESTRICTIONS

[Rjk]

Probably a good decision as we would be last in the queue for distribution as an ex-member state. Also Germany, France and Holland have already committed to purchase 400m doses of the AZ vaccine and this will be folded into the EU numbers.

Knowing a bit about the European medicines supply chain and regulatory issues around licensing of new products I reckon we are better doing our own thing

I know a bit about the regulatory requirements as well, why do you think we are better doing our own thing?
if we had different regulatory requirements to the EU then nobody is going to target our market first, they would go for the EU first then look at what they would need to do to launch in the smaller markets afterwards

[lisvaneblue]

I know a bit about the regulatory requirements as well, why do you think we are better doing our own thing?
if we had different regulatory requirements to the EU then nobody is going to target our market first, they would go for the EU first then look at what they would need to do to launch in the smaller markets afterwards

Assuming no deal Brexit we will have different licensing and MHRA will be responsible for approval new medicines and issuing MAs. The UK gov is setting about streamlining the UK approval process so it may be that we give approval for Covid vaccines ahead of the EU. EMA will no longer be in control of UK.

Pharma will launch first in markets that give earliest approvals. They will also have a commitment to pre-orders as and when approval is granted. UK is an attractive market as it is a reference point for many countries for approvals and price.

Also the manufacture and distribution will be phased, it's not as if they will drop 400m doses off at a warehouse in Germany.

[Rjk]

Assuming no deal Brexit we will have different licensing and MHRA will be responsible for approval new medicines and issuing MAs. The UK gov is setting about streamlining the UK approval process so it may be that we give approval for Covid vaccines ahead of the EU. EMA will no longer be in control of UK.

Pharma will launch first in markets that give earliest approvals. They will also have a commitment to pre-orders as and when approval is granted. UK is an attractive market as it is a reference point for many countries for approvals and price.

Also the manufacture and distribution will be phased, it's not as if they will drop 400m doses off at a warehouse in Germany.

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.

[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.