so much for convenience...

layoutshooter

Veteran Expediter
Retired Expediter
What is different with Canada's "generic" law? How long does a pharma company get to hold a patent? Do they get enough time to recover the cost of new drug development? Does it cost as much up there to bring a new drug to market? Do they get sued as much?
 

OntarioVanMan

Retired Expediter
Owner/Operator
This is a very lengthy read but it explains the differences that allows generics in Canada so early....
Not to worry ALL generic drug suppliers MUST pass Canada's standards of quality and manufacturing....it is called the yellow list....sellers just can't buy them from any lab and have them made without being approved....

http://www.hazzardandhore.com/docs/papers/p7.pdf
 

layoutshooter

Veteran Expediter
Retired Expediter
This is a very lengthy read but it explains the differences that allows generics in Canada so early....
Not to worry ALL generic drug suppliers MUST pass Canada's standards of quality and manufacturing....it is called the yellow list....sellers just can't buy them from any lab and have them made without being approved....

http://www.hazzardandhore.com/docs/papers/p7.pdf

Does early removal of patents allow for enough time to recover costs? What kind of pharma industry does Canada have of their own?

I am not so much concerned with the quality in Canada, I am sure it is on par with down here. It is the production/research side I am more concerned with.

The cost to bring a new drug to market is beyond sane now. How can a company stay in business if they are unable to recoup those costs?
 

OntarioVanMan

Retired Expediter
Owner/Operator
I am reading bill C-22 came out of the Shamrock Summit with then President Reagan during PM Mulrooney days..you know Irish Eyes....Reagan actually suggested Canada toughen its laws to protect the pharma industry...but Canada would have none of instead it appears drug companies can get up to 4% of the royalities from the active ingredient..

It also appears the same 20 year patent rule in both countries....the dif being if the generic manufacture applies for early entry...the pharm company can opt out of the 20 yr deal and take the 4% forever....instead of getting nothing after 20...
 
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layoutshooter

Veteran Expediter
Retired Expediter
I am reading bill C-22 came out of the Shamrock Summit with then President Reagan during PM Mulrooney days..you know Irish Eyes....Reagan actually suggested Canada toughen its laws to protect the pharma industry...but Canada would have none of instead it appears drug companies can get up to 4% of the royalities from the active ingredient..

It also appears the same 20 year patent rule in both countries....the dif being if the generic manufacture applies for early entry...the pharm company can opt out of the 20 yr deal and take the 4% forever....instead of getting nothing after 20...


I wonder how that 4% thing works out for them? I wonder if that is enough to cover costs, allow for profit and have enough for further research? Do Canadian pharma companies put out a lot of new drugs?
 

OntarioVanMan

Retired Expediter
Owner/Operator
I wonder how that 4% thing works out for them? I wonder if that is enough to cover costs, allow for profit and have enough for further research? Do Canadian pharma companies put out a lot of new drugs?

all the same as down here...BM, Phizer...and ya know they ain't suffering...4% of say 10B a year forever or until the competition comes out with a new one...
 

layoutshooter

Veteran Expediter
Retired Expediter
all the same as down here...BM, Phizer...and ya know they ain't suffering...4% of say 10B a year forever or until the competition comes out with a new one...


It costs a billion or more to bring a drug to market and can take decades. Just wondering out loud, I wish I had the answer. I don't like what we have now but everything else I have seen is really no better.

It would seem to be if that system worked as good as some think that there would be a thriving independent pharma industry based in Canada, not connected to companies down here.
 

OntarioVanMan

Retired Expediter
Owner/Operator
It costs a billion or more to bring a drug to market and can take decades. Just wondering out loud, I wish I had the answer. I don't like what we have now but everything else I have seen is really no better.

It would seem to be if that system worked as good as some think that there would be a thriving independent pharma industry based in Canada, not connected to companies down here.

I think there is..only off shore....there appears to be an organized Lab and manufacturing base...to meet high standards and self policing....The Jan drug site lists these...
 

layoutshooter

Veteran Expediter
Retired Expediter
It is a web they weave Joe...a lot of drugs are not made here or there...it is just who holds the rights to market them....NOT where they are made...

I am lost but that is nothing new. Maybe we need to get a really big island somewhere, call it Pharmaland, have all the research done there, no national taxes. No army, no roads, no welfare to support. Just pure research without any government interference.

Governments could set quality standards for importing drugs from Pharma land.

I wish I had the answer. I would not be sitting here posting right now if I did!!
 

OntarioVanMan

Retired Expediter
Owner/Operator
I am lost but that is nothing new. Maybe we need to get a really big island somewhere, call it Pharmaland, have all the research done there, no national taxes. No army, no roads, no welfare to support. Just pure research without any government interference.

Governments could set quality standards for importing drugs from Pharma land.

I wish I had the answer. I would not be sitting here posting right now if I did!!


you and me both buddy...:D


But wait...Greg knows everything and he drives a truck... ;)
 

greg334

Veteran Expediter
Layout, OVM, you both need lessons on how the system works.

The billions that are spent are recouped without a doubt - don't buy into the propaganda. There is a cost analysis done when the compound is discovered to "cure" something and then after the phase I studies are done at almost all the companies. A lot of drugs never make it out of Phase I and if they do, a lot more are killed in Phase II and III studies.

Here in the US more money is spent on marketing form the top ten companies than on drug R&D. Many of the drugs that don't make it through Phase II and III can end up at other companies to be developed and marketed, one company just specialists in that - buying rights to patents and doing the development phases for the New Drug Application.

Canada, the UK, the EU and Japan are the leading countries where they have equal or better requirements for drug approval than the US. Japan is a PIA when it comes to the quality of the study where we don't always care and so is the EU, they have ripped into one company about their applications and lack of efficacy support. But on the other hand they also approve a lot more drugs than we do here because the FDA and the drug companies "work together" on key issues to get through the process and the independence is lost with our FDA. Also don't forget, we also fast track Drug Applications to get the drug on the market which we shouldn't do as much as we should not allow advertising of drugs.
 

layoutshooter

Veteran Expediter
Retired Expediter
I said that I don't understand it. I was just asking out loud.

I doubt if it is simple though. Problem that there are few, if any, unbiased sources to learn how it works.
 

greg334

Veteran Expediter
I know, I was just living up to my reputation of being condescending and arrogant - I can now check that off my things to do list for today.
 

layoutshooter

Veteran Expediter
Retired Expediter
I know, I was just living up to my reputation of being condescending and arrogant - I can now check that off my things to do list for today.

OK, that is acceptable. I would make other remarks but I am in my NICE stage!! LOL!! :p
 
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