Oct. 27 (Bloomberg) – Taiwan plans to start making Tamiflu, the most effective treatment for bird flu, in December although the government hasn’t obtained a license from Roche Holding AG for producing it. [/quote]
Bootleg vaccines for saving lives, how interesting. Are private companies too greedy? Will this help Taiwan make any international friends?
Well, if I understand it at this point they still could get a license before they actually start making it. (though if they can’t get a license they’ll probably make it anyway)
Hmm, as someone who is generally hard on piracy this is a very interesting topic for me. I say if you’re Taiwan you fight like hell to get some legal access to the drug, but in the meantime get your facilities ready just in case the situation demands it. If there are signs of a major breakout, Taiwan really has no choice but to fight it however they can, legal or not. If it comes to an epidemic situation, the people aren’t going to care about the legallities or the drug companies’ profits.
One needs to look at this issue in a proper context. Here are excerpts from an earlier related report. It’s no longer available on the web so I’m posting a good chunk of it. Hope I’m not violating any intellectual property.
Drug industry tries to avert bird flu PR disaster
20 Oct 2005
Reuters
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON, Oct 20 (Reuters) - Drug industry executives are working overtime to prevent what could be a positive news story on bird flu from turning into a public relations disaster.
…
Switzerland’s Roche Holding AG <ROG.VX>, which makes the best of the products, Tamiflu, finds itself on the defensive as critics demand it allow production of generic versions, in a row echoing past patent controversies over AIDS.
…
Roche says it can satisfy current levels of demand for a normal flu season and deliver on stockpiling orders it has received from governments around the world.
That is not good enough for the likes of U.S. Senator Charles Schumer, who called this week for the Swiss group to license production of Tamiflu to five U.S. drug companies within the next 30 days.
The World Health Organisation, meanwhile, says there are not nearly enough supplies of Tamiflu and other antivirals …
…
Under World Trade Organisation (WTO) rules, governments can issue so-called compulsory licences, allowing others to produce a patented product without consent of a foreign patent owner.
Normally, there must be an attempt to negotiate a voluntary licence but in a national emergency that step can be bypassed in order to save time, though the patent holder would still be entitled to a payment, according to the WTO secretariat.
FEELING THE HEAT
James Love, director of the Consumer Project on Technology, a U.S. lobby group, believes every government that does not have sufficient stockpiles on Tamiflu should now be issuing compulsory licences.
“Roche is clearly feeling the heat, but also falling well short of the measures that would best protect the public health,” he said in a statement.
The U.S. government came close to over-riding Bayer AG’s <BAYG.DE> patents on Cipro in 2001 during the scare over anthrax in the postal system before deciding it was not necessary.
For drug companies … the Tamiflu controversy is worryingly reminiscent of the furore over AIDS treatments.
The industry famously mishandled an AIDS dispute five years ago, by contesting a South African law to loosen patent restrictions and suing Nelson Mandela’s government.
…
Kofi Annan, the secretary general of the United Nations, warned earlier this month he did not want to see intellectual property obstructing the supply of flu drugs to the poor in the same way.
From what I’ve been reading in the papers, there is no way that Roche can even make enough Tamiflu to use as a speed bump at the location where the virus initially breaks out. It seems the stuff doesn’t have an especially long shelf life. Just the other day, mainland health authorities were complaining because the small stocks that were sent to them by Roche were just weeks away from their expiration dates (Roche sent them its oldest stock). I think that if H5N1 continues to spread so quickly among migratory and farm birds, a lot of governments will say to hell with the patent and then make their own. I don’t think that would be a bad thing at all if the virus continues to spread like it is now. Any IP lawyers in the house who could make an educated comment on this situation?
Countries like Taiwan are lucky to have the necessary technology to copy the drug. Think about what’s going to happen to the third world countries that don’t. People are going to drop dead like flies if an epidemic breaks out.
Here’s today’s update from the Taipei Times. Essentially, it appears that Taiwan is going ahead with preparations to make its own generic version, including buying enough raw materials for 2.3 million doses, in order to pressure the manufacturer Roche into speedy approval of a license and/or favorable pricing thereof.
My understanding is that the patent holder still gets paid when countries like Taiwan decide to override the patent and grant licenses to produce a drug domestically due to public health emergencies. In Taiwan’s case, if negotiations with Roche broke down, the IPO authority would issue a ruling setting the amount of compensation to Roche.
I’d be interested in opinions from some of our own pharmaceutical industry professionals and IP lawyers on this issue.
Yes, they stand for proteins on the surface of the virus which enable it to attach to host cells, in the case of H, or exit the cell upon production of new viral particles, in the case of N.
I think in this case it is more like a “taking” of private propery by the government for the common good. It occurs quite often in America. Don’t know about other countries.
Often the landowner is offered" fair market value" for the property and if they refuse the government “takes” or condemns the land and still gives the owner “fair market value”.
I don’t see any wrong in doing that in this case, millons of lives could depend on it.
[quote=“bobl”]I think in this case it is more like a “taking” of private propery by the government for the common good. It occurs quite often in America. Don’t know about other countries.
Often the landowner is offered" fair market value" for the property and if they refuse the government “takes” or condemns the land and still gives the owner “fair market value”.
I don’t see any wrong in doing that in this case, millons of lives could depend on it.[/quote]
However, the people who paid the R&D fees to develop it, and planned to profit greatly for their efforts probably see something wrong with it.
Despite that, Roche is doing the right thing:
[i]"Swiss drug maker Roche Holding AG reiterated on Sunday that it is looking for outside producers for its Tamiflu drug, amid skyrocketing demand amid concerns about a possible pandemic caused by bird flu.
“We are currently assessing which organisations and countries have the ability to supplement our own capability,” Roche Chairman Franz Humer said on the sidelines of an event in Shanghai.
and
Some countries, such as Argentina and Taiwan, have said they will prodcue their own version of Tamiflu.
Humer said the decision whether or not countries should stockpile the drug was up to individual nations.
“Countries need to make up their own mind what they intend to do,” he said. "[/i]
Yes, they should get paid “fair market value”, as was stated in my analagy, but when they planned to profit from this drug, it was only to help relieve some symptoms of the common cold. I’m sure helping prevent or lessen a global pandemic was not on their radar screens then.
Hopefully they will release it on their own and earn much “goodwill” , but I still think governments have the right to takings in cases like this.
But how do you determine fair market value? In many cases for drugs, life expectancy of the patient and labor figures into the market value.
One shot a season for a lifetime of an average Taiwanese and labor cost.
Since the method to making this vaccine is somewhat archaic labor could be quite high. A fertilized chicken egg is infected with the virus for 6 months. At which time the virus is harvested from the egg whites and neutralized to make the vaccine.
AC, are we talking about the same thing?
I was referring to Tamiflu, an antiviral drug.
There is no vaccine for bird flu yet. Only for the regular flu.
Tamiflu lessens the effects of the flu after you get it.
How much of this “technique” is made available to local mfg
Let’s see if Roche ever gets compensated if the gov. goes ahead with production
Anyway, many local mfg are not fully (as in to FDA standards) GMP compliant so good luck on the quality of the output.
So much for IP protection. Great message to send to companies if your trying to get them to begin to invest in Taiwan facilities or to have Taiwan become a center for R&D.
BTW (to all), I’d suggest we keep this thread focused on the Taiwanese political aspects of the bird flu issue, and discuss other aspects in the above linked Health thread.