Dear Ms Laverdière - This parrot is dead!

Diogenes's picture

Dear Ms Laverdière,

Re: Your private members bill C-398 -- An act to amend the Patent Act (drugs for international humanitarian purposes)

I promised not to mention this again, but you leave me no choice.

Although this bill died in parliament on a free vote, you and your colleagues keep bringing it up in Business of the House and in Question Period. Stop it please. This parrot is dead.

Let's review a little history here. In May 2005, Bill C-9, The Jean Chretien Pledge to Africa Act became law.

It is now called Canada's Access to Medicines Regime (CAMR). This legislation allows for the manufacture of patented drugs under a compulsory license by others (without patent holder consent) if it is for humanitarian purposes and if it is for a poor and/or developing country in serious need. This licensing is allowed under WTO rules.

A company that is granted a compulsory license can manufacture a patented drug and pay only a minimal royalty to the patent holders; typically a maximum of 4%.

This can mean substantial consumer savings, as high as 95% or more. This kind of price reduction is not unheard of when a patent expires on a patented drug. A pill that used to cost $20 can still be made and sold in a free market for $1 after it becomes a generic.

Since a compulsory license can deprive a patent holder of substantial income (though time limited), there are rules in place to prevent abuse.

The country in need must apply. A tender process for a specific quantity must be followed. The contract is monitored for fulfillment.


The Rwanda case study

Apotex, Canada's largest generic drug manufacturer, came up with a nifty AID/HIV retro-viral pill that combined 3 different active ingredients into a single pill. The problem was that each of the active ingredients was a patented drug, and each patent was owned by a different entity.

But CAMR was made for that purpose. In 2007 Rwanda made a request for the retroviral combo pill designed by Apotex. There was an open tender process that was followed.

Although Apotex had earlier stated that such a pill could be made and sold for 34¢ a pill, there was strong competition from India, which also has a healthy pharmaceutical industry.

Apotex won the tender at a price of 19.5¢ per pill.

The total turnaround time for the compulsory license to be issued was 68 days. Some government sources say the compulsory license approval was done in 15 days.

Apotex shipped 14.4 million of its Apo-Triavir pills to Rwanda.  This probably did save thousands of lives. Rwanda has continued the program with great success, with medicine now supplied from India. Some sources say that Rwanda is leading Africa in the fight against AIDS/HIV.

CAMR was a success that one time. It served a good purpose. Just because it has only been used once does not mean that it is flawed. The critics of CAMR claim that this is a sign of failure. They claim that the process is mired in too much government red tape and bureaucracy.

To date, the only people that experienced this government red tape and bureaucracy was Apotex.  But apparently they had a big, big problem with those government 'request for information' emails and letters and the interminable 68 day wait. Apparently Apotex has never had to wait for Employment Insurance.

You insisted that Bill C-398 was the answer. Repeal this, add that, and set up a website to insure that WTO rules are followed. Just relax the rules and regulations to remove the government red tape and bureaucracy so our generic drug companies can go about their business of saving Africa and the world from  AIDS/HIV, TB and Malaria.

You and your many supporters claimed that:

  1. Hundreds of thousands, maybe even millions of lives would be saved by providing low cost generic drugs to poor countries.
  2. It would not cost Canadians a penny - free humanitarian aid!
  3. It would comply with WTO rules.

Bill C-398 and it's predecessors were not about giving Canada's generic drug companies the right to export low cost generics to developing countries. These bills were all about granting our generic drug companies the right to make a patented drug without paying the royalties normally associated with a patented medicine. It is a special exemption for a special purpose.

The issuance of a compulsory license does not magically turn a patented drug into a generic drug. The patent is still in force.

Canada's generic drug companies are currently free to sell real generic drugs (i.e. where the patents have expired) around the world, the same as other generic drug companies in other countries. It is a free and competitive market.

It is also doubtful that Canada's generic drug makers make any drugs for treating malaria. There is no market in Canada for that. And although generic TB drugs have been available for a long time, it is also doubtful that our generic producers even bother with low margin products like generic TB drugs.

It is only for special cases that CAMR regulations are required, as was the case for the Apotex AIDS drug that was shipped to Rwanda.

Bill C-398 would have relaxed the rules so that a single compulsory license could be used to export a patented drug to any scheduled country without the requirement that the recipient country apply and without the oversight that CAMR now provides.

Now you and others want us to believe Canada somehow leads the world in intellectual property rights and management? That our politicians have discovered a way to save millions of lives and at no cost!? I even heard Stephen Lewis claim that Norway was waiting for Canada to lead by example in the passage of this bill. Puh-leeze.

Allow me to summarize what those 68 days of government bureaucracy and red tape back in 2007 have turned into:

  1. Three years and three failed bills - S-232, C-393 and C-398, along with many, many hours of wasted debate and committee work.
  2. 23,000 signatures and 20 MP's presenting petitions in the House of Commons just  in this session.
  3. Hundreds, maybe thousands, of rallies, news reports and media stories on this subject.

This has been such a remarkable waste of time and money on an effort to help Canada's generic drug companies to compete in a world market by rigging our patent laws (again) to give them an unfair advantage.

I hope you see the irony in the recent Supreme Court of Canada victory by Teva in killing the patent protection on Viagra, or the fact that six of our generic drug manufacturers have lined up to produce generic versions of Ocytocin, also known as 'Hillbilly heroin'.

Maybe it's a good time refocus and ask why the millions of Canadians who have to pay for their own generic drugs are still paying $5 or $10 for a drug that cost $1 in Europe or New Zealand.


Diogenes - a Canadian generic drug user