Canadian Patent Rule Would Delay Generics
8 CommentsBy Ed Silverman // May 6th, 2008 // 12:03 pm
A new set of patent rules proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, The National Post reports. And generic drugmakers, not surprisingly, are warning the effort will cost consumers and taxpayers tens of millions of dollars annually.
The government says the regulations would simply restore fairness and stability to the brand-name industry after two court rulings put unexpected new curbs on the practice of “evergreening,” which involves filing new patents on a drug in an attempt to stave off generic competition. Generic drugmakers say the move is an unjustified sop to the brand-name industry, the paper writes.
“It completely surprised us. We had no inkling it was coming,” Jim Keon, president of the Canadian Generic Pharmaceutical Association, tells the Post. “The provincial drug plans (which pay for many medications) are really going to feel this in a big way.”
The affected drugs have combined sales of more than a $1 billion a year and generic versions are up to 50 percent cheaper than the brands in some provinces. But Deirdra McCracken, a spokeswoman for Industry Minister Jim Prentice, tells the paper the new regs are just an attempt to uphold government policy as it was before the court rulings, and avoid abrupt changes to the pharmaceutical market.
“Canada currently has a reputation as an internationally competitive location for innovation and investment,” she tells the Post. “To ensure that reputation stays intact, we need predictable and stable intellectual property laws.”
In the tangled world of drug patent law, the suggested new regulations have a complex background. In 2006, the government cracked down somewhat on evergreening. Still, brand-name drugmakers are often able to obtain a two-year, court-ordered stay on generic competition while patent disputes are adjudicated.
In October, 2006, amendments included a grandfather clause that allowed new patents filed before June of that year to stay on the books. A month later, though, the Supreme Court of Canada brought down a decision that said many new evergreen patents were improper. The Federal Court later applied the reasoning in a separate decision.
Such court judgments could result in “sudden and unexpected loss of market exclusivity for a number of innovative drugs,” Industry Canada says in a preamble to the new reg. The changes would override the rulings and allow Industry Canada to keep the grandfathered patents on the books.
While the amendments could result in “delayed savings” to consumers and provincial drug plans, they are needed to maintain the industry’s confidence in Canada as a place to invest and introduce new products, the department’s statement says.
“The government never intended this part of the [2006] regulations to apply retroactively, since this would have been inequitable,” Jacques Lefebvre, spokesman for Canada’s Research-Based Pharmaceutical Companies, tells the Post. “This will in no way prevent the generic drug makers from entering the market after the expiry of patents.”
Lefebvre noted that the prices for generic meds in Canada are among the highest in the industrialized world. Meanwhile, Keon says the changes were likely the result of lobbying by brand-name companies, according to the paper.
Lobbyists for the industry association, according to a federal registry, include two prominent Conservatives. Goldy Hyder is a Tory strategist and was chief of staff to Joe Clark, then opposition leader, in 2001-2002. Geoff Norquay was director of communications in the office of Stephen Harper, the Prime Minister, in 2004 and 2005, the Post writes
Dan
Long article I wrote not long ago about generics, which should be more accessible than they are. If you read it, thanks for taking the time to do so:
An Improvement to a Flawed System
More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable, for one reason. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System.
Not long ago, generic meds were not prescribed that often, or produced to a great degree because of the cost of bringing such a med to the market, which required the same protocols as branded meds until 1984, when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer. The reduced cost of generic production allowed for more of these meds to saturate the market, and doctors started prescribing more generic meds as a result. Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds, through such tactics as reformulation, which is called Evergreening, of their meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason.
Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.
Former pharma Marketing Exec
Very good article Dan.
I think the Canadian government is penalizing themselves with this ruling, after all it is a subsidized drug market in Canada.
Stephen Harper however, is way too friendly with the Bush administration. There is a dangerous trend to try and foist the lousy US health care system on to unsuspecting Canadians.
Hopefully this will herald the much needed wake up call to our friends north of us.
C. Alexander Brown
We have one of the world’s best medical system. The Neo-Cons who have taken over the Progressive Conservative party and their provincial governments counterparts have been doing their best to sell it off piecemeal to their rich buddies and US based companies. And quietly, they are among George W. Bush’s best international friends.
Bruce
Hi Dan and FPME
Being a Canadian ex-pat in the USA, I have mixed emotions about the change.
Dan, A very good article. What is your profession, if I can ask?
One clarification, in Canada, generic drugs are generally 60 to 85% the cost of the branded drug.
I think this investment in the intellectual-based industry of research based pharmaceuticals is a better one than the continual “investment” in the automotive industry.
I am sure there is a statistic somewhere from Rx&D, but I think that there are more pharma employees in Canada that are paying much more in taxes than in the automotive industry.
I just read this back and it sounds like I am a PR person, but I am not.
But like FPME said, the main difference between the Canadian and US market, is that the Canadian market is a cost-center and the US market is a profit-center.
With Harper having a minority government, I doubt that any concrete changes to the Health Act would cause the opposition to have a vote of non-confidence and he would be foisted on his pittard!
Dan
To Bruce,
I’m a middle aged man with no profession presently, yet I am an author and healh care advocate on the internet as a medical writer. Before that, I worked for three of the largest pharma companies in the world for over a decade. That ended when I became aware.
But let me add I’m not angry or bitter about the pharma industry or the health care system for that matter. Both are important and necessary. My desire is to improve what we need, and presently I do that through the written word.
Thanks for asking. I enjoy reading the comments of others more than my own, though. Very knowledgeable readers out there,
Dan
LILLI
To Dan,
How have you improved the medial profession and pharma companies in providing ethical medthica care?
Bruce
Hi Dan,
I was curious about your background as you are well informed and have an opinion. It is kinda refreshing on the internet.
We probably have worked for some of the same companies. Good luck with your “mission”!
Dan
To Lilli and Bruce,
It’s an attempt by me (and others) to create awareness, in my case, through the written word, for many others to possibly acquire knowledge. I may be dreaming, but perhaps in the future U.S. citizens will take action to prevent harm to the public health. Presently, I believe people accept what they are told, and should question more, perhaps, for thier own benefit as well as others. My opinion.
As far as ethics and pharma, this use to exist, and for it to be resurrected, it will require a major paradigm shift to the point of a revolution, which is another opinion of mine.
Thanks for the questions,
Dan