moved that Bill C-274, an act to amend the Patent Act, be read the second time and referred to a committee.
Mr. Speaker,it is a pleasure today to rise and speak about the very important private member's bill that I first introduced in the House in November 2004. The bill is quite simple. The beginning of the bill provides certain definitional changes that are necessary for purposes of clarification, but the real essence of the bill is a small paragraph in bold at the very end, which states:
The Patented Medicines (Notice of Compliance) Regulations are repealed.
I hope that the spirit of cooperation on moving bills forward to committee will be extended to this very important initiative. I think Canadians deserve to know that the politicians they elect take issues seriously, especially when those issues hit them right in the pocketbook.
The cost of pharmaceutical products has been on the rise in recent years. The current regulatory regime puts an upward push on prices, which results in average Canadians not only paying more through their benefit plans or at the pharmacy counter, but also through their tax dollars that support our public, universal health care system.
Before going too far, I want to talk about what this bill is not about. The bill is not about reducing patent protection for innovative pharmaceutical companies. The bill is also not about taking sides in the ongoing war of words and actions between brand name and generic pharmaceutical industries and producers in this country.
This bill is about making sure that the pharmaceutical industry is treated like all other industries before the law. That is what will benefit Canadians most. Currently there are loopholes, which means that both industries can use a variety of tactics which keep lower cost generic drugs off the market longer than the patent period and encourage litigation and waste of money and time.
The amount of legal machinations that are employed as a result of these regulations is sickening because of the money that is wasted, money that could be better spent on development and innovation, on getting generic versions to the market, and lastly, on getting people the medications they need to treat their illnesses.
Ensuring fair competition is an important public policy of this country. However, our drug regulation regime fosters anti-competitive behaviour. The end result is that Canadians suffer en masse.
Drugs are the fastest rising cost component in our health care system. I believe that we all have a duty in this Parliament to try to address this in the larger context of improving the affordability of our public medicare system. In fact, I believe it is part of saving it in order to ensure that we pass on this national treasure and heritage to our children and our children's children.
Consumers pay more for their drugs than they should have to, particularly for some of the drugs most needed by Canadians. When drug monopolies are extended past the 20 year patent period, consumers, patients, governments and our health care system pay more for drugs, because generic drugs are priced on average 40% to 55% lower for the same brand version of a drug. It has been estimated that the various legal techniques used have cost close to $1.5 billion since the regulations came into effect just over 10 years ago.
No other Canadian industry has similar regulations. This is isolated and alone and exceptional, so how does this happen? Why has the Liberal government allowed $1.5 billion of Canadians' money to go into the pockets of the mostly multinational pharmaceutical companies?
It happens because the regulations, known as the patented medicine notice of compliance regulations, or PM(NOC) regulations, allow it. Even though they legally are abusive and generally damaging, these regulations have been in place in their existing form for over seven years. To date the government has not changed those regulations.
The purpose of the regulations was and continues to be to develop a balance between the competing interests of the brand and generic industries. Unfortunately, they have the ability to do the exact opposite. Successive Liberal and Conservative governments have chosen to sweep this important public policy issue under the carpet and also keep Parliament in the dark.
Let me give members a little bit of history. The regulations we are talking about now are relatively new in a Canadian context. They took their first form in 1993 with Bill C-91 and have been the subject of several regulatory changes since that time.
In the past, the Canadian government saw a key role for itself in limiting market monopolies in pharmaceutical products. Compulsory licensing was used, which meant that a generic could compete with the lower priced versions. In 1985, a federal commission of inquiry known as the Eastman commission, set up by Trudeau's government, concluded that: the use of compulsory licensing had saved hundreds of millions of dollars, no adverse impact on the research of the pharmaceutical industry happened, and nor were the decisions of multinational drug companies regarding investment in research and development affected by this regime.
But with pressure from the U.S. around the 1988 and the Canada-U.S. Free Trade Agreement and NAFTA in 1994, Bill C-22 and Bill C-91 radically altered the way Canada deals with pharmaceutical patents. The 17 year patent protection became 20 years. Products, not just processes, could be patented, and compulsory licensing was completely removed with Bill C-91.
A federal commission of inquiry today would likely find the opposite of the 1985 findings to be true. The radical shift in government policy, largely the result of pressure from the United States in negotiating free trade deals, has undermined the possibility for our government to retain some element of real control over pharmaceutical prices to ensure Canadians have access to affordable pharmaceuticals at the pharmacy counter and in our public health care system.
What do the regulations do? The easiest way to describe the regulations from a consumer's perspective is that through a variety of legal techniques which even the government itself has tried to stop but has failed in the courts, brand companies are able, if they choose, to delay generic drugs entering the market. How does this happen?
The Liberals would like us to believe it is a very complicated system that is best left to the bureaucrats. I would say it is only complicated if we believe that the bureaucrats are the best people situated to make decisions on behalf of the country. The truth of the matter is that the industry that regularly ranks first among all Canadian industries in terms of profitability, whose main operation is to repackage drugs that are actually researched, developed and manufactured in other countries, continues to get its cake and eat it too.
The regulations got off to a very bad start in the dying days of the Mulroney government when Bill C-91 was rammed through Parliament when the PM(NOC) regulations were instituted without any public consultation through the normal gazetting period. All of the changes since have been regulatory. This means that the representatives of the people in the House had no opportunity to debate them in a binding way. As a result, generic manufacturers have been kept off the market in a couple of different ways through what is known as evergreening and automatic injunctions.
Automatic injunctions allow brand companies to allege patent infringement when a generic applies for a notice of allegation. This process in and of itself would be relatively harmless if the real problem of determining what kinds of patents are allowed to be listed on the patent register were clear, but they are not.
A brand name can list many different patents for the same product by claiming different uses, patenting different forms, such as capsules or tablets, changing the name of the drug, or in the past, the name of the drug company. There sometimes are numerous patents that can hold up a generic from entering the market. In addition, the courts have interpreted that the regulations allow brands to list all of these multiple patents even though in one case the judge reported that it was “opposite to logic”.
Although the generics eventually win in 75% of these cases, they are on average kept off the markets between 15 and 21 months when the automatic stay is applied for. However, when we look at a few blockbuster drugs, we can see that when it is more profitable, brands have been able to maintain their monopoly for up to four years on average by applying for automatic injunctions on patents that it is fairly obvious have been strategically registered to maintain their monopoly and maximize profits, at the expense of consumers and our drug industry.
Is rewarding an innovative manufacturer with strong patent protection such a bad thing? No it is not, but that is not what we have with the PM(NOC) regulations. Instead we have a system that continues to add virtual patent extensions without accompanying results in research and development or domestic manufacturing.
It is important to note that not all brand companies employ such abusive tactics and are not actually in keeping with good business principles and the spirit of the regulations. The problem, however, is that it does not stop all those and a certain amount of patent infringements or claims have delayed generic versions in some of the worst situations costing hundreds of millions of dollars.
In 2003 the Patented Medicine Prices Review Board, the primary independent policy tool available to Canadians to examine how brand companies operate, reported that of 103 patents added to the patent register, only 16 were new active substances. Patents are being registered for uses not approved by Health Canada, for new coatings, and changes to active ingredients. This is not innovation; this is just delay.
The brand companies promised us innovation when the PM(NOC) regulations were first introduced. They continue to maintain that they are the only way to allow them to do innovative R and D in this country. Even with the favourable regulations today, which the brands actually do support, they have been failing to meet the commitment they made to Canadians of a ratio of 10% R and D to sales for the last three years.
In 2003 brand spending on research and development fell to its lowest level since 1989. Spending on basic research continues to be the smallest portion of R and D. In 2003 it actually fell by over 9%. Over half of the R and D spending was on clinical trials. Meanwhile they spend tons of money and an exorbitant amount of resources on marketing and advertising to people.
In a 2003 study by Research Infosource a generic company placed high, ranking at number 13 of Canada's top 100 corporate R and D spenders. This is the first time a generic company has ranked higher than a brand company. This clearly indicates it is not just the brand companies that can make exclusive claims to R and D expenditures as a justification for the system.
The president and COO of that highly ranked generic company made a presentation at the June 2003 industry committee hearings. That person in favour of a review, in favour of eliminating the automatic injunctions and the need for stronger regulations to prevent evergreening and argued that more R and D would happen on the generic side if the situation resolved.
Why should automatic injunctions and evergreening concern us here?
Drug prices are the fastest rising component of our health care system. The average price of a drug produced by a brand company increased by 75% in the decade between 1993 and 2003. In the same time period generic drug prices only increased by 42%. Generic drugs are part of the solution to keeping drug prices under control.
The system and the regime needs to change. Recently there have been many calls from a variety of sources not only for a review of the regulations but also to make sure that regulations allow for accelerated access to non-patented drugs.
We must make a real effort to improve this situation. Those who can least afford it are suffering the most because of the abusive strategies that are legally used under the PM(NOC) regulations.
Canadians, benefit plan workers, benefit plans themselves, employers and all levels of government that purchase pharmaceutical products for delivering public health care are hurt the most under the current regulatory regime. In fact, it often leads to labour disputes because benefit packages are one of the most contentious issues among organized workforces and their employers. Generic companies which may be prevented from entering markets and thus are losing potential revenue at least have an opportunity to sue for damages when they are put off in the market, but the Canadian public does not.
Brand drug companies can be investigated by the Patented Medicine Prices Review Board and if they are found to be selling at excessive prices, they are asked if they will voluntarily pay back the money. This is called a voluntary compliance undertaking, known as VCU. There is, however, no mechanism for this money to be reimbursed to consumers, drug benefit plans, or even provincial governments. All the money simply goes back into the Liberals' general coffers. There is not even a guarantee that the money will be spent on health care.
The consumers at the most vulnerable state overpay for drugs; the companies pay that money back and it goes to the government, not back to them. That is unconscionable and it should be corrected.
The PM(NOC) regulations are above and beyond what we is required in terms of patent protection for the pharmaceutical industry.
Public policy objectives must be more important than pressure from multinational companies. Any changes to the regulations must address the most important public policy objective when it comes to pharmaceuticals: making sure that Canadians and our publicly funded health care system have access to affordable drugs.
Just last September the Liberals promised to work with the provinces. The first ministers task force on developing a pharmaceutical strategy has as one of its nine key components to accelerate access to non-patented drugs. In order for that to happen the PM(NOC) regulations in their current form have to be eliminated.
Some independent sources have reviewed this issue over the last several years. One of the more interesting ones came from stock analyst Hemant Shah from the Wall Street Journal :
The anti-generic strategy by pharmaceutical companies has probably the highest rate of return of any business activity they do right now.
That shows the demonstrated awareness of Wall Street on what the practices of the industry have been through these regulations to maximize their profits at the expense of people.
I will conclude with the following quote from Dr. Marcia Angell, who is former editor-in-chief of the New England Journal of Medicine :
Nothing drug companies do is as profitable as stretching out monopoly rights on their blockbusters. Extending that privileged time by a variety of stratagems is the most innovative activity of big pharma. For blockbuster drugs, it is certainly the most lucrative.
The health and welfare of Canadian citizens, and with an aging population, the requirement of access to drugs and medicines to treat their illnesses is a paramount issue not only for our generation but also for the future of Canada and saving its medicare system. Let us stop the abuse and make sure that we innovate and do not litigate.