Evidence of meeting #37 for Industry, Science and Technology in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was generic.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Susan Goebel  E. coli Project Manager, Bioniche Life Sciences Inc.
Jim Keon  President, Canadian Generic Pharmaceutical Association
Rob Livingston  Vice-Chair, Federal Affairs Committee, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Normand Laberge  Vice-President, Federal Government Affairs and Federal Provincial Territorial Relations, Canada's Research-Based Pharmaceutical Companies (Rx, & D)
Linda Gowman  Chief Technology Officer, Trojan Technologies
Howard Alper  Chair, Science, Technology and Innovation Council
Heather Munroe-Blum  Member, Principal and Vice Chancellor, McGill University, Science, Technology and Innovation Council
Clerk of the Committee  Ms. Michelle Tittley

May 8th, 2008 / 11:25 a.m.

Linda Gowman Chief Technology Officer, Trojan Technologies

Thank you.

I think you have our submission before you.

Mr. Chair, members, it's a privilege to be here today.

Trojan Technologies is based in London, Ontario, and has been treating water with ultraviolet light since 1977. Trojan Technologies remains a Canadian corporation, although in November 2004, with annual sales of roughly $100 million, the company was wholly sold to Danaher Corporation of Washington.

Our growth has continued at a double digit rate, and our global reach is expanding. The majority of our roughly 500 employees are located in London, Ontario. Our sales are heavily global, and we have installed technology on every continent. Our considerable focus on research and development has allowed us to continue to innovate to bring clean water to an increasingly water-stressed world. We believe that out-innovating our competition is a key strength of our company.

Trojan Technologies has always invested heavily in S and T, but S and T isn't just about doing beautiful research or building wonderful technologies; often it's about building the market itself, and doing that profitably. Research itself--and we do fundamental research sometimes--can't be justified in business if it cannot be tied to business expectations. How, then, can we enhance S and T initiatives in Canada to have greater impact on our global competitiveness?

Challenges in successful S and T initiatives can often exist for us on the deployment end. Once the research and development is done, new environmental technologies need to be tested and purchased by a few alpha sites before they are readily accepted by others and before a market can develop. There is a requirement here for government agencies at many levels to facilitate the testing and adoption of new technologies by having qualified staff capable of conducting testing and rendering decisions of suitability in a timely fashion. The world economy is becoming ever faster paced, and timeliness of technology validation cannot be measured in years, or parts of years, when the natural scientific timelines do not warrant such delays.

In addition, staff at government agencies must be sufficiently educated and informed to be able to request or receive information to make informed judgments. The more educated and skilled these adjudicators are, the less risk there is for all. Education and skills should be obtained with the recognition that we are a small economy in a global sense, that consolidation of regulatory requirements within Canada is efficient, and that we must avail ourselves of the knowledge and practice that exists globally.

From a client’s perspective, purchasing new environmental technology can be seen as being a bit risky. Government incentives for the purchase of new environmental technologies can be very helpful in changing the perceived risk for a purchaser.

This sort of program in the U.S. was highly beneficial to Trojan 30 years ago when we started building the technology and market for our products. Such programs, if continued throughout the environmental sector, would likely serve to stimulate more innovation and, equally importantly, establish a climate within Canada for acceptance of innovation. The new technology, demonstrated to work in real life within Canada, becomes saleable internationally, helping to grow the Canadian economy.

The first installations are key, and these demonstration sites continue to be vital for our industry. Wouldn’t it be nice if the first full-scale demonstrations of Canadian technology were easier to conduct in Canada than elsewhere? This does not mean that regulations and requirements for technology should be slack. Canadian regulations should be robust, and regulators and their staff should be informed, aware, and empowered, and execute their roles quickly and thoroughly.

On the front end of S and T we work with Canadian and international universities, tending to go where the expertise exists. Trojan benefited significantly in its infancy by participating in IRAP, whose small grants helped to fund essential research when moneys were extremely tight. The best experiences were always those that were executed quickly.

As the company has grown and become more profitable, SR and ED tax credits are a very efficient and effective means to support research and development. It is our recommendation that this tax credit remain.

The challenges in working with universities surround negotiations around intellectual property rights and managing public disclosure of findings that give strategic business advantage. In addition, the timelines of industry and those of universities are sometimes not aligned. We see the same challenges internationally, but perhaps therein is the possibility to distinguish ourselves as a country. There is a change at universities in Canada toward welcoming industrial participation in research, and that is very good because it is our collective knowledge, our collective value-added, and our collective focus on targeted research that will accelerate the innovation process.

Perhaps agencies such as NSERC, CIHR, SSHRC, and others could facilitate industrial researchers' participating at Canadian universities by offering career awards in the form of salary contributions toward qualified industrial researchers who wish to spend sabbaticals at Canadian universities. Bringing industrial researchers closer to universities and their students will also show graduate students that a life in research can mean a life in business and entrepreneurship, impacting global problems and benefiting the Canadian economy.

We have shared a few experiences and thoughts with you, hoping to be helpful. We are privileged to have been given this opportunity to participate in this forum.

I thank you.

11:30 a.m.

Conservative

The Chair Conservative James Rajotte

Thank you very much for your presentation.

We'll now go to the members for questions. Mr. McTeague, for six minutes.

11:30 a.m.

Liberal

Dan McTeague Liberal Pickering—Scarborough East, ON

Thank you, Chair.

Thank you, witnesses, for being here at our meeting today. This is a very important area that we haven't covered in some time.

I'll go directly to you, Mr. Keon. Your presentation pointed out the changes to the NOC regulations. I have had discussion with other members here about this. In essence, if I am to take you correctly, it reopens the loopholes on the subject of evergreening, something that certainly I thought had been addressed some years ago. Not only that, but I thought the balance had been seen in giving the brand name industry data exclusivity. That was a way of saying we're going to take away what appears to be an opportunity for the brand names; at the same time, we're going to provide them with that exclusivity.

I note that the research component as a ratio of their investment is down. I also note that Apotex, according to what our own Library of Parliament has pointed out, is at 17.6% in terms of R and D as a percentage of revenue.

Going back a few years, I remember that seniors, provinces, and a number of organizations came together to decry this. Most notably, the Supreme Court of Canada referred to the practice of evergreening as draconian. I was very surprised to see, following these things as closely as I do, that in the actual edition...or the first Gazette of this proposal—without much consultation, I add—the government freely admits that there will be delays in the generic market entry and that there will be costs associated with these delays.

Can you give us an idea of what the cost is going to be, given that there was anticipation, certainly by the provinces, that this practice would not be reallowed through the back door?

11:30 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

Thank you.

Yes, I mentioned briefly in my comments that we were very disappointed in the changes. You're right, in 2006 the government had taken steps to seal off evergreening, to make it much more difficult to add on patents. And then after the government did that, the Supreme Court validated that and said yes, that was the law.

The government has said that anything prior to 2006 that was on a patent list at Health Canada--which gives a brand company an automatic right to stop a generic--can go back on the list. So we're very concerned; we think the regulations are difficult to interpret, but right now our patent experts are telling me that very large drugs that have not yet been genericized could get extra protection through these extra patents.

Take a drug like Lipitor, which has sales of $1.1 billion. Again, if I just do a very rough calculation here.... I mentioned earlier that we've negotiated new pricing regimes with Ontario and Quebec, so the generics are down to no more than 50% of the brand. As soon as we're able to come to market, on Lipitor alone we will bring savings of $500 million to $600 million a year--that's on one drug--for the health care system.

So these are very large numbers we're talking about here. The provinces, as we know, pick up most of the drug costs in Canada for seniors and people on social assistance.

11:35 a.m.

Liberal

Dan McTeague Liberal Pickering—Scarborough East, ON

How much notice were you given by the government about these changes in the RIAS?

11:35 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

We were given no notice. And from talking to the provinces, I believe they were given no notice either.

11:35 a.m.

Liberal

Dan McTeague Liberal Pickering—Scarborough East, ON

Mr. Livingston, I want to ask you a question.

In previous times we dealt with products like Taxol. We dealt with Losec in the past, because it was an issue that did come up with respect to evergreening. These types of issues tend to be almost causes célèbres.

In the case of Taxol, members of your industry claimed a patent that was actually produced, created, and paid for by American taxpayers. It was later determined by the Supreme Court of Canada that in fact one of your member companies didn't have the right to it. The company that produced it in St. Catharines--the riding of a chairman who was previous to Mr. Rajotte--was allowed to in fact proceed with the product.

We also have the issue of Losec. Before, your members gave testimony to the fact that none of these products were produced in Canada. No research was done in Canada. Not even the packaging was done in Canada.

If you're asking for greater patent protection, and you're asking for more opportunity to extend to 20 years, why should Canada give you that extension when you're not prepared to make the investments in R and D to begin with?

11:35 a.m.

Vice-Chair, Federal Affairs Committee, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Rob Livingston

Normand can talk to the industry level.

In terms of investment in Canada and actually products produced, we at Merck Frosst have a very large therapeutic research centre in Kirkland, with about 300 world-class citizens. We've developed about half a dozen products there over the years: Blocadren, Timoptic, Flexeril, Singulair, Arcoxia, and now Laropiprant.

I think there are some good examples of Canadian developments in Canada. As well, we have been investing about $120 million a year in Canadian R and D. That's more than $2 billion over the past 15 years. We put that research facility in as a result of the government's announcement to enhance patent protection.

So I think there are some good examples of where there has been some direct benefit from that patent protection.

11:35 a.m.

Liberal

Dan McTeague Liberal Pickering—Scarborough East, ON

On that subject, Mr. Livingston, could you or Mr. Keon tell us about the impact? For instance, Mr. Keon talks about Lipitor with respect to British Columbia, which has already anticipated what the cost savings are going to be if these changes in regulations are in fact reversed.

Can anybody give us a description of what impact it's going to have on their provincial health care budget?

11:35 a.m.

Conservative

The Chair Conservative James Rajotte

Mr. Keon.

11:35 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

I would just repeat that the product Lipitor is the largest-selling product in the history of pharmaceuticals. Canada-wide sales are $1.1 billion. In British Columbia, sales would be over $100 million. Delaying a generic for a year or two years adds an extra $50 million a year, if we assume the price would be roughly half the current price. That's $50 million a year in British Columbia alone for that one product.

11:35 a.m.

Liberal

Dan McTeague Liberal Pickering—Scarborough East, ON

Thank you.

11:35 a.m.

Conservative

The Chair Conservative James Rajotte

Thank you, Mr. McTeague.

We'll go to Monsieur Vincent.

11:35 a.m.

Bloc

Robert Vincent Bloc Shefford, QC

Thank you, Mr. Chair.

My question goes to Mr. Livingston. In 1987, when the Patent Act went into effect, you predicted that you would be investing 10% in research and development. Last year, you were only at 8.5%, and, in 2006, at 8.1%.

How do you explain this drop in the ratio of research and development to sales of patented products in recent years? Why has the proportion of research and development gone down? You predicted 10% and you reached 8.1%. Why?

11:40 a.m.

Vice-President, Federal Government Affairs and Federal Provincial Territorial Relations, Canada's Research-Based Pharmaceutical Companies (Rx, & D)

Normand Laberge

I will answer that question.

The commitment of the member companies of Rx&D was indeed to raise the average ratio of research to sales to 10% before 1996. We actually fulfilled that commitment in 1993. We met the target, and it continued to increase to almost 12% or 13% in 1997-1998, after which it began to drop. But, averaged over the last 19 years, the ratio exceeds 10%. The exact figure is 10.17%.

The environment in which we work has changed a great deal in recent years. There have been regulatory challenges, such as market access because of the drug review, or the price freeze that was imposed, and they have changed the situation. At the same time, other countries have been able to attract more research dollars by changing their regulatory approaches as well as their patent protection programs. Our member countries are trying worldwide to attract those dollars, but they are having difficulty doing so because, as a result of the changes, the Canadian market is less appealing. Nevertheless, we maintained our average at 10.17%. We want to increase that average and to change the situation. The decline is explained by the changes in the regulatory framework in recent years.

As an example, I should mention that the changes Quebec made to its drug program very quickly brought in $650 million in investments. So you see the direct impact of regulatory changes. The recent change caused the drop. So there is a way to level the playing field, and that is what we are suggesting. We want to become partners and good ambassadors for Canada internationally and we want to attract those new dollars.

11:40 a.m.

Bloc

Robert Vincent Bloc Shefford, QC

Research and development expenditures for pharmaceutical patents reached $1.2 billion in 2006, but only $232 million was invested in new products, or less than 2% of Canadian sales.

Can you explain why only $232 million have been invested in new products?

11:40 a.m.

Vice-Chair, Federal Affairs Committee, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Rob Livingston

Just to clarify, I think what you're referring to is that in the PMPRB report they break down that total R and D spent. Of the $1.2 billion, they categorize it as “discovery”, “applied”, and “other”. I think the issue is the discovery component, that $232 million, which represents about 20%. Is that enough?

If you look globally at the allocation of the total cost, because there's not only the discovery, there are various steps--you have the discovery, and then you have the development, and then you have the approval of the drug.... I've been trying to find the latest statistics, but historically the drug discovery component usually runs at around 25% to 30% of those total costs. There are various steps involved in that, where you identify a disease, where you identify potential candidates, where you do some safety testing. Then if you have candidates that it appears are going to be safe and work for a condition, you then start the development process. That development process is where you try it in patients who have the disease, you try it then in healthy patients, and that's where the cost starts to grow significantly. So the fact that it's $232 million is probably maybe a little on the low side, but not that far off what it is globally.

Certainly at our facility in Montreal the majority of our $120 million is in what you'd call the basic research, but you still have to have the development component as well before you can get a drug on the market.

11:40 a.m.

Conservative

The Chair Conservative James Rajotte

There is one minute left.

11:40 a.m.

Bloc

Robert Vincent Bloc Shefford, QC

Mr. Laberge, you mentioned earlier that 20,000 jobs were highly skilled. How many of those jobs are in manufacturing?

11:40 a.m.

Vice-President, Federal Government Affairs and Federal Provincial Territorial Relations, Canada's Research-Based Pharmaceutical Companies (Rx, & D)

Normand Laberge

Almost exactly half the jobs in manufacturing companies are in direct research. On the manufacturing side, these are high-tech jobs requiring a high degree of knowledge because the industry is highly regulated. In basic manufacturing, the jobs are fewer in number, it is true. Our companies work in innovation. They are more focused on research and development than manufacturing. So regulation and patents are very important. We are in partnership with the knowledge industry to a greater extent than with manufacturing. That is what sets us apart, and it is why our recommendations seek to change this aspect in order to attract research dollars and high levels of income. The average overall salary level for our employees is much higher than the Canadian average. These are jobs that require a high level of knowledge; they are not by and large manufacturing jobs.

11:45 a.m.

Conservative

The Chair Conservative James Rajotte

Merci, monsieur Vincent.

We'll go to Mr. Carrie, please.

11:45 a.m.

Conservative

Colin Carrie Conservative Oshawa, ON

Thank you very much, Mr. Chair.

I want to thank the witnesses for being here for this very important study on science and technology. It hasn't been done in a long time, and I think it's important now that government starts to look at this to see how we can start stimulating more science and technology development here in Canada.

I'd like some clarification on a statement. In Mr. Keon's brief here, he made a statement, basically, that increased intellectual property protection had not led to increased domestic R and D spending for the pharmaceutical industry. He talks, as Mr. Vincent said, about this 10%. It says that big pharma is breaking its R and D commitment to Canadians, less than 2% of sales revenue is spent on basis research into new drugs, Canada's pharmaceutical R and D spending is well behind other countries, and that most new drugs are not truly innovative.

As we're looking at this right now, from listening to Rx&D, it seems there's one side of the argument, and from listening to the generics association, there's the other side of the argument. I was wondering if you could clarify both of your viewpoints on this very important statement, because government does play an important role in the work that both of you do. We're trying to do the best we can, but there seems to be a conflict in your opinion on that statement.

Is it true increased IP protection does not lead to increased domestic R and D and spending? Is that true, Mr. Keon? Could you start?

11:45 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

Yes, thank you.

The data that we present in our brief come from the government agency, the Patented Medicine Prices Review Board. Those are not our data; they're data that it reports every year. I think we had provided to the clerk this morning a chart that basically shows that subsequent to Bill C-22 and Bill C-91, going back 20 years and then 15 years, the commitment of 10% in R and D--the research companies' commitment--has fallen below that for several years now.

So I guess our message to the committee would be to be very careful about buying that argument. It doesn't seem to have applied in Canada. We have seen, over the years, consecutive increases in patent protection through regulations, data protection, etc., yet the R and D numbers are not there.

One of the other messages I want to get to the committee today is that when we're looking at science and technology, Canada has a very strong generic drug industry. We should be proud of that. We have 10,000 or 11,000 jobs, many of them in manufacturing, many of those in the manufacturing sectors and areas that are being hard hit now with the Canadian dollar and losing jobs, which is one of the reasons we're concerned about the changes. But we're spending money on research and development. We're developing our products in Canada. Fifteen percent of our sales is going back into research and development for new products. They're being exported.

So when we develop intellectual property policy, we need to have a balance in Canada, and that balance has to be in terms of protection versus competition. We're arguing that the competition from generics is very valuable to Canada as well.

11:45 a.m.

Conservative

Colin Carrie Conservative Oshawa, ON

But are you saying that the generics are spending more money in research and development, percentage-wise, than the researchers, the Rx&D?

11:45 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

Yes. It's almost double.