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CANADA’S GAME CHANGER
CANADA’S
GAME CHANGER
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When it comes to the protection of life sciences intellectual property (IP) in Canada, the executive director of research and development at Amgen Canada believes that it is a factor confronting Canada’s ambition to be a global life sciences leader.
“Canada is losing ground on global R&D investment,” says Dr. Clive Ward-Able. “We must find a way to turn that around.”
One of Canada’s shortcomings is an IP policy framework that lags behind other nations, putting us at a disadvantage when competing for a share of the estimated $100 billion that is invested annually in pharmaceutical research around the world.
As negotiations progress towards the completion of the Comprehensive Economic and Trade Agreement (CETA) with the European Union (EU), there is renewed hope in Canada’s research community that stronger IP standards are on the way as part of the deal.
But negotiating competitive IP rights in a free trade agreement is generating considerable concern among certain factions, notably anti-trade activists and the generic drug industry.
Ward-Able says that a strong, stable and consistent set of parameters to protect the work that goes into R&D is critical to securing economic growth in Canada. Since R&D creates IP, the protection of IP plays an important role in the work done by the life sciences sector in Canada, and the benefits of that work are far reaching.
“Canada does perform good research,” Ward-Able says. “We can bring innovation to the world, but it’s also about attracting investment into our country. When that investment comes, a lot of the skills and expertise it creates gets shared.”
Canada certainly has a lot of work to do to be competitive with the IP standards of our major trading partners, such as the EU, the United States and Japan. For example, among G7 nations, Canada is the only one that does not provide any form of patent term restoration to compensate for patent time lost during the lengthy approval processes and clinical trials.
International investors will put their money where they have the best chance to recoup their investment, and competitive IP safeguards are a significant factor in their decision making.
Attracting research is becoming very competitive globally. Companies are looking at many factors that differentiate one country from another when it comes to placing resources and investment, including the cost, speed and quality of the research and also the ability to recoup those costs over a longer period of time.
“If you don’t have good IP protection, you can anticipate less R&D investment,” says Ward-Able. “Many nations around the world are realizing that the more R&D they do in their country, the more benefits there are for everybody. So many countries are strengthening their IP policies to attract more research dollars, particularly from multi-national companies.”
Canada wasn’t always in this position.
There was a time when our domestic policy environment encouraged investment in pharmaceutical development, and Canada was a real player in the competitive global race for research funding.
CETA is a tool, say researchers, which will help swing momentum back in Canada’s favour.
The wide-ranging free trade agreement is a priority for Canada’s government. International Trade Minister Ed Fast often asserts liberalized access to a market of 500 million people in the EU, the world’s biggest single market, will mean a $12-billion boost to the economy and the creation of 80,000 new jobs.
Canadian officials are hoping CETA can be finalized by the end of the year, as the parties have already agreed on many key issues. But among the sensitive issues remaining on the table is the strengthening of Canada’s life sciences IP standards.
The EU position is to bring IP safeguards in Canada to the same level as its own by extending protection of clinical trial data from eight to 10 years, introducing patent term restoration, and creating an effective right of appeal for innovative pharmaceutical companies in patent invalidity proceedings.
From the perspective of Canada’s Research-Based Pharmaceutical Companies (Rx&D), CETA presents an excellent opportunity for Canada to take a bold step forward. The economic advantages of more liberalized trade with the world’s single largest free market are obvious to most Canadians. But equally important is the economic and healthcare benefits that come with competitive IP safeguards – a notion supported by 75 per cent of Canadians according to a July 2012 Nanos Research poll.
“Upgrading Canada’s IP policies will promote innovation and investment from global markets, a critical step in building Canada’s knowledge-based economy,” says Russell Williams, president of Rx&D. “When Canadian life sciences companies innovate, they improve the lives of individuals and families across this country. The aim of life sciences is to develop new treatments that result in better health outcomes, thereby contributing to health system sustainability and saving lives.”
It has been a generation since Canada engaged in any kind of meaningful improvements to its patent policy. Back in 1987, Prime Minister Brian Mulroney strengthened patent protections as part of his government’s effort to stimulate the economy by encouraging job creation and investment in R&D.
In the 25 years since then, pharmaceutical R&D investment has increased 1,500 per cent, from $93 million in 1987 to more than $1.3 billion in 2010.
According to Williams, this translated into improved healthcare for Canadians while creating good-paying high-tech jobs, stimulating the economy and making Canada more competitive in life sciences. The strategy worked, but other countries have continued to improve IP and investment in Canadian R&D has declined in recent years.
“Interestingly, the arguments we are hearing against CETA today were the same arguments used by critics 25 years ago,” says Williams. “But they were wrong back then, and they are equally wrong today. The historical impact of better IP is clear.”
The hope in Canada’s research community is CETA will help turn the tide of declining investment and allow Canada to re-establish itself among the global leaders in life sciences innovation.
Adopting the standards in place in the EU will position Canada to attract not only international dollars, but also the top minds
based economy,”— Russell Williams
L: Dr. Clive Ward-Able, executive director of research and development at Amgen Canada. Photo courtesy of Amgen Canada. R: Neil Maresky, vice president of scientific affairs with AstraZeneca Canada. Photo courtesy of AstraZeneca Canada.
who are seeking a productive and supportive environment where their work makes a difference.
“Intellectual property is the cornerstone of our business and of applied research,” says John-Michel T. Huss, president and CEO of Theratechnologies. “We want to make sure whatever we discover benefits people. If it is increasingly expensive and takes a prohibitively long time to commercialize, then investors won’t be willing to expend the capital necessary to fund the research.”
For small biotech firms like Montréalbased Theratechnologies, it is vital that Canada be more competitive for international life sciences investments.
Huss says small biotech firms are the future of pharmaceutical development, but they need investor support to realize their full potential.
“If we don’t have strong IP, we simply
won’t get investments,” he says. “Small biotech firms are completely dependent on outside investors to raise money for R&D. But if you have weak IP, you won’t raise any money, and without the funding we won’t be able to develop new drugs.”
Not only would stronger IP inspire a wave of innovation in the development of new drugs, but it would drive economic development.
The innovative pharmaceutical industry employs more than 12,000 Canadians in more than 50 companies located across Canada, in addition to even more indirect jobs across the country in universities, charitable organizations, research agencies, and in healthcare.
These are the types of jobs upon which economic growth can be built. At Theratechnologies, all 30 employees are university-educated, and roughly half of them have PhDs.
However, if Canada continues to allow its IP regime to erode relative to the world, those jobs will begin to evaporate. In fact, it has already begun.
AstraZeneca Canada has experienced firsthand the effect of Canada’s weak IP safeguards. Recent court decisions have undermined confidence in Canada’s enforcement regime and created unacceptable uncertainty for pharmaceutical companies.
The launch of generic products mimicking AstraZeneca drugs prior to patent expiry have led to job losses and a decline of AstraZeneca’s R&D investments in Canada.
“We have experienced dramatic and immediate market erosion because of weak IP enforcemen here in Canada,” says Neil Maresky, vice president of scientific affairs with AstraZeneca Canada. “This sends a strong message globally that Canada does not protect patents effectively and therefore is no longer a stable market in which to invest.”
Enhanced IP safeguards are fundamental to reversing that trend and propelling Canada back as a world leader, attracting and retaining world-class medical researchers and creating a knowledge-based economy essential to driving economic prosperity.
A key part of that is rejuvenating clinical trials in Canada, which are known to create a culture of excellence wherever they are carried out.
“Canada possesses a critical mass of worldclass universities and research hospitals with the ability to lead global clinical trials,” says Maresky. “But Canada is facing significant challenges. As the cost of clinical trials climbs relative to countries in Eastern Europe, South America and Asia, Canada’s lagging IP regime makes the business case for investing that much harder.”
Strengthening Canada’s IP is a key factor in encouraging global corporations to invest in early and late stage research in Canada, says Maresky. And that means more clinical trials that bring with them broad benefits beyond the pharmaceutical industry.
“Clinical trials allow patients involved to be the first to benefit from new medical breakthroughs,” Maresky says. “They also provide important scientific opportunities for Canadian researchers and medical practitioners to develop expertise and advance their knowledge.”
In short, all of Canada benefits when a policy framework is put in place to encourage more research, more innovation and more international investment.
Huss agrees with the assessment that Canada is currently losing ground on the international stage. More competitive IP could be a game changer, and would help to elevate Canada’s status to a global leader.
“If we align ourselves and do the right things with good researchers, good physicians and good pharmaceuticals, we can put Canada back on the map,” Huss says. “It’s an increasingly important industry that improves the local, provincial and national economies.”
“Health should be a strategic concern for all nations. Canada is not competitive and it should be. It can be.”
“Adopting the standards in place in the EU will position Canada to attract not only international dollars, but also the top minds who are seeking a productive and supportive environment where their work makes a difference.”— Russell Williams
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