Mr. Chairman and members of the committee, it is with great pleasure that we appear today on behalf of Pharmascience before the Standing Committee on Industry, Science and Technology.
Before we share with you our recommendations to improve and modernize Canada's health product regulatory system, I'd like to first introduce our company and underline its unique contribution to the Canadian pharmaceutical industry and economy.
Pharmascience is a privately owned, entirely Canadian pharmaceutical company founded in 1983 by my father, Morris Goodman, and his partner and fellow pharmacist, Ted Wise, with a goal to offer high-quality, accessible and affordable pharmaceuticals to Canadians and global citizens. Our headquarters and manufacturing facilities are in the greater Montreal area. Over time, our growth has been very significant, and we've become the largest pharmaceutical employer in Quebec, all categories confounded, with a workforce exceeding 1,500 employees.
Through our affiliate Pharmascience International, we export close to $100 million of high-quality, Canadian-manufactured pharmaceuticals to more than 60 countries. Our exports have been growing above 10% per year for the last few years.
Less well known is our contribution to pharmaceutical R and D. We have invested more than $250 million over the past five years in R and D initiatives, which places Pharmascience among the top 10 investors in our field in Canada, and we have been ranked in the top 100 by Report on Business Magazine every year for the past five years. We employ close to 200 people in our R and D lab in Candiac, Quebec.
Pharmascience's R and D contribution goes far beyond product development and formulation. We are currently supporting and sponsoring a major clinical trial in partnership with the Montreal Heart Institute and Dr. Jean-Claude Tardif, its principal investigator.
The COLCOT trial, which we're involved with, will be a global, randomized trial of colchicine, an old agent used in the treatment of gout and in the prevention of morbidity and mortality outcomes related to cardiovascular diseases. This trial generates a great deal of interest in the international cardiology community. It will last 20 years and could shape the prevention and treatment of cardiovascular disease, which remains the number one cause of human death at the global level. Of significant importance, colchicine is a very affordable drug and would not pose the sort of financial challenges to health care budgets that we have become accustomed to with many new specialty drugs. The contribution of the COLCOT trial to Canada's health care system could be unique. Without Pharmascience's support, this trial could not have been undertaken. It is made possible because both the Montreal Heart Institute and Pharmascience are so deeply rooted in the Montreal community.
What truly distinguishes Pharmascience from almost all other pharmaceutical companies operating in Canada is the fact that what we produce and commercialize in Canada and abroad is essentially reinvested here to create wealth and economic growth locally. No foreign-owned company can offer this sort of contribution to the Canadian economy, with all the decision-making done locally.
This outstanding business contribution to the Canadian economy is completed by our philanthropy. More than $70 million worth of drug products have been donated by Pharmascience through Health Partners International of Canada to more than three million people in more than 100 countries since 1985.
The Goodman Foundation has supported the creation of the Goodman Pediatric Formulations Centre at the CHU Sainte-Justine in Montreal to help support the development of child-friendly formulations of essential drug products. The foundation is also a major supporter of the Rosalind and Morris Goodman Cancer Research Centre at McGill University, and is a major donor to the Université de Montréal's faculty of pharmacy, where the main agora bears our name.
While Pharmascience is considered a large player in the Canadian generic space, we remain a small enterprise at the global level. Yet the future of our company will largely rest on our ability to grow in global markets and to create wealth in our country by exporting high-quality, Canadian-manufactured pharmaceuticals. It is from this perspective that we'd like to contribute to the work of your committee, to bring the perspective of a fully Canadian enterprise.
I'd like now to identify a few areas that Pharmascience views as needing significant regulatory modernization and improvement for small Canadian businesses that are involved domestically and globally in the pharmaceutical field.
First we will speak about how Health Canada's regulatory role is essential, and we are the first ones to recognize it. Health Canada has also pledged, as a fair regulator, to apply equal standards to all manufacturing facilities, domestic or foreign, and we have no doubt about its intent to do so.
However, our perception is that it has in fact been difficult to maintain an equal playing field between Canadian and foreign facilities regarding compliance audits. This can have a very significant competitive impact on Canadian manufacturers, which, because of their greater accessibility, are under direct control by Health Canada; whereas foreign facilities are certified indirectly through foreign regulators. In this context, it's difficult to fully harmonize application of the standards.
Our experience is that this has played against Canadian manufacturers such as Pharmascience, a situation that can greatly hurt our competitiveness and ability to create growth and wealth and reinvest it locally. We would ask that this matter be addressed jointly with Health Canada.
Submission fees are also now charged systematically to Canadian manufacturers of pharmaceutical products seeking a regulatory authorization to commercialize products. These fees can be substantial and are applied with a one-size-fits-all approach aimed at ensuring procedural fairness. The fee structure does not distinguish enough between large, small and very small enterprises, and it's not adapted to potential market size and anticipated product revenues. Consequently, submission fees can be disproportionate barriers to the decision to bring in a new product or formulations that would fulfill important health care needs.
The best examples of that are the pediatric formulations. Pediatricians in Canada have complained for more than 30 years that critical drugs they need to prescribe for infants or children are not available in child-friendly formulations and need to be compounded by pharmacists or parents before they are administered to children. Many of these products are available in other international markets. However, manufacturers are de-incentivized from bringing such pediatric formulations to market in Canada. Most of the time, drugs are off patent, and the costs of developing a new formulation would be impossible to recover in small, low-price markets such as those existing in pediatrics.
A solution would be to waive submission fees for pediatric formulations. Such an exception would be perfectly consistent with the public health objective to enhance the availability of child-friendly formulations. We need to have this discussion with Health Canada. Successful development of pediatric formulations will also require a specific pricing grid from the pan-Canadian Pharmaceutical Alliance, and federal and provincial drug pricing negotiation bodies where the federal plans are represented.
International harmonization is also a major goal of agencies such as Health Canada, and there are many trusted regulators with which it could be possible without impeding on public protection. However, we continue to experience multiple examples of Canada-only product standards, such as specifications or in-process testing standards, which make efficient production and market supply difficult, when not outright impossible. We must remember that Canada only represents 1% to 2% of the global pharmaceutical market. A greater collaboration effort to align with trusted regulators is essential.
The list of topics could be longer, but to foster a useful discussion with members of the committee, we'll limit ourselves to the above.
In closing, and before addressing members' questions, I wish to reiterate our gratitude for the opportunity to share our suggestions with the committee, and to assure you of Pharmascience's commitment to co-operating with Canadian governments—federal, provincial and territorial—in the pursuit of our common objectives of local economic growth and wealth creation in the health care field. Thank you.