Thank you very much, Mr. Chair.
Good morning. On behalf of the Canadian Generic Pharmaceutical Association and our member companies, I would like to thank you, Chair, and honourable members, for this opportunity to participate in your study of CETA, the comprehensive economic and trade agreement.
I'm joined today by Jody Cox, who is federal affairs director for the CGPA. She is responsible for our intellectual property and international trade files.
The generic pharmaceutical industry operates the largest life sciences companies in Ontario, Quebec, and Manitoba. We are Canada's primary pharmaceutical manufacturers and exporters, and are among the top R and D spenders across all industrial sectors. Generic pharmaceutical companies directly employ more than 12,000 Canadians in high-skilled research, development, and manufacturing positions. Our industry is a strong supporter of free and open trade. We export our high-quality, made-in-Canada generic medicines to more than 115 countries. We also procure raw materials and other imports for our medicines from around the world.
Canadian generic pharmaceutical manufacturers are globally focused, and all play an integral role in their companies' sophisticated global supply chains. This includes companies headquartered in Canada that are successfully competing in the global environment, as well as many of the world's leading generic pharmaceutical companies that have made strategic investments in Canada. The generic pharmaceutical industry also plays an important role in controlling health care costs in Canada. Generic drugs are dispensed to fill 65%—nearly two in three—of all prescriptions but account for less than 24% of the $22 billion that Canadians spend annually on prescription medicines.
Before moving on to the specific topic of CETA, I would like to provide a brief overview of the Canadian generic pharmaceutical industry's perspective on trade negotiations. The global generic pharmaceutical industry, as you might expect, is highly competitive. In order to operate in this environment, companies need to be able to access export markets for new generic medicine as soon as they open up to competition. Being late to the game generally means a permanent loss of potential market share that can never be recovered. The country's intellectual property regime for pharmaceuticals has a direct impact on the competitiveness of its domestic generic pharmaceutical manufacturing facilities. Generic pharmaceutical companies must navigate a domestic intellectual property system in order to manufacture for both its domestic market and its export markets. Companies typically have multiple manufacturing sites around the world, and the larger international companies have dozens of global manufacturing sites.
When changes are made to a domestic intellectual property system that create delays in when a generic medicine can be manufactured in a country, it becomes difficult for that country's domestic manufacturing facilities to compete effectively for new global R and D and production mandates from their headquarters. Excessive and conflicting IP requirements in trade agreements hinder competition and create barriers to trade for generic pharmaceutical manufacturers. Before CETA, Canada was already home to one of the strongest pharmaceutical IP regimes in the world. Canada's period of data protection, for example, was three years longer than that of any other country with a patent linkage system.
In addition, our patent linkage system created a great deal of unnecessary and costly litigation, because it did not bring finality to proceedings. This created an enormous financial risk for generic pharmaceutical companies that launched new generic medicines in Canada. It is the CGPA's view that too much emphasis in trade negotiations is placed on the wish list of rights-holders. More emphasis should instead be placed on the types of things that actually help to facilitate trade and would be beneficial to all life sciences stakeholders. These include things like regulatory cooperation, increased harmonization of regulatory standards, and mutual recognition of inspections.
Interestingly, the European Union's negotiations with the United States with respect to pharmaceuticals are focused in these areas, and not on intellectual property. The CGPA would like to see Canada take a similar approach in future trade negotiations.
I will now focus my remarks specifically on the CETA negotiations and the pharmaceutical aspects of those. Early in the negotiations, the European Commission tabled a series of proposals aimed at increasing pharmaceutical intellectual property measures for pharmaceuticals in Canada. This happened despite the fact that the actual pre-CETA market protected periods provided to brand name drugs in Canada were already consistent with the EU and about six months longer than in the U.S.
A study prepared for the CGPA by two leading Canadian health economists in early 2011 estimated that, if adopted, the proposals would delay the introduction of new generic medicines in Canada by an average of three and a half years. The cost to pharmaceutical payers of this delay was estimated at $2.8 billion annually, based on generic prices in 2010, and they've actually come down. In addition to increased drug costs, these original proposals would have had a major impact on generic pharmaceutical manufacturers. As I mentioned earlier, generic companies must navigate the domestic intellectual property system before they can manufacture for both domestic and export markets. Delays of this magnitude would have made Canadian generic manufacturers uncompetitive in attracting new R and D and production mandates to the country.
How did the CETA negotiations end up? The measures in the agreement, in principle, fall short of the European Commission's original and necessary demands on behalf of brand name drug companies. That's a good thing. But the measures will still delay market entry of cost-saving generic prescription medicines in Canada in the future. The full cost to Canadians of the actual delays in generic drug competition resulting from the new measures will depend on the specific manner in which they are implemented by the government.
The responsibility for the negotiation fell to Minister Fast and the Department of International Trade. The responsibility for ensuring the provisions are implemented in the least harmful way falls to Minister Moore and Industry Canada. That implementation is very critical to us. We are pleased that the government has made commitments for additional safeguards and reforms to Canada's pharmaceutical intellectual property regime to provide greater business certainty for Canadian generic pharmaceutical manufacturers. These commitments are actually outlined in a letter that Minister Fast sent to the CGPA.
I will quickly address each of the three areas, the first being the right of appeal. This was a very one-sided ask of the European Union. The Government of Canada understood there are major problems with our linkage system and the CGPA, as I said, has received written assurances from the Government of Canada that, in implementing the right of appeal that's spelled out in the treaty, it will also address the excessive and duplicative litigation by ending the practice of dual litigation. We welcome this. We've been advocating for these reforms for several years. Canada is the only country that allows brand name pharmaceutical companies to sue generic manufacturers multiple times on the same patents. This adds to the costs and risks of bringing generic drugs to the Canadian market.
While the specific implementation details will be crucial to the success of the reforms, we again welcome the commitment to reduce the burden on the courts, to bring earlier finality to pharmaceutical patent disputes, and deliver greater business certainty for generic companies in Canada. If implemented correctly, the reforms should end dual litigation and help protect Canadian consumers by ensuring invalid or non-infringed patents do not prevent cost-saving competition from coming to the market.
On patent extensions, we are disappointed by the inclusion of patent term extension in CETA. Given the overall strength of our Canadian intellectual property regime for pharmaceuticals, the adoption of such a measure was unnecessary. That said, as I said earlier, we do welcome some of the mitigating factors, including the government's commitment that the maximum length of extension—and this was in the technical document—will never exceed two years. The government has indicated that other predefined safeguards will also be part of the extension, reflecting the concerns that we raised. CETA sets an international precedent. It's the first trade agreement that permits an exception under the period of patent extension for the production and other activities related to the export of generic medicine. This provision recognizes the importance of Canada's generic pharmaceutical manufacturing to the domestic economy. If implemented correctly, this provision will help our members keep life sciences jobs in Canada.
We're pleased that CETA does not impose changes to the domestic data protection regime which were asked for by the European Union. We're disappointed, however, that the treaty obligations have been extended by three years to reflect current levels. From a global perspective, this is the first time that eight years of pharmaceutical data protection has been included in a trade agreement. It sets an unfortunate precedent for future agreements.
While the negative outcome of the CETA negotiations has been mitigated by the Canadian negotiators, the CGPA is also concerned about upcoming negotiations in the Trans-Pacific Partnership agreement. We are concerned that the hard-fought concessions achieved by Canada are not eliminated for pharmaceuticals. The TPP negotiations are complex and involve 12 countries with a wide range of economic and trade interests.
In the TPP negotiations, the U.S. has tabled measures that go far beyond the provisions tabled in CETA. We understand that this committee is planning a separate study on the TPP, and I would recommend that members play close attention to the pharmaceutical IP aspects of those negotiations.
In conclusion, I would say that the outcome of the pharmaceutical IP negotiations in CETA was mitigated by the Canadian negotiators and the minister, particularly when compared to the original proposals. However, as I said, it will cost Canada in the future with patent extensions.
I cannot stress it enough; proper implementation of provisions is key, and we are aware that the brand name pharmaceutical industry may attempt to undo many of the concessions and the commitments provided by the Government of Canada, particularly in regard to the patent linkage system. As such, we ask government members of this committee to ensure that pharmaceutical IP provisions are implemented in a manner both consistent with the new treaty obligations and in line with the commitments that the government has made to the pharmaceutical industry.
Jody and I would be pleased to answer any questions you have this morning.