Looking to sell your medical devices or wanting to secure your pharmaceutical patents in Canada? The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) is designed to facilitate and boost your business opportunities in Canada’s healthcare industry.
For the pharmaceutical industry
For pharmaceutical products, CETA includes a form of sui generis protection between the EU and Canada commonly referred to as patent term restoration meaning that your pharmaceutical inventions now benefit from an additional protection in Canada. More specifically, if you face a loss in the effective life time of the patent due to the long process of obtaining a marketing authorisation for the pharmaceutical product, the sui generis protection will take effect for a duration equal to the time elapsed between the initial filing of the patent and receiving the marketing authorisation, yet not exceeding a period of two years in Canada, and five years in the EU.
The Government of Canada also provides Certificates of Supplementary Protection (CSPs), which serve as additional compensation schemes for time lost from the market authorisation process. See here [1] for additional information on CSPs and the application process for receiving one.
European Federation of Pharmaceutical Industries and Associations (efpia) and also Medicines for Europe, which represent national associations and leading pharma companies, positively welcomed CETA implementation. efpia considers CETA a step forward: “International trade is a key driver of growth, jobs and competitiveness for the research-based pharmaceutical sector in Europe. This underpins our industry’s mission to develop life-saving innovative treatments for patients, which is why the pharmaceutical sector strongly supports the CETA agreement.” Medicines for Europe views CETA as an opportunity to strengthen the European manufacturing base of the generic, biosimilar and value added medicines industries.
More information on research & development and innovation collaboration, funding, commercialisation and licensing opportunities in Canada can be found here.
For medical device producers
With CETA, the Canadian customs duties on medical devices and optical instruments are down to 0% from the previous maximum of 8% which gives new incentive to European exporters to Canada. Medical device imports to Canada are regularly increasing. In 2016 alone, imports rose from $6.5 billion to $8.6 billion, showing the growing presence of foreign-owned companies in Canada’s medical device sector.
To sell your medical device in Canada as a European manufacturer, you do not need to have an in-country representation in Canada. Nevertheless, you would need to submit a device registration application and hold a registration. You must also meet the regulatory requirements as defined in the Medical Devices Regulations. There are two types of licenses issued by Health Canada with different requirements: Health Canada Medical Device Establishment License (MDEL) and Health Canada Medical Device License (MDL). Read more about the requirements here and about the Canadian Medical Device Conformity Assessment System here.
Furthermore, Health Canada, the Federal department responsible for maintaining and improving healthcare in Canada, offers several funding programs, grants and contribution funding opportunities that are also useful for European businesses.
For health service providers
While CETA puts European companies on an equal footing with their Canadian competitors, governments may act in the public interest when regulating health, safety, environment, transport, education and energy services. For example, the EU (with the exception of BE, FI, NL and SE) has not opened up the cross-border supply of all health-related professional services, including those provided by medical doctors, dentists, midwives, nurses, physiotherapists, paramedics and psychologists which are required to have residency in EU territory to be able to provide their services in the EU. The EU Trade Commissioner Ms. Cecilia Malmström explained that “Public authorities – local, regional and national – will continue to have full freedom to organise public services as they wish.” Similarly, Canada reserves the right to adopt or maintain any measure concerning the provision of health services that are established or maintained for a public purpose. Nevertheless, European health service providers can seek and secure public procurement contracts in the Canadian health provision sector. A suitable starting point for European providers is Public Works and Government Services Canada, which provides an online procurement database [3] for numerous tenders, including in health service contracts. Various privately-held organisations can also make the procurement process easier, and give European providers access to a great number of healthcare facilities in Canada. These include networks such as HealthPRO or Medbuy, which can present competing bids to their member health facilities, in compliance with the equal footing provisions that CETA provides. European providers should also note that each province and territory in Canada manages its own healthcare system, including having their own procurement networks with differing protocols and procedures to take into account. Through these various paths, European providers can now access the Canadian market on an equal footing. [4]
Whether it is promoting your products and/or services, installing new business partnerships, or researching the market for opportunities, there are plenty of medical and pharma industry trade fairs taking place in Canada. Lastly, do not forget to contact your EEN Partner for future business missions and events.
[1] 2018: Government of Canada, www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates.html
[3] 2018: Government of Canada, https://buyandsell.gc.ca/
[4] 2017: “Selling to provincial, territorial and municipal governments,” https://canadabusiness.ca/government/selling-to-governments/selling-to-provincial-territorial-and-municipal-governments/
