Canada’s Evolving Regulatory Landscape


CANADA FlagCanada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public. Beginning with the amendment of the Food and Drug Act in 1939, in which Canada’s government was authorized to regulate the conditions of sale of any drug likely to be harmful to health, the Canadian government has played a vital role in helping its people improve and maintain their health.  In the 1953 revision to the Food and Drug Act, the government was approved to inspect all drug manufacturing plants. The government worked with representatives from the Pharmaceutical Manufacturers’ Association of Canada (PMAC), now known as Innovative Medicines Canada, to not only establish the manufacturing standards, but also train the inspectors.1 Further collaboration with PMAC led to the development of good manufacturing practices (GMPs), which came into effect in 1981 in Canada.1 Today, Health Canada continues evolve its regulations to address current and new treatment options, and ultimately safeguard public health.

Regulatory Approvals and Harmonization Efforts

There are more than 400 new products in development in Canada with the majority of the products in the early stages of research and development.2 Canadian companies develop a variety of products in a host of therapeutic areas, including infectious diseases, diabetes, inflammatory disease, cardiovascular disease, blood disorders and HIV. Similar to other countries, Health Canada scientists must assess the safety, efficacy, and quality of pharmaceuticals as required by the Food and Drugs Act and Regulations. Once a drug has successfully gone through the drug review process it can be authorized for sale in Canada. In 2016, Health Canada authorized a total of 38 New Active Substances,* 150 new generics, 1 new biosimilar, and new indications for 2 previously authorized biosimilars. 3 

Yet in 2015, for drugs approved in Canada and in the EU or the US or both, the mean delay from first submission in the foreign jurisdiction until submission in Canada was 540 days, and the approval process for a drug in Canada was approximately 90 days longer than the processing time at FDA or EMA.4  Delays in submission to Canada maybe the result of various factors, such as a company’s reduced capacity for submissions.

In order to improve the submission process, Health Canada and FDA are working together on various joint initiatives. First, FDA and Health Canada are in the process of implementing a common electronic submission gateway that would provide companies the opportunity to submit documents simultaneously to both agencies. FDA and Health Canada are also seeking to harmonize their Good Manufacturing Reports, to prevent duplication, ultimately reducing public and private compliance burden. This initiative is being undertaken as part of FDA’s and Health Canada’s participation in the International Coalition of Medicines Regulatory Authorities (ICMRA)

ICMRA is a voluntary, strategic coordinating, advocacy, and leadership entity of national and regional medicines regulatory authorities who 1) collaborate to provide direction for a range of areas and activities common to many regulatory authorities’ missions and goals; 2) identify areas for potential synergies to be made; and 3) leverage existing efforts to maximize the global regulatory impact. ICMRA first convened at the DIA Annual meeting in Washington, DC in 2015 and continues to use DIA’s global forum as a platform to disseminate updates to the public.  In the most recent update at the DIA 2017 Global Annual Meeting in Chicago, Health Canada’s Assistant Deputy Minister, Mr. Pierre Sabourin noted that Canada is leading the ICMRA big data/pharmacovigilance working group, studying ways to use high volume data for making regulatory decisions. He indicated that Canada wants to improve access, affordability, and appropriate use of medicine, and is making an effort to prioritize patient-centricity in the product review process.

Regulatory Transparency and Openness

As part of Canada’s Open Government initiative, Health Canada launched the Regulatory Transparency and Openness Framework beginning in 2014. The objective of the framework is to give insight into Health Canada’s decision-making process, and provide the public with information to make well-informed health decisions. The Framework outlines Health Canada’s actions to improve public access to timely, useful, and relevant health and safety information. The Framework is also designed to assist industry in addressing current or future regulatory requirements or changes. A few of Health Canada’s Activities for 2016-2017, include making more information available on drug shortages, and ensuring that datasets of Health Canada’s scientific work are available more broadly.

From the EMA Policy 0070 to the US Final Rule, authorities across the globe are now requiring sponsors and researchers to publically share clinical data. Health Canada followed, and on March 10, 2017 published a white paper entitled, “Public Release of Clinical Information in Drug Submissions and Medical Device Applications” to introduce regulations and supporting guidance to permit public release of clinical data in drug submissions and device applications, post final regulatory decision.



 

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Intellectual Property Challenges

While Canada is making great strides in promoting a culture of innovation and transparency, there are challenges related to its intellectual property environment. In patent law, an invention must be “useful” or “capable of industrial application.” However, Canada’s definition of the patent utility requirement differs from that of other counties, and it is not clear how much evidence is required to meet the utility standard for a patent in Canada. This is problematic for pharmaceutical drug patents since drug efficacy data is obtained from clinical trial studies after the patent application is filed. Also, courts have retroactively invalidated multiple patents as a result of the new interpretation of the utility standard, greatly impacting the pharmaceutical sector in Canada.

Recognizing the importance of innovation, the Government of Canada finalized the Comprehensive Economic and Trade Agreement (CETA) in 2013 to help with intellectual property protection, and promote innovation. Two important parts of CETA are 1) patent term restoration, which allows pharmaceutical companies the potential to recover up to 2 years of time lost on their patent protection during regulatory approval; and 2) the right to appeal court decisions where a patent has been deemed invalid.

Conclusion

The Canadian regulatory environment will continue to progress as the Government of Canada promotes a culture of innovation. Regulatory harmonization will help reduce compliance burden for sponsors, and Canada’s efforts to increase openness and transparency will enable the public to receive timely information to enhance health-related decision making. Canadian life science innovators have some intellectual property hurdles, but government recognition of the importance of innovation is the first step towards progress. However, advancements and innovation in health care product development will only occur through timely interactions between key stakeholders - health authorities, including Health Canada, industry, patients, and academia. The 2017 DIA Canadian Annual Meeting presents a neutral forum for these individuals to come together to address the opportunities and challenges associated with Canada’s health care product ecosystem. Attend the conference for an opportunity to join the conversation with Health Canada and industry experts on health care product innovation as Canada celebrates its 150th anniversary. 

 


2017-bl-author-raliegh-malikDr. Raleigh Malik is a Sr. Scientist at the Drug Information Association (DIA) in Washington, DC, where she supports the advancement of DIA’s global content strategy by providing scientific expertise related to therapeutic drug development and regulatory disciplines. Prior to joining DIA, Dr. Malik supported medical and commercialization functions within pharma as both a medical writer and medical reviewer of promotional communications. Dr. Malik has a PhD in Molecular Biology and Biochemistry from Indiana University School of Medicine and a BS in Cell Biology and Biochemistry from Bucknell University.


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