Thank you Madam Chair. I am pleased to be here today to speak about emerging technologies in health care and the important regulatory role played by Health Canada.
I am the Director General of the Therapeutic Products Directorate within the Health Products and Food Branch (HPFB).
The health products and food branch, HPFB, is the part of Health Canada responsible for the regulation of food and health products such as pharmaceuticals, biologics, and medical devices. A key part of our mandate is to take an integrated approach to managing the health-related risks and benefits of health products and food. We do this by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food. As a regulator, it is essential that we adapt to the evolving expertise required to effectively assess submissions by continually re-evaluating our approaches. Many new technologies push the boundaries between the impossible and the possible. Technologies once thought impossible are now seen as mainstream therapies to address long-standing medical conditions. I have prepared a short document highlighting a few key initiatives, and I will take this opportunity to speak more generally to how our current priorities support emerging technologies.
To keep pace with evolving scientific innovations, we are taking steps to modernize our regulatory framework by advancing the regulatory road map, implementing ways to support innovation by reducing unnecessary regulatory burden on industry, and strengthening our partnerships and alignments with both domestic and international partners.
Providing timely access to new innovative therapies so that Canadians can maximize their health outcomes is a key departmental objective. One manner in which to achieve this objective is the priority review process, which facilitates fast-tracking and shorter review time of eligible new drugs and devices intended for treatment, prevention, or diagnosis of serious, life-threatening or severely debilitating diseases or conditions. The review time for a typical new active drug substance is 180 days as opposed to 300 days. For a medical device such as a class IV, or highest-risk, device, the priority review time is 45 days as opposed to 90.
For example, Health Canada granted priority review status to the Edwards Sapient heart valve, which will provide certain patients who cannot undergo open heart surgery with the option of valve replacement. This device was licensed on June 22, 2011.
In the field of oncology, Health Canada has granted priority review for drugs that serve disease states with high unmet needs and drugs for personalized medicines. An example is Jakavi, which is intended for the treatment of the effects of a rare blood cancer. It received priority review status because it demonstrated a marked and durable improvement in overall patient quality of life. This drug was approved on June 19, 2012.
In the area of innovative biologics, Canada became the first country in the world to license, in May 2012, a stem cell therapy for the treatment of complications of transplant in children.
Other mechanisms that enhance access to innovative therapies include setting internationally competitive performance targets for review times, facilitating earlier access to drugs by physicians and patients based on promising evidence of clinical effectiveness, adding a 30-day default review period for all clinical trial applications, and expediting the review of alternate sources of drugs that were recently in a shortage situation.
The increasing pace of technological change and the globalization of the health products industry present opportunities for HPFB to seek and promote harmonized standards and technical requirements, regulatory convergence, reduction of duplication, and increased collaboration with international regulatory counterparts. We continue to introduce guidance, when applicable, to assist sponsors in meeting the regulatory requirements relating to evolving technologies.
HPFB is highly respected worldwide and continues to strengthen international ties with other key regulators through our active involvement in all aspects of the International Conference on Harmonisation and through collaborative agreements such as the oncology cluster. In addition, the branch continues to build knowledge capacity by using foreign reviews and pooling expertise with international partners in innovative areas.
In an effort to facilitate innovative therapies, HPFB has also implemented new regulatory frameworks allowing decisions to be made for new drugs that are intended to be used in emergency situations, based on limited human studies that are supported by animal studies.
To conclude, HPFB places considerable emphasis on supporting innovation and emerging technologies to improve the health and safety of Canadians. As well, Canada has strong patent laws that provide eight years of market exclusivity for sponsors of innovative products. This makes our country attractive for clinical researchers and drug developers in the area of emerging technologies.
Thank you for the opportunity to appear before you today and I would be happy to respond to questions.