Regulatory science: Enhancing Canada’s leadership in regulatory science and technology

Regulation is an important tool for protecting and advancing the health, safety and environment of Canadians. It is also important for creating conditions for an innovative and prosperous economy. Federal regulators (see chart) work in a complex, changing environment, characterized by fast-paced science and technological advancement, increasing trade flows and integrated supply chains. In the midst of our eternal dilemma of labelling science as either applied or fundamental, we are forgetting an essential component and one of Canada`s strengths on the international stage — regulatory science. Regulatory science deserves greater considerations from all stakeholders, public and private and some simple programmatic tweaking, policy modifications, and/or behavioral changes could easily do the trick.

Canada’s 2014 science and technology (S&T) strategy included a commitment to maintaining strong support for S&T, including support for federal science-based institutions to perform research to deliver on regulatory, public policy and operational mandates.

Considering the importance of regulation and the role of S&T in supporting it, one would expect that regulatory science would be a hot topic in Canada today. While Canada has had some success in the area, more can be done. While the five research priorities identified in Canada’s 2014 S&T strategy are all heavily regulated (environment and agriculture, health and life sciences, natural resources and energy, information communication technology (ICT), and advanced manufacturing), none of these  specify any regulatory science priorities. Similarly, neither the 2012 nor the 2014 State of the Nation Reports on Canada’s science, technology and innovation activities had any emphasis on regulatory science.

So what are the challenges associated with regulatory science? Why should it be more highly visible? And how can the current situation be improved?

Regulation is more complicated today because of the speed of scientific and technological change. Genomics, computational chemistry, advanced manufacturing and artificial intelligence are just a few of the scientific fields that have exploded in terms of generating lots of data that require ever increasing computational power to manipulate and analyze.

In addition, regulators often work on real-world applications that demand new scientific knowledge for which theoretical models or existing model organism data are not readily applicable. For example, to accurately identify and take regulatory actions on the Asian gypsy moth, the Canadian Food Inspection Agency (CFIA) developed new molecular tools to help differentiate this invasive moth from other morphologically identical non-invasive gypsy moths. These technical innovations were made possible through the successful funding of the BioSurveillance of Alien Forest Enemies (BioSAFE) Large Scale Applied Research Project in collaboration with the University of British Columbia, Université Laval, and many other stakeholders.[1] Therefore, regulators must rely heavily on their ability to connect and collaborate with partners from both public and private sectors.

In addition to often having to develop fundamental scientific knowledge, regulators must also transfer that knowledge for the effective and consistent utilization of the technology/method for regulatory applications. Such a process requires systematic quality management systems through the implementation of international standards like ISO/IEC 17025,[2] as well as strict oversight from accreditation bodies like the Standards Council of Canada.

ISO/IEC 17025 is a generic standard that is used to accredit laboratories in many different fields, ranging from biological testing (food testing) to electrical testing (fiberoptics) and other technical disciplines. Accreditation demonstrates that a lab operates to a global standard and has passed a rigorous examination of methods, facilities and staff. It also assures that the testing laboratory can produce data that are accurate, traceable and reproducible. Obtaining and maintaining laboratory accreditation represents significant expenses for federal regulators, adding to the increasing pressures on already limited resources.

As stated in the Cabinet Directive on Regulatory Management, regulation is a key policy instrument used by government to enable economic activity and to protect the health, safety, security, and environment of Canadians. When regulating, governments aim to achieve various outcomes including: 1) protect and advance the public interest, 2) make decisions based on evidence, 3) promote a fair and competitive market economy, and 4) monitor and control the administrative burden. Therefore, regulators are important end users of research results and technologies, enabling them to achieve their respective mandates.

In Canada, considering the many regulatory mandates and significant differences with international counterparts, departments and agencies such as Health Canada, Transport Canada, and the CFIA must all rely heavily on internal capacities to generate research results. This situation is amplified by the limited flexibility available to Canadian regulators under existing grants and contributions to partner with academia.  Currently, federal granting agencies do not fully recognize regulators as eligible partners for collaborative research with academia.

In 2002, Canada was recognized by the Organisation for Economic Co-operation and Development (OECD) as having one of the best regulatory environments among its 30-member countries.[3] Today, the level of Canadian stakeholder engagement in developing regulations is 3.0.  This is higher than the OECD average of 2.4.[4] While these point toward Canada’s successful regulatory system, the aforementioned observations also point toward the need to raise regulatory science priority and find solutions to improve our capacity to perform and apply regulatory science.

In closing, here are a few suggestions that could start to address these issues:

• Regulatory science should be explicitly identified in key documents (national S&T strategy, sector-specific research strategies, etc.) to emphasize its essential role in support of Canada’s aggressive trade agenda.
• Federal granting agencies and other funders should fully recognize federal regulators as eligible partners in research partnership programs, encouraged to foster collaboration with academia and to train the next generation of regulators.
• Regulators must do a better job of engaging with regulated parties and stakeholders to discuss scientific regulatory challenges facing their sectors and develop meaningful solutions to address them collaboratively.

These important steps would enhance innovation and collaboration among regulators, support domestic and international trade, and enhance Canada’s global leadership in regulatory S&T.

Pierre Bilodeau is Acting Executive Director, Science Branch, at the Canadian Food Inspection Agency (CFIA).

[1] BioSurveillance of Alien Forest Enemies (BioSAFE) https://www.genomecanada.ca/en/biosurveillance-alien-forest-enemies-biosafe.

[2] ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories (https://www.iso.org/standard/39883.html)

[3] Let’s Protect Canadian without Strangling Them (2002) David Zussman, President, Public Policy Forum. This article appeared in The Ottawa Citizen.

[4] OECD Better Life Index, Canada (http://www.oecdbetterlifeindex.org/countries/canada/)