Speeches
Health Products and Food Branch Management
Council Workshop
"THE ROLE OF THE REGULATOR"
September 23, 2003
Speech by Gaétan Lussier, Chair
External Advisory Committee on Smart Regulation
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Introduction
Thank you for that kind introduction.
Thank you also very much for inviting me to open your Branch
Management Council Workshop. As you may know, being the Chair
of the Committee is not a full time appointment. So I will not
be able to accept to meet with all the Regulatory Branches of the
federal government. However, when I received your invitation, I
thought it was important to meet with you and here is why.
First, you have a very complex and challenging mandate and I
want to acknowledge the important contribution that you have in
making Canada a healthy and safe country. Second, the corner
stone of the vision that the Committee is proposing is that
whatever changes are brought to the regulatory system, they must
lead to citizens and consumers trust in Canadian products and
services, markets and government institutions. I believe that
your work is extremely important to ensure this trust. Second, I
think that your work is going to become more and more complex as
the pace of change, particularly in science and technology,
continues to increase. Third, because you have an impact on both
the health and safety of Canadians and this is the core of your
mandate, but you also have an impact on the economic life in
Canada and the concept of protecting and enabling are the essence
of what smart regulation is about.
I am very honoured that the Prime Minister has asked me to
take up the challenge of chairing this committee. And I accepted
because I believe that renewing the Canadian regulatory system is
important work for the future of the country and because there
was an opportunity to make a meaningful and transformative contribution.
Whatever job or task I have accepted, I have always considered
myself as a change agent. This is no different. My objective is
to instill enduring and sustainable changes in the way Canada
regulates so that it fully recognizes 21st century life.
Overview of the speech
Today, I would like to speak to you in three capacities:
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as chair of the External Advisory Committee on Smart Regulation;
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as a manager who has led change and is passionate about it;
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as a person who had scientific training and is watching with
a lot of interest scientific and technological developments.
I will therefore briefly present to you an overview of how and
where our Committee will be deploying its energies over the
coming months, as we move to implement the ambitious agenda we
have received from the Prime Minister.
I will then share with you some of my experience and my own
"commandements" with respect to change management and
finally, I would like to leave with you some reflections and
questions on what I see are the challenges facing the regulator
of the 21st century that may give you food for thought
during your retreat.
But what exactly is our mandate, and what precisely is meant
by "smart regulation"? Let me briefly answer these
questions, before providing you with a summary of our work
program and a status report on our progress to date.
EACSR Mandate
The terms of reference our Committee received in
May of this year from the Prime Minister, and which we have been
asked to complete by next summer, has three distinct components.
The first component is to develop a regulatory strategy for
the 21st century, supporting Canada as a sovereign
trading nation offering a high quality of life to its citizens.
The second component is to identify priority sectors and areas
requiring regulatory reform that are critical to maintaining a
"Canadian advantage".
And the third component is to review and provide an external
perspective on current regulatory issues identified by
departments and stakeholders.
For now I want to focus on the first component of our mandate
- Creating a 21st century regulatory strategy for Canada.
Pressures
There are many pressures that are affecting the regulatory
system, and I want to highlight three that are of particular importance.
The first is coping with the rapid pace of change. As you
know, this is particularly an issue with respect to science and
technology developments. The regulatory system will be impacted
at a number of levels. Advances in areas like the life sciences
and biotechnology pose increasingly complex challenges for
legislators and regulators, including how to address risk and how
to resolve the inevitable ethical dilemmas to which these
advances give rise.
We will also need to ensure that the existing stock of
regulation is continually renewed to reflect new knowledge. This
is essential not only for enabling innovation and growth but also
to ensure that when better, safer or cleaner ways of producing
things or delivering services become feasible, Canadians obtain
the benefits as quickly as possible. I would also add that the
speed at which regulatory decisions are made need to increase. I
have not met a single industry that says that it wants less
regulation. Very often it also agrees with the policy objective
being pursued. But it wants speedy decisions and
implementation.
The second area is the need to align the Canadian regulatory
system more strategically and deliberately with our trading
partners. We are one of the most trade-dependent nations. As a
country whose prosperity is directly linked to our exports, we
will also need to reflect on the degree of fit between our
regulations and those of our trading partners. Not only is this
one of the most important issues for industry, but as I have just
said, in a world where knowledge evolves fast, it is becoming
increasingly difficult for a single country to do everything by
itself. I know that Federal Departments, including yours, are
already cooperating with other countries.
And the third area is the need for better integrated
regulatory institutions, policies and tools. Regulating is an
act of public interest. It should be developed from the
citizen's perspective. At the same time, this should be
done with true care to make it simple, streamlined and not overly
costly for the regulated party to comply. This calls for the
different orders of governments and different departments to work
more closely together and take a more holistic approach to policy
issues and policy instruments.
Smart Regulation
But what is a "smart regulation" or more
appropriately, what does smart regulation entail?
Let me start by stating, for the record, that this is NOT a
deregulation exercise.
What we have been asked to do is to recommend ways to make the
practice and process of regulation in Canada, relevant to the
changes inherent in 21st century life.
This means:
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that in addition to its traditional role of protecting the
health and safety of Canadians and of the environment, regulation
serves to enable innovation and entrepreneurship.
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that consumers can enjoy more choice and make more informed
decisions.
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that our markets remain dynamic, flexible and
responsive.
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that businesses can more easily export our goods and
services to global markets.
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that investors see Canada as a desirable place to invest.
But if those are the ends, then what are the means? How can
we achieve the profound cultural change that will be needed to
enable all of the actors in this field to move forward together?
Vision and Principles
Our Committee's initial views are expressed in a Vision
and Principles statement that we have developed to guide our
activities. The statement is premised on ensuring regulation
continues to both protect Canadians and enable innovation by
making the practice more effective, flexible, collaborative,
transparent, and accountable.
You will notice that at the core of the vision is the notion
of collaboration. I truly believe that the transformation of the
regulatory system will happen only if governments, business and
citizens work more together.
Let me take you quickly through the three components of the vision.
As I mentioned in my introduction, whatever changes are
eventually brought, the regulatory system must instill trust,
confidence and credibility at home and abroad in Canadian
products and services, markets and government institutions. This
is important because I would argue that this trust has both an
economic and a social cohesion value but also because, if the
trust is lost, it leads to an increased demand for regulation.
The regulatory system should enable innovation. It should
make it easier for entrepreneurs to develop and sell new products
and services. In the regulatory world, there is no difference
between perception and reality. Canadian regulation must not
only be conducive to innovation; it also has to be perceived as
such both domestically and abroad.
Finally, the regulatory system must be effective in protecting
the public interest, and it must be clearly demonstrated to
citizens that this is not at stake as governments find new and
innovative ways to regulate, particularly as international
regulatory cooperation increases.
We have identified 5 principles that we believe are at the
heart of an effective regulatory system and are key to the
cultural change that will be required if we are to be successful:
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EFFECTIVENESS - Ensuring that regulation in
achieve the intended results.
-
FLEXIBILITY - The regulatory system should be
"just in time" if not one step ahead. Decisions need
to be made on real time for both the citizens and the regulated
party and regulation should be regularly reviewed. It should
also be recognized that in our days and age, one size does not
always fit all
-
TRANSPARENCY - Increasing the transparency of the
system has a lot of transformative potential. Governments need
to explain in a more open manner their decisions. I would also
argue that industry must be more transparent with its consumers.
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ACCOUNTABILITY - Results must be measured,
reported and communicated. This is necessary to maintain the
trust of the citizens and regulated parties. This is also
necessary to ensure that we continuously learn and improve.
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COOPERATION - This is my "dada". The
nature of the issues in the knowledge age requires different
- more collaborative-relationships, whether it be with
other countries, between levels of governments, with industry and
consumers.
These are all elements of what we believe to be a "smart
regulation" agenda. I have brought copy of the document
for your information.
EACSR Workplan
I will now share briefly the core elements of our work plan.
Since we cannot possibly address every challenge confronting
Canada's regulatory system, or every issue that is brought
to our attention, we felt it imperative to focus our efforts on a
limited number of areas where we feel we can have a real impact.
To that end, in addition to the Vision and Principles statement
that we have developed to frame our efforts, we will focus our
research and fact-finding on six over-arching issues:
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The first is Defining the Public Interest. How have Canadian
values and interests changed over the last 10-15 years and what
does this mean for a Smart Regulatory Strategy? What will the
public interest mean in the coming decade given the stresses of
new technologies, globalized markets, new environmental and
health risks and the demand from stakeholders for greater speed,
responsiveness and transparency?
-
The second is International Cooperation. We want to address
such dimensions as regulatory cooperation, harmonization and
mutual recognition, with respect to the free movement of capital,
services and goods. The issue is therefore how we do this more
strategically and more deliberately. In which circumstances do
we align our regulatory regimes? With whom, on what, and how?
In which circumstances should there be a Canadian-made solution?
Where would it be beneficial for Canada to be a regulatory
leader? What process is required for determining when and how
we should adopt or recognize the regulatory standards of other countries?
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The third is Federal-Provincial-Territorial Cooperation.
What new mechanisms or approaches are needed to make faster
progress in this area? What are key priorities for
inter-jurisdictional cooperation? Where a project or
undertaking requires regulatory approval from multiple
jurisdictions, how can they work together to streamline the
process that proponents have to go through to meet all of the
legal, technical and operational requirements of each jurisdiction?
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The fourth is Process Efficiency. How can we improve the
quality, timeliness, efficiency, and the transparency of our
regulatory system? How can we ensure the regulatory system has
the human and technical resources necessary to keep abreast of
scientific and technological advances?
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The fifth is Risk Management. How do we regulate in the
absence of full knowledge of the potential effects of very
promising, but recent technological advances? What could be
innovative options to effective and proactive formulation within
a Smart Regulation Strategy?
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The sixth is Instrument Choice. How do we implement a
proactive government-wide approach to choosing the most effective
instrument mix for achieving policy and regulatory
objectives?
I have mentioned that the third component of our mandate is to
provide an external perspective on specific regulatory issues.
One interest for the Committee is drug approval and we hope to be
able to support your efforts in this area.
At the end of our mandate, we will propose strategy for a new
regulatory system. We will also be making concrete
recommendations on how to improve the regulatory process. And I
also want to consider carefully implementation.
Change Management
This will mean that change will need to happen: changes in
processes, in policies, in roles. Change in organizational
culture. I would like to share with you some of my experience in
managing change which stems from 18 years of experience in the
public sector and as many in the private sector.
It is in 1982, when I became Deputy Minister of Employment and
Immigration that I decided that I decided to commit to
implementing excellence in the public service. I was heading a
department of 27 000 employees who annually were having tens of
thousands of face to face interactions with the citizens and
answering millions of telephone calls. At that time, I became
seized by the fact that we had to change how we were doing our
business and became closer of the persons I was then calling our "clients".
But how can we implement change?
I developed my own equation: C I = A + C. Continuous
improvement is function of attitude and competencies.
Attitude - or organizational culture- becomes the heart of
change. Let me quote George Bernard Shaw, "Progress is
impossible without change and those who cannot change their
attitude will never change anything".
I also adopted a management philosophy based on values. It is
essential that staff develop a sense of mission rooted in a value
system which has to be nurtured and sustained. Values become
then our guide. This is the cement - or what I like to call the
crazy glue - that enables an organization to have very solid
roots and a strong sense of direction. As Seneque said:
"The wind direction does not have importance if first of
all you do not know where you are going". The public
service has always been guided by a strong set of values. These
values define the institution and are at a source of pride and
commitment for public servants.
I want to encourage you to read the paper "Strong
Foundations", which was developed under the leadership of
the late John Tait, a former colleague of mine. It is still very
current and presents the cores values of the public service and
the challenges of living up to them in a very inspiring manner.
This document is what I would consider the "bible" of
the public service. It can be found on the Canadian Centre for
Management Development Web site.
So I challenge you to bring change to your organization. The
competencies you already have a lot and you will need to develop
new ones. And this is important but I would argue that the
competency part of the equation is easiest to work on. Changing
the attitude - or the culture- is usually the biggest challenge.
I am convinced that you can make it happen.
The regulator of the 21st century: roles and
challenges
This leads me to the role and challenges of the role of the
regulator in the 21 century.
The role of the regulator will become more and more complex.
In addition to being a rule maker -this will not go away-
you will increasingly have to be more a communicator and
information broker, a negotiator, a conflict manager, to mention a few.
I believe that regulating will be transformed over the next
years. With the advancement of science and technology, the
manner in which the protection of the public is ensured will have
to be transformed. This will be necessary, not only to ensure
timeliness in the regulatory system but also to ensure its effectiveness.
As you enter these two days of reflection, let me share with
you some challenges that I believe will be inherent to your role
of regulator in the 21st century.
How to ensure that the best ad latest science is used in a
timely fashion when making regulatory decision?
In a time when citizens have increased access to information
and, want sometimes to make their own choices, how do you ensure
the right balance between providing the general level of
protection to the public and individual choices? Where is it
appropriate for government to intervene?
Which risks have to be managed by the regulator? Which ones
should be managed by industry or the individuals?
What are the values and ethics that you need to obey by to
ensure that you have a deep understanding and care about the
industry your regulate and other interested organizations while
keeping the necessary arm's length relationship with it?
Which networks, whether in Canada or internationally, do you
need to be part of? How to use those networks more strategically?
How do you work with other countries to improve the
performance of the regulatory system?
I could add more questions but let me finish here.
Conclusion
Before concluding I want to let you know that our interactive
web site is up and running: www.smartregulation.gc.ca. I
encourage you to check the site periodically for updates on our
activities, to review our research and share with us your views and advice.
In closing, I would simply make the observation that the
regulatory system we currently have in Canada was largely
developed for an industrial economy, and it has served us
extremely well. But Canada now needs a regulatory approach
designed for the knowledge age.
We are determined to produce a final report that makes a real
contribution to our quality of life and to our international competitiveness.
Being part of the regulatory community is going to be an even
more exciting in the future than it is now. Implementing a smart
regulatory strategy will require your support and continued hard
work. I know the public service and I know that it has all the
creativity, commitment and energy to make it happen.
Thank You!
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