Strategic Plan 2021 2025 - Delivering for patients through collaborative health product regulation - HPRA
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Strategic Plan 2021 – 2025 Delivering for patients through collaborative health product regulation
Introduction
This Strategic Plan sets out our ambition for Scientific and technological innovation has
the next five years to deliver better outcomes accelerated dramatically in recent years with
for people and animals through value-driven advances in personalised medicines, convergence of
regulation and partnerships. health products with digital information, and novel
manufacturing technologies. Innovative products
Building on our partnerships with others is a key
can greatly improve patient outcomes but may pose
theme of this five-year strategy. The twin challenges
challenges to the current regulatory system as well as
of Brexit and Covid-19 have demonstrated the need
create the need for appropriate supports. Working
for, and value of, working collaboratively across
together with European and international partners,
Europe and internationally, with the health system in
we will contribute to more timely and consistent
Ireland, and with patients and the public. Working
approaches to regulating innovative products. We
with national agencies, professional bodies and
will also need to develop the necessary expertise to
patient groups can help us regulate more effectively
regulate effectively in a digitised environment.
taking into account the needs of the health system,
while our input into relevant parts of the system can The Strategy has been developed in a highly
influence the safe use of health products in clinical collaborative way, involving all staff and the
practice. The pandemic has also highlighted the members of the Authority and the statutory advisory
importance of the interconnectedness of the health committees. A public consultation provided
of people, animals, plants and the environment, feedback from many stakeholders to help guide the
known as the One Health concept. development of the plan. We would like to thank
all those who took the time and effort to make
Patients are the users of medicines, devices and
submissions which have been taken into account in
health products and our most important stakeholder
the preparation of this plan.
group. Regulators are increasingly mindful that
the views of the public and patients must be Implementation will require a high level of
incorporated into the regulatory process. While we commitment and effort from everyone, enabled
have taken forward specific initiatives over recent by continuing development of our people, ways of
years, we are committed through this plan to working and a digital transformation programme.
building greater engagement with patients which we Key targets will be included in the Performance
believe will contribute to broader-based and better- Delivery Agreement with the Department of Health.
informed regulatory decisions. Detailed activities will be planned and delivered
through the annual business planning cycle, and
Major legislative changes will occur over the next five
implementation monitored through reporting to
years, with the implementation of EU Regulations
senior management and the Authority.
on clinical trials, veterinary medicines, medical
devices and in-vitro diagnostics, and each Regulation We look forward to working with the Authority,
will impact significantly on the operation of the the advisory committee members and our staff
relevant regulatory system. For the HPRA, these in delivering on this strategy in a time of some
constitute major projects which require contribution uncertainty but great potential for enhancing the
to national legislation, extensive engagement with value of health product regulation for people,
all stakeholders, and development of information animals and the healthcare system.
resources for those affected by the legislation.
We are living in a time in which public demand
for information is increasing, and numerous,
sometimes unreliable, information sources exist.
Conflicting information and multiple channels
of communication can undermine the critical Ann Horan Lorraine Nolan
importance of the regulatory system. We will Chairperson Chief executive
maintain a focus on increasing understanding of the
work we do, being transparent around decision-
making, communicating via suitable channels in a
timely manner, and identifying and appropriately
managing emerging risks.
2 HPRA Strategic Plan 2021 – 2025
What we regulate How we regulate
Human We inspect companies and
medicines facilities which test, make
or distribute health products
to ensure that they comply
Veterinary
with relevant standards and
medicines
legislation
Medical devices
for human use
We grant licences to
companies to make,
Clinical distribute and market
trials medicines after a review
of their safety, quality and
effectiveness
Blood and blood
components
Human tissues
We continuously monitor
and cells
medicines, medical devices
and other health products,
Human organs for responding quickly to any
transplantation safety or quality concerns
Controlled
substances
We produce safety and
quality information to
Cosmetics support the safe use of
health products
The use of animals for
scientific purposes
HPRA Strategic Plan 2021 – 2025 3
Our mission, vision and values
Our mission
We regulate medicines
and devices for the benefit
of people and animals
Excellence in health product
Our vision
regulation through science,
collaboration and innovation
Patient focused Collaboration Excellence
We put the interests of We work with others We work to the highest
those who use health in partnership, respect personal, professional
Our values
products first and trust and scientific standards
Integrity Inclusion Innovation
We are independent, We believe in the power We continually learn,
transparent and of diversity, where adapt and improve
accountable everyone is equal
4 HPRA Strategic Plan 2021 – 2025
Our strategy
Delivering for patients through collaborative
health product regulation
Goal 1 Goal 2 Goal 3 Goal 4
Our goals
Health system Progressive Communication Enabling
partnerships regulation and engagement innovation
Strengthening Increasing our use of Improving Enhancing our
our proportionate and our models of supports for
collaborations adaptive approaches engagement innovation from
across all areas of for better patient to strengthen discovery through
the health system outcomes public trust and to regulatory
confidence approval
Address current and Maximise the Engage with Promote an
emerging public opportunity stakeholders to agile approach
health challenges presented by drive improvements to appropriate
and priorities new legislation to in regulatory regulation of
enhance regulation activities innovations
Enhance the role of health products
Where our focus will be
of the HPRA as Strengthen Contribute to Irish
a partner and Strengthen use trust in the research through
contributor within of risk based regulatory system outreach and
the health system, approaches to through greater engagement
to optimise safe regulation transparency and
and effective use of clarity Prioritise areas
health products Respond to the of innovation for
globalised industry Further develop organisational
Enhance national and markets information development
systems to better resources and
regulate animal communication
health products and platforms
scientific animal use
Goal 5
What we need to do to succeed
Great people, great processes
Developing our organisation and people to
successfully achieve our goals
Develop and empower our people to achieve and succeed
Improve organisation effectiveness through extended and enhanced use of digital technologies
Create better ways of working for the organisation, its stakeholders and the environment
Ensure financial stability and capacity to meet the future needs of the organisation
HPRA Strategic Plan 2021 – 2025 5
Goal 1
Health system
partnerships
Strengthening
our
collaborations
across all areas
of the health
system
Goal 1: Health system partnerships
Strengthening our collaborations across all areas of the health system
Objectives Specific actions Outcomes
1.1 Address Improve preparedness for significant Formalised mechanisms and systems with
current and change, threats and crises impacting in regulatory and health system partners
emerging health product regulation and availability. provide greater responsiveness, continuity
public health and resilience.
challenges and
Collaborate with government, the health The impact of Brexit on availability of health
priorities system and other stakeholders to manage products is minimised and measures are in
the regulation and availability of health place that strengthen integration with other
products post Brexit. European markets.
Collaborate nationally and internationally Covid-19 diagnostics, therapeutics and
on the regulation and surveillance of vaccines used in Ireland are robustly
medicines, medical devices, diagnostics regulated and monitored, with up-to-date
and vaccines for Covid-19. information provided to all stakeholders.
Contribute to One Health initiatives Improved understanding of wider impacts
including antimicrobial resistance and of health products, and actions taken to
impacts of health products on the reduce adverse effects.
environment.
1.2 Enhance Strengthen systems for exchange of Better quality and diversity of data enhance
the role of information and reporting on health monitoring and surveillance over the
the HPRA as products between health system partners, lifecycle of a health product.
a partner and healthcare professionals, members of the
public and the HPRA.
contributor
within the
Leverage collaborative efforts to promote Engagement across stakeholders enables
health system,
and support system-wide responses to cohesive and coordinated responses to
to optimise important health product issues. important health product issues.
safe and
effective use Enhance understanding of how important Approaches developed to evaluate the
of health regulatory action is best embedded impact and effectiveness of significant
products and implemented into clinical practice regulatory action at national level.
nationally.
Contribute to the implementation of the Health system developments informed and
Sláintecare programme for healthcare enhanced by regulatory requirements for
delivery. health products.
Support the continued development of the Clinical researchers have access to
clinical research infrastructure in Ireland. integrated supports and a streamlined
system for clinical study approvals.
1.3 Enhance Embed the application of 3R principles in Projects and clinical trials conducted in
national animal-based research in Ireland. Ireland meet international best practice in
systems to 3Rs.
better regulate
animal health Strengthen the pharmacovigilance system The pharmacovigilance system is more
through new methods and tools for responsive and effective, with increased
products
promotion and analysis of reports and reporting by healthcare professionals and
and scientific
dissemination of safety information to animal owners.
animal use healthcare professionals and animal owners.
HPRA Strategic Plan 2021 – 2025 7
Goal 2
Progressive
regulation
Increasing our use
of proportionate
and adaptive
approaches for
better patient
outcomes
Goal 2: Progressive regulation
Increasing our use of proportionate and adaptive approaches for better
patient outcomes
Objectives Specific actions Outcomes
2.1 Maximise Develop stakeholder partnerships to Implementation delivers value to all
the support implementation of new legislation stakeholders, reduces regulatory burden
opportunity for medical devices, clinical trials and where appropriate, while ensuring
presented by veterinary medicines. protection for the users of health products.
new legislation
Promote European network approaches, Strengthened cooperation across the
to enhance expertise development and mutual EU regulatory network with measurable
regulation reliance among regulators in line with new impacts.
of health requirements.
products
Influence the development of national Gaps in regulatory approaches and areas
legislation to enhance standards and not covered by regulation identified and
regulation. actioned.
2.2 Strengthen Further develop internal capabilities to Increased organisational competency
use of identify areas of risk through greater use of in risk and risk management principles.
risk based intelligence sources. Intelligence sources identified for proactive
approaches to management of emerging risks.
regulation
Adapt assessment, compliance monitoring Risk-based strategies increase use of
and enforcement approaches in line with proactive approaches, and reduce the level
identified risks. of non-compliance.
Enhance focus on lifecycle management in Demonstrated use of data-driven, risk-
our regulatory approach. adaptive approaches to support regulatory
decisions pre and post approval.
2.3 Respond to Promote greater use of mutual reliance Demonstrated influence on the European
the globalised among global regulators. and international networks’ strategic
industry and objectives on mutual reliance.
markets
Drive the development of greater Active participation and contribution in
international convergence and relevant international committees and
harmonisation on regulatory standards. projects.
Promote greater communication of risk Demonstrated influence on the
and intelligence sharing among global establishment of infrastructure to support
regulators. intelligence sharing among global
regulators.
HPRA Strategic Plan 2021 – 2025 9Goal 3
Communication
and engagement
Improving
our models of
engagement
to strengthen
public trust and
confidenceGoal 3: Communication and engagement
Improving our models of engagement to strengthen public trust and
confidence
Objectives Specific actions Outcomes
3.1 Engage Develop new engagement and Stakeholder analysis is regularly conducted,
with communications strategies in consultation their views are valued and taken into
stakeholders with stakeholders. account across corporate and regulatory
to drive activities.
improvements
Use the voices of patients and the public to Demonstrable proactive partnership model
in regulatory
inform our regulatory and safety monitoring based on listening, understanding and
activities
programmes. communicating with the public.
Establish a greater level of ongoing Engagement with healthcare professionals
engagement with healthcare professionals contributes to greater patient safety and
and their representative bodies. optimal use of health products.
3.2 Strengthen Promote awareness and understanding of Greater public profile of the agency and
trust in the the HPRA’s role in protecting the health of perception of trust in health product
regulatory people and animals. regulation.
system
through Increase proactive publishing of clear, Additional information and data sets
relevant and understandable information. published, with greater transparency
greater
around the evaluation process.
transparency
and clarity Incorporate current best practices in Improved ability to communicate in clear
communicating science and risk. terms with the recipient in mind.
3.3 Further Develop our website as a key Communications with stakeholders
develop communication tool for interacting with integrated into organisational processes.
information stakeholders and an authoritative source of Timely website content in plain language,
resources and reliable regulatory information. accessible in formats appropriate to the
different stakeholder groups.
communication
platforms Increase use of social media and other Increased reach and diversity of content
communication methods including across different audiences and channels,
traditional and non-media where supporting key safety messaging.
appropriate.
Contribute to educational programmes for A range of resources is available for
key target groups. patients, and for healthcare professionals
and researchers at relevant points in their
careers.
HPRA Strategic Plan 2021 – 2025 11Goal 4
Enabling
innovation
Enhancing our
supports for
innovation from
discovery through
to regulatory
approvalGoal 4: Enabling innovation
Enhancing our supports for innovation from discovery through to
regulatory approval
Objectives Specific actions Outcomes
4.1 Promote an Actively contribute to EU and international The regulatory system is well positioned
agile approach horizon-scanning initiatives. to respond to the dynamic life sciences
to appropriate environment.
regulation of
Support regulatory science tools and Novel therapies and technologies are
innovations
approaches that effectively respond to effectively regulated while facilitating safe
scientific and technological innovation. and timely access.
Promote cooperation and integration Regulatory standards and guidance provide
between regulatory networks and for consistent and integrated evaluation of
frameworks to facilitate harmonisation and borderline/combination products.
avoid duplication.
4.2 Contribute Work with national partners to use existing Established mechanisms in place for
to Irish networks to raise awareness of regulatory systematic outreach to relevant research
research supports among Irish life sciences communities.
through researchers.
outreach and Provide advice and guidance for researchers Regular use by researchers of regulatory
engagement that can be accessed throughout the and scientific advice provided by the HPRA
development cycle. or the European regulatory system.
Engage with Irish researchers and Input from researchers informs the
developers to identify mechanisms and development of new or improved
support initiatives that facilitate the regulatory supports. Irish researchers
translation of research into clinical practice. participate in initiatives aimed at this sector.
4.3 Prioritise Develop and implement a strategy that A programme of activities for competence
areas of identifies key areas of innovation for development in focus areas relevant to
innovation for organisational specialisation. patients, the research community and the
organisational life sciences sector in Ireland.
development
Develop knowledge and skills to regulate Capabilities contribute to and keep pace
in a digitised environment encompassing with the advances in digitisation in the
regulatory processes, products, regulatory environment.
manufacturing, wholesaling, and healthcare
delivery.
Engage with EU regulatory network to Increased levels of advice provided within
maximise contribution of key expertise. areas of specific expertise.
HPRA Strategic Plan 2021 – 2025 13Goal 5
Great people,
great processes
Developing our
organisation
and people to
successfully achieve
our goalsGoal 5: Great people, great processes
Developing our organisation and people to successfully achieve our goals
Objectives Specific actions Outcomes
5.1 Develop Design and implement a new people An organisation-wide strategy based on
and empower strategy. developing the skills and competencies
our people to needed to ensure a resilient, evolving
achieve and workplace.
succeed An enhanced employee experience and
wellbeing at work.
Values based, purposeful working.
Define key areas of expertise and future Agreed development pathways to access
skills needs. key skills, e.g. training programmes,
recruitment, contract workers.
Enhance leadership capability to manage A resilient organisation, flexible, responsive
the organisation through change and and adaptable to meet emerging
growth. challenges.
5.2 Improve Consolidate case management onto a Streamlined operational processes
organisation single, optimised platform. Enhance data and analytics. Reduced complexity of
effectiveness quality and decision support capabilities. technology environment.
through
Extend digital integration with stakeholders, Enhanced engagement with stakeholders
extended and
providing integration with core applications. and contribution to the national health
enhanced
system. Improved integration with the
use of digital
European regulatory network.
technologies
Improve performance and resilience of Improved technology risk profile and
the technology infrastructure. Enhance the enhanced operational flexibility. Reduced
security of the digital infrastructure. risk of cyber intrusion or data loss.
5.3 Create Define the optimal organisational design to A sustainable organisational structure
better ways support delivery of our remit now and into underpinned by a robust succession plan
of working the future. and people strategy.
for the
Develop models of working that meet the Flexible approaches to support
organisation,
changing environment and future of work. performance and productivity conducive to
its
an adaptive model of working.
stakeholders
and the Improve cross-organisational Balanced resource utilisation, consistency of
environment methodologies for better management of processes, and enhanced use of expertise
capacity and organisational performance. across different functional areas.
Continue to take actions that sustain more Government targets for public sector
environmentally friendly practices. energy efficiency are met, staff encouraged
to reduce their own energy usage and
CO2 emissions, and goods purchased
reflect environmental considerations where
possible.
Ensure ongoing compliance with the public Equality of opportunity and treatment
sector equality and human rights duty. for staff, stakeholders and those we
communicate and interact with.
HPRA Strategic Plan 2021 – 2025 15Goal 5
Objectives Specific actions Outcomes
5.4 Ensure Update financial and fee modelling to take Stable financial systems allowing
financial account of the changing environment for management of the organisation in a
stability and the organisation and for regulated sectors. steady state and with ongoing changes in
capacity the external environment.
to meet
the future Conduct a structured review of the use of Sustainable and efficient use of resources
needs of the the infrastructure and utilisation plans to including the building.
organisation reflect the new paradigms of working.
16 HPRA Strategic Plan 2021 – 2025Health Products Regulatory Authority Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland D02 XP77
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