Transcript Review of regulatory capacity

Review of regulatory capacity:
a strategy to strengthen national
authorities
Valerio Reggi, Eshetu Wondemagegnehu, HTP/EDM/QSM
1 October 2003
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WHO - HTP
Outline of presentation
• Background
• Strengthening national
authorities
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Review of regulatory capacity
Background
Review of national
regulatory situation
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World Health Assembly resolution 52.19 24
May 1999: WHO’s Revised Drug Strategy
URGES Member States:
(1) to reaffirm their commitment to …… taking all
necessary concrete measures in order to ensure
equitable access to essential drugs;
(2) to ensure that public health interests are
paramount in pharmaceutical and health policies;
(3) to explore and review their options under relevant
international agreements, including trade agreements,
to safeguard access to essential drugs;
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World Health Assembly
resolutions & statement
Implications for national regulatory authorities:
- put public health as first priority of regulatory system
development strategy and decisions
- contribute to develop market of good quality, safe,
effective,and affordable drugs and vaccines
- improve regulatory assessment and market control
Improve regulatory system's capacity to meet
needs of health decision makers , professionals and public
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Consequences of weak regulatory
capacity
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Irrational consumption and prescription
Substandard, counterfeit, harmful,
useless drugs and vaccines on sale
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Regulation of drugs and vaccines is
an essential public-sector function
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Equity: who cares for the poor?
Information imbalance: access to and capacity to
assess information on quality, safety, efficacy, value for
money, appropriateness
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External benefits:
immunizations and treatment of
contagious diseases benefit all, if left to market laws
alone many will not be immunized or treated
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Key elements of drug regulatory system
Drug regulation comprises all the legal, administrative
& technical arrangements meant to ensure that:
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all premises, persons & practices engaged in the
development, manufacture, importation, exportation,
wholesale, supply, dispensing & promotion of drugs comply
with approved standards, norms, procedures and
requirements
drug products are safe, effective and of acceptable quality
product information is unbiased, accurate and appropriate
drugs are available
drugs are used rationally
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Key elements of drug regulatory system
Basic functions in drug regulation (1)
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Licensing of manufacturers, importers,
distributors, wholesale and retail outlets
(premises, persons and practices)
Marketing authorization for drug products
Quality control laboratory testing
Provision of drug information and monitoring of
drug promotion and advertising
Continues……...
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Key elements of drug regulatory system
….continued
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Basic functions in drug regulation (2)
Inspection of manufacturing and distribution
channel premises
Adverse drug reaction monitoring
Authorization of clinical trials
Monitoring of drug dispensing and prescribing
practices
Monitoring of drug utilization and promotion
of rational drug use
Application of sanctions
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Drug regulation is a multi- faceted activity at the
centre of complex interactions
Government
Manufacturers
Products
Regulatory
authority
Experts
Prescribers
Medicines
Importers/Wholesalers/Retailers
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Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at the
centre of complex interactions
Government
Manufacturers
Products
Regulatory
authority
Experts
Prescribers
Medicines
Importers/Wholesalers/Retailers
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Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at the
centre of complex interactions
Government
Manufacturers
Products
Regulatory
authority
Experts
Prescribers
Medicines
Importers/Wholesalers/Retailers
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Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at the
centre of complex interactions
Government
Manufacturers
Products
Regulatory
authority
Experts
Prescribers
Medicines
Importers/Wholesalers/Retailers
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Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at the
centre of complex interactions
Government
Manufacturers
Products
Regulatory
authority
Experts
Prescribers
Medicines
Importers/Wholesalers/Retailers
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Patients/Consumers
WHO - HTP
The challenges:
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the health system counts on DRA for good, safe, and
effective medicines and for fair rules and control on
drug trade, information, and use
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any strategy to improve anything in the
pharmaceutical area involves DRA
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any problem encountered in the pharmaceutical area
has something to do with the DRA
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Country strategies for achieving effective
drug regulation
1.
Assess drug regulation performance
2.
Identify and develop priority functions
3.
Provide clear mission and purpose
4.
Create a supportive environment
5.
Formulate adequate legislation
6.
Create appropriate organisational structure
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Allocate adequate human and financial resources
8.
Minimise corruption and conflict of interest
9.
Apply appropriate regulatory & enforcement strategies
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Effective regulation depends on the environment
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adequate consideration is given to the public health value of
drugs
norms and regulations are locally meaningful
drug regulation is not fragmented
drug regulation processes are transparent
DRA is also accountable to the public
appropriate sanctions are regularly applied
strong, organised public interest groups are encouraged to play
a role in the drug regulatory area
there is freedom of association and information
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Drug regulation and public health
Good regulatory practice requires:
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Mission and objectives clearly stated
Possibility to assess attainment of objectives
Procedures and outcomes transparent to
applicants, health professionals, and public
Arguments used to reach decision accessible to
the public
Reasonable duration of assessment without
compromising quality, safety & efficacy
9th ICDRA 29/4/1999
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Drug regulation and public health
Good regulatory practice requires:
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Expedite review for orphan and outstanding
public-health-value drugs
Accountability to government, those
regulated, and the public
Personnel adequately trained, highly
qualified, of high integrity
Human resource development programme
9th ICDRA 29/4/1999
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Drug regulation and public health
Good regulatory practice requires:
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Mechanisms for appeal and for citizens'
complaints
Access to appropriate knowledge and
technology
Citizens are provided with accurate and
appropriate drug information
Mechanisms to ensure quality of operating
procedures
9th ICDRA 29/4/1999
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Drug regulation and public health
No national authority meets all criteria,
......but some are closer than others
All want to improve,
.... but some are much better placed
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Big gaps exist
TECHNICAL COMPLEXITY OF
REQUIREMENTS
ICH
IC
LDC
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Thousands of highly qualified professionals
Thousands of highly qualified external
experts
Virtually unlimited access to the most
sophisticated technology and knowledge
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What is the best approach
to strengthening national
regulatory authorities?
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WHO Expert Committee on Specifications for
Pharmaceutical Preparations, TSR 790, 1990:
...approach to regulation must be attuned to
available resources...
...problems in establishing regulatory control
have too often resulted from the introduction
of provisions successful elsewhere but of a
complexity that precludes their effective
implementation in the country of adoption...
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No importable models
Need for review of national
regulatory situation and
definition of country-specific
strategy and priorities
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WHO's approach:
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develop policies
tools for review of regulatory situation
"how to" manuals
training
independent advice
support to regional technical cooperation
initiatives
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Review of regulatory capacity
Background
Review of national
regulatory situation
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Review of regulatory situation
Most elements are common to drugs and vaccines
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A single national authority
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Same legal basis
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Same basic infrastructure & expertise
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Same public-health values
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Same need to ensure close links with health system
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Same need to assess quality, safety and efficacy
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Same need to ensure effective market control
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Review of national situation
Only a few issues specific to either drugs or vaccines
Vaccines
Lot release
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Drugs
Generics
Drug information
& promotion
WHO - HTP
Key issues
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Identify general indicators and key NRA functions
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Develop data collection tool that permits to obtain
information enabling to identify areas of strength
and weakness
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Develop criteria to review information collected and turn
findings into recommendations
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General indicators
1
2
Regulatory System
Reports and figures
Regulatory functions
1
2
3
4
5
6
Licensing: Marketing authorizations
Companies
Post-marketing activities: pharmacovigilance, special
programmes (e.g. counterfeit drugs), control of promotion
and advertising
Lot release
Laboratory testing
Inspections: GMP & distribution channels
Clinical Trials
Review tool
Function
Component
Examples & Criteria
Component
Examples & Criteria
Component
Examples & Criteria
Component
................
Examples & Criteria
Examples & Criteria
..............................
Regulatory functions
1
2
3
4
5
6
7
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Regulatory System
Licensing: Marketing authorizations
Companies
Post-marketing activities: pharmacovigilance, special
programmes (e.g. counterfeit drugs), control of promotion
and advertising
Lot release
Laboratory testing
GMP & distribution channels (Inspections)
Clinical Trials
Reports and figures
Components of “regulatory system”
1. Statutory basis for establishment of regulatory system and
enforcement power
2. Independence of the regulatory authority in decision making
3. Capacity to ensure market control (i.e. effective capacity to
detect unauthorized products or companies)
4. Recall system with mechanism to ensure the proper disposition of
affected lots
5. Appropriate expertise/qualification of staff
6. NRA institutional development plan
7. Transparency & Accountability: NRA provides information on
legislation, regulations, procedures, approved products, approved
companies, sanctions, recalls, public health warnings
8. Interaction with civil society
9. Intersectoral collaboration
Examples/criteria to review statutory basis
•Drug legislation exists
•NRA established and empowered in law
•QC lab established and empowered in law
•inspectorate empowered to access facilities, documentation, collect samples
•legal provisions for marketing authorisations
•legal provisions for control of importation
•legal provisions for control of exportation
•legal provisions for control of manufacturing
•legal provisions for control of distribution (wholesale and retail)
•legal provisions for monitoring safety of marketed products
•legal provisions for monitoring quality of marketed products
•legal provisions for control of promotion and advertising
•legal provisions for control of clinical trials
•legal provisions for appropriate sanctions
•legal provisions requiring NRA to ensure confidentiality of data, and to be
transparent and accountable
•legal framework to identify and sanction illegal products and activities
•regulations based on legislation issued for all areas, and kept up to date
Review findings can be summarized in
graphical format
100
%
i
m
p
l
e
m
e
n
t
e
d
80
60
1999
40
2001
20
0
1
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2
3
4
5
6
NRA Key Functions
7
WHO - HTP
Review and follow up
Review Teams
Drug Vaccine
NRA
Review
Institutional
development
plan
3-5 days review
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Training
needs
identified
Technical
support
Within 3 months
Follow up
visits
6-24 months
depending on
review findings
WHO - HTP
Outcome of a review visit
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opportunity for NRA staff to seat and look at
own situation
agreed document that highlights strengths and
weaknesses and indicates priorities for action
direct technical support and training
document can be used to apply for additional
support from other sources
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Achievements (1): reviews
AFR
Algeria
Nigeria
Zimbabwe
Senegal
South Africa
Uganda
AMR
Argentina
Bolivia
Cuba
Chile
EMR
Oman
Saudi Arabia
Syrian AR
Egypt
Iran
Pakistan
Tunisia
Morocco
EUR
Hungary
Kazakhstan
Rep Moldova
Turkmenistan
Bulgaria
Poland
Romania
Sweden
Turkey
Ukraine
Uzbekistan
Russia
Joint Drug & Vaccine assessments
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SEAR
Myanmar
DPR Korea
India
Sri Lanka
Thailand
Indonesia
Nepal
WPR
Philippines
China
Viet Nam
Lao PDR
Cambodia
Malaysia
Australia
WHO - HTP
Achievements (2): synergy
Drug/vaccine teams synergy benefits WHO work:
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learning from each other (data
collection tools, GTN)
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same message to countries
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harmonized technical support tools
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Achievements (3):
progress at country level
Vietnam: within 6 months from review
revised
regulations
Tailor-made
training
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Less bureaucracy and
more time for meaningful
technical work
Reliable access to
technical literature
Established capacity to
assess new drugs
WHO - HTP
Achievements (4):
progress at country level
Tunisia: within 6 months from review
Weak links with
health system
Survey to assess
prescribers’ perception
of regulatory work
Inadequate
drug information
Ad hoc training and expertise
to enable issuance of drug
information by end 2002 for
all drugs
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Thank you
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