Drug legislation and regulation as part of the health care system - PowerPoint PPT Presentation

Loading...

PPT – Drug legislation and regulation as part of the health care system PowerPoint presentation | free to download - id: 4b944-ZDc1Z



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

Drug legislation and regulation as part of the health care system

Description:

Essential state functions in the pharmaceutical sector ... or explore physiological systems or pathological states for the benefit of the recipient. ... – PowerPoint PPT presentation

Number of Views:93
Avg rating:3.0/5.0
Slides: 76
Provided by: EDM
Learn more at: http://archives.who.int
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: Drug legislation and regulation as part of the health care system


1
Drug legislation and regulation as part of the
health care system
Valerio Reggi, Eshetu Wondemagegnehu HTP/EDM/QSM
- 3 October 2001
2
Outline of presentation
  • Rationale for state role
  • Key elements of legislation
  • Key elements of regulatory
    system
  • Regulation and public health

3
Drug legislation and regulation
4
Rationale for state role
Regulation in medicine is 4000 years old
  • Hammurabi's Code of Laws ( 2000 BCE)
  • physician fees adapted to patients status
  • 215. a physician shall receive ten shekels
    in money.
  • 216. If the patient be a freed man, he receives
    five shekels.
  • 217. If the patient be the slave two shekels.
  • sanctions for malpractice
  • 218. If a physician make a large incision with
    the operating knife and kill the patient or .
    cut out the eye, his hands shall be cut off.

5
Rationale for state role
Essential state functions in the pharmaceutical
sector
  • Essential means that if the public sector is
    unable to perform these functions, public health
    goals cannot be achieved and the least privileged
    part of the population will suffer.

6
Essential state functions in the pharmaceutical
sector
Rationale for state role
  • Policy making, priority setting what are the
    problems? how do we address them? how do we know
    what we have achieved?
  • Regulation control what are the rules? are
    the rules respected? do we need to change rules?
  • Professional standards who is allowed to do
    what?
  • Access to drugs can people use the drugs they
    need?
  • Information can people use drugs properly?

7
Market failure
  • Equity who cares for the poor? Public/private
    mix
  • Information imbalance access to and capacity to
    assess and compare information on quality,
    safety, efficacy, value for money,
    appropriateness
  • External benefits immunizations and treatment
    of contagious diseases benefit all, if left to
    market laws alone many will not be immunized or
    treated
  • Failure of competition who can develop new
    drugs? who can influence prescription/consumption?
    who takes the less profitable activities?
    competition based on product differentiation
    rather than price
  • Market asymmetry who pays does not choose, who
    chooses does not pay

8
. drugs are a public good and not simply just
another commodity first for their high social
value, and then because consumers and prescribers
are unable to assess their quality, safety and
efficacy.
9
Rationale for state role
  • Selection of essential drugs is a two-step
    process
  • 1 - market approval of a pharmaceutical product
    on the basis of efficacy, safety and quality.
    This regulatory decision defines the availability
    of the drug in the market.
  • 2 - most public drug procurement schemes have
    mechanisms to limit procurement or reimbursements
    to certain drugs. For these decisions an
    evaluation is necessary, based on a comparison
    between various drug products and on
    considerations of value for money.

10
Rationale for state role
  • The reality (or the paradox)
  • - only richer countries make use of this second
    selection step, and therefore enact mechaisms to
    rationalise consumption and keep expenditure
    under control,
  • - in poorer countries, where health insurance
    mechanisms are not fully developed and people pay
    most drug out of pockets, there ar no adequate
    mechanisms to protect consumers

11
Rationale for state role
  • In industrialized countries regulatory work takes
    place in an environment characterized by
    longer-established regulatory traditions. In
    addition, there is a relatively mature
    interaction of interests, actions, and views of
    regulators, industry with different focuses
    (innovative medicines, generics, OTC products,
    alternative medicines), professionals, patient
    and consumers groups, and individuals.

12
Rationale for state role
  • In developing countries regulation is often less
    consolidated than in industrialized countries,
    and the interaction between the different
    interested parties is not always balanced. In
    addition, the resources that can be made
    available for the implementation of regulatory
    work and control are not always adequate for the
    task that regulatory authorities are expected to
    undertake. This puts special responsibility and
    burden on decision makers and regulatory
    officials of developing countries.

13
Rationale for state role
Consequences of weak drug regulatory capacity
Irrational consumption and prescription, substanda
rd, counterfeit, harmful, useless drugs on sale
14
Drug legislation and regulation
15
Purposes of drug legislation
Key elements of drug legislation
  • Distinguish permissible or lawful from
    impermissible or unlawful
  • Specify rights, duties, powers
  • Provide a legal basis for regulation
  • Specify sanctions and penalties to be imposed
    upon those who violate legislation or
    regulations.

16
Scope of drug legislation
Key elements of drug legislation
  • What products should be regulated
  • What companies/institutions should be regulated
  • What activities should be regulated
  • To what extent should the above be regulated
  • Who should be responsible for regulation
  • What sanctions should apply in case of violations

17
Items of drug legislation (1)
Key elements of drug legislation
  • Technical aspects (title, date of operation,
    areas of application/exclusion, relationship to
    other existing laws, transitional arrangements).
  • Definitions of terms and concepts
  • Statutory powers (right of inspection), duties
    and responsibilities of the regulatory authority,
    and its organization and resources
  • Requirement for company and product licensing and
    duration of validity of licences

18
Items of drug legislation (2)
Key elements of drug legislation
  • Special issues e.g. patents, prices, clinical
    trials, post-marketing surveillance, conflicts of
    interest, access to information, advertising and
    promotion
  • Enforcement procedures, penal provisions, and
    administrative penalties
  • Right of complaint and appeal against regulatory
    decisions
  • Scope and power of regulation-making (i.e. main
    text must authorize that additional provisions
    are made through regulations)

19
Definitions in drug legislation (1)
Key elements of drug legislation
  • Products subject to legislation
  • clear, unambiguous, comprehensive definition of
    medicinal product

Any substance or pharmaceutical product for human
or veterinary use that is intended to modify or
explore physiological systems or pathological
states for the benefit of the recipient.
20
Definitions in drug legislation (2)
Key elements of drug legislation
  • Borderline products criteria and attitudes
    change, new problems arise
  • flexibility to enable DRA to cover specific
    classes of product to be within scope of law
  • claims in promotion/labelling and consumer
    perception decide if a product is for medicinal
    purpose (tonics, food supplements, vitamins,
    soaps and shampoos)

public health approach demands that what people
perceive as a drug should be regulated as a drug
21
Definitions in drug legislation (3)
Key elements of drug legislation
  • The term "medicinal product" must include, at
    least pharmaceutical, biological (vaccines,
    blood products, other biologicals) and herbal
    products, including traditional medicines (not
    harvested by traditional medicine practitioners
    and sold in package form), products known in many
    countries as "pharmafoods", "nutriceuticals", or
    "cosmeceuticals" intended for therapeutic use and
    whether for animal or human use.

WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 1998, WHO Technical
Report Series, No.885
22
Definitions in drug legislation (4)
Key elements of drug legislation
  • The drug regulatory authority must also determine
    to what extent it intends to exempt related
    products, such as diagnostic materials, medical
    devices, cosmetics, health foods and food
    supplements from its scope of issuing marketing
    authorizations. ... In borderline cases it
    might be left to the regulatory authority to
    decide whether a substance or preparation is
    considered as a medicinal product.

WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 1998, WHO Technical
Report Series, No.885
23
Definitions in drug legislation (5)
Key elements of drug legislation
  • Activities subject to legislation
  • The legislation must apply to all institutions
    and individuals, within both the public and
    private sectors, that are engaged in, or
    connected with any aspect of manufacture,
    promotion, procurement, distribution, sale or
    supply of medicinal products.

WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 1998, WHO Technical
Report Series, No.885
24
Definitions in drug legislation (6)
Key elements of drug legislation
  • Statutory powers in legislation
  • primary responsibility of the national drug
    regulatory authority is to operate a system of
    administration and enforcement intended to
    achieve the objectives of the legislation

WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 1998, WHO Technical
Report Series, No.885
25
Definitions in drug legislation (7)
Key elements of drug legislation
  • Statutory powers in legislation
  • A department of veterinary services or a
    department dealing with traditional medicine
    practices may exert administrative oversight of
    services without exercising regulatory control
    over the products used within the specific
    discipline.
  • ensure close and effective coordination
    between all concerned parties.

WHO Expert Committee on Specifications for
Pharmaceutical Preparations. 1998, WHO Technical
Report Series, No.885
26
Drug legislation and regulation
27
Key elements of drug regulatory system
Drug regulation comprises all the legal,
administrative technical arrangements meant to
ensure that
  • 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

28
Basic functions in drug regulation (1)
Key elements of drug regulatory system
  • 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...
29
Basic functions in drug regulation (2)
Key elements of drug regulatory system
.continued
  • 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

30
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
31
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
32
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
33
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
34
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Government
Experts
Manufacturers
Regulatory authority
Prescribers
Products
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
35
The challenges
  • the health system counts on DRA for good, safe,
    and effective medicines and for fair rules and
    control on drug trade, information, and use
  • any strategy to improve anything in the
    pharmaceutcal area involves DRA
  • any problem encountered in the pharmaceutical
    area has something to do with the DRA

36
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. Form
ulate adequate legislation 6. Create appropriate
organisational structure 7. Allocate adequate
human and financial resources 8. Minimise
corruption and conflict of interest 9. Apply
appropriate regulatory enforcement strategies
37
Effective regulation depends on the environment
  • adequate consideration is given to the public
    health value of drugs
  • drug regulation is not fragmented
  • DRA is also accountable to the public
  • drug regulation processes are transparent
  • appropriate sanctions are regularly applied
  • strong, organised public interest groups are
    incentived to support drug regulatory activities
  • there is freedom of association and information

38
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Political will and commitment
  • clear, firm, and equitable legislation addressing
    all the relevant issues and carries appropriate
    sanctions
  • financial and other resources that are
    commensurate with the designated functions
  • willingness to defend decisions and policies
    which are to the benefit of public health
  • support when legislated sanctions are imposed for
    violations of legislation.

39
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Accountability
  • means being required to account for ones conduct
    and actions, usually to an individual or group
    but ultimately to the public
  • field of medicines is highly commercialized, it
    is characterized by extreme pressures on the DRA
    and by intensive lobbying from stakeholders at
    many levels
  • a system of accountability is essential in
    managing these tensions.

40
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Mechanisms to ensure accountability
  • requirement to provide public reports
  • publication of decisions, processes and policies
  • mechanism for appeals against DRA decisions
  • code of conduct for DRA staff and procedure for
    complaints about actions of DRA and conduct of
    individual staff
  • formalized mechanisms for consulting experts
  • web site with information about the DRA

41
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Staff skills
  • evaluators should be qualified in pharmacy,
    clinical pharmacology, medicine or a similar
    discipline
  • external expertise should also be available, but
    authoritys own staff must be capable of
    understanding and implementing expert advisory
    bodys recommendations
  • DRA needs staff to investigate breaches of
    legislation and initiate action in the courts
  • a suitable number of competent administrative
    staff and computer specialists.

42
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Staff number
  • Number of staff depends on responsibilities
    to be undertaken.
  • Major determinants of staff numbers
  • degree to which DRA is prepared to rely on
    decisions made, and reports prepared, by DRA in
    other countries
  • presence of local pharmaceutical industry
  • number of products to be processed.

43
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Staff training
  • Routine training for new staff
  • Scientific skills must be continuously updated to
    keep pace with drug discovery and development
  • It is therefore essential for suitable training
    and practical experience to be offered regularly
    to the staff concerned.

44
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Premises
  • Data submitted by applicants should be stored
    with sufficient security to give the applicants
    the confidence that they cannot be subject to
    theft or unauthorized copying.
  • Professional staff whose responsibilities include
    sustained periods of concentration will perform
    more efficiently (in terms of output and
    reliability) in quiet surroundings.

45
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Computerized system
  • progress of assessment of applications
  • premises for which an inspection is due
  • date of latest approved product information
  • previous decisions taken on same or similar
    active ingredient guidance for assessment
  • list of marketing authorizations due to expire
  • regular reports and lists
  • automation of administrative tasks
  • alerts for deadlines.

46
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Access to the Internet
  • information from web sites of other DRAs
  • access to technical literature
  • up-to-date safety information
  • access to web sites of professional associations
    and NGOs.
  • Own web site
  • information on decisions
  • regulatory information
  • safety information and alerts
  • open channel for receiving input from society.

47
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Expert advice
  • local expertise from universities, research
    institutes, and health care facilities (all
    levels)
  • individuals whose advice is seen by community,
    health workers and government as authoritative
    and credible
  • fixed-term assignments to reduce risk of
    dependence on political considerations
  • set broad technical policies so that only
    difficult applications need to be referred
  • declaration of no conflict of interest before
    and during activities of the expert advisory
    body
  • reimbursement travel and accommodation plus
    reasonable remuneration not related to outcome of
    evaluation.

48
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Fees and cost recovery
  • for all applications and unrelated to outcome
  • certifications annual fees (support PM
    activities)
  • high enough to contribute significantly to
    effective functioning of DRA without affecting
    drug price
  • conducting services for profit is contrary to
    purpose and ethic of and distracts from
    regulatory work
  • fees relate to amount of work (fees for generics
    are lower because they require less assessment
    work)
  • low or no fees for vital drugs with limited
    market, annual fee can be based on annual sales
  • fee structure should be transparent.

49
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Special access schemes
  • allow access to unregistered drug products in
    special or emergency situations
  • avoid de facto marketing.

50
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Transparency (1)
  • DRA must answer to both government and the
    public on
  • how it fulfils its mission to protect public
    health
  • how it prevents corruption
  • how it prevents decisions unfair to those
    regulated.

51
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Transparency (2)
  • printed and published policies and procedures
  • give reasons for decisions
  • transparency is the most efficient way to work
  • no time spent clarifying policies and attitudes
  • terminology is defined so that the parties use
    the same terms to mean the same thing
  • risk of arbitrary decisions is reduced
  • DRAs image is they implement rules rather than
    they decide
  • competence vs bureaucracy.

52
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Written policies
  • decisions on individual applications become
    easier
  • examples
  • when data on bioequivalence are required
  • when evaluation reports prepared by another DRA
    will be accepted
  • which fixed-dose combinations are considered
    rational
  • when and from which countries certificates are
    accepted
  • what are the acceptable reference sources for
    drug information.

53
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Written procedures
  • staff understand their own role
  • assessment deadlines are predictable
  • lines of communication are clear
  • documentation and reasons for decisions
    accessible and are easy to identify
  • SOP written procedure giving instructions for
    performing operations (e.g., reception of
    applications, individual steps of assessment,
    issuance of marketing authorization, equipment
    operation, validation of analytical methods)

54
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL

Example of part of SOP on WHO-type certificate
Decision tree for WHO-type certificate
Obtain WHO-type Certificate
Issueing authority is in list of reference
countries?
Does product have MA in exporting country?
Proceed as if no certificate was submitted
Check if product is exactly the same Review
product information and adapt if necessary Review
bioequivalence if required Review stability data
if required Check if analytical methods are
applicable in QC lab
55
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Quality system
  • infrastructure, encompassing organizational
    structure, procedures, processes, and resources
  • organized set of actions necessary to ensure that
    patients, applicants, and regulators are
    satisfied that assessment and decisions are
    within legal requirements and guidance, and
    consistent with protection and promotion of
    public health.

56
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Quality manual
  • contains defined and documented DRAs policies
    and objectives
  • DRA must ensure that policies are understood and
    implemented at all levels in the DRA
  • describe legal status of all elements of DRA
    (drug registration, inspectorate, QC lab, etc.)
  • code of ethics and conduct relating to all DRA
    activities
  • names, qualifications, and terms of reference of
    the senior staff and other DRA personnel, both
    internal and external

57
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Quality manual (continued)
  • training strategies and arrangements for all DRA
    staff
  • organization chart showing lines of authority,
    responsibility and allocation of functions
  • documented procedures for issue, suspension and
    revocation of marketing authorizations
  • list of subcontractors used for specific DRA work
    and details of the documented procedures for
    assessing and monitoring their competence
  • details of appeals procedures
    .

58
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • Quality manual (continued)
  • procedure for ensuring that complaints are
    investigated and shortcomings revealed
  • list of staff members responsible for
    investigating complaints and those with authority
    to take remedial action
  • system of records which demonstrates compliance
    with obligations under national legislation and
    demonstrates that the quality system is operating
    satisfactorily.

59
The EMEA Quality Manual/Documentation System
Structure
EMEA Mission Statement Quality Policy
EMEA Policies
EMEA Core Key Tasks (Process Maps/Flowcharts)
EMEA SOPs
EMEA Forms Standard Documents Templates
60
The EMEA Quality Manual/Documentation System
Structure
EMEA Forms Standard Documents Templates
EMEA SOPs
EMEA Core Key Tasks (Process Maps/Flowcharts)
EMEA Policies
EMEA Mission Statement Quality Policy
61
  • PROVISIONS AND PREREQUISITES FOR REGULATORY
    CONTROL
  • A regulatory culture
  • DRA should lead its staff to independent
    thinking, impartiality and pride in their work.
  • Everyone should be motivated by a desire to
    ensure that effective, safe and good-quality drug
    products are available to the public in adequate
    quantities and are used rationally.
  • It should be stressed that staff who succumb to
    favours from outside sources are damaging the
    reputation of the whole organization, including
    that of their colleagues.

62
Drug legislation and regulation
63

World Health Assembly resolution 52.19 24 May
1999 WHOs 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

64

World Health Assembly resolution 52.19 24 May
1999 WHOs Revised Drug Strategy
Implications for drug 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
  • - improve drug assessment and market control

Improve regulatory system's capacity to meet
needs of health professionals and public
65
Access to quality drugs
  • To ensure access to quality drugs there is no
    better strategy than building a reliable and
    effective national drug regulatory authority

66
9th ICDRA 29/4/1999
  • Drug regulation and public health
  • Good regulatory practice requires
  • 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

67
9th ICDRA 29/4/1999
  • Drug regulation and public health
  • Good regulatory practice requires
  • 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

68
9th ICDRA 29/4/1999
  • Drug regulation and public health
  • Good regulatory practice requires
  • 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

69
  • 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
70
Big gaps exist
71
Thousands of highly qualified professionals
Thousands of highly qualified external experts
Virtually unlimited access to the
most sophisticated technology and knowledge
72
Gaps also exist between non-ICH counties e.g.
between newer and older members of ASEAN
Harmonisation
Mutual understanding, ...or one-way understanding?
73
No importable models
  • ..approach to drug regulation must be attuned to
    available resources...
  • ...problems in establishing drug control have too
    often resulted from the adaptation of provisions
    successful elsewhere but of a complexity that
    precludes their effective implementation in the
    country of adoption...

WHO Expert Committee on Specifications for
Pharmaceutical Preparations, TSR 790, 1990
74
  • Drug regulation and public health
  • Setting priorities based on available resources
  • ensure effective market control
  • establish list of authorized/marketed products,
  • strengthen inspection of distribution channels
    (if appropriate limit number of entry points for
    imported drugs and number of distributors),
  • establish adequate sanctions for violators
  • establish GMP requirement and inspections
  • identify reference DRAs for reports, decisions,
    drug information, safety alerts
  • focus on regulation and control of generics
  • build collaboration with academic and research
    intitutions and NGOs to address drug selection
    and rational use.

75
  • Huge differences in regulatory environment do
    exist.
  • What can regulators do?
  • Wait for political will, improved legislation,
    more resources to appear ?
  • Or rather try to improve regulatory work with
    current environment and resources in order to
    maximise its potential for improving public
    health?
About PowerShow.com