Drug legislation and regulation as part of the health care system

1
Drug legislation and regulation as part of the
health care system
Dr Valerio Reggi, HTP/EDM/QSM 27 July 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 chart 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

• 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.

61
Drug legislation and regulation
62

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

63

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
64
Access to drugs has three dimensions

• drug has been developed
• drug is locally available
• drug is affordable

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

• Drug regulation and public health

• Establishing locally meaningful measures (1)
• Public health need
• decide, as a part of national health policy,
  whether to allow a large number of drugs to be
  authorized, or instead to concentrate financial
  and distribution resources on a smaller number of
  drugs considered essential in the light of public
  health need.

Very similar to approach to limiting product
reimbursement taken by private and public
insurance companies
76

• Drug regulation and public health

• Establishing locally meaningful measures (2)
• Limit number of new products
• exclude from registration all active ingredients
  not marketed for at least 3 years in at least one
  of the reference countries where reliable PMS is
  implemented, unless exceptional circumstances
  demonstrated a local need.

77

• Drug regulation and public health

• Establishing locally meaningful measures (3)
• Limit number of importers/distributors
• decide, as a part of national health policy,
  whether to limit number of companies dealing with
  large amounts of drugs to a manageable number
  consistent with the regulation and control
  capacity of the DRA.

Basic economic reasoning says that procuring
small quantities is inefficient.
78

• Drug regulation and public health

• Establishing locally meaningful measures (4)
• Limit number of interchangeable products
• decide, as a part of national health policy,
  whether to limit number of companies marketing
  the same active ingredient.

79

• Drug regulation and public health

Considerations against limiting number of
interchangeable products

• in the absence of price controls, price
  competition may - depending on local
  circumstances - lead to lower prices
• competition can stimulate local economic growth
  and employment
• competition promotes manufacturing efficiency,
  and quality if regulatory controls are
  comprehensively applied
• enforcement of regulations becomes difficult if
  only one brand is authorized and drug is
  essential
• if only one brand is authorized, failure of that
  source means drug is no longer available.

80

• Drug regulation and public health

In favour of limiting number of interchangeable
products
more resources are needed for drug
registration, inspection, and QC testing more
resources are needed for storage and
distribution multiple products stimulate
competitive promotion, leading to more pressure
on pharmacists and prescribers and possibly to
unnecessary prescribing.
81

• Drug regulation and public health

• Establishing locally meaningful measures (5)
• Help developing good-quality generics

• product development authorized during patent life
• abbreviated marketing authorization
• differential registration fees
• generic labeling
• generic prescribing and substitution

82

• Drug regulation and public health

Help developing good-quality generics

• Examples of early workings for generics
• access to innovator product safety and efficacy
  data
• production tests on a patent-protected product
• laboratory tests for marketing approval
• e.g. bioequivalence
• production and stockpiling prior to patent expiry
• Countries with some early workings provisions
• Argentina ? Hungary ? USA
• Australia ? Israel
• Canada ? Poland

83

• Drug regulation and public health

Help developing good-quality generics

• Gain professional and public acceptance
• involvement of professional and consumer groups
• phased implementation
• all training by generic name
• use of generic names in clinical manuals
• brand-generic / generic-brand indexes
• public promotional information and activities

84

• Drug regulation and public health

Help developing good-quality generics

• Work on economic incentives
• price information for professionals and the
  public
• retail margins favorable to generics
• use of generics for insurance/reimbursement
• public procurement systems based on generics
• 'reliable' environment for development of generic
  industry

85
Requirements for abridged marketing
authorization application (i.e. without clinical
data)

• product information previously approved,
• active ingredient previously approved,
• route of administration, strength and dosage form
  equal to those of previously approved product,
• adequate information on analytical methods,
  manufacturing process, manufacturers of finished
  product and starting materials,
• stability studies,
• proof of therapeutic equivalence with approved
  comparator product.

86
Generics can play an important role in public
health
This can be achieved through

• supportive legislation and regulations
• capable and credible regulatory authorities
• favorable economic environment
• information and advocacy initiatives

87

• 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?