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					Being an effective regulator:

                  A case study
                  for medicines
                      in Malta



           Dr. Patricia Vella Bonanno


 4th Annual International Regulatory Affairs
                 Symposium



         London, 27th-28th March, 2012
                                               1
Case study methodology

A case study for Malta

                             The Case


                            Case Study


                         Evidence / Questions




                             Applicability




                           Generalisation
                                                2
Applying a general logic model for the case study

Case study methodology
        Resources             Activities       Outputs        Customers             Outcomes – changes or benefits
                                                               reached


Structural &     Inputs                                                     Short term      Intermediate      Long term
   Human                                                                                          term
Human          Inputs        All the        The products,     Customers    Those           Those changes    Program
and            required to   action steps   goods and         served and   changes or      that result      impacts –
financial      support the   necessary to   services          the people   benefits that   from an          follow from
resources      programme     produce        provided to the   who work     are most        application of   the benefits
                             programme      programme’s       with the     closely         the short term   accrued
                             outputs        direct            partners     associated      outcomes         through the
                                            customers         who work     with or                          intermediate
                                                              with the     caused by                        outcomes
                                                              program to   the program
                                                              enable       outputs
                                                              actions to
                                                              lead to
                                                              results


 External influences

                                                                            Adapted from Mc Laughlin and Jordan (1999)   3
General logic model representing the framework

                                                                     Stakeholder   Outcomes
                  Resources                  Activities   Outputs
                                                                          s


   Structural &                                                     Customers
                         Inputs to support
      Human                                                         reached




External influences
                                                                                              4
Information on the case

Malta

•       Population : 409,836

•       Island in the
        Mediterranean Sea

•       Area of 316sq km

•       Accession into the EU
        on 1st May 2004

•       Republic with a
        Parliament

                                5
Information on the case

Malta a member of the European Union




                                      Political Map of Europe
                                   depicting EU and EEA Member
                                                States
                                   (map adopted from Nations Online, 2008)



                                                                             6
Characteristics of the country, generalisability

Malta is the smallest state in Europe and an Island

Population in EU/EEA States

  Country           Pop. (CIA,    Area     Pop. density   Island
                     estimate    sq. km    Inhabitants/
                    July 2012)               sq. km




Cyprus        EU    1,138,071
                                  9,241        91          yes


Luxembourg
                      509,074     2,586        194         no


Malta
                      409,836     316         1,322        yes

Iceland       EEA

                      313,183    100,250       3.1         yes

                                                                   7
Characteristics of the country, generalisability
Number of products authorised in small member states
                    Number of Available Medicines in EU/EEA Member States
                                                              Number of Authorised
                 Country                 Population
                                                                 Products (2007)
      Slovakia                                  5,447,502                    19,693
      Greece                                   10,706,290                    16,648
      Austria                                   8,199,783                    15,527
      United Kingdom                           60,776,238                    11,633
      Sweden                                    9,031,088                     8,504
      Ireland                                   4,109,086                     7,309
      Finland                                   5,238,460                     7,071
      Hungary                                   9,956,108                     5,525
      Norway                                    4,627,926                     3,853
      Latvia                                    2,259,810                     3,660
      Iceland                                     301,931                     3,426
      Estonia                                   1,315,912                     2,925
      Cyprus                                      788,457                     2,300
                                                                                      8
      Malta                                       401,880                     1,612
International policies and conventions
WHO : National Medicines Policy

   •Access:                  equitable availability and affordability of essential medicines
   •Quality:                 the quality, safety and efficacy of all medicines
   •Rational use:            the promotion of therapeutically sound and cost-effective use of
                            medicines by health professionals and consumer

                     Components of a national drug policy, linked to key policy objectives
    Components:                                Objectives:       Access        Quality       Rational use


    Selection of essential drugs                                    X            (X)              X
    Affordability                                                   X
    Drug Financing                                                  X
    Supply systems                                                  X                            (X)
    Regulation and quality assurance                                              X               X
    Rational use                                                                                  X
    Research                                                        X             X               X
    Human resources                                                 X             X               X
    Monitoring and evaluation                                       X             X               X
                                                                                                            9
National legislative / policy framework

Framework for regulation of medicines in Malta
                                           Pharmacies
                   Policy Makers
                                                                Wholesale Dealers
               Healthcare
              Professionals                   National
                                            Stakeholder
                                                                        Importers
                                              Groups
                Patients and
           Patient Organizations
                                                                    Manufacturers
                              Consumers




                                                                                                           EU
                                                                                        National     Pharmaceutical
                                                                                       Legislation     Legislation
                                                       Medicines
                         Rational                      Regulation
                           Use
              National
                                                                        Supply
             Medicines
                                                                       Systems
               Policy
           Essential                                                        Research
                                      Medicines
           Medicines
                                       Policy
             Human                                                         Medicines
            Resources                                                      Financing
                                                                Affordabilit
               Legislation                Monitoring                 y
                                          Evaluation


                                                                                                                      10
The processes within the framework

The processes of the pharmaceutical framework




  Research   Authorisation   Manufacture   Wholesale Dealers   Pharmacy   Patient




                                                                                    11
Regulation as part of the medicines framework

Regulatory framework for medicines in Malta

                                                                                                            Stakeholder                                    Outcomes
                     Resources                                 Activities                Outputs
                                                                                                                 s




                                                                                                                                   Access


                                                                                                                                            Availability

                                                                                                                                                            Affordability



                                                                                                                                                                            Quality,


                                                                                                                                                                                                  Rational use
                             Inputs to support
     Structural &




                                                                                                                                                                                  efficacy
                                                                                                                                                                                  safety&
        Human
                                 Legislation


 Marketing
 Authorisation Holders
                           EU/National                R & D, Registration, Safety                                                  √        √                    √                √           √
                                                                                                               Patients
 Regulatory                                           Registration,, Safety,                                                                                                                  √
       Authorities
                           EU/National
                                                      Enforcement                       Public Health                              √        √                    √                √

                                                                                                              Consumers
 Pricing Authorities       EU/National                Setting of price and profit                                                                                √

 Reimbursement             EU/National                Establishment of                     Free
      Authorities                                            Reimbursement list         Movement of          Healthcare                     √                    √
                                                                                          Goods             Professionals
 Manufacturers and         EU/National                Manufacture/
      Importers                                       distribution
                                                                                                                                            √                    √                √
                                                                                                             Pharmacies
 Wholesale dealers         EU/National                Distribution                         Open                                             √                    √                √
                                                                                         Competition          Wholesale
 Pharmacies                National                   Distribution
                                                                                                               Dealers                      √                    √                √
  Healthcare               National                   Prescribing/Dispensing/
  Professionals                                       Administration                                        Manufacturers                                        √                            √
                                                                                        A True Single       and Importers
 Patient/ Consumer         National                   Administration                       Market                                                                √                            √
 External influences: Cross border activity; Policies in other Member States; ‘Political’/stakeholder pressure, lobby, interests                                                             12
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   13
Regulatory bodies, their remit and impact on different processes

The Medicines Authority – Regulation of quality, safety and efficacy
Strong EU legal framework




                                                                       14
Regulatory authorities, their remit and impact on different processes

Pricing of medicines in retail pharmacies –
‘Voluntary’ regulatory mechanism




                                                                        15
Regulatory authorities, their remit and impact on different processes

Reimbursement by the National Health Services:
Equity, allocation of resources, affordability
National remit, covered by ‘Transparency Directive’




                                                                        16
The regulatory agency and its mission

Mission of the Medicines Authority


  To protect public health through the
  regulation:                                Pharmacies




                                                    Wholesale dealers




  of medicinal products and
                 pharmaceutical activities       Manufacturers


                                                                   17
Remit, objectives, activities of the regulatory agency

Objectives of the Medicines Authority
   Regulation of the safety, quality and efficacy of medicinal products for
    sale or supply on the Maltese market and the EU market.

   Regulation of clinical trails – scientific evaluation

   Regulation of      GMP,    GDP,   Pharmacies,     GCP,   Pharmacovigilance
    inspections

   Regulation of advertising of medicinal products

   Ensuring quality of products on the market

   Enforcement of legislation

   Information about medicinal products, availability and rational use of
    medicinal products on the local market.
                                                                             18
The regulatory agency – its set up

The Medicines Authority


  Set up in 2003 through the Medicines Act, 2003
  Functions delegated by the Licensing Authority
  Regulation of medicinal products and pharmaceutical activities
  Protection of public health patients & consumers




    Licensing of         Post-licensing       Inspectorate and
     medicinal        -Pharmacovigilance        Enforcement
      products            -Advertising
                                                             19
The regulatory agency - organisational structure
Organisation structure of the Medicines Authority
                                                                  CEO
                                                                                               44 Staff Members
                                               Finance and Administration Executive


     Information Systems
                                                                                      Operations and Regulatory Affairs




     Finance and Administration                                                       Quality Management


       Finance and Administration Executives
       Finance and Administration Assistants



Licensing Directorate                           Post-Licensing Directorate                   Inspectorate and Enforcement Directorate


   Clinical Assessors
                                                   Pre-Clinical Assessor                       Medicines Inspectors
   Quality Assessors
                                                   Medical Assessor                            Pharmacist
   Senior Pharmacists
                                                   Pharmacist                                  Finance and Administration Executive
   Pharmacists
   F&A Executives


                                                                                                                                 20
Structures, decision making, transparency, committees and appeals

Structure for regulation at the Medicines Authority
                                                                                                                      Office of the CEO
                                                                                                                                                                                                                Licensing Authority
                                                                                                                                                                Operations and Regulatory
                                                                                             Information Systems                                                         Affairs                     Delegates functions to the
                                                                                                                                                                                                     Medicines Authority as per
                                                                                                                                                                                                     Medicines Act

                                                                                   Finance and Administration                                                           Quality Management


                                                                                                                                                                                                             Medicines Review Board
                  EU Commission                                                                                                                                     Inspectorate and
                                                                                             Licensing Directorate                                               Enforcement Directorate
    European




                  European Medicines Agency

                                                                                                                     Post-Licensing Directorate
                  Heads of Medicines Agencies
                                                                                                                                                                                                            Patients

                                                                                                                                                                                                            Consumers

                                                                                     Management                                                                                                             General Public
                                                       Leadership and Management




                                                                                                                                                                                                            Health Care Professionals
                                                                                     Information Systems                                                 Interface Meetings
                                                                                                                                                                                                            Manufacturers
                                                                                     Corporate Staff Meetings                                            Medicines Review Committee
                                                                                                                                  Technical Committees


                                                                                                                                                                                                            Importers
                Parliament
                                                                                     Directorate Staff Meetings                                          Enforcement Commitee                               Wholesale Dealers




                                                                                                                                                                                             Stakeholders
                Ministry for Fair Competition, Small                                                                                                                                                        Pharmacies
                                                                                     Health, Safety and Well Being                                       Inspectorate Review Committee
                Business and Consumers
                                                                                     Committee
Line Ministry




                                                                                                                                                                                                            Chambers and Unions
                                                                                     Communications and Public                                           Borderline Classification
                Permanent Secretary                                                  Relations Working Group                                             Committee                                          Others
                                                                                                                                                                                                                                   21
Collaboration with other regulatory agencies, authorities, ministries

Main collaboration of the Medicines Authority


   Superintendence of Public Health
   Consumer and Competition Affairs Authority (medical devices,
    cosmetics, foods)
   Customs
   Police
   Broadcasting Authority
   Small and medium enterprises
   College of regulators
   Consumer Affairs Council
                                                                        22
Quality Management Structure

Quality Management within the Medicines Authority

  Based on ISO
  System for continuous quality improvement
  Corrective and preventive action
  Quality manual, Standard Operating Procedures
                                                     Act     Do
  Investigation and follow up of complaints
  Internal audit
  Management Review
                                                     Plan   Check


  Benchmarking of the European Medicines Agencies


                                                              23
Effective leadership and management structure for the regulator
Corporate cycle for the Medicines Authority


                                                                                                             Key tasks and
  Management Review
                                                                                                          performance targets
  Staff Meeting
                                                                                                          Medicines Authority
                              4. Evaluate &
                                                                                   1. Plan                   Directorates
                                   Act                                                                        Employees

                                                               CEO
                                                       Management Team
                                                        Directorates and
Risk Register                                                Units
Monitoring of
                                                           All together
performance of tasks and
outcomes                                                                                                       Activities
                                3. Measure
Performance appraisal of                                                            2. Do              Activity flow charts
employees every 6 months         & Report
                                                                                                       Documentation of
Internal audit and                                                                                     processes
corrective action                                                                                      Implementation of
                                                                                                       processes results

        Quality Management System, Benchmarking of the European Medicines Agencies (BEMA III), Mutual Recognition
        Agreement, Memoranda of Understanding.
                                                                                                                              24
Effective corporate management
Annual Corporate Calendar

                        Main Activities                        Q1   Q2   Q3   Q4

    Audit of Financial Statements
    Main objectives set following consultation (Operational
    Planning)

    Annual Report
    Extraordinary Staff Meeting (Communicating)

    Business Plan Preperation

    Performance Appraisal (Monitoring)


    Extraordinary Staff Meeting (Motivating/ Training)


    Management Review (Evaluation and Planning)


    Extraordinary Staff Meeting (Evaluation and Planning)


    Evaluation of achievement of objectives and targets


    Setting of Objectives and Operational Plan for next year
                                                                                   25
Collaboration/participation on external Regulatory Fora
Malta’s Participation on European and WHO Fora

  -The Medicines Authority forms part of the European
  network of medicines agencies including EMA

  -Representation on EMA scientific committees for medicines
  such as the Committee for Human Medicinal Products,
  Committee for Paediatric Medicines, Committee for Orphan
  Medicinal Products, Committee for Herbal Medicinal Products

  -Participation on Committees of
  The European Commission

  -Collaboration – WHO, Uppsala Centre                          26
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   27
Legislation : applicable to all processes in framework

The Medicines Act 2003 and subsidiary legislation
                                          Resources


                                                 Inputs to support
                            Structural &
   EU Legislation              Human
                                                    Legislation

   National Legislation
                          Marketing
                          Authorisation          EU/National
   Transposition          Holders

                          Regulatory
   Drafting                     Authorities
                                                 EU/National

                          Pricing
   Technical input        Authorities
                                                 EU/National

                          Reimbursement          EU/National
   Consultation                Authorities

                          Manufacturers          EU/National
   Better regulation           and
                               Importers

   Reducing               Wholesale dealers      EU/National

   administrative         Pharmacies             National

   burden                  Healthcare
                           Professionals
                                                 National



                          Patient/ Consumer      National

                          External influences:
                                                                     28
Interpretation, clarification and information on legislation
‘Neutral’ position without succumbing to pressures

‘Counterfeit and generics’ – a ‘misconception’




                                                               29
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   30
Activities: Regulation of research and development
Assessment of Clinical trials


    Clinical trials have been regulated since 2005


    Authorisation is based on evaluation of scientific information
     (protocol etc) as well as ethical approval (patient consent etc)

    Regulation is primarily aimed at protecting clinical trial subjects

    Clinical trials produce information required for the evaluation of
     marketing authorisations and changes to authorisations

    List of clinical trials authorised is published


                                                          Research
                                                                           31
Information about innovation findings - globalisation

Research and development in Malta and globally




                                                        32
Activities: benefit – risk evaluation, evidence - based
Licensing of medicinal products

                             Evaluation

          Benefits                              Risks
           Efficacy                             Safety
  Use of medicines                              Side effects
                                                ADRs
                                                Contra-indications
    Quality of products
              Expiry dates            •Classification (POM/non POM)
  Active ingredients (API)            •Labeling
      Inactive ingredients            •Patient information leaflet
       Storage conditions             •SPC
                                                              33
Participation in European Procedures – impact of size

Malta as CMS and RMS January 2010 – June 2011




                                                        34
Activities: Authorisation of products for the market,
Information on products
Medicinal products – Information to be included and language




                                                               35
Information for patients, comprehensible and readable
Package Leaflet for medicinal product




                                                        36
Information about medicinal products - accessibility
patients, consumers and health care professionals

Malta Medicines List on Website




                                                       37
Globalisation of the availability of medicinal products
Depends on registration, marketing by industry and reimbursement

Information about new medicines authorised in other countries




                                                                   38
Activities: post authorisation monitoring and evaluation
Post-authorisation evaluation

                                Evaluation

           Benefits                            Risks
              Efficacy                         Safety
     Relative efficacy                         Relative safety
       Effectiveness                           Adverse events
                                               ADRs
Relative effectiveness                         Overdosage
                                               Medication errors
                              Variations
                Classification (POM/non POM)
                Labeling
                Patient information leaflet
                SPC                                            39
Activities: Monitoring of products, market surveillance

Pharmacovigilance and market surveillance


 - Following marketing authorisation products are monitored for safety and quality

 - Marketing authorisation holders
 remain responsible for the products

 - Variations to marketing authorisations

 - Reporting of adverse drug reactions

 - Reporting of medication errors

 - Monitoring of the quality of products on the market – market surveillance,
 sampling, complaints

 - Marketing authorisations may be suspended or withdrawn
                                                                                40
Activities: Suspension/withdrawal of authorisations

Marketing Authorisations withdrawn or suspended




                                                      41
Perception, actual risk and the regulatory decision

Safety of medicinal products on the market




                                                      42
Activities: Inspection and licensing of activities

Inspectorate

  Inspections in line with EU standards

  Follow up of corrective actions

  Authorisation of pharmaceutical activities

  Issues are addressed in a disciplined way within stipulated timeframes


                        2004   2005   2006      2007   2008   2009   2010   2011

 GMP authorised sites     5      6      11       18     21     24     28         29
 Wholesale Dealers       82     74      66       69     74     72     71         68

 Community Pharmacies   208    206     207      207    208    209     211    213

                                                                            43
Competence and capacity in line with market needs

Licensing of GMP Pharmaceutical Activities


                                           35
  Number of EU GMP activities authorised




                                           30


                                           25
                                                                                                        Importers
                                                                                                        Partial Manufacturers
                                           20
                                                                                                        Laboratories
                                                                                                        Manufacturers (API)
                                           15
                                                                                                        Manufacturers (gases)
                                                                                                        Manufacturers (generics)
                                           10


                                           5


                                           0
                                                2004   2005   2006   2007   2008   2009   2010   2011
                                                                            Year
                                                                                                                                44
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   45
Outputs: standards, information, empowerment ……
Ensuring and enforcing standards, information, empowerment

 Ensuring that standards are achieved and maintained by all

 Balance between public health and competitiveness

 Ensuring that the medicines supply chain is secured to prevent
falsified medicines from entering the regulated supply chain

 Enforcement of the legislation

 Investigation of complaints

 Market surveillance and sampling

 Increased information
                                                     y
                                                                   46
 Empowerment of patients
Communication / information about medicines
Questionnaire for communication strategy with consumers
  Respondents:

   Did not know the difference between branded and generic medicines

   Frequently ask for advice and information about medicines

   Ask advice mainly from their pharmacist

   Have the biggest trust in their doctor

   Frequently read their patient information leaflet

   Few respondents bought medicines over the internet

   Store medicines mainly in their kitchen and their bathroom

   Use medicines up to the expiry date
                                                                        47
   Dispose of medicines with domestic waste
Communication and consultation with stakeholders
‘Support’ without compromising the regulatory role

Communication and initiatives


   Know Your Medicines Inititiave
   Leaflets to pharmacies and households
   Website and Social Media
   Articles on newspapers and academic journals
   Training sessions with the Malta College of Pharmacy Practice
   Complaints Procedure
   Individual Meetings with Companies, Associations and Prospective
    investors
   Consultations on legislation and different areas

                                                                       48
Information to patients

Leaflets and information material




                                    49
Communication through different media

Launch of the ‘Know Your Medicines’ campaign




                                               50
Role of the regulator in informing / empowering consumers

Information to consumers




                                                            51
Informing and educating the public – national issues

Buying medicines over the internet in an unregulated environment




                                                                   52
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs    Customers            Outcomes – changes or benefits
                                                 reached


Structural &   Inputs                          Stakeholders   Short term    Intermediate       Long term
   Human                                                                          term




 External influences

                                                                                                      53
National Stakeholders
Local Stakeholders: Patients and consumers, professionals,
industry
   Chambers
   The Malta Chamber of Commerce, Enterprise and Industry
   Malta Chamber of Small and Medium Enterprises
   Malta Chamber of Pharmacists


   Professional Associations
   Prima Malta Association
   Malta Qualified Persons Association
   Malta College of Pharmacy Practice
   Malta College of Doctors
   Association of Private Family Doctors
   Medical Association of Malta


   Consumer and Patient groups
   Consumers' Association Malta
   Association of Medical Representatives
                                                             54
   Malta Health Network
Feedback from stakeholders on regulator
Stakeholders’ Satisfaction Survey 3/2011

 Quality of services of the Medicines Authority (76%)
 Level of experience and knowledge of staff members (77%)
 Responsiveness of the Medicines Authority to stakeholder needs (71%)
 Provision of an effective yet supportive regulatory environment (71%)
 Approach and attitude of the Medicines Authority to its customers (71%)
 Integrity of the Medicines Authority (76%)




 Serving customers and honouring commitments (7% unsatisfied)
 How the Medicines Authority prevents/ solves problems (12% unsatisfied)
 Quality of service (4% unsatisfied)                                     55
Perspectives of different stakeholders

Example of regulation of herbal products




                                           56
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   57
Access – Availability – Affordability of productsto
Outcome: measurement, initiatives                                                         affect outcome

Number of medicinal products authorised to be placed on the market


                                  4500

                                  4000

                                  3500
     No. of Products Authorised




                                  3000
                                                                                                        126a

                                  2500                                                                  National (MT)
                                                                                                        MRP/DCP
                                  2000                                                                  PMA/MA
                                                                                                        PMA
                                  1500

                                  1000

                                  500

                                    0
                                         2004   2005   2006   2007          2008   2009   2010   2011
                                                                     Year

                                                                                                                        58
Outcome: comparative measurement, follow-up

Access to medicines by WHO ATC classification (%)
             Level 1 - Anatomical main group                 Level 2   Level 3   Level 4
                                                                (%)       (%)       (%)
   A - Alimentary tract and metabolism                          100        98        67
   B - Blood and blood forming organs                           100       100        89
   C - Cardiovascular system                                    100        85        64
   D - Dermatologicals                                          100        90        65
   G - Genito-urinary system and sex hormones                   100        88        75
   H - Systemic hormonal preparations, excluding sex            100        83        83
   hormones and insulins
   J - Antiinfectives for systemic use                          100        95        70
   L - Antineoplastic and immunomodulating agents               100       100        83
   M - Musculo-skeletal system                                  100       100        70
   N - Nervous system                                           100       100        74
   P - Antiparasitic products, insecticides and repellents      100       100        29
   R - Respiratory system                                       100       100        72
   S - Sensory organs                                           100       100        80
   V - Various                                                   78        85        53
                                                                                    59
   Total                                                         98        93        68
Outcomes: Quality of products

Falsified medicines – a public health threat




                                               60
Outcomes: dependence on national framework
Impact of the national framework on outcomes

                                                 ACCESS
                                                QUALITY
                                                                           AVAILABILITY
                             Manufacture/                                 AFFORDABILITY
                              Wholesale
                               Dealers                                            SAFETY

   MAH                                                                        EFFICACY
                                                                           RATIONAL USE

                          Wholesale dealers
                                                       Health Care
                                                       Professionals




     Manufacture

     ACCESS

     AVAILABILITY                                                      Patients
                                          Pharmacies                                       61
     AFFORDABILITY
General model for an effective regulator

Case study methodology – holistic and strategic
              Resources                    Activities       Outputs     Customers reached      Outcomes


 Structural & Human         Inputs                                        Stakeholders
                          Legislation
External framework Legislation          Regulation      Public health   Patients            Access
Regulatory agency     Policies          Monitoring
                                                       Free movement Consumers              Availability
                      Decision
Legal framework                         Enforcement of goods
                      framework
                                                                     Professionals          Affordability
Staff (competence)    Transparency      Information    Competition
Leadership            Equity            Inspection                   Chambers               Market share
                                                       Single market
                      Voluntary
Quality                                 Evaluation                   Associations           Innovation
                      mechanisms
management            4
                                                       Communication
                      Customer          Decisions
                                                                     Private sector         Good use
Appeals body and      satisfaction      Market surveil Empowerment
procedure
                      Data                                           Public sector          Safety
                                        Complaints
Regulatory mech –     protection                       Enabling
self, voluntary       FOI               Recalls                      Trade unions           Efficacy
regulation

External influences: national characteristics (demographic etc), political influences (EU and
national), lobby/interests from stakeholders, conflicts of interest, perceptions, risk (risk averse), 62
public trust, public expectations, transparency
General model for an effective regulator

Case study methodology
        Resources       Activities   Outputs   Customers          Outcomes – changes or benefits
                                                reached


Structural &   Inputs                                      Short term    Intermediate       Long term
   Human                                                                       term




 External influences

                                                                                                   63
Case study methodology

References

Gillham, B. (2000) Case Study Research Methods. London: Continuum.


Mc Laughlin, J.A and Jordon, G.B. (1999) ‘Logic models: a tool for telling your
programs performance story’, Evaluation and Program Planning, 22(1): 65-
72.


Vella Bonanno, P. (2010) The managed entry of new drugs into a national
health service: a case study for Malta, prior to its becoming a Member State
of the European Union. Germany: LAP Lambert Academic Publishing.


Vella Bonanno, P. and Flores, G. (2011) ‘Seven years of EU pharmaceutical
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