Data Disclosure: An Ongoing Progress Towards Transparency

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Data Disclosure An Ongoing Progress Towards
Transparency

• Abeer Rabayah
• B.Sc Pharmacy -MBA /Marketing
• MeTA National Coordinator

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Presentation Outline

• Introduction
• Survey Background
• Survey Objective
• Key Findings
• Challenges
• Lessons Learned
• Recommendations

3
Introduction

• MeTA a multi-sector approach to improving the
  quality and transparency of information on the
  pharmaceutical sector and strengthening
  accountability for access to medicines

4
Survey Background

• The main hypothesis of MeTA is
• Transparency (disclosure of robust
  information) and mutual accountability
  (stakeholders in the supply chain holding each
  other to account) results in informed policy
  change leading to greater efficiency and improved
  access to medicines.

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MeTA Process
Disclosure of
Disclosure of
New validated
New validated
Changes in drug
Changes in drug
data and
data and
data on
data on
Policy change
Policy change
prices,
prices,
scrutiny by
scrutiny by
Development of
pharmaceutical
pharmaceutical
Development of
and
and
availability,
availability,
multi
-
multi
-
policy options
sector
sector
policy options
implementation
implementation
quality and/or
quality and/or
stakeholder
stakeholder
promotion
promotion
group
group
Improved information for
.
Improved information for
.
Improved processes
Improved processes
management
management
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What kinds of information?

• Availability
• Policy financing, selection/EML (including who
  selects),
• Data availability in public/private sectors,
  length of stock outs - urban/rural, facility
  level
• Quality
• Policy regulatory and registration requirements
  (e.g. GMP), inspection
• Data quality monitoring at port and in supply
  chain, non-registered drugs

• Price
• Policy price control, competition, supply chain
  mark-ups, generics
• Data procurement, prices in supply chain, market
  structure (competition, volumes)
• Promotion
• Policy regulations and codes of ethics, direct
  to consumer advertising, curriculum
• Data brand prescribing where generics exist

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MeTA Tools

• Baseline
• Disclosure survey/sector scan
• Availability (WHO-HAI facility and/or household
  surveys)
• Multi-stakeholder (IDS)
• MIT supply chain analysis
• HAI Medicines Promotion Tool
• NICE evidence based STGs

• Harvard Pharmaceutical Policy Flagship Course
• Multi-stakeholder tool/training
• Know-how!
• Technical assistance
• Networking
• South-south learning (e.g. Ghana NHIA analysis)

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Data Disclosure Survey Core Components

• Medicines Registration and Quality Assurance
• Availability of Medicines
• Price of Medicine
• Polices and Practices concerning the promotion of
  medicines

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Objective

• The Data Disclosure Survey Tool aims to achieve
  the following objectives
• Assess the current status of data disclosure in
  the four core MeTA categories
• Disclose the currently available data in the four
  MeTA core categories
• Identify where there are gaps in information

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Overview of disclosure process and engagement of
stakeholders In Jordan 

• Data Disclosure Survey Tool was sent to all
  members by mail to have an overview.
• Start discussing the tool and its rational with
  each committee especially within their areas of
  expertise and getting feedback on the best way to
  precede working.
• The national MeTA Secretariat Organized special
  MeTA Council Meetings to share and discuss the
  key disclosed data
• Collected data was categorized in special tables
  in order to be verified and accurately referenced
  based on its official sources.
• Findings were discussed in a special MeTA council
  meeting

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• Key Findings under each Key Component

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Key Findings- Registration and Quality

• Detailed regulations on process for registration
  and de-registration is available and disclosed on
  JFDA website.
• Registered medicines are disclosed but not in the
  form of a list. Access is by searching by generic
  name in English logged in as 'guest' on JFDA
  website. Successful for some medicines
  (salbutamol) but unsuccessful for others
  (metformin, simvastatin, amoxicillin)
  http//www.jfda.jo/barcode_java/index.jsp?LangIDe
  n
• Average length of time to register dataprotected
  or generic medicines and related fees are
  disclosed/published.
• List of GMP compliant Manufacturing plants is
  available but NOT disclosed.
• No criteria or list for pre-qualified suppliers
  in public procurement tenders.
• Number of samples from market that are sent to
  quality control laboratories by government
  inspectors for routine testing in last year are
  available disclosed/published in the annual
  report
• JFDA does not publish a summary of Adverse Event
  activities regularly. But if any action is taken
  regarding any medication the results will be
  published after withdrawal from the market.

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Key Findings- Availability

• Public sector budget for medicines disclosed only
  for MOH
• There is no national Standard Treatment
  Guidelines (STG) committee and there are no
  national STGs- but there are specific STGs at
  some institutions (like RMS) which are not
  published/disclosed
• Essential Drugs lists available at institutional
  level in public sector. Often not
  published/disclosed. RDL at JFDA published.
• Patent law exists. In general 5 year Data
  Protection regulation followed. List of patented
  or data protected medicines available (Ministry
  of Trade) but not published/disclosed as a list.
• Number of health facilities audited in last year
  available and published/disclosed
• Volume and value of medicines supplied in the
  private sector is not available. Can only be
  obtained from for a specific fee (e.g from IMS
  Health)

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Key Findings- Pricing

• Laws and regulations governing ex-manufacturing
  and end user (patient) pricing of medicines in
  the public (JPD website) and the private sector
  (JFDA website) are available and disclosed
• Individual private sector retail medicines prices
  are disclosed and accessible through JFDA
  website, but not user friendly
• http//www.jfda.jo/RDU/ar-JO/HomeSearch.aspx
• List of ex-manufacture medicine prices in private
  sector available but not disclosed. Can only be
  obtained for a fee from JFDA
• Public sector procurement prices available and
  published/disclosed on JPD website. Not always
  user friendly and lack of awareness of data
  available on website.

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Key Findings- Promotion

• List of manufacturers and distributors that
  subscribe to internationally or nationally
  recognized codes of conduct is not available
• List of individuals with their affiliations who
  are on the national committee to monitor
  adherence to industry codes of conduct is not
  available
• Reports of numbers and types of complaints
  submitted to the national monitoring committee
  regarding promotional practices, numbers of
  violations, and resolution of the complaints is
  not available

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• Recommendations

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Recommendations

• Quality Assurance results available but NOT
  disclosed.
• For consideration publishing available data
  about GMP compliant manufacturers list of
  prequalified suppliers and adverse reactions
  reports might be beneficial for all stakeholders.
  
• Products cannot be registered before passing lab
  testing, one assumes that all registered products
  have passed lab testing.
• For consideration publish this
  information at the time of product registration
  approval.

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Recommendations

• No national STGs available.
• For consideration Develop national STGs.
• Where STGs exist, consider publishing/disclosing
  them (e.g RMS). What are barriers to publishing?
• Increase awareness of STGs and Essential Drugs
  List by teaching as official guidelines in
  medicine/pharmacy/nursing schools
• Prices of medicines in public (JPD) and private
  (JFDA) are available on relevant websites, but no
  user friendly or easy to access.
• For consideration improve ease of access to
  information on relevant websites and raise
  awareness amongst stakeholders on data
  available
• Lists of patented or data protected medicines not
  disclosed.
• For consideration publish these lists to enable
  easier and faster introduction of generics to
  market.

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Recommendations

• Prices of medicines in public (JPD) and private
  (JFDA)
• are available on relevant websites, but no user
  friendly or easy to access.
• For consideration improve ease of access to
  information on relevant websites and raise
  awareness amongst stakeholders on data available
• Promotion guidelines procedures are available
  but currently JFDA has no monitoring plan but
  would like to develop one.
• For consideration set up national committee
  with the authority to monitor adherence to
  guidelines and the power to implement appropriate
  sanctions for non-adherence

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Recommendations on the level of the disclosure
process

• National Councils can classify data to A, B and C
  categories using and then they can start working
  on transferring data gradually from category C to
  B and then to A where they reach to a level where
  most data are available and disclosed.
• DPL Disclosure
• Process Ladder

Available And Publicly Disclosed
Available Not Publicly Disclosed
Not Available
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Recommendations on the level of the disclosure
process

• This tracking and classification process should
  be accompanied with an awareness campaigns in
  collaboration with stakeholders (private, public,
  CSOs) in order to improve access to available
  data
• The data disclosure report highlighted some gaps
  regarding publicly available data and created a
  debate for discussion between stakeholders
  (public, private, CSO). This debate can be
  considered as an ongoing exercise to assess the
  pharmaceutical data disclosure status on regular
  basis in order for MeTA Jordan to track changes,
  improvements or drawbacks in data disclosure and
  improve MSP

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Challenges

• Key disclosure data on medicines Availability to
  patients is difficult to obtain (except through
  Level II Household Health Facility baseline
  surveys which are ongoing)
• Some key data sources not easily accessible (fee
  needed to obtain data)
• Official websites sometimes not user friendly or
  data not frequently updated
• Private sector is not 'obliged' to provide data
• Limited contribution from CSO members
• Data and policies are often complex/technical and
  not easy to understand by the public

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Lessons Learned

• Sharing data among stakeholders is important to
  raise questions and stimulate discussion
• Stakeholders exchanged data amongst each other
  and learned new things
• Data disclosure meetings were an opportunity for
  different stakeholder to understand why some data
  are not disclosed or available
• Data disclosure meetings uncovered some of the
  official websites' weaknesses that hinder
  accessibility to published data
• Data disclosure meetings raised useful and
  important COLLECTIVE recommendations
• Collecting data through focused group and
  personal interviews helped in understanding a lot
  of important topics and generated recommendations
  and key topics for discussion such as topics
  related to IP and patency.

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I would like to thank MeTA Jordan Council Chair ,
Council Members National / International MeTA
Secretariat who dedicated their time and effort
to finalizing the Data Disclosure Survey
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• THANK YOU