Data Disclosure: An Ongoing Progress Towards Transparency

Abeer RabayahB.Sc Pharmacy -MBA /Marketing

MeTA National Coordinator

Presentation Outline

Introduction Survey Background Survey Objective Key Findings Challenges Lessons Learned Recommendations

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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

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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Pilot

MeTA Process

New validated data on pharmaceutical sector

Disclosure of data and scrutiny by multi -stakeholder group

Development of policy options

Policy change and implementation

Changes in drug prices, availability, quality and/or promotion

Improved information for management

Improved processes .

New validated data on pharmaceutical sector

New validated data on pharmaceutical sector

Disclosure of data and scrutiny by multi -stakeholder group

Development of policy options

Policy change and implementation

Changes in drug prices, availability, quality and/or promotion

Changes in drug prices, availability, quality and/or promotion

Improved information for management

Improved processes .

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

‘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)

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:

1. Assess the current status of data disclosure in the four core MeTA categories

2. Disclose the currently available data in the four MeTA core categories

3. 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 it’s 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

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?LangID=en

• 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

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Not Available

Available Not PubliclyDisclosed

Available And Publicly Disclosed

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

THANK YOU

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