Medicine Transparency Alliance Jordan Workplan...1 Medicine Transparency Alliance Jordan Workplan October 2012 Submitted by: Dr. Sana Naffa Health System Strengthening Officer World

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Medicine Transparency Alliance

Jordan Workplan

October 2012

Submitted by:

Dr. Sana Naffa

Health System Strengthening Officer

World Health Organization - Jordan

E-mail: [email protected]

Dr. Adi Nuseirat

MeTA Assistant Programme Officer

World Health Organization – Jordan

E-mail: [email protected]

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Acknowledgment

We are grateful to his Excellency Dr. Abdellatif Wreikat the Minister of Health and to senior

policymakers and officials from the Ministry of Health, we would like to thank the Jordan Food

and Drug Administration chaired by Dr. Hayel Obeidat and their staff for their support towards

MeTA work.

Special appreciation goes to the technical team that developed and consolidated the workplan,

as well as the finalization of the narrative part of the workplan.

We are sincerely thankful to the MeTA Working groups’ members for their contributions to the

development of the country workplan and success of MeTA in Jordan.

We would like to extend our sincere gratitude to the staff of High Health Council for their

contribution for the success of the pilot phase.

On a final note, thanks are owed to Dr. Tim Reed and Dr. Deirdre Dimancesco in the review of

the draft and providing helpful input.

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Table of Contents

Executive Summary ....................................................................................................................................... 4

List of Acronyms ............................................................................................................................................ 5

1. Introduction and Background ............................................................................................................... 6

2. Situation Analysis .................................................................................................................................. 8

2.1 Drug Legislations ............................................................................................................................. 8

2.2 National Drug Policy ........................................................................................................................ 9

2.3 Medicines Procurement and Supply ............................................................................................... 9

2.4 The Medicines Market in Jordan ................................................................................................... 10

2.5 Rational Drug Use ......................................................................................................................... 11

3. Needs Assessment and Identification of Transparency Priorities ...................................................... 13

3.1 WHO/HAI Pricing Survey Data ...................................................................................................... 13

3.2 Household and Health Facility Survey Data .................................................................................. 13

4. Strategies and Description of Activities .............................................................................................. 15

4.1 Work Area Selection for National MeTA Workplan ...................................................................... 15

4.2 Methodology for developing the workplan .................................................................................. 15

4.3 Objectives, Expected Output and Outcomes ................................................................................ 16

4.4 Description of activities................................................................................................................. 17

5. Risks and risk management strategies ................................................................................................ 22

6. Management arrangement ................................................................................................................. 23

6.1 Advisory Board ........................................................................................................................ 23

6.2 Steering Committee ................................................................................................................ 23

6.3 Hosting MeTA Secretariat ....................................................................................................... 23

7. Financial arrangements and budget ................................................................................................... 25

7.1 Administrative & Technical Support and activity funding stream ................................................ 25

8. Monitoring system .............................................................................................................................. 27

9. Annexes ............................................................................................................................................... 28

Annex 1 Key References ...................................................................................................................... 28

Annex 2 list of Participants ................................................................................................................. 29

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Executive Summary

This document presents the workplan, budget and logical framework of the MeTA Jordan

project covering the period of October 2012 – September 2013, as developed by MeTA Jordan

Working groups and approved by MeTA International Secretariat.

The Medicine Transparency Alliance (MeTA) is an innovative multi-stakeholder partnership that

aims, through information provision, to increase transparency along every link of the medicines

supply chain: from policy development and implementation; to procurement, promotion and

distribution of medicines. MeTA Jordan was launched as a pilot in the beginning of 2009, and

was the first forum in Jordan to bring together all stakeholders in medicines from the

government, the private sector and civil societies. The pilot ended in September 2010 and has

been proven to be successful and beneficial towards increasing transparency and access to

essential quality-assured medicines.

The second phase of MeTA is being guided by the World Health Organization and Health Action

International, and will be hosted by Jordan Food & Drug Administration (JFDA) for the next four

years.

The activities of MeTA Phase II will support the government of Jordan to improve access to

medicines in both the public as well as the private sector; in the preparation of the workplan,

six expert committees have developed the draft workplan in the following areas: National

policies; Inefficiencies and cost containment in the Pharmaceutical Sector; Access and Equity;

Advocacy with high level policy makers using evidence based discussions, Public Education;

Monitoring & Evaluation. This workplan is based on a clear understanding of national context,

challenges and priorities, and it responds to national needs and aligned with policy objectives. A

logical framework with SMART indicators was added to allow project management, monitoring

and evaluation. In addition, risks and risk management strategies were identified.

The suggested organization for MeTA Jordan phase II (MeTA Council) includes: Advisory Board

consists of 5-6 members with representation of from the three stakeholder sectors (public

sector, private sector and civil society) and other relevant organizations and will serve as the

consultative and main decision making body. The Advisory Board will supervise the over-all

implementation of programmes in Jordan. A Steering Committee consists of 10-12 members

will be responsible for overall coordination, planning, management and evaluation of MeTA

activities. The Steering Committee will nominate and guide working groups and contractors to

implement the activities. A National Secretariat will coordinate and facilitate the Advisory

Board and Steering Committee activities. The funds available for MeTA are approximately GBP

71,500 per year.

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List of Acronyms

ADR Adverse Drug Reaction

CSO Civil Society Organization

DFID Department For International Development

EML Essential Medicines List

GBP Great British Pound

GDP Good Distribution Practice

GGM Good Governance for Medicines

HAI Health Action International

HHC High Health Council

IMS International MeTA Secretariat

IRP International Reference Price

JAPM Jordanian Association of Pharmaceutical Manufacturers

JCSOHA Jordanian Civil Society Organizations Health Alliance

JFDA Jordan Food and Drug Administration

JPD Joint Procurement Department

MeTA Medicine Transparency Alliance

MOH Ministry Of Health

MPR Median Price Ratio

MRA Medicine Regulatory Authority

NDP National Drug Policy

RDL Rational Drug List

RDU Rational Drug Use

RMS Royal Medical Services

SMART Specific, Measurable, Achievable, Relevant, and Time-bound

STGs Standard Treatment Guidelines

USD United States Dollars

WHO World Health Organization

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1. Introduction and Background

Although Access to essential medicines remains a major objective of people everywhere, and is

widely featured as an objective of countries’ national medicines policies; one third of the

world’s population lacks access to essential medicines1. Lack of access to medicines is

symptomatic of wider problems relating to the way health services are organized, financed and

delivered.

In response to these challenges, the UK Department for International Development (DFID), in

partnership with World Health Organization (WHO), the World Bank and the health action

international (HAI) carried out the design, consultation and planning for a “Medicines

Transparency Alliance” (MeTA) to increase transparency and accountability in medicines supply

chains.

Medicines Transparency Alliance (MeTA) brings together public, private and civil society

stakeholders with an interest in the outcomes of the medicines market to improve access,

availability and affordability of medicines for low income populations; MeTA builds bridges,

stimulates dialogue among stakeholders, helps identify areas of common interest, facilitates

alignment of goals between stakeholders. The main focus will be on strengthening capacity to

collect, analyze, disseminate and use data on medicine quality, availability, pricing and use. This

will help improve transparency and accountability in procurement, management, supply,

prescribing, dispensing and use of medicines.

In Jordan, MeTA was launched as a pilot in January 2009, and was the first multi-stakeholder

initiative aiming to improve access to medicines in the country. The initiative was spearheaded

by the Ministry of Health (MOH), and led from the beginning by the High Health Council (HHC)

and for the first time brought together the government, the private sector and civil society to

discuss the need for more information and greater transparency in the Jordanian medicines

market. The MeTA Jordan pilot workplan was endorsed by the MeTA council and covers the

operational period January 2009 - September 2010. Of seven strategic areas identified within

the workplan, three were given higher priority and include:

1. Evidence-based decision-making for selection of medicines for the Rational Drug List

(RDL).

2. Encouraging best-practice and improving rational use of medicine.

3. Capacity-building of civil society.

1 WHO Medicines Strategy 2004-2007

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To drive progress in these areas three sub-committees were convened and tasked with

developing detailed workplan.

A large amount of pharmaceutical information has been collected from Pharmaceutical Sector

Scan, Data Disclosure Survey, Analysis of the Pharmaceutical Supply Chain, Household and

Health facility Surveys and MeTA Multi-stakeholder Assessment. The pilot phase involved

increased engagement of CSOs in advocacy for access to medicines. It involved engagement

with RDU and STGs. The pilot ended in September 2010 and has been proven to work as a

catalyst for evidence-based policy change and implementation.

MeTA phase II is guided by the WHO and HAI, HAI is expected to lead coordination,

administration and communication, and will support Civil Societies. The WHO is expected to

provide technical assistance, provided at different levels of the organization and limited funding

for surveys and studies. JFDA will offer staff, meeting room, stationary, communication means

(telephone, fax …etc.).

The activities of MeTA Phase II will support the government of Jordan to improve access to

medicines in both the public as well as the private sector, and will be hosted by Jordan Food &

Drug Administration (JFDA). In the preparation of the workplan, six expert committees have

developed workplan in the following areas:

1. National policies: including updating NDP, policies on rational use and compliance with

STGs, policy on selection of EML, disclosure policies, and pricing policies.

2. Inefficiencies and cost containment in the Pharmaceutical Sector: including forecasting

at facility level in procurement, supply chain management, STGs availability and use,

accountability system at public sector for supply chain cycle, RDU strategy, training for

service providers on STGs and integrity system/code of ethics, and training on facility

needs estimation.

3. Access and Equity: including availability of essential medicines in public sector,

affordability in private sector to vulnerable groups, identification of vulnerable groups

and catastrophic diseases, and disclosure of access reports and vulnerabilities to

medicines.

4. Advocacy: including advocacy meetings with high policy makers, advocacy meetings

with media, collecting data on vulnerable groups’ access to medicines, building

capacities in advocacy campaigns, and use of data as advocacy tools.

5. Public Education to improve knowledge on generics; raise awareness on human and

patient rights; public campaign to improve compliance of patients with the instructions

in prescriptions.

6. Monitoring & Evaluation: including monitoring framework for project’s outcomes and

indicators, and governance framework for sustainability of projects achievements.

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2. Situation Analysis

2.1 Drug Legislations

In Jordan the pharmaceutical sector is highly regulated and organized through detailed laws

and regulations governing the public and the private sectors. The Jordan Food and Drug

Administration, a semi-independent body with its board of directors headed by His Excellency

the Minister of Health, is the formal medicines regulatory authority as outlined by the JFDA

Law2. Since its inception in 2003, the JFDA has built on existing laws, including the Drug and

Pharmacy Law3, with detailed legislation and guidelines covering nearly all aspects concerning

medicines. As such, the JFDA is mandated to execute existing legislation concerning medicine

quality assurance, registration, importation, exportation, and pricing. In addition, the JFDA

carries out inspections of local pharmacies and manufacturing sites, both locally and

internationally, to confirm compliance with the national rules and regulations. No assessment

of the medicines regulatory system has been conducted in the last five year.

There are no legal provisions requiring the MRA to make the list of registered pharmaceutical

products publicly available and update it regularly. A summary of product characteristics of the

medicines that are registered is not required to be published. Legal provisions requiring the

establishment of an expert committee involved in the Marketing Authorization process are in

place. By law, potential conflict of interests for experts involved in the assessment and

decision-making for registration need not be declared.

A laboratory exists at JFDA for quality control testing. Samples are collected by JFDA inspectors

for undertaking post-marketing surveillance testing. The results of quality testing are not

publicly available.

A national pharmacovigilance centre is available at JFDA. The center has not published an

analysis report in the previous two years and it regularly publishes an ADR bulletin.

The government runs an active national medicines price monitoring system for retail prices.

Regulations do not exist mandating that retail medicine price information should be publicly

accessible.

National Good Pharmacy Practice Guidelines are not published by the government. By law, a

list of all licensed pharmaceutical facilities is not required to be published.

2 Jordan Food and Drug Administration Law. http://www.jfda.jo/Download/Laws/31_135.doc

3 Drug and Pharmacy Law 2001. http://www.jfda.jo/Download/Laws/32_142.doc

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Access to essential medicines as part of the fulfillment of the right to health, is not recognized

in the constitution4, but it is included in national drug legislation.

Currently there is no national good governance policy. However the government has taken

steps toward such a policy by creating a code of conduct for public employees, establishing the

Anti-Corruption Agency, and is currently working with WHO in a Good Governance for

Medicines programme (GGM) 5

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2.2 National Drug Policy

In 2002, Jordan joined the list of countries that have developed a National Drug Policy (NDP).

The Jordan’s NDP was to serve as a framework for future pharmaceutical use in both the public

and private sector. The major objective of Jordan’s NDP is to ensure that the medical needs of

the population are covered by the availability at all times of essential drugs, consumables, and

medical devices that are safe, effective, and of high quality. The other major objective is to

improve the rational use of drugs by providers and consumers of health care services. The NDP

in Jordan has 10 components, namely the legislative and regulatory framework; drug selection;

drug supply; economic strategies for drugs; human resource development; monitoring and

evaluation; research and development; technical cooperation among countries and

international organizations; rational use of drugs; and other issues related to coordination

between different directorates within the JFDA.

A NDP implementation plan that sets out activities, responsibilities, budget and timeline do not

exist. Pharmaceutical policy implementation is not regularly monitored or assessed.

2.3 Medicines Procurement and Supply

Procurement for the public sector is carried out through the Joint Procurement Department,

which was established in 2004 with the objective of improving the efficiency of the

procurement process in the public sector through demand aggregation, process

standardization, and duplicity elimination. It serves as the procurement agency for its five

partners: MOH, RMS, Jordan University Hospital, King Abdullah University Hospital, and the

King Hussein Cancer Center (KHCC). Public sector procurement in Jordan is both centralized and

decentralized6. The Board of Directors of the Joint Procurement Department (JPD) is headed by

the Prime Minister. Public sector request for tender documents are publicly available and public

4 Drug and Pharmacy Law 2001. http://www.jfda.jo/Download/Laws/32_142.doc 5 Jordan Food and Drug Administration Law. http://www.jfda.jo/Download/Laws/31_135.doc

6 Joint Procurement Law 2002, JPD; Available from: www.jpd.gov.jo/ReadPaner.php?id=110&sub_id=5

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sector tender awards are publicly available. A list of samples tested during the procurement

process and the results of quality testing are not available.

The MOH in Jordan has a central medical store at national Level (also known as Supply and

Procurement Department). There are national guidelines on Good Distribution Practices (GDP).

A licensing authority that issues GDP licenses does not exist.

Routine procedure to track the expiry dates of medicines at the Central Medical Store exist. The

Public Central Medical Store is not ISO certified; the second tier public warehouses are not GDP

certified by a licensing authority.

The biggest challenge in the public sector supply chain is poor availability as certain drugs are

consistently out-of-stock in the public sector health centers due to lack of accurate data and

information about the true demand for pharmaceuticals, also there is poor visibility (ability to

track and trace shipments) in the supply chain after the product is delivered to districts,

interfering with the ability to create optimal stock positioning.

For private sector legal provisions exist for licensing wholesalers and distributors in the private

sector. A list of GDP certified wholesalers or distributors do not exist in the private sector.

2.4 The Medicines Market in Jordan

A reasonable member of local pharmaceutical manufacturers operate in Jordan (16

manufacturers); however the contribution of the Jordanian pharmaceutical market currently

remain relatively small with only 30% of the market share; and most of these companies are

export oriented, with around 70% of their production sold outside Jordan in 65 countries. The

major barriers to increasing the use of generics in Jordan are7: the price difference between

some generics and the originator brand is judged insignificant by consumers; the activities of

pharmaceutical companies encourage doctors to prescribe specific brands; there is lack of trust

in the quality of some generics; and there is lack of awareness of generic alternatives.

There are 84 medicine agents and around 160 subagents and herbal/ food supplement

products importers. In 2011 Jordan imported medicines by 511 million USD, and exported

medicines by 612 million USD.

7 Jordan Health Sector Reform Project, August 2004, Study 3: Impact of brand substitution and scenarios for generics use

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2.5 Rational Drug Use

2.5.1 Rational Drug Use Policy

The rational use of medicine strategy in Jordan is highly fragmented. According to legislation,

the Rational Drug Use Department within the JFDA is the coordinating entity for activities

surrounding the rational use of medicine, including the development of standard treatment

guidelines and the updating of the Jordan Rational Drug List and Jordan National Drug

Formulary. The rational drug use policy is not fully implemented.

2.5.2 Prescribing and dispensing practice

The system lacks clear legislation aimed specifically at monitoring the rationality of prescribing

by the physician and the dispensing by the pharmacist. Studies in prescribing practice in Jordan8

showed that over reliance on brand names, prescription by habit, and favoring particular

brands without sufficient evidence and due to absence of national STGs. Clinician prescribe

drug for every single complaint to satisfy the patient expectations and demand of quick relief;

also antibiotics prescribing is prevalent.

There is over reliance on pharmaceutical industry to provide information on medicines through

face to face meetings with medical representatives, lectures conducted by pharmaceutical

companies, samples, and brochures.

The existing activities aimed toward rational use, such as the Good Pharmacy Practice within

the pharmacists syndicate and the new Jordanian Infection Control Association, are based

mostly on relatively small group initiatives and do not obligate any health care professionals.

2.5.3 Self-Medication and Patient Compliance

In a qualitative research conducted on Jordan consumers9, a number of focus groups had

revealed that doctor “shopping” was common; pharmacists were viewed primarily as

dispensers of medicines (but were also used for the treatment of minor illnesses). Many

consumers believed medicine was a “last resort” in treating illness; less so for those with

chronic illness.

The information gathered by the study suggests that consumer medication literacy (the

understanding by consumers of the wise use of medications) is not particularly high within

8 Jordan health sector reform project, deliverable 9: A study of Jordanian prescribing practice, October 2004

9 Jordan health sector reform project, deliverable 10: Patient compliance and self medication, July 2004

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Jordan. The data suggests that the majority of people, who seek antibiotics without

prescription, do so for reasons of convenience rather than cost.

2.5.4 Drug Promotion Control

Inadequate control of drug promotion has left a wide gap in the promotion of rational drug use.

Also, while several activities have been carried out to promote rational prescribing and

dispensing in the public sector, a lot remains to be done in the private sector. A study

conducted in 2007 to measure transparency & good governance in the public pharmaceutical

sector10

revealed that the area of medicine promotion control is extremely vulnerable to

corruption, this low ranking was the result of a combination of several factor. First, the

provision in the medicines legislation does not cover all the activities regarding drug promotion.

Pre-approval of promotional and advertising materials is not officially required, the provision

does not foresee an enforcement mechanism on promotion and advertisement of medicines,

and the law does not indicate the type of sanctions or penalties to be incurred in the case of

breach of the law. There is no formal complaints procedure to report unethical promotional

practices. There is no government service or committee responsible for drug promotion. In

2008 JFDA issued guidelines to control drug promotion activities and it was updated in 2009 but

these guidelines are not fully implemented.

2.5.5 Public Education

In Jordan, the total amount of Gross Domestic Product spent on health in 2008 reached 9.3%,

of which there is a split between public (4.3%) and private (5%) spending11

. Health spending is

higher in Jordan than in other countries in the region. This high spending pattern is attributed

to systemic problems of the Jordanian health care strategy in addition to lack of commitment

to rational drug use at professional and public levels, absence of public education on general

health programmes, low patients’ compliance, lack of trust in generic medicines’ which all

contribute to inefficiency and waste.

The cases demonstrate, for example, that facilitating the public’s access to information,

enhancing generic substitution, and improving patients’ compliance can be powerful strategies

in improving public and private spending and protecting economic and social rights.

10 Measuring transparency to improve good governance in the public pharmaceutical sector In Jordan, WHO 2009

11 Jordan National Health accounts 2008 (Jordan NHA 2008), 2011; Available at: http://www.who.int/nha/country/jor/en/

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3. Needs Assessment and Identification of Transparency Priorities

3.1 WHO/HAI Pricing Survey Data

In 2004, a WHO/HAI pricing survey was conducted in Jordan12

. The study covered four regions

in Jordan, 29 medicines, 18 public sector facilities, and 20 private pharmacies. The study

showed that the availability of originator medicines was 0 % in public sector, while availability

of the lowest priced generic medicines was 27.8 %. Availability in the private sector was higher

(60 % for originator and 80 % for generics). Public procurement prices were above International

Reference Prices (IRP); the Median Price Ratio (The MPR is an expression of how much greater

or less the median local medicines price than the international reference price) for originators

was 1.38 and for generics 0.57. As for patient prices, the MPR in the public sector was 5.95 for

originators and 0.85 for generics, while the private sector had higher prices (17.05 for

originators and 10.50 for generics).

3.2 Household and Health Facility Survey Data

In 2009, a WHO Level II Assessment Household and Health Facility Surveys13

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has been

undertaken to assess the access to medicines. The study covered 6 regions in Jordan, 50

medicines, a total of 41 public health facilities, 6 public medicines warehouses, 72 private

pharmacies, and 17 private hospitals were surveyed between October and December of the

year 2009.

3.2.1 Access

The private sector performs better in access to medicine, both in terms of availability of

medicine and in geographic accessibility than public sector. In addition, the private sector had

less stock-out days than the public sector, and therefore patients are more likely to find their

medications in the private sector.

12 Medicine Prices, Availability and Affordability in Jordan. Available at:

http://www.haiweb.org/medicineprices/surveys/200405JO/survey_report.pdf

13 WHO Level II Assessment, Household Medicines Survey. Not published yet

14 WHO Level II Assessment, Health Facilities Survey. Not published yet

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The availability of the WHO 15 Key medicines was good overall, and better in the private sector

than in the public sector. The average availability in the public sector was nearly 74%, while

that in private hospitals and private pharmacies were 92% and 96% respectively.

When considering cost, a patient visiting a private pharmacy is paying, on average, eight times

more for his medicines than a patient obtaining medicines from a public facility.

In households with sick members, catastrophic medicines expenditures are (7%). About 23% of

household respondents believe that medicines are not affordable.

3.2.2 Quality

An extremely low incidence of expired medicine was found in both the public and private

sector: 2.4% in public centers, 0.1% in private pharmacies, and 0.4% in private hospitals.

The conservation conditions and handling of medicines at the facilities, although variable, was

overall good. Areas consistently performing poorly, however, included poor monitoring of cold

storage temperatures and the handling of medicines by naked hand.

3.2.3 Rational Use

The health facility survey showed that the public sector facilities had the lowest average of

adequate labeling; with only 61% of medicines adequately labeled. The average number of

medicines per prescription was slightly higher in public sector compared to private hospitals.

However, both public and private facilities prescribed antibiotics to nearly 60% of their

outpatients.

Only 8.3% of the medicines prescribed in the public facilities were prescribed using the generic

name of the medicine; in the private sector the number was even lower at 1.8%. Standard

treatment guidelines for both hypertension and pneumonia were physically present for the

prescriber to utilize in only 28% of the public facilities, and in 35% of private hospitals.

3.2.4 Pricing, Availability, and Affordability from the WHO/HAI basket of 50 Medicines

The availability of the 50 lowest priced generic medicines in the public sector was nearly 63%,

and the average in the private hospitals was not much better at 65%. Private pharmacies

performed slightly better with an average availability of 77%. While the availability of brand

medicines in the public sector was rationally very low, in the private hospital and private

pharmacies the average availabilities were 42% and 38% respectively.

The MPR for public procurement was 0.75 for the lowest price generics. Subsequently, the

public health facilities were providing patients with medicines at MPR of one. On the other

hand, private pharmacies had a ratio nearly 10 times the IRP. For branded medicines, the prices

in the private pharmacies stand at a staggering ratio of 19 times the IRP. When comparing the

median price ratios found in Jordan to the ratios found in similar, and even wealthier

neighbouring countries, those found in Jordan are several times high.

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4. Strategies and Description of Activities

The MeTA Jordan workplan reflects the MeTA global project focus on strengthening capacity to

collect, analyze, utilize and disseminate data on medicines quality, availability, pricing and use

with a view to Increase availability and affordability of high quality assured essential medicines.

4.1 Work Area Selection for National MeTA Workplan

Based on throughout discussions and suggestions during considerable number of meetings with

key stakeholders some of the potential priority areas are listed; in the preparation of the

workplan, six expert committees have developed workplan in the following areas for the

activities of MeTA Phase II:

1. National policies: This is to include providing recommendations for an updated NDP and

promote adoption of this policy; making recommendations for improving pricing

regulations to ensure availability and affordability of medicines; developing a strategy

for promoting adoption, implementation and monitoring rational use of medicines; and

adopting concepts of transparency and accountability in all relevant public institutions

and make all documents publically available.

2. Inefficiencies and cost containment in the pharmaceutical sector: including forecasting

at facility level in procurement, supply chain management, national STGs, accountability

system at public sector for supply chain cycle, RDU strategy, and code of ethics.

3. Access and Equity: including improving access and availability of essential medicines in

public sector, affordability in private sector, identification of vulnerable groups and

catastrophic diseases, and disclosure of access reports and vulnerabilities to medicines.

4. Advocacy with High Level policy makers using evidence based discussions, routine

disclosure and advocacy tools.

5. Public Education of high quality assured generic medicine value, raise awareness on

patient rights, communications.

6. Monitoring & Evaluation: including monitoring framework for project’s outcomes and

indicators, and governance framework for sustainability of projects achievements.

4.2 Methodology for developing the workplan

Each committee of the six expert committees met 4 times at least during three weeks to

develop this work plan. The team studied the current situation on access and equity to

medicines and came up with a number of strategies after setting the objectives. The workplan

was then shared and reviewed with the rest of stakeholders including MOH, JFDA, CSOs, HHC,

Academia, JPD, RMS, local pharmaceutical manufacturers, drug importers and WHO.

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4.3 Objectives, Expected Output and Outcomes

4.3.1 Goal

The principal goal of MeTA for Jordan is to increase availability and affordability of quality

assured essential medicines in Jordan, expanding transparency measures.

4.3.2 Objectives

The major objectives of MeTA phase II for Jordan are:

1. To have a multi-stakeholder group with clear and publicly available term of reference

and transparent criteria of selection the members.

2. Develop an annual workplan with detailed budget addressing transparency gaps and

approved by International MeTA Secretariat.

3. Obtain a country support for MeTA Council from country level sources.

4. To conduct an assessment of the feasibility and requirements to monitor medicine

availability and prices in Jordan taking advantage of mobile technology.

5. To develop indicators and tools to measure availability, affordability and prices and

improve procurement & supply chain management.

6. Obtain consensus on updates to the NDP.

7. Obtain consensus on improving pricing regulations to ensure availability & affordability

of medicines.

8. Obtain consensus on rational drug use policy.

9. To have a multi-stakeholder consensus in the reports of studies and surveys based on

evidence based discussions.

10. Adopt concepts of transparency and accountability in all relevant public institutions and

make all documents publically available.

11. Identified health policy changes are advocated at the political level

12. Raise awareness on patients' rights to access to medicines, information, and to

affordable medicines.

13. Raise awareness of using generics as the best alternative with similar efficacy of the

originators.

14. Enhance rational use of medicines among the patients and consumers.

15. Improve capacity building for CSOs on rational use of medicines, generics,

communication and advocacy.

16. Develop a framework for the evaluation of MeTA phase II for Jordan at a global level.

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4.3.3 Outputs

Seven main outputs are envisaged for MeTA phase II:

1. strengthening governance, improving efficiency, and encouraging innovative and

responsible business practices and multi-stakeholder approach, through the existence of

a functioning multi-stakeholder group that have national government support and will

be working towards increasing transparency focusing on the selection, regulation,

procurement, and distribution of medicines in Jordan.

2. Capacity building to collect and analyze data, using innovative methods as required.

3. Strengthening transparency and accountability of the pharmaceutical sector.

4. Strengthening CSOs capacity to support improvements in transparency and

accountability of the pharmaceutical sector.

5. Policy makers in Jordan engage in multi stakeholder policy dialogue to develop new or

review access to medicines policies.

6. International engagement with MeTA increases.

7. External evaluation of MeTA outcomes against baselines established during the pilot

phase. In the longer-term, MeTA will be evaluated on the degree to which improved

transparency and accountability can increase the affordability, availability and quality of

medicines.

4.3.4 Outcome

The expected outcome is to improve all the component of the supply chain (pricing, selection

procurement, distribution ...etc.) and other policies and practices on the basis of a multi-

stakeholder review of robust evidence.

The great value of MeTA in Jordan is its potential to help improve transparency and facilitate a

disclosure regime that will enable medicines information to be shared in a way that will

promote transparency among relevant stakeholders. Data analysis and use will be facilitated by

MeTA, through data collation and interpretation and through discussion within the MeTA

council, followed by dissemination of data and related interpretation via the MeTA Jordan

website and other communication activities.

4.4 Description of activities

Below are the potential areas that are suggested by the key stakeholders, and a description of

the activities of these areas:

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4.4.1 National Policies

• Updating National Drug Policy

The following activities will be involved in updating NDP:

1. Appoint multi-stakeholder revision committee that consists from public sector, private

sector, and CSOs to revise NDP and provide recommendation on updated NDP and

promote adoption of NDP.

2. Conduct national workshop to disseminate the recommendations for updated NDP.

3. Appoint multi-stakeholder committees to develop plan for implementation and

monitoring NDP.

• Update pricing regulations to ensure availability & affordability of medicines

1. Appoint multi-stakeholder revision committee that consists from public sector, private

sector, and CSOs to revise pricing regulation and make recommendations to ensure

availability and affordability of medicines.

2. Appoint a committee to develop recommendations for the criteria and guidelines of

selecting members and decision making process in pricing committee.

• Develop policies for promoting rational use of medicines

1. Form a committee that consists from public sector, private sector, and CSOs to develop

strategy for adoption, implementation and monitoring of STGs.

2. Build consensus & raising awareness of STGs strategy.

3. Develop a strategy for adoption, implementation & monitoring of RDL.

4. Build consensus & raising awareness of RDL strategy.

5. Form a technical committee to develop criteria for selection and dissemination of EML.

• Policies on Disclosure

1. Form a committee responsible for promoting the adoption of the concept of

transparency and accountability in all relevant public institutions, and for making all

documents and information publically available.

2. Collect all studies, guidelines, lists, requirements, processes, standard operating

procedures, members of national committees, and produce recommendations to make

them publically available in an accessible & transparent way on the government

websites.

19

4.4.2 Inefficiencies and cost containment in the pharmaceutical sector

The following activities will be involved to have indicators and tools to measure availability,

affordability and prices and improve procurement & supply chain management:

1. Hire a consultant to develop recommendations for an ideal system of supply chain

management at the public pharmaceutical sector.

2. Develop methodology at a national level regarding estimations of needs at facility level

in procurement.

3. Train staff of JPD and other procurement departments at the public institutions on

good procurement practices (transparency in rules of procurement, transparency in

information on individual supply contract, procurement methods: international

competitive bidding, national competitive bidding, informal competition, and direct

negotiations)

4. Train staff of MOH and other supply departments at the public institutions on supply

chain management (good distribution practices, good storage practices, estimation of

needs and management of stock).

5. Train CSOs, patients and consumers on rational use of medicines.

4.4.3 Access and equity

In order to ensure full access to essential medicines in the public sector, the reasons for

unavailability should be identified, and then there should be an implementation of appropriate

interventions to resolve the reasons of unavailability, but as a first step feasibility study should

be carried out in determining the methodology to be used to monitor medicines availability and

prices in Jordan. The following activities will be involved to conduct an assessment of the

feasibility and requirements to monitor medicine availability and prices in Jordan taking

advantage of mobile technology:

1. Appoint a consultant committee to plan for a feasibility study to determine the

methodology to be used for the assessment of the availability of medicines taking

advantage of mobile technology.

2. Conduct meetings and interviews with key persons.

3. Data collection and analysis.

4. Report writing and interpreting research outcomes.

5. Dissemination of the results and development of a new technology for monitoring

medicines availability, affordability and prices in Jordan based on the feasibility study.

6. Recommendations to increase Access and equity.

20

4.4.4 Advocacy

Advocacy strategy in MeTA phase II aims to reach political commitment to achieve legislative

changes that will help enhancing equitable access to health care and improving the

effectiveness of the service delivery and consumer satisfaction at all levels.

Advocacy is crucial to CSO’s work as current legislative framework does not encourage civil

society to take an active part in the development and implementation of public policy. CSO’s in

Jordan do not have much of a voice to influence policymaking. They mainly consist of

fundraising patient groups, with very little expertise in advocacy and campaigning.

Practical experience shows that as far as advocacy is concerned, civil society’s approach is

accidental, unsystematic and lacking effective efforts towards institutionalizing civil society

participation in local development.

Empowerment combined with capacity building will enable CSO’s to acquire advocacy skills to

become strong partners at different stages of the decision-making process in the struggle to

improve service delivery and the living conditions of the public. Advocacy activities involve

advocacy meetings with high policy makers; advocacy meetings with media; collecting data on

vulnerable groups’ access to medicines; building capacities in advocacy campaigns; use of data

as advocacy tools.

For strengthening advocacy role of CSOs the following activities are suggested:

1. Organizing capacity building workshop for JCSOHA, on communication, advocacy, RDU,

and Generics.

2. Forming the advocacy committee from CSOs with clear TORs to guide advocacy.

3. Analyse and develop a "legislative agenda" addressing needed legislative changes

ranked by priority.

4. Organizing communication and advocacy meetings and workshops with all stakeholders.

4.4.5 Public Education

Public education involve Public campaigns to improve knowledge on generics; Raise awareness

on Human rights and patients rights of equitable access to medicines; Public campaign to

improve compliance of patients with the instructions in prescriptions; Mobilize resources for

civil societies campaigns; Media campaigns.

For raising awareness on patients' rights to access to medicines, information, and to affordable

medicines; the following activities are planned:

1. Form a committee from CSOs with clear TORs responsible for public education.

21

2. Establish forum for patients groups societies to raise awareness on patients' rights to

access to medicines.

3. Develop brochures containing statements of rights for patients and citizens, facebook

and twitter.

4. Use Patients' rights advertising in official and nonofficial gazettes, TV spots.

5. Conduct seminars to health care providers in public and private sector on patients'

rights to access to medicines.

4.4.6 Monitoring and Evaluation

Monitoring and evaluation will be conducted through the MeTA council and will involve the

following activities:

1. Establish Monitoring and evaluation committee.

2. Build up the skills and capacity of M&E committee to maintain the project's

achievements.

3. Plan, measure, analyze the indicators & write the report (included recommendations

and lessons learned).

22

5. Risks and risk management strategies

The following constitute some potential risks that could affect the smooth implementation of

MeTA Phase II in Jordan:

1. There is a need to ensure that all plans for this phase are realistic, applicable, and not

overambitious.

2. Resistance to change and poor implementation.

3. There is inconsistency across the public sector, private sector and CSOs in terms of how

standards (e.g. quality, availability, and pricing) are developed and applied. In addition

to the mutual suspicion between these sectors.

4. Although the private pharmaceutical sector is strong and powerful, civil society in

Jordan is still in its infancy stage, expertise in advocacy campaigns and negotiation is

limited.

5. Civil Societies sector has a significant lack of capacity and resources and as such has a

relatively low-level of participation in the health sector. There is a danger that CSO

representation on the Council is a token representation, and there is a need to address

the best ways of achieving a meaningful multi-stakeholder alliance.

6. Turn- over in the key senior champions, and the degree of commitment to transparency

by all stakeholders and a willingness to be mutually accountable.

To overcome most of these risks, the following have been suggested and adopted:

1. This workplan have been developed by different committees from different institutions

and involved a truly multi-stakeholders participation, involving government, private

sector and civil society representation; it addresses the core issue of MeTA to improve

transparency and accountability in the pharmaceutical sector; containing clear

qualitative and quantitative goals; SMART performance indicators were added to allow

project management, monitoring and evaluation.

2. Commitment of the stakeholders with this initiative is very crucial. JFDA, the formal

medicines regulatory authority will host this initiative, most of the activities needs to be

implemented by JFDA departments in a multidiscipline approach.

3. Diversity of multi-stakeholders is very significant for the success of this initiative.

4. One of the suggestions for MeTA council is that the Advisory Board needs to comprise

government, private sector and civil society. Steering Committee should have at least

two members from CSOs, and CSOs will lead advocacy and public education activities.

5. It is important that the MeTA principles and concepts are widely shared, advocated and

adopted at all levels of the institutions represented in the MeTA committees.

23

6. Management arrangement

The suggested organization for MeTA Jordan Phase II includes: Advisory Board which will be

responsible for monitoring and supervising the project. Steering Committee responsible for

overall coordination, direction, management and evaluation of the workplan, and National

Secretariat which will serve the Advisory Board and the Steering Committee and will be the

main point of contact with the International MeTA Secretariat (IMS). It is recommended that

full terms of reference, including membership criteria and operational procedures, for the

MeTA Council (Advisory Board, Steering Committee, and National Secretariat) should be

developed within the first two months from the official launch of the MeTA project in Jordan.

These should be placed in the public domain, along with membership and affiliation once

finalized.

6.1 Advisory Board

Based on the stakeholders and expert committee meetings and recommendations, the Advisory

Board consists of 5-6 members with the representation of high level key stakeholders from the

government, private sectors and civil society organizations. The council serves as the main

decision making body and the highest policy making and consultative body for MeTA, their

duties will be to oversee the over-all implementation of programmes/projects in Jordan, review

progress against workplan objectives, and decide on any other matter related to the

implementation of all MeTA project in Jordan. As technical advisors to MeTA, a representative

from the World Health Organisation will be in the Advisory Committee.

6.2 Steering Committee

The steering committee consists of 10-12 members with the representation of each of the key

stakeholders as the government, private sectors, civil society organizations and professional

organizations, and academia. The Steering committee shall develop policies and procedures to

control the operations of medicine management and adoption of all documents issued from

MeTA project including the disclosing policies, review progress against workplan objectives.

The steering committee will be responsible for the overall coordination, management and

evaluation of the MeTA activities. The steering committee will nominate working groups to

conduct the activities.

6.3 Hosting MeTA Secretariat

The administration of the MeTA program shall be carried out through a national MeTA

Secretariat which will serve the Advisory Board and the Steering Committee. The national

24

Secretariat will be the main point of contact with the International MeTA Secretariat (IMS). It is

recommended that the Secretariat be comprised of technical experts and administrative staff.

The IMS will provide guidance on the desired qualifications for the technical expertise upon

requested.

It would be advantageous if the institution hosting MeTA secretariat has a clear political

mandate to convene all the pharmaceutical institutions, and political and regulatory power to

national government so that MeTA can be integrated into policy processes, based on these two

criteria, the Minister of Health decided that JFDA host the secretariat.

JFDA is an independent public sector regulatory institution created in April, 2003 according to

the Provisional law #31 for year 2003; Number of employees are 530; JFDA is financially and

administratively independent. Its main objective is to ensure safety, efficacy, and quality of

drugs and pharmaceutical products and any other substances related to the cure of human

beings. JDFA is responsible for food control, to ensure safety for human consumption through

all handling processes whether locally produced or imported. JFDA is deemed to carry out all

necessary actions to fulfill its mission through setting & implementing legislations; monitoring &

surveillance and raising public awareness.

JFDA board of directors chaired by the Minister of Health and the membership of the following:

JFDA director general; secretary general of MOH; secretary general of the ministry of

agriculture; director general of the Jordan institution for standards and metrology; director of

food directorate; director of drug Directorate; and Four experienced and competent experts in

the areas of food and medicine appointed by a decision of the council of Ministers on the

recommendation of the Minister of Health for a period of two years, renewable for one-time

and in the same way may change any of them to appoint a replacement for the remainder of

the membership. The JFDA’s Drug Directorate works through a series of expert committees

made up of representative from the public, private and academic sector.

25

7. Financial arrangements and budget

The funds available for MeTA are approximately GBP 71,500 per year for four years. These

funds are managed through several funding streams in the following amounts:

• Approximately GBP 40,000 through the funding stream managed by the HAI for

administrative/content and civil society capacity building.

• Approximately GBP 31,500 for technical work and support through the funding stream

managed by WHO.

The majority of the budget is meant for the key MeTA activities. Staff, office and administration

costs are account of almost 24% of total budget. Meetings of MeTA Council consume 10% of

the budget. 5% of the budget is for contingency.

7.1 Administrative & Technical Support and activity funding stream

7.1.1 Fund management structure

The WHO Jordan office will manage funds for administrative and technical support and for

MeTA activities.

7.1.2 Fund Transfer

Upon approval of workplans, HAI and WHO Headquarters will proceed with the transfer of

funds to the WHO Jordan Office.

7.1.3 Expenditure

Expenditure on the MeTA project will be in line with the approved workplan. Expenditure will

be made to the recipient in accordance with HAI and WHO rules and procedures.

7.1.4 Accounting

Accounting will be in accordance with HAI and WHO rules and procedures. The MeTA Country

Secretariat with WHO Jordan Office will carry out periodic reviews of expenditure against work

plans as part of the regular progress review of the project.

26

7.1.5 Reporting

The WHO Country Office will provide biannual financial and technical reports according to the

reporting format agreed with WHO Headquarters and HAI.

7.1.6 Support

Where countries request support or, if the financial management systems proposed by

countries are not deemed satisfactory, the IMS is able to provide advice, either distant through

telephone or email or through the visit of a qualified accountant to assist countries to establish

adequate systems. The country should work with the national authorities to agree the financial

regulations and reporting formats for the management of the country funds.

Where necessary, the IMS can help to train recipients in standardized, DFID-approved financial

procedures, ensuring the capacity to provide regular quarterly reporting of financial

expenditure.

The IMS can provide ongoing support to the in-country accounting functions through telephone

and email or more intensive input, if necessary or requested, through an accountant’s visit.

If problems cannot be resolved through distant support, the IMS can authorize a supportive

supervision visit by the IMS.

27

8. Monitoring system

Monitoring is the systematic collection and analysis of information as a project progresses. It

aimed at improving the efficiency and effectiveness of a project. It is based on targets set and

activities planned during the planning phases of work. It helps to keep the work on track, and is

considered as a valuable tool for good management, it enables managers to determine whether

the available resources are sufficient and are being well used, Evaluation is the comparison of

actual project impacts against the agreed strategic plans. It looks at the planned activities, to

what extent they have accomplished, and how they are accomplished.

Sustainability is achieved when the host country partners and beneficiaries are empowered to

take ownership of development processes, including financing, and maintain project results and

impacts beyond the life of the project.

Monitoring is the responsibility of the MeTA Jordan council. WHO will day to day support and

guidance to project management including the monitoring. The following monitoring systems

are envisaged:

1. Monthly reports of the progress of the working committees.

2. Quarterly reports by the steering committee.

3. Quarterly financial and technical reports by country MeTA Secretariat to the

International MeTA Secretariat.

4. The MeTA Country Secretariat should carry out periodic reviews of expenditure against

work plans as part of the regular progress review of the project.

5. Independent external audits of the funds upon request by the International MeTA

Secretariat or DFID.

28

9. Annexes

Annex 1 Key References

1. Administrative and budgetary guidance for submission of MeTA country workplans.

Available from:

http://www.medicinestransparency.org/fileadmin/uploads/Documents/Resources_MSH/Co

untry_Guidance_Note/Administrative_budgetary_MeTA_worklpan_guidance_v1_1_01.pdf

2. A Framework for Good Governance in the Pharmaceutical Sector. The Hashemite

Kingdom of Jordan, 2010; Available from:

http://apps.who.int/medicinedocs/documents/s17057e/s17057e.pdf

3. Jordan Pharmaceutical Country Profile 2011; Available from:

http://apps.who.int/medicinedocs/documents/s19143en/s19143en.pdf

4. Jordan Pharmaceutical Supply chain Report. Available from:

http://www.medicinestransparency.org/fileadmin/uploads/Documents/countries/Suppl

y_Chain_Reports/MeTA_Jordan_Supply_Chain_Report.pdf

5. Measuring transparency to improve good governance in the public pharmaceutical

sector In Jordan, WHO 2009. Available from:

http://www.who.int/medicines/areas/policy/goodgovernance/MeasuringTransparencyJ

ordan.pdf

6. Medicine Prices, Availability and Affordability in Jordan. Available from:

http://www.haiweb.org/medicineprices/surveys/200405JO/survey_report.pdf

7. MeTA Pharmaceutical Sector Scan. Available from:

http://www.medicinestransparency.org/fileadmin/uploads/Documents/countries/Phar

ma_Scan/MeTA_Jordan_Pharmaceutical_Sector_Scan_-_Summary_report.pdf

8. Ministry of Health Report 2010, Department of Statistics, available at:

www.moh.gov.jo/MOH/En/publications.php

9. Pharmaceutical Sector Scan; Available from:

http://www.medicinestransparency.org/fileadmin/uploads/Documents/countries/Phar

ma_Scan/MeTA_Jordan_Pharmaceutical_Sector_Scan_-_Data_Collection_Tables.pdf

10. WHO Level II Assessment, Household Medicines Survey; DRAFT.

11. WHO Level II Assessment, Health Facilities Survey; DRAFT.

29

Annex 2 list of Participants

No. Name Position/

Organization

Mobile no. e-mail

1 Dr. Hayel Obeidat Director General/

JFDA

+962 79 9050323 [email protected]

2 Dr. Taher Abu

ElSamen

Former Secretary

General/ HHC


3 Dr. Taher Shakhshir Drugstores Owner s

Association


4 Dr. Mahmoud

Batayneh

Director General/

JPD

+962 65560956 [email protected]

5 Dr. Ahmad Qatitat Director/ Hospital

Administration/

MOH


6 Dr. Lama Homoud Director/ Pharmacy

Directorate/ MOH

+962 79 8519999 Lama.hmoud@ yahoo.com

7 Dr. Sana Naffa Medical Officer/

WHO Jordan


8 Brigadier General

Khalil Bajes

Director/ Supply

and Purchasing

Department/ RMS


9 Dr. Hakim Hadidi Professor/ Jordan

University of

Science Technology


10 Dr. Hanan Sboul Secretary General/

JAPM


11 Dr. Maisa Sakit JCSOHA +962 79 9054000 [email protected]

12 Dr. Rania Bader Director of Medical

Applications/

Electronic Health

Solutions


13 Dr. Ibrahim Abbadi Deputy General

Manager for

Administration

Affairs / Jordan

University Hospital


14 Dr. AbdelRahim

Maaia

Chairperson/

Generics importer

Association


30

15 Dr. Raef Faris Jordan Medical

Association


16 Dr. Fadia Samara JCSOHA +962 79 5197000 [email protected]

17 Dr. Taiseer Malkawi Director of

Pharmacy/ King

Abdullah University

Hospital


18 Dr. Mohammad

Sabbagh

Drug Stores Owner

Association


19 Dr. Jamal Abu Saif High Health Council +962 77 5609573 [email protected]

20 Dr. Khaled Abu Hdeb Director of medical

tourism

directorate/ MOH

+962 77 7650004

21 Dr. Musallam

Qatarneh

Director/

Department of

Procurement and

Supply/ MOH


22 Dr. Saed Jaddoua Director of

pharmacy/ King

Hussein Cancer

Center


23 Dr. Thamer Obeidat Secretary General/

Drugstores Owner s

Association


24 Dr. Senan Kilani Jordan Pharmacy

Association


25 Dr. Ikhlas Hadidi Director/ Drug

Directorate/ JFDA

+962 79 6669595 Ikhlas .Hadidi @jfda.jo

26 Dr. Lubna Qusous Head of Quality

Control Drug Lab/

JFDA


27 Dr. Raghad Hadidi High Health Council +962 79 9055032 [email protected]

28 Dr. Sana Shakhsheer Academia/ Jordan

Pharmacy

Association

+962 79 5272607

29 Dr. Adi Nuseirat Head of RDU

Department/ JFDA


30 Muin Abu Shaer High Health Council +962 77 5609577 [email protected]