1 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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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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List of Acronyms ............................................................................................................................................ 5
1. Introduction and Background ............................................................................................................... 6
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
.
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: