Pharmaceutical Sector in Palestine … · UNRWA, NGOs, and Private Insurance ..... 15 High Medicine...

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Pharmaceutical Sector in Palestine An Introduction Dima M. Qato, Jenny S. Guadamuz, Bashayer Al-Shehri, Reem Al-Sultan, and Rania Shahin Contents Background and Introduction .................................................................... 3 Demographics and Health Indicators ............................................................. 5 The Provision and Availability of Health Care and Pharmacies ............................. 5 Health Care Financing ........................................................................ 7 The Pharmaceutical Sector in Palestine .......................................................... 8 Pharmaceutical Regulations in Palestine, Including Sanctions and Border Controls ........... 10 Marketing Authorization and Registration ................................................... 10 Manufacturing Licensing, Quality Control, and Counterfeit and Substandard Medicines . . 11 Restrictions in the Importation and Exportation of Pharmaceuticals ........................ 12 Pharmacovigilance ............................................................................ 12 Medicines Supply System in Palestine ........................................................... 13 Shortages of Essential Medicines ............................................................. 13 Medicines Financing .............................................................................. 14 National Health Insurance and MOH ......................................................... 14 UNRWA, NGOs, and Private Insurance ...................................................... 15 High Medicine Costs .......................................................................... 15 D. M. Qato (*) Department of Pharmacy Systems, Outcomes and Policy, University of Illinois College of Pharmacy, Chicago, IL, USA Department of Pharmacy Practice, University of Illinois College of Pharmacy, Chicago, IL, USA Palestinian American Research Center Fellow 20132014, Washington, DC, USA e-mail: [email protected] J. S. Guadamuz Department of Pharmacy Systems, Outcomes and Policy, University of Illinois College of Pharmacy, Chicago, IL, USA Institute of Minority Health Research, University of Illinois at Chicago, Chicago, IL, USA B. Al-Shehri · R. Al-Sultan Department of Pharmacy Practice, University of Illinois College of Pharmacy, Chicago, IL, USA R. Shahin Ministry of Health, Nablus, Palestine © Springer Nature Switzerland AG 2019 I. Laher (ed.), Handbook of Healthcare in the Arab World, https://doi.org/10.1007/978-3-319-74365-3_64-1 1

Transcript of Pharmaceutical Sector in Palestine … · UNRWA, NGOs, and Private Insurance ..... 15 High Medicine...

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Pharmaceutical Sector in Palestine

An Introduction

Dima M. Qato, Jenny S. Guadamuz, Bashayer Al-Shehri,Reem Al-Sultan, and Rania Shahin

ContentsBackground and Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Demographics and Health Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

The Provision and Availability of Health Care and Pharmacies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Health Care Financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

The Pharmaceutical Sector in Palestine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Pharmaceutical Regulations in Palestine, Including Sanctions and Border Controls . . . . . . . . . . . 10

Marketing Authorization and Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Manufacturing Licensing, Quality Control, and Counterfeit and Substandard Medicines . . 11Restrictions in the Importation and Exportation of Pharmaceuticals . . . . . . . . . . . . . . . . . . . . . . . . 12Pharmacovigilance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Medicines Supply System in Palestine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Shortages of Essential Medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Medicines Financing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14National Health Insurance and MOH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14UNRWA, NGOs, and Private Insurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15High Medicine Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

D. M. Qato (*)Department of Pharmacy Systems, Outcomes and Policy, University of Illinois College ofPharmacy, Chicago, IL, USA

Department of Pharmacy Practice, University of Illinois College of Pharmacy, Chicago, IL, USA

Palestinian American Research Center Fellow 2013–2014, Washington, DC, USAe-mail: [email protected]

J. S. GuadamuzDepartment of Pharmacy Systems, Outcomes and Policy, University of Illinois College ofPharmacy, Chicago, IL, USA

Institute of Minority Health Research, University of Illinois at Chicago, Chicago, IL, USA

B. Al-Shehri · R. Al-SultanDepartment of Pharmacy Practice, University of Illinois College of Pharmacy, Chicago, IL, USA

R. ShahinMinistry of Health, Nablus, Palestine

© Springer Nature Switzerland AG 2019I. Laher (ed.), Handbook of Healthcare in the Arab World,https://doi.org/10.1007/978-3-319-74365-3_64-1

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Pricing Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Medicines Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Essential Medicines List and Rational Use of Medicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Pharmacists and Their Role . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Conclusions: Summary and Implications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Implications and Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

AbstractPolicies aimed at strengthening the delivery of safe, effective, and affordablemedicines in Palestine have improved over the last decade. The capacity of boththe public and private pharmaceutical sector in Palestine, particularly in the WestBank, has improved. However, several areas warrant increased attention bothfrom policy and public health officials. These include the high cost of essentialmedicines, the lack of pharmacovigilance and safety regulations, and a monitor-ing and evaluation system to ensure prescribing practices and the use of medi-cines in the population to promote public health. Moreover, future policy andhealth delivery reforms should incorporate the government, the private sector,NGOs, and UNRWA, especially concerning the areas of payment and reimburse-ment systems, medicine supply chain, and the cost of medicines. This is importantconsidering the largest payer of health care are households and that the vastmajority of the population utilize services from the private sector, including localpharmacies.

KeywordsMedicines in Palestine · Medicines access · Pharmaceuticals in Palestine ·Medicines expenditures · Pharmaceutical regulations

List of AbbreviationsADE Adverse drug eventsAPI Active pharmaceutical ingredientsCAM Complementary and alternative medicineCDS Central drug storeDDCR Drug Control and Registration DepartmentDirectorate General Directorate of PharmacyEML Essential medicines listEU European UnionGDP Gross domestic productGHI Government Health insuranceGMP Good manufacturing practicesIMOH Israel’s Ministry of HealthMOH Palestinian Ministry of HealthMOSA Ministry of Social AffairsNGO Nongovernmental organizationsPCBS Palestinian Central Bureau of Statistics

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PHIC Palestinian Health Information CenterPMMS Palestinian Military Medical ServicesPNA Palestinian National AuthorityUNRWA United Nations Relief and Works AgencyUSAID United States Agency for International DevelopmentUSD United States dollar $WB World BankWHO World Health Organization

Background and Introduction

Medicines are necessary in the treatment and prevention of acute and chronic illnessfor which the pharmaceutical sector is responsible for ensuring policies areimplemented that promote their access and use. Palestine, which is comprised ofthe West Bank and Gaza, is a state under occupation. Thus, the population ispersistently exposed to violence and political conflict and is undergoing an epide-miologic transition with both infectious and chronic conditions prevalent for whichthe pharmaceutical sector must address. To assure that Palestinians have appropriateaccess to medicines, one must understand the political background, the healthsystem, and the pharmaceutical regulations that impact the pharmaceutical sector.

In this chapter, we discuss pharmaceutical situation in Palestine with a focus onpharmaceutical policies and regulations.

Palestine, also known as the occupied Palestinian territories of the West Bank andthe Gaza Strip (Fig. 1) (Giacaman et al. 2009), has been occupied by Israel since1948 (Sweileh et al. 2016). In 1993, negotiations between Israel and the PalestineLiberation Organization led to the Declaration of Principles on Interim Self-Gover-nance Arrangements, or the Oslo Accords, which aimed to provide a framework fortransition to Palestinian self-governance while negotiating a final peace treaty(Giacaman et al. 2009). No such treaty has been completed.

The Oslo Accords divided the West Bank into three zones, with some areas underthe control of the transitional Palestinian National Authority (PNA) (Giacaman et al.2009). The PNA has civilian and security authority over Zone A, which includesmost of the urban areas in the West Bank but only 3% of the land (Giacaman et al.2009). The PNA has civilian authority and shared security authority with Israel overZone B, which includes an additional 27% of land in the West Bank. The remaining70% of the West Bank is completely controlled by Israel and contains agriculturalland, natural reserves, Israeli settlements, and military areas (Giacaman et al. 2009).The PNA does not have control over borders including the movement of people orgoods (Giacaman et al. 2009). Israel has placed progressively stricter restrictions onmovement of Palestinian goods and labor across the borders between the West Bankand Gaza and within the West Bank (Giacaman et al. 2009). West Bank communitiesare further separated by settlements, military zones, controlled roads, and a barrierwall between East Jerusalem and the rest of the West Bank (De Ville de Goyet et

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Fig. 1 Governorates in Palestine, figure reprinted as originally appeared in “Health status andhealth services in the occupied Palestinian territory” (Giacaman et al. 2009)

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al. 2015; Daher 2015). Hamas gained de facto control of Gaza in 2007 (Giacaman etal. 2009) and Israel responded by blockading the area for the last 12 years.

In part due to restrictions of movement and periodic military violence, thePalestinian economy has contracted 4.2% between 2001–2005 and 2006–2010 anddeclined a further 1.5% in 2011–2015 (World Bank 2016; Giacaman et al. 2009;World Health Organization 2013). As of 2014, the gross domestic product (GDP) isUSD 12.7 billion, or USD 2,966 per capita (World Bank 2016). (For comparison,Israel’s GDP per capita was USD 37,206 in 2014 (World Bank 2015).) In 2014, theunemployment rate reached 26.2% (World Bank 2016). However, the labor forceparticipation rate is under 50% (Palestinian Central Bureau of Statistics 2016a).Unemployment is known to be much higher in Gaza compared to the West Bank(World Health Organization 2013; Palestinian Central Bureau of Statistics 2016a).Nearly 40% of people in Gaza live in poverty versus 17.8% of West Bank residents(Palestinian Central Bureau of Statistics 2016a).

Demographics and Health Indicators

Nearly 5 million people live in Palestine, 60% reside in the West Bank (PalestinianCentral Bureau of Statistics 2016a). Palestine is in the middle of the demographicand epidemiological transition (Mataria et al. 2009; Palestinian Central Bureau ofStatistics 2016a). As such, the population is still relatively young and both infectiousand chronic diseases are common. In 2017, children under 14 years of age accountedfor 36.6% of the total population and only 5.1% of the population was 60 years ofage or older; however, the middle- and older-aged populations are growing in size(World Health Organization 2013; Palestinian Central Bureau of Statistics 2016a). In2011, the crude birth rate and death was 32.7 and 3.9 per 1,000 people, respectively(Palestinian Central Bureau of Statistics 2016a; Sweileh et al. 2016). The birth anddeath rates are declining in Palestine (Sweileh et al. 2016; Palestinian Central Bureauof Statistics 2016a). Life expectancy is 72.1 for men and 75.2 for women, the lifeexpectancy of men and women is lower in the Gaza Strip than the West Bank(Palestinian Central Bureau of Statistics 2016a). Noncommunicable diseases arethe leading cause of morbidity and mortality in Palestine, but infectious diseases andmaternal and child health are still significant burdens (Table 1) (Sweileh et al. 2016;Giacaman et al. 2009; World Health Organization 2013; Palestinian Health Infor-mation Center (PHIC) 2011, 2014).

The Provision and Availability of Health Care and Pharmacies

Most health care in Palestine is provided by (1) the Ministry of Health (MOH), (2)the United Nations Relief and Works Agency (UNRWA), (3) nongovernmentalorganizations (NGOs), (4) Palestinian Military Medical Services (PMMS), and (5)the private sector (Mataria et al. 2009). These varied actors result in a fragmentedsystem within and between the West Bank and Gaza.

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The MOH was established in 1994, after the Oslo Accords, and inherited a healthsystem that was fragmented and neglected (Mataria et al. 2009). Due to the physicaland political separation between the West Bank and Gaza, two ministries emerged(Mataria et al. 2009). The MOH provides care for all individuals enrolled in theGovernment Health Insurance (GHI) scheme – 57% and 62% of the population inthe West Bank and the Gaza Strip, respectively (United States Agency for Interna-tional Development and International Chamber of Commerce Palestine 2013).UNRWA was established in 1949 to provide services to the approximately700,000 Palestinians expelled from their homes in 1948 (Giacaman et al. 2009;Comité nacional UNRWA España 2013) – UNRWA provides free health care,including medicines, to Palestinians in refugee camps (Giacaman et al. 2009).

There are approximately 1,000 private pharmacies and 600 MOH health centerswith a pharmacy (World Bank 2009). There are 604 primary health centers in theWest Bank and 163 in Gaza – the MOH (68%), NGOs (20%), and UNRWA (9%)operate most of the centers (Palestinian Health Information Center (PHIC) 2014).Eighty hospitals serve Palestine as of 2014–2015 in the West Bank and 30 in Gaza.In 2014, a similar number of hospital beds were available in the West Bank andGaza (13.1 per 10,000 people) (Palestinian Health Information Center (PHIC) 2014).During the 2014 Israel–Gaza conflict, more than half of the health facilities in Gazawere damaged or destroyed and 23 health care workers were killed (De Ville deGoyet et al. 2015; Daher 2015) – exacerbating the inequities in resources betweenthe West Bank and the Gaza Strip.

In terms of human resources, there are only 2.2 physicians per 1,000 people inPalestine (Table 2), significantly lower than neighbors, including as Israel (3.6) andJordan (3.4). A quarter of all health service personnel in Palestine are employed byMOH. From 2010 to 2014, the number of personnel employed byMOH increased by12% in the West Bank but declined steeply in the Gaza Strip (21%) (Table 3)(Palestinian Health Information Center (PHIC) 2014). Therefore, efforts shouldconsider focusing on expanding health services, including in the pharmaceuticalsector, especially in Gaza.

Table 1 Top ten leading causes of death, adapted from “Health Annual Report Palestine 2014”(Palestinian Health Information Center (PHIC) 2014)

Cause of death % of deaths

Cardiovascular disease 29.5

Cancer 14.2

Cerebrovascular disease 11.3

Diabetes 8.9

Respiratory system disease 5.4

Perinatal conditions 5.2

Accidents 5.0

Renal failure 3.9

Infectious disease 3.3

Senility 3.1

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Health Care Financing

Total health expenditures in Palestine were USD 305.8 per capita. Most healthexpenditures were sourced from households (i.e., out-of-pocket) (40.8%) and thegovernment (36.9%) in 2014 (Table 4). While total health expenditures and healthexpenditures per capita increased, GDP spent on health expenditure declined from13.7% in 2010 to 11.0% in 2014 (Palestinian Central Bureau of Statistics 2016b).Household expenditure is growing as a portion of total health expenditure (Pales-tinian Central Bureau of Statistics 2016b).

Table 3 Number of MOH health service personnel in the Palestine by region in 2010 and 2014(Palestinian Health Information Center (PHIC) 2014)

2014 versus 2010

2010 2014 Gross change Growth rate

West Bank Total 3,357 3,776 419 12%

General physician 653 622 �31 �5%

Specialist physicians 310 345 35 11%

Dentist 47 60 13 28%

Pharmacist 172 198 26 15%

Nurse 1,975 2,275 300 15%

Midwife 200 276 76 38%

Gaza Strip Total 4,320 3,425 �895 �21%

General physician 1,567 1,173 �394 �25%

Specialist physicians 594 464 �130 �22%

Dentist 238 216 �22 �9%

Pharmacist 240 206 �34 �14%

Nurse 1,597 1,295 �302 �19%

Midwife 84 71 �13 �15%

Palestine Total 7,677 7,201 �476 �6%

General physician 2,220 1,795 �425 �19%

Specialist physicians 904 809 �95 �11%

Dentist 285 276 �9 �3%

Pharmacist 412 404 �8 �2%

Nurse 3,572 3,570 �2 0%

Midwife 284 347 63 22%

Table 2 Number of health service personnel in Palestine in 2014 (Palestinian Health InformationCenter (PHIC) 2014)

No. No. per 1,000 people

Physicians 9,783 2.15

Pharmacists 5,795 1.27

Nurses 10,556 2.32

Midwives 941 0.21

Dentists 3,005 0.66

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Health care and medicines are financed through taxes, health insurance, co-pay-ments, out-of-pocket payments, international donors, and in-kind donations (Mataria etal. 2009; Palestinian Central Bureau of Statistics 2011). The economic downturn,increasing health expenditures, and sanctions have led to funding gaps for theMOH’s health budget. For example, in 2006, Israel withheld Palestinian tax revenuesfor 11 months in protest of Hamas winning a majority in the PNA – tax revenuesaccount for 75% of the PNA budget (Giacaman et al. 2009). International donors alsoexcerbate instability – they often fail to fulfill their commitments and demand spendingthat may not be based on the health needs of the country (Giacaman et al. 2009;Matariaet al. 2009; De Ville de Goyet et al. 2015). International aid has fallen significantlybetween 2009 and 2014 (De Ville de Goyet et al. 2015). As of 2014, international aidaccounts for less than 1% of health services provided in Palestine (excluding UNRWAand other nonprofits) (Palestinian Central Bureau of Statistics 2016b).

The Pharmaceutical Sector in Palestine

The Palestinian pharmaceutical market is valued at least USD 150 million (Pales-tinian Ministry of Health 2011) with a disproportionate share donated in-kind (WorldBank 2009). Generics account for half of the pharmaceutical market value (Pales-tinian Ministry of Health 2011). In Palestine, approximately 2,800 pharmaceuticalproducts are registered as drug products for human consumption (Palestinian HealthInformation Center (PHIC) 2014).

In terms of manufacturing, the pharmaceutical industry employs approximately1,200 people and is one of the most productive industries in Palestine (Almi et al.2012). Between 2002 and 2009, manufacturers in Palestine invested over USD 50million to update facilities and many qualify for good manufacturing practices(GMP) certification (United States Agency for International Development andPalestinian Federation of Industries 2009). Four Palestinian manufactures areGMP compliant and two have European Union (EU) GMP certifications (Table 5)(Palestinian Ministry of Health 2011; Almi et al. 2012).

Manufacturers in Palestine have the ability to formulate medicines from activepharmaceutical ingredients (API) and repackage medicines in their finished dosage

Table 4 Funding sources as a percentage of health expenditure in Palestine in 2013–2014, adaptedfrom “Statistical Report, Palestinian Health Accounts 2014” (Palestinian Central Bureau of Statis-tics 2016b)

% of health expenditure

Funding source 2013 2014

Government/MOH 43.3 36.9

Private insurance 2.2 3.1

Households 37.7 40.8

Nonprofit institutions 15.8 18.3

International aid 1.0 0.9

Total expenditure (USD millions) 1,347.4 1,391.4

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forms (Table 6) (Palestinian Ministry of Health 2011). As a result, all medicinesproduced in Palestine are generics, either branded or unbranded (World HealthOrganization 2000; United States Agency for International Development and Pales-tinian Federation of Industries 2009) – mostly anti-infective, musculoskeletal, andalimentary agents (United States Agency for International Development and Pales-tinian Federation of Industries 2009; Palestinian Health Information Center (PHIC)2014).

Ninety percent of drugs manufactured in Palestine are sold locally (United StatesAgency for International Development and Palestinian Federation of Industries2009). Approximately, half of the Palestinian pharmaceutical market (55% interms of quantity and 50% in terms of revenue) is supplied by local manufactures(United States Agency for International Development and Palestinian Federation of

Table 5 Palestinian pharmaceutical manufacturers (Palestinian Ministry of Health 2011; GeneralDirectorate of Pharmacy and Ministry of Health 2016; Salah 2015)

Compliant

CompanyYearestablished Location GMP

EU-GMP

Birzeit Palestine Pharmaceutical Company(BPC)

1973 Birzeit,West Bank

✓ ✕

Jerusalem Pharmaceutical Company (JePharm) 1967 Al-Bireh,West Bank

✓ ✕

Beit Jala Pharmaceuticals (Jordan ChemicalLaboratory)

1969 Beit Jala,West Bank

✓ ✓

Gama Chemical Company 1973 Beitunia,West Bank

✕ ✕

Dar Al Shifa Pharmaceuticals (Pharmacare) 1985 Beitunia,West Bank

✓ ✓

SAMA Pharmaceuticals Manufacturing Co.LTD

Nablus,West Bank

Middle East Pharmaceutical and CosmeticsLaboratories Company LTD (MEGAPHARM)

1993 BeitHanoun,Gaza Strip

✕ ✕

SAMCO Gaza Strip

Arab-German Pharmaceuticals & CosmeticsCompany

2013 Gaza Strip

Table 6 Palestine pharmaceutical manufacturing capabilities, adapted from “PharmaceuticalCountry Profile – Palestinian National Authority” (Palestinian Ministry of Health 2011)

Manufacturing capabilities

Research and development actives to develop new active substances (e.g., new molecularentities)

Production of active pharmaceutical ingredients (APIs) ✕

Production of formulations from APIs ✓

Repackaging of finished dosage forms ✓

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Industries 2009). The second half of the Palestinian pharmaceutical market consistsof imports; 15% from the Israel alone (Almi et al. 2012).

In Palestine, quality control testing is performed in Central Public Health Labo-ratory, which is not a functional part of Medicines Regulatory Authority. Theexisting laboratory facilities have not been accepted by WHO PrequalificationProgram. Table 7 summarizes the reasons for drug testing:

Over a 2-year period, 2900 samples were tested, and 4% of the samples failed topass the quality standards. Additionally, post-marketing surveillance testing is notperformed by the government inspectors (Palestinian national Authority 2011).

Pharmaceutical Regulations in Palestine, Including Sanctions andBorder Controls

The General Directorate of Pharmacy (referred to as the “Directorate” henceforth)holds regulatory authority over pharmaceuticals in Palestine and is housed within theMOH in Ramallah (Palestinian Ministry of Health 2011). Funding for the Director-ate is not provided through the regular government budgets; it does not retain therevenue from regulatory activities (e.g., licensing fees), instead the Ministry ofFinance receives these funds (Palestinian Ministry of Health 2011). The Directoratereceives technical assistance from the WHO and the World Bank (PalestinianMinistry of Health 2011; World Bank 2009). Israel’s Ministry of Health (IMOH)regulates import and exports of raw and finished pharmaceuticals products inPalestine, because PA does not control over borders between countries (UnitedStates Agency for International Development and International Chamber of Com-merce Palestine 2013; Almi et al. 2012).

Marketing Authorization and Registration

All pharmaceutical products sold in Palestine require market authorization (DrugControl and Registration Department 2007). The Drug Control and RegistrationDepartment (DDCR) within the Directorate processes all applications. The objec-tives of the market authorization process are to assure “acceptable standards ofquality, safety and efficacy” (Drug Control and Registration Department 2007).Product registration is valid for 5 years (Drug Control and Registration Department

Table 7 Reasons for medicines testing

For quality monitoring in the public sector ✓

For quality monitoring in the private sector ✓

When there are complaints or problem reports ✓

For product registration ✓

For public procurement prequalification ✓

For public program products prior to acceptance and/or distribution ✓

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2007). The DDCR does not utilize a computerized system to manage or storedocuments from registrations (Palestinian Ministry of Health 2011).

Marketing authorization applications must include information about the compo-sition, development (e.g., clinical studies), pharmacodynamics and pharmacokinetics,packaging, and finished product specifications (Drug Control and Registration Depart-ment 2007). Generic product applications must include bioequivalence studies if theyare from local manufactures and countries which are “considered not highly regulated”(Drug Control and Registration Department 2007). The applicant must also submit asample of the medicine, and innovator drug in the case of generic medicines, which istested to meet quality standards and specifications reported in the application.

Legal provisions for granting patents to pharmaceutical manufactures does notexist in Palestine (Palestinian Ministry of Health 2011). Therefore, Palestinianmanufactures can legally produce products that are patent protected in other coun-tries (United States Agency for International Development and International Cham-ber of Commerce Palestine 2013). In the past, Israel has stopped production linesand financially penalized Palestinian companies who manufacture medicines that arepatent protected in Israel, in response to demands of multinational pharmaceuticalcompanies (United States Agency for International Development and InternationalChamber of Commerce Palestine 2013).

Manufacturing Licensing, Quality Control, and Counterfeit andSubstandard Medicines

Both local and imported drug manufactures must be licensed and comply with theGMP adopted in 1992 from the WHO (Palestinian Ministry of Health 2011).Importers, wholesalers, and distributors must be licensed but are not required tocomply with good distribution practices (Palestinian Ministry of Health 2011). Thereare 83 wholesalers and importers in Palestine (World Bank 2009).

Laboratories to test the quality of medicines exist in Palestine but they are not partof the Directorate (Palestinian Ministry of Health 2011). The adequacy of the staffand equipment at outsourced laboratories is questionable – there have been severalcases in which university laboratories in Palestine report that seized medicines meetquality control standards but in reality, the medicines are either fake or expired (Bake2012). In 2014, the MOH reported that 8.2% samples tested failed to meet qualitystandards (Palestinian Health Information Center (PHIC) 2014). Test results are notpublicly available making it impossible to know which medicines or patients wereaffected (Palestinian Ministry of Health 2011). There are no legal provisions to allowquality control testing of medicines imported through authorized ports (PalestinianMinistry of Health 2011).

The Directorate disseminates counterfeit drug warnings from the WHO on itswebsite and requests that providers report any counterfeit drugs encountered (Gen-eral Directorate of Pharmacy and Ministry of Health 2016; Palestinian Ministry ofHealth 2011). However, no publicly available information reports the extent ofcounterfeit drugs in Palestine. It is known that counterfeit drugs are produced and

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distributed in Palestine (Park 2010; Bake 2012). For example, counterfeit Gleevec(imatinib) was found in a raid of a Palestinian distributor which supplies the MOHand 15 people served by a public hospital in Hebron died of leukemia (Bake 2012).

Restrictions in the Importation and Exportation of Pharmaceuticals

Palestinian manufactures are required to receive an importation license from theIsraeli Ministry of Health (IMOH) for each shipment of raw products (including allAPIs) from abroad (Almi et al. 2012). Securing licenses for each shipment isexpensive and often causes delays in productions (up to several weeks) (Almi etal. 2012). Importing raw products into Gaza is even more expensive and compli-cated. It requires docking the goods in Israel to undergo security screenings andcharged import duties (Almi et al. 2012). Afterwards, Israeli trucks deliver theproducts to the Gaza Strip border before undergoing additional screenings andtransfers to Palestinian trucks (Almi et al. 2012).

In addition to Palestinian market authorization, all pharmaceuticals imported inPalestine must be registered with the IMOH and are held to Israeli standards(Schoenbaum et al. 2005; Palestinian Ministry of Health 2011). Most companiesregistered in Israel are from Western countries thus Palestine is deprived of cheapergenerics from China, India, and Eastern Europe (Almi et al. 2012). Smaller foreigncompanies are also unable to enter the Palestinian market due to the expenses ofregistration in Israel and transportation from Israel to Palestine (Almi et al. 2012).

Due to the Paris Protocol (joint customs envelope) within the Oslo Accords,Palestine and Israel do not directly tax each other for most goods (Almi et al. 2012).Therefore, Israeli medicines enter the Palestinian market without customs, importtaxes, or extraneous logistical burdens (e.g., shipment disturbances) (Almi et al.2012). Israeli manufacturers are not required to label their medicines in Arabic;however, user guides are required to be printed in English, Hebrew, and Arabicaccording to IMOH regulations (Almi et al. 2012).

Palestine does not export any pharmaceuticals to neighboring counties (with theexception of Jordan) because these counties refuse to send their delegations to Israel(Almi et al. 2012; Sweileh et al. 2016). Palestine cannot export to Israel due to“security concerns”; Israeli inspectors for product registration refuse to enter Pales-tine because their safety cannot be assured (Almi et al. 2012; Sweileh et al. 2016). Asa result of these trade restrictions, Palestinian pharmaceutical products are oftenmore expensive than products from other developing nations, further hampering anyexport potential (Almi et al. 2012; Sweileh et al. 2016).

Pharmacovigilance

There is no legal mandate to provide pharmacovigilance activities by the PharmacyDirectorate or pharmaceutical Companies (Palestinian Ministry of Health 2011). Nonational pharmacovigilance agency exists (Palestinian Ministry of Health 2011). No

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system is in place to report adverse drug events (ADEs) to the Directorate (Pales-tinian Ministry of Health 2011). National data on ADEs is not collected (PalestinianMinistry of Health 2011). The Directorate does not have a national committee toprovide technical assistance for ADEs (Palestinian Ministry of Health 2011). Anofficial standardized form to report ADEs was developed by the Directorate; how-ever, its utility is questionable given that no agency is responsible for collecting oranalyzing this information (Palestinian Ministry of Health 2011).

Medicines Supply System in Palestine

Medicines in Palestine are procured by a variety of health care operators. The privatesector purchases medicines directly from local manufactures or distributors (WorldHealth Organization 2000). UNRWA procures medicines through an internationaltendering process and distributes them to two main drug stores – one in Jerusalemand another in the Gaza Strip (World Health Organization 2000). NGOs usually usemedicines donated in-kind (World Health Organization 2000). When necessary,NGOs purchase medicines from local manufactures or distributors (World HealthOrganization 2000).

The MOH in Ramallah, West Bank, procures medicines for the West Bank andthe Gaza Strip through a tendering procedure which includes quality and priceconsiderations (World Health Organization 2011; Palestinian Ministry of Health2011). Medicines purchased through this procedure are randomly tested for qualityand these results are made public (Palestinian Ministry of Health 2011). Due topreferential policies toward the local industry, 40% of medicines procured by theMOH come from local manufactures (World Health Organization 2011, PalestinianMinistry of Health 2011). However, HIV, tuberculosis, oncology, epilepsy, andpsychiatric medicines are always procured abroad (World Health Organization2011). The MOH has a Central Drug Store (CDS) at the national level and anadditional CDS in the Gaza Strip (World Health Organization 2011; PalestinianMinistry of Health 2011). Both CDSs distribute to local warehouses and healthfacilities (World Health Organization 2011; Palestinian Ministry of Health 2011).Items that are not available at either CDS can be purchased directly by healthfacilities with authorization from the General Directorate of Pharmacy (World HealthOrganization 2000).

Shortages of Essential Medicines

Since 2000, drug shortages of at least 10% of essential medicines (as per essentialmedicines lists (EML) in the West Bank and Gaza) are reported by the MOH inRamallah and the Gaza Strip (World Health Organization 2012). Shortages havebeen more desperate in Gaza due to ongoing armed conflict with Israel and thedestruction of health infrastructure (e.g., in 2011 an MOH drug warehouse wasbombed) (World Health Organization 2011). During the last 10 years, at least 20% of

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essential medicines were at zero stock (i.e., less than 1 month supply is available atthe CDS) in Gaza (Daher 2015). As of January 2018, the Gaza CDS reported that on40% of medicines were at zero stock (Hass 2018). This had led to staff in the MOHto resort to reusing medical disposables and prescribing second- or third-line med-icines (Health Cluster 2014). Patients with financial means are able to buy medicinesfrom the private sector, which is usually better stocked, therefore, access to medi-cines depends on the wealth of the individual (Health Cluster 2014).

The MOH in Ramallah cites that budgetary restrictions are the main reason for themedicines shortages at the central level (World Health Organization 2011, 2012).The political rift between Fatah and Hamas may further disturb logistics between theWest Bank and Gaza (World Health Organization 2011).

In-kind donations to Gaza helped bridge the gap in medicine procurement.Unfortunately, less than 10% of medicines donated in-kind were donated to theMOH in Ramallah, and were instead donated to UNRWA or NGOs (World HealthOrganization 2011). Twenty-two percent of medicines donated during 2008–2009were expired or inappropriate and an additional 20% resulted in a surplus overpharmaceutical needs in Gaza (World Health Organization 2011).

Medicines Financing

Public expenditure on pharmaceuticals was USD 54.1 million in 2010 (PalestinianHealth Information Center (PHIC) 2011). Private expenditure on pharmaceuticals in2009 were estimated at USD 100 million (Palestinian Ministry of Health 2011). TheWorld Bank estimates that per capita pharmaceutical expenditure is between USD 35and USD 40 per year (World Bank 2009). Seventeen percent of expenditure is spenton antibiotics and another 16% are spent on chronic conditions (World Bank 2009).Medicines expenditure account for 50% of household and 20% of MOH healthspending (World Health Organization 2011; World Bank 2009).

No recent studies have examined the impact of medicines expenditures onhouseholds and their well-being. However, it is known that over 12% of Palestinianhouseholds fall into poverty due to health spending and that households with lowerincome spend a larger portion of health spending on medicines (World Bank 2009;Mataria et al. 2010).

National Health Insurance and MOH

In 1994, the newly established PNA created the Government Health Insurance (GHI)under the administration of the MOH (World Bank 2009). The GHI is funded bypremiums and co-payments; however, the health services and goods delivered costfar more than GHI premiums and co-payments (World Bank 2009). While thecreation of the GHI was intended to be the first step towards universal healthinsurance coverage, this model has not proven sustainable in its current form(World Bank 2009).

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Six categories of beneficiaries are covered under the GHI: (1) governmentworkers, (2) Palestinians who work in Israel, (3) individuals and households, (4)businesses and employer groups, (5) hardship cases/individuals and families onsocial assistance, and (6) unemployed individuals (World Bank 2009). The firsttwo categories are mandated to purchase insurance, and the last category is exemptfrom premiums and co-payments (World Bank 2009). All categories have the optionto extend their coverage to dependents and extended family for an additionalpayment (Table 8) (World Bank 2009). As of 2007, 30% of individuals insured byGHI are covered under the unemployed category (World Bank 2009).

UNRWA, NGOs, and Private Insurance

NGOs generally finance medicines through internal and international donations,both monetary and in-kind, and deliver medicines at reduced costs or free of charge(World Health Organization 2000). Similarly, UNRWA receives international dona-tion for its operations and provides medicines free of charge (World Health Organi-zation 2000). Private insurance policies, which cover less than 3% of the population,generally provide medicines coverage but they are not required to provide coverageof medicines on the EML (World Health Organization 2006; Palestinian Ministry ofHealth 2011).

High Medicine Costs

Medicines in Palestinian are more expensive than in other Arab countries withsimilar economic development and some branded products are more expensivethan in Israel (World Bank 2009). A World Bank survey in 2007 found that MOHprocurement prices are on average 6.9 times more expensive international referenceprices (World Bank 2009). Generic medicines purchased for sale in the private sectorare 9.7 times more expensive than international reference prices (World Bank 2009).Most patients in the public sector do not receive medicines free of charge in Palestine(Palestinian Ministry of Health 2011). Patients under 3 years of age must pay NIS 1and patients over 3 years of age must pay NIS 3 (USD 0.79), regardless of theirability to pay (Palestinian Ministry of Health 2011). Individuals with tuberculosis,sexually transmitted diseases, HIV/AIDS, and childhood vaccines are delivered at nocost to all Palestinians (Palestinian Ministry of Health 2011).

Pricing Regulations

The political instability and trade barriers discussed in earlier sections of this chapterhave resulted in high medicine prices in Palestine. Additionally, Palestine does notbenefit from differential pricing policies applied by multinational companiesaccording to the country’s economic development (referred to as “pricing

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discrimination”) (World Bank 2009). Instead, Palestine is considered to be the sameeconomic zone as Israel, a country 12 times as wealthy as measured by GDP percapita (World Bank 2009, 2015, 2016).

The PNA and MOH have also failed to regulate pricing adequately. In the publicsector, local manufacturers have preferential treatment, thus prices offered by these

Table 8 GHI premiums and collection system, adapted from “Reforming Prudently Under Pres-sure: Health Financing Reform and the Rationalization of Public Health Sector Expenditures”(World Bank 2009)

Beneficiarycategory Compulsory Monthly premium Collection

Government/Public sector

✓ 5% of basic salary, minimumNIS 50 (USD 12.9),maximum NIS 100 (USD25.8)For pensioners: 5% ofpayment, no minimum,maximum NIS 100

Deducted from salary andtransferred to GHI/MOH

Workers inIsrael

✓ NIS 93 (USD 24.0) collectedby Israeli authorities, NIS 75(USD 19.1) provided toMOH in Palestine

Israeli authorities shoulddeduct NIS 93 (USD 24.0) permonth and transfer NIS 75(USD 19.1) to Palestine everymonthMost individuals have not paidsince 2000

Individualsandhouseholds

✕ NIS 80 (USD 20.6) perfamilyNIS 50 (USD 12.9) for anyindividualNIS 20 (USD 5.2) for anystudentNIS 80 (USD 20.6) for anymember of any professionalunionNIS 50 (USD 12.9) for anymember of a workers’ union

Paid to one of the healthdirectorates in the West Bankor to post offices in Gaza on amonthly, half yearly, or yearlybasis

Businessesandemployergroups

✕ 5% of basic salary, minimumNIS 50 (USD 12.9),maximum NIS 100 (USD25.8)

Payments made collectivelythrough employer on amonthly or yearly basis

Hardshipcases

✕ No cost to family. Ministry ofSocial Affairs (MOSA) paysNIS 45 per family

MOSA identifies “hardshipcases” per household income.The Ministry of Financetransfers the allocated portionof MOSA’s budget to MOH

Registeredasunemployed

✕ Exempt Must be registered asunemployed with the Ministryof Labor

Allcategories

✕ NIS 5 (USD 1.3) peradditional dependent

Collected via correspondingcategory

Israeli new shekel (NIS)

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firms are on average 15% higher than international bidders (World Bank 2009).Because of reasons that may be outside of Palestinian control, the number ofinternational bidders for MOH tenders are usually low; for 10% of tenders, thereare no international bidders (World Bank 2009).

Prices of medicines purchased by private retailers for resale are not regulated,instead prices are stipulated by distributers or manufacturers (World Bank 2009).Due to limited competition, Palestinian manufacturers sell at relatively high prices(World Bank 2009). Medicines produced in Palestine are known to sell for up to 50%below local private sales price abroad (World Bank 2009).

Markup caps are in place to regulate private retail prices (Palestinian Ministry ofHealth 2011). On average, locally manufactured drugs have a 25% markup andimported products have a 10–15% market up in private pharmacies (Qadah et al.2011). Generic medicines may be substituted at the point of dispensing in publicsector facilities but not in private facilities (Palestinian Ministry of Health 2011).

Medicines Use

While population-level prevalence of medicines use is unknown, information fromhousehold surveys and expenditure data indicate that medicines are commonly usedin Palestine. Medicines commonly stored in Palestinian households include analge-sics, nasal preparations, antibiotics, and cardiovascular medicine (Sweileh et al.2010). However, this is not indicative of use and cannot be used to determine thenumber of individuals using these therapeutic classes (Sweileh et al. 2010).

Even though selling prescription medicines without a prescription is prohibited,in practice, pharmacies are not regulated and sales of prescription medicines withouta prescription are common (Palestinian Ministry of Health 2011; Jaradat and Sweileh2003). Antibiotics and injectables are often sold over-the-counter. Antibiotics,analgesics, and drugs to alleviate flu/cold symptoms are the most commonly usedself-prescribed medicines (Al-Ramahi 2012). Self-prescribing may result in poormanagement of conditions, inappropriate use of dangerous medicines, and, at thepopulation-level, antibiotic resistance. Use of alternative medicines is also common,resulting in high risk for interactions with prescription or over-the-counter medicines(Ali-Shtayeh et al. 2012, 2016; Al-Ramahi et al. 2015).

Essential Medicines List and Rational Use of Medicines

To improve the rational use of medicines and contain costs, the MOH in Ramallahintroduced an essential drug list in 2000; this list was last updated in 2013 (State ofPalestine Ministry of Health 2013a). A second EML was developed by the MOH inGaza (World Health Organization 2012). Currently, there are 517 medicinesincluded in the West Bank EML and 480 medicines included in the Gaza EML(World Health Organization 2012; State of Palestine Ministry of Health 2013a). TheEML for the West Bank is relatively comprehensive and includes medicines for

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infectious diseases, chronic conditions, and a variety of mental health and psychiat-ric conditions (State of Palestine Ministry of Health 2013a).

The Committee of Therapeutics and Pharmacology in the MOH in Ramallah –considers “evidence based-medicine, the epidemiological situation in the country,and the principle of cost-effectiveness”when selecting medicines for inclusion in theEML; however, the process used to make these determinations is not available(World Health Organization 2011; Palestinian Ministry of Health 2011). Publiclyavailable documents do not outline the process for the EML created by the MOH inGaza.

The introduction of EMLs improved rational use of medicines in Palestine. Afterthe initial introduction (1997–1999 vs 2000–2003) researchers observed that theaverage number of medicines prescribed per clinic visit decreased, the percentage ofmedicines prescribed that were antibiotics and injections decreased, and the percent-age of medicines included in the EML being prescribed increased (Younis et al.2009).

Given the positive effect of EMLs, it is surprising that the MOH has not made itofficial policy to align the standard treatment guidelines with the EML or tocoordinate with the local industry to assure essential medicines can be locallyproduced (Palestinian Ministry of Health 2011). The most updated guidelines onlymake suggestions for 11 conditions/treatments – notably, diabetes and hypertensionwere excluded (State of Palestine Ministry of Health 2013b). Local industry can onlyproduce 160 medicines on the EML (World Bank 2009).

Pharmacists and Their Role

Pharmacists are required to be licensed by the Palestinian Pharmaceutical Associa-tion to practice (Palestinian Ministry of Health 2011). However, graduates ofPalestinian universities are not required to sit in an exam, and there are no continuingeducation requirements and no published code of ethics for pharmacist (PalestinianMinistry of Health 2011; Sweileh et al. 2016).

Palestine has a relatively high density of pharmacists per 10,000 people, twice asmany as the 5 pharmacists per 10,000 recommended by the WHO (Qadah et al.2011). Most patients surveyed about their perception of community pharmaciesindicated that they would like to receive additional preventive health services fromtheir pharmacists (Khdour and Hallak 2012). Eleven percent of pharmacists inNablus were unemployed and 34% worked in community pharmacies (Qadah etal. 2011). Pharmacists may be underutilized as clinicians considering patient desiresand the ongoing shortage of other health care providers.

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Conclusions: Summary and Implications

While Palestine has made strides in improving and expanding its ability to manu-facturer generic medicines, these efforts may be undercut by instability in its supplychain due to international pressures, such as sanctions and border controls. Theseinternational pressures also hamper the ability to import necessary medicines thatcannot be produced domestically. Continual shortages of essential medicines (espe-cially the Gaza Strip) threaten the health of the population in terms of acuteconditions and management of increasingly common chronic diseases.

Domestic and international pressures have resulted in high medicines costs.While the MOH provides care for a large portion of the population, the governmentschemes do not appropriately protect from the financial burden of medicines,because they are often unavailable through government channels meaning thatpatients must purchase medicines through private pharmacies. Out-of-pocket healthcosts are increasing in Palestine – contributing to an inequitable health system.

Implications and Recommendations

In terms of domestic policy, the MOH should align their EML with their treatmentguidelines – this would improve medicine prescribing via rational drug use. Toimprove the availability and stable supply of medicines, the MOH should continue toencourage the domestic pharmaceutical production, especially production of essen-tial medicines. While often under-discussed in the context of developing countries,policy makers need to address the lack of pharmacovigilance, quality and safetyregulations, and a monitoring and evaluation systems to ensure prescribing practices– addressing these issues would improve the quality, efficacy, and safety of themedicines used in Palestine.

Future policy and health delivery reforms should incorporate the government, theprivate sector, NGOs, and UNRWA, especially concerning the areas of payment andreimbursement systems, medicine supply chain, and the cost of medicines. This isimportant considering the largest financer of health care are households and that thevast majority of the population utilize services from the private sector, includinglocal pharmacies.

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