albania laws and regulations affecting commercial supply of modern contraceptives

146 Pages·2009·0.62 MB·English

ALBANIA LAWS AND REGULATIONS
AFFECTING COMMERCIAL SUPPLY OF
MODERN CONTRACEPTIVES: ANALYSIS
AND RECOMMENDATIONS
November2009
This publication was produced for review by the United States
Agency for International Development. It was prepared by
Pamela Riley and Kristen Maddock for the Private Sector
Partnerships-Oneproject.
Country Report
Country ReportSeries:PSP-One CountryReportswere developed to informspecific PSP-One
country program operations, but theyalso contain results that may beofinterest to a wider audience.
All papers inthe series were reviewed byPSP-One technical staff inthefield and in Washington,DC, as
well as by relevant PSP-One program management staff.
Recommended Citation: PamelaRiley and KristenMaddock.November 2009. Albania Laws and
Regulations AffectingCommercial Supply of ModernContraceptives: Analysis andRecommendations. Bethesda,
MD: PrivateSector Partnerships-One project, Abt Associates Inc.
Download: Download copies ofPSP-Onepublications at: www.psp-one.com
Contract/ProjectNo.: GPO-I-00-04-00007-00
Submitted to: PatriciaMengech,CTO
Bureau ofGlobalHealth
Global Health/Populationand Reproductive Health/Service Delivery Improvement
Center for Population, Health and Nutrition
Bureau forGlobalPrograms, Field Support and Research
UnitedStatesAgency forInternational Development
AbtAssociatesInc.4550MontgomeryAvenue,Suite800North
Bethesda,Maryland20814Tel:[phone]Fax:[phone]
www.PSP-One.comwww.abtassoc.com
Incollaborationwith:
BanyanGlobalDillonAllmanandPartnersFamilyHealthInternational
ForumOneCommunicationsIntraHealthInternationalO’Hanlon
ConsultingPopulationServicesInternationalTulaneUniversity’sSchoolof
PublicHealthandTropicalMedicine
ALBANIA LAWS AND REGULATIONS
AFFECTING COMMERCIAL SUPPLY OF
MODERN CONTRACEPTIVES: ANALYSIS
AND RECOMMENDATIONS
DISCLAIMER
The author’s views expressed in this publication do not necessarily reflect the views of the United
States Agency for International Development (USAID) ortheUnited StatesGovernment.

CONTENTS
Acronyms........................................................................................i
Acknowledgments........................................................................iii
Executive Summary......................................................................v
Introduction and Overview..........................................................1
1. Background, Objectives, and Methodology...........................3
1.1 Background...............................................................................................3
1.2 Objectives.................................................................................................4
1.3 Issues OutsidetheScope of thisReport: HealthCareReform
and FP Demand.......................................................................................4
1.4 Methodology............................................................................................5
1.5 Summary ofFindings..............................................................................5
2. CompendiumofLaws, Decisions, and Regulations Relevant
to Supply of Modern Contraceptives, with Analysis and
Recommendations…...………………………………………….7
2.1 SocialMarketing......................................................................................8
2.2 Registration............................................................................................12
2.3 Customs and Importation..................................................................14
2.4 Pricing......................................................................................................16
2.5 Reimbursement.....................................................................................18
2.6 Taxes and Tariffs...................................................................................19
2.7 Prescribing..............................................................................................20
2.8 Promotion.............................................................................................22
3. Advocacy Strategy..................................................................23
3.1 Background/Context............................................................................23
3.2 ACPD Advocacy Plan to PromoteRH in Albania.........................23
3.3 ImprovingRH intheContext ofMCHPolicies.............................24
4. Conclusion...............................................................................27
Annex A:List of Sources Interviewed.......................................29
Annex B: Listof ApplicableLawsand Regulations..................31
Annex C: Copiesof Translated Laws, Regulations, and
Decisions......................................................................................35
Bibliography...............................................................................131
LIST OF TABLES
2.1 SocialMarketing Lawsand Decisions.........................................................8
2.2 Registration Laws andDecisions...............................................................12
2.3 Customs and Importation Laws and Decisions.....................................14
2.4 Pricing Laws and Decisions.........................................................................16
2.5 Reimbursement Laws and Decisions........................................................18
2.6 Taxes and Tariffs Lawsand Decisions.....................................................19
2.7 Prescribing Laws and Decisions.................................................................20
2.8 Promotion Lawsand Decisions.................................................................22
3.3 MCH Policy Framework..............................................................................24

ACRONYMS
ACCESS Access to Clinical and CommunityMaternal, Neonatal, and Women’s HealthServices
ACPD Albania Center for Population and Development
C-Change Communicationfor Change
CIF Cost, Insurance, Freight
COM Council of Ministers
CSO Civil SocietyOrganization
DFID Department for International Development,UK
DHS Demographic and Health Survey
DNC Drug NomenclatureCommission
DPC Drug Pricing Commission
EU European Union
FP Family Planning
FPRA Family PlanningRegionalActivity
HII Health InsuranceInstitute
IPH Institute for PublicHealth
IPPF InternationalPlanned Parenthood Federation
IUD Intrauterinedevice
JSI John Snow,Inc.
KfW Kreditanstalt für Wiederaufbau
MCH Maternal and Child Health
MOF Ministry ofFinance
MOH Ministry ofHealth
NCQSAHI NationalCenterofQuality, Safety, and Accreditationof Health Institutions
NCDC NationalCenterforDrugControl
NGO NongovernmentalOrganization
OTC Over theCounter
PSP-One USAID PrivateSectorPartnerships-One Project
RH Reproductive Health
RH/FP Reproductive Health/Family Planning
SMO Social MarketingOrganization
UNFPA UnitedNations PopulationFund
USAID UnitedStatesAgency forInternationalDevelopment
VAT Value-addedTax
WHO World HealthOrganization
i