assessment of pharmaceutical sector governance in selected...
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Pharmaceutical Sector Governance in the
Middle East and North Africa Region –
A Regional Review by the World Bank
Presented at the Workshop on
Governance of Pharmaceuticals in MENA
Amman, Jordan
June 6, 2010
Overview of Presentation
1. Key Issues in Pharmaceutical Governance
2. Summary of Pharmaceutical Governance
Issues in MENA
3. Policy Options
Annex of Country Summaries and Cases
Sources of information and
analysis
Eight Country Studies
1. Algeria (2005)
2. Djibouti (2008)
3. Iran (2006)
4. Jordan (2009)
5. Morocco (2006)
6. Tunisia (2006)
7. Yemen (2008)
8. The Palestinian Territories (2009)
WHO/Health Action International Surveys
1. Key Issues in
Pharmaceutical Governance
• Governance: the rules, procedures, and the
related behaviors by which a function is
performed
• Specific regards to openness, accountability,
and effectiveness
• Rationale for Good Governance in
Pharmaceuticals: “Market failures”
A Framework for
Pharmaceutical Governance Analysis
1. Registration and approval process
2. The public procurement process
3. Pricing policies
4. Rational use of drugs
Framework area Framework Issue
Policies •There is a suitable drug law
•There is a national drug policy
•The national drug policy is implemented
Committee Structure and Operation •There is a well structured and operated drug registration committee
•There is a well structured and operated drug reimbursement listing committee
•Committee member conflict of interest processes are in place and operating
Essential Drug List •An essential drugs list is in place that guides purchasing, and it is adhered to
•The essential drugs list is based on evidence
Control and Testing •Regulations in place to control drug manufacture, distribution, storage and
clinical practice
•Effective measures to ensure compliance with regulations
•Adequately funded and staffed quality control laboratories are in operation to test
drug quality
Pricing and generics •An effective pricing policy is in place and adhered to
•There is an effective generic substitution policy in place that is implemented
•Appropriate physician incentives are in place to promote generics
•Appropriate pharmacist incentives are in place to promote generics
•Appropriate consumer incentives are in place to promote generics
Public Procurement •Procurement of pharmaceuticals is in quantities that ensure lowest price is
obtained
•Procurement agencies operates in a transparent manner and with effective
procedures in place
•Pharmaceuticals are only procured by generic name
•There are bioequivalence regulations in place
•There is sufficient public funding made available for the required essential drugs
Monitoring and Rational Use of
Medicines
•Pharmaceutical data is gathered and analyzed electronically
•A rational use of medicines unit is in place operating a range of programs
•Clinical guidelines are present, relevant and implemented
•Prescription-only drugs are not supplied without prescription
•There are active measures in place to control the various types of counterfeit
drugs
International approaches to…
• Pricing
• Reimbursement
• Procurement
Approaches to Pricing of Drugs
a) Unregulated
b) List of preferred medicines
c) Prices based on country of origin
d) Prices based on a basket of external country
references
e) Price based on value
Approaches to Reimbursement
• The listing process
• Determining the reimbursement prices
• Copayments
• Generic substitution
Approaches to Procurement
• Good pharmaceutical procurement
– Transparent process
– Risk management
Approaches to Procurement
• Pooled procurement
– Informed buying
– Coordinated informed buying
– Group contracting
– Central contracting and procurement
2. Pharmaceutical Governance in
the MENA Region• Policy and legislation
• Registration of drugs
• Listing of drugs for reimbursement
• Pricing methods
• Procurement
• Generics
• Quality
• Storage and distribution
• Rational use of drugs
GOVERNANCE ISSUE/AREA MENA
Status
Findings
Policies •Most countries have
developed a national
drug policy.
•But implementation is
still an issue in several
countries.
•Legislation is weak in
several areas including
supply chain ,
procurement, and
inspections
There is a suitable drug law Partial
There is a national medicines policy Partial
The national medicines policy is
implementedMinimal
GOVERNANCE ISSUE/AREAMENA
StatusFindings
Registration and listing
processes and organization
There has been criticism
in all countries of the level
of transparency in the
process for selecting
committee members and
the making of registration
and listing decisions.
There is an adequate drug
registration committeePartial
There is an adequate drug
reimbursement listing committeePartial
Conflict of interest processes are in
place and operatingMinimal
GOVERNANCE ISSUE/AREAMENA
StatusFindings
Essential Drug List In all countries, the lack
of confidence by
stakeholders in the drug
list is undermining
compliance with
procurement and rational
drug use
An essential drugs list is in place and
adhered to Partial
The essential drugs list is based on
evidencePartial
GOVERNANCE ISSUE/AREAMENA
StatusFindings
Control and Testing There are concerns
about
•Manufacture and
distribution (Iran and
Morocco),
•Testing facilities
(Djibouti, Yemen,
Iran),
• Inspections (all
countries), and
•Counterfeit drugs (all
countries)
Regulations in place to control
drug manufacture Partial
Compliance measures are effective Partial
Quality control laboratories are in
place and effectivePartial
GOVERNANCE ISSUE/AREAMENA
StatusFindings
Pricing and generics •Pricing strategies are
weak throughout the
region, with resulting
high prices for brand
drugs in the public
sector and high process
for all drugs in the
private sector.
•Generic substitution is
weak in all countries
with inadequate
incentives and low
consumer confidence in
generics
An effective pricing policy is in place
and adhered toPartial
There is an effective generic substitution
policy Minimal
Physician incentives are in place to
promote generics Minimal
Pharmacist incentives are in place to
promote genericsMinimal
Consumer incentives are in place to
promote genericsMinimal
GOVERNANCE ISSUEMENA
StatusFindings
Procurement •The main issue in all
countries is lack of
funding for public
procurement of drugs
leading to low
availability in the public
sector, forcing patients
into the highly priced
private sector.
•There are also
organizational issues in
some countries (eg
Djibouti)
Joint procurement is in place Partial
Procurement agencies are transparent
and efficient Partial
Pharmaceuticals are procured by
generic name Partial
Bioequivalence regulations in place Minimal
There is sufficient funding available for
essential drugsMinimal
GOVERNANCE ISSUE MENA
Status
Comments
Monitoring and
Rational Use of Medicines
•There are various efforts
throughout the region to
improve rational drug use
•Lack of electronic data
and comprehensive
rational drug use programs
Pharmaceutical data is gathered
electronicallyMinimal
A rational use of medicines unit is in
effective operation Partial
Clinical guidelines are present,
relevant and implementedMinimal
Prescription-only drugs are not
supplied without prescriptionMinimal
Measures in place to control
counterfeit drugs Minimal
Critical Emerging Issues…
1. Pricing of drugs and generic substitution
2. Procurement of drugs
3. Monitoring and Rational Use of Drugs
3. Policy Options
• Overall strategy development
• Transparent and credible registration and listing process
• Optimizing the approach to pricing
• Efficient procurement processes
• Ensuring adequate funding
• Promoting the use of generics
• Ensuring drug quality
• Storage and distribution
• Rational use of drugs
Prioritizing the Next Steps…
Area
Jo
rdan
PA
Mo
rocco
Yem
en
Djib
ou
ti
Alg
eri
a
Iran
Leb
an
on
National Drug Policies M M M M M M M M
Drug Registration and
Reimbursement Listing
H H H H H H H H
Optimize Pricing H H H H H H H H
Public Procurement Processes M H H M H M M M
Funding for Public Procurement H H H H H H H H
Promoting Generics M M H M M M M M
Drug Quality H H H H H H H H
Storage and Distribution M M H H H M M M
Rational Use of Medicines M M M M M M M M
H=High priority; M=Medium priority
Points of Discussion…
1. How does MENA compare with other
emerging regions?
2. How can implementation of policies and
regulations be strengthened?
3. How can regional cooperation and
collaboration on pharmaceutical governance
be enhanced?
4. Other key issues…?