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…?