Pharmaceutical Sector Governance in the Middle East and North Africa Region A Regional Review by the World Bank

Transcription

1 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

2 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

3 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

4 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

5 A Framework for Pharmaceutical Governance Analysis 1. Registration and approval process 2. The public procurement process 3. Pricing policies 4. Rational use of drugs

6 Policies Framework area Committee Structure and Operation Essential Drug List Control and Testing Pricing and generics Public Procurement Monitoring and Rational Use of Medicines Framework Issue There is a suitable drug law There is a national drug policy The national drug policy is implemented 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 An essential drugs list is in place that guides purchasing, and it is adhered to The essential drugs list is based on evidence 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 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 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 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

7 International approaches to Pricing Reimbursement Procurement

8 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

9 Approaches to Reimbursement The listing process Determining the reimbursement prices Copayments Generic substitution

10 Approaches to Procurement Good pharmaceutical procurement Transparent process Risk management

11 Approaches to Procurement Pooled procurement Informed buying Coordinated informed buying Group contracting Central contracting and procurement

12 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

13 GOVERNANCE ISSUE/AREA MENA Status Findings Policies There is a suitable drug law There is a national medicines policy The national medicines policy is implemented 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

14 GOVERNANCE ISSUE/AREA Registration and listing processes and organization There is an adequate drug registration committee There is an adequate drug reimbursement listing committee MENA Status Findings 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. Conflict of interest processes are in place and operating

15 GOVERNANCE ISSUE/AREA MENA Status Findings Essential Drug List An essential drugs list is in place and adhered to In all countries, the lack of confidence by stakeholders in the drug list is undermining compliance with procurement and rational drug use The essential drugs list is based on evidence

16 GOVERNANCE ISSUE/AREA MENA Status Findings Control and Testing Regulations in place to control drug manufacture Compliance measures are effective Quality control laboratories are in place and effective There are concerns about Manufacture and distribution (Iran and Morocco), Testing facilities (Djibouti, Yemen, Iran), Inspections (all countries), and Counterfeit drugs (all countries)

17 GOVERNANCE ISSUE/AREA Pricing and generics An effective pricing policy is in place and adhered to There is an effective generic substitution policy Physician incentives are in place to promote generics Pharmacist incentives are in place to promote generics Consumer incentives are in place to promote generics MENA Status Findings 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

18 GOVERNANCE ISSUE Procurement Joint procurement is in place Procurement agencies are transparent and efficient Pharmaceuticals are procured by generic name Bioequivalence regulations in place There is sufficient funding available for essential drugs MENA Status Findings 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)

19 GOVERNANCE ISSUE MENA Status Comments Monitoring and Rational Use of Medicines Pharmaceutical data is gathered electronically A rational use of medicines unit is in effective operation Clinical guidelines are present, relevant and implemented Prescription-only drugs are not supplied without prescription Measures in place to control counterfeit drugs There are various efforts throughout the region to improve rational drug use Lack of electronic data and comprehensive rational drug use programs

20 Critical Emerging Issues 1. Pricing of drugs and generic substitution 2. Procurement of drugs 3. Monitoring and Rational Use of Drugs

21 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

22 Jordan PA Morocco Yemen Djibouti Algeria Iran Lebanon Prioritizing the Next Steps Area 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

23 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?