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Measuring transparency toimprove good governancein the public pharmaceutical sectorA comparative analysis of fivecountry assessment studies

Bolivia CambodiaIndonesiaMongoliaPapua New Guinea

WHO/PSM/PAR/2008.5

MEASURING TRANSPARENCY TO IMPROVE GOOD GOVERNANCE IN THE PUBLIC PHARMACEUTICAL

SECTOR

A COMPARATIVE ANALYSIS OF FIVE COUNTRY ASSESSMENT STUDIES

BOLIVIA

CAMBODIA INDONESIA MONGOLIA

PAPUA NEW GUINEA

© World Health Organization 2008 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e‐mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e‐mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

A comparative analysis of five country assessment studies

Contents ACKNOWLEDGEMENTS ............................................................................................................................... v ABBREVIATIONS.......................................................................................................................................... vii EXECUTIVE SUMMARY ................................................................................................................................ ix 1. INTRODUCTION.......................................................................................................................................... 1 2. OBJECTIVE OF THE STUDY...................................................................................................................... 3 3. METHODOLOGY ......................................................................................................................................... 5

3.1 DATA COLLECTION METHOD ........................................................................................................... 5 3.2 DATA ANALYSIS AND SCORING....................................................................................................... 6 3.3 NATIONAL ASSESSORS ........................................................................................................................ 7 3.4 CLEARANCE FROM THE MINISTRY OF HEALTH .......................................................................... 7

4. FINDINGS AND DISCUSSIONS .............................................................................................................. 9 4.1 GENERAL.................................................................................................................................................. 9 4.2 REGISTRATION..................................................................................................................................... 10 4.3 CONTROL OF DRUG PROMOTION .................................................................................................. 16 4.4 INSPECTIONS ........................................................................................................................................ 20 4.5 SELECTION ............................................................................................................................................ 24 4.6 PROCUREMENT.................................................................................................................................... 28

5. RECOMMENDATIONS FOR ACTION.................................................................................................. 37 5.1 GENERAL................................................................................................................................................ 37 5.2 INDICATOR‐BASED RECOMMENDATIONS.................................................................................. 38 5.3 COUNTRIES’ RECOMMENDATIONS ............................................................................................... 41 5.4 RECOMMENDATIONS FOR THE NEXT PHASES........................................................................... 45

6. CONCLUSION............................................................................................................................................. 47

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Measuring transparency to improve good governance in the public pharmaceutical sector

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Acknowledgements

This report is a synthesis of the results of five country studies carried out by WHO (WPRO, SEARO, and Headquarters) with the participation of Bolivia, Cambodia, Indonesia, Mongolia, and Papua New Guinea. WHO would like to thank the governments of these countries for their cooperation and assistance. The country assessment studies were conducted by the following national assessorsʹ teams recruited by WHO: Bolivia

- Dr Shiva Sharizadeh (Research Director) - Lic. Edwin Ramos Bustillo (Principal Assessor) - Dr Mabel Frías Carrasco (Principal Assessor) - Dr Vladimir Gallardo (Assistant Researcher) - Dr Miriam Rocha (Assistant Researcher) - Dr Eloy Anello (Adviser)

Cambodia

- Ms Marie‐Hélène Bouchard (Principal Assessor) - Mr Channa Chin (Data Collection)

Indonesia

- Dr Sri Suryawati (Principal Assessor) - Anita Lestari, Dra MS (Data Collection) - Rustamaji MD, MKes (Data Collection) - Bambang Saparyono, Drs, MPHM (Data Management) - Sri Hidayati, S. Ked (Data Management)

Mongolia

- Professor Tsetsegmaa Sanjjav (Principal Assessor) - Mrs D. Uranchimeg (Principal Assessor) - Associate Professor R. Tserenlkhagva (Survey Team Member) - Dr D. Enkhjargal (Survey Team Member) - Mr S. Munkhbat (Survey Team Member)

Papua New Guinea

- Dr Phillip G.K. Kigodi (Principal Assessor) - Ms Stella Pihau‐Tulo (Principal Assessor)

Dr Budiono Santoso and Ms Vanchinsuren Lkhagvadorj (WHO Regional Office for the Western Pacific (WPRO)) and Dr Krisantha Weerasuriya (WHO Regional Office for South‐East Asia (SEARO)) coordinated the contacts and follow‐up with countries. The assessment methodology used in the studies was developed by Dr Guitelle Baghdadi‐Sabeti (WHO/Department of Medicines Policy and Standards), Dr Jillian Cohen (Toronto University Faculty of Pharmacy) and Mr Eshetu Wondemagegnehu (WHO/Department of Technical Cooperation for Essential Drugs and Traditional Medicine).

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Dr Guitelle Baghdadi‐Sabeti (WHO) and Ms Carolina Belisario (Consultant), Dr Ma Lou Rebullida (Consultant) and Professor Abubak Majid (Consultant) conducted training with the teams of national assessors from Mongolia, Cambodia and Papua New Guinea respectively, before the assessment began. The Bolivian and Indonesian teams considered that the assessment instrument was complete and sufficiently clear to proceed without training, other than self‐study of the methodology before conducting the assessment. This synthesis report was prepared by Ms Marie‐Hélène Bouchard and Dr Guitelle Baghdadi‐Sabeti. The authors gratefully acknowledge the contributions of Professor Tsetsegmaa Sanjjav, Dr Phillip G.K. Kigodi, Dr Sri Suryawati and Dr Shiva Anello who reviewed and commented on the draft document. WHO is grateful to the Australian Agency for International Development (AusAID) and the UK Department for International Development (DFID) for their generous contribution to this project. The studies would not have been possible without these sources of financial support.

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Abbreviations

AusAID: Australian Agency Development COI: Conflict of interest DDF: Department of Drugs and Food (Cambodia) DFID: Department for International Development of the UK Government DILOS: Local Health Board (Bolivia) DINAMED: Office of Medicines and Health Technology (Bolivia) DPMD: Department of Pharmaceuticals and Medical Devices (Mongolia) EDB: Essential Drug Bureau (Cambodia) EML: Essential Medicines List GDP: Good Distribution Practices GMP: Good Manufacturing Practices KI: Key Informant MEF: Ministry of Economy and Finances (Cambodia) MIS: Management Information System MoH: Ministry of Health MoHS: Ministry of Health and Sports (Bolivia) MSB: Medical Supply Branch (PNG) NA: National assessor NADFC: National Agency for Drug and Food Control (Indonesia) NEML: National Essential Medicines List NGO: Nongovernmental organization PEAC: Pre‐qualification, Evaluation, and Awarding Committee (Cambodia) PNG: Papua New Guinea PSTB: Pharmaceuticals Supplies Tenders Board (PNG) PU: Procurement Unit (Cambodia) SEARO: WHO Regional Office for South‐East Asia SOPs: Standard Operating Procedures SPIA: State Professional Inspection Agency (Mongolia) SSMO: Senior Specialist Medical Officers (PNG) WHO: World Health Organization WPRO: WHO Regional Office for the Western Pacific

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Executive summary

Access to good quality essential medicines is still very limited in many parts of the world. Market failures, government inefficiencies, poverty, war and corruption are among the underlying causes of the problem. Corruption is gaining increasing attention and more people recognize the need for a transparent and accountable environment in order to have effective social, political and economic development. The pharmaceutical sector has been identified as one that is highly vulnerable to corruption and unethical practices. Recognizing this long‐standing problem, WHO initiated the Good Governance for Medicines (GGM) Programme, which offers a technical support package for tackling unethical issues in the public pharmaceutical sector. Initially, the countries implementing this project conduct an assessment measuring the transparency of national medicines regulatory agencies and public procurement systems. This is followed by a process of policy reform, promotion of good governance and the application of ethical principles. This report summarizes the findings of the transparency assessments carried out in the five countries that joined the GGM programme in 2006 ‐ Bolivia, Cambodia, Indonesia, Mongolia and Papua New Guinea. The level of transparency and the potential vulnerability to corruption are measured in five essential functions of the public pharmaceutical sector – registration, promotion, inspection, selection and procurement of medicines. In each country, two national assessors collected qualitative and quantitative data, conducting a series of interviews with carefully selected key informants (KIs).

General findings

Qualitative information revealed that although the five countries have different public pharmaceutical sector profiles, they have some common strengths and weaknesses, and face similar challenges to improve good governance in the public pharmaceutical sector. The information collected is converted, using a rough quantification method, into a zero to 10 scale which provides a score for each country and each function in terms of vulnerability to corruption (minimally to extremely). The scoring in no way indicates the level of possible existing corruption in the countries.

Registration

Most of the countries reported having a list of registered pharmaceutical products, procedures including a standard application form for submission of applications and a committee responsible for registration. However, not all the countries had publicly available written procedures for assessors on how to assess applications, nor publicly available documents describing the composition and the terms of reference of the registration committee. All committees appeared to follow consistent procedures in the decision‐making process but the committees’ processes were often not publicly available. The majority of the countries reported having no conflict of interest form for committee members.

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Not all countries reported having criteria for selecting the members of the registration committee but all mentioned that members are expected to have appropriate professional and technical qualifications. Not all countries had an appeals process for those whose application was rejected. No country had written guidelines on how and where medicine registration officers meet with applicants.

Promotion

All countries reported having a provision in the medicines legislation covering drug promotion and advertising but there was variation in the extent to which activities related to promotion of medicines were covered by the provision. Only two countries reported having a committee for monitoring and enforcing the provisions on drug promotion. Standard operating procedures (SOPs) guiding the committee on approval and monitoring of drug promotion were revealed to be incomplete. In addition, assessments showed that law enforcement was inadequate and inconsistent.

Inspection

Although inspection processes varied between countries, all reported having a comprehensive provision covering the inspection of pharmaceutical manufacturers and distributors. Unfortunately, most of the countries lacked classification on non‐compliance with GMP or GDP and the corresponding measures to be taken. All countries required that inspection findings and conclusions should be subject to an internal review but no country had a conflict of interest policy for inspectors. The assessment found different degrees of transparency for the five countries with regard to criteria for the recruitment of inspectors and on procedures for conducting inspections. Only one country reported having any written mechanism to prevent personal relations between an inspector and manufacturers or distributors that might provoke unethical behaviour. Two countries reported having some mechanisms which are unavailable in written format.

Selection

All countries reported having a national essential medicines list in line with WHO recommendations. Most of the countries have a committee responsible for the selection of essential medicines but the members are not required to fill in a conflict of interest form. Not all countries have written criteria for choosing members of the committee which reduces the transparency of the selection of the members. Criteria for the selection process for inclusion in or deletion from the list existed in some but not all countries. Finally, different levels of clarity and transparency were found in the SOPs and the decision‐making process for selection committee membership.

Procurement

All countries reported using written procedures for the procurement of pharmaceutical products, with the type of procurement method to be used chosen according to the value of

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medicines being purchased. All countries also used an objective quantification method to determine the quantity of products to be procured. Each country had a tender committee but none had an obligation to declare conflict of interests. Criteria for membership vary between countries, with some having criteria based on qualifications and others on ministerial position. Audit of procurement offices was conducted in all countries but the results were not publicly available. Only one country had a formally‐established appeals system for applicants whose bid had been rejected. In some of the others, applicants could write a letter but there was no formal guidance for doing this. In general, countries performed inspections of consignments but there were variations in their SOPs. The management information system to monitor the drug procurement process was an area that needed strengthening in all countries. Selective monitoring was performed to varying extents in the five countries but there was no efficient and integrated post‐tender system, and this weakness needed to be addressed.

Conclusions and recommendations

In order to improve good governance in the pharmaceutical sector, experience has shown the need for two basic strategies: a “discipline approach” based on the legislative and administrative reforms necessary to establish transparent and accountable systems; and a “values approach”, building institutional integrity through the promotion of moral values and ethical principles. The results of the transparency assessments will indicate to the five countries their strengths and weaknesses, enabling them to revise and adjust their existing laws, policies, administrative structures and processes in order to ensure transparency and accountability in the pharmaceutical sector. The assessments will also provide a platform for discussion at national level on developing a national Good Governance for Medicines Framework and for implementing a national programme promoting good governance in medicines regulation and supply. Such a national programme needs to include some basic components, such as codes of conduct, a whistle‐blowing protection mechanism, training of government officials and health professionals, and nomination of a working group for coordinating and managing programme implementation.

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1. Introduction

Promoting good governance and ethical practices in the public pharmaceutical sector has become an important priority of global and regional strategies for improving access to essential medicines, which is still very limited in many parts of the world. There are many causes of this problem, including market failures, government inefficiencies, poverty, war and corruption. The pharmaceutical sector has been identified as one which is highly vulnerable to corruption and unethical practices. Unethical practices, which can be defined as practices influenced by individual or collective interests to obtain personal benefits, can be found throughout the pharmaceutical chain, from the registration of pharmaceuticals to distribution and service delivery. Corruption in the health sector, perhaps the most vital of all, is gaining increasing attention. It is a worldwide problem but the effects can be more disastrous in lower‐income and transitional countries. Although it is very difficult to measure, experience has shown that corruption in this sector has a three‐fold impact:

1. A health impact — waste of public resources by purchasing expensive or non‐essential products reduces government capacity to provide access to good‐quality essential medicines. Equally, when purchasing agencies collude with suppliers and purchase poor‐quality products not only is public money wasted but also the health of consumers is adversely affected. Patients treated with poor‐quality medicines are not cured quickly ‐ they suffer for longer and in some cases they may even develop resistance to treatment.

2. An economic impact — when the budget of public sector procurement agencies is

wasted in purchasing expensive products instead of good‐quality versions of the same products at cheaper prices, or when funds are mismanaged, it means wasting national foreign exchange reserves as well as national currency. Such practices impact very negatively on national health budgets and contribute to shortages of medicines.

3. A government image and trust impact — inefficiency and lack of transparency reduce

the credibility of public institutions, and erode public and donor confidence in government capacity to deliver on promises.

There is an urgent need to make the use of resources transparent and optimal, especially those directed to health and in particular to medicines. Corruption is a complex problem and solutions to overcome it are not simple. Nevertheless, corruption is not inevitable or unavoidable; action can be taken to tackle it. In late 2004, WHO launched the Good Governance for Medicines programme, identifying transparency and good governance as essential conditions for development. This project had two main objectives: the first was to increase awareness of the potential for corruption and its impact on health system functioning, the second, to minimize such corruption by promoting and implementing good governance within the public

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pharmaceutical sector. The project highlighted that strong technical processes and policies need to be developed alongside ethical practices. The project is implemented through a three‐step process:

1. National assessment of transparency and vulnerability to corruption of national public pharmaceutical systems;

2. Development, through a consultative process, of a national Good Governance for

Medicines framework defining the basic components that need to be in place; 3. Implementation and promotion of the national programme by training national

officials on good governance principles in the public pharmaceutical sector. Bolivia, Cambodia, Indonesia, Mongolia and Papua New Guinea (PNG) joined the project in 2006 by conducting national transparency assessments. This report summarizes the findings and recommendations of the five countries. These findings were presented and discussed during the Second Bi‐regional Workshop on Promoting Ethical Practices in Medicine Registration and Procurement held in Manila, the Philippines, from 14‐16 June 2006. In 2005, Lao People’s Democratic Republic, Malaysia, the Philippines and Thailand, conducted a similar assessment. Their findings are published in another report.1 They are currently in the second or third phase of the programme.

1 Baghdadi‐Sabeti G, Wondemagegnehu E. Measuring transparency in medicines registration,

selection and procurement: Four country assessment studies. Geneva, World Health Organization, 2006.

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2. Objective of the study

The objective was to provide countries with a comprehensive picture of the level of transparency and potential vulnerability to corruption in five pharmaceutical sector functions:

1. registration of medicines 2. control of medicines promotion 3. inspection of establishments 4. selection of essential medicines 5. procurement of medicines

Before launching any intervention aimed at improving governance, the actual structures of the system should be carefully examined, particularly the mechanisms in place to prevent unethical practices and the extent to which their existence is known to public officials, people in the private sector and members of civil society. Findings could help to identify those aspects which are more vulnerable to unethical practices, and to determine what could be done to increase transparency. This report summarizes the findings of the transparency assessments carried out in the five countries that joined the project in 2006. Comparing five different countries is a challenge since each country has its own historical, political, social and economic context. Moreover, each country faces specific difficulties, for example, lack of human resources, restrictive budgets, recent war and internal conflicts or inexperience in the pharmaceutical sector. Specificities of countries should be taken into account when analysing such reports. Scores resulting from the assessment can lead to an informative evaluation of how the country performs against international standards of transparency as well as facilitating the monitoring of the country’s progress overtime. This comparative analysis should definitely not be seen as a country classification but rather as a tool to assess the strengths and weaknesses of each country. More than once, analysis has shown that countries are facing similar challenges and could benefit from the experiences of others. Countries started to share their respective experiences during the second annual workshop on promoting ethical practices in medicines, and it is in this spirit that the comparative analysis has been carried out. The project’s vision is that the transparency assessment is not an end in itself, but is rather the beginning of a process aimed at bringing long‐lasting changes in the efforts to promote good governance practices among health professionals in the public pharmaceutical sector. It is essential that in today’s circumstances the vulnerabilities of all five countries be identified and corrected because of the gravity of the potential impacts of corruption in the pharmaceutical sector.

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3. Methodology

The study focuses on five functions of the public pharmaceutical sector, namely registration of medicines, control of medicine promotion, inspection of establishments, selection of essential medicines, and procurement of medicines. The methodology used in this assessment provides qualitative information on structural indicators and a rough quantification of the level of vulnerability to corruption. The five countries under assessment used the second version of the data collection instrument (2006).1 Compared to the previous one (2005), two more regulatory functions, control of drug promotion and inspection, have been added. The assessment instrument is continually upgraded and refined in the light of experience gained in countries. In 2006, an external review was performed and finally in February 2008 an expert consultation was held to produce the latest version, dated March 2008, which is available on the WHO website.2 The revised assessment instrument has now been expanded to an additional three functions (distribution, licensing of establishments and control of clinical trials). This document will also continue to be regularly revised and improved in the light of country experiences and identified needs.

3.1 Data collection method

The assessment instrument used by these five countries contains five questionnaires, one for each function. An implicit gold standard model of policies, procedures and structures aimed at reducing vulnerability to corruption is indicated by the questionnaires themselves, all of which were put to the Key Informants (KIs )who were selected for their first‐hand knowledge of and/or involvement in the pharmaceutical sector. At least 10 KIs were interviewed for each function or group of functions, namely regulation (registration, promotion, and inspections), selection and procurement (Table 1).3

1 World Health Organization. Measuring transparency to improve good governance in the public

pharmaceutical sector. Draft assessment instrument. January 2006.

2 World Health Organization. Measuring transparency in the public pharmaceutical sector. Assessment instrument. Working document. March 2008.

3 The qualitative and quantitative values of PNG should be read with caution because PNG did not have the minimum number of 30 respondents specified in the study design. The number of people involved in making decisions related to pharmaceuticals is small in PNG.

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Table 1: Number of interviews for each function in the five country assessments

Regulation

Registration Promotion Inspection Selection Procurement

BOLIVIA 14 21 25 CAMBODIA 10 10 10 10 13 INDONESIA 10 10 10 10 20 MONGOLIA 15 4 3 11 11 PNG 7 7 6 6 9

KIs were carefully selected from the central level of government, public hospitals, the private sector (pharmacies, companies and manufacturers), professional associations, nongovernmental organizations (NGOs) and international organizations. For each function, the selection had to include both senior and junior professionals, and represent all the categories listed above. In each country, purposive selection of KIs was made after all the actors in the pharmaceutical sector had been identified, either by exhaustive desk research or after discussion with the government. Interviews were conducted after the KIs were assured that their answers would be kept confidential and would be anonymous. Special emphasis was given to explaining clearly that the questions were not designed to accuse any particular individual of unethical practices and that they did not reflect on the interviewees’ personal or professional conduct.

3.2 Data analysis and scoring

Four methods are used to determine the level of transparency.1 In order to minimize subjective interpretation of KIsʹ responses, the first category of indicators requires a binary answer (yes/no). The second method includes a series of sub‐questions or criteria that also require a binary answer. For these two categories of questions, a “yes” is given a value of one (1) and a “no” is given a value of zero (0). A value of one represents low vulnerability to corruption. A rating of zero represents potential vulnerability to corruption since the absence of a standardized process or decision criteria provides decision‐makers with broad discretion in their decision‐making. Information collected is validated with existing evidence within the country. Even though KIs indicated that documents exist in the country, assessors were sometimes unable to access them. In those cases, documents were classified as non‐existent because it showed a lack of transparency in some procedures. Once all the interviews were completed and all indicators rated according to the criteria, an average score was calculated for each function and converted to a zero to 10 (0.0 to 10.0) scale to represent different degrees of vulnerability to corruption (Table 2). It should be noted that looking at countries’ scores without a careful reading of the qualitative information can be misleading.

1 For more details and the exact quantification method used, see assessment instrument.

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Table 2: Ten-point rating scale

Extremely vulnerable Very vulnerable

Moderately vulnerable

Marginally vulnerable

Minimally vulnerable

0.0 – 2.0 2.1 – 4.0 4.1 – 6.0 6.1 – 8.0 8.1 – 10.0 The third method involves subjective questions that probe the perceptions of the KIs. KIs were asked whether they strongly agreed, agreed, were undecided, disagreed, or strongly disagreed with a number of statements. Basic frequencies have been used to present the results. Finally, the fourth method uses open questions, and gives the opportunity to KIs to provide additional input on the function in general.1

3.3 National assessors

Two national assessors (NAs) were selected for and from each country to undertake the assessment. Due to the scarcity of available independent researchers, the Cambodian assessment was conducted by only one NA and a research assistant. To ensure an objective interpretation of the results, NAs were chosen from independent groups outside the Ministry of Health (MoH). Given that the subject under review had the potential to raise sensitivities in some countries, it was essential for the credibility of the results that the assessments be conducted by senior professionals from well‐recognized and trusted organizations in the country. The national assessor teams from Cambodia, Mongolia and PNG were introduced to the WHO assessment methodology during local training by a WHO consultant before conducting the assessment. National assessor teams from Bolivia and Indonesia self‐studied the methodology provided by WHO before doing the assessment.

3.4 Clearance from the Ministry of Health

Before starting the assessment and organizing meetings with KIs, senior level officials in the MoH were briefed. Clearance from the MoH and strong political commitment were crucial to ensure smooth progression of the project and its continuity after the first phase of the project (assessment). Each country obtained clear support from the MoH by way of an official letter from the institution. This letter sanctioned the interview process and encouraged officials to participate in interviews.

1 The last two methods were not included in the previous version of the assessment.

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4. Findings and discussions

The overall scores for each country and each function are summarized in Table 3.

Table 3: Overall survey summary scores of vulnerability for the functions assessed

SCORES FUNCTIONS

Bolivia Cambodia Indonesia Mongolia PNG

Registration 8.6 Minimally

5.1 Moderately

7.2 Marginally

6.2 Marginally

4.3 Moderately

Promotion 4.7 Moderately

5.1 Moderately

7.6 Marginally

4.4 Moderately

1.7 Extremely

Inspection 6.2 Marginally

5.0 Moderately

8.7 Minimally

7.8 Marginally

2.6 Very

Selection 7.6 Marginally

6.2 Marginally

5.5 Moderately

5.9 Moderately

4.5 Moderately

Procurement 6.2 Marginally

5.4 Moderately

7.0 Marginally

6.2 Marginally

6.6 Marginally

4.1 General

Even though Bolivia, Cambodia, Indonesia, Mongolia and Papua New Guinea (PNG) have different regulation, selection and procurement profiles, the findings show common strengths and weaknesses in all five countries. Among the common strengths is the existence of a list of registered products and a national list of essential medicines. Most of the countries have committees for registration, selection of medicines and procurement. Countries also have provisions in their medicines legislation to cover the control of drug promotion and inspections. In addition, countries reported having SOPs for public procurement and for applicants who want to register their drugs in the country. One common weakness in most systems is the lack of a declaration of conflict of interest policy. In general, the public does not have equal access to information; thus most KIs outside the MoHs were not aware of the procedures in place. It is important to note that this scoring indicates vulnerability to corruption, given the policy, regulatory and administrative procedures in place at the time of the survey. The assessment provides a baseline estimate for self‐evaluation of the country. In all countries much has been done and others are currently in process so it means that if the assessment was repeated, the scores could be higher. The scoring system is meant to help countries monitor progress in their efforts to improve transparency and good governance practices in the public pharmaceutical sector over time. It does not imply in any way that one country’s system is more corrupt than another.

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Higher scores are associated with clearer regulations, transparent committees, monitoring of practices, more official documents, written procedures and written decision‐making processes. Therefore, the findings will be presented in such a way as to evaluate each of these criteria to achieve system transparency. A general statement will accompany each indicator and specific comments on an individual country will be added as required. In each section, the strengths and weaknesses will be highlighted and will be used as the framework for the recommendations section. This report can be complemented with the section “Comments on Each Indicator” in the WHO assessment instrument.1

4.2 Registration

Registration of pharmaceutical products is the responsibility of a regulatory agency, for which the MoH is responsible. The names given to these regulatory agencies differ between countries as summarized in Table 4 below.

Table 4: National medicine regulatory authorities

Bolivia Ministry of Health and Sports (MoHS) Office of Medicines and Health Technology (DINAMED)

Cambodia Ministry of Health (MoH) Department of Drugs and Food (DDF)

Indonesia Ministry of Health (MoH) National Agency for Drug and Food Control (NADFC)

Mongolia Ministry of Health (MoH) Department of Pharmaceutical and Medical Devices (DPMD)

PNG National Department of Health (DOH) Medical Supply Branch (MSB)

General trends The scores for registration indicate different degrees of vulnerability in the five countries, ranging from moderate to minimal vulnerability. However, the assessment revealed general trends in the countries registering their medicines (Bolivia, Cambodia, Indonesia and Mongolia). All countries have an up‐to‐date list of registered medicines, written procedures for applicants on how to submit an application for registration with a standard application form, and a formal committee responsible for assessing these applications. In order to increase transparency, a policy on conflict of interests, written guidance for the committee’s decision‐making process and written procedures for the assessors on how to evaluate applications submitted for registration could be developed and made publicly available.

1 World Health Organization, 2006. Measuring transparency to improve good governance in the

public pharmaceutical sector. Draft assessment instrument. Departments of Medicines Policy and Standards and Ethics, Trade, Human Rights and Health Law, Geneva.

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Box 1: Country specification – Papua New Guinea

At the time of report writing, PNG has not started registering its medicines. An intention notice to

register medicines was issued to all drug importers and distributors in 2005 calling on them to provide information about medicines they handle. An application form and guidelines for

registration of pharmaceutical products were then issued.

Official Documents • A list of all registered pharmaceutical products (indicator 1) with a minimum level of

information (indicator 2) exists in all countries except PNG. Each list contains most of the information suggested by WHO in order to ensure effective medicines regulation (description of the product; the name, country of manufacture and site of the manufacturer; the date of the registration; validity of the registration; and whether the medicine is prescription only or can be bought over‐the‐counter).

- In addition to the printed form that is available, Bolivia (www.sns.gov.bo), Indonesia

(www.bpom.go.id) and Mongolia (http://moh.mn) have made their respective list of registered products available through the government’s web site. Access to Cambodiaʹs list must be purchased at DDF.

Box 2: Country specification – Cambodia

The Registration Bureau is responsible for registering all drugs coming into the country. All

medicines available and used in the private sector must be registered. At the time of report writing, there is no requirement for drugs procured through the public sector to be registered.

A notice on this matter was issued in December 2005 by the MoH inviting companies to register the products destined to be purchased through the public procurement process.

• A standard application form for the submission of applications for registration is publicly and

readily available in government offices in all countries (indicator 5). All countries reported that their forms require a certain level of information as a minimum, such as the name of the product, summary of product characteristics (pharmacological action, therapeutic classification) and the packaging material. In PNG, the application form has been prepared but is not currently used.

Procedures • Each country reported having written procedures for applicants on how to submit an

application for registration of medical products (indicator 3) describing the process to follow and fees required. PNG has procedures but they are not implemented.

• Apart from Indonesia, no country reported having any procedures for assessors on how to

assess the applications submitted for registration (indicator 4) available to the public. Procedures are confidential, intended for internal use only. Consequently, a considerable proportion of KIs were not aware of similar written procedures. - In Indonesia, the existing guidelines cover hypertension drugs and antibiotics.

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http://www.sns.gov.bo/

http://www.bpom.go.id/

http://moh.mn/


- In Cambodia, evaluators are working with checklists to assess applications. The Registration Bureau and the international consultant working there have developed complete guidance for evaluators on how to assess applications submitted for registration. This manual was completed in 2006 but was not being used at the time of writing this report.

- In PNG, procedures have been developed but are not implemented. However, the procedures do not provide details of the issues to be considered in assessing submissions and do not provide guidance on report writing.

• No country has guidelines setting limits on how and where medicine registration officers should

meet with applicants (indicator 6). • If applicants have their drug application rejected and feel that they were unfairly

evaluated, Bolivia, Indonesia and Mongolia have a formal appeals system (indicator 13). It is reported that the appeals system in Indonesia is functioning well.

Committee and criteria for membership

Box 3: Country specification – Papua New Guinea

Since there is no committee for registration, PNG’s answers will not be included in the analysis of

the next four indicators. No committee has been formed as part of the preparation to register medicines; this task is planned to be done by senior pharmacists at the Medical Supply Branch

(MSB).

• All countries have a formally established and operational committee responsible for registration

of pharmaceutical products (indicator 7). A summary description is included in Table 5.

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Table 5: Summary description of committees responsible for registration

Country Description of the committee Functions

Bolivia National Pharmacological Commission

- Advise the MoHS on technical and scientific issues

- Evaluation and registration - Surveillance and control - Quality control

Cambodia Registration Committee Three sub‐committees ‐ Pharmaceutical ‐ Quality ‐ Clinical

- Make the final decision on registration - Sub‐committees assist the committee

with technical questions

Indonesia National Committee for Evaluation of Medicinal Products Three Evaluation Committees ‐ Efficacy and Safety ‐ Quality ‐ Labelling

Mongolia Drug Council Three sub‐committees ‐ Pharmaceutical ‐ Pharmacological ‐ Bio‐preparation

- Make the final decision based on results of evaluation and tests presented by officers from the National Center for Health Development

• There are variations in the criteria for selecting the members of the registration committee

(indicator 8) between the four countries.

- Bolivia has written criteria covering all important information. Each institution (government, association, universities) represented in the Commission must designate members who are closely linked to the tasks that the organization will carry out. KIs reported that the principles of regular rotation of board members and selection based on professional merit have not always been respected.

- Mongolia reported that criteria were incomplete and not always applied. - In Cambodia, members are expected to have appropriate professional and technical

qualifications. However, there are no written criteria for the selection of committee members.

- In Indonesia, members are selected based on technical and professional qualifications

and integrity but so far, no written criteria are publicly available.

• A written document that describes the composition of the committee (indicator 9) exists in all countries but the assessment demonstrated that it was incomplete and not publicly available. Documents are not always clear in regards to description of the roles, responsibilities and accountability of the committee members. Information concerning

13


the required professional qualifications, technical skills and work experience for committee members is not always included in the document.

• Except for Indonesia, no country has a conflict of interest (COI) form that members of the

committee and public officials are obliged to complete (indicator 10). Decision making‐process • Each registration committee appears to follow consistent procedures in the decision‐

making process (indicator 12). However, the indicator scores low in all four countries.

- In Mongolia, there are written procedures (Medicines Registration Procedures) but many KIs were unclear as to whether these are publicly available or not.

- Indonesia has no written procedures for the decision‐making process in general but

has written procedures covering the decision making‐process related to several categories of drugs (e.g. antihypertensives, antibiotics).

- The information on the process is not in written format in Cambodia and is not

publicly available in Bolivia. - All regulatory authorities produced an official written document to support their

decisions but this document is not publicly available.

KIs’ perceptions Graph 1: KIsʹ responses on whether members of the registration committee are systematically selected based on the written criteria existing in their country (indicator 11).

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8

StronglyDisagree

Disagree Undecided Agree Strongly Agree

Don't know

Not Applicable

BoliviaCambodiaIndonesiaMongoliaPapua New Guinea

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StronglyDisagree


Don't know

Not Applicable



14


• The majority of KIs in Bolivia agreed that members of the registration committee were selected systematically, based on written criteria while it was the contrary in Mongolia. Many KIs in Cambodia and PNG selected the “Not Applicable” option since they had answered that there were no criteria to select members of the registration committee in indicator 8.

Graph 2: KIʹs responses on whether gifts and other benefits given to the officials in charge of medicine registration have no influence at all on the final decision (indicator 14).

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8

StronglyDisagree


Don't know

Not Applicable


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StronglyDisagree


Don't know

Not Applicable



• Among all KIs (n=49), the majority (57%) thought that gifts and other benefits given to the officials in charge of medicine registration influence the final decision. Answers from PNG were not computed in these results.

• Unethical behaviour in the registration system (indicator 15) was reported in all five

countries. With no difference between countries, the most emphasized aspects were bribes, gifts, meals, favouritism, discrimination, conflict of interest, political and/or personal pressure.

Although most of the countries have requirements for registration, irregularities have been mentioned in almost all assessment reports in regard to the registration of drugs. Unregistered, unapproved and sub‐standard medicines can be found on the market. In addition, existing rules and regulations are not always strictly imposed.

15


4.3 Control of drug promotion

General trends Even though major variations were found in the countries’ scores for the control of medicine promotion, general trends between countries can be outlined. All countries have a provision in the medicines legislation covering drug promotion and advertising but only two countries reported having a committee for monitoring promotion and having sanctions for violations, although they admitted that law enforcement is weak. Therefore, monitoring drug promotion and enforcing legal provisions need to be addressed in all countries. Regulations • All countries reported having a provision in their medicines legislation covering drug

promotion and advertising (indicator 17). None of the countries authorizes direct‐to‐consumer promotion of prescription medicines. However, there are some variations in the activities covered by the provision on drug promotion and advertising (indicator 19). In order to achieve good control of drug promotion, the provision should cover all types of activities such as advertisements to the public and health professionals, medical representatives, free samples, symposia and scientific meetings, post‐marketing scientific studies, packaging, labelling, package inserts, and gift‐giving.

- Indonesia reported that the provision is complete and covers all promotional

activities. - The provision in Mongolia covers the majority of activities except post‐marketing

scientific studies and symposia or scientific meetings. Mongolia’s MoH has also established ethical norms for the promotion of medicines in the country (2005).

- In Bolivia, Cambodia and PNG, provisions provide only minimal direction for the control of drug promotion. PNG’s provisions mention only the restriction on advertising of prescription medicines.

• There are variations between countries regarding the enforcement mechanism for controlling

promotion of medicines foreseen in the provision (indicator 20). No country reports having formal written procedures to report or lodge complaints on unethical practices in drug promotion.

- Bolivia, Cambodia, Indonesia and Mongolia require by law pre‐approval of advertising

materials before they are made public but evidence from KIs suggested that this does not always happen in practice. In Bolivia, it was mentioned that most advertising materials go directly to the media without any official approval being given.

- Cambodia and Indonesia are the only countries which reported having sanctions for

violating the provision but law enforcement is inadequate and inconsistent.

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Committee and criteria for membership • Half of the countries did not report having a service or committee for monitoring and

enforcing the provisions on drug promotion (indicator 21). Cambodia and Indonesia are the only countries with formally established committees composed of professionals with technical skills.

- A public document including the terms of reference is only available in Indonesia.

- Meetings are held as needed in Cambodia and on a regular basis in Indonesia.

Meeting decisions are not made public in either of the two countries.

Decision making‐process • Standard Operating Procedures for pre‐approving or monitoring drug promotion and advertising

(indicator 22) are not in place in all countries.

- Committees in Cambodia and Indonesia check that information complies with indications that were approved for drug registration.

- Indonesia reported having publicly available SOP, while Cambodia reported having

no written guidance for the evaluation. Balance of information for health professionals The assessment tool contains two questions regarding the impact of pharmaceutical companies on the clinical practice of countries’ health professionals. The first one looks at the balance between registered sales representatives and number of physicians (indicator 26); the second one looks at the balance between the promotional information provided by pharmaceutical companies and independent information to which physicians are exposed (indicator 27). Even though these indicators are pertinent to this assessment, no country was able to provide information on them due to a lack of information on the registration of health professionals and medical promoters. In addition, no company provided information on the amount of money spent on drug promotion.

17


KIs’ perceptions Graph 3: The legal provisions on drug promotion were prepared in broad consultation with all interested parties (indicator 18).

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StronglyDisagree


Don't know

Not Applicable


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Don't know

Not Applicable



• In Mongolia, most KIs did not think that there was enough consultation with all interested parties during the development process of the current legislation. In Cambodia, 60% of KIs did not know how the provision was developed. The majority of KIs from Bolivia, Indonesia and PNG agreed or strongly agreed with the statement. The reasons for this differed between Indonesia and PNG.

- In Indonesia, provision was prepared with government, representatives from

manufacturers, health professionals, consumersʹ organization, pharmacologists, psychologists, journalists from print media and representatives from advertising agencies.

- In PNG, enactment of the Medicines and Cosmetics Act has followed the normal

procedure of having the bill published for comments followed by debate in parliament.

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Graph 4: Civil society and nongovernmental organizations are very much involved in reviewing, evaluating and monitoring the promotion of medicines (indicator 23).

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StronglyDisagree

Disagree Undecided Agree StronglyAgree

Don't know NotApplicable


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StronglyDisagree



StronglyDisagree





• Except for Indonesia, countries do not seem to have organizations outside the MoH involved in monitoring promotional activities and in promoting integrity in the marketing practices of the pharmaceutical industry. PNG’s assessment mentioned that the promotion of medicines is limited in the country, which reduces the importance of active reviewing, assessing and monitoring by government or civil society.

Graph 5: The provisions on the promotion of medicines are much respected in the country (indicator°24).

19

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12

StronglyDisagree


Don't know

Not Applicable


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StronglyDisagree


Don't know

Not Applicable




• This indicator showed that the majority of interviewees felt that the provisions on the promotion of medicines were not respected in their country. It should be restated that only Cambodia and Indonesia reported having a mechanism to enforce sanctions for violating their provisions (indicator 20). In Indonesia, industry respondents were positive that the control of promotion was well respected while government respondents expressed their worries that the regulation was not well‐respected by industry.

• The majority of people interviewed in all five countries admitted that there is some

unethical behaviour in the control of promotion of drugs (indicator 25). The most frequently mentioned practices were: distorted or exaggerated information on medicines or promotion made without scientific evidence, illegal promotion of prescription‐only medicines, gifts or bribes to health professionals and illegal discounts on the total value of purchase.

4.4 Inspections

General trends The countries’ scores on inspection differed, indicating various degrees of vulnerability to corruption. But again, the assessment revealed general trends in this area. All countries have a comprehensive provision covering inspections, and inspectors are required to produce inspection reports that are subject to an internal review. In order to increase transparency, a policy to avoid any conflict of interest with regards to inspection activities could be developed in all five countries. Regulations • Although inspection processes varied between countries, all reported that they have a

comprehensive provision in their pharmaceutical legislation covering inspection of medicines manufacturers and distributors (indicators 29 and 30). The provision was recognized by the majority of KIs.

- KIs from Cambodia reported that, even though the provision is there, the powers of

inspectors and the MoH are limited and that law enforcement is weak.

Box 4: Country specification – Mongolia

The State Professional Inspection Agency (SPIA) is responsible for the enforcement of the medicine regulations in the entire country. It also contracts all types of inspections as well as post-marketing surveillance of medicine quality through random sampling. Inspectors are government officers and have to pass the government Agency exam before being selected. Inspectors perform independent

inspections which are not under the instruction of the MoH. SPIA advises the Special Licensing Committee, in the MoH, on whether applicants and premises should be licensed to engage in

medicine-related activities.

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Criteria for inspectors • Even though countries have similar professional and technical requirements for the

recruitment of inspectors, criteria for the selection (indicator 36) were found to have different levels of transparency.

- In Indonesia, the indicator received the maximum score indicating that the written

criteria include requirements related to professional qualification, work experience, recommendation and examinations.

- Other countries reported that the existing written criteria for selection and

recruitment of inspectors are either not complete (Mongolia and Bolivia) or non‐existent (Cambodia and PNG).

• Management of conflict of interest with regard to inspection activities is a common weakness in

the five countries (indicator 33). - In Cambodia, government officials are commonly involved in private sector business

to supplement their low public sector salary (around US$30 per month). Inspectors are allowed to own pharmacies or to be linked to a pharmaceutical company but they cannot inspect their own facility

- In Indonesia, some KIs mentioned that there is an “Inspector’s Oath” which is well

established and has strong legal value. All inspectors have to sign this formally when they are recruited.

Procedures • Countries reported that they have different versions of procedures for inspectors on how to

conduct inspections with different levels of transparency (indicator 35). A comparative analysis of written procedures is presented in Table 6.

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Table 6: Comparative analysis of written procedures for inspection


Contains inspection checklist Yes Yes1 Yes Yes No

Details requirements for pre‐inspection activities

Yes No Yes Yes No

Details requirements for post‐inspection activities

Yes No Yes Yes No

Includes a schedule identifying companies due for inspections

Yes Yes Yes Yes No

Details format and content of inspection reports

Yes Yes Yes Yes No

• All countries reported having inspection findings and conclusions subject to an internal review

(indicator 34). The inspection report needs to be reviewed by the head of the inspectorate and findings have to be discussed with the manager of the establishment being inspected.

• Having written procedures or mechanisms to prevent personal relations between an inspector and

the manufacturers or distributors (indicator 32) that may provoke unethical behaviours is not a common practice for the majority of the five countries. However, even though they are not available in writing, some countries have mechanisms to prevent this situation, as summarized in Table 7.

Table 7: Mechanisms to prevent personal relations that may provoke unethical behaviours


Procedures available in writing No No Yes Yes No

Rotation of inspectors based on a scheduling system No No Yes Yes No

Inspections in teams with a team leader No Yes Yes Yes No

Peer review (from other inspectors in the team) No Yes Yes Yes No

Rotation mechanism from one city to another city No No Yes No No

External audit of the inspections (from another country)

No No Yes No No

1 The schedule is prepared on a quarterly basis. Premises should be inspected every 3 months but

this is not strictly respected (human resource and financial limitations).

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• Most of the countries do not have written guidelines on classification of non‐compliance with Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP) and the corresponding measures to be taken (indicator 31).

- Indonesia and Bolivia provided evidence on classification of non‐compliance with

GMP/GDP. However, KIs from Bolivia reported that regulations were not applied at the time of the survey.

- In the other countries, there is either no GMP/GDP code (PNG and Cambodia) or no

specifications of the measures to be taken in case of non‐compliance with the existing code (Mongolia). At the time of writing, a draft version of a GMP code was available in Cambodia but it was not yet formalized and implemented.

• Bolivia, Cambodia and PNG do not have an official appeals mechanism for companies being

inspected (sub‐indicator 31). Indonesia and Mongolia have an appeals system but it is not independent of the body making the original decision.

KIs’ perceptions Graph 6: The integrity of inspectors is not at all influenced by personal gains such as bribes, gifts, materials or other benefits, etc. (indicator 37).

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StronglyDisagree


Don't know

Not Applicable


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Not Applicable



• In Bolivia, Cambodia, and Mongolia answers from KIs indicate that bribery and material gifts do influence the results of inspections. This is confirmed by qualitative answers on unethical practices.

• The majority of people interviewed in all countries admitted that there is unethical

behaviour in the inspection area (indicator 38). Unethical behaviour was not limited to one

23


country. The most emphasized aspects were: facility to bribe inspectors (gifts, money), conflict of interest, political influences, external pressure and weak law enforcement.

4.5 Selection

General trends The countries’ scores indicated either marginal or moderate vulnerability in the area of selection of medicines, and revealed general trends in the five countries. All countries have an official national essential medicines list in line with WHO procedures. Most of the countries have a formally established committee responsible for the selection of medicines. However, countries were found to be lacking in publicly available standard operating procedures to describe the roles and the responsibilities of the members, and to guide the decision‐making process. In order to increase transparency, a conflict of interest policy for members of this committee could be developed. Official documents • In all countries, a national essential medicines list exists and KIs were aware of this

(indicator 40). In Mongolia, it is incorporated in a more comprehensive document which outlines the conditions under which the medicines are to be provided, while in the other countries it is a simple list. The terminology used to refer to the national EMLs is given in Table 8.

Table 8: Terminology used by countries to refer to their national essential medicines list

Country Name of the document Last revision Bolivia National List of Essentials Medicines (NLEM) 2005 (written)

2006 (online) Cambodia Cambodia’s Essential Medicine List (EML) 2006 Indonesia Daftar Obat Esensial Nasional

National Essential Medicine List (NEML) 2005

Mongolia National Essential Medicine List (NEML) 2005 PNG Medical and Dental Catalogue (MDC) 2002

• Each country’s EML is generally in line with World Health Organization procedures (indicator

43). All countries reported that it was published and accessible. Each list is organized according to generic names, is linked to national standard treatment guidelines, and has been revised within the past three years. Some variations between countries were noted in terms of disseminating the list.

1. The list is widely distributed in Bolivia, Cambodia, Indonesia and Mongolia but this was not the case in PNG.

• The criteria for the selection process for including or deleting medicines from the EML were

found to be clear but not always in written format (indicator 42).

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2. Bolivia and Mongolia reported that they have written documents with selection criteria. Mongolia uses the WHO Model List for inclusion and exclusion of medicines in its National Formulary but cases were reported where WHO recommendations were given too much importance and the actual country conditions were ignored.

3. In Cambodia, answers showed that committee members follow the same criteria

to include or delete medicines from the EML but these criteria are not in written format.

4. In PNG, there are no written criteria. Selection of the National EML is performed

as one of the routine duties of Senior Specialist Medical Officers (SSMOs) coordinated by the staff in MSB. It is unclear if the SSMOs are required to submit their views after consulting with colleagues.

Committee and criteria for membership • There is a committee responsible for selection of the national EML in all countries (indicator

44) except PNG. The name of the committee varies from one country to another.

- In Bolivia, the decision on selection is made by the National Pharmacological Commission. In addition, hospitals providing second and third level of care1 have a Pharmacy and Therapeutic Committee and Multidisciplinary Team that are involved in the selection of essentials medicines

- In Cambodia, the National Committee on Essential Medicines is composed of

members appointed by the Chair and the Vice‐Chair of the committee and approved by the Minister of Health.

- In Mongolia, a primary selection is done in hospitals (Councils of Medical Cures and

Drug Therapeutic Committee). Suggestions and recommendations from all committees are sent to the Drug Council whose decisions should be approved by the Under‐Minister’s Council.

Since there is no selection committee in PNG, this country is not included in the analysis of the next indicators.

• All countries require that the selection committee be made up of professionals and

experts from different fields with clinical experience. However, the transparency of criteria for the selection of members of the selection committee varies between countries (indicator 46).

- Criteria for the selection of members were reported to be clear and publicly available

in Bolivia while this is not the case in Cambodia and Indonesia. There are no written

1 Health establishments are classified into three levels of care in Bolivia. The second level represents

the basic hospitals and the third level, the general and specialized hospitals.

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criteria to select members in Mongolia but they are chosen based on their clinical working experiences and professional knowledge.

- Except for Bolivia, membership is not time‐limited in any of the countries; therefore

the rotation of members is not assured. In Bolivia, members should rotate every two years.

• Declaration of interest is an area which requires strengthening in the five countries

(indicator 47). Decision‐making process • Different levels of clarity and transparency were found in the standard operating procedures

that describe the role and responsibilities of the selection committee (indicator 48) and the decision‐making processes included in the SOP (indicator 49). A comparative analysis is presented in Table 9.

Table 9: Comparative analysis of the clarity and transparency of the decision-making process in the selection committee1

Bolivia Cambodia Indonesia Mongolia

Public SOP describing the rules for decision‐ making process

Yes No No No

Decisions are made by all members in a democratic manner

Yes Yes Yes Yes

Decision‐making requires consultation with interested parties

Yes Yes Yes Yes

Final decision for selection process are done independently No Yes In general Yes

Decisions on selection process are publicly available

No No Yes2 In general

Decisions are disseminated widely No No No No

- There are standard rules for the decision‐making process in Cambodia, Indonesia and

Mongolia but there is no written document. - In Cambodia and Indonesia, decisions are made once an agreement is reached among

all members but there is no vote. - In general, decisions on the selection process are not made publicly available. KIs

from Cambodia and Indonesia noted that decisions can be indirectly accessed via the EML. In that sense, only decisions regarding the addition or the deletion of medicines are publicly available.

1 This indicator received no response from PNG since there is no rule in regards to this issue.

2 For members of the health community only.

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KIs’ Perceptions Graph 7: The national essential medicines list has been prepared in consultation with, and taking into account, the opinion of all the interested parties (indicator 41).

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StronglyDisagree


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StronglyDisagree


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Not Applicable



• Regardless of the country, a large proportion of KIs were in agreement or very much in agreement with the statement. Bolivia is the exception with a wider range of answers.

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Graph 8: The committee in charge of the selection of the EML is operating free from external influences (indicator 45).

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• KIs from Cambodia, Indonesia, Mongolia and PNG were, on the whole, in agreement or strongly in agreement with the statement but it should be noted that there is no formal committee in PNG

In Bolivia, precisely the same number of KIs figured on each side of the scale and a considerable proportion preferred not to answer or showed that they were undecided. KIs reported that the selection of essential medicines is at times subjected to different types of pressures – business, political, social, market or others.

• Interviews in each country revealed that there is unethical behaviour in the selection process

(indicator 50). The most frequently mentioned practices were: bribes, favouritism, traffic of influences, conflict of interests and external influences (directly or indirectly from pharmaceutical companies).

4.6 Procurement

General trends In the majority of the countries, the scores on procurement of medicines indicate a marginal vulnerability to corruption. All countries reported having written documentation on the procedures for procurement with guidance on the type of procurement method that needs to be used. All countries were found to have a tender committee. Quantification of needs is done using an objective method in all countries.

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However, some areas need to be addressed in the five countries in order to increase transparency; for example, a conflict of interest policy for members of the tender committee needs to be implemented; the management information system and the post‐tender system in place need to be strengthened in the five countries to assure efficient monitoring of the process and the suppliers’ performances; and finally, the results of the audit of procurement offices need to be made available to the public.

Box 6: Country specification – Cambodia

This research focused on the procurement process using the national budget which is undertaken by the Procurement Unit (PU) of the MoH. Two others bodies are in charge of assessing the needs and

the procurement of drugs for the public sector but will not be discussed in the assessment: these are the Secretariat of the Principle Recipient (PR) for Global Funds (GF) and the Health Sector

Support Project (HSSP) for groups of donors.

Box 7: Country specification – Indonesia

Currently responsibility for the national buffer stock, social security for the poor and drug

procurement for vertical programmes is at national level. As it accounts for the largest proportion of procurement in terms of value compared with the other two aspects and also because of its nationwide distribution, the procurement of the national buffer stock was selected for this

assessment.

Procedures • All countries reported having regulations and written procedures for the procurement of

pharmaceuticals (indicator 52) which were supposed to be publicly available but were not always easily accessible. In current practice, there is no requirement that information related to the tender process and results be made public, except in Indonesia, where results are published on an announcements board. Details are provided in Table 10. - In Indonesia, the criteria used for adjudication of tender are quality and price. In

addition to these two criteria, Bolivia uses accessibility and opportunity. - Cambodia’s study found that the MoH and the Ministry of Economy and Finances

(MEF) work with different criteria, one focusing on high quality medicines and the other on prices.

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Table 10: Comparative analysis of transparency in procurement procedures


Written procedures Yes Yes Yes Yes Yes

Publicly available No Yes1 Yes Yes Not clear

Describe internal procedures for processing the bids

Yes Yes Yes Yes Yes

Use of generic names Yes Yes Yes Yes Yes

Based on the NEML Yes Yes Yes2 Yes Yes

Advertisement of tenders Yes Yes Yes Yes Yes

Contract specifications are publicly available

Yes Should be purchased

Yes Yes Should be purchased

Criteria for adjudication of tender are included in tender package

Yes Yes Yes Yes No

Contract awards are made by the tender committee

No Yes Yes Yes Yes

Information on tender process and results are made public

Yes No Yes Yes No

• Countries reported the employment of written guidance on the procurement method to be

used (indicator 53). All countries reported that the procurement method is based on the value of drugs being purchased: methods can be direct procurement (minor purchases), public invitation, open tender (domestic or international) or exceptional contract. Further, Cambodia and PNG clearly differentiated between the methods of procurement to be used, according to the value of the contract.

• Each country uses an objective quantification method to determine the quantity of

pharmaceuticals to be purchased (indicator 54). Different levels of the system (local, provincial, national) are involved in the quantification of needs. All countries determine the quantity based on past consumption data. In addition to this, Indonesia and PNG based their estimates on epidemiological data and predictions on population and disease patterns.

- However, PNG’s report mentioned that the accuracy of the quantification procedure

is limited by the accuracy of the inputs. In particular, the precision and thoroughness of disease pattern mapping and medicines consumption data are uncertain, which may lead to shortages or overstocking.

1 KIs answered that it was publicly available but NAs were not able to obtain the document.

2 Some KIs mentioned that, in general, procurement was based on the EML.

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- Another problem mentioned in Cambodia’s assessment is that even with good estimations; the budget should be approved by the Ministry of Finances which frequently releases less money than requested.

• Not all countries have an appeals process for applicants that have their bids rejected (indicator

55). An apeals system is formally established in Indonesia with the Presidential Decree No.80 (2003). In the other countries, there are currently no official appeals procedures or avenues to lodge complaints. Even so, Bolivia and PNG mentioned that unsuccessful bidders can write a letter setting out the nature of their dissatisfaction.

Committees and criteria for membership • All countries have a tender committee with some variation in terms of the names and the

functions of the committee (indicator 56). A comparative analysis of key procurement functions is presented in Table 11. - In Mongolia, the tender committee (or evaluation committee) is non‐standing and

each government level has to establish a committee to evaluate and select suppliers.

- In general, the tender committee does not make the final decision on the contract award. This is the case in Bolivia, where contracts are normally awarded by other bodies

such as the Presidency, Executive Management or General Management, depending on the situation. Their decisions are based on technical reports.

In Cambodia, the Pre‐qualification, Evaluation, and Awarding Committee

(PEAC) acts as the tender committee and makes recommendations to the Minister of Health who takes the final decision in consultation with the Minister of Economy and Finances.

In Indonesia, the award contract is made by the Head of Health Unit and in

Mongolia, by the Head of the Tender Committee.

Table 11: Separation of key procurement functions between individuals and committees


Collates information on needs DILOS EDB

Tender Committee MSB

Manages the tender process† PU

Tender Committee

Technical team‐MSB

Selects suppliers for restricted tenders

Bidding Committee

No pre‐qualification

Tender Committee

Tender Committee MSB

Revises and evaluates the information on suppliers

Bidding Committee PEAC

Tender Committee

Tender Committee


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Makes the recommendation for the contract award

Bidding Committee PEAC

Tender Committee

Tender Committee


Awards contracts Executive Director14

Ministers of Health and Finances15

Head of the Health Unit

Head of the Tender

Committee PSTB16

†Tender’s advertisement, publication of contract specifications, production of tender package DILOS: Local Health Board; EDB: Essential Drug Bureau; MSB: Medical Supplies Branch; PEAC: Pre‐qualification, Evaluation, and Awarding Committee; PSTB: Pharmaceuticals Supplies Tenders Board; PU: Procurement Unit • The existence and use of specific criteria for tender committee membership varies from

country to country (indicator 57). In general, countries do not answer all requirements to achieve maximum transparency.

- All countries expected that members would be professionals with specific skills. In

Indonesia, members should be pharmacists trained and certified by the MoH. In Mongolia, members should be specialized in procurement or related sectors of given goods, services or works. In Cambodia and PNG, members are appointed according to their ministerial functions. In Cambodia, the Minister has the power to add a new member to the committee if thought beneficial. Members are subject to change according to the government in power.

- Bolivia and Indonesia are the only countries which have made the criteria publicly

available. - No country requires representation of officials from user facilities in the committee.

Cambodia and PNG require representation of senior government officials in the committee, but this is not the case in other countries. Indonesia’s NA noted that this indicator seems to be contrary to the country’s regulation. The Presidential Decree clearly states that involvement of senior government officials in the Tender Committee is prohibited because they are considered as funding users, and therefore their involvement in the tender committee conflicted with their interests.

- Except for Indonesia, no country requires rotation among the members to reduce

opportunities for unwarranted influence on committee activity. 14 Executive Director of each institution, for example, National Safety Health Insurance, National

Programme of Chagas’ Disease Control.

15 The MEF’s approval is not required for contracts with a value of less than one billion KHR (US$°250 000).

16 Report mentioned that the contract award is made by the tender committee usually the PSTB but it can be also be awarded by the Central Supplies Tenders Board (CSBT) on the National Executive Council’s endorsement.

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• There is no requirement for members of the tender committee to complete a conflict of interest form (indicator 58) in the majority of the countries.

- In Indonesia, members have to sign the “Pacta of Integrity” but this indicator scores

low since some KIs raised the issue that there was no declaration of interest by the Tender Committee members.

Monitoring of practices • The indicator on the management information system (MIS) used to report product problems in

procurement scores low in each country (indicator 60). Efficient MIS should include product records, quality assurance information, status of each order and quantity purchased in relation to estimates. MIS should monitor suppliersʹ and clientsʹ performances. In all countries, some of the monitoring components are accomplished but there is no integrated computerized or manual MIS.

- PNG is the only country stating that there is an MIS to report product problems in

procurement. However, it does not monitor suppliers’ and facilities’ performance.

- The majority of components mentioned above are applied in Bolivia, Cambodia, and Indonesia but there is no integrated MIS. In Cambodia, the lack of a comprehensive MIS suggests that it would be very difficult to report problems through the distribution channels for products procured with the National Budget.

- According to the KIsʹ answers, Mongoliaʹs MIS is not clear enough.

• The standard operating procedures for routine inspection of consignments are generally applied

in all countries (indicator 61). All countries use checklists except Bolivia which, although it has no written procedures, does nonetheless inspect consignments.

Table 12: Comparative analysis of routine inspection of consignments


Each shipment is physically checked Yes Yes Yes Yes Yes

Samples taken and sent to QCL randomly for all consignments

Yes No Yes Yes No

Samples taken and sent to QCL systematically for new suppliers

Yes No Yes Yes No

Inspections reported in documents and archived in the procurement office

No Yes Yes Yes Yes

QCL: Quality control laboratories

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• A post‐tender system to monitor and report annually on suppliers’ performance is neither efficient nor well‐integrated in most of the five countries (indicator 62).

- Based on interviews, only selective monitoring is done in the five countries.

Suppliers’ lead‐time and the shelf‐life and packaging of products are generally checked but not systematically reported.

- A post‐tender system exists in Mongolia but the KIs mentioned that it was not clear

enough.

- Indonesia’s report mentioned that the monitoring was done manually and it usually took a long time to follow‐up with the reports.

- All countries reported having a list of previous suppliers but criteria to blacklist

suppliers are not clearly defined or available in writing. • Audits of procurement offices are conducted in all countries (indicator 63) but the related

scores are low. This is mainly because the results are not available publicly. A comparative analysis of specific criteria under review in this assessment is presented in Table 13.

- PNG reported that, in practice, the time lapse between auditing all government

departments may be as long as five years. However, a bilateral aid programme with the Australian Government enabled the DoH to engage a private accounting firm to streamline financial management as well as act as external auditors at MSB.

- Despite a law17 stating that the reports issued by the Auditor‐General of Cambodia

are public documents, it was impossible to access the audit report. In addition, no KI stated whether or not the results of such audits are available publicly. Requests to meet with the National Audit Authority (the highest independent audit institution) were made but these were rejected as in their view procurement requirements, with which they complied, are set by MEF.

- In Mongolia, an audit of the procurement office is performed regularly but the

indicator scores low since the majority of KIs were not aware of these procedures.

Table 13: Comparison of the transparency of the audit of the procurement office

Indicators Bolivia Cambodia Indonesia Mongolia PNG

Audit compulsory by law Yes Yes Yes Yes Yes

Done on an annual basis Yes Yes Yes Yes ±

Results are publicly available No No No Yes No

17 Article 29 of the Law on Audit of the Kingdom of Cambodia

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Indicators Bolivia Cambodia Indonesia Mongolia PNG

Conducted by an independent unit (internal or external)

Yes Yes Yes Yes Yes

Reports operating costs of procurement office

No ? Yes No Yes

Reports pharmaceutical products tendered Yes ? Yes Yes ?

Reports quantities of the products

Yes ? Yes Yes ?

Reports the beneficiaries Yes ? No No ?

KIs’ Perceptions Graph 9: The members of the tender committee are systematically selected based on specific criteria (indicator 59).

In general, KIs were in agreement or very much in agreement with the statement. However, answers reflect each country’s particular situation, for example, in Cambodia and in PNG, members are appointed as a function of their ministerial position.

0

2

4

6

8

10

12

14

16

StronglyDisagree


Don't know

Not Applicable


0

2

4

6

8

10

12

14

16

StronglyDisagree


Don't know

Not Applicable



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Graph 10: The procurement system in your country is operating in a totally transparent manner (indicator 64).

0

2

4

6

8

10

12

StronglyDisagree


Don't know Not Applicable


0

2

4

6

8

10

12

StronglyDisagree


Don't know Not Applicable



• A quite significant proportion of KIs preferred not to answer or indicated their indecision (20% in Bolivia, 36% in Cambodia).

- In Cambodia, two of the three KIs who agreed with the statement specified that their

answer reflected current practices when compared to those of the past. Others agreed with the statement as long as the processes for procurement were followed.

- In PNG, the NI mentioned that some KIs contradicted themselves in declaring a

totally transparent procurement system in their country while concurrently admitting the possibility of unethical practices in the same system (indicator 65).

• The majority of people interviewed in all five countries admitted that there is unethical

behaviour in the procurement of medicines (indicator 65). The most frequently mentioned practices were: bribes, favouritism, conflict of interests and external influences, procurement of poor‐quality medicines, and political or personal pressures.

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5. Recommendations for action

5.1 General

This assessment was based on the assumption that the more transparent a system is, the less vulnerable to corruption it will be. The indicators that make up the assessment instrument suggest a ʺgold standard modelʺ with law, regulations, policies, procedures and structures aimed at reducing vulnerability to corruption. Recommendations derived from this model are presented in the following section. These recommendations are considered to be the basic requirements for minimizing the system’s vulnerability to corruption and unethical practices. Each country should look at these recommendations and decide how it wants to apply them to its own situation. In addition, other important issues will need to be addressed by and developed in all countries, and some of these are outlined in the following paragraphs. Publicly available This assessment methodology establishes the minimum requirements on public availability and lists the basic documents that should be in the public domain. Ideally, publicly available should mean available on the Internet but since this is not always possible depending on country settings and resources, it could mean easily accessible by anyone needing the document (for example, university, business or media). A system of delivery of documents made only on special request, with government authorization as a prerequisite, should not exist. Management of conflict of interest A conflict of interest policy should be adopted by all countries. This measure is intended to ensure that all activities related to the public pharmaceutical sector are carried out with complete impartiality and transparency. The policy should contain a standardized conflict of interest (COI) form and express clear and comprehensive sanctions and penalties in case a conflict of interest is not declared. The COI form should be signed by all committee members (registration, promotion, selection, procurement) and other government officials (drug registration assessors, inspectors). The fact of having any form of interest in a company in the sector should not exclude individuals from providing their services to the MoH for any period of time but, nonetheless, they should not be authorized to participate in work involving that company when this risks undermining the MoHʹs professional neutrality. It is essential that the information on real, perceived or potential conflict of interest should be made public.

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Law enforcement This assessment revealed that there are very well prepared specific rules and legal acts in all countries for the registration, promotion, inspection, selection and procurement of medicines. However, they are frequently neither complied with nor enforced. All laws and regulations should be made easily and publicly accessible. Processes to enforce the laws should be clearly defined, as should the powers and the specific roles of those officials, committees and entities able to enforce the law. Human resources capacity and motivation Salaries in the public sector are generally low and civil servants face work overload. In all countries and in all sectors of activities, KIs mentioned that more qualified human resources are needed as well as salary incentives. Incentives can be in the form of money (fair and adequate salary levels) or alternatives (possibilities for career advancement, advantages or social protections), and they can be a good method to increase motivation and stability in the employment of civil servants.

5.2 Indicator-based recommendations

This section summarizes the recommendations derived from the assessment methodology. These recommendations indicate what could be done to increase the transparency and accountability of the pharmaceutical sector.

Indicator

Recommendations for registration Bo

livia

Cambodia

Indonesia

Mongolia

PNG

1 Make the list of all registered pharmaceutical products easily accessible to the public and all stakeholders by publishing the list on the web

4

Develop or complete the written procedures for assessors on how to assess application submitted for registration of medicinal products with specifications on process to follow, timeframe for processing, issues to be considered, and guidance on report writing

4 Make written procedures publicly accessible to ensure that decision‐making is based on objective criteria

6

Develop a policy statement governing meetings between applicants and registration officers. The request should be in writing, should indicate the purpose and who will attend on the applicantʹs side. More than one officer should attend the meeting and the minutes should be kept as part of the record of the applicant’s submission

7 Establish a committee made of experts responsible for assessing applications for registration of pharmaceutical products

8 Develop or complete the criteria for the selection of registration committee. Criteria should be publicly available

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Indicator


livia

Cambodia

Indonesia

Mongolia

PNG

9 Add information concerning terms of reference, roles, and responsibilities of the members of the registration committee and make the document publicly available

10 Implement a declaration of interest policy for members of the registration committee

12 Make the guidelines for the committee’s decision‐making process and the decisions made at the meetings publicly available (official written document)

13 Develop clear and written guidance on the appeals process

Indicator

Recommendations for control of drug promotion Bo

livia

Cambodi

a

Indonesia

Mongolia

PNG

19 Complete the regulation concerning drug promotion to cover all aspects of drug promotion

20 Complete the regulation to indicate the sanctions and the type of penalties on public officials or pharmaceutical companies for breaching the law on drug promotion

20

Develop a complaints mechanism for health professionals, organizations and public to report unethical practices in drug promotion. Make this mechanism publicly available (mass‐media, Internet)

21 Establish a committee for approving, monitoring and enforcing the provisions on drug promotion

22 Develop SOPs with criteria for pre‐approving and monitoring drug promotion and advertisements

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Indicator

Recommendations for inspection Bo

livia

Cambodia

Indonesia

Mongolia

PNG

31 Develop a document on classification of GMP and/or GDP deficiencies and the related sanctions

31 Establish an appeals system independent of the body making the original decision and develop clear and written guidance on the appeal process

32 Develop written procedures to prevent relationships developing between inspectors and manufacturer or distributor

33 Develop conflict of interest policy and declaration of interest form to be completed by all inspectors

35 Develop uniform and complete procedures for inspectors on how to conduct inspections

35 Revise the procedures to include the requirements for pre‐ and post‐inspection activities

36

Complete the criteria for selection and recruiting inspectors to include requirement for professional qualifications, work experiences, examinations, and recommendations from former employers. Make the criteria publicly available

Indicator

Recommendations for selection Bo

livia

Cambodia

Indonesia

Mongolia

PNG

42 Publish the criteria for updating (inclusion, deletion, rejection) the national essential medicines list

43 Increase the distribution and availability of the list to all stakeholders by publishing the list on the MoH web site

44 Establish a committee of experts responsible for the selection of the national essential medicines list

46 Make the criteria for the selection of members of the committee publicly available

47 Develop a conflict of interest policy and declaration of interest form to be used by members of the selection committee

48 Publish in the public domain the SOP describing the rules for the decision‐making process in the selection of essential medicines

48 Make the decisions on the selection process publicly available and widely disseminated

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Indicator

Recommendations for procurement Bo

livia

Cambodia

Indonesia

Mongolia

PNG

52 Develop a specific, explicit policy document for the procurement of pharmaceuticals to be incorporated as part of the existing public procurement procedures

?

52 Make the written procedures for the procurement of pharmaceuticals publicly available and easily accessible

52 Make the information on the tender process and results public to the extent permitted by the law

52 Make the bidding committee directly responsible for the contracting processes and the final decisions on the award that emerge from these processes

54 Use objective quantification method to determine the country’s need in medicines

55 Establish an appeals policy and develop clear and written guidance on appeals process

56 Establish a committee with legal power to pre‐ and post‐ qualify the suppliers

57 Make the criteria for tender committee membership publicly available

57 Include officials from user facilities in the tender committee, in order to have members with skills that complement each other

58 Develop a declaration of interest policy and a declaration form to be used by members of committees involved in the procurement process

60 Integrate all the monitoring components of the drug procurement process in a sole computerized or manual management information system

61

Include the analysis of batch samples by the quality control laboratories (random sampling for known suppliers and systematic sampling for new ones) in the SOP for routine inspection of consignments

62

Integrate the actual selective monitoring (lead time, shelf‐life, packaging of the product) in an efficient post‐tender system to monitor and report on supplier performance and to blacklist poor performers

63

Make results of the annual audit of the procurement office available publicly, including reporting on the operating costs of the procurement office, pharmaceutical products tendered, quantities of the product procured, and the beneficiaries

5.3 Countries’ recommendations

During the interview, each KI was asked for the first action that they would take to improve the quality and the transparency of each area of the pharmaceutical sector. These questions give the opportunity to KIs to provide additional input on the function (method 4). KIs’

41


answers provide guidance on future actions to improve the pharmaceutical sector. This section summarizes the suggestions made by the KIs for their own country that were not discussed in previous sections.


livia

Cambodia

Indonesia

Mongolia

PNG

Completion of medicines registration in the country should be given the highest priority

Ensure that all medicines are registered as soon as possible and informing the public on this

Apply a specific policy in registration of medicines in the country that conforms to the market needs, the EML and the conditions of disease prevailing in the country

Support the national industry on the part of the government and local authorities, to improve the quality of products and facilitate the registration process

Validate the applications for registration with neighbouring countries to facilitate control

Develop a GDP code with a section describing deficiencies and the related sanctions

Present the applications with a distribution list to facilitate follow‐up of the process

Make accessible to the public all information on both the process on successful and unsuccessful applications ideally in written format and via the Internet

Create and enable both horizontal and vertical flows of information and enable provinces and districts to access a computer network

Recommendations for promotion Bo

livia

Cambodia

Indonesia

Mongolia

PNG

Forbid companies to promote their drugs in public hospital Collect information on usage, storage and harmful effects of medicines by a Drug Information Centre

Conduct ethical training on the promotion of medicines targeting the media

Integrate courses on critical assessment of pharmaceutical studies and scientific literature in the curricula of pharmacy and medical schools

42


Recommendations for inspections Bo

livia

Cambodia

Indonesia

Mongolia

PNG

Hire highly qualified inspectors who possess broad knowledge without any back records

Increase the training of inspectors Improve the availability of inspectors, especially in rural areas Allocate sufficient funds for regular inspection activities Increase the role of the general public and NGOs in the supervision of inspectors

Require attendance of representatives from the inspected agencies during the inspection process

Create a system to openly announce the results of inspections through the media

Recommendations for selection Bo

livia

Cambodia

Indonesia

Mongolia

PNG

Incorporate cost‐benefits, efficiency, safety, national and regional epidemiological profiles in the criteria for the selection of EML

Educate SSMO on the significance of drug costs Apply a single policy, based on scientific studies, to determine the need for a medicine to appear in the national EML

Take measures to register currently illegal unregistered medicines in the NEML

Ensure that PAC exists and operates as a subcommittee of the Pharmacy Board.

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Recommendations for procurement Bo

livia

Cambodia

Indonesia

Mongolia

PNG

Implement legal requirements for registration of all pharmaceuticals used in the public sector

Develop a policy to supply the population with domestically manufactured medicines

Purchase drugs that meet institutional needs and have sufficiently long expiry dates

Pay particular attention to demands, quality, storage and transportation of medicines procured through tendering programmes

Strengthen data collection on disease patterns and medicines consumption to improve quantification of medicines purchased

Eliminate shortage of supplies of medicines procured through tendering programmes

Improve coordination between central and provincial levels and districts

Follow up on public complaints Denounce agencies with sub‐standard services End the peddling or shadow procurement of medicines Establish a system in which all sides adhere to what has been agreed via the tendering agreement and openly inform the public through the media on the conclusions reached

Develop quality control facilities to carry out simple or preliminary tests on medicines. The facilities will screen to determine which samples to refer on for official assays

Increase the drug control laboratory capacity for the analysis of batch samples

Demand proper performance by staff, including punctuality and productivity

Submit a request to amend the organic law in order to allow DoH to deliver a level of health care that is unhindered by legal technicalities

Submit an upward review of the ceiling limit for tenders to be awarded by PSTB if the current limit is outdated

Separate procurement activities from regulatory functions

44


General recommendations Bo

livia

Cambodia

Indonesia

Mongolia

PNG

Update the legal compendium covering legislation related to pharmaceuticals

Include ethical practices in the curriculum of the pharmacy school Develop a web site for the department of Drugs and Food and the Procurement Unit of the MoH

All countries will have to hold a national workshop with key national stakeholders to share the results of the national transparency assessment and review the recommendations made by the national assessors. Each country’s report contains highly relevant information and suggestions to increase transparency in the public pharmaceutical sector, but it was impossible to include everything in the comparative analysis. It is therefore recommended that countries publish the national assessment report on measuring transparency to improve good governance in the public pharmaceutical sector and ask for comments from key partners.

5.4 Recommendations for the next phases

The following recommendations are related to the second and third phases of the GGM programme. They are based on experience gained by WHO while working with countries piloting the programme, as well as on the lessons learnt by other organizations that have been most active in curbing corruption and promoting good governance during the last decade. These include the World Bank, Transparency International and the Organisation for Economic Co‐operation and Development.

1. Hold a national workshop with key stakeholders to validate the findings of the transparency assessment and agree on the main components of a national GGM framework aimed at promoting good governance for medicines regulation and supply management. This national workshop marks the end of the first phase and the beginning of the second phase of the programme.

2. Develop a national GGM framework through a consultation process based on

consensus‐building. This can be based on the model WHO GGM framework18 and will need to be adapted to the specific needs and context of each country.

3. Publish and disseminate the findings of the assessment to health officials, policy‐

makers, academia and industry. This is a sign of transparency on behalf of the government. It also helps to increase awareness of the need to address the loopholes in the system among all actors concerned and to promote an ethical infrastructure.

18 WHO. A framework for good governance in the public pharmaceutical sector. Working draft,

April 2008.

45


4. Officially adopt the national GGM framework document, giving political backing to government officials to take the actions necessary to promote good governance in the pharmaceutical sector.

5. Promote the national GGM programme. At the heart of promoting and establishing a

national GGM programme is an institutional learning process that facilitates the understanding of the framework components and the development of capabilities necessary to apply them. To promote a national GGM programme WHO suggests a four‐stage process: i) Preparation; ii) Promoting awareness; iii) Capacity building; and iv) Consolidating and administering the national GGM programme.

6. Nominate an agency that will be responsible for coordinating and managing

implementation of the GGM programme at national level. Additionally, the working group will evaluate the programme on a regular basis. It is suggested that the transparency assessment is undertaken every two years.

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6. Conclusion

Experience in promoting good governance shows that efforts to address corruption require two basic strategies: a discipline approach and a values approach. The discipline approach, based on legislative reforms, establishes the laws against corruption with adequate punitive consequences for violating these laws. It also defines the administrative structures and processes needed to establish transparent public pharmaceutical systems as well as defining the legal sanctions to be applied for non‐compliance with the law. The discipline approach is therefore by nature top‐down. If there are only structures and procedures, corruption is still possible. For a significant impact, the discipline approach needs to be coordinated with the values approach. This second approach promotes institutional integrity by promoting moral values and ethical principles. It attempts to motivate ethical conduct by instilling in public servants and high‐level officials a sense of belonging to and a personal identification with, a common project. The values approach tends to be bottom‐up. The results of this assessment will help countries to apply the discipline approach described above. In the light of the findings, it is recommended that each country adjusts its laws, administrative structures and procedures in terms of medicines regulation and supply management. These changes will need to be discussed in a national workshop. Things are moving forward ‐ to date, each country has held at least one national workshop to discuss the proposed changes to increase transparency and improve good governance. Implementation of the Good Governance for Medicines programme is an ongoing process. Changes will not happen overnight, but experience has shown that it is possible to achieve results in the short‐term. It is important to highlight that there is no standard formula that can be applied universally. Each country will need to devise a strategy according to its own needs and reality, and adjust this strategy over the years through a systematic process of planning, implementation and evaluation.

47