MEETING GUIDE

Good Governance For Medicines Global Stakeholders Meeting 3-5 December 2007, Bangkok, Thailand TRANSPARENCY F R CHANGE

The Ministry of Public Health, Thailand

CONTENTS

Welcome to the Good Governance for Medicines Stakeholders Meeting • Welcome by World Health Organization 7 • Welcome to Bangkok 9 • Welcome to The Montien Hotel Bangkok 11

Professional Programme • Meeting Agenda 13 • Plenary Sessions’ Objectives 18 • Workshop Sessions’ Objectives 22

Networking Events • Welcome Cocktail 29 • Off Site Dinner 29

Speakers • Speaker Profiles and Photos 31

Evaluation Form 63

Notes 71

WELCOME

7 WELCOME BY THE WORLD HEALTH ORGANIZATION

Dear Participants,

I would like to personally welcome you to the Global Stakeholders meeting of the WHO Good Governance for Medicines programme. This is the programme's 2nd global stakeholders meeting that WHO has organized, and we are delighted to see so many of you here in Bangkok. This is a real sign that transparency in the pharmaceutical sector is an area of increasing interest for our stakeholders and that more and more countries are keen to work in this challenging, but rewarding area. The theme of the meeting is "Transparency for Change". I can promise you that the next three days will be full of learning and networking opportunities for you all, with the opportunity to review experiences and to learn from each other. We have an impressive line up of eminent speakers who will share their insights into today’s issues and challenges. Our speakers will not only increase our knowledge of the world of good governance in general, and of the medicines area in particular, but our inten- tion is that they will also motivate us to increase our efforts to improve the situation in the pharmaceutical sector when we leave Bangkok and return to our various work settings. The goal is eventually to offer a process for long-lasting change - for all of us to mobilize a "call for action" to meet the challenges ahead, and ultimately to help make quality essential medicines accessible and affordable for all. Having launched its programme in 2004, WHO remains committed to promoting good governance for medicines in the future. It will do so by further refining its policy and technical guidance and by providing technical support to countries who request it. WHO will also continue to act as a facilitator to bring all the key stakeholders together on a regular basis to provide this platform to exchange experiences and network. We would like to thank our hosts, the Thai Ministry of Public Health, as well as WHO’s Country Office in Bangkok and the WHO Regional Office for South-East Asia for 8

their valuable support. The conference would not have been possible without their dedication and hard work in the last few months. And finally, I thank everyone for coming - panellists, moderators and participants. I hope you have an enjoyable and rewarding time with us. If you need assistance of any kind, please contact one of our team members, who will be making themselves known to you.

I look forward to meeting you,

Dr Hans V. Hogerzeil Director Medicines Policy and Standards World Health Organization 9 WELCOME TO THE KINGDOM OF THAILAND AND ITS CAPITAL BANGKOK

Did you know that there are more than 10 million people living in Bangkok? Or, did you know that the locals call Bangkok “Krung Thep” which means the City of Angels? Thailand’s capital city, Bangkok, has changed into a modern, exciting and sophisti- cated city. It offers to visitors not only the cosmopolitan amenities they would expect from other big cities, but also a unique treasure trove of cultural attractions. Bangkok offers visitors the opportunity to experience a fascinating glimpse of Thailand’s gentle culture amidst the bustle of a great and dynamic metropolis.

Interesting facts — did you know that . . . ? • Siam changed its name in 1939 to Thailand, meaning “land of the free”. • 75% of the people living in Thailand are Thai, 14% are Chinese and 11% other nationalities. • there are 400 glittering Buddhist temples in Bangkok. • there are 3.8% Muslims in Thailand, 0.1 Hindus, 0.5% Christians, 0.6% other religions and 95% Buddhists. • Bangkok has developed into one of the most popular shopping locations in Asia. • Bangkok was founded in 1782 by the first monarch of the present Chakri dynasty and it is today a constitutional monarchy. • Skytrain fares cost between 10 Baht and 40 Baht per person depending on the distance, about one third the cost of a comparable taxi ride. • Thailand has 3290km of coastline. • taxis outnumber private cars 2:1 in Bangkok and most journeys can be completed for well under 100 Baht. Make sure you take a genuine taxi with a taxi meter. • one US dollar is equal to approximately 30 Baht. • the Thai language is similar to Tai, the language spoken by the people who live in Southern China. • King Bhumibol Adulyadej, the beloved king of Thailand, is going to be 80 years old on December 5th. He was born in Cambridge, Massachusetts, USA, and edu- cated in Lausanne in Switzerland. 10 Your Small English – Thai Dictionary:

ENGLISH THAI

Good morning, Good evening, Good afternoon, Good sa-wat-dee night, Hello Hello (male speaker) sawatdee krup Hello (female speaker) sawatdee kaa Yes chai No mai Mr./Miss/Mrs. khun How are you? sabai dee reu Fine thanks sabai dee Where is the rest room? hong nam yoo tee nai I am going to . . . chan-cha-pai . . . Stop yut How much does this cost? nee tao-rai What is this ? nee arai Very expensive paeng maag Any discount? lot-ra-kha-dai-mai Please wrap it for me ho-hai-duai The bill please gep taang Please speak slowly prot-phut-cha-cha Very Good di-mak Not Good mai-di Goodbye la gon See you again laew phob gan mai Good luck kor hai chok dee Sorry/excuse me kor thoad 11 WELCOME TO THE MONTIEN HOTEL BANGKOK

The Montien Hotel Bangkok is located in the heart of Bangkok's major business and entertainment district, within easy walking distance of many offices, shops and night- spots. Just five minutes away is the nearest station of the Mass Transit System, which provides rapid access to other parts of the city. Offering 475 rooms and suites, includ- ing Executive Floors with private lounge, meeting rooms and fully equipped business centre, the hotel is perfectly situated for both the business traveller and the leisure visitor to Bangkok.

The hotel is located on Surawongse Road, your business address in the heart of the city with the most flexible combination of superior accommodation and business facilities to meet your every demand. Montien Hotel Bangkok is proud to offer a wide variety of cuisine including a Chinese and a European restaurant as well as a 24-hours Inter- national Coffee Shop.

It is with delight that the hotel welcomes all participants to the Good Governance for Medicines Stakeholders Meeting, 3-5th December 2007.

Hotel Address: 54 Surawongse Road, Bangkok 10500, Thailand. Tel.: (662) 233-7060-9 http://www.montien.com/bangkok/

13

PROGRAMME 14

TIME DAY 1

08.00-08.45 Registration 08.45-09.00 Official Opening by the Thai Ministry of Public Health 09.00-10.15 Plenary Session 1: Think transparency! Good Governance in the pharmaceutical sector. Room: Rajmontien IV, Mezzanine Facilitator: Dr. Hans Hogerzeil, World Health Organization

Panelists: Promoting Good Governance in the Pharmaceutical Sector, a Global Experience Dr. Guitelle Baghdadi-Sabeti, World Health Organization

Good Governance for Medicines Programme: the Thai Experience Dr. Chanvit Tharathep, Ministry of Public Health, Thailand

Toward Scientific Drug Administration Mr. Changyuan Lin, State Food and Drug Administration, People’s Republic of China

Transparency in the Governance of Bulgaria’s Pharmaceutical System – results of a case study Mrs. Gergana Andre, International Healthcare and Health Insurance Institute, Bulgaria 10.15-10.30 Questions and plenary discussions 10.30-11.00 Coffee Break 11.00-12.15 Plenary Session 2: The root of corruption. Understanding the issues to cure it! Room: Rajmontien IV, Mezzanine Facilitator: Dr. Clive Ondari, World Health Organization

Panelists: Governance and Corruption: the Gray Area of Policy Dr. Maureen Lewis, The World Bank

Fighting Corruption - Challenges and Threats Mr. Martin Kreutner, Federal Bureau for Internal Affairs, Austria

Systems, Attitudes, and Action as Root Causes of Corruption Dr. Steven Rood, Asia Foundation, Philippines

Transparency International Global Corruption Report 2006 Transparency International Secretariat, representative to be announced 12.15-12.30 Questions and plenary discussions 15

12.30-14.00 Lunch: Monti Restaurant at the hotel 14.00-15.30 Workshops 1a and 1b: Seminar I & Seminar II, 6th Floor BRIDGING THE RESEARCH GAP – what do we still need to know, and how do we go about it? 14.00-15.30 Workshops 2a and 2b: Seminar III & IV, 6th Floor MAXIMIZING THE USE OF INTERNET TO INCREASE TRANSPARENCY – how? 14.00-15.30 Workshops 3a and 3b: Seminar V & VI, 7th Floor ESTABLISHING A NATIONAL GGM TASK FORCE – what are the challenges ahead? 14.00-15.30 Workshops 4a and 4b: Seminar VII & VIII, 7th Floor JOINING FORCES ON A NATIONAL LEVEL WITH ANTI-CORRUPTION AGENCIES – what works, what doesn’t? 15.30-16.00 Coffee Break 16.00-17.00 Presentations/Feedback from Workshops 19.00-21.00 Welcome Reception

TIME DAY 2

09.00-10.15 Plenary Session 3: Practicing transparency! Good Governance in the health sector. Room: Montienthip, Mezzanine Facilitator: Dr. Hans Hogerzeil, World Health Organization

Panelists: Good and Bad Practices in Good Governance and What Can Be Done to Promote Good Governance Dr. Maureen Lewis, The World Bank

Protecting Healthcare Systems Against Fraud so that They Can Better Protect the Health of Citizens Mr. Jim Gee, KPMG Forensic, United Kingdom

Detecting and Solving System Weaknesses Mr. Paul Vincke, European Healthcare Fraud and Corruption Network, Belgium

Promoting Good Governance in Medicines: Industry’s Role Dr. Eric Noehrenberg, International Federation of Pharmaceutical Manufacturers & Associations, Switzerland 10.15-10.30 Questions and plenary discussions 10.30-11.00 Coffee Break 16

11.00-12.15 Plenary Session 4: Keeping it together! The basic ingredients for ensuring Good Governance. Room: Montienthip, Mezzanine Facilitator: Dr. Kerstin Leitner, WHO, GGM Global Advisory Group

Panelists: The Ethical Dimension of Good Governance Dr. Eloy Anello, Núr University, Bolivia

Promoting Good Governance, the Experience of the Ministry of Health in Germany Dr. Sonja Füsser, Ministry of Health, Germany

A National Strategy for Ensuring Good Governance Mrs. Fatuma Sichale, Anti-Corruption Commission, Kenya 12.15-12.30 Questions and plenary discussions 12.30-14.00 Lunch: Monti Restaurant (We will collect questions for the next morning’s session.) 14.00-15.30 Workshops 5a and 5b: Seminar I & Seminar II, 6th Floor CAN YOU BREAK THROUGH THE GIFT-GIVING CULTURE? – how do we bring transparency to the grey zone? 14.00-15.30 Workshops 6a and 6b: Seminar III & IV, 6th Floor DEFINING INTEGRITY – how do we raise the standards and motivate permanent change? 14.00-15.30 Workshops 7a and 7b: Seminar V & VI, 7th Floor WHAT RADICAL CHANGES WILL TRANSPARENCY BRING TO THE PHARMACEUTICAL WORLD? • who are the players? • what will be the impact on public health? 14.00-15.30 Workshops 8a and 8b: Seminar VII & VIII, 7th Floor SERVING TRANSPARENCY! How can WHO be of better service when facilitating GGM programme implementation? Give ideas and feedback. 15.30-16.00 Coffee Break 16.00-17.00 Presentations/Feedback from Workshops 18.30-21.00 Off Site Networking Dinner 17

TIME DAY 3

09.00-10.30 Plenary Session 5: Questioning transparency. Our panelists respond to you! Room: Montienthip, Mezzanine Facilitator: Dr. Kerstin Leitner, WHO, GGM Global Advisory Group 10.30-11.00 Coffee Break 11.00-12.15 Plenary Session 6: Rolling out transparency. What is your role? Room: Montienthip, Mezzanine Facilitator: Dr. Clive Ondari, World Health Organization

Panelists: USAID Support for Good Governance in Medicines Mr. Anthony Boni, USAID, United States of America

Civil Society Organizations: What is Their Role in Promoting Transparency? Mrs. Carole Belisario, Procurement Watch Inc., Philippines

How can the academia support the global efforts to promote transparency and good governance? Dr. Niyada Kiatying-Angsulee, Chulalongkorn University, Thailand

The role of development institutions in promoting good governance in the pharmaceutical sector Dr. Zafar Mirza, WHO Regional Office for the Eastern Mediterranean

12.15-12.30 Questions and plenary discussions Official Closing by the Thai Ministry of Public Health 12.30-14.00 Lunch: Monti Restaurant 18 PLENARY SESSIONS’ OBJECTIVES

Session 1: Think transparency! Good Governance in the pharmaceutical sector. Facilitator: Dr. Hans Hogerzeil, WHO, Switzerland Panellists: • Dr. Guitelle Baghdadi-Sabeti, WHO, Switzerland • Dr. Chanvit Tharathep, Ministry of Public Health, Thailand • Mr. Changyuan Lin, State Food and Drug Administration, People's Republic of China • Mrs. Gergana Andre, International Healthcare and Health Insurance Institute, Bulgaria

The importance of transparency and accountability in pharmaceutical systems is in- creasingly recognized by the various key players at the country and international lev- els. Recent initiatives, whether aiming at improving good governance or tackling cor- ruption per se, provide concrete evidence. These include global initiatives such as the WHO Good Governance for Medicines programme, as well as practical country applica- tions. During this session, experiences in reflecting on and promoting transparency will be shared, together with lessons learnt to date.

Session 2: The root of corruption. Understanding the issues to cure it! Facilitator: Dr. Clive Ondari, WHO, Switzerland Panellists: • Dr. Maureen Lewis, World Bank • Mr. Martin Kreutner, Bureau of International Affairs, Federal Ministry of Interior, Austria • Transparency International Secretariat, representative to be announced • Mr. Steven Rood, Asia Foundation, Philippines

Corruption is a world-wide problem, existing in both high- and low-income countries. It is recognized as the single greatest obstacle to social and economic development. Corruption erodes the institutional capacity of governments, increases the cost of 19

business and is demeaning for poor people, worsening their financial burden. This ses- sion will aim at defining corruption, and highlight its causes as well as its negative impact.

Session 3: Practicing transparency! Good Governance in the health sector. Facilitator: Dr. Hans Hogerzeil, WHO, Switzerland Panellists: • Dr. Maureen Lewis, World Bank • Mr. Jim Gee, KPMG Forensic, United Kingdom • Mr. Paul Vincke, European Healthcare Fraud and Corruption Network (EHFCN), Belgium • Dr. Eric Noehrenberg, International Federation of Pharmaceutical Manufacturers & Associations, Switzerland

The pharmaceutical sector is an integral element of health systems. Activities in medi- cines regulation and supply have a direct impact on health systems' functioning and vice versa. Efforts to promote good governance in the pharmaceutical sector and in the health sector as a whole need to complement each other. In this session, panelists will shed additional light on how health care systems can be protected from abuse.

Session 4: Keeping it together! The basic ingredients for ensuring Good Governance. Facilitator: Dr. Kerstin Leitner, WHO, GGM Global Advisory Group Panellists: • Dr. Eloy Anello, Nùr University, Bolivia • Dr. Sonja Füsser, Ministry of Health, Germany • Mrs. Fatuma Sichale, Anti-Corruption Commission, Kenya

Good governance programmes require a combination of various, complementary 20

components. These include: an ethical framework and code of conduct; established anti-corruption legislation; regulations and administrative procedures; collaboration mechanisms between existing anti-corruption initiatives; whistle-blowing mechanisms; and sanctions for reprehensible acts. Panellists will share experiences in implementing some of these components at the country and global levels.

Session 5: Questioning transparency. Our panellists respond to you! Facilitator: Dr. Kerstin Leitner, WHO, GGM Global Advisory Group

In this session, your panellists will reply to your questions that may have remained un- answered from the previous plenary sessions, or new ones raised during the afternoon workshops and informal discussions among participants. Please take time to write your questions and place them in the box provided.

Session 6: Rolling out transparency. What is your role? Facilitator: Dr. Clive Ondari, WHO, Switzerland Panellists: • Mr. Anthony Boni, USAID, United States of America • Mrs. Carole Belisario, Procurement Watch Inc., Philippines • Dr. Niyada Kiatying-Angsulee, Chulalongkorn University, Thailand • Dr. Zafar Mirza, WHO Regional Office for the Eastern Mediterranean, Egypt

Stakeholders in the pharmaceutical sector are many and diverse. They include drug regulatory authorities and medicines supply managers, civil society organizations and academia, the public and the private sectors, donors and recipient governments. Each one has a role and eventually their actions will bring changes. We may have different roles, but we should aim to make activities complementary in the global efforts to increase access to quality medicines. In this session we will discuss the roles of each stakeholder in rolling out transparency, and a call for action will be made.

22 WORKSHOP SESSIONS’ OBJECTIVES

DAY 1 MODERATORS BACKGROUND AND OBJECTIVES

WORKSHOP 1 Workshop 1.a: Corrupt practices in the pharmaceutical (a and b): Abu Bakar Abdul Majeed, sector are being increasingly docu- University of Technology mented. For example, Transparency In- BRIDGING THE Mara, Malaysia ternational’s Global Corruption Report RESEARCH GAP – Paul Vincke, European 2006 consolidates a large amount of the what do we still Healthcare Fraud and existing knowledge. Still, the scale of need to know, and Corruption Network these practices and their impact (health how do we go about (EHFCN), Belgium and economic) is not yet fully known. it? Workshop 1.b: The objective of this workshop is to Niyada Kiatying-Angsulee, define the areas where more research Chulalongkorn University, will be needed in order to better Thailand prevent corrupt practices and promote Clive Ondari, WHO good governance in the pharmaceutical Headquarters, Geneva sector. At the end of Each workshop has a PC for notes each day: and to prepare the short PowerPoint Presentation/ presentation which will be the result feedback from of the discussions. The moderators will workshops. Note: present feedback from their group. 8 minutes per group WORKSHOP 2 Workshop 2.a: The internet is a remarkable and unique (a and b): Chanvit Tharathep, Ministry tool to promote transparency. More and of Health, Thailand more medicines regulatory agencies MAXIMIZING THE Sri Suryawati, Gadjah Mada post on their website the information USE OF INTERNET University, Indonesia that needs to be publicly available, as TO INCREASE well as the details of procedures for TRANSPARENCY - Workshop 2.b: administrative processes. how? Eshetu Wondemagegnehu, WHO Consultant, Ethiopia The objective of this workshop is to learn Sirinart Vasanavathana, from countries that have comprehensive Office of Food and Drug internet services that aim to promote Administration, Thailand transparency in the pharmaceutical sector. 23

DAY 1 MODERATORS BACKGROUND AND OBJECTIVES

WORKSHOP 3 Workshop 3.a: Governments must delegate the (a and b): Rosminah Mohd. Din, implementation of a Good Governance Ministry of Health, Malaysia for Medicines programme to an appro- ESTABLISHING A Nazarita Tacandong, WHO priate implementing agency or task NATIONAL GGM TASK Regional Office for the force. If such an agency or task force FORCE Western Pacific, Philippines does not already exist, it needs to be – what are the established with the appropriate human challenges ahead? Workshop 3.b: and financial resources. Carole Belisario, Procurement Watch, Inc., The objective of this workshop is to Philippines learn from countries that have recently Socorro Escalante, WHO, set up a Good Governance for Medicines Philippines implementing agency on how best to go about it.

At the end of Each workshop has a PC for notes each day: and to prepare the short PowerPoint Presentation/ presentation which will be the result of feedback from the discussions. The moderators will then workshops. Note: present feedback from their group. 8 minutes per group WORKSHOP 4 Workshop 4.a: Most countries have already established (a and b): Eloy Anello, Núr University, national anti-corruption agencies as Bolivia part of their efforts to tackle corruption JOINING FORCES Wilfred Dodoli, WHO, with a cross-sectoral perspective. These ON A NATIONAL Malawi agencies can provide strong support to LEVEL WITH ANTI- national Good Governance for Medicines CORRUPTION Workshop 4.b: programmes. It is useful to establish AGENCIES Maria Miralles, Management collaboration mechanisms with them, – what works, what Sciences for Health, USA. not only to gain their support but also doesn’t? Moses Chisale, WHO to avoid duplication of efforts. Regional Office for Africa, Gabon The objective of this workshop is to identify types of existing national agencies that can help national Good Governance for Medicines programmes and to define the best approach for establishing collaboration mechanisms. 24

DAY 2 MODERATORS BACKGROUND AND OBJECTIVES

WORKSHOP 5 Workshop 5.a: Gift-giving in the working environment (a and b): Sirinart Vasanavathana, is common practice in many settings. On Office of Food and Drug the one hand, it is a way of showing CAN YOU BREAK Administration, Thailand appreciation of collaboration between THROUGH THE GIFT- William Mfuko, WHO, staff or institutions. On the other, GIVING CULTURE? Cambodia studies by social scientists have proved - how do we bring that gift-giving also creates a sense of transparency to the Workshop 5.b: indebtedness and reciprocity, and can grey zone? Moses Chisale, WHO influence decision-making processes. Regional Office for Africa, Gabon The objective of this workshop is Nazarita Tacandong, WHO to review the impact of gift-giving Regional Office for the practices, and reflect on how these Western Pacific, Philippines practices can be changed over time.

At the end of Each workshop has a PC for notes each day: and to prepare the short PowerPoint Presentation/ presentation which will be the result feedback from of the discussions. The moderators will workshops. Note: present feedback from their group. 8 minutes per group WORKSHOP 6 Workshop 6.a: Overcoming corruption in the pharma- (a and b): Chanvit Tharathep, Ministry ceutical sector requires a long-term of Health, Thailand strategy and the implementation of DEFINING INTEGRITY Eloy Anello, Núr University, good governance. Experience has – how do we raise Bolivia shown that its impact will depend on the standards and the coordinated application of two motivate permanent Workshop 6.b: basic strategies, one establishing anti- change? Abu Bakar Abdul Majeed, corruption laws and regulation for the University of Technology practice of pharmacy, and the other Mara, Malaysia building institutional integrity through Clive Ondari, WHO the promotion of moral values and Headquarters, Geneva ethical practices.

This workshop will focus on the second strategy: building institutional integrity. 25

DAY 2 MODERATORS BACKGROUND AND OBJECTIVES

WORKSHOP 7 Workshop 7.a: Having a vision of what a country or (a and b): Eshetu Wondemagegnehu, the whole world would look like with WHO Consultant, Ethiopia a corrupt-free pharmaceutical sector is WHAT RADICAL Niyada Kiatying-Angsulee, essential to designing a national Good CHANGES WILL Chulalongkorn University, Governance for Medicines programme. It TRANSPARENCY Thailand also helps in acquiring the motivation BRING TO THE and the drive to address an issue that PHARMACEUTICAL Workshop 7.b: is often perceived as a taboo subject or WORLD? Jim Gee, KPMG Forensic, too difficult to tackle. - who are the United Kingdom players? Carole Belisario, The objective of this workshop is to - what will be the Procurement Watch, Inc., develop a clear vision of a corrupt-free impact on public Philippines pharmaceutical sector and find ways to health? create the motivation among key players to act upon it. At the end of Each workshop has a PC for notes each day: and to prepare the short PowerPoint Presentation/ presentation which will be the result feedback from of the discussions. The moderators will workshops. Note: present feedback from their group. 8 minutes per group WORKSHOP 8 Workshop 8.a: Since WHO established the Good (a and b): Maria Miralles, Management Governance for Medicines programme Sciences for Health in 2004, a model operating process and SERVING (Virginia, USA) a technical package for countries have TRANSPARENCY! Budiono Santoso, WHO been developed. Still, WHO is aware that - How can WHO be Regional Office for the it has embarked on a learning process, of better service Western Pacific and its policies and technical package when facilitating will need to be further refined over the the GGM programme Workshop 8.b: years. implementation? Tsetsegmaa Sanjjav, Health Give your ideas and Sciences University of The objective of this workshop is to feedback. Mongolia reflect on WHO’s work to date in this Zafar Mirza, WHO Regional area and make recommendations on Office for the Eastern how it can better support countries Mediterranean, Egypt in implementing national GGM programmes.

NETWORKING EVENTS

29 WELCOME COCKTAIL

Monday 3rd December, 19.00 - 21.00 Venue: Montienthip Room at the Montien Hotel

We invite you to join us for a welcome reception. This is the perfect opportunity to meet everyone participating in the meeting and an excellent networking opportunity to exchange ideas, share experiences and discuss the outcome of the professional pro- gramme of the first day.

OFF SITE DINNER: GRAND CHAO PHRAYA CRUISE Tuesday 4th December, Departure from the Montien Hotel 18.30.

We are delighted to invite you for a cruise along the Chaophraya river, the principal river of Thailand, which is regarded as the bloodline of the Thai people. Much of Thai history can be traced along its banks. On both sides of the Chaophraya river, a tourist can see magnificent temples and architectural buildings, including the First Presby- terian Church, the Royal Thai Navy Dockyard, the Thai Maritime Navigation Company, the Old Customs House, Wat Prayunwong, Wat Arun, the Grand Palace, Wat Rakhang Kositaram, and the Royal Boat House. We will enjoy a wonderful buffet dinner, accompanied by live music in the lovely atmosphere of the city of Bangkok.

AGENDA Check in time: 18:45 pm at River City Pier # 1 (Siphraya/charoenkrung soi 30) Cruising time: 19:00 pm to 21:00 pm

WELCOME!

SPEAKERS 32

Name: Prof. Abu Bakar Abdul Majeed Institution: Faculty of Pharmacy, Universiti Teknologi MARA (UiTM) Country: Malaysia

Abu Bakar Abdul Majeed obtained his Bachelor of Pharmacy degree from Al-Zagazig Univer- sity, Egypt, in 1983, PhD in Neurophysiology from Sheffield University in 1988 and Masters in Business Administration (MBA) from Universiti Sains Malaysia in 1996. In 1997 Abu Bakar joined the Institute of Islamic Understanding Malaysia (IKIM) as senior Fellow at the Centre for Economics, Social Science and Technology. He wrote fort- nightly in the Saturday Forum column of the New Straits Times between 1997-2002. In 2002 Abu Bakar was awarded two fellowships, one to do research on ‘Bioethics’ at the Centre for European Integration (ZEI) in Bonn, Germany, and the other an individual in- ternational visitor’s programme on ‘Religion and Society’ by the US State Department in September – October. In February 2002 Abu Bakar was appointed as Professor, Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Shah Alam, and on 1.9.2002 as Dean of the Faculty, UiTM, In January 2004, he was made Founding Chairman of College of Science and Technology, comprising 12 science-based faculties at UiTM, including medical, engineering and applied sciences. He has written the book entitled, ‘Making the Best of Both Worlds – volume 1: Faith and Science’ and ‘Making the Best of Both Worlds – volume 2: Heaven and Earth.’ Among the titles edited are: ‘Islam and Development in Asia’, Islamic World and Europe – Some Issues’, ‘Bioethics – Ethics in the Biotechnology Century’, ‘The Concept and Operations of Islamic Medicine’, ‘Islam and Preventive Medicine’, ‘Islam and Multimedia’, ‘Enhancing the Understanding of Islam for the Media’, and ‘New Knowledge – R&D in the Islamic World.’ Abu Bakar is married to Balkhis Othman. They have two boys, Abdul Azeem and Abdul Azeez, and twin girls, Aisyah and Atikah. In his leisure time, Abu Bakar enjoys travelling, sports and photography. 33

Name: Mrs. Gergana Andre Institution: International Healthcare and Health Insurance Institute Country: Bulgaria

Mrs. Gergana Andre has a Masters degree in Pharmacy and her postgraduate special- ization is on Management Systems of Wholesalers and Retail Pharmacies. Later, she obtained a Masters degree in Health Management. Currently she is doing a doctorate on “The National Drug Policy Model as a Moving Factor in Health Reform in Bulgaria”. From 1995 she worked for the international humanitarian organization “Pharmaciens Sans Frontières” in Tajikistan, Bulgaria and Egypt and later she moved to the Bulgarian state administration. From 2000 to 2002 Mrs. Andre led the “Drug Policy” Department at the Ministry of Health in Bulgaria where she was responsible for harmonizing phar- maceutical sector legislation with EU standards. At present Mrs. Andre is Head of the ”Pharmaceutical Analysis and Drug Policy” department. She works on the integration of information in the pharmaceutical sec- tor, and organization and participation in international projects in the pharmaceutical sector, including projects under Phare Programmes, DG SANCO, participation in the Study of Governance in Bulgaria’s Pharmaceutical System by the IRIS Center, and the University of Maryland, USA. 34

Name: Dr. Eloy Anello Institution: Andean Centre of Excellence for Training, Nur University Country: Bolivia

Dr. Eloy Anello is the National Director of Nur University’s “Andean Center of Excellence for Training” in Santa Cruz, Bolivia. He is also the General Academic and Research Advisor for Nur University. During the last 25 years he has provided consultancy and training services in the areas of public health and education to many international agencies throughout Latin America. These include PAHO/World Health Organization, UNICEF, World Bank, Inter-American Development Bank, Kellogg Foundation, Ford Foundation, USAID, DFID, and Plan International. For the last two years he has been a consultant to WHO’s Good Governance for Medicines programme, developing an ethical framework for good governance in the pharmaceutical public sector. 35

Name: Dr. Niyada Kiatying-Angsulee Institution: Faculty of Pharmaceutical Sciences, Chulalongkorn University Country: Thailand

Niyada Kiatying-Angsulee has a BSc in Pharmacy from Chulalongkorn University in Thailand, an MSc in Pharmacology from Mahidol University, Thailand, and a PhD in Health Policy from the London School of Hygiene and Tropical Medicines, University of London, UK. Her areas of expertise include drug systems, consumer protection, regulation, policy analysis, women’s drugs, ethics and promotion. She is involved in several national and international academic activities, such as: • Advisor for the World Health Organization • Governing Council Member of Health Action International Asia Pacific • Expert Member of the Drug Committee according to the Drug Act B.E.2510 • Member of the Subcommittee on Safety of Medicines, under the Drug Committee. • Reviewer, Thai Health Promotion Fund • Member of Administrative Board, MSc and PhD. Social and Administrative (International Program) • Member of the Administrative Board, Center for Peace and Conflict Studies, Chulalongkorn University • Chair, Social Pharmacy Research Unit, Chulalongkorn University 36

Name: Dr. Guitelle Baghdadi-Sabeti Institution: World Health Organization Country: Switzerland

Guitelle Baghdadi-Sabeti has over 15 years experience in public health and develop- ment work, particularly in international pharmaceutical policies and practices aimed at increasing access to good quality essential medicines. She has collaborated and provid- ed country support to over 50 Ministries of Health, NGOs and development partners. She holds a Masters degree and a Doctorate in Pharmacy from the University of Grenoble as well as a Masters in Public Health from the Université Libre de Bruxelles. She started her career in 1991 in working with Pharmaciens Sans Frontières and joined WHO in 1994 where she has worked in different locations and capacities. These include the WHO office at the United Nations in New York, the WHO country office in Haiti and since 1998 she has worked at WHO Headquarters, Geneva, in the Department of Medicines Policy. In November 2004, she initiated and developed WHO’s Good Governance for Medi- cines programme, aimed at promoting good governance and curbing corruption in the pharmaceutical sector. This project is currently operating in 19 countries and is using a bottom-up approach, involving country officials and international experts in the de- velopment of national good governance programmes for the pharmaceutical sector. 37

Name: Mrs. Carole Belisario Institution: Procurement Watch, Inc. Country: Philippines

Ms. Caroline R. Belisario obtained her Accountancy Degree at the Heald Business Col- lege in San Francisco, California U.S.A. She has been working at Procurement Watch, Incorporated in the capacity as Supervising Technical Officer since 2001 and a free- lance Governance/Procurement Consultant. Some of her involvement in the area of Governance include Good Governance for Medicines Programme of the World Health Organization, Procurement Assessment of sixteen (16) Local Government Units for the Health Sector Policy Support Programme of the European Union Commission, Differential Expenditure and Efficiency Measure- ment Tool for TAF-USAID, and promoting greater transparency and accountability in the health sector through the Medicines Transparency Alliance (MeTA) Council. 38

Name: Mr. Anthony Boni Institution: United States Agency for International Development (USAID) Country: United States of America

Anthony Boni is a Pharmaceutical Management Specialist in the Office of Health, Infec- tious Diseases and Nutrition of the Global Health Bureau of the U.S. Agency for Inter- national Development (USAID). He has designed and manages the Agency’s worldwide technical assistance programmes in pharmaceutical management, drug information and medicines quality assurance. His new programme, Strengthening Pharmaceutical Sys- tems, has improving governance in the pharmaceutical sector as a major objective. Mr. Boni has direct involvement in the implementation of HIV/AIDS, malaria, TB, maternal and child health, and antimicrobial resistance (AMR) programmes in more than 30 countries, and has collaborated with all international organizations and initiatives working in the pharmaceutical area. He also consulted with the Global Fund to Fight AIDS, Malaria and Tuberculosis (GF) regarding quality assurance issues, worked with the procurement team on supply chain assessment methodologies, and manages USAID tech- nical assistance to GF recipients to remove bottlenecks impeding the implementation of country programmes. A technical advisor to the U.S. Government, he provides guidance on pharmaceutical management and procurement, quality assurance and prequalification issues, access to and the rational use of medicines, IPR and patents, and AMR. With regard to the latter, he drafted the AMR component of USAID’s Infectious Disease Strategy and is responsible for USAID’s portfolio of AMR activities. In his AMR role, he provided technical and fi- nancial support to the World Health Organization for the development of the WHO Global Strategy for the Containment of Antimicrobial Resistance. He is also a member of various international task forces, including the Global Fund/UNITAID Technical Advisory Group and the United States Pharmacopeia International Health Expert Committee. Prior to joining the Health Office, he helped set up the Agency’s centralized procure- ment and distribution systems for contraceptive commodities and managed the provision of technical assistance in logistics management to USAID-supported programmes. 39

Name: Dr. Socorro Escalante Institution: World Health Organization Regional Office for the Western Pacific Country: Philippines

Dr Socorro Zarate Escalante is currently the Programme Officer for Pharmaceuticals at the World Health Organization Office in the Philippines. She is a medical doctor by profession, has a law degree and a Masters in Business Administration in Health from the Ateneo Graduate School of Business (Ateneo de Manila University). Dr Escalante was an elected member of the Provincial Board of La Union for nine years, and as such chaired the Committees on Health, Ethics and Good Government and Social Welfare and Development. She has extensive experience of local governance, lo- cal health systems and pharmaceutical management at the local level. Prior to joining WHO, she also worked with the Centre for Health Development-I of the Department of Health. 40

Name: Dr. Sonja Füsser Institution: Federal Ministry of Health, Bonn, Germany Country: Germany

Sonja graduated from Cologne University with a degree in law. She holds a PhD in law and is a specialist in the field of social security and health system. Sonja started her career with the German Federal (Social) Insurance Authority (Bundesversicherungsamt) where she dealt with legal problems which arise in con- nection with the authorization procedures of the Disease Management Programs. In 2005 Sonja joined the German Federal Ministry of Health as desk officer (Referentin) and deputy director. Her area of responsibility is the supervision of the Federal Self- Government Bodies, the implementation of a new reform legislation and the regulation of pharmaceutical spending in the statutory health insurance system. From September 2005 to March 2006 Sonja worked for the European Commission, Directorate-General Health and Consumer Protection. 41

Name: Mr. Jim Gee Institution: KPMG Forensic Country: United Kingdom

Jim Gee has more than 25 years operational, policy and strategic experience as a counter fraud specialist operating in the UK in central government, local government and the NHS. After 8 years heading up counter fraud work in London local authorities and advising the Association of London Government, he joined the Department of Health in 1998 as Director of Counter Fraud Services, to advise the Minister of State for Health and to establish and head the new NHS Counter Fraud Service (NHS CFS). In 2003 he became Chief Executive Officer of the NHS Counter Fraud and Security Management Service. Between 2000 and 2006 the NHS CFS has financially benefited the NHS to the tune of around £811 million – a 12 : 1 return generated from a £67 million budget. Fraud losses were reduced by up to 60%. The NHS CFS also has a 96% successful prosecution rate and has never lost a civil legal case on fraud. In 2003 his remit was expanded to cover security management in the NHS and to ensure the proper protection of NHS staff, patients, resources and property. Since that time he has succeeded in reducing assaults against staff for the first time. In 2005 he became Director-General of the new European Healthcare Fraud and Corruption Network (EHFCN), an organization which he helped found in 2004. At the founding conference, organizations from 29 countries unanimously agreed the Euro- pean Healthcare Fraud and Corruption Declaration. Since 2005, Jim has been a member of the UK Government’s Fraud Review Steering Group which developed the UK’s first cross-economy counter fraud strategy. This is now being implemented by Government and the UK Attorney-General asked him to chair the Fraud Review’s Stakeholder Group and Working Group on Fraud Loss Measurement. At the start of 2007, he joined KPMG Forensic as its Director of Fraud Services, with a remit to develop the holistic, professional approach he pioneered in the NHS, and to offer a high-quality, integrated service designed to accurately identify and reduce fraud losses. He has since delivered this service to the New Zealand Ministry of Health and is currently in discussions with colleague in Canada and South Africa. 42

Name: Dr. Hans V. Hogerzeil Institution: World Health Organization Country: Switzerland

Hans V. Hogerzeil MD, PhD, DSc, FRCP Edin. qualified as a medical doctor from Leiden University in the Netherlands and received a PhD in public health in 1984. For five years he was a mission doctor in India and Ghana and in 1985 he joined the WHO Ac- tion Programme on Essential Drugs, first in the Regional Office for the Eastern Mediter- ranean in Alexandria, and later in WHO’s Headquarters in Geneva. As a staff member of WHO he has advised more than 40 developing countries, especially in Africa and Asia, on the development of their national medicines policy, essential drugs list and essen- tial drugs programme. As Secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines he initiated the recent changes in procedures for updating the Model List of Essential Medicines, with stronger emphasis on evidence-based selec- tions. He established the web-based WHO Essential Medicines Library and is one of the editors of the WHO Model Formulary 2006. In his position as Director of the Department of Medicines Policy and Standards he is technically responsible for all WHO’s global policies, norms and standards on medi- cines. He is also the Chair of the Interagency Pharmaceutical Coordination Group which coordinates the pharmaceutical policies and programmes of all major UN agencies, the Global Fund and the World Bank. Dr Hogerzeil is the editor of several WHO books on essential medicines policies, the quality use of medicines, medicines in emergency situations and essential medicines for reproductive health. He has published over 50 scientific papers in peer-reviewed journals and teaches every year at international courses all over the world. In 1996 he was invited to become a Fellow of the Royal College of Physicians in Edinburgh and in 1998 he received an honorary Doctorate of Science from the Robert Gordon University in Aberdeen, Scotland. He is married with four children. His recent interests include essential medicines for reproductive health, and access to essential medicines as part of the fulfilment of the right to health. 43

Name: Mr. Martin Kreutner Institution: Federal Bureau for Internal Affairs, Federal Ministry of the Interior Country: Austria

Born in 1964; studied law at the University of Innsbruck. Commissioned officer in the Austrian Armed Forces with various troop, staff and ministerial assignments; served a total of five years with different UN and NATO missions in Syria, Israel, Lebanon and Albania. In 2000, he transferred to the Austrian Federal Ministry of the Interior and was commissioned to build up an anti-corruption service unit (BIA); since 2001 heads the Austrian Federal Bureau for Internal Affairs (BIA); 2004 obtained an additional degree as Master of Science in Policing and Public Order Studies at the University of Leicester in U.K.; guest-lectured on international humanitarian law at the German Red Cross, as well as the Ruhr University in Bochum, Germany; he also lectured on general and special security and anti-corruption topics at several European security and mili- tary academies as well as universities. In the course of his work he has spoken widely at international conferences – inter alia – in Brazil, Canada, China, Hong Kong, Jordan, Thailand and throughout Europe. Member of Interpol’s International Group of Experts on Corruption, member of the Executive Committee of the European Healthcare Fraud and Corruption Network, EH- FCN, member of the Advisory Board to Transparency International – Chapter Austria, juror to the Speyerer Quality Competition on Corruption, was put in charge of corrup- tion issues by the World Bank; he is a court expert on general criminology as well as VIP protection, in addition to being chairman of the Supreme Disciplinary Commission of the Federal Ministry of the Interior and member of the Federal Appeals Tribunal; author of many articles and papers on security issues, editor of a book on corruption (2006) and co-author of a legal commentary (2005). Martin Kreutner has maintained a relationship with his partner, a pharmacist. He loves sports, music and nature. 44

Name: Dr. Kerstin Leitner Institution: World Health Organization GGM Global Advisory Group Country: Germany

Kerstin Leitner earned her PhD with a thesis on socio-economic development in Kenya at Berlin’s Free University in her native Germany in 1975. A year later she embarked on what was to become a 27 year career with the UN Development Programme (UNDP). She held several posts in Africa, Asia, Europe and the Middle East. Most recently, from 1998 until 2003, she was UN Resident Coordinator and UNDP Resident Representative in China. Before that, from 1997 – 1998, she was Senior Special Adviser to the UNDP Assistant Administrator and Director in Asia and the Pacific. In September 2003, she became Assistant Director-General of WHO’s Sustainable De- velopment and Healthy Environments Cluster of departments. Her team has sharpened its focus on providing information and knowledge to numerous WHO Member States on the public health impact of environmental factors. 45

Name: Dr. Maureen Lewis Institution: The World Bank Country: United States of America

Maureen Lewis is Chief Economist, Human Development at the World Bank encom- passing health, education and social protection. Much of her research, publications and policy work examine governance and efficiency in the social sectors, particularly health. She was formerly a Senior Fellow at the Center for Global Development for two years and prior to that managed a unit in the World Bank dedicated to economic policy and human development research and programs in Eastern Europe and Central Asia. Before joining the World Bank, she established and oversaw the international health policy agenda at The Urban Institute. She has published dozens of articles in peer-reviewed journals on a range of topics in the social sectors. She earned her PhD. at Johns Hopkins University. 46

Name: Mr. Changyuan Lin Institution: State Food and Drug Administration Country: People’s Republic of China

Mr. Changyuan Lin is a principal staff member of the General Office in the State Food and Drug Administration (SFDA), PRC, where he is responsible for drafting policy re- ports and speeches that need to be delivered by the Commissioner. Before Joining the SFDA in 2004, he had been a researcher and assistant professor for 4 years in the Law Institute, of the Chinese Academy of Social Sciences. A lawyer, Mr. Changyuan Lin has both bachelor and masters degrees in law and was awarded a postgraduate diploma with distinction by London University in 2003. 47

Name: Dr. Maria Miralles Institution: Management Sciences for Health’s Rational Pharmaceutical Management (MSH) Country: United States of America

Dr. Maria Miralles is the Deputy Director for Management Sciences for Health’s Ratio- nal Pharmaceutical Management (RPM) Plus Program as well as the recently awarded Strengthening Pharmaceutical Systems (SPS) Program and is based in Arlington, Vir- ginia. She has more than 25 years of experience in public health and international development, half of them with a focus on pharmaceutical management. With a strong background in operations research, research design and methodology, and monitoring and evaluation, she has worked in all aspects of pharmaceutical systems and supply management. With RPM Plus and SPS, Dr. Miralles oversees programmes in more than 20 countries. She guides the development and implementation of appropriate phar- maceutical management mechanisms and systems based on best practices and the principles of good governance to increase access to quality essential medicines and enhance the effectiveness of health care systems. She holds a PhD in Pharmacy Health Care Administration in addition to a Masters degree in Anthropology. 48

Name: Dr. Zafar Ullah Mirza Institution: World Health Organization Regional Office for the Eastern Mediterranean Country: Egypt

Currently working as Regional Adviser – Essential Medicines & Biologicals at the East- ern Mediterranean Regional Office of the World Health Organization in Cairo, Egypt, covering 22 countries. Medical graduate with Masters in Public Health. Special inter- est, experience and trainings in drug policy/management issues. Other experience includes psychiatry and rural health service. In 1992 established a non-profit “Associa- tion for Rational Use of Medication in Pakistan” later transformed it into the first na- tional consumer organization in the country: “The Network for Consumer Protection”, served as its founding Executive Director for 12 years. The organization is active in pharmaceuticals, tobacco, water, unethical marketing, consumer mobilization, legal research, consumer redress, trade issues relevant to public health. In 1995 won Bri- tannia Scholarship for MPH in London and selected as Eisenhower Fellow for the year 2003 by Eisenhower Foundation, USA. Has served on the faculty of Boston School of Public Health and was part of UN Millennium project Task Force. Served as member of Foundation Board of Health Action International and as member of WHO International Scientific Advisory Group on Globalization and Health. Led a delegation of Consumers International at the 3rd & 4th WTO ministerial meetings in Seattle and Doha. Co- authored a joint WTO/WHO publication: “WTO Agreements and Public Health”. 49

Name: Mrs. Rosminah Mohd. Din Institution: Pharmaceutical Services Division, Ministry of Health Country: Malaysia

Rosminah Mohd. Din has a Masters in Medical Science (Public Health), 2003, University of Malaya, Malaysia, as well as a Bachelor of Pharmacy, 1983, South Australian Insti- tute of Technology, Australia. She is today Head of the Ministry of Health Drug Formulary Unit, in the Pharmaceu- tical Services Division. Her main job functions include Management of the MOH drug formulary, development of the Malaysian drug code (MDC), management of requests for drugs not included in the MOH formulary, and Secretariat to the National Drug Formu- lary Panel, which is responsible for the selection of drugs for inclusion in the MOH drug formulary, National Essential Drugs List (NEDL), pharmacoeconomics and GGM. Her areas of interests are: drug utilisation, quality use of medicines, pharmacoeco- nomics, medication safety and good governance. 50

Name: Ms. Nazarita Tacandong Institution: World Health Organization Regional Office for the Western Pacific Country: Philippines

Ms. Tacandong is a pharmacist by profession. She has obtained her Bachelor of Science in Pharmacy at the Southwestern University, Cebu City, Philippines. She pursued her studies and graduated with a Masters in Public Administration. Ms Tacandong is a short term professional at the World Health Organization, Western Pacific Regional Office in Manila. She has been with the Bureau of Food and Drugs, the national drug regulatory authority of the Philippines, for 29 years. She has taken the lead in the fight against counterfeit drugs in the country. As such, she has been invited as resource speaker/ lecturer to many conferences, both local and international. She was responsible for the implementation of Good Manufacturing Practices (GMP) for pharmaceutical establishments and later for cosmetic establishments, and eventu- ally for the drafting of GMP guidelines for food establishments. Ms. Tacandong has recently received the AWARD OF EXCELLENCE from the Philippine Federation of Professional Associations of the Philippines. In June this year, she was awarded “THE PRC OUTSTANDING PROFESSIONAL OF THE YEAR” in the field of Pharmacy and awarded as ALUMNI GREAT in January and also as Outstanding Pharmacist in the Government in 2006. Ms. Tacandong has been instrumental in the development of the National Ethical Infrastructure for Good Governance in the Philippines. She has represented the Bureau and the country in meetings on good governance. 51

Name: Dr. Eric Noehrenberg Institution: International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Country: Switzerland

Dr. Eric Noehrenberg is Director of International Trade and Market Issues at the In- ternational Federation of Pharmaceutical Manufacturers & Associations and has held this position since October 1999. In this capacity, Dr. Noehrenberg is responsible for negotiations regarding trade and market issues between the global, research-based pharmaceutical industry and the major international organizations involved in these issues, including the, the World Health Organization (WHO), the World Trade Orga- nization (WTO), and the World Intellectual Property Organization (WIPO). He is also responsible for AIDS issues, bioterrorism concerns, and Internet matters. Prior to joining IFPMA, Dr. Noehrenberg was an External Relations Officer in the unit of Donor and Corporate Relations, Joint United Nations Programme on HIV/AIDS (UNAIDS), from 1996 to October 1999. Dr. Noehrenberg was a Project Manager at the World Economic Forum from 1994 to 1996, where he was responsible for the develop- ment of the Global Growth Companies membership, as well as for coordinating Forum events in Singapore, the Mekong Subregion and Chicago. Dr. Noehrenberg began his career in the health field as a policy analyst in the de- partment of Pharma Economics and Policy at CIBA-GEIGY (now Novartis) headquarters in Basel. Dr. Noehrenberg graduated with a doctorate cum laude from the University of Tübin- gen, Germany. He earned his master’s degree with a concentration in International Trade and Finance from Harvard University and his Bachelor of Arts from Princeton University. 52

Name: Dr. Clive Ondari Institution: World Health Organization Country: Switzerland

Clive Ondari has over 20 years of experience in pharmaceutical policies and programmes, having worked for the Government of Kenya and WHO on various assignments. He holds a Doctorate in Pharmaceutical Sciences and Master of Science in Business Administra- tion (Strategic Planning). He started his career in academia and regulatory affairs in Kenya where he was Associate Professor and Head of Department at the University of Nairobi and Chairman of the Pharmacy Board (Committee on Registration of Medicines) for over 10 years. For the last 2 years, he has been the Coordinator for Medicines Policy, Access and Rational Use, which incorporates WHO Headquarter’s guidance work on national medi- cines policies, selection, supplies management and rational use of medicines. 53

Name: Dr. Steven Rood Institution: The Asia Foundation Country: Philippines

Steven Rood is The Asia Foundation’s country representative for the Philippines and Pacific Island Nations. In his concurrent role as Regional Advisor for Local Governance, he helps to build local government, decentralization, and municipal government pro- grammes throughout the region. Dr. Rood, an expert on local government, decentral- ization, and public opinion polling, has been a consultant to both government and nongovernmental organizations, including Associates in Rural Development Inc., The Social Weather Stations in Manila, and USAID. Dr. Rood served as professor of Political Science at the University of the Philippines College Baguio from 1981 until joining the Foundation in 1999, and was the only foreign faculty member with tenure in the University of the Philippines system. Dr. Rood is the author of a number of works on Filipino politics, with a special focus on democracy and decentralization. His most recent publication is Forging Sustainable Peace in Mindanao: The Role of Civil Society (East-West Center Washington, Policy Stud- ies 17, 2005); Education: B.A. in political science, University of Washington; M.A. and Ph.D. in political science from Boston University. 54

Name: Dr. Tsetsegmaa Sanjjav Institution: Health Sciences, University of Mongolia Country: Mongolia

Professor Sanjay has a Ph.D in pharmacy. She is also Dean of the School of Pharmacy, Health Sciences at the University of Mongolia in Ulaanbaatar. 55

Name: Mrs. Fatuma Sichale Institution: Kenya Anti-Corruption Commission (KACC) Country: Kenya

Mrs. Fatuma Sichale is the Deputy Director/Assistant Director in-charge of the Legal Services Directorate at the Kenya Anti-Corruption Commission. The Kenya Anti-Corrup- tion Commission is a statutory body set up to spearhead the fight against corruption in Kenya. She was appointed to this position in September 2004. Prior to her appointment as an Assistant Director, Mrs. Sichale was in private legal practice. Her practice of the law spans a period of over 20 years. She had also had a short stint at the judiciary where she resigned at the level of Resident Magistrate to enter into the competitive world of legal practice. Besides working in the judiciary and her legal practice, Mrs. Fatuma Sichale has served in other capacities i.e. i) She was one of the seven Board Members of the defunct Kenya Anti-Corruption Authority. ii) Advisor to the Kenya Anti-Corruption Police Unit, a body that replaced the defunct KACA. iii) Council Member, Law Society of Kenya. iv) Council Member of the Federation of Women Lawyers (FIDA) Kenya Chapter. v) Board Member, Kenya Anti-Corruption Commission before resigning to competitively apply for the position of an Assistant Director, Legal Services. Mrs. Sichale holds a Bachelor of Law degree from the University of Nairobi and a Di- ploma in Law and Practice from the Kenya School of Law. She is an advocate of the High Court of Kenya. 56

Name: Dr. Sri Suryawati (Surya) Institution: Centre for Clinical Pharmacology and Medicines Policy Studies, Gadjah Mada University Country: Indonesia

Dr. Sri Suryawati (Surya) is Acting Director of the Centre for Clinical Pharmacology and Medicines Policy Studies, and Coordinator of the Master Degree Program for Medicine Policy and Management, Gadjah Mada University. She is a member of the UN International Narcotics Control Board. Executive Board of the International Network for Rational Use of Drugs (INRUD), and the WHO Expert Advisory Panel for Medicine Policy and Management. She is also a WHO Expert Commit- tee member for the Selection and Use of Essential Medicines (since 2002), WHO Expert Committee member for the Medicines Causing Dependency (2002-2005), and a member of the UN Millennium Project: Millennium Development Goal Task Force 5 on HIV/AIDS, TB, Malaria, and Access to Essential Medicines. Her areas of work include medicines policy and promoting the quality use of medi- cines (since 1990), drug evaluation and new drug application (since 1987), and clini- cal pharmacokinetics and bioequivalence testing (since 1984). Since 1996 she has supervised >100 master and doctoral theses on clinical pharmacokinetics, medicine policy, medicine supply management, and improving medicine use in health facilities and the community. She also works as an international consultant on essential medicine programmes, promoting rational use of medicines, medicine policy, drug evaluation, bioequivalence testing, as well as being a Facilitator on various international training courses, e.g. on Promoting Rational Use of Medicines, Hospital Drug and Therapeutics Committees, and Medicine Policy Issues in Developing Countries. 57

Name: Dr. Chanvit Tharathep Institution: Bureau of Health Service System Development, Health Service Support Department, Ministry of Public Health. Country: Thailand

Dr. MD. Chanvit Tharathep, FRCST (Fellow of the Royal College of Surgeons Thailand), Diploma of Family Medicine Thailand, is the Director of the Health Service System Development Bureau in Thailand.

Other experiences: system analysis, hospital information systems, diagnostic- related group research awards:

1. Peritoneovenous shunt for ascites; Preliminary report. 2. Computer based information system for OR register. 3. Re-engineering of the Out Patient Department. 4. Peritoneovenous shunt for ascites or medical treatment, a prospective comparative study.

Current Responsibilities:

• Project about autonomous hospitals in Thailand. • Implementation of diagnostic-related group (DRG). • Hospital information system and other information in the Provincial Hospital Division. • Financing and budgeting for hospitals. • Pharmacy Information Centre. 58

Name: Dr. Sirinart Vasanavathana Institution: Office of Food and Drug Administration, Ministry of Public Health Country: Thailand

Education: B.Sc. in Pharmaceutical Science from Faculty of Pharmacy, Mahidol University, Bangkok, Thailand M.S. and Ph.D in Medicinal Chemistry, College of Pharmacy, The Ohio State University, Columbus, Ohio, U.S.A.

Experience: Review quality, efficacy and safety of pharmaceutical products submitted for registra- tion in Thailand. Review ethical and scientific issues for the Ethics Committee of the Ministry of Public Health, Thailand. Co-development of guidelines on bioequivalence studies, GCP in Thailand and WHO GMP for Radiopharmaceuticals, development of and training in Standard Operating Procedures for Ethical Review Committees in Asia and the western Pacific region. Co-editor and a writer of articles for Thai FDA and Safety Bulletin of Health Products Journals. Consultant on registration requirements for phar- maceutical products during research and development. Proceeding on reduction and phase-out of pharmaceutical products (Metered Dose Inhalers) containing CFC. Survey and evaluation of SIDCER-FERCAP quality on ethical review process of IEC/IRB commit- tee. Inspection and evaluation of manufacturing plants for GMP Compliance. Trainer on quality management, process validation and good laboratory practice. 59

Name: Mr. Paul Vincke Institution: European Healthcare Fraud and Corruption Network (EHFCN) Country: Belgium

Paul Vincke was Treasurer and Deputy Director-General from October 2005, before be- ing nominated President of the European Healthcare Fraud and Corruption Network in October 2007. In this new function he wishes to continue his efforts by committing himself fully to establishing a Network to be recognized and appreciated for playing an important role and providing real added value in countering fraud and corruption in healthcare in Europe and elsewhere. By profession Paul Vincke is Director of Staff at the Service of Medical Evalua- tion and Control (SECM) of the National Institute for Health and Disability Insurance, Belgium (INAMI). He has a degree in Criminology from the Katholieke Universiteit Leuven. After being with the National Pension fund for Miners as a Financial and Personnel Director for 14 years, he joined the SECM of the INAMI in 1999 becoming Director of Staff responsible for personnel, organization and general policy. As a member of the management team he is directly involved in the reorganization of the Service, aiming at the development of highly efficient systems and tools of evaluation, prevention, detection and investigation of alleged improper use of the Federal healthcare resources by healthcare providers. This should result in active surveillance of good medical prac- tice and the imposition of appropriate sanctions. 60

Name: Mr. Eshetu Wondemagegnehu Institution: World Health Organization GGM Global Advisory Group Country: Ethiopia

Mr Eshetu Wondemagegnehu is an Ethiopian by nationality. He holds B. Pharm. and MSc degrees in Pharmacy and Pharmaceutical Quality Control respectively. He has worked for the Ethiopian Government in different capacities, including as head of the Drug Control and Toxicology Laboratory at the Institute of Pasteur in Addis Ababa, Ethiopia, for over nine years and as head of the Drug Control Department of the Ministry of Health of Ethiopia for 12 years. From 1993 to 2006 he worked for WHO, Geneva, as a Technical Officer in the Department of Essential Drugs and Medicines (EDM). While at WHO, Mr Eshetu’s main work was building medicine regulatory capacity and training regulatory officers in Africa, Asia and other WHO regions; collaborating in the development of WHO norms and guidelines for ensuring the quality, safety and efficacy of medicines; carrying out operational research to assess the status of medicines regulation in Member States; developing WHO policy documents in the area of medicine regulation and quality assurance; promoting sub-regional and regional harmonization of medicine regula- tion; combating counterfeit and substandard medicines; training medicine regulators and other law enforcement authorities on detection and investigation of counterfeit medicines; enhancing inter-country, regional and interregional technical cooperation to promote ef- fective drug regulation; developing tools for assessing medicine regulation better manage- ment and implementation of quality assurance and regulatory mechanisms; and promoting awareness among the public, high level decision-makers and politicians, health profession- als, etc. of the need for effective medicine regulation. Mr Eshetu has also been active in conducting field studies and in the publication of WHO guidelines and documents. In connection with his work he has travelled to over 60 countries in Africa, Asia, Eu- rope, North America and the Pacific to organize training courses, provide technical support and make presentations on issues related to effective medicine regulation and counterfeit medicines. At present he works as a Pharmaceutical Consultant. He is also a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and the GGM Global Advisory Group. 61

EVALUATION FORM 64 Evaluation Form Your experience at this stakeholders meeting is important to us. Please take a few mo- ments to complete the following evaluation to give us your views on the meeting and what we can do better at future meetings.

Name

Institution

Panel Sessions and Panellists For the sessions you attended, please • indicate how interesting/relevant the session contents was for you/your institution 4 = Very high 3 = High 2 = Good 1 = Low • rate the value of the presentations and participation of the panellists within each session 4 = Excellent 3 = Very good 2 = Good 1 = Poor

Panel Session 1: Think transparency! Good Governance in the pharmaceutical sector.

Overall value of the panel session 4 3 2 1

Value of the presentation and participation of the panellist

Dr. Guitelle Baghdadi-Sabeti, WHO, Switzerland 4 3 2 1

Dr. Chanvit Tharathep, Ministry of Public Health, Thailand 4 3 2 1

Mr. Changyuan Lin, State Food and Drug Administration, China 4 3 2 1

Mrs. Gergana Andre, International Healthcare 4 3 2 1 and Health Insurance Institute, Bulgaria 65

Panel Session 2: The root of corruption. Understanding the issues to cure it!

Overall value of the panel session 4 3 2 1

Value of the presentation and participation of the panellist

Dr. Maureen Lewis, World Bank 4 3 2 1

Mr. Martin Kreutner, Bureau of International Affairs, 4 3 2 1 Federal Ministry of Interior, Austria

Transparency International Secretariat 4 3 2 1

Dr. Steven Rood, Asia Foundation, Philippines 4 3 2 1

Panel Session 3: Practicing transparency! Good Governance in the health sector.

Overall value of the panel session 4 3 2 1

Value of the presentation and participation of the panellist

Dr. Maureen Lewis, World Bank 4 3 2 1

Mr. Jim Gee, KPMG Forensic, United Kingdom 4 3 2 1

Mr. Paul Vincke, European Healthcare Fraud and 4 3 2 1 Corruption Network (EHFCN), Belgium

Dr. Eric Noehrenberg, International Federation of 4 3 2 1 Pharmaceutical Manufacturers & Associations 66

Panel Session 4: Keeping it together! The basic ingredients for ensuring Good Governance.

Overall value of the panel session 4 3 2 1

Value of the presentation and participation of the panellist

Dr. Eloy Anello, Nùr University, Bolivia 4 3 2 1

Dr. Sonja Füsser, Ministry of Health, Germany 4 3 2 1

Mrs. Fatuma Sichale, Anti-Corruption Commission, Kenya 4 3 2 1

Panel Session 5: Questioning transparency. Our panellists respond to you!

Overall value of the session 4 3 2 1

Panel Session 6: Rolling out transparency. What is your role?

Overall value of the panel session 4 3 2 1

Value of the presentation and participation of the panellist: 4 3 2 1

Mr. Anthony Boni, USAID, United States of America 4 3 2 1

Mrs. Carole Belisario, Procurement Watch Inc., Philippines 4 3 2 1

Dr. Niyada Kiatying-Angsulee, Chulalongkorn University, Thailand 4 3 2 1

Dr. Zafar Mirza, WHO Regional Office for the 4 3 2 1 Eastern Mediterranean, Egypt 67

Workshops For the workshop sessions you attended, please indicate how interesting/relevant the session topic and discussion was for you/your institution 4 = Very high 3 = High 2 = Good 1 = Low

1. BRIDGING THE RESEARCH GAP – what do we still need to know, and how do we go about it? 4 3 2 1

2. MAXIMIZING THE USE OF INTERNET TO INCREASE TRANSPARENCY how? 4 3 2 1

3. ESTABLISHING A NATIONAL GGM TASK FORCE what are the challenges ahead? 4 3 2 1

4. JOINING FORCES ON A NATIONAL LEVEL WITH ANTI-CORRUPTION AGENCIES what works, what doesn’t? 4 3 2 1

5. CAN YOU BREAK THROUGH THE GIFT-GIVING CULTURE? how do we bring transparency to the grey zone? 4 3 2 1

6. DEFINING INTEGRITY how do we raise the standards and motivate permanent change? 4 3 2 1

7. WHAT RADICAL CHANGES WILL TRANSPARENCY BRING TO THE PHARMACEUTICAL WORLD? who are the players? what will be the impact on public health? 4 3 2 1

8. SERVING TRANSPARENCY! How can WHO be of better service when facilitating GGM programme implementation? Give your ideas and feedback. 4 3 2 1 68

Rate the following aspects of the meeting 4 = Excellent 3 = Very good 2 = Good 1 = Poor

Overall value of the meeting 4 3 2 1

Meeting agenda 4 3 2 1

Networking events 4 3 2 1

Location 4 3 2 1

Hotel venue 4 3 2 1

Questions: What panel sessions and workshop topics would you like to see at the next stake- holders meeting?

How could the next meeting be a better and more valuable resource for you?

Do you intend to attend the next WHO stakeholders meeting? Yes / No 69

Any additional feedback or comments?

Thank you so much for your time, it is appreciated!

NOTES 72 NOTES 73 NOTES 74 NOTES 75 NOTES 76 NOTES 77 NOTES 78 NOTES 79 NOTES 80 NOTES 81 NOTES 82 NOTES 83 NOTES 84

WHO's Good Governance for Medicines programme was launched in 2004. It is currently operating in nineteen countries globally. The programme's goal is to reduce corrup- tion in pharmaceutical systems through the application of transparent, accountable administrative procedures and the promotion of ethical practices. Its ultimate aim is to ensure that essential medicines reach people – not the black market.

WHO is grateful to the German Federal Ministry for Economic Cooperation and Develop- ment (BMZ) for its financial support, without which this meeting could not have been held.

Additional information: http://www.who.int/medicines/ggm

or contact Dr Guitelle Baghdadi-Sabeti - Email [email protected]