Report of the WHO Technical Briefing Seminar for international staff active in

pharmaceutical support programmes

Seminar No 919 September–23 September 2005

BackgroundThe ninth technical briefing seminar was organized jointly by the Department of Medicines Policy and Standards (PSM) and the Department of Technical Cooperation for Essential Drugs and Traditional Medicine, in collaboration with UNICEF Supply Division, Copenhagen. The seminar took place in Geneva, from 19 September to 23 September 2005. The first such seminar was held in November 1998 for World Bank, WHO and UNICEF staff, and similar meetings have been held annually since.

Seminar objectivesBy the end of the programme participants will:

1. have a general understanding of the most common problems in the pharmaceutical sector in developing countries;

2. have a general understanding of how WHO and the UNICEF Supply Division support developing countries in strengthening the pharmaceutical sector;

3. appreciate the importance of national drug policies as the best approach to make essential drugs, of good quality, available to all who need them, and ensure the rational use of drugs; and

4. be aware of ways to strengthen collaboration with WHO and other organizations supporting the pharmaceutical sector in developing countries;

5. understand the impact of international agreements on pharmaceuticals.

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Target audience

The seminar is intended for technical advisers and field staff of WHO, and of other UN and bilateral agencies, governmental and non-governmental organizations active in pharmaceutical and health sector support programmes in developing countries. It is also open to medicines experts working in the public sector, academic institutions and civil society organisations.

Seminar web site A new web site was developed for this year's Seminar: http://mednet2.who.int/tbs/.

The site provided the programme, application form, PPT presentations from previous seminars, background readings and other useful information for prospective applicants and eventual participants. Different sections of the site, particularly the PPT presentations, were updated as and when new information was made available by the presenters.

At the end of the Seminar, an 'image' of the site (including the PPT presentations, key readings, etc) was burnt on CD-ROM and copies provided to all participants.

AnnouncementThe seminar was announced on the Medicines website shortly after the Seminar of March 2004, by an e-drug message on 19 April, by memorandum within WHO, to individuals and organizations on the Documentation Centre mailing list and to focal points in organizations known to be interested in pharmaceutical programmes. Members of the WHO Medicines family, including Regional Advisers, were also informed. It was made clear that all participants were to be self funded or had to arrange their own sponsorship.

Application and selection procedure

Potential applicants are requested to fill in a simple application form giving contact details and to allow scrutiny of the candidate’s credentials. Participants were selected by a Working Group of staff from PSM and TCM, taking into account academic background, work experience, nationality and gender of the applicants. A complete listing of participants and faculty is available at http://mednet2.who.int/tbs/PARTICIPANTS2005.doc.

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ParticipantsNumber of participants accepted 35Total number of participants who attended 28

Attending participants

Female Male

1612

Working from middle income and developing countries Working from developed country

1513

Accepted participants applied from:

Bosnia and HerzegovinaCabo Verde IslandsCanadaEgypt

FranceGhanaIndiaIndonesiaKenya Korea, NorthMalta

The NetherlandsPakistanPhilippinesSaudi ArabiaSomalia South Africa Spain

SudanUgandaUKUSAZambia

Professional affiliationsMinistry of Health 7NGO 6WHO country office 5UNHCR 1

University/academia 2Foundation 4Pharmaceutical industry 2 Independent consultant 1

Professional qualifications

Pharmacy Medicine Public health Communications

22 2 2 1

Law/Public policy 1

Programme

A copy of the final programme is to be found as Annex 1. The majority of presentations were made by senior and other staff members of the two departments. In addition, for certain sessions e.g. the panel discussion on the Access Framework, guest speakers were invited from other WHO departments, UNICEF and The Global Fund to fight AIDS, Tuberculosis and Malaria. A seminar reader was provided to all participants. This included relevant 6-pagers, the 12-page Medicines Strategy document and a few other selected materials from the Essential Drugs Monitor.

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Evaluation of the seminar

Colour coded evaluation sheets for each day of the seminar were given out at the start of each day and collected at the end. Participants were asked to evaluate sessions with regard to relevance and quality of presentation on scales of 1 to 5 and to make comments. In addition, participants had the opportunity to provide an overall view at the end of the Seminar.

The response rate was excellent and a number of participants took the opportunity to provide detailed comments and feedback on individual sessions. The average ratings per session and feedback received are provided in Annexes 2 and 3, to be used as appropriate by the organizers and presenters concerned.

Observations and conclusions

This year's seminar was greatly enhanced by joint facilitation by R Laing (PSM/PAR), Z Mirza (Regional Adviser, EMRO) and J-M Trapsida (Regional Adviser, AFRO). The interventions and regional perspectives provided were appreciated by the participants.

The seminar was oversubscribed and very well received, and the next seminar is being planned for 2006.

The optimal number of participants for the Seminar in Salle G is 30 people. Consideration may be given to changing the room used for the seminar to M505.

This year the vast majority of PPT presentations were provided by staff in advance and were posted on the Seminar web site. Paper handouts were provided at the start of each session rather than in the participants' folder for convenience and also because a number of presenters mentioned that they might make last-minute changes to their slides.

'Not enough time' and 'more time for group discussion' were as always the two most repeated comments. Participants did, however, appreciate the difficulties in achieving a balance between presentation and discussion, given the range of issues covered.

The panel discussion format was a success, and there were calls for more of the same in future.

Significantly, there were no 'complaints' this year about the PPT slides. On the contrary, some participants did point out that the slides were useful in following the session when the accent or delivery of the presenter was unfamiliar to them.

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Recommendations

All speakers should again be invited to provide their presentations in advance of the seminar to allow time for web posting and preparation of handouts. It would very helpful if presenters avoided making minor, last-minute changes to the PPT slides - easy to do in PPT but the consequences in terms of organization are nothing short of panic-inducing.

Participants appreciated receiving a CD-ROM of the Seminar and this should be repeated.

Next seminar

Dates to be decided.

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Annex 1: Programme

Monday 19 September 2005 (Facilitation: Dr Richard Laing, Dr Zafar Mirza, Dr Jean-Marie Trapsida)

Registration08.45 – 09.00 Salle G, Main building (8th floor)

Introduction09.00 – 09.30 Welcome - Objectives of the Seminar

Dr Hans V. Hogerzeil, Director PSM, Dr Precious Matsoso, Director TCM

09.30 – 10.15 Introduction of participants: Gallery of ExpertsDr Zafar Mirza, RA/EMRO

10.15 – 10.45 Coffee

10.45 – 11.00 Seminar Overview and Administration Dr Richard Laing, Dr Lalit Dwivedi, PSM/PAR

11.00 – 12.30 PSM and TCM roles and responsibilities in implementing the WHO Medicines Strategy Dr Hans V. Hogerzeil, Director PSM, Dr Precious Matsoso, Director TCM(Background documentation: WHO Medicines Strategy: 2004-2007 Countries at the core)

12.30 – 14.00 Lunch

National Drug Policies14.00 – 14.30 National Medicines Policies

Dr Richard Laing, PSM/PAR, Dr Hans V. Hogerzeil, Director PSM(Background documentation: How to develop and implement a national drug policy)

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Selection of Essential Medicines14.30 – 15.30 Update 2005 WHO Model List of Essential Medicines

Selection, Evidence-Based ApproachDr Hans V. Hogerzeil, Director PSM (Background documentation: The Selection of Essential Medicines)

15.45 – 16.00 Tea

Information resources16.00 – 17.00 EDM Documentation Centre, Essential Medicines Library

& Bookshelf, WHO Model FormularyMr Claude Da Re, Dr Lalit Dwivedi, PSM/PAR(Background documentation: Selected key publications in Essential Medicines)

17.30 – 19.00 Reception (Asian Buffet) with PSM & TCM staff members(WHO Restaurant, Main Building)

Tuesday 20 September 2005(Facilitation: Dr Zafar Mirza)

What is quality? 09.00 – 12.30 Medicine/Drug regulation and quality assurance

WHO normative functions in the field of pharmaceuticalsDr Lembit Rägo, Dr Sabine Kopp, PSM/QSM(Background documentation: Effective medicines regulations)

Assessment of regulatory capacity at country level including 10 country studyDr Valerio Reggi, Mr Eshetu Wondemagegnehu, PSM/QSM(Background documentation: Essential Drugs Monitor No. 32 pages 2 & 3)

10.45 – 11.00 Coffee

12.30 – 14.00 Lunch

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Prequalification 14.00 – 15.30 Prequalification of essential medicines

Dr Lembit Rägo, Mr Olivier Gross, PSM/QSM(Background documentation: Prequalifying Priority Medicines)

15.30 – 15.45 Tea

Global issues

15.45 – 17.00 Impact of globalisation, international trade agreements, Doha, CancunDr German Velásquez, Ms Cecilia Oh, TCM/DAP(Background documentation: Globalization, TRIPS and access to pharmaceuticals)

Evening: Dinner, Geneva (Optional: all have to pay for themselves: sorry!)

Wednesday 21 September 2005(Facilitation: Dr Richard Laing)

What is access?09.00 – 11.30 Access framework, HIV/AIDS, TB and Malaria

Ms Marthe Everard, Dr Clive Ondari, PSM/PAR, Mr Peter Graaff (WHO/HIV), Mr Robert Matiru (GDF-TB), Dr Murtada Sesay (UNICEF), Mr Luca Li Bassi (Global Fund), Mrs Helen Tata, TCM/DAPShort presentations + Panel discussion(Background documentation: Equitable access to essential medicines)

10.30 – 10.45 Coffee

11.30 – 12.30 Essential Medicines as a Human RightDr Hans V. Hogerzeil, Director PSM(Background documentation: Essential Drugs Monitor No. 33 pages 25 & 26)

12.30 – 14.00 Lunch

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Medicine Prices and Financing

14.00 – 15.45 Medicine prices, WHO/NGO Price Survey MethodologyDr Richard Laing, PSM/PAR, Dr Gilles Forte, TCM/DAP(Background documentation: Medicine Prices - a new approach to measurement)

15.45 – 16.00 Tea

Hot Topics (to be revised based on participant interest)

16.00 – 17.30 Medicines promotion and ethical criteriaDr Guitelle Baghdadi, PSM/PARKey issues in access and best practices: MDGs; private sector (OTC/prescriptions); human resources; medical education curricula; special needs in small countriesDr Richard Laing, PSM/PAR, Dr Zafar Mirza, RA/EMRO

Thursday 22 September 2005(Facilitation: Dr Jean-Marie Trapsida)

Country programmes

09.00 –9.30 WHO Strategy for working with and in countriesDr Gilles Forte, TCM/DAP(Background documentation: WHO Medicines Strategy 2004-2007)

9.30 –10.45 TCM strategy for working with countries - regional and country perspectiveDr Jean Marie Trapsida, WHO/AFRO, & TCM team

10.45 – 11.00 Coffee

11.00 – 12.30 EDM strategy for working with countries - the experience of KenyaMrs Helen Tata, TCM/DAP, Dr Regina Mbindyo, WHO/AFRO(Background documentation: Essential Drugs Monitor No. 33 pages 2 & 3)

12.30 – 14.00 Lunch

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Monitoring

14.00 – 15.30 Indicators on pharmaceutical situationsDr Daisy Carandang, TCM/DAP

15.30 – 15.45 Tea Traditional Medicine16.00 – 17.30 International harmonization focus on the regulatory

requirements for quality and safety of herbal medicinesDr Samvel Azatyan, TCM/TRM(Background documentation: Traditional Medicine - Growing Needs and Potential)

Friday 23 September 2005(Facilitation: Dr Richard Laing)

Safety

09.00 – 10.00 Pharmacovigilance: New challenges for WHODr Mary Couper, Dr Shanthi Pal, PSM/QSM(Background documentation: Pharmacovigilance: ensuring the safe use of medicines)

What is rational medicine use? 10.00 – 12.30 Promoting rational medicine

Dr Kathleen Holloway, PSM/PAR (Background documentation: Promoting rational use of medicines: core components. Containing antimicrobial resistance)

10.45 – 11.00 Coffee

12.30 Closure

14.00 Additional time for sessions, individual appointments with TCM/PSM staff

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ACRONYMS

PSM Department of Medicines Policy and StandardsQSM Quality Assurance and Safety: MedicinesPAR Policy, Access and Rational UseTCM Department of Technical Cooperation for Essential Drugs

and Traditional MedicinesDAP Drug Action ProgrammeTRM Traditional Medicine

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Annex 2: Evaluations by participantsRelevance of session (n = no. of completed evaluations: score range 1 - 5, high = 5 low = 1)National drug policies (n=27) 4.70Essential Medicines Update 2005 (n=26) 4.69Information resources (n=27) 4.52Quality assurance and WHO normative functions (n=27 ) 4.22Regulatory capacity assessment (n=27) 4.48Prequalification (n=27 ) 4.44Impact of globalization (n=26 ) 4.27Panel discussion - Access framework (n=25 ) 4.84Essential medicines as human right (n=25 ) 4.6Medicine prices (n=24 ) 4.67Hot topics session (n=20 ) 4.05TCM strategy -working with regions & countries (n=24 ) 4.33TCM strategy - regional perspective (n=24) 4.29TCM strategy - country perspective (n=25) 4.52Indicators (n=27) 4.59Traditional medicine (n=11) 4.27Pharmacovigilance (n=25) 4.64Rational use (n=25 ) 4.8

Calculated average rating 4.50Quality of session (n = no. of completed evaluations: score range 1 - 5, high = 5 low = 1) National drug policies (n=27) 4.56Essential Medicines Update 2005 (n=26) 4.58Information resources (n=27) 3.96Quality assurance and WHO normative functions (n=27 ) 3.74Regulatory capacity assessment (n=27) 4.67Prequalification (n=27 ) 4.59Impact of globalization (n=26 ) 4.35Panel discussion - Access framework (n=25 ) 4.52Essential medicines as human right (n=24 ) 4.79Medicine prices (n=24 ) 4.54Hot topics session (n=20 ) 3.95TCM strategy -working with regions & countries (n=22 ) 3.86TCM strategy - regional perspective (n=22) 3.86TCM strategy - country perspective (n=22) 4.55Indicators (n=25) 3.72Traditional medicine (n=9) 3.55Pharmacovigilance (n=24) 4.75Rational use (n=25 ) 4.8

Calculated average rating 4.30

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Annex 3: Participants comments

This unsorted listing is primarily intended as feedback for presenters and organisers. Quotes are verbatim and a number of positive but non discriminatory comments (often one word) have been left out.

Monday 19 September 2005

1. National medicines policies Very good presentation. Now that 138 Member States have NDPs,

emphasis should shift to implementation, monitoring and evaluation.

Very clear and well conducted. Nice introduction and overview of the process of making NDPs, challenges and stakeholders involved.

Would like to see more comparing and contrasting good and bad policies. More examples would be great.

A rather quick overview, more depth would be better. Time is quite limited. Some issues need more elaboration.

2. WHO Model List of Essential Medicines: 2005 update Sessions were very involving, informative and have given a clear

understanding of what happens in terms of updating and reviewing such important lists. Keep up the good work, it's not easy!

Experienced and good communicator Again, comparing and contrasting good and bad examples would

be great. Nice lecture, but Mr Hans H speaks very fast.

3. Information resources Navigation of the web site was a bit rushed. Select some

publications which can be demonstrated fully, rather than random picking during the presentation.

Good and informative as this information is not easy to find. The availability of the key documents in Word is really a good idea.

Communication was not very clear due to different tones (dialects) Good overview of knowledge resources by a committed and expert

team. Too much time on how to get documents for free. WHO should not

discuss internal differences on book pricing policies but solve them internally.

A bit too much complaining about moving to Net, though it is legitimate to still have paper documents available.

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Tuesday 20 September 2005

4. Quality assurance and WHO normative functions The second part of the session had a very broad scope and it was

difficult to follow. No time to get deeper into very interesting topics which were treated too generally (MR).

Presentation could have been briefer. Would have been better as the first presentation for an overview (MR).

Dr Rago's presentation was very informative and balanced. Second presenter went into too much detail in the beginning.

5. Assessment/strengthening regulatory capacity & assessment

Highly relevant topic, very engaging presenter. Countries have varying levels of capacity to conform to ideal

regulatory requirements. The talk deliberated on all possible situations.

6. Prequalification of essential medicines Was a very good, broad overview of prequalification. Very relevant for those coming from the developing world. More time required as it is a critical topic to most of us with the

scaling up of program's HIV/AIDS 3x5 initiative.

7. Impact of globalization Very good presentation with good overview of IPR relation to

Access to Medicines. She speaks too quick although the information is very interesting

and more time to debate will be interesting. Maybe too TRIPS focused - there are number of other issues

affecting access. Presenter showed clear command of subject. Cecilia however was

little too fast. The more one dilates on this topic the more one confuses the

audience. Might be interesting to present the industry's view/innovator's

view on TRIPS.

Wednesday 21 September 2005

8. Access framework: panel discussion Good presentation - foundation of drug supply mgt system. The

panel was great and it was a very good idea to have them here. Fantastic. Panel discussion is a rich way to discuss. I think can be

used more in the TBS. Also we can promote group discussion among participants.

Useful information, but too many presenters made it difficult to absorb information.

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9. Essential medicines as a human right A very provocative and very well thought out session. Good delivery, very strategic for the empowerment of consumers

and assurance of regulatory efficiency. Most relevant subject linking HR obligations of govts.

10. Medicines prices Interesting project and results. Discussion about prices was useful

for thinking about policies at country level. Excellent facilitation and presentation. Very hands-on demonstration & discussion of pros and cons, ways

to control pricing, very enlightening.

11. Hot topics More participants presentations could bring the group experience

out for everybody's benefit. Promotion topic very good, but more data required from

developing countries. Very useful to have a specific time set aside for participants to

raise issues and share experiences. A rich experience sharing, can be in future improved. All

presentations organized by call for papers before meeting. Promotion of medicines presentation was one-sided + contained

out-of-date information. Priority medicines was excellent.

Thursday 22 September 2005

12. TCM strategy for working with countries The topic is very relevant as we got to know more about the

operations of WHO in the area of Essential Medicines policy implementation & related issues in member countries.

13. TCM strategy for working with countries - regional perspective

Good opportunity to know more about the roles of NPOs in their countries of operation.

The speaker was precise in presentation and gave clear observations on questions asked.

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14. Indicators on pharmaceutical situations A bit long, but very useful information. From my point of view, the session was very complex. Very

important topic which deserved another kind of approach. Too many results presented in overheads which deserved more analysis. Methodology could have been better explained.

Good presentation, discussion was skewed, i.e. participation was poor.

15. Experience of Kenya Important to show the specifics of a case example in a country.

Also useful to hear the logistics of how country level is connected to HQ.

Interesting to see and hear from a concrete example the work of WHO regional offices.

Very useful in involving participants at the introduction to pose questions and look up answers (Helen's session).

16. Traditional medicine: international harmonization focus Presenter spoke softly. Good overview of traditional medicine from WHO perspective. The session raises a very important issue - the need to regulate

traditional medicine. It was interesting and well conducted but did not provide solutions or ideas as to possible ways to do it.

Friday 23 September 2005

18. Pharmacovigilance Good presentation and good interaction with participants Good slides. Interesting to see what can be done. Might be interesting to shed more information and knowledge of

how the WHO Collaborating Centres in Uppsala works and 'success stories' of their work.

19. Promoting rational medicine use Very good, interactive session. More time on this session would be

good to discuss better the implementation of RDU policies at country level.

The best session of the entire seminar. Highly relevant, and the interactive technique the presenter used were very effective.

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20. General comments on the seminar Very valuable course overall, many excellent presentations, well

run and facilitated. The main issues in essential medicines policies were clearly

conveyed … More workshops and exercises would help increase interaction. It would make the seminar that little bit better if there was more contribution from developed countries and their experience.

The participants were well selected making all the topics relevant to their work; this kept us coming and we really looked forward to what else was in store. ... The Bookshelf and all the Internet links have been appreciated.

Should allocate time to review expectations forwarded by participants.

A couple of presenters did not really seem enthusiastic. I therefore think selection of presenters need to be reviewed.

Thank you for the abundant and concentrated material provided even before we asked for them.

Drinking water ran out by the afternoons most days … Improve ventilation in the rooms

I would like more panel presentations + discussions instead of presentation from slides (Access panel was excellent).

I learnt a lot and think a broader audience (at country level or at least at regional level) should have the same opportunity.

I feel we lack points of view from a pharmaco-economics view on the issues of essential medicines policies.

I got information that enables me to try to implement some action in problematic areas in my country.

Learnt a lot on Thursday on how cooperation within or with WHO works. Actually, Thursday was the best day paying a lot of attention to processes.

Time discipline in managing sessions exemplary. Excellent general management capabilities exhibited by all ranks connected with Seminar.

Crucial recommendations made here should be noted and disseminated widely.

Lalit Dwivedi, PSM/PAR, September 2005

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