Organizer:
KILEN-Consumer Institute for Medicines and Health
and Consumers´ Association for Medicines and Health

In co-operation with:
Dag Hammarskjöld Foundation
HAI - Health Action International
HAI - Sweden
People's Health Assembly 2000
Uppsala Monitoring Centre
The Swedish Consumers' Association
The Sigtuna Foundation

The Conference is sponsored by:
SIDA (Swedish International Development
Cooperation Agency)
The National Board of Health and Welfare
The National Institute of Public Health

Organizing committee:
David Finer, IHCAR, Karolinska Institutet
Jan Albinson, KILEN
Lena Westin, KILEN
Graham Dukes, Editor of the "International Journal
of Risk and Safety in Medicine", compiled and edited the Concensus Document.

The Swedish organisation KILEN applies a consumer perspective to its work on issues of dependence, side effects and injuries related to medicinal drugs as well as to health care in general. During the early years, from 1975-1991, these activities were conducted within the framework of the client organisation RFHL, the National Swedish Association for Assistance to Abusers of Medicinal Drugs.

Originally, KILEN started its work because of needs expressed by people who suffered from problems related to the use of medicinal drugs. They were dependent on them or had suffered other adverse effects from them and were unable to get any help within the health care system. The system denied their problems against the backdrop of pharmaceutical marketing which promoted the image of drugs as efficient, almost devoid of adverse effects and lacking potential for dependence.

In 1992, we founded KILEN as an Institute for the development of methods of treatment, building a knowledge base and influencing public opinion, all in the interests of prevention. We provide treatment with confidentiality and accept people from the whole country seeking help for problems related to dependence, side effects and other health care-related problems. To a significant extent, we also provide these services by telephone.

The preventative work includes information, seminars, training and direct contact with health care staff, politicians and the general public. The Institute is mainly run on public funding.

From the outset, there was controversy surrounding the issues of drug dependence, side effects and health-related injuries. Public debate in Sweden quickly became bogged down in a quagmire. In 1993, we started a Nordic collaboration in order to loosen this national stranglehold and simultaneously to investigate conditions in our neighbouring countries. In 1994, KILEN organised the first Nordic seminar, "Drug dependence in a Nordic perspective", gathering together representatives of consumer organisations, clinicians, researchers and authorities from the Nordic countries. Since then, we have arranged three more seminars in various Nordic countries on the same theme.

In 1995, at the Reykjavik seminar, KILEN was given the task of establishing a data base of adverse drug effects, based on reports straight from the consumers

themselves. The background was the fact that our program to assist those with problems of dependence on medicinal drugs had benefited from knowledge about drugs provided by the patients.

In 1997, the consumer data base ELIN (in Swedish the acronym stands for Experiences of Medicinal Drugs in the Nordic countries) started to receive financial support from the European Commission as well as from the National Board of Health and Welfare and the National Institute of Public Health. ELIN was built up of reports from consumers, family members and health care professionals.

There is now considerable experience gathered from working with the ELIN data base. Some of the most significant lessons learned are:

• Consumers are extremely keen to share their experiences of drugs - if only somebody cares to listen!
• Consumer reporting of drug-related problems contributes to alerting us to early signals and problems. It is an important complementary "early warning system".
• Consumer reporting of drug problems contributes to strengthening consumers in a situation where otherwise the manufactures exercise total market control.
• Consumer reporting contributes to increasing knowledge about medicinal drugs and thereby to reducing drug-related adverse effects and injuries.
• There is a lot of interest in this model on the part of low-income countries, where in many cases systems and organisations for the reporting of side effects are lacking.

Hence, this conference is being organised on the basis of work spanning a quarter of a century in order to make the best use of patient and consumer experiences of medicinal drugs.

The experiences of consumers and their willingness to report any problems is an un-tapped force which this Conference seeks to call attention to. We wish to create global co-operation in order to learn from the reactions of consumers to drugs and to create a consumer pharmacovigilance system.

Jan Albinson Lena Westin

Male managing director Female managing director

We need drugs

We need drugs to alleviate symptoms and cure diseases.

We need drugs so that each of us during our lifetimes can contribute our share of work, enthusiasm and other benefits to the world around us.

The job of making drugs accessible for those in need of them is unfinished. Access to so called essential drugs is lacking in many countries of the world. In other countries, there is an abundance of drugs; yet many serious diseases still cannot be cured. In addition, in both these categories of countries, we find a number of drugs which have no effect as well as drugs which do more harm than good.

Hence, in working towards equitable drug utilization, we cannot be content with simply providing access to drugs. We should add the condition that they be of good quality. The drugs must have the desired influence on the symptoms or diseases and be as free of adverse effects as possible.

We need knowledge

Currently, as patients or consumers of the products of the pharmaceutical industry, we are almost completely dependent on the information about drug effects and side effects provided by the manufacturers. The same is true for our physicians, pharmacists and authorities.

That portion of knowledge about drugs with which the industry provides us is intended to market the product and is not necessarily beneficial to our health. Neither does it always protect us from side effects or injuries or assist us in adopting a more critical approach towards the use of drugs.

In the case of a new drug, we know that the knowledge available to the manufacturer is also limited, even when the drug has been subjected to extensive clinical trials. We know that it will not have been tested on children, not on pregnant women,

typically not on elderly people and usually not in combination with drugs for other diseases than it is intended for. Yet, we know that it will be used among these groups of people as well. We know that it might be used among many millions of people instead of a few thousand people, as in the clinical trials.

Hence, we are faced with the need for knowledge which can be rapidly compiled and communicated to prescribers, dispensers and consumers in order to maximise the benefits of the drug and minimise its hazards for the user.

Currently, an almost limitless and vital source of knowledge about drugs, their effects and side effects remains virtually untapped. We refer to the experiences and reactions of the drug users themselves. Even in countries with existing systems for receiving reports of adverse drug reactions (ADRs), they are commonly limited to receiving reports from physicians or other professional staff. These systems are necessary but they are also fraught with weaknesses and there are many arguments for supplementing them with systems for direct-from-consumer (DFC) reporting.

A broader base for collecting knowledge would in addition to providing a more sophisticated and rapid information growth also clearly demonstrate to the consumer that s/he shares the responsibility for the effects of the drug. In this way, a system for gathering user experiences also serves to counteract the enormous resources which the pharmaceutical industry devotes to marketing activities.

In addition, it serves to strengthen the role of the consumer/drug user as a partner in the discussion about what drugs we need and how and when they should be used.

In working towards rational use of drugs (RUD), patient participation and responsibility are decisive factors without which the concept of RUD can have no real meaning.

We build knowledge

Knowledge is a prerequisite for participation and shared responsibility. For this reason, it is vitally important that the knowledge that has been collected about a drug can also be communicated to those who use them. Whatever society we live in, we know that the kind of knowledge we are most likely to accept is knowledge that affects us directly. So knowledge about drugs should be established and communicated directly via consumer, patient and practitioner organisations. Obviously, when possible, this should be done in co-operation with national and international regulatory authorities.

The objective of the Conference Consumer Reports on Medicines is to give participants the tools and the inspiration needed to establish systems that capitalise on user experiences. These systems must be national, maybe even local ones, but they should also be co-ordinated in an international network for development and exchange of methods as well as knowledge. The Conference also seeks to lay the foundation of such a network.

The aims of the Conference are to:

• Make invisible knowledge visible
• Establish a pharmacovigilance system based on consumers' experiences of
  drugs
• Increase drug users' knowledge about the effects and side effects of drugs
• Develop a countervailing force to the marketing efforts of the pharmaceutical industry
• Emphasise pharmacovigilance as an indispensable instrument in working for improved public health

The Conference (CRM) aims for a movement towards the goals formulated for the People´s Health Assembly, to be held December 4-8, 2000 in Savar, Bangladesh.

• To hear the unheard;
• To reinforce the principle of health as a broad cross-cutting issue;
• To develop co-operation between concerned actors in the field;
• To formulate a People's Health Charter;
• To improve communication between concerned groups, institutions and actors; and
• To share and increase knowledge, skills, motivation and advocacy for change

11.30
Lunch

12.45
Music

13.00
Welcome greetings.
Dr Mary R. Couper - WHO
Olle Nordberg - Dag Hammarskjöld Foundation
David Finer - Karolinska Institute
Jan Albinson & Lena Westin - KILEN

13.30
It´s all about me and you.

13.40
Knowledge about drugs
Dr. K. Balasubramaniam

14.05
Round-table discussions

14.20
Pharmacovigilance systems throughout the world
Dr. Sten Olsson - WHO - Uppsala Monitoring Centre

14.45
Round-table discussions

15.00
Coffee, tea

15.30
Consumers have a part to play
Dr. Rohini Fernandopulle 15.30
Jan Albinsson & Lena Westin - KILEN 15.55

16.15
Round-table discussions

16.30
Direct-to-consumer Advertising
Charles Medawar - Social Audit

16.55
Round-table discussions

17.10
Break

19.00
Welcome speech
Dr. Gunnar Ågren , Director-General, National Institute of Public Health

19.20
Dinner

20.30
Get to know your theme-group members

21.00
Socialising and refreshments

07.00
Breakfast

07.30
Movements
Francine Lee Mirro-Finer

08.30
Meditation
Chaplain Håkan Sandvik

09.00
It´s all about me and you.

09.10
Summary of responses to the five questions
David Finer

09.25
Round-table discussions

09.40
Experiences of different systems/initiatives for Direct-From-Consumer reporting.
Marianne Beutler - Switzerland
Manubai Shah - India
Sonja Wallbom - Sweden
Gio Bakker - The Netherlands
Libby Roughead - Australia
Andrew Herxheimer - Great Britain

11.30
The Consumer database ELIN presentation
Jan Albinsson & Lena Westin - KILEN

12.00
Lunch

13.30
Introduction to workshop

13.40
Workshop (in themegroups including tea, coffee)

15.30
Presentations

17.00
Plenary discussions

17.30
Break

18.00
Dinner

20.00
Socializing, refreshments and music

07.00
Breakfast

07.30
Movements
Francine Lee Mirro-Finer

08.30
Meditation
Chaplain Håkan Sandvik

09.00
It´s all about me and you

09.10
Consumer reports and drug safety
Dr. Wilbert Bannenberg
Sharon Batt

10.00
People's Health Assembly 2000
Olle Nordberg

10.20
Summary and conclusions.
The network RE:ACT

11.45
Break-up cermony, Music

12.00
Lunch

14.00
Departure. Social programme in Stockholm

Post conference activity
Monday, the 2 of October. Studyvisits. See other place

Organizer:

" KILEN ; Consumer Institute for Medicines and Health and Consumers´ Association for Medicines and Health

In co-operation with:

" Dag Hammarskjöld Foundation

" HAI ; Health Action International

" HAI ; Sweden

" People's Health Assembly 2000

" Sigtuna Foundation

" Uppsala Monitoring Centre

" The Swedish Consumers' Association

KILEN works with medicine dependency, side effects and injuries of health care based on a consumer and patient perspective. During the early years, 1975-1991, this work was carried out within the framework of the organisation RFHL.

In 1992, KILEN was established ; an Institute which can offer anonymity and which serves people from all over the country who seek help for medicine dependency, side effects and problems related to health care.

Preventative work is an important aspect of the work at the Institute. This takes the form of information-giving, seminars, training and direct contacts with health care staff, politicians and the general public. The running of the Institute is mainly supported by public funds.

 The background of the conference is 25 years of work documenting the experiences and reactions of consumers and patients to medicinal drugs. We know that the experiences and willingness to report drug effects that consumers have constitutes an untapped force that we hope to highlight during this conference.We aim to achieve global co-operation to utilize consumer reports of medicinal drugs ; and create a consumer pharmacovigilance system!

In 1997, the consumer data base ELIN (ELIN = Experiences of Medicines in the Nordic Countries) for reporting medicine reactions straight from the consumer as well as from others (professionals groupings, relatives, etc) received funding from the EC as well as from the National Board of Health and Welfare and the National Institute of Public Health.

There is now considerable experience gathered from working with the ELIN data base. Some of the most significant lessons learned are:

• Consumers are extremely keen to share their experiences of medicines ; if only somebody cares to listen!
• Consumer reporting of drug-related problems contributes to alerting us to early signals and problems. It is an important complementary "early warning system".
• Consumer reporting of drug problems contribute to strengthening consumers in a situation where otherwise the manufactures exercis total market control.
• Consumer reporting contributes to increasing knowledge about medicinal drugs and thereby to reducing drug-related adverse effects and injuries.
• There is a lot of interest in this model on the part of low-income countries, where in many cases systems and organisations for the reporting of side effects are lacking

Conference aims

The Conference seeks to provide the participants with tools and inspiration to establish systems for utilizing the experiences and reactions of the consumers of medicinal drugs. These systems must be both national and international in scope, but they also need to be coordinated in an international network. The Conference aims to establish such a global network ; Consumers' Coordination of Pharmacovigilance.

The aims of the Conference are to:

• Make invisible knowledge visible
• Establish a pharmacovigilance system based on consumers´ experiences of drugs
• Increase drug users knowledge about the effects and side effects of drugs
• Develop a countervailing force to the marketing efforts of the pharmaceutical industry
• Emphasise pharmacovigilance as an indispensable instrument in working for improved public health.

Conference participants

People from all over the world will participate in the Conference. The Conference primarily targets consumer organisations in the health field but also concerned professionals and national and government authorities working in pharmacovigilance.

The number of participants is estimated at about 70. The Conference program will be distributed in about 10 000 copies, both in the form of a "paper programme" and as an e-mail programme. In addition, it will be advertised in various NGO magazines as well as in the trade journals.

We know from experience the great importance of the preparatory work for a Conference of this kind, aiming as it does towards achieving a concrete outcome. Not only is it important to attract people to the Conference. It is also necessary to ensure that a discussion on these issues is initiated and that the "consumer movement" in the field of medicines and health grows and develops.

Sweden is a costly country for conferences. This is particularly true in terms of providing real opportunities for consumer organisations globally to participate. Hence, the conference fee is low, as it should be.

We hope to be able to provide financial support for both conference fees and travel expenses for key individuals in the NGO community to take part, people who we know can be inspired and can communicate the experiences from the Conference to others. By participating in the Conference, interested key individuals will also get the opportunity to take part in the global network Consumers Coordination of Pharmacovigilance ; CCP.

Why Sweden?

Despite the fact that Sweden is an expensive country for conferencing, it is important to stage the meeting there. KILEN is one of the first consumer organisations to establish a system of reporting consumer reactions to medicinal drugs. This statement may be supported by the fact that the WHO Collaborating Center for Drug Monitoring in Uppsala, in responding to questions on consumer reporting, refers to the experiences of KILEN. In other words, we could even say that Sweden is the "homeland" of consumer reporting. The fact that the WHO Collaborating Center for Drug Monitoring is situated in Sweden is an additional argument for making Sweden the Conference venue this time. The WHO Center supports the Conference and views consumer reporting of medicinal drugs as an extremely valuable asset.

Who is sponsoring the Conference?

The Conference is sponsored by various organisations. First of all, KILEN collaborates with the Swedish Consumers´ Association, HAI-Health Action International and HAI-Sweden. KILEN is a member of both these organisations. Furthermore KILEN cooperates with Uppsala Monitoring Centre, Dag Hammarskjold Foundation, People's Health Assembly 2000 and the Sigtuna Foundation.

The Conference is sponsored, inter alia, by SIDA ; Swedish International Development Cooperation Agency, The National Board of Health and Welfare, The National Institute of Public Health.

Other bodies who have expressed interest in the Conference coming about are, inter alia, the WHO Quality Assurance and Safety of Medicines Unit, the EC Directorate Health and Consumer Protection as well as a large number of consumer NGOs all over the world.

How can we reach out?

Last fall, at an international HAI conference in the Netherlands, we had the opportunity to present ELIN, and the work carried out in Sweden and the Nordic countries in terms of consumer reporting of reactions to medicinal drugs. There was a lot of interest and there are currently a number of committed individuals from different parts of the world doing work in preparation for the Conference. They all regard the Conference as an important starting point in establishing consumer knowedge about drugs ; a vital countervailing force to the global drug marketing efforts of the pharmaceutical industry. The Conference will also create incentives for countries that currently lack all pharmacovigilance, and help to set up a system which not only, as in many countries, covers physicians and pharmacists, but also from the outset includes consumers as important sources of reports.

Our network of contacts includes, inter alia, the contact network of Health Action International, other health-related consumer networks, institutions working in pharmacovigilance (addresses and contacts via WHO Collaborating Center in Uppsala), the contact network of The Dag Hammarskjold Foundation, consumer organisations and government agencies from Europe and Eastern Europe, contacts with the EC Directorate, WHO Quality Assurance and Safety of Medicines, etc.

"Pre-Seminar" to the People's Health Assembly (PHA)

In addition, the Conference is in contact with the People's Health Assembly (PHA) and will constitute a "pre-seminar" in preparation for PHA. PHA will be held in Savar, Bangladesh, December 2-8, 2000. PHA is a world-wide initiative in collaboration between Asian Community Action Network (ACHAN),Consumers International (CI), Dag Hammarskjöld Foundation (DHF), Gonoshasthaya Kendra (GK), Health Action

International (HAI), International People´s Health Council (IPHC), Third World Network (TWN), and Women's Global Network for Reproductive Rights (WGNRR).

Evaluation, documentation

Before attending the Conference, participants are asked to respond to "5 questions" (see the Conference Programme). The questions relate to consumer reporting and to what extent consumers in various countries have the opportunity of accessing information on side effects and reactions of drugs. The objective of the brief questionnaire is to stimulate a process whereby participants investigate the situation in their respective home countries, something which could contribute to the discussion as well as providing a more realistic picture as a basis for the Conference deliberations. The whole Conference will be documented. Conference participants will get the chance to evaluate the meeting, as well as what the "Conference Project" has meant to them in terms of their work before and after the meeting.

The evaluation and documentation will be published and distributed to participants and other interested as a basic document on "Consumer Reports on Medicines".

How to proceed?

Of course, the work of creating a consumer pharmacovigilance system will not be accomplished solely by the Conference itself, but we do regard it as an important point of departure. If the considerable interest already manifested, is sustained after the Conference as well, there will be a process initiated for "Consumers Coordinating of Pharmacovigilance, CCP". Funding for this coordinating venture will be sought from various national and international bodies.