European AIDS Treatment Group (EATG)
Link to EATG Web Site (Includes their publication, European AIDS Treeatment News, in several languages)

European Community Advisory Board (ECAB)

EATG Access Working Group

Description of EATG

Since its foundation 10 years ago, the European AIDS Treatment Group has developed a working relationship with most of the pharmaceutical companies. In many ways this is a very original relationship. As treatment activists we need to put up string fights at times with, and against the pharmaceutical industry. Especially when our interests do not coincide, when companies have only their own interests at heart and do not recognise the interest of the people living with HIV and AIDS. But there are also times that treatment activists and the pharmaceutical companies can work together very productively. Although we may come from a different perspective and sometimes a whole different world, their are many issues that can bring us together. Both people with HIV/AIDS, being the consumers of drugs, and the pharmaceutical companies, being their producers, can have parallel interests in bringing new and promising drugs to the market in an orderly but still speedy way. We have learnt how the struggle for life from patients-consumers and the wish to make money from the industry can indeed go hand in hand. A unique example of good and sometimes productive co-operation can be found in the EATG's European Community Advisory Board (ECAB), that interacts with a whole range of pharmaceutical companies active in HIV/AIDS in both the stages of development and the pre and post marketing of new drugs. The ECAB gives input in protocols for trials, it discusses many issues from the patient's perspective that are extremely important for both the new consumers and the manufactures to optimise the safety and efficacy of new drugs.

The European AIDS Treatment Group (EATG) was founded in 1991 as a group of people affected by HIV and AIDS in Europe and concerned about treatment issues. Over 150 people from 27 different countries are individual members, and the majority work for AIDS service organisations in their own countries. Our expertise comes from our own personal experience as HIV positive and negative people, service providers, and/or members of affected communities. Some of us have scientific/medical backgrounds, while others have become experts through hard work on their own initiative.

The EATG is a registered charitable association under German law. Our Secretariat is in Düsseldorf, Germany. The EATG was the first, and is still the only, pan-European organisation advocating for the interests of people living with HIV and AIDS (PWA) on treatment issues in Europe.

The EATG's goals are:
a.. To ensure that the maximum number of people with HIV/AIDS in Europe have rapid access to state-of-the-art treatment, including treatment trials and monitoring tests.
b.. To improve the availability of accessible information about new treatment options through a variety of media.
c.. To enable people with HIV and their advocates to give as much input as possible to the process of drug testing and approval, as well as to the mechanisms which govern availability in each country.
d.. In order to achieve its goals, the EATG has defined a number of objectives.
To advocate for the rapid introduction of expanded access programmes for promising experimental drugs in as many European countries as possible.
To promote a common Standard of Care and treatment for all people living with HIV, based on rapid incorporation of recent advances in the field of HIV/AIDS care.
To improve the efficiency and speed of drug testing and approval systems, and to promote the rights of people with HIV and their advocates to participate in the design and management of drug trials.
e.. We have established a working relationship with officials of the European Medicines Evaluation Agency (EMEA) to ensure wider and more equitable access to treatments.
f.. We established a European Community Advisory Board (ECAB) within which people from affected communities work with pharmaceutical companies to review clinical trial designs and their ethics, promote best practice procedures, monitor ongoing trials and interact with researchers and also with the community at a national level.
g.. We have trained more than 200 new community treatment activists in four training conferences in Southern and Eastern Europe.
h.. We have prepared educational materials in several languages including English, French, Italian, Portuguese and Spanish. These include a video on managing treatments and a magazine, the European AIDS Treatment News (EATN), which is funded by the European Commission.
i.. We have established ongoing relationships with the European Commission Directorates responsible for pharmaceuticals, health, research and consumers, and have been consulted on various Commission initiatives.
j.. We have organised HIV treatment seminars, and have organised meetings supported by Members of the European Parliament..
k.. We co-sponsor an expert panel, which defines best practice in HIV treatment, with the European AIDS Clinicians Society.
l.. We have established a good working relationships with other international organisations, and the EATG is an active participant in international networks of people with HIV/AIDS and their advocates.

The EATG provides community input into the organisation of international HIV/AIDS conferences, including the Geneva World AIDS Conference (1998) and the 5th International Conference on Drug Therapy in HIV Infection (Glasgow, 2000).

EUROPEAN COMMUNITY ADVISORY BOARD (ECAB)

The European Community Advisory Board (ECAB) was founded by the EATG in the autumn of 1997 to facilitate a better and more productive interaction on the research and development of new agents to combat HIV and its complications with pharmaceutical companies, researchers, investigators and the European HIV+ communities.

The functions of the ECAB are as follows:
a.. review the design of clinical trials during the process of protocol development;
b.. promote best practice procedures;
c.. suggest/initiate trials when dictated by common needs;
d.. review informed consent procedures for both, content and language;
e.. monitor ongoing trials as far as adverse events, compliance and community needs are concerned;
f.. be informed of interim results;
g.. interact with other involved entities such as investigators, DSMB etc.;
h.. be visible to all involved parties and in particular to the community of patients participating in the trials.
i.. For this purpose, all ECAB members, volunteers, give their commitment to work with continuity and, when necessary, sign and respect confidentiality agreements.
ECAB consists of approximately 25 operative members working according to the twin/buddy system. Therefore, each member is in reality supported by a colleague who enjoys the same training and the two twins may alternate during different meetings without impairing the continuity of the commitment of the ECAB members . Therefore, a full 20 members group is present at each session and the number of ECAB members totals approximately 40.

The centralised ECAB structure is meant to guarantee a better quality of training, a lighter organisational structure, and especially a possibility for members to become knowledgeable in all aspects of the HIV/AIDS problematic. The centralised organisation also guaratees smooth and effective logistic preparation and permits ECAB to self-administer its functions rather then being dependent of pharmaceutical initiatives.

Pharmaceutical companies are requested to contribute to the expenses covering the meeting, travel and accomodation of the ECAB members and to cover the expenses of the training session to be held during the weekend. This contribution will be handled to EATG under the form of an unconditional grant. All fund raising and financial operations are under the responsibility of the BoD of the EATG.

ECAB is a volunteering, community-based structure. Members are recruited inside the community and particular attention is being made to obtain representation of the different patient-communities in Europe (women, gay people, drug-users, ethnic minorities etc.).

The structure of ECAB is aimed to be geographically representative as well as socially representative (women, drug-users, children, ethnic minorities etc.). As a result, ECAB wants to be a "reflection of diversity" of the different communities involved with HIV in Europe. However, considering the difficulty of recruiting activists from certain groups and populations, social diversity should be put in front of geographical diversity. Since its foundation in 1997 the ECAB has welcomed members from Belgium, France, Germany, Greece, Italy, Luxembourg, The Netherlands, the Nordic Countries (Finland). Portugal, Spain, Turkey, Central and Oriental Europe and the United Kingdom.

The EATG Access Working Group

August 7, 2001

According to a Board Of Directors proposal at the EATG 2001 General Assembly held in May in the aim of improving and enlarging the scope of the EATG in the field of access-to-treatment for Eastern Europe and developing countries the ACCESS WORKING GROUP has been officially formed.

The primary aim of the ACCESS WORKING GROUP, AWG, is to work on, define and develop strategies to put and maintain pressure on the pharmaceutical companies, local government agencies and health organizations to make treatment and drugs available wherever there is a need in those countries where access-to-care is lacking.

The EATG views access to medicines as a global issue, which affects the HIV positive community throughout the world to varying degrees. Access to health is a basic human right. Nevertheless, the global market system considers pharmaceutical products to be the same as any other goods on the market. A comprehensive rights-based approach to the fulfilment of the individual's right to health must include access to prevention information and commodities, and access to care, support and treatment, including the most appropriate medicines. In the case of HIV/AIDS, this means access to anti-retroviral (ARV) therapy. Universal access to treatment is therefore the objective we have to reach. It should be raised as a major political issue.
Recommendations from the access working group:

a.. There should be a rapid implementation of the Declaration of Commitment approved at the UNGASS, particularly with regard to the scaling up of available resources to support the on-going national development process and implementation of national HIV/AIDS strategies.

b.. To be an effective innovative and equal partnership between developing countries, donors, the multilateral system, civil society and the private sector, The Global Fund for AIDS, Malaria and TB, must start involving all the stakeholders at the planning stage.

c.. The estimated amount of health expenditure needed to effectively address the HIV/AIDS pandemic must be reached in the very short term. Donor countries should allocate 0.7% of their GNP to development co-operation.

d.. There should be rapid implementation of the European Commission's Action Programme on Accelerated Action. However, in view of the magnitude of the HIV/AIDS problem in Africa, the EATG believes that at least 15% of the total development co-operation budget should be allocated to health, AIDS and population interventions (as opposed to the current 8%). We also call for the European Commission to ensure that it has adequate staffing levels in the relevant departments in order to ensure that the planned actions be carried out properly.

e.. Debt relief should be linked to health programmes. Further financing possibilities - reallocation of existing expenditures, revolving funds - need to be explored by the World Bank and the European Commission

f.. The role of NGOs and CBOs, both in recipient and donor countries, is essential to the success of any access programme either in the area of resource mobilisation and allocation. These organisations are uniquely placed to implement and supply affordable, efficient and effective access to healthcare, support and treatment, as well as providing transparency and accountability of all decision-making processes at national and global levels

g.. NGOs must also play an important role both in developing countries and in Europe, by advocating their proposals to the EU institutions and EU Member States' authorities

h.. Capacity-building is required to help countries help themselves over the long term

i.. The current review of the TRIPS Agreement should maintain the existing safeguards that ensure the rights of developing countries to obtain the cheapest possible life-saving medicines. AIDS research must be subsidised.

j.. Closer co-operation is needed between the WHO, UNAIDS, the European Commission, the World Bank, the G8, the pharmaceutical industry and the generic makers

k.. The EATG asks for a wide debate concerning the interpretation of TRIPS agreement, recognizing the balance between the interest of consumers and the right holders, encouraging a more equitable sharing of the benefits of the medical technological developments in order to correct the present imbalance between the exercise of private property and public interest.

l.. The EATG strongly supports a wide scope interpretation of article 31 of the TRIPS to ensure that governments have the right to override patents in the interests of public health. At the same time we ask to avoid any restrictive and anti-competitive interpretations of country obligations under article 39 of the TRIPS, concerning health registration data. In the meanwhile we ask to extend the implementation deadlines within TRIPS for developing countries

m.. The EATG asks not to exert bilateral or regional pressure on developing countries, which take measures to exercise their rights under TRIPS to promote access to treatment. We ask the bodies in question to stop all dispute settlement action against developing countries that would hinder their ability to promote access to treatment.

n.. The EATG supports any initiative seeking for alternative ways to increase R&D financing for neglected diseases replacing the current emphasis on private commercial rights with a system obligating countries and international bodies to support essential medical R&D that address public health needs when the market fails to address those needs.

o.. The EATG supports enhancing measures to encourage and improve pharmaceutical technology transfer with the aim to build or strengthen infrastructure and encouraging local and regional production of essential medicine according to article 66.1 of the TRIPS.

The Chair of the Group is: Mauro Guarinieri [email protected]

Revised September 12, 2003

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