AIM
ASSOCIATION INTERNATIONALE DE LA MUTUALITE
Secretariat
AIM contribution
To the high level conference on ‘Priority Medicines for the Citizens of Europe’
AIM fully supports the initiative of the Dutch Presidency to create a R&D agenda for medicines and vaccines to meet real health needs. According to WHO, among 18.000 known illnesses, 66 % doesn’t benefit of a satisfactory treatment. AIM strongly supports the idea that public money should exclusively be used for research fitting with public health needs and not be driven by market considerations. Moreover, AIM strongly insists on the need of European support concerning the development and implementation of non-drug related prevention and health education strategies.
The objective of the high level conference organised on ‘Priority Medicines for the Citizens of Europe’ organised by the Dutch presidency with the support of WHO concerns the identification of a research agenda for medicines based on public health grounds which should benefit of European funds.
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In the terms of reference, the organiser recommended to focus the project to the following three focus areas:
-Neglected diseases (insufficient or insufficiently effective or insufficiently safe treatment)
-Neglected groups (children, older elderly, pregnant women, etc.) but also off-label and unlicensed use of medicines
-Ways of administrating medicines (development of forms and dosage)
From a general perspective, it can be said that at European level, the diseases framework is constituted by 75 % of chronical diseases and 25 % of acute diseases.
For AIM , the discussions on priority medicines, should take into account the following aspects:
Prevention, health education, living and working conditions
Most illnesses in Europe are the result of bad life-styles and could thus be prevented. In addition to every person’s genetic make up, their social and economic conditions, their working and living conditions all play a major role. The poor die earlier. Also personal behaviour – smoking, drinking, diet – plays an increasingly important role.
The critical task relies in the implementation of this awareness in citizens every day life. Public authorities have a major role to play in prevention and health education strategies and activities.Especially the Youth should be sensitised to health education and promotion. Particular attention should be paid to the organization of the work and living conditions (target-group-specific health consultation for socially deprived persons, health promoting working culture).
AIM strongly insists that the Dutch conference should come forward with suggestions and good practices in the field of prevention strategies and health education.
Relative Effectiveness: added therapeutic value
There is the fact that in most cases, health providers are confronted with a multitude of medicines for one disease. On the other side there is no or too few information available on the real therapeutic value of these medicines. This problem should be highlighted by the conference.
Internationally, an increasingly number of pharmaceuticals is being authorised, advertised, sold and prescribed; products that, while patented, offer only limited additional benefits in comparison to already available products. Variations on old products are offered as new, usually just as the patent expires on the original product. These "pseudo-innovations" with their limited advantages can cost ten times as much, or more. Most of these "me-too" products "clog" the market, distracting and inhibiting attention from genuine innovations. This is true not only for Europe: an analysis by the American drug authorisation authority, the FDA, revealed that only 153 of the 1,035 new medicines authorised in the past ten years represented "significant medical progress". Most of the newly authorised products contained analogue active substances, and accounted for the highest price increases. This development is also triggering increasing criticism in the United States.
This is a waste of resources. What we need is not mass, but class.
The pharmaceutical industry is currently facing an innovation crisis. More and more money is being spent on marketing for available medicines and less on research and development of real new preparations. The productivity of research is falling and innovative substances are in short supply.
Therefore more European financial support for academic-fundamental/clinical research, independent of pharmaceutical industry, is necessary to be able to develop drugs for the diseases for which there exist no appropriate drugs.
AIM strongly appeals for the comparison of new medicines with a reference treatment and the systematical realisation of clinical trials of phase III and IV in order to know the added therapeutic value of the new products available on the market as well as to evaluate their efficiency and safety at a long term perspective.
Dutch presidency priority research domains
Neglected diseases need to get full attention. The existing European tool to support research on orphan drugs seems to be successful. AIM however calls on for an independent study on the use made by the pharmaceutical industry of the regulation on orphan drugs and the concrete results for the patients suffering of rare diseases. Other neglected diseases, especially in underdeveloped countries and diseases with a high global burden of disease but little or no evidence of clinically efficacious and/or safe interventions should be considered of course as a priority target for public research.
As regards neglected groups Europe will face in the coming years a growing ageing population which will increase the number of patients suffering of neurodegenerative diseases and cancer. Fundamental and clinical research on these diseases should therefore be a priority research topic as there are no satisfactory treatments available yet. Regarding paediatric medicines, emphasis should be given on clinical research. The main problem in this field concerns the right dosages and not new therapies. Solutions have to be found to overcome the problem of off-label use and unlicensed use of medicines. The EU is preparing a specific legislation on this topic. Politicians and all concerned stakeholders should be vigilant that this legislation focuses on real needs of the paediatric population.
AIM is of the opinion that infectious diseases (aids, hepatitis C, tuberculosis, food borne infections (BSE), antibiotic resistant infections, and vaccine-preventable diseases) are a problem at world-wide level which needs international collaboration, including the support from the European Union.
To summarize, the AIM considers as priorities:
-to focus primarily on prevention (non- pharmaceutical) and health education
-to focus on infectious and neglected diseases
-to compare new medicines with reference treatments in order to get a clear idea on their real added therapeutic value
-to realise long-term evaluation studies of medicines, especially for chronical diseases, for safety and efficiency reasons
-to launch a reflection on how to reward break-through innovation
-to focus on rational use of medicines
-to focus on permanent independent training of health providers, especially doctors.
Adopted in Nice, 11-10-2004
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