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<p align="justify"><b>Doc. 8551</b></p>

<p align="justify">1 October 1999</p>

<p><b>Health security for Europe's populations</b></p>

<p align="justify">Report</p>

<p align="justify">Social, Health and Family Affairs Committee</p>

<p align="justify">Rapporteur: Mr Jean-François Mattéi, France, Liberal, Democratic and Reformers' Group</p>

<p align="justify"><i>Summary:</i></p>

<p align="justify">Health security is concerned with health risks that are avoidable because they are controllable.  There is now greater awareness of health security issues.  Although this awareness is partly a result of the breathtaking development of technologies and new products, it can also be explained by the increasing number of incidents and scandals posing a threat to public health.</p>

<p align="justify">This report summarises the many food-safety and health-security proposals the Assembly has put forward.  Its conclusion is that a comprehensive analysis is needed with a view to adopting a coherent and effective overall policy.  Risk management must be guided by common principles, for example the principle of prevention and precaution.  Unified machinery, such as a European health security agency, should be set up to monitor implementation of the policy.</p>

<p align="justify"><b>I.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Draft recommendation</b></p>

<p align="justify">1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly is concerned about the health risks linked to a speeding up of technological developments and ecological change, and about the difficulty of keeping these under control in a situation in which products and goods are moved around freely.  While these developments may be beneficial to human health, they may also pose a threat to it, as several recent problems have shown at international level (AIDS, asbestos, mad cow disease, dioxin in animal feed and poisoning linked to mass-market beverages).</p>

<p align="justify">2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; It notes that people are increasingly anxious and extremely sensitive to health security issues, and therefore considers it to be of the greatest importance to be able to give all concerned reliable information about the actual situation and about the level of health risks which exist, so that these may be managed on a rational basis.</p>

<p align="justify">3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly takes the view that the interests of economic development must not be regarded as conflicting with the absolute need to protect health.  It emphasises that it is impossible to do other than attach equal importance to both aspects, and that these are indissociable.</p>

<p align="justify">4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Concerned about the effectiveness of resource allocation, the Assembly wishes to promote a comprehensive and coherent framework for the analysis of health security issues, applicable to all European countries, regardless of the sector involved.  It is illogical for the rules applied to the assessment and management of health risks to vary according to causes, type of product to blame, polluted environments, branches of manufacturing concerned or channels through which human beings are exposed to the various physical, chemical or microbiological pollutants.  These rules must be unified at European level.</p>

<p align="justify">5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly considers that the avoidable nature of the risks to which the people of Europe have been unreasonably subjected has recently given rise to public indignation and a feeling of insecurity, potentially jeopardising democracy through the naming of scapegoats, an accusation of laxism and a loss of public confidence, all of which may encourage the development of a totalitarian logic detrimental to human rights and to human health and wellbeing.</p>

<p align="justify">6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly notes that society very much expects correct application of the principles of prevention and precaution, and should receive a reasonable and effective response.  Excessive precaution could render progress sterile, as could too much laxism.  It is therefore necessary to give real substance to these principles, which are all too often mere empty words.</p>

<p align="justify">7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly is convinced that a comprehensive analysis of health security would be the logical outcome of the action it began with a number of recommendations, particularly<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1389"> Recommendation 1389</a> (1998) on consumer safety and food quality and<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1417"> Recommendation 1417</a> (1999) on the dioxin crisis and food safety.  It now wishes to widen its treatment of these issues to include all aspects of health security for Europe&#8217;s populations.</p>

<p align="justify">8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Consequently, the Assembly recommends that the Committee of Ministers:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; extend the role of the steering committee responsible for public health by setting up within it a public health unit to offer advice to member states in the various fields connected with this subject as proposed in<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1417"> Recommendation 1417</a> (1999) of June 1999.  It is logical that the Council of Europe, as the first European institution to lay down recommendations on public health, should pursue this pioneering role. It would be the task of the unit to:</p>

<p align="justify"><i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a. </i>help member states to diagnose their own needs in the sphere of health security;</p>

<p align="justify"><i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b. </i>draw up a guide to the tasks incumbent on the departments which are in charge of health security in each member state;</p>

<p align="justify"><i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c. </i>suggest a course of action enabling priorities for health security activity to be defined;</p>

<p align="justify"><i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;d. </i>provide member states with a facility for reviewing health warning management arrangements, culminating in the possible award of a Council of Europe seal;</p>

<p align="justify"><i>e. </i>propose to the Assembly a charter on the promotion of health security in Europe;</p>

<p align="justify"><i>f. </i>prepare a handbook describing how to achieve quality in health security arrangements;</p>

<p align="justify"><i>g. </i>devise a methodological framework for assessing the effectiveness of health security arrangements;</p>

<p align="justify"><i>h. </i>compare risk management techniques in Europe, particularly using methods based on feedback;</p>

<p align="justify"><i>i. </i>in conjunction with the appropriate institutions, devise European training programmes covering health security.</p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; invite the European Union and the appropriate international organisations to take part in the work of the unit;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; associate the Assembly with the establishment and operation of the unit.</p>

<p align="justify">9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In addition, the Assembly recommends that the Committee of Ministers invite member states to:</p>

<p align="justify">i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; increase their knowledge of the various problems which may affect the health security of their population, and, to this end:</p>

<p align="justify"><i>a. </i>make the observation of health, risks and health risk factors systematic;</p>

<p align="justify"><i>b. </i>develop health monitoring in connection with the main sources of human exposure in order to be able to detect and identify the nature of health risks as rapidly as possible;</p>

<p align="justify"><i>c.</i> list in order of importance the problems and risks to which people are subjected;</p>

<p align="justify"><i>d. </i>organise expert advice on health security in an effective way;</p>

<p align="justify"><i>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;e. </i>stimulate health security research (into risk detection and risk assessment and management in emergency situations);</p>

<p align="justify">ii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; do more to control the health risks to which their population is exposed, and therefore:</p>

<p align="justify"><i>a. </i>share responsibility for health risk management among the appropriate state services;</p>

<p align="justify"><i>b. </i>lay down guidelines for risk management policy based on the following ten principles, set out in more detail in the report and need to be enshrined in a health security charter:</p>

<p align="justify">1. Transparency</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2. Comprehensiveness</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;3. Rationality</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;4. Prevention and precaution</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5. Efficiency</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;6. A geographical approach</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7. Ethics</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;8. The use of more than one expert</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;9. Responsibility</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;10. Harmonisation;</p>

<p align="justify"><i>c. </i>start processes of public debate on public health decisions, particularly where there is great scientific uncertainty about the problems concerned;</p>

<p align="justify"><i>d. </i>make the use of health cost-benefit analyses systematic;</p>

<p align="justify">iii.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; react better to events jeopardising health security, and to this end:</p>

<p align="justify"><i>a. </i>ensure that there is effective epidemiological investigation capacity in respect of health threats (epidemics, clusters, abnormal exposure), and analysis capacity for identifying pollutants in the different environmental milieus;</p>

<p align="justify"><i>b. </i>acquire means of understanding how the public perceives risk problems, so as to have appropriate strategies for action;</p>

<p align="justify"><i>c. </i>make communication into a veritable instrument of health security;</p>

<p align="justify"><i>d. </i>make health security activities &quot;legible&quot; so as to foster renewed public confidence;</p>

<p align="justify"><i>e. </i>make the use of feedback systematic.</p>

<p align="justify">10.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Assembly invites the European Union to set up in consultation with the Council of Europe, a European health security agency which could provide high-level expert advice in the various sectors not covered by existing arrangements, particularly the chemical pollution of consumer products, quality control in the production of food for human and animal consumption, soil pollution, the management of risks throughout the various branches of waste processing, and the traceability of products on sale.</p>

<p align="justify"><b>II.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Explanatory memorandum by Mr Mattei</b></p>

<p align="justify"><b>Introduction</b></p>

<p align="justify">1.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The protection of health is a fundamental right enshrined in the European Social Charter of the Council of Europe.  The Bioethics Convention states that compliance with the rules of health security is one of the ethical foundations of our society.</p>

<p align="justify">2.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; While the free movement of goods and products corresponds to an expectation of consumers and is from now on a feature of the rules of world trade, the health risks involved should be kept under control.  The protection of health, however, is not one of the responsibilities of the European Union.</p>

<p align="justify">3.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Nonetheless, it is necessary to take a general interest in a series of sources of health risks:</p>

  <ul><p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; products with therapeutic effects, which have recently given rise to serious health problems, such as the transmission through transfusion of AIDS and of hepatitis C, as well as Creutzfeld-Jakob disease;</p>

  <p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; food products and stock feed, to which the recent crises of mad cow disease and dioxin-contaminated poultry are linked, and which raise questions about issues such as the use in agricultural production of hormones, antibiotics and genetically modified foods; quality control in the production and distribution of feedstuffs for sheep, cattle and farmed fish; and the fact that products on sale to the public are often insufficiently traceable;</p>

  <p align="justify">-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; pollution of the environment (air, water, soil) by chemical substances, while the diseases to which asbestos gives rise underline the importance of making health concerns part of environment management.</p>

</ul><p align="justify">4.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The aim of this report is to describe practical steps which member states are invited to take so as to preserve public health, and to propose the setting up of a European &quot;health watch&quot; system. It is designed to complement<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1417"> Recommendation 1417</a> (1999) on the dioxin crisis and health security, adopted by the Assembly in June 1999 in a debate under urgent procedure at the height of the crisis  and aims to take the discussion a stage further, extending the scope for action to  areas other than  food safety.</p>

<p align="justify"><b>The current importance of health security issues </b></p>

<p align="justify">5.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Health security encompasses all the activities enabling risks to public health to be detected, identified, anticipated, quantified, prevented or reduced, and their origins to be discovered.  It is states' responsibility to offer their population a high level of health security.</p>

<p align="justify">6.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Several recent occurrences (in particular the transmission of HIV and the hepatitis C virus through blood transfusions, human contamination by prions, the epidemic of cancers caused by asbestos, the contamination of poultry with dioxin, and poisoning linked to the consumption of Coca-Cola) have shown that the health security of the European population has gaps linked not only to a lack of medical and scientific knowledge, but also to the inappropriate way in which existing knowledge was used in decision-taking processes.  Furthermore, the principle that precautions must be taken requires action to promote health, even if the available scientific knowledge is uncertain.  Risk management in the event of scientific uncertainty is highly complex, requiring specific preparation of the decision-taking processes.</p>

<p align="justify">7.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; There is also legitimate anxiety within society, even if this is not always justified in medical and epidemiological terms, about health risks possibly connected with the use of new production or breeding processes, of antibiotics and of new technologies such as the genetic modification of organisms.  Public emotion could make it impossible to use these tools.  If they are to bring progress, their development must be subject to strict supervision, so that the occurrence of any undesirable health effects may be detected as early as possible.</p>

<p align="justify">8.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; These events and situations have shown both that insufficient account was taken in public policies of health concerns and that basic instruments making possible health security were not used judiciously.</p>

<p align="justify">9.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The management of recent incidents adversely affecting health security gave rise to industrial and commercial consequences and considerable management costs for European countries, and these could have been avoided if efficient &quot;health watch&quot; systems had been introduced.</p>

<p align="justify">10.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The increase in the number of human and economic exchanges, as well as technological progress, which are factors in the improvement of human wellbeing, may also give rise to health risks.  In order to reconcile health security and free movement of people and goods, new facilities for assessing and managing health risks on the basis of rules which are clear and explicit for all ought to be developed.</p>

<p align="justify">11.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As the management of health risks connected with the environment or with products consumed is likely to lead to unfair competition conditions, European countries are justified in adopting a unified doctrine laying down a set of minimum rules binding on all.</p>

<p align="justify"><b>Some salient facts relating to health security in Europe </b></p>

<p align="justify">12.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Where avoidable risks are concerned, the existence of health inequalities in the various European countries shows that there is genuine scope for progress, justifying the use of international comparisons.  Such comparisons should make it possible both to identify the environmental causes of the problems and to guide preventive policies. There are still differences in life expectancy in Europe that are probably attributable to environmental factors. Thus, while life expectancy in certain countries (Spain, France, Greece, Iceland, Italy, Norway, the Netherlands, Sweden and Switzerland) is almost 80 years, it is less than 70 years in others (Estonia, the Russian Federation, Kazakhstan, Kyrgyzstan, Latvia, the Republic of Moldova, Romania, Turkey and Ukraine).</p>

<p align="justify">13.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The fact that 70% of Europe's population now lives in urban areas (although the percentage varies greatly from country to country) represents a major development, significant in terms of health security.  In these conditions, pollution, particularly of the air and of products for everyday consumption, although it gives rise to a low level of individual risk, may produce significant collective risks, because of the large number of persons exposed to it.  In this context, certain recent health trends are specific grounds for concern.</p>

<p align="justify">14.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The geographical variations in the incidence of the different cancers, as well as their development over time show the role which environmental factors and human behaviour may play in their occurrence.  Environmental causes - such as tobacco, and asbestos where mesothelioma is concerned - have been clearly identified for certain cancers of which the incidence has been growing for several decades. The European Union estimated recently that some 250,000 people would suffer from mesothelioma in the next 35 years - an indication of the serious consequences of mismanaging health risks even when they have been correctly evaluated.</p>

<p align="justify">15.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Cancers affecting other parts and growing in frequency, such as lymphomas (the incidence of which rose by around 100% between 1975 and 1995), have poorly understood causes (apart from AIDS), although exposure to certain pesticides has been put forward as one explanatory factor.  Where chemical substances are concerned, it is very difficult to assess the pathogenic role of prolonged exposure to low doses.  There are probably synergies between the various chemical pollutants, but these are difficult to identify in epidemiological or toxicological studies.  Bladder cancer is one of the conditions that may be linked to exposure to certain chemicals as well as tobacco and it is becoming more common in some countries, such as France (where its incidence rose by 25% among men and 9% among women between 1975 and 1995).  Other countries where the incidence of this cancer is also high are Spain, Italy, the Netherlands and the United Kingdom.  The pattern is similar for liver cancer, which over 20 years has become 50% more common among men.  Likewise, the incidence of brain tumours is rising sharply in all countries (a statistic probably due in part to improved diagnostic techniques).</p>

<p align="justify">16.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; As people are living longer, cancer is increasingly important to morbidity and mortality (it is the medical cause of death in some 25% of cases) and is therefore a major concern in the field of health security in Europe. Half of all men in Europe and a third of all women will have cancer at least once in their lives.</p>

<p align="justify">17.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Another source of anxiety relating to environmental factors is the epidemic development of inflammatory diseases and atopic complaints. Pollen allergy affects more than 20% of the adult population in countries such Germany, Spain, Italy, the Netherlands, the United Kingdom and Switzerland. The frequency of asthma among children and adults has doubled in several European countries. Allergic rhinitis sometimes affects 30% of the groups studied.  Atopic dermatitis (in the form of eczema and urticaria) is also on the increase.  Possible interaction between chemical substances and pollen agents has been demonstrated experimentally, and requires close attention.  A growing frequency of inflammatory arthritis has also been noted, the causes of which could be associated with microbiological and chemical agents.</p>

<p align="justify">18.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; While the AIDS epidemic has been partly brought under control thanks to health education efforts, it remains a cause for concern, particularly in certain groups, such as drug addicts.  On 31 December 1998, there were almost 220,000 reported cases of AIDS in the World Health Organisation&#8217;s European region - a figure that gives the lie to the reassuring forecasts made during the 1980s. Other infectious diseases are still worrying, such as tuberculosis and legionellosis.  One of the main reasons for anxiety in the years to come is antibiotic resistance in humans and animals.  In a comparable position are the nosocomial diseases, which are currently a major problem in terms of health security.</p>

<p align="justify">19.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Whether there will be a massive epidemic of new-variant Creutzfeld-Jakob disease is still an open question. So far only 39 cases have been identified in the United Kingdom and one in France.  Recently, the number of deaths has tended to increase significantly (there were 9 in the UK in the last quarter of 1998), but it is still too early to identify a large-scale epidemic.  Such a prospect is in itself justification for seeking to improve health security systems in Europe.</p>

<p align="justify">20.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mental health problems in relation with health security have not been given sufficient attention.  People who, rightly or wrongly, believe that they are being exposed to agents which endanger their health may develop psychological manifestations of a traumatic type, which are not usually recognised and treated as such, but which may have significant repercussions on the everyday life of the persons concerned.  Recent studies have shown that up to a third of attack victims suffer psychological trauma.  </p>

<p align="justify">21.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Home and car accidents remain a health security priority, because they occur so frequently, are so serious in medical terms and affect young people.  The avoidable nature of most such accidents means that they are an unacceptable risk to which priority must be given.</p>

<p align="justify">22.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Generally speaking, numerous pathologies linked to chemical or microbiological agents may lead to significant functional effects which, while they are not life-threatening, make a significant difference to quality of life.  In this context, levels of exposure to heavy metals warrant strict controls.</p>

<p align="justify">23.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Grounds for great vigilance, in addition to the currently identifiable risks in epidemiological and medical terms, are the speed of ecological changes to which the European population is currently subjected, the problems of physiological adaptation to which these might give rise and the ability constantly to create new potential risk factors in the context of industrial activities and technological progress.  It is often impossible to detect the possible health dangers of these developments in advance.  This, for instance, is the case of genetically modified organisms.  Precautions must be taken when placing new products such as these on the market.  So as not to forego the progress they may bring, it is essential to introduce effective epidemiological monitoring, similar to that used in relation to medicines, capable of detecting the occurrence of undesirable health effects at the earliest possible stage.</p>

<p align="justify"><b>The problems to be resolved in order to avoid new health security crises </b></p>

<p align="justify">24.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Analyses of recent health crises, such as mad cow disease and the transmission through blood transfusion of AIDS, have enabled shortcomings in Europe's health security organisation to be identified, those described below being to the fore, constituting explanations of recent problems and thereby representing grounds for concern which require appropriate responses.</p>

<p align="justify">25.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In many European countries, there is an inadequate public health culture, with proper use not being made of the available scientific knowledge (failure of the principle of prevention), especially in the field of epidemiology.  Thus exposure to certain substances, the dangers of which are known, was poorly controlled (the case of asbestos) or is still poorly controlled (the case of heavy metals or of benzene in the air, for instance).</p>

<p align="justify">26.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; All too often the concept of risk is misunderstood, with deterministic reasoning in terms of all or nothing frequently giving rise to a dilemma.  The binary approach leaves the decision-maker with only two options, either to do nothing (exposing him or her to possible accusations of negligence) or to do everything (perhaps leading to wastage of available resources).  Only reasoning based on risk, i.e. based on probabilism, can enable the complexity of the problems likely to have an effect on public health to be dealt with properly. </p>

<p align="justify">27.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This reflects the fact that, hitherto, insufficient attention has been given to the training of health professionals and senior administrative staff in the disciplines involved in public health, especially toxicology, epidemiology and risk analysis.  Only a few European countries are entitled to claim a level of excellence in this area.  They have led the way, and others should follow.</p>

<p align="justify">28.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Production methods in some sectors of the economy have rapidly become highly industrialised without due attention to the considerations of quality control that are necessary to the proper functioning of any industrial system. This has happened in the food-processing and animal-feed sectors.  In response to this situation, some governments may, for example, ban meal from animal feedstuffs, a step that could lead to secondary risks potentially more serious than the dangers it was intended to avoid.  It is important that the public authorities, working in co-operation with those in charge of the sectors concerned, should have adequate means of monitoring them. </p>

<p align="justify">29.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The ability to anticipate emerging dangers has proved to have many weak spots over recent years.  Thus the problems possibly linked to prions were not tackled sufficiently early, although reputable scientific journals did give warnings.  This type of situation may lead decision-makers to come up with an extravagant response, committing resources that are out of all proportion with the risk which it is the intention to avoid.  This has been the case with the recent anxiety about dioxins, in relation both to emissions from domestic and industrial waste incineration plants and to the contamination of stock feed.</p>

<p align="justify">30.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Health monitoring and information systems in Europe are insufficiently developed to enable studies to be made, in particular, of planned developments or industrial plants, or assessments of the risks connected with the use of certain products containing chemical substances or microbiological agents.  This penalises certain plants or products, for public anxiety is sometimes so great that the project is wrongly regarded as unfeasible or a product as unmarketable.  Conversely, development mistakes are sometimes made, with far-reaching consequences for health, for want of proper incorporation of the health dimension at the planning stage.  In this highly complex context, while zero risk is a Utopian dream, the public must be able to be properly told about the health effects of such projects or products, in terms of both risks and benefits, to which end people must have relevant information.  This may mean conducting ad hoc studies.  But it is often preferable, and less costly, to have international databases available.</p>

<p align="justify">31.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Available knowledge about the distribution of levels of public exposure to chemical substances and to microbiological agents, in particular, is often inadequate and incomplete. On the one hand, studies have so far been completed on only 19 out of 110 chemical products given a priority listing for toxicity analysis by the European Commission in 1993, whereas of the 100,000-plus chemical substances that exist, around 3,000 are in widespread use and can<u> </u>affect health.  On the other hand, it is not enough to know how toxic products or plants are.  In order to quantify the associated risks, it is necessary to know the frequency, intensity and duration of individuals' contact with the various pollutants likely to affect health.  Nor is it enough, for this purpose, merely to know the concentrations of these pollutants in the various places (air, water, soil, food), although this is useful. </p>

<p align="justify">32.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Correlatively, there is all too often no overall view of the health security problems needing to be resolved as a matter of priority, particularly in the environmental sphere. Risks are often dealt with one by one, as they hit the headlines or solely in the light of the instruments available to deal with them, without any overview being taken of the respective importance of each.  Thus certain risks have remained neglected, despite their importance (the lead poisoning of children in the centre of old towns), while other less important ones were the subject of great attention.</p>

<p align="justify">33.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This inconsistent allocation of the resources assigned to protect people against various risks is detrimental both to the health of the people not receiving the best protection possible in the light of available knowledge and resources and to economic interests, for want of a predictable basis for taking the costs of risk management into account.  </p>

<p align="justify">34.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; An analysis of recent health security crises has also highlighted frequent confusion between the functions of assessment and management of health risks.  While it is logical for there to be a link between the way in which risks are evaluated and that in which they are managed, it is, in contrast, dangerous to bring the weight of the constraints of risk management to bear on risk assessment from the outset.  Economic, industrial, social and political considerations must not affect the analysis of risks, although it is perfectly legitimate for these to be taken into account as secondary factors when a risk management policy is drawn up.  Nor is it acceptable for the functions of those who supervise and those who are supervised to be confused.  There has to be a guarantee of independence here, or the credibility of the economic players will be suspect and the confidence of society will be shaken.  While it is desirable for firms to be involved in supervisory tasks, it is for the authorities to ensure that these tasks are carried out with all the necessary rigour.</p>

<p align="justify">35.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Particular attention must therefore be paid to the means of monitoring preventive regulations.  Rules are unsound if they are not supervised and monitored.  Those virtuous players who strive to comply with them are at a disadvantage as compared to less scrupulous competitors.  In the health security sphere, it is essential for monitoring procedures to be laid down at the same time as risk management rules, and it must be ensured that public services will effectively have the means of verifying on the ground that these rules are complied with.</p>

<p align="justify">36.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; More and more frequently, decision-makers responsible for health security face complex situations characterised by great scientific uncertainty.  This is where it is vital to have credible and effective levels of investigative capacity and scientific expertise.  The highly specialised nature of the issues to be resolved, and their multidisciplinary nature, justify the use of collective forms of expertise, rather than a single expert.  There is a need to make the expert advice process truly independent and to ensure that all sides of the argument are heard, or the process could not be credible.  The resources required to obtain high quality expert opinions on complex issues are often underestimated, and this fact has its effects on the functioning of committees of experts.</p>

<p align="justify">37.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Public departments are more legitimate agents in terms of prevention and monitoring where health effects are certain.  Similarly, the application of legal rules generally relies on sufficient levels of proof.  From now on, it is important for thought to be given to the way in which public decision-making systems operate in the face of a situation of scientific uncertainty calling into question health security.  A mere evocation of the principle of precaution is not enough.</p>

<p align="justify">38.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; One of the features of health security problems is that their management is usually a responsibility of several ministerial departments.  Each country organises its central government services in its own way, depending on its history and its administrative traditions.  But the management of problems that cut across departments creates specific difficulties in every country. In particular, where health and the environment, health and agriculture or health and consumer affairs are concerned, there are numerous possibilities, none of which is obviously superior.  The position held by the ministries responsible for health varies, and it is frequently found that the interlinking between the different ministerial departments on health issues is poor.  Rather than vainly seeking the ideal administrative arrangements, it would be better to consider drafting common operating rules for every administrative tier. </p>

<p align="justify"><b>European arrangements</b></p>

<p align="justify">39.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The Social, Health and Family Affairs Committee has often focused on health issues in reports dealing with specific topics.  See, for example,<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1101"> Recommendation 1101</a> on protection of non-smokers,<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1136"> Recommendation 1136</a> on a European policy on alcohol,<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1141"> Recommendation 1141</a> on drug misuse and illicit trafficking and the question of legalisation,<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1317"> Recommendation 1317</a> on vaccination in Europe and<a href="/ASP/Doc/RefRedirectEN.asp?Doc= Recommendation 1369"> Recommendation 1369</a> on the dangers of asbestos.  Nonetheless, in view of the increasing number of health accidents, work on more comprehensive health monitoring was required, and the Social, Health and Family Affairs Committee and the Committee on Agriculture are accordingly engaged in parallel action.</p>

<p align="justify">40.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In the intergovernmental sector, the Council of Europe set up a body some time ago which has proven its worth: the European Department for the Quality of Medicines (formerly the Pharmacopoeia).  With systematic application of single-reference analysis procedures and gradual harmonisation of national standards, the Pharmacopoeia has adopted and published some 900 mandatory specifications.  It operates under an agreement covering only some of the member states.</p>

<p align="justify">41.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; There is also a Partial Agreement in the Social and Public Health Field, bringing together 17 member states; it recently stepped up its activities on health control of food and cosmetics.  A Forum on Functional Food, held in December 1998, gave rise to an instructive publication.  But although these activities are very worthwhile, they are not binding and tend to be somewhat fragmented.</p>

<p align="justify">42.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; With regard to the European Union, it should be stressed at the outset that the Treaty of Rome did not provide any powers in this area.  This situation has been rectified to some extent by a series of Council resolutions, particularly that of 26 November 1998, which laid down the basis for Community action in the field of public health.  After the entry into force of the Treaty of Amsterdam, the Council asked the Commission to draw up specific proposals for a medium-term programme<sup><a href="#P219_32609" name="P219_32610">1</a></sup>.  The main points of that programme might encompass questions such as tackling major health scourges, pollution-related diseases, applications of biotechnology, health promotion and prevention.  The idea of setting up Community surveillance to allow rapid reaction to health threats is the salient feature of the Conclusions of 26 November 1998.</p>

<p align="justify"><b>A need for Consistent rules for the management of health risks</b></p>

<p align="justify">43.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Ideally, the management of health risks has to be consistent, comprehensive and strategic.  To this end, risk management should always be based on ten fundamental principles:</p>

<p align="justify"><u>Principle No.1</u>: democratic<b> transparency</b>.  The risk assessment processes and the major rules which guide public decisions must be clear and explicit for all involved, so as to avoid pointless public controversy and to enable firms to anticipate them at the earliest possible stage, minimising their economic impact.  This could also be termed the justification principle.</p>

<p align="justify"><u>Principle No.2</u>: <b>comprehensiveness</b>.  The management of health risks must encompass every risk source and every channel of exposure to the risk, taking account of the short and the long term, of every environment and of all branches.  It is not logical to reason differently according to the types of product, channels of exposure or environments concerned.  Such comprehensive management is essential so as to avoid the transfer of risks, the case of waste management giving a clear illustration of this possibility.  What is more, this management must be able to be applied universally to every segment of the population, children, pregnant women, workers, and so on.  In order to avoid managing only those risks which are publicised by the media, and so as to ensure such comprehensive consistency, programming is necessary, meaning the prioritising of the problems to be resolved and the setting of a realistic timetable for the achievement of objectives.</p>

<p align="justify"><u>Principle No.3</u>: <b>rationality</b>.  It is essential that risk management should be based upon scientific evidence and information.  To this end, the available knowledge must be collected, interpreted, disseminated and analysed, using explicit procedures.  </p>

<p align="justify"><u>Principle No.4</u>: <b>prevention and precaution</b>.  Risk management must not only make it possible preventively to manage risk factors, the role of which is known in medical terms, but also to take into account uncertain effects, which remain hypothetical, but which are likely to pose a threat to public health.</p>

<p align="justify"><u>Principle No.5</u>: <b>efficiency</b>.  Risk management must enable optimum use to be made of financial, human and administrative resources, which means allocating resources in proportion with the level of risk.  Health risk management policies must be scientifically evaluated in terms of benefit and risk, and this must be done on a periodical basis so that the resources committed remain in line with the problems to be solved.  To this end, quantified aims must be set.  When these aims are set, account must be taken of the seriousness of the dangers, the levels of risk in relation to the actual level of human exposure to pollutants and the frequency of the said exposure.  Risks may be high but concern only a small population group, requiring corrective measures so that a relatively fair distribution of risks within society can be achieved.  However, it should also be realised that low risks to which a large number of people are exposed may represent a collective risk that is not negligible.  Urban air pollution is a good illustration of this situation, one which is encountered increasingly frequently in the environmental health sector.</p>

<p align="justify"><u>Principle No.6</u>: <b>a geographical approach</b>.  A problem of this kind cannot really be taken into account unless a geographical approach is taken to risk analysis and management, each country being able to define the relevant geographical unit in the light of its demography, urbanisation, geographical size and administrative traditions.</p>

<p align="justify"><u>Principle No.7</u>: <b>ethics</b>.  Risk management is not an exact science.  It has to respect the values and preferences of those concerned, particularly where knowledge is uncertain.  It has to be based on clear and fair information, so that machinery can operate enabling those concerned to participate and to be consulted, particularly when priorities and objectives are to be set.  The risk analysis process must be clearly distinguished, where players and responsibilities are concerned, from the risk management process.  Just because technical instruments are available, this does not mean that reasonable use is made of them and that they are usable in the field.  The economic, industrial, legal and cultural feasibility of their use must be carefully appraised when an action strategy is defined.  </p>

<p align="justify"><u>Principle No.8</u>: <b>the use of more than one expert</b>.  The scientific knowledge available for assessing and managing risks in accordance with the principle of rationality must be brought into play through a process of consultation of several competent and specialised experts.  Care should be taken to ensure that every opinion, every school of thought has been taken into account, even marginal ones.  Unless credible expert opinions are obtained, the public and economic players will not be able to abide by the recommended measures, possibly leading to crises on a scale disproportionate to the actual size of the problems.</p>

<p align="justify"><u>Principle No.9</u>: <b>responsibility</b>.  Arrangements must be made to ensure that those who cause risks responsibly and prudently manage the problems they are likely to create.  It is for member states to ensure that members of the public have someone responsible for public health to whom they may turn.  When individuals are anxious about possible risks to themselves and their families connected with their home or working environment, the proximity of industrial plants or community facilities or the products which they consume, it is of the greatest importance for a responsible body to exist from which they will be able to obtain objective information about the reality of their fears and the measures taken by the authorities to deal with them.  </p>

<p align="justify"><u>Principle No.10</u>: <b>harmonisation</b>.  The globalisation of the economy must be accompanied by international harmonisation of the rules on the management of health security problems, so as to avoid distortion of competition conditions likely to give rise to huge transfers of risks from one country to others.  This is why member states are invited to take into account the international, particularly the European, environment when they define their public risk management policies.</p>

<p align="justify">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;These ten principles may serve as a basis for a charter of health security risk management in Europe.</p>

<p align="justify"><b>Conclusions</b></p>

<p align="justify">44.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Health security is a new concept, expressing the importance that the European population attaches to protection against health risks which are avoidable because they are linked to factors which humankind can control. </p>

<p align="justify">45.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The high speed of changes in living conditions, generalised urbanisation, the capacity to multiply new risk factors, the legacy of an industrial past that attached little importance to protection of the environment, the ill-conceived industrialisation of food production for humans and animals, these all give rise to problems which, were they not taken seriously, could jeopardise economic and social progress.</p>

<p align="justify">46.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The globalisation of trade must go hand in hand with an effort to control the health risks linked to the now freely circulating products, goods, foodstuffs, materials and manufacturing and distribution technologies in the industrial and agricultural sphere.  </p>

<p align="justify">47.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Taking into account the resources and knowledge currently available, a good deal of progress is possible in this sector, thanks to the taking of greater account of health when public policies are designed.  </p>

<p align="justify">48.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; It is important to promote a comprehensive, consistent and European approach in this field, where both the evaluation and the management of risks are concerned.  This approach must be based on the concept of risk and must be guided by better knowledge of the levels of exposure to environmental factors.</p>

<p align="justify">49.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In those spheres where risk evaluation remains subject to scientific uncertainties, the holding of public debates is an important element in public health policies.</p>

<p align="justify">50.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; In this context, it is necessary for the Council of Europe to take initiatives to set up a genuine European system of health security, to harmonise and guide the action of European authorities in the field of health security and to promote modern and democratic principles of health risk management, which would be collected and included in a charter for health security.</p>

<p align="justify">*</p>

<p align="justify">*   *</p>

<p align="justify">Reporting committee: Social, Health and Family Affairs Committee</p>

<p align="justify">Budgetary implications: none</p>

<p align="justify">Reference to committee: <a href="/ASP/Doc/RefRedirectEN.asp?Doc=Doc. 8100">Doc. 8100</a> and Reference No. 2282 of 27 May 1998</p>

<p align="justify">Draft recommendation unanimously adopted by the committee on 2 September 1999 </p>

<p align="justify">Members of the committee: <i>Mr Cox, (Chairman)</i>, <i>Mr Weyts</i>, Mrs<sup> </sup>Ragnarsdottir, <i>Mr Gross</i> (Vice-Chairs), Mrs Albrink, <i>MM. Alis Font</i>, <i>Arnau</i>, <i>Mrs Belohorska</i>, <i>Mrs Biga-Friganovic</i>, Mrs Björnemalm, Mrs<sup> </sup>Böhmer <i>(Alternate: Mr Hornung)</i>, MM. Chitaia, <i>Christodoulides</i>, <i>Chyzh</i>, Dees, Dhaille <i>(Alternate: Mr About)</i>, Duivesteijn, <i>Evin</i>, <i>Flynn</i>, Mrs Gatterer, MM. Gibula, Gregory, <i>Gülek</i>, Gusenbauer, <i>Haack</i>, <i>Hancock</i>, <i>Hegyi</i>, Mrs<sup> </sup>Høegh, Mrs Hornikova, Mrs Jirousova, Mr Kalos, Mrs Kulbaka, Mrs Laternser <i>(Alternate: Mr Brunhart)</i>, Mr Liiv, <i>Mrs Lotz</i>, Mrs Luhtanen, Mr Lupu, Mrs Markovska, MM. Marmazov, Martelli <i>(Alternate: Mr Lento)</i>, <i>Mattéi</i>, Mozgan, Mularoni, Mrs Näslund, MM. Niza, Paegle, <i>Poças Santos</i>, <i>Mrs<sup> </sup>Poptodorova</i>, <i>Mrs Pozza Tasca</i>, <i>Mrs Pulgar</i>, <i>MM. Raskinis</i>, Regenwetter, Rizzi, Sharapov, Skoularikis, Mrs<sup> </sup>Stefani, <i>MM. Surján</i>, Tahir, <i>Telek</i>, <i>Valkeniers</i>, Vella, Mrs Vermot-Mangold, MM. Volodin, Voronin, <i>Wójcik</i></p>

<p align="justify">NB:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The names of those members present at the meeting are printed in italics.</p>

<p align="justify">Secretaries to the committee: Mr Perin, Mrs Meunier and Mrs Clamer</p>
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<p align="justify"><sup><a name="P219_32609" href="#P219_32610">1</a> </sup> Resolution of the Council of the European Union of 8 June 1999.</p><!-- TRANSIT - INFOAFTER -->
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