Michèle LEGEASLecturer and researcher in managing

microbiological risk situations;

previously in charge of ‘Health security’

seminars for top public sector

management at the École Nationale de

la Santé Publique (1997-2000).

Health security

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SOMMAIRE

Introduction ............................................................................................................ 4

Chapter I The context in which the idea of health security emerged ............... 5

1. Definitions of ‘health crises’ ............................................................................... 5

2. Sorts of health crisis ........................................................................................... 6

3. State reform .......................................................................................................... 8

Chapter II The law on health security: what approach? .................................... 9

1. Broad principles of the law ................................................................................. 9

2. No benchmark definition ................................................................................... 11

Chapter III Health security: a five-stage approach ........................................... 12

1. Distinguishing between vigilance and surveillance ........................................ 12

2. Identifying problems .......................................................................................... 15

3. Evaluating risk ................................................................................................... 15

4. Decisions ............................................................................................................ 17

5. Evaluating actions ............................................................................................. 21

Chapter IV Organisations .................................................................................... 24

1. French bodies created by the law of July 1998 ............................................... 24

2. Targeted environmental risks in France .......................................................... 25

3. International organisations ............................................................................... 26

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Chapter VForeign ways of understanding the French concept of health security . . 27

1. Features specific to France ............................................................................... 27

2. Health security abroad ...................................................................................... 27

Conclusion ............................................................................................................ 29

Some recommended reading .............................................................................. 30

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Introduction

Since 1997 the concept of health security has emerged and been taken up, both by decision makers and by the general public. It figures in a law of July 1998, and has substantially changed the context within which participants and institutions in charge of risk prevention operate.The aim of this module is to provide the reader with the keys to understanding how this concept emerged, a broad outline of its definition, the resulting rules for action, as well as a reminder of the resulting new institutional landscape.It is therefore divided into four major sections:

♦ The context within which the concept emerged,

♦ The elements which go to make up the concept and the resulting action rules,

♦ The institutional landscape and its evolution,

♦ Questions relating to public health objectives, which still remain open.

The concept was largely devised in 1998, and has undergone several transformations and amendments so as to take into account scientific and legislative progress.This module is intended for EHESP students in initial or continuing training, both professionals and academics, for students studying for the EHESP’s entrance exams for professional training, as well as for everybody interested in acquiring a better appreciation of this concept.

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Chapter IThe context in which

the idea of health security emerged

The concept of health security is a specifically French concept that was first

introduced in the law of 1 July 1998 relating to the reinforcement to

monitoring procedures. It emerged and evolved with successive heath

scares, known in French as a crise sanitaire or ‘health crisis’.

It is therefore necessary to start off by clarifying the notion of a health crisis.

1. Definitions of ‘health crises’

1.1 What is a crisis?

Etymology is of no use here, as the word originally meant ‘decision’ or ‘judgement’, and by extension the crucial stage in an illness. In the non-medical field, the word ‘crisis’ has come to mean disruption, states of radical imbalance, and even disorder (be it economical, political, geopolitical, climactic, or so on). The word comes from the field of medicine but … has in fact only recently returned to the health domain to refer to not just critical individual states but situations of disruption resulting from threats to health which bring the health care system into question or even show it wanting, or a state of disorder in society or a production system.‘Crisis management’ is, in a certain sense, a contradiction. Disruption is not something one can manage; instead one seeks to prevent it happening, to limit its effects, and to re-establish order.Extrapolating from this, crises cannot be predicted. Crises fall outside the signal - risk evaluation – risk management linear model. At best one may observe certain factors which, if they come together, are likely to degenerate into a crisis and practice reacting in disrupted contexts and learn from past experience so as to be able to react more swiftly when faced with a given situation.

WHAT IS A CRISIS? – GIRARD REPORT

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Passage from the report of the health monitoring in France evaluation and

expertise panel.

Girard report (fr)

P.Lagadec puts forward a way of categorising crises, going from the easiest

to control to the hardest:

♦ Rapid increase in a known phenomenon,♦ Loss of control of a relatively well-known situation,♦ Unforeseeable or previously inconceivable change.

For health, a slightly different perspective may be used.Irrespective of the sort of crisis, it is brought about by a chain of events and circumstances.

© Health security in France today - Crises - M.Legeas, ENSP, 1999DIAGRAM OF A CRISIS

2. Sorts of health crisis

It is possible and necessary to distinguish between two sorts of crisis:

♦ "real" health crises♦ and public health scares.

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2.1. “Real" health crises

The expression real health crises refers to crises that have unfortunately

claimed victims and which could have been avoided, arising from

malfunctions and mistakes.

ExampleContaminated blood, asbestos, nosocomial infections.

Such crises occur frequently, and since they result in avoidable cases of

illness they are of interest primarily to public sector participants.

2.2. Public health scares

Public health scares come from the public are not of the same order as real

health crises. They may or may not have actually or reputedly resulted in

cases of illness, and may or may not be associated with genuine

malfunctions. Instead a state of doubt relating to a given situation results in

worries, and this at times results in the public calling the public services to

account.

ExampleHepatitis B vaccination

The question of generalising the use of a new vaccine gave rise to

widespread concern at a given moment. It is an excellent example of

“health scare” crisis. There was no proof of any health error. The

decision to conduct widespread vaccination against hepatitis B even

seemed to be a judicious one in terms of health risks-benefits. Yet

nevertheless, public concern reached such a level that the public

services did a U-turn, renouncing the original idea of pushing through

systematic vaccination. The upshot is that France will trail some way

behind on this public health issue in the years to come.

It is important to appreciate the differences between these two sorts of

crisis.

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This is because they cannot be handled in the same way, and so the

distinction has to be made between two different health security

approaches, one for dealing with genuine crises resulting in cases of illness,

and the other responding to public concern.

ObservationThe concept of health security arose largely as a result of the problem

of contaminated blood.

This was present everywhere in the media in 1997, leaving but little

room for media coverage of other sorts of health problems, such as

asbestos for instance. And the law put forward by the senate was

based on analysis of the contaminated blood “affair”, to the virtual

exclusion of any others. This law is therefore designed to respond first

and foremost to this sort to heath crisis, and thus has a certain number

of shortcomings.

3. State reform

In 1997 joint ministerial working groups piloted by the Ministry of the Public Sector had been working on State reform for quite some years. Increasing emphasis was being placed on the need for the public sector to work together so as to be more efficacious. The request for a rapid increase in high level joint ministerial training arose from this.

Activity Report 1997 (fr)

ExplanationGiven its position, the ENSP was entrusted late 1997 with the

responsibility of providing training in health security, when the "health

security" law was still being debated by the two houses.

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Chapter IIThe law on health security:

what approach?

"The importance the French health system gives to prevention is

comparatively minor. This is due to the history of the approach to public

health in France which, unlike such countries as Great Britain or Germany,

has been primarily medical " (Murard & al., 1996)

Yet health security is more a matter of prevention than of care or of

“remedy” in general. In theoretic terms it is positioned prior to problems

since it seeks to prevent crises.

Any enquiry into the effectiveness of health systems should take the place

of prevention into account. And yet the Senate’s preparatory work for the

law resulting in the notion of health security makes no mention of the

equivalence, in abstract terms, between health security and prevention. It is

simply a question of handling health crises, of seeking to avoid them, but

not really of trying to create the means for anticipating them or rapidly

intervening so as to limit their effects. (This will be what the l aw of 9 August

2004 seeks to rectify subsequent to the 2003 heat wave, in particular via its

redefinition of the role of the InVS [Health Monitoring Institute, see chapter 4

relating to “organisations”].)

1. Broad principles of the law

1.1 Separating expertise and management

The senators behind the health security law were familiar with health and

health care issues. One of them, Claude Huriet, had been the driving force

behind the first “bio-ethics” law.

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ExplanationIn 1997, subsequent to the contaminated blood affair and faced

with the judicial implications and questioning of the role played by

public figures in this saga, the senators were convinced of the

need to regulate, reorganise and improve the French health

system so as to prevent another such case arising again. More

specifically, they conclude that it is absolutely essential to

separate the activity of managing from that of evaluating (or

providing expertise), where the word management is understood

as referring to economic and financial issues.

In their opinion the contaminated blood affair was attributable to

the fact that the key participants were in the dual role of judge and

judged - judge insofar as they were the recognised experts in the

risks relating to blood transfusions and the use of blood products in

general, and judged since they played a role in the financial

management of transfusion centres and were therefore under

pressure to exceed authorised risk limits so as to make them as

cost-efficient as possible.

1.2. Harmonising

The senators observed that in France there was a whole host of different structures, organisations, expert panels, and various groupings, all of which were working in their corner on similar issues. For example, they listed over thirty participants in charge of food and water issues (Ministries, expert commissions, consultation panels, etc.) and over ten structures interested in medicine usage. In other words, a myriad of different organisations which were meant in theory to work together yet which all functioned wholly independently of one another. The senators wished to put an end to this dispersal since it gave rise to conflicts.They wished to harmonise the systems as so ensure all the structures worked together, and to bolster the rules and oversight methods for which these structures were responsible. [Senate social affairs commission report, P196, 1996-1997.]

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1.3. Defining the limits of products for human consumption

The senators considered that health security was above all a matter for products for human consumption, i.e. heath products and food products.Yet an approach which is limited in this way to these two categories is problematic, especially as regards the environment since here, the risk comes precisely from products which are not intended for human consumption. This explains why the law only makes a passing reference to the creation of an agency specialising in habitat risk in a specific article relating to the establishment of a discussion process within two years of the law’s promulgation. This finally led to a further, specific law in May 2001. [See chapter 4 on "organisations"]

2. No benchmark definition

It is remarkable that, despite the law’s name, there is not one single attempt to define “health security” in all of the texts drawn up by parliament in the drafting of the law. This represents a major problem with this law.In most cases the first article of a law sets out the goals to be fulfilled, but in this instance it announces the creation of the Institut de Veille Sanitaire. The concept itself is never defined and thus the objectives of the reform are not defined either. It is therefore just not possible to ascertain what issues this law seeks to tackle by reading it.

ObservationsThe only reference document underpinning all subsequent discussion on the

concept of health security and how it transpires in practice is provided by the book

"D.Tabuteau: La sécurité sanitaire." (Tabuteau, 1994)

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Chapter IIIHealth security:

a five-stage approach

The definition that was finally adopted for "health security", subsequent to the wok of the EHESP, takes D.Tabuteau’s ideas and applies them more widely : "The entire set of conditions (be they technical, organisational, economic, etc.) required to ensure individuals the confidence and safety they aspire to vis-à-vis health risks."Using this definition as a basis, it is possible to devise an approach to meet the following objectives:

♦ Distinguish between vigilance and surveillance♦ Identify problems♦ Evaluate risks♦ Take decisions♦ Evaluate actions

Preventing negative changes in population health involves the prior implementation of all measures known to be effective against known or expected risks. But it also involves being able to spot new, unexpected situations which could lead to heath problems as early as possible. Once observed it should be possible to take appropriate action as rapidly as possible so as to reduce individual or collective effects.

1. Distinguishing between vigilance and surveillance

1.1. Surveillance

ExplanationSurveillance presupposes a known, identified occurrence that one wishes to assess on a permanent basis. It might be a matter of routine surveillance (for example, monitoring notifiable diseases) or drawing up routine reports (for example monitoring long-term variations in the number of articles being published on SARS).Surveillance consists in recording data and monitoring their change over time and/or space, then interpreting these data by looking for scientific publications on a disease or phenomenon.

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In the case of legionnaire’s disease, for example:surveillance involves recording all the cases declared in France, either so as to just describe this data or else to issue an alert. Surveillance can and where necessary should result in alerts, which in turn result in planned responses.Flu surveillance is a good example of the process:Sentinel doctors across who also belong to the European GROG network, record the arrival of the first cases of confirmed types of flu. [See below for the notion of confirmed cases]. As soon as these are observed and the migration of the virus is detected, an alert is sent out to all French heath authorities to start preventative vaccinations for people who are the most fragile or at risk.Surveillance would involve crisis "rapid increase" as defined by P.Lagadec. [See chapter 1 "The context in which the idea of health security emerged"]Cases: it is important to distinguish between “possible”, “probable” and “confirmed” cases.Possible cases: these are people presenting some or several signs suggesting an illness, but where this illness has not been confirmed (in general by biological means);Probable cases: these are people presenting some or several characteristic signs of an illness and for which some examinations tend to confirm the presence of that illness, but without it being definitively confirmed;Confirmed cases: these are people presenting several signs of an illness and for which the diagnosis has been confirmed.

1.2. Vigilance

ExplanationVigilance is based on detecting singular, unexpected and sometimes even unforeseeable events. It serves to prevent “loss of control” or “mutation" crises as defined by P.Lagadec. [See chapter 1 "The context in which the idea of health security emerged"]If we consider the example of the SARS epidemic [Severe Acute Respiratory Syndrome] between late 2002 and mid-2003 (8000 cases with nearly 800 deaths), the phenomenon could be detected using information available on certain web sites several month before the news broke in the media (and even before public participants defined their position on it).Vigilance involves trying to identify “odd’ information in everything one hears and sees, which raises questions and which could merit the attention of health authorities and might result in an alert.

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Vigilance therefore has a place in the activities of a school such as the

ENSP via a documentary vigilance system based on sharing and comparing

information between colleagues working in different fields.

Sanitary Surveillance Letter, n°3, 2008 (fr)

An essential characteristic of vigilance is that cannot be rigidly predefined.

At best it can be improved, especially by providing processes and conditions

which encourage it.

Missions of INVS (fr)

The summer 2003 heat waveIn the summer of 2003 a certain number of participants rapidly detected

a surprising increase in the number fragile people dying or being

admitted to hospital (and especially the elderly). Unfortunately, as these

people worked in very different sectors such as health and social

authorities, undertakers, emergency services, home help associations

and so on these signals were not rapidly all put together. It took some

time for the signals to converge, resulting in an alert only being tardily

issued.

Hepatitis A epidemicThere was a hepatitis A epidemic in the Côtes d’Armor. Fortunately, it did not spread as the medical inspector and director of a medical laboratory knew each other well and kept in touch. The director of the medical laboratory contacted the medical inspector when, in the space of a few days, he signed several requests to transfer serums from the Institut Pasteur to confirm the presence of the hepatitis A virus and was surprised by this group of cases. The medical inspector alerted all the directors of medical laboratories in the Côtes d’Armor, and all the data on increases in the number of hepatitis A cases in the area were rapidly pooled. In parallel, the medical inspector very rapidly passed on the information to homes for the elderly, to centres for handicapped adults, young children, and all the places which might witness a sudden increase in secondary cases of the epidemic.Thanks to this swift and well organised response no secondary cases were recorded. The vigilance was initiated by the director of the laboratory. Yet, in order to be lastingly effective, it required the presence of a network of individuals who trusted each other.

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2. Identifying problems

Once vigilance has enabled a phenomenon to be detected by sharing and comparing information, the problem can be identified by a specialist.This specialist may be either:

♦ The person who was vigilant, if it falls within their specific competences,♦ Or a third party who has been informed of the observations.

Identifying problems requires organisation, and especially information systems enabling anybody working in a regional Health ministry department to have a regularly updated address book with the names and phone numbers of a toxicologist, infectious diseases specialist, or someone working in health care for risk populations, for instance.It is not easy to pool data since, in practice, very few services have joint ministerial files.

ExampleThe Directorate of Health and Social Affairs does not compare public

health data with data relating to habitat or to population health

monitoring. The information systems in operation do not enable

information to be jointly monitored. But it is just as crucial to be able to

find the right person rapidly as it is to be vigilant. Vigilance is pointless

unless one can find the person to whom to communicate the

observations and interpret them as things unfold.

ObservationExploring a problem requires highly competent people in documentary,

scientific and technical research who can work very rapidly and find the

right, scientifically and technically prove references. But such skills are

not appreciated at their true value by institutions and are far from

widespread.

3. Evaluating risk

When possible risk evaluation can use standard ‘button push’ methods to measure and characterise risks or the effects on a population.

ObservationThere are fascinating American articles on this subject. Models can be used to calculate the price of a life on the basis of a person’s sex, age

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and “race”. Depending upon this price it is possible to assess whether it is financially more viable to set up prevention measures or let people fall ill or die.

It is only possible in a very few cases to carry out risk quantification.Risks may always, however, be described.

If factors contributing to the triggering of Creutzfeldt-Jakob disease are still not fully known rendering it impossible to predict how many cases there will be in a given population at a given time, the disease can still be characterised by showing that it is fatal in 100% of cases.

ExampleA few years ago, estimations of the number of victims of ‘mad cow disease’ in Europe stood at between 100,000 and 500,000 cases (and hence deaths). Currently less than 300 cases have actually been identified. Ongoing observations have resulted in a re-evaluation of the severity of the crisis.ExplanationWhilst people knew of the existence of this new disease in British cattle from 1986 on, it was not until 1997 that particularly vigilant British doctors formulated the hypothesis of a link between the cattle disease and the appearance of Creutzfeldt-Jakob in young patients, throwing the authorities into a state of panic. It is no doubt thanks to these doctors that the population avoided the worst, with the implementation of the appropriate measures. These measures became an increasing hindrance over time when in fact the disease had been largely eradicated. This observation illustrates the importance of carrying out

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cost-benefit analysis or evaluating actions and programmes [see following section].

4. Decisions

As has already been stated several times so far, vigilance and identifying a problem or risk for population health is not an end in itself, but must act as a basis for taking proportionate action.Selecting and implementing these actions requires a decision first to be taken and formally approved by those in charge of public action.Several frequently mentioned principles act as a basis for these decisions. They are presented below, separately, even though in many cases several of them come into the discussion process prior to making a choice.

4.1. Relationship between decision and the precautionary

principle

The precautionary principle does not amount to not taking action.The fact of doing nothing has its own repercussions. Inaction therefore does not exist. The precautionary principle is often confused with the principle of inaction, and this would only hold good on a desert island. Not taking action corresponds to a sort of default decision.

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ExplanationContrary to a widespread idea, the precautionary principle did not

originate at the Rio conferences, but does in fact predate them. It

is in fact mentioned for the first time in a “Channel/North Sea”

agreement [drawn up in 1987 at a conference of the Ministers for

the Environment of the relevant countries] which sought to tackle

an exceptionally high death rate in seal populations by fighting

pollution, the presumed cause of death.

Even in its most recent new definition [Rio Agreement, 1992], the precautionary principle does not apply to everyday events. To simplify, this principle states that it is not necessary to know and understand everything before implementing technically and economically acceptable measures when so required due to the emergence of an exceptional event.

ExampleThe term “economically acceptable” depends a lot upon the total

expense and the forecast number of victims. For mad cow

disease, the solution was to slaughter herds and withdraw

products likely to contain prion [nerve material] and to indemnify all

the farmers and pay for the destruction of the carcases and by

obliging local authorities and school canteens to no longer serve

certain cuts of beef. The 201 deaths from new variant Creutzfeldt-

Jakob disease [total as of July 2007] have resulted in considerable

expense and action. Nevertheless, these measures were deemed

to be technically and economically “acceptable” since it seemed

that the expected damage could be enormous.Rio Agreement (fr)

4.2. Relationship between prevention and precaution

Prevention has been carried out for centuries, and the first law in France on public hygiene was adopted in 1902

ExampleIt is known that transforming surface water into water for human

consumption can result in certain harmful health effects (cholera,

typhoid, reduced fertility for boys who ingest molecules which have

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endocrine disruption effects, etc.) due to the initial quality of the

water if there is no suitable drinking water treatment plant.

Setting up such a treatment plant amounts to rational prevention.

ExampleOn the other hand, uncertainties relating to the mechanisms

involved in transmitting pathological forms of prion protein between

cattle and humans were such that the only measures which could

be taken, when the existence of new human disease was proved,

were necessarily extreme, going as far as the total withdrawal of

all bovine products for consumption. This was an instance of

applying the precautionary principle due to the presence of a new,

unconventional form transmissible disease, calling into question

certain basic ideas of biology and thus requiring non-traditional

ways of thinking in order to contain it.

Essentially, precaution is more closely related to vigilance and prevention to surveillance.In everyday situations prevention fortunately nearly always outweighs precaution.

4.3. Cost-benefit analyses (for health, not for economics)

Generally cost-benefit analysis is a matter of money.It can also however also be a matter of the risk of secondary effects (the cost) of a new medicine in relation to the expected health care benefits.Cost-benefit analyses therefore also apply to health security. It is not a question of monetary value but of the efficacy or “health and social” value attributed to this efficacy.

ExampleIs the use of replacement hormone treatment for menopausal

women to combat osteoporosis worthwhile given the known

associated risks of heart attacks? The Agence du médicament

[Afssaps, the Medicine Agency] bases its decision to withdraw or

continue the use of certain medical products and substances using

this sort of study.

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However, health cost-benefit analysis ought to be based more on social sciences and take into account individual and collective opinion. Yet these two approaches are different. Cost-benefit analyses carried out thus far in the field of health have virtually never taken into account the psycho-social aspect of care or “health”.

4.4. Taking into account social demands

Non-financial cost-benefit analyses involve taking social demands into account. On occasions social demands do not correspond to what experts deem justified. It is therefore necessary to work closely with the public to restore confidence, even if the question does not seem to be a priority.This is associated with questions of individual responsibility, ethics ad deontology.The risks (fr)

Tacking into account social demand is still weak in the field of care, medicine is said to treat whereas a doctor is said to cure. With the exception of a few powerful associations representing patients (in particular those suffering from AIDS or CRI), the population affected by an illness has rarely become sufficiently involved in the issue to be recognised by experts as a valid interlocutor. Social pressure is in fact comparatively weak in the field of treatment. And it is inexistent in the field of diet, with each individual acting as a consumer within an economic system.In the field of environmental health, social demands at least appear almost systematically taken into account, and this in fact is the case but due more to environmental than health concerns.

4.5. Communicating a decision

The feeling of security corresponds to the subjective representation of the degree of safety.

ExampleIt is possible to be safe when all the doors and windows in the

house are locked, yet not to feel safe. Equally, one can feel safe

when driving whilst unaware of the fact that the brakes discs need

changing.

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The degree of safety is something palpable and measurable, whilst security is a state of mind.A well known problem in communication is that the message received is not always that which was meant. For a state of confidence to reign explanations are necessary. Confidence is based on tests and arguments. For real confidence to reign explanations need to be provided.

ExampleIn the field of nuclear power the CEA (French Atomic Energy

Commission) nearly always practices safety. It builds new modes

to test the level of risk, and implements measures within plants

and at their points of exit. It does not expend much effort on

security as people are still afraid of nuclear power. They are afraid

because they do not have much confidence in the CEA. And yet

this body makes considerable efforts to communicate and

reassure the outside world, but these efforts are often poorly

devised since they are too learned and poorly understood by non-

experts.

Receiving information from someone one does not believe is worthless, just as there is no point going to a conference if one has no confidence in the speaker. Experience shows that confidence does not depend upon the degree of proof.It is the responsibility of health care participants to explain very clearly when so-called health arguments are specious and equally to spell out the risks, even when these are minor or not clearly known, without systematically fearing that the population will be thrown into a state of panic.

5. Evaluating actions

5.1. A necessity

Once a situation that could have an effect on people’s health has been documented and analysed, the competent authorities take a decision to act and correct the situation and then implements this decision via the appropriate public or private participants. Later, once the spectre of danger has receded and the secondary (and in particular economic) consequences will start to make themselves felt, then the question of whether or not this decision was justified will probably arise.

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Creutzfeldt-Jakob diseaseTo take the example of decisions taken on the appearance of what

was known as mad cow disease, the latest estimates suggest that

the number of cases of Creutzfeldt-Jakob will probably diminish

after 2006 or 2007. [additional note made 2007: this forecasts

have turned out to be correct – see the diagram in the preceding

section of “evaluating risks”]. That will be the right moment to

evaluate the measures that were implemented to combat the risk,

in particular so as to convince EU authorities not to carry on

issuing ever more directives.

Such evaluations are necessary. And it continues to be necessary when they conclude that the actions used to combat a problem when it emerged were wrong or failed. One has to accept that one made mistakes, and accept the risk that new knowledge will reveal that the decision taken was erroneous or unjustified. Yet it is likely that the person in charge of the decision will be most uncomfortable if their choice led to a large number of victims and will perhaps not wanted this error to be revealed to all, or for victims rightly to demand damages.That is why it is important to devise indicators from the outset which provide a means to study actions and any differences between forecasts and events, and assess scientific progress between the moment a decision was taken and the moment of its evaluation. This could help prevent such errors being made again out of fear of the consequences of action, whilst throwing an objective light on any errors which may indeed have been made.

5.2. Example relating to the environment: nitrates in water

For twenty years now the presence of nitrates in water has given rise to debates and repeated tension.Nitrates in water (fr)

The lesson to be learnt from this example is that public authorities never established the means of evaluating the actions being implemented against the rather hazy objectives that had been fixed. Given the lobbying it is far from certain that the current limit of 25, or even 50 milligrams of nitrates per litre be maintained in the future.

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5.3. Another example: hepatitis B vaccination

Unlike for the case of nitrates in water discussed above, the rapidly developing controversy about the potentially harmful effects of vaccination against hepatitis B led to the public authorities rapidly expediting a “cost-benefit” type evaluation.

ExplanationThis involved weighing the number of forecast cases of hepatitis B

in the French population without vaccination, and the fraction of

cases which could lead to severe forms (cancers and fulminating

forms), against the forecast number of cases of neurological

problems due to the vaccine given the available data. In order to

give this analysis greater authority, European epidemiological data

from medicinal vigilance programmes were fed into the French

data. This analysis was carried out twice and in both cases gave

the same trends in favour of preventative vaccination and therefore

targeted primarily at people who were exposed to risk via their job

or behaviour. The principle which had prevailed against the mass

vaccination campaign was not brought into question.

Nevertheless, the incomprehension and hesitations that had

characterised the way public concerns were managed resulted in a

loss of public confidence and the more or less total halt in

vaccinations of children before adolescence.

Vaccination against hepatitis B and multiple sclerosis (fr)

What is more, experts have concluded that this cost-benefit analysis will have to be reassessed on a regular basis.Whilst it is essential to evaluate decisions, this on its own does not guarantee that the population will adhere to the conclusions of an evaluation.

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Chapter IVOrganisations

1. French bodies created by the law of July 1998

This law established four new bodies [without counting the reorganisation of existing bodies such as the EFS]:

♦ The comité interministériel à la sécurité sanitaire (joint ministerial committee for health security) was replaced by the Comité National de Santé Publique (National Committee for Public Health) by the law of 9 August 2004; its missions are largely unchanged, and involve coordinating policies and agencies.

♦ l'Institut de Veille Sanitaire (InVS, Health Monitoring Institute) was create by transforming the RNSP (GIS) into a State agency and is in charge of health monitoring. Since the heat wave in summer 2003 and its impact on deaths in France, it has been charged with a new mission of health vigilance [see chapter 1]. This institute currently has about 300 people working for it. The InVS is the key structure in the new system.

♦ l'Agence Française de sécurité sanitaire des Produits de Santé (AFSSaPS, the French Health Security Agency for Health Products) was created from the former Medicine Agency which used to employ 750 people when it was transformed. It has since employed many more. It has two, or even three overseeing bodies and some of its staff have police powers (those from the Ministry of Agriculture and the Ministry of the Economy) whilst others do not (employees from the Ministry of Health). The powers vary significantly depending upon the Ministry. This situation conceals major economic issues at stake.

♦ l'Agence Française de sécurité sanitaire des Aliments (AFSSA, the French Health Security Agency for Foodstuffs) was created from the CNEVA (Centre du médicament vétérinaire, Veterinary Medicine Centre). Originally, people working for this body were for the most part specialised in veterinary medicines and their traces in foodstuffs. This had a major impact on the way the agency was subsequently structured and its remit. It now has over 1000 people.

♦ l'Agence Française de sécurité sanitaire de l'Environnement (AFSSE, French Health Security Agency for the Environment), which has since become the AFSSET (et du Travail, and for Work):

The last agency resulting from the reforms to health security is the Agence Française de sécurité sanitaire de l'Environnement (the French Health Security Agency for the Environment), which was created by a new law (law of 9 May 2001 and the decree of 1 March

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2002) then a decree of 2003 making it responsible for health in the workplace. As the law of July 1998 related to products for human consumption, a new la was required to be able to include issues relating to environmental contaminants. The agency is currently expanding, and having started with thirty or so people is now nearing one hundred.

The different number of employees of each of these bodies reveals the different means and significance accorded to each by political decision makers.

2. Targeted environmental risks in France

2.1. Sorts of risk

For environmental health, expert assessments related mainly to chemical risks and in particular to soil pollution. There are however three sorts of risk that need to be taken into account: chemical risk, biological risk and physical risk.

♦ Chemical riskChemical risk concerns all the molecules found in the environment (dioxins, heavy metals, etc.), both those produced by human activity (the most common case) and those naturally occurring (for example, soils rich in heavy metals in zones that are volcanically active).

♦ Biological riskBiological risk includes both biological risk proper and microbiological risk. An example of biological risk would be rapid increase in the number of allergens, a current preoccupation of the DDASS. Many people feel that microbiological risk is under control thanks in particular to vaccinations and medicine. Nevertheless, increasing resistance to antibiotics, for instance, or the appearance of new viruses such as H5N1 bird flu or Chikungunya show that a false sense of security about microbial agents can be dangerous, even in developed countries.

♦ Physical riskPhysical risk corresponds to the effects of ionic radiation, in other words everything related to radioactivity, and to non-ionic radiation (noise, aerials, mobile phones, etc.).

2.2. Their impact

It is often difficult to fully seize the impact of these substances and agents.There are about 40,000 molecules or chemical substances which are likely to cause harmful health effects.

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ExampleExample of Cadmium

This substance can be absorbed directly from the soil via plants

that are consumed (wheat, fruits, wine), from animals which have

consumed plants grown in soil polluted by this metal, from

inhalation (the atmosphere can contain cadmium), or via the skin

(some workers come into contact with cadmium dust).

Some elements have a different effect depending upon the environment in which they occur and on whether they are swallowed or inhaled. New substances and products appear every day. One of the challenges of the AFSSET is to try to coordinate and update databases on the effect all these molecules have on health.

3. International organisations

The international landscape is similar to the French setup, with several structures providing expert scientific guidance: the European Medicines Agency, the European Food Safety Agency, the European Agency for Safety and Health at Work, and the European Agency for the Environment.The European Union has introduced a research programme to initiate and conduct prior toxicity tests for all new products or substances, not just for toxic effects on the environment but also for people (REACH Directive, 2007). This method is similar to that governing to launch of new medicines. In other words, there is a harmonisation of methods used.

ObservationHowever, whereas the initial idea was for thousand of pre-existing molecules to also be evaluated, such evaluations will now only be conducted for a few substances in France, officially due to insufficient staffing and problems relating to practise.

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Chapter VForeign ways of understanding the French

concept of health security

1. Features specific to France

Features specific to France: installations and activities requiring prior authorisationThere are in France a large number of installations and activities which require the prior authorisation of the Prefect before they can be effected. One of the documents that is required in order to obtain such authorisation is a study of the potential impacts of the activity or installation in question on the environment.Health has recently been included in environmental protection (LAURE Loi sur l'Air et l'Utilisation Rationnelle de l'Energie, the Law on Air and Rational Energy Use of December 1996). This change follows the logic of current health security policy.This process of impact studies is pretty much unique. Most industrialised countries simply check that the party wishing to build an installation complies with standard documents resulting from national debates and decisions. It is only in France that the health effects have to be analysed for all installations requiring prior authorisation. It is currently reckoned that this amounts to over 100 dossiers per year in the most affected departments. These dossiers have to be studied by all the participants and in particular by regional public bodies, and an advisory opinion drawn up on the project. One can easily imagine the extra volume of work this creates in France in comparison to what happens elsewhere.

2. Health security abroad

Abroad, major industrial installations and activities may also necessitate specific prior studies, but these are the responsibility of public bodies and not private service providers, as is the case in France. This means that the reliability of the results is not open to debate.Generally, outside France national scientific committees and expert panels meet and pronounce on the best way to protect health in the light of current knowledge. Their recommendations apply to all irrespective of context.Expert bodies exist. In the USA, the FDA and EPA have similar missions to that of French agencies. At the European level, the European Medicines Agency works in similar way to the Afssaps. It is an evaluation body and its opinions act as a sort of certificate label. There is also a European Agency for Foodstuffs.

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The main difference is less therefore a question of what they do than the way they carry out their prerogatives:The permanent questioning of what the norm relates to, of the reglementary value, of the reference text is a typically French approach. This is at the heart of the idea of health security and is the reason why it does not exist elsewhere. In Anglo-Saxon culture safety is essential. Scientists state the risk. Technical experts propose means to reduce them. Decision makers then select means in the light of economic costs.In France, wit its Latin culture and Cartesian mindset, the State is also called to act yet is equally always suspect, hence the permanent need to prove a choice is justified.This does not only have negative effects, and is why France can, on occasion, act as an example for others. It is France, for example, that ‘invented’ regulations for what are known as SEVESO risks.

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Conclusion

The concept of health security has become part of everyday language within the space of a few years, and is frequently used by the media, if less so in the press.Unfortunately it has, to a certain extent, replaced the concept of public health, which in France is little known and poorly understood, thus reducing problems relating to health care to the regular incrimination of system malfunctions, especially when a policy or State body can be blamed. This amounts to downplaying the key role played by policies in the fields of prevention, education and the management of health and social conditions. Further, it reinforces the feeling of powerlessness people have and makes them feel that some external power is imposing unfair risks. In this case the only solution becomes a matter of tightening technical controls overseen by experts. But this ignores the responsibility of each individual to live as a citizen and as an actor in health-related matters (taken in the WHO meaning of the term), as a patient or patient’s relative, in life choices, and to assume one’s individual undertakings and responsibilities.

Additional noteThe notion of health emergency has recently replaced the notion of

health security, due to the climate of fear induced by the threat of bio-

terrorist strikes and following on from the 2003 heat wave. The

Direction Générale de la Santé (General Health Directorate) has

recently set up a specific department for handling health alerts, initially

called the DESUS and acting independently of the DHOS which also

handles these alerts. It then became the DUS and now handles all

health as well as all social emergencies and alerts, once the signals

have been handled by the CORRUS (Operational Centre for Receiving

and Regulating Health and Social Emergencies). The law of 5 March

2007 (and its implementing decree of 28 August 2007) has recently set

up the EPRUS (Establishment for Preparing for and Responding to

Health Emergencies).

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Some recommended reading

GIRARD J, "Rapport de la mission d'évaluation et d'expertise de la veille

sanitaire en France", Rapports de la documentation française, August 2006.

HURIET C, DESCOURS C, "Sécurité sanitaire: les enjeux de la réforme", M&M

Conseil, 1998.

LAGADEC P, "Chapter XVII - La recherche confrontée à la question des

crises. Pour des ruptures créatrices", in "Risques collectifs et situations de

crise. Apports de la recherche en sciences humaines et sociales, Paris", in

Claude Gilbert dir , "Risques collectifs et situations de crise. Apports de la

recherche en sciences humaines et sociales, Paris", pp., L'Harmattan,

Paris, 2003.

MURARD L, ZYLBERMAN P, "L'hygiène dans la république", Fayard, 1996.

SEGUIN E, "La crise de la vache folle au Royaume-Uni - Quelques

explications possibles" in "Revue française de sciences politiques", 2002, n

°.52 (2-3), pp.273-289.

TABUTEAU D, "La sécurité sanitaire ", Berger - Levrault, 1994.

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