Strengthening Europe’s health security shield

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Strengthening Europe’s health security shield

An independent discussion paper on health security

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Date of publication: November 2012

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Three years on from our discussion paper, Raising bio-preparedness levels in Europe, the SDA brings together experts in the field of health security to discuss the European Commission’s health threats package, which was proposed in December 2011. If approved by the European Council and the European Parliament, it will create the legal basis for addressing serious cross-border health threats and strengthening the role of the Health Security Committee.

The focus of this SDA discussion paper is on strengthening Europe’s health security shield, and how the health threats package could contribute to these efforts. How do member states view the package? How coordinated are member states’ policies and activities in the area of health security? What progress has been made? What can be learned from NGOs, and how best can we cooperate with industry?

This paper aims to provide a coherent overview of the package and its possible effects on European health security, as well as detailing possible further action.

SDA discussion papers consist of a series of short opinion articles written by experts in various fields. They are widely disseminated to government departments, think tanks, NGOs, industry experts and academics worldwide.

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Strengthening Europe’s health security shield

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Foreword

Paola Testori-Coggi

Director General for Health and Consumers, European Commission

In today's world of fast travel to far-flung places, diseases or contaminated goods do not stop at national borders; they can spread around the globe within hours. That’s why the European Union and its member states must act together in a fully co-ordinated manner to stop diseases from spreading.

The lessons learnt from previous crises, such as the 2009 H1N1 pandemic and the outbreak of E-Coli in 2011, are that Europe needs long-term solutions to protect citizens effectively against such threats.

In this spirit, the European Commission adopted in December last year a proposal for a Decision on serious cross-border threats to health. This strengthens the EU health security framework and improves preparedness and response in the event of a crisis.

Our endeavours in this area don’t start from scratch. The European Union and its member states have over the years developed the capacity to prevent communicable diseases, and to coordinate the management of health crises. A network is already in place for the surveillance of communicable diseases, and it is composed of the European Commission, the European Centre for Disease Prevention and Control and national authorities. The new proposal extends this co-ordination mechanism to all types of health threats arising from biological, chemical and environmental events.

The EU Health Security Committee, which has supported responses to crises since 2001 by

coordinating risk assessment and management of serious cross-border threats, is formalised in this legal proposal and given a broader mandate.

The initiative also foresees member states’ strengthening their preparedness planning in close cooperation with one another. I believe all member states need to have a minimum equivalent preparedness plan in place; otherwise, Europe’s ability to fight a pandemic is only as strong as its weakest link. In response to a request by EU Health ministers after the 2009 pandemic, the proposal also provides a basis for the joint purchasing of vaccines and other voluntary medical countermeasures.

Our proposal foresees a mechanism to recognise a European "health emergency situation"

for the purpose of making medicines available more rapidly. It also proposes that the European Commission should adopt, in very specific emergencies, measures to supplement action at national level.

I am persuaded that the proposal for a decision on serious cross border threats to health will strengthen health security in the EU and will help protect citizens more effective against these threats.

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The public body perspectives

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The World Health Organisation’s perspective

Margaret Chan

The Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza (H1N1) 2009 rightly stated that “myriad health threats have the capacity to cross borders. In anticipation and response, the World Health Organisation (WHO) gives voice and leadership on behalf of the global community.

WHO’s principal line of defence is the IHR. The emergence of the influenza A (H1N1) pandemic in April 2009 provided the first major stress test since the Regulations came into force in 2007.” Other major lessons learnt by WHO and by its members states include the essential need for establishing national preparedness and international collaboration before emergencies occur to facilitate access to medical counter measures (vaccines, antibiotics), rapid information exchange, communication with the public and response coordination.

The European Commission’s initiative on serious cross-border threats to health reflects these lessons, and its aim to streamline and strengthen capacities and structures of the European Union (EU) is to be welcomed. It is an initiative that should strengthen the global

spirit of the IHR which enjoins collaboration with competent intergovernmental organisations, international bodies and between states parties.

A major effort is now needed for improved preparedness through more effective national and regional alert and response systems. That’s why the first summary conclusion of the IHR Review Committee states that although the IHR helped make the world better prepared to cope with public-health emergencies, the core national and local capacities called for in the IHR are not yet fully operational and so are not on a path to timely implementation worldwide. In June 2012, the deadline for acquiring IHR core capacity, many countries, including a number of EU member states, requested a two-year extension.

More efforts are needed within the EU, which should set a global example in the implementation of the IHR, demonstrating coordination and solidarity between its members whilst addressing challenges posed by the free movement of people and goods within the Union.

The EU should also strongly support other countries across the world in fulfilling their

Margaret Chan has been the Director General of the World Health Or- ganisation since 2006. She joined the WHO in 2003 as Director of the Department for Protection of the Human Environment. In 2005, she was named Assistant Director General for Communicable Diseases.

Chan started her public health career in 1978 by joining Hong Kong Department of Health. In 1994, she was appointed Director of Health of Hong Kong. In her nine-year tenure as director, she launched new services to prevent the spread of disease and promote better health. She also introduced new initiatives to improve communicable disease surveillance and response, enhance training for public health professionals, and establish better local and international collaboration.

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obligations under the IHR, given its leadership in a truly globalised world and its relative wealth. Such a global role is particularly relevant for the EU given the major international trade and travel hubs that constitute its main ports and airports, the large number of mass gathering events organised by its member states, and the overseas territories present in all regions of the world administered by some members of the EU.

The WHO European Region remains vulnerable to cross-border health threats as shown through many public health emergencies that have challenged Europe’s health systems, ranging from the emergence of a new variant of Creutzfeldt-Jakob Disease in the United Kingdom in 1996 to the E.coli outbreak in Germany in 2011 and the unusually large measles outbreaks which are challenging the regional goal of measles elimination.

WHO will continue its effective collaboration with the European Commission and institutions such as the European Centre for Disease Prevention and Control (ECDC) and the

European Food Safety Authority (EFSA). WHO is an observer to the EU Health Security Committee (HSC) and maintains daily operational links between ECDC Surveillance and Response units and the WHO Alert and Response teams, including the EU Early Warning and Response System (EWRS) and WHO IHR Event Information Site. Surveillance systems for a number of epidemic-prone diseases (e.g. influenza, measles) are coordinated between WHO Europe and ECDC, avoiding double reporting for countries. These close operational links are supporting implementation of the IHR in the European region.

The Lisbon Treaty has given the EU a stronger role to support, coordinate or supplement the action of its member states for “monitoring, early warning of and combating serious cross-border threats to health”. This could give the European Union a more active role in supporting national and regional preparedness, including further development of the special arrangements needed to facilitate rapid information sharing, joint risk assessment and communication of messages to the public, and joint procurement, where appropriate, together with the required regulatory framework for efficient response. The European Union would then become an important facilitator for the implementation of the IHR within the borders of the Union.

It is essential that EU-specific reporting requirements, response procedures and legally binding agreements are consistent with, or cause no prejudice to, the obligations of States Parties to the IHR. This is particularly critical during emergency responses to ensure effective global coordination, decision making and leadership. The National IHR Focal Points present in all EU member states should see their work facilitated through EU coordinated action. The decisions and recommendations of the EU Health Security Committee, as proposed in the Commission’s Working Paper, will have to support countries to fulfil both their obligations as States Parties to the IHR and as member states of the European Union.

In this perspective, WHO would welcome a close collaborative approach with the Commission and EU member states in exercises to test the proposed EU framework for all serious cross-border threats to health.

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The public bodies’ perspectives

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Budget cuts affect EU countries’ ability to manage the threats envisaged in the health security package

Stavros Malas

Addressing serious cross-border health threats is among the major issues to be dealt with by both the member states at the national level and by the European Union, including cooperation with non-EU countries. It is also a challenge for healthcare systems that are called on for immediate action on the basis of preparedness. Under the current financial circumstances, preparedness for and response to health threats demands availability of resources, without irrational healthcare budget cuts.

One of the priorities of Cyprus’ EU Presidency is to advance discussion at the European Council concerning the proposal by the European Commission (EC) for a decision of the European Parliament and the Council on serious cross-border threats to health. This legal proposal addresses all the key aspects of health security, including preparedness, early alerting and reporting, surveillance and response to threats posed by communicable diseases. The proposal also supports the implementation of the International Health

Regulations (IHR) and provides a possibility for joint procurement of medical countermeasures.

At this point we have to consider whether the current budget cuts are going to affect the ability of national infrastructures to efficiently manage the health threats envisaged in the health security package.

In recent years, the world has witnessed serious public health threats like the H1N1 pandemic (2009), the volcanic ash cloud (2010) and the E. coli outbreak (2011). Europe is a constant recipient of infectious agents transmitted from within the continent, as well as from other regions, due mainly to its geographical position, its great variety of populations with their socio-economic statuses, being a global hub for air transport and a frequent host of mass gathering events. It is also a source of infectious agents exported to other regions, notably cases of MDR Tuberculosis, measles and CJD.

These incidents clearly showed that diseases don’t recognise national borders and cannot

Stavros Malas is the Minister for Health of the Republic of Cyprus. He served as the National Representative in various committees of the European Commission dealing with policy issues on biomedical research. Specifically, he served as the National Representative to the European Strategy Forum for Research Infrastructures, the Program Committee for Health and the States Representative Group of the Innovative Medicines Initiative. In 2008 and 2009 he was appointed as Special Advisor to Androula Vassiliou, the previous European Commissioner for Health.

Malas obtained PhD in Genetic in the United Kingdom and later worked in the Cyprus Institute of Neurology and Genetics to set up a research team working on early brain development

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be confined to a specific sector or dealt with by a national government acting alone.

They also showed that responses to these situations require a preparedness infrastructure, relevant capacity and collaboration mechanisms, as well as the appropriate financial, human and medical resources. The current discussions at EU level on the health security package lead in this direction. Collaboration should not be limited to EU level, but must be extended to other neighbouring non-EU countries and international organisations, such as the World Health Organisation.

The current economic crisis has indisputably influenced the allocation of resources within the healthcare sector. So, when looking at the steps to be taken at the national and European levels, we need to consider the negative impact that the financial crisis may have on preparedness for and response to cross-border health threats.

The impact of previous and current budget cuts on the management of health threats are highlighted in:

• The budget cuts of the 1980s in New York City raised tuberculosis incidences in central Harlem to 45 times the national average.

• After the collapse of the USSR, diphtheria vaccine coverage dropped dramatically with consequent increase of the incidences of diphtheria.

• The Greek tragedy of a 52% increase in HIV incidents in 2010-2011, because of both prostitution and injecting drug use.

It is important to mitigate the impact of the financial crisis through national and European- policies. Using available resources efficiently, health systems are provided with a

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The public bodies’ perspectives

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momentum to overcome limitations and challenges in times of crises. Investment in health systems and availability of resources are of paramount importance to respond to rising

needs. Health workforce deficits are increasing globally. Considering all this, our responsibility is to direct investments in health in the best possible way, both socially and

economically.

Preparedness is key in addressing public health emergencies and it is more important to prevent rather than respond. This can be achieved through collaboration and by ensuring joint plans on risk communication and emergency response. Training as an important element of preparedness can be achieved through a joint, long-term and structured regional training initiative in the areas of crisis management, risk communication and emergency response. Though collaboration in planning has already been established in

some areas which proved to be effective, for example the implementation of the International Health Regulations and influenza pandemic preparedness planning, further

work needs to be carried out.

To promote “cross border health threats in the EU and its neighbouring countries” as a priority, the Cyprus Presidency organised, in July 2012, an expert level conference in Nicosia that brought together policy makers and experts from all over the EU and neighbouring countries. Other issues discussed were the strengthening of existing structures and projects, early warning mechanisms, joint interventions, institutional links, mutual technical assistance, joint human research development and operational research, for assuring health security on a cross border perspective in times of austerity.

All this leads me to say on the challenges of the coming years: “It is safe to say that in times of crisis, investing in health can be the right cure.”

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Preparedness

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The thinking behind the Commission's new framework on health security

Paola Testori-Coggi

Article 168 of the Treaty on the Functioning of the European Union mandates the Commis- sion to supplement and coordinate member states' policies to fight against major health scourges. Yet a coherent framework for such a comprehensive task is only in place for communicable diseases.

That is why the EU Commission proposed in December 2011 an initiative on Health Security to better protect citizens from a wide range of serious cross-border threats to health.

Threats can be of biological origin, such as communicable diseases, but can also be due to antimicrobial resistance or caused by healthcare-associated infections or biotoxins. Threats can also be of chemical, environmental or simply of unknown origin. There have recently been a number of serious events that fall under these categories; to mention a few: 2010 alone saw the volcanic ash clouds in Iceland and the red aluminium sludge in Hungary.

More recently, there’s been the E.coli event.

The Commission considers that a high level of human health protection can only be ensured through enhanced coordination at Union level. To achieve this, a comprehensive and coherent legal framework on public health measures is needed, so the proposal for a decision on serious cross-border threats to health was based on a thorough impact assessment of existing problems and gaps. The focus of this proposal is to improve preparedness for health crises in all sectors of society and to mitigate their public health consequences. The proposal sets out provisions for preparedness planning, surveillance and monitoring of threats alert notification, public health risk assessment and crisis management.

The framework developed in the draft legal proposal builds upon the already well- established system for communicable diseases in place since 1998. However, for the first time other serious cross border health threats are included as well. The Ref. Ares (2012) 1102795 - 24/09/2012 framework also addresses public health emergencies of international concern as defined in the International Health Regulations. It excludes, however, threats arising from ionising radiation, as these are already covered by the EURATOM Treaty.

Paola Testori Coggi has been the Director General for Health and Consumers (DG SANCO) since 2010. She joined the European Commission in 1983 in the Directorate General for Environment where she worked in the field of the control of dangerous chemicals and industrial risks. She later held responsibility for the research programmes on life sciences, environment and energy in the Cabinet of the Vice-President of the European Commission, Filippo Maria Pandolfi. Testori Coggi also worked in the EU Joint Research Centre where she was responsible for administrative coordination.

In July 2007 she became Deputy Director General for Health and Consum- ers with specific responsibility for food safety and animal health, inspections and scientific matters. She worked on the definition of the new EU policy on consumer health after the food safety crisis.

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One of the major objectives of the proposal is to reinforce the current systems for preparedness planning, namely by setting up a binding coordination process to improve the interoperability of national preparedness plans and the implementation of core capacity requirements laid down in the International Health Regulations. The proposal also lays the ground for a joint procurement procedure to purchase medical countermeasures such as pandemic vaccines. Participation in this scheme is voluntary. The idea is to strengthen the purchasing power of the contracting parties by pooling similar procurement requirements.

The Commission also proposes to enhance the current coordination of response by having recourse to common temporary public health measures – a "safety net" to be used in extraordinary situations to complement member states' action. Such measures will only be applied where coordination of national response proves insufficient. They will respect national sovereignty and may concern travel advice, common communication messages to the general public or health professionals, and common protocols for investigating the source of a threat.

The proposal reinforces the role of the Health Security Committee, which currently exists only at informal level. It is a platform where high-level representatives of the health authorities of the member states and observers from third countries and international organisations such as the World Health Organisation and the European Centre for Disease Prevention and Control can exchange information and discuss public health measures to mitigate a health crisis. The Committee has proven its added value in past health crises such as the H1N1 influenza pandemic, the E.coli outbreak or the unsafe use of breast implants, and will have a formal status in the future.

The proposal seeks in addition to improve the development of common communication strategies by better integrating communicators, decision makers and risk managers into the crisis management process. The Commission expects the Health Security Initiative to have significant impacts. The most important ones are:

- strengthened preparedness at member states and EU level with common procedures, shared standards, sharing of resources, improved exchange of expertise and information;

- providing a legal base for joint procurement schemes for medical counter-measures, in particular pandemic vaccines;

- reinforced capacities for rapid and efficient response, including coordination of measures and crisis communication;

- increased synergies with third countries and international bodies such as WHO.

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Preparedness

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How does the Red Cross and Red Crescent Movement approach health threats, and are its coordination

mechanisms different to those proposed in the package?

Anitta Underlin

Healthy and safe living is central to the mission of the International Federation of Red Cross and Red Crescent Societies (IFRC). Governments have primary responsibility for the health

of their people, but Red Cross and Red Crescent Societies, as auxiliaries to public authorities, complement those efforts and act wherever there is a humanitarian need, either nationally or internationally.

The IFRC’s approach to health threats is to mobilise the resources to provide timely healthcare and save lives when a health threat emerges. Preventive measures – including awareness-raising, immunisation and adequate water and sanitation systems – plus a quick response at the first signs of health threats are crucial measures to avoid the rise of a new disaster.

During the spring of 2010, Tajikistan registered an outbreak of poliomyelitis, with over 129 cases in 20 districts of the country and 10 deaths; eight years after the country had been declared polio-free in 2002. The IFRC immediately responded to the outbreak by mobilising resources in support of the activities of the Red Crescent Society of Tajikistan. In the same region a few months after, IFRC assisted the Red Crescent Society in neighbouring Kyrgyzstan to carry out a country-wide polio vaccination campaign as part of higher state of anti-epidemic preparedness measures introduced in the region.

What is crucial at national and community level where a health threat emerges is the capacity to provide timely response using local resources. We strive to ensure that our network of Red Cross and Red Crescent Societies has such capacity. At the Secretariat level, we develop assessment and response tools and promote training which is adaptable to regional or national contexts. Likewise, international deployment of health care structures and specialised personnel is needed to complement national resources and capacities.

Anitta Underlin became Director of Europe for the International Federation of Red Cross and Red Crescent Societies (IFRC) in June 2007. She started her humanitarian work in 1982 heading a European Union-funded project for socially excluded youth in Denmark. During her 17 years of work with the Danish Red Cross and IFRC, Underlin worked on missions in Albania, Sudan, Uganda, Kenya, India, and Nepal.

Prior to her first mission to Africa, she was awarded a diploma in tropical medicine by Copenhagen University. She also worked for the Danish Ministry of Foreign Affairs as a financial management advisor to the Ministry of Health in Uganda (1996-2000).

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At the end of January 2012, an extreme cold wave gripped several countries across Europe, with wind, heavy snow and extremely low temperatures, in some areas as low as -35 C, over Swiss Francs 1.2 million from its Disaster Relief Emergency Fund (DREF) in support to eight national societies, to supplement local capacities in support of the affected populations, particularly elderly people living alone and homeless people.

The contribution of the Red Cross Red Crescent to tackling health threats also covers

slower-onset – and often less visible – threats to health, including HIV and AIDS, Tuberculosis and drug abuse. In recent years, in contrast to trends from other regions of

the world, Eastern Europe and Central Asia have witnessed a relentless escalation of the HIV epidemic, mainly related to injecting drug use and fuelled by stigma and discrimination.

As part of its mandate, the IFRC works for and with the most at risk populations living at the edge of national health systems, and seeks to strengthen national societies to help deliver and sustain increased HIV programmes, to reduce vulnerability to HIV and its impact, also in cooperation with partner organisations.

In the broader context of moving towards greater resilience, and strengthening critical capacity at national level, Red Cross Red Crescent Societies around the world, together with partners, can play a successful and unique role when a country is preparing and facing outbreaks and emergencies, as well as slow-onset threats.

In the IFRC’s neutral and impartial role, we advocate for the most vulnerable people and their communities, whoever and wherever they are. IFRC advocates for this cause and supports Red Cross Red Crescent Societies in persuading their respective governments to act at any time in the interest of the most vulnerable people and do whatever they can to support and protect those affected by any health threat they may face.

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Preparedness

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With health budgets being strangled by the current round of budget cuts, how can governments and international or- ganisations cooperate with industry to compensate?

Didier Houssin

In Europe, the medical products industry is an important economic actor, exporter and employer, but the outlook for many European nations’ growth is grim and public budget deficits need to be downsized. The strangling of health budgets will most probably last a

few years. In this context, there are strong tensions within the health domain:

stakeholders’ expectations appear contradictory and cannot be met at the same time.

Governments wish to protect the health of their populations, improve their employment levels, reduce public budget deficits, and continue cooperating to improve health in countries in worse situations. International organisations, such as the World Health Organisation, struggle to improve the health of the world’s population, through mobilising the internal support of governments for health in their own countries, the external support of the richest countries to less favoured countries, and support from pharmaceutical companies. Pharmaceutical companies are health professionals, but they are confronted with the obligation to maintain an economical equilibrium, and severe constraints caused

by concurrence, evolutions in research and development, strong regulation and solicitations for donation.

Major health threats became a painful reality during the last ten years, through events like the anthrax bioterrorist attacks, SARS epidemic, bird flu epizooty, and the H1N1 influenza pandemic. The possibility of other health security problems occurring has not vanished. But severe constraints in the health domain mean there is a risk that economic difficulties justify putting preparedness aside. At the European level, to give up the reinforcement of epidemiological, clinical and biological surveillance systems in developing countries, the development and acquisition of medical countermeasures against identified health threats, and the efforts of cross-sector and member states coordination would be concrete proof of that.

To prevent such a short-sighted attack, it is easy to put forward questions of responsibility

Didier Houssin has been President of the French Evaluation Agency for Research and Higher Education (AERES) since May 2011. He is also President of the Pandemic Influenza Preparedness Framework Agreement Advisory Group at World Health Organisation

A liver surgery and transplant Specialist, Houssin served as Executive Director of the French transplant agency from 1994 to 2003, as Head of surgery at Paris's Cochin hospital, from 1998 to 2003, as the Paris Hospitals' medical policy Director, from 2003 to 2005, and as Health Director General at the French Ministry of Health in from 2005 to 2011 . During this last period, he was also the inter-ministerial delegate for Pandemic Influenza in France.

He authored 2 books and several original scientific publications.

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towards the population of Europe and other countries and to underline what collective and coordinated European action can bring to the construction of the European Union. Precise initiatives to alleviate tensions must also be created, and these should be based upon improved cooperation between European governments and international organisations on the one hand, and industry on the other.

An initial initiative could be the creation of a forum to enhance exchanges about preparedness for major health threats between these three groups of actors, to better understand the respective constraints weighing on each category of actor, to explore ways to cope with them, and to formulate main priorities in terms of products (antibiotics, vaccines, diagnostic tools, antidotes etc.).

A second series of initiatives could be to organise the European action on this matter in a more integrated way, to better coordinate preparedness and response, including cross-sector and communication aspects; structure the capacity to acquire, stockpile and renew medical countermeasures ; promote research and development in this field, - also by learning from the US bio-shield and BARDA initiatives- ; and set the rules for an expertise that will not be under the suspicion of conflicts of interest.

A third series of initiatives could be oriented towards a coherent European action programme for capacity building in developing countries, through the World Health Organisation, and including support for it through interaction with industry.

European incentives concerning industry should be developed, through the implementation of dedicated fiscal instruments, particularly products without markets, and the promotion of development cooperation between academic research and industry.

In the wide field of public health, health security is sometimes confronted with severe major events. A striking aspect of these events is that they are without borders. To face such events, health security preparedness and response requires more from Europe - internally, on the international scene, and in closer cooperation with industry.

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Preparedness

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In a borderless EU with high levels of movement between states, are current preparations and plans equally borderless?

Michael Kunze

This article addresses one of the most interesting public health issues in the EU, which despite recent financial problems and political debate has been a unique success story.

Although considerable progress has been achieved, but there is still room for improvement and an enduring need to strengthen cooperation within the EU to address pressing public health tasks. The best examples include some aspects of infectious disease control, which will be expanded on later in this article. Meanwhile, recent reports highlighting the measles situation in Europe are somewhat dramatic, although measles can not only be prevented, but eradicated, with the implementation of a successful vaccination programme.

The European Commission and the European Centre for Disease Control are aware of the problem and very active on this front, but international cooperation must be enhanced to take into account underlying problems which make it so difficult to eliminate measles.

Travel streams are an issue, particularly among underprivileged ethnic groups who are sometimes hard to reach because of their living conditions. There are also some people who have ethical and/or religious objections to vaccination.

All of these factors become even more problematic in a borderless Europe. The international community attempts to overcome these obstacles by employing very carefully designed action plans.

Compared to measles, the new threats presented by West Nile fever and Chickungunya are less important for public health in Europe, and vector-borne diseases like tick-borne encephalitis are in any case on the agenda of the relevant international agencies. Tick- borne encephalitis is one of the travel-associated health conditions which can be prevented quite easily if travellers are aware of the possible risks before departure, and vaccination is the best way to cope with this.

In 2009 Europe was hit by the H1N1 influenza pandemic. Many lessons were learned from Michael Kunze is Director of the Institute of Social Medicine

at the University of Vienna, where he has been a professor since 1983 and has produced approximately 600

publications.

Kunze began his career studying medicine at the University of Vienna and went on to secure a number of positions at the university, including research assistant; M.D., Assistant Professor Medical Faculty; Head, Department of Social Medicine in the Institute for Hygiene; and Associate Professor, before he took up his current position.

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this experience and it highlighted the need for a new supranational approach. This epidemic is now regularly discussed in EU member states, albeit with great differences in intensity, and the same is true for the pandemic preparedness plans that were in place before the epidemic began.

It was the EU and the ECDC, together with the WHO, which were to some extent in the driver’s seat, advising the member states on a scientific basis. Yet there was a large variance in the level of individual nations’ efforts: whilst many states devised very elaborate plans to combat the epidemic, others settled for much less sophisticated procedures.

In general, one could state that this pandemic is now widely regarded as a rather mild event. One must nevertheless recognise that it was less dramatic than would have been the case, if the worst case scenarios had become reality. The first lesson learned is obvious:

prepare for the worst and be happy if it doesn’t happen. This ought to be the principle for any disaster planning.. A further lesson to be drawn from the so-called swine flu pandemic is that the stockpiling of vaccines, antivirals, masks, and so on varied significantly across Europe. The implementation of pandemic plans also happened to be very different across the EU, so the vaccination rates in each member state show a wide percentage range of people receiving the influenza jab.

But convincing some EU member states to restructure their plans would be a very complex political process, especially given prevailing financial constraints. Another public health issue that should also be mentioned is tobacco-related problems. Particular attention ought to be paid to the smuggling of cigarettes and pricing policies for tobacco products.

Europe’s open borders (and very few voices want to close them again) make it very easy to move tobacco products illegally across the continent, despite all the efforts of customs authorities. The differences in the price of cigarettes between member states are the most important motivators for transferring tons and tons of cigarettes throughout the community - and beyond. The only solution to this would be a common EU price policy which would make it less attractive to produce and/or transport cigarettes across the borderless EU in order to gain illegal revenues.

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Preparedness

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Response planning

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How prepared are national civil protection structures to handle health threats? What reforms are needed for EU civil protection to tackle serious health threats?

Claus Haugaard Sørensen

Serious threats to human health caused, for instance, by communicable diseases, extreme weather conditions or technological accidents, do not stop at borders. So responding to cross-border health threats in Europe and elsewhere requires a concerted approach among the EU’s member states.

The European Commission’s Directorate General for Health and Consumers (DG SANCO) and Directorate General for Humanitarian Aid and Civil Protection (DG ECHO) made legisla- tive proposals in late 2011 to strengthen their respective instruments. These proposals are currently being discussed in the European Council and EU Parliament, and allow for coher- ence between the EU’s health and civil protection policies.

DG SANCO's proposal addresses gaps in EU-level public health structures, and would extend the existing coordination mechanism for communicable diseases to all health threats triggered by biological, chemical or environmental causes. It would also reinforce the mandate of the Health Security Committee which groups high-level representatives from health ministries to better coordinate national measures.

Both DG SANCO's and DG ECHO's proposals consolidate ways that the EU Civil Protection Mechanism can be used by member states to channel in-kind assistance like mobile hospitals, medical teams and equipment or vaccines in acute health emergencies to countries overwhelmed by a disaster. This was done in response to the H1N1 acute respiratory disease in Ukraine in 2009 and during the 2010 cholera outbreak in Haiti. The EU’s €1bn budget for humanitarian relief enables us to give our support to health emergencies around the world.

The proposed civil protection legislation also sets out the role of the Emergency Response Centre which we are creating by merging DG ECHO's monitoring and information centre with DG ECHO's humanitarian crisis rooms. The Emergency Response Centre will serve as a genuine 24/7 crisis platform, coordinating with other Commission services involved in

Claus Haugaard Sørensen has been the Director General for Humanitarian Aid and Civil Protection at the European Commission since 2011. Between 2006 and 2011 Sørensen was Director General for Communication.

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Response planning

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cross-sectoral emergencies.

A main field of cooperation between DG SANCO and DG ECHO are chemical, biological, radiological and nuclear incidents (CBRN), including terrorism. Both DGs share information about CBRN alerts, exercises and response modules.

Because CBRN incidents, although of low probability risk having a high impact, EU member states might find it advantageous to pool their resources and share investment costs. Our proposed legislation therefore includes the concept of "EU-funded assets". In a similar vein, we want member states to place core resources on standby in a voluntary pool of assets and experts that can be deployed in a European response, supported by a modest but targeted financial incentive.

I, myself, strongly believe that burden-sharing for common needs that are beyond the capacity of individual member states should be developed even further.

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The German perspective on response planning under the Health Security Initiative

Karin Knufmann-Happe

Germany welcomes the European Commission's initiative for improving the mechanisms to co-ordinate prevention and response in the event of serious cross-border threats to public health at EU level. We support any effort to achieve efficient and transparent crisis management structures. In particular, the formalisation of the Health Security Committee is a necessary step forward. The German government has actively collaborated with other EU member states, the Commission and the European Parliament (EP) to find the best solutions, and will continue to do so in the ongoing negotiations.

When extending the well-established crisis management system for communicable diseases to other health threats, we need to be cautious so as not to endanger functioning mechanisms of the 'acquis' as established by the EP and the European Council. A key concern for us is how to effectively link existing crisis management systems in the food safety, medicinal products and medical devices, and other sectors so that in a crisis, capacities at national and EU levels can be used in an efficient and economic manner. We need to clarify which regulations apply should an event occur and close the gaps where necessary. Indeed, in a crisis, there will be no time for discussions on responsibilities and applicable rules. To create synergy effects and efficiency, instead of additional work devoid of added value, the application of more specialised mechanisms in the food, medicinal products and medical devices areas etc. needs to be given clear priority. In the event of a public health crisis, all resources will be needed and duplication must consequently be avoided. The new system should come into play as an 'emergency back-up system' only if no other mechanism is able to deal sufficiently with the public health aspects. The Health Security Committee should be given a clear mandate to be able to refer cases to the appropriate committees of the Union.

The Health Security Committee should in our view be the central body for member states and the Commission to exchange information rapidly on best practice and to respond to crises. A formalised Health Security Committee will further enhance this exchange with regard to preparedness planning, the evolution of a crisis situation and the necessary re- Karin Knufmann-Happe has been the Director General for

Health Protection, Disease Control and Biomedicine at the German Federal Ministry of Health since 2006.

From 1992 to 1995, she was seconded to the European Commission in Brussels where she worked as a national expert in the 'Pharmaceuticals' Unit of Directorate-General III (Industry). Since February 1995, Knufmann-Happe has held various functions in public service, including Director General for Matters relating to Disabled Persons, Social Assistance' at the Federal Ministry of Health and Social Security.

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sponse. However, collaboration in the Health Security Committee may merely facilitate, but not replace, decisions on national countermeasures. Having preparedness or response measures approved in advance within the Health Security Committee is neither feasible nor useful. The reason is that in a large, federal state such as Germany, preparedness planning includes plans prepared by numerous authorities at federal, land and municipal levels.

Instead of overloading each other with information, member states should decide for themselves, within the Health Security Committee, in which precise areas they wish to have an exchange of information for the purpose of coordinating prevention measures. Over the past eleven years, this practice has proven very successful in the Health Security Committee. Moreover, certain information is of national security concern and cannot be revealed, especially with regards to the prevention of bio-terror.

It is vital for the Health Security Committee to be a permanent committee with changing membership so as to flexibly gather expertise from all sectors concerned according to the crisis situation at hand. The Committee should also be the place where information on an emerging event, in the case of chemical or environmental health threats, is exchanged.

Unlike the threats posed by communicable diseases, other threats do not require a surveillance network for constant monitoring but a crisis mechanism for monitoring only when an event occurs. We doubt the added value of additional networks tying up national resources already tasked elsewhere in a crisis situation. Also, in acute crisis situations we would be better advised to have recourse to established, practiced structures instead of relying on ad hoc networks.

The German Government believes that, in accordance with the treaty, the Commission should support the member states in their planning process by giving advice on best practice as the Commission possesses the best overview of all the information from the member states, as well as access to all of the various information channels. Since the protection of the population from health threats falls within the core responsibility of member states, countermeasures must be decided on by those responsible on the ground, that is, at the appropriate national level. We consider delegated acts for common countermeasures at EU level to be incompatible with both the subsidiary principle and the Treaty's comitology provisions. The Commission has presented no convincing examples to justify delegated acts as set out in Article 12 of the Proposal. In particular, any binding common crisis communication is to be rejected. Crisis communication follows the measures to be communicated, not vice versa. It must adapt to the demands of the emerging crisis situation on the ground and can therefore not be unified. Instead, member states should keep each other mutually informed of the measures taken, within the Health Security Committee, so that they will be able to inform their own population if necessary. This practice has proven its worth and should not be confused with harmonised warnings to the population. Since warnings represent public (health) measures with external legal effects, they fall within the exclusive jurisdiction of member states.

Of all of the provisions of the proposal, Article 12 confers the strongest powers on the Commission. But these affect original competences of the member states, while both the possible public health countermeasures and the procedure to be followed according to Article 12 seem too vague. The provision therefore does not contain the specific, non- essential elements required by Article 290 of the Treaty for delegated acts and should be deleted.

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The well-established system at the European Centre for Disease Prevention and Control (ECDC) should be preserved. Alongside its surveillance network, ECDC should continue to operate the Early Warning and Response System for communicable diseases (EWRS) within the framework of its independent mandate. Further threats must be reported through other existing systems, as any expansion of the EWRS without a modification of ECDC's mandate and resources would jeopardise a well-established and functioning system. The existing early warning systems must remain unaffected. The Commission itself should take measures to ensure that it receives all of the relevant information from the various early warning systems which operate in different areas. Member states should not be obliged to communicate information and alerts on the same event multiple times via different systems.

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How will the adoption of the health-security package concretely affect current national policies and procurement? A Spanish perspective

María Mercedes Vinuesa Sebastián

In decades past, public health development included increased detection, assessment, response, management and evaluation of illnesses at country level. Some risks were controlled or even eliminated and populations’ health improved. But socio-economic changes have now modified the risk landscape, and transnational health threats are becoming the major focus of public health (PH). Countries have begun to adapt their PH

systems and capacities to this new scenario and have identified the need for an international approach to PH.

The International Health Regulations (IHR 2005) at the global level and different EU decisions, including the creation of the European Centre for Disease Prevention and Control (ECDC), are the results of this new approach to confront PH threats.

Spain is adapting its national legislation to improve the response to PH threats and to comply with international and EU requirements. Further modifications are still needed and the Health Security Package (HSP) may foster these changes.

The aim of the measures proposed by the Commission is to streamline and strengthen EU capacities and structures for an effective response to serious cross-border threats to improve Europe’s resilience to crises in an “all-hazard approach”.

However, the scope of the proposal excludes radiation and nuclear energy, which are covered by the European Atomic Energy Treaty. There is a need to have a clear link among this “lex specialis”, regulated hazards and the HSP.

The Decision should assure coordination with existing legally binding instruments (pharmaceuticals products, medical devices and food stuffs).

María Mercedes Vinuesa Sebastián has been the Director General of Public Health, Quality and Innovation at the

Spanish Ministry of Health, Social Services and Equity since January 2012.

Prior to that, she was Coordinator of the National Plan of Hemotherapy and Medical Director and Specialist in preventive medicine at the University Hospital of Móstoles, Spain. Vinuesa Sebastián specialises in management and

methodology for a high-quality care, health care and business management as well as preventive medicine and public health.

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Member states retain responsibility for PH crisis management at the national level.

Nevertheless, PH emergencies are increasing their transnational impact. The enlarged movement of travellers and goods requires coordinated international responses and cooperation to control associated PH threats.

Article 168 of the Lisbon Treaty reinforced PH action at the EU level by establishing a legal basis for combating serious cross-border threats to health. This article calls for action by the EU, which will complement national policies. The European Parliament and the Council should adopt incentive measures to protect and improve human health. According to the principle of subsidiary in Article 5, the Union action shall respect member states’ national policy definitions. Consultations within the formalised Health Security Committee (HSC) would be the appropriate procedure when facing an event of international concern.

The Commission’s impact assessment report states that IHR requirements are not fully covered by current EU structures and legislation. The EU and its member states will have to assure the provisions needed, guided by the HSP.

Events such as the 2011 E. coli outbreak, associated with sprouted seeds, showed the need to learn from past experiences in the health threats communication process. Lives were lost and the food industry, trade and travel were affected; there were numerous transnational implications. Evidence-based decision making should be ensured. Adopted measures and effective communication should have balanced the risks and damages in terms of the population’s health but also on other sectors’ impact.

Emergencies should be controlled, minimising adverse consequences and applying proportionate measures at member states’ discretion. Accurate and up-to-date information is crucial and messages should be adapted to target audiences. Coordination

between affected countries and EU institutions should be intensified through the HSC. The reputations of countries and the EU institutions are at stake.

The HSP will foster improved cooperation. It highlights the EU added value for coordination. EU institutions have a key role in helping countries to manage events, facilitating the exchange of information and improving decision making. Situations experienced during the H1N1 influenza pandemic led to a popular mistrust in vaccination

and a lack of credibility of health authorities. Clear, strategic and evidence-based communication is the target.

EU institutions should provide pools of specialised resources (professionals, systems, knowledge) and assistance to improve member states’ capacity building, maintaining and strengthening current structures. The EU should ensure the independence of Scientific Committees and their reports should be discussed at the Health Security Committee. EU specialised agencies (EFSA, ECDC, EMA, etc) should also play a key role.

The HSP will require member states to adapt national legislation to comply with all requirements. This is not a new process since efficient PH action implies a non-stop development approach and international commitments are actively promoted by national authorities to respond to local needs.

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Since 1986, the Spanish Health Authorities have developed several acts, in order to improve detection and response capacities at local, regional and national level and to comply with international commitments.

Further steps are needed. The multi-sectoral approach of PH including detection, warning and response to health threats proposed by national authorities, IHR and the EU HSP still lacks a strong legal backing in Spain. Our main challenge would be to achieve inclusive regulation and structures for all health threats independent of the source, coordinated at the national and European levels.

The HSP, once it is adapted to countries’ needs, may become a powerful and efficient tool for improving Europe’s capacity for responding to serious cross-border threats to health.

The commitment of national authorities to comply with all requirements included in the package will make the difference.

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Surveillance and early warning

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Governments are sometimes accused of over-hyping disease threats. How difficult is it to keep the public informed of real health risks without scaremongering?

Do they sometimes err on the side of caution?

Justin McCracken

Providing accurate, unbiased information on matters of importance is a standard that modern societies properly expect. Further, it is widely assumed that timely, targeted, communication on the nature of hazards, their associated risks, and the precautions that can be effectively employed by, or on behalf of its citizens, is important to a society’s response to health threats.

The essential elements of best practice, in terms of openness, transparency and credibility of information given to the public were, in the UK, clearly set out in the Philips inquiry on the Government's handling of the Bovine spongiform encephalopathy (BSE) crisis; the difficulties in assessing and representing risk as set out in the Blackett Review and the practice of risk communication is well explored in a number of publications that focus on evidence-based best practice. A synthesis of the advice from these sources suggests that good public communications have the following characteristics:

• Consistency, and the ability to explain differences between different sources

• The importance of a timely message, even before all the information is available

• Presentation of absolute risk together with relative risk

• Visual presentation of information

• Describing data sources and their limitations

• Distinguishing between fact, educated opinion and speculation

• Distinguishing between actual data analysis and hypothetical data modelled with assumptions

• Use of everyday language but avoiding over-simplification

• Communicating with particularly vulnerable or hard to reach groups of people However, there are no agreed standards for handling significant uncertainty, and this is Justin McCracken is Chief Executive of the UK Health

Protection Agency. Prior to becoming HPA Chief Executive, he worked for ICI from 1976-1998, where his career covered business development and operational management, marketing, research and process development. From 1998-2002, he was a Regional Director

for the UK Environment Agency, and was Deputy Chief Executive of the Health and Safety Executive from 2002- 20008.

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where the credibility of governments and their scientific advisors can be at most risk, since the actual health risk consequent on a novel threat, is only calculable in retrospect.

Forward projections are necessary to plan an effective and efficient response, but can only encompass a range of likely values based upon the best information available at that time.

This has led to the current common approach of determining a likely mid-value and statistical range, together with a reasonable worst-case scenario, (which is not of itself a refined concept), to allow planners to set limits to the resources allocated to that threat.

Herein lies one of the most pervasive problems that a government faces in mass communication, in that it is at the mercy of the filters that the messengers will apply; for an

example of how this problem can seriously interfere with the best intentions to balance honest best middle projections with worst case planning assumptions, see the discussion of the 65,000 deaths scenario projection for swine flu reported by the Science and Technology Committee.

The Health Protection Agency’s experience and research on risk communication, have demonstrated that despite the problems of the filters that might be applied, the public want to be told the facts about health threats, set in a context that makes the information comprehensible. People want to make their own risk assessments and judgements based on a personal perspective and understanding. They neither wish to be unduly scared or overly reassured and they can be surprisingly willing to make determined efforts to understand the science behind the advice.

In some circumstances, governments may struggle to get the public to listen to public health messages and respond appropriately. For example, one study of public perceptions of swine flu reported that approximately 50% of a representative sample of the general public agreed that “too much fuss” was being made of swine flu (vi). In future pandemics, it

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is possible that this perception of an over-reaction to swine flu may result in scepticism and limited uptake of official advice, particularly in the early stages of an outbreak. To counteract a muted response to a public health threat, governments may need to place emphasis on the seriousness of the threat, whilst being careful to maintain credibility and trust through ensuring that the information provided is based on transparent assessments of risk and acknowledgement of uncertainty.

Governments, in the UK at least, do not seem in our experience to deliberately over-estimate risk. However they may not be able, even with the best scientific advice, to

give estimates of risk in emerging situations with the accuracy they desire. Additionally, they may not always be successful in communicating the degree of risk they truly believe to be present because of the filters through which information is disseminated. Under some circumstances a greater emphasis on the seriousness of a situation may be needed to ensure that protective actions are undertaken in a timely manner. The temptation to temper poor information by initial over-estimation should be avoided, and can be self- defeating; most experienced politicians have learnt that lesson.

Strengthening Europe’s health security shield