NEWS - EU NEWS

Brussels, 15.9.2009

COM(2009) 481 final

In April 2009, a novel strain of human influenza H1N1 was identified that had caused illness

in Mexico and the United States first, in March and April 2009.

On 11 June 2009, the World Health Organisation (WHO) declared a pandemic caused by the

novel influenza A(H1N1) virus, called ‘pandemic (H1N1) 2009’. This declaration was in line

with the WHO’s global influenza preparedness plan where phase 6, the pandemic phase, is

defined as the virus causing sustained community-level outbreaks in at least two countries in

one WHO region and in at least one other country in a different WHO region. The declaration

therefore reflected the spread of the new virus, not the severity of illness caused by it.

In 2005, in the aftermath of the A (H5N1) ‘bird flu’ outbreaks, the Commission adopted a

Communication on Pandemic Influenza Preparedness and Response Planning in the European

Community, which set out the objectives for each inter-pandemic and pandemic influenza

phase and the action to be taken to achieve them at both national and Community levels1. This

plan has provided a basis for the preparedness and response to the current public health

situation.

Today the European Union is better prepared than ever before to tackle cross-border and

global health threats in general and Pandemic (H1N1) 2009 in particular. Member States and

the Commission have legal and operational provisions in place to authorise pandemic

vaccines and anti-viral medication after careful consideration of risks and benefits on the basis

of available data in the current pandemic, allowing an adequate response to this pandemic

(H1N1) 2009 situation.

Now there is a need for closer coordination across sectors and Member States, whether at

Community, national, regional or local levels, to help to mitigate the societal impact of an

influenza pandemic by means of appropriate preparedness and response planning within their

individual remits.

The main objective of this Communication is the protection of public health, by ensuring the

best possible protection of citizens against the current pandemic. To this aim, the

Communication presents in a single document the key issues on the public health coordination

on pandemic (H1N1) 2009 at the EU level and internationally. In addition, it aims to highlight

the important cross-sectoral dimension of this pandemic. To this end, and in response to

requests by the Council of Health Ministers, the Commission is also making available in

parallel to the present text, five separate Commission staff working documents on vaccine

development, vaccination strategies, joint procurement, communication to the public and

support for third countries.

Community action in the field of public health, as set out in Article 152 of the Treaty, must

complement national policies and be directed towards improving public health, preventing

human illness and diseases and obviating sources of danger to human health. The aim is to

tackle the major health scourges by promoting research into their causes, their transmission

and their prevention and to provide health information and education.

Community action in the field of public health must fully respect the responsibilities of the

Member States for organising and delivering health services and medical care. In relation to

the international collaboration necessary during a global outbreak such as this pandemic,

Article 152 states that the Community and the Member States will foster cooperation with

third countries and the competent international organisations in the sphere of public health2.

A global pandemic is a cross-border health threat which affects not only public health but also

society and economies within the EU. However, the technical capacity, budgetary resources

and preparedness structures are not equivalent and equally available in every Member State.

Consequently, a coordinated and supportive EU-level approach to public health measures

between the EU Member States can provide substantial benefits. Firstly, Member States can

draw on the scientific advice and guidance of the European Centre for Disease Prevention and

Control, thereby ensuring that national resources for scientific assessments are allocated more

efficiently.

Secondly, coherent and agreed approaches between Member States authorities on issues such

as travel advice or school closures contribute to a better public understanding and trust in

public health measures. Thirdly, Europeans demand information on pandemic situation and

how to protect themselves. Good, objective, up-to-date communication with the public and

the media means no mixed or wrong messages between countries.

As a prophylaxis, vaccination is one of the most effective public health mitigation responses

in a pandemic while for the treatment anti-viral medication remains a key option. Due to the

limited global manufacturing capacity within a short time vaccines will only be available in

the EU gradually. In addition, solidarity towards the third countries including developing

countries is also an issue that can be best coordinated at the European level between the

donors to ensure maximum benefits for the receiving countries addressed.

Availability of vaccines and stockpiling and access to anti-viral drugs is determined at

national level and Member States have taken preparatory action in this respect. To support

those Member States with fewer financial resources or adequate capacities, the Commission

has been working with the EU Health Security Committee to explore ways to support

Member States for procurement of vaccines.

On 30 April 2009, the Ministers of Health adopted Council conclusions on influenza A/H1N1

infection3. They highlighted the need to coordinate national measures in Europe and called

upon the Commission to continue to facilitate information sharing and cooperation between

the Member States, in particular on risk evaluation, risk management and medical

countermeasures.

These coordination functions should be carried out in the Health Security Committee (HSC),

the Early Warning and Response System for Communicable Diseases (EWRS) and the

Committee of the Network for the Epidemiological Surveillance and Control of

Communicable Diseases as well as with third countries and international organisations, in

particular the WHO. The Commission has chaired joint meetings of Member States’ EWRS

national authorities and the HSC regularly since the beginning of the outbreak.

On 8 and 9 June the Council discussed vaccines and vaccination strategies against Pandemic

(H1N1) 2009 and gave the HSC a mandate to work on these two issues. The Health Ministers

met again informally on 6 and 7 July 2009 to discuss preparedness and response to Pandemic

(H1N1) 2009, focusing on a Commission information note on vaccination policy and the

outcome of the meeting of technical experts organised by the Swedish Presidency on 4 and 5

July 2009.

At international level, the Commission is a member of the Global Health Security Initiative on

pandemic influenza and other health security-related issues bringing together G7 countries

and Mexico. This network has been useful for sharing information between members on

public health measures planned or taken.

The Global Health Security Initiative held informal meetings twice, first during the World

Health Assembly in May and then, at the invitation of Mexico, in Cancun at a ministerial

meeting on 2 and 3 July 2009 on Pandemic (H1N1) 2009. Another meeting was held in

September in Brussels upon the invitation of the Commission.

The Commission monitors the situation internally and externally through various networks,

expert groups and fora by which it enables exchange of information with MS and

international organisations. The internal crisis management mechanism of the Commission

(ARGUS) has been activated, enabling all affected services to jointly assess the multi-sectoral

dimensions of this pandemic and respond accordingly.

In the health sector, the Commission cooperates closely with the scientific assessment

agencies – the European Centre for Disease Prevention and Control (ECDC), the European

Medicines Agency (EMEA) and the European Food Safety Authority (EFSA) – on specific

issues and liaises closely with the WHO to ensure that measures taken at European Union

level are in line with the WHO recommendations and international health regulations.

In order to ensure an effective, horizontal public health response to the pandemic at European

level, as outlined in the Commission Communication on Pandemic Influenza Preparedness

and Response Planning, the European Union has already taken a number of key measures

using existing legal and public health mechanisms4:

• The common case definition, adopted in a Commission decision on 1 May 20095;

• Agreement on advice to persons planning to travel to or returning from affected areas on

18 May 2009;

• Extension of the surveillance system to identify new cases in the EU on 18 May 2009;

• Guidelines on case management and treatments and advice on medical countermeasures for

health professionals on 18 May 2009;

• Advice for the general public on personal protective measures agreed and made available

to Member States in all the official EU languages on 4 May 2009;

• Statements by the Health Security Committee and the Early Warning and Response System

(EWRS) contact points on school closures and travel advice on 13 August 2009;

• Statement on ‘Vaccination strategies: target and priority groups’ agreed by the Health

Security Committee and the EWRS contact points on 25 August 2009.

Decision 2119/98/EC6 places an obligation on Member States to report influenza outbreaks to

the Community network on communicable diseases. They must give prompt notification of

cases and then the Commission will transmit the information immediately to all the other

Member States, prior to, where possible consultation and coordination of countermeasures by

the Member States. The ECDC collects this information. In the case of pandemic influenza,

daily situation reports are prepared for the Member States. ECDC is also providing ongoing

support to Member States and the Commission in terms of surveillance and response to the

crisis. This includes advice to the public on personal protective measures, and to Member

States on mitigation activities7.The Community Civil Protection Mechanism is available to

facilitate mutual assistance between Member States if national response capacities become

overwhelmed. This may include immediate civil protection and medical assistance. Third

countries can also appeal for assistance through this mechanism

As regards the authorisation of the necessary medicinal products, Community legislation sets

out instruments which are well prepared for a pandemic through:

• Specific regulatory provisions for a fast-track scientific assessment and subsequent

authorisation for marketing of human influenza vaccines and key medicinal products, such

as anti-viral medication, in a pandemic situation.

• Specific regulatory provisions which allow Member States to take national decisions to

authorise the distribution of unauthorised vaccines in an Influenza pandemic.

European Medicines Agency (EMEA) provides scientific opinions on the risk-benefit

evaluation of those medicinal products, including vaccines and anti-viral medication, which

are subject to a Community authorisation through Commission Decision (central

authorisation). In addition, through technical assistance, EMEA supports the network of the

Member States on scientific discussions in preparation of national marketing authorisations

of medicinal products. In the preparation of a scientific assessment of Influenza A (H1N1)

2009 vaccines the EMEA is exchanging views with registration authorities in third countries,

such as in the US.

While various anti-viral medicines received approval for marketing in the past and are

available for treatment of pandemic influenza in the EU, new measures have been

concentrated on an accelerated assessment of applications for marketing authorisations of

pandemic Influenza A(H1N1) vaccines. Both the EMEA and Member States have received or

are expecting such applications.

At Community level, the EMEA is currently evaluating data and applications for several

vaccines. As soon as the EMEA provides a positive scientific opinion on each vaccine based

on a detailed assessment of risks and benefits, the Commission will ensure a swift decision on

an authorisation. After authorisation, specific pharmacovigilance monitoring is intended to

allow an ongoing assessment of the safety and efficacy of these medicines. In the case of

national authorisations, it is up to Member States to decide on any acceleration of the

scientific assessment and regulatory procedure.

The Commission has also taken action on an additional issue concerning possible infection of

pigs with the Pandemic (H1N1) 2009 influenza virus in Europe. This event has already been

reported in Canada, Argentina and Australia, probably due to previous human-to-pig

transmission. Although in those countries pigs have played no role as an additional source of

the virus for humans so far, any possible detection and spread of the pandemic virus amongst

pigs in Europe could raise unjustified fears amongst the public.

On 14 July 2009, the Standing Committee on the Food Chain and Animal Health endorsed a

guidance document drafted by the Commission on surveillance and control measures for the

pandemic virus in pigs8, in order to ensure that farmers and veterinary and public health

authorities are prepared for any such event and thereby reduce the risk of unjustified panic

amongst the public. In addition, recently the Pandemic (H1N1) 2009 virus was detected in

turkeys in Chile most likely due to virus transmission from infected humans. The Commission

will monitor these developments.

Regarding air transport a specific meeting with the Civil Aviation Authorities was organised

on 5 May 2009. As a conclusion, it was agreed to activate the network of national contact

points for health issues, which allows to exchange and share relevant information on all air

transport issues linked to the Pandemic (H1N1) 2009 between EU Member States.

A key question in contingency planning for a possible influenza pandemic is the value of

restricting international travel to and from affected countries or regions, or imposing entry or

exit screening of passengers at airports. The potential for infectious diseases to spread rapidly

through an increasingly well-connected, steadily growing world population was brought into

sharp focus during the 2003 epidemic of severe acute respiratory syndrome (SARS).

Nevertheless, as it appeared then, the measures on travel restrictions were targeting specific

countries in which the epidemic had spread a lot and have a limited effect. Moreover, H1N1

pandemic current situation appears to be very different as it has already spread all over the

world. Thus, according to WHO recommendations, travel restrictions were not considered as

an appropriate tool in the present situation. Such position was also sent to all aviation

authorities by International Civil Aviation Organization (ICAO) on 1 May and confirmed

during ICAO's Council meeting on 11 May 2009. In line with this position, no

recommendation on travel restriction, including air transport, has been taken at EU level.

Moreover, it was also agreed that according to the evolution of the situation, and taking into

account the advice of the relevant health authorities, Member States should take all

appropriate measures in the air transport sector. Such measures should be proportionate, nondiscriminatory

and strictly limited to meet the health risks. In any event, EU coordination of

national measures shall continue to be ensured.

The European Union Solidarity Fund may be called upon by Member States and countries in

process of negotiating their accession to the EU9 in case of major natural disasters for the

reimbursement of certain costs to repair damage. Public health crises and in particular

expenditure for buying vaccines do not fall within the scope of the Solidarity Fund.

It should be noted that a Commission initiative to enlarge the scope of the fund to include,

among other elements, action in the event of public health crises is pending before the

Council without any progress since 2005 (EC proposal COM(2005)108)10, it would be

important to reflect how to move forward on this particular issue. Other structural funds

prioritise health investments in infrastructure, hence are less viable in urgent situations.

The accompanying Commission Staff Working Document "Support to third countries to fight

Pandemic (H1N1) 2009" addresses the international dimension of the EU response. Should

assistance be requested by third countries, the EU could respond as appropriate through its

programmes and instruments, including through humanitarian aid.

As far as the Commission is concerned, this financial assistance is expected to be covered by

existing financial instruments. If additional important needs rise, the Commission will

examine possible available ways of facing these needs

The Framework Programmes for Research (FP7 and its predecessors FP6 and FP5 have made

significant contributions to public health-related research into influenza and to better

preparedness for pandemics. Innovative vaccination technologies and adjuvants, surveillance

studies on birds and pigs, development of point-of-care diagnostic tools and new antiviral

drugs have all been financed by projects under the FPs. In particular, two ongoing FP7

projects are directly relevant to the current pandemic11.

Since the first reports on the outbreak of (H1N1) influenza, the European Commission has

been stressing the importance of exchanging information and coordinating measures at

international level. The Commission supports the leading role of the WHO in monitoring the

pandemic under the International Health Regulations, preparing recommendations and

evidence-based guidance, and facilitating support to the poorest countries including providing

expertise, supporting capacity building and even procurement of vaccines and antivirals.

As mentioned earlier, the Commission has been also coordinating with the Global Health

Security Initiative (GHSI) on public health action and, particularly, exchanging information

on public health measures.

The GHSI network is working on issues similar to those identified in the EU context and

striving to ensure that they are addressed in a coordinated way across the GHSI countries. The

Commission hosted an extraordinary ministerial meeting of the GHSI on 11 September 2009

on issues of common interest related to preparedness for and response to pandemic (H1N1)

2009. Mindful of the potential for a more virulent wave of the (H1N1) 2009 influenza virus in

the months ahead, the meeting addressed a range of issues critical for an effective response.

During the 14th ministerial meeting of the European Union and the Rio Group (all Latin

American countries, the Dominican Republic, Jamaica, Belize, Guyana and Haiti), held in

Prague on 13 May 2009, a Joint Declaration on the ‘Novel Flu Virus’ was adopted. It called

for enhancing the ongoing coordination of measures between all competent organisations and

bodies.

For the preparation of strategies for the assessment and authorisation of vaccines the

European Commission, the ECDC and the EMEA are in close contact with the WHO and via

the WHO also with other regulatory authorities worldwide. Furthermore, the Commission and

the EMEA concluded bilateral confidentiality arrangements with regulatory agencies of three

third countries for the regulatory and scientific collaboration (US, Canada, Japan) which has

been experienced a useful mechanism for information exchange in the current pandemic.

The World Bank estimates that the measures put in place to slow down the spread of a

pandemic, although appropriate, could have a great economic impact. They are said to

account for 60 % of the total costs. Only 12 % would be linked to mortality and 28 % to

absenteeism and illness. Experience has shown that the economic impact of a health crisis is

rarely directly correlated to the medical severity of the virus.

The immediate impact is likely to attract the most public attention. However, depending on

the duration and severity of the pandemic, the long-term effect can significantly exceed the

short-term costs.

The most immediate economic impact of a pandemic might arise not from actual death or

sickness but from uncoordinated efforts by individuals to avoid becoming infected.

It is anticipated that there could be growing demand for hospitalization and medical treatment,

as well as for medicines, including antivirals and vaccines, masks, gloves, antimicrobials and

other counter measures. However, limited spare capacity of some service providers could lead

to a situation when other health services could be crowded out by those which are

pandemic-related.

Apart from healthcare-related developments, people are expected to take additional

precautions and to minimise face-to-face interactions in order to avoid infection. In the worst

case scenario, this could trigger a decline in demand in some economic and cross-border

mobility of people and goods could be hampered.

For the labour market, the main cost is linked to the increased morbidity. This would lead to

absenteeism from work, disruption of production processes, shifts to more costly procedures

and, eventually, lower productivity. If the psychological impact of the pandemic is especially

severe, absenteeism amongst otherwise healthy workers can also be expected.

The Health Council in its Conclusions of 16 December 2008 asked the Commission to take

into account the inter-sectoral dimension of preparing for pandemic influenza by reviewing

the arrangements covering this area and by updating the Communication from the

Commission to the Council and the European Parliament of 28 November 2005 on Pandemic

Influenza Preparedness Planning.

The Commission is reflecting on possible on strengthening of inter- and multi-sectoral

collaboration, to help mitigate the more general effects of the current pandemic and possible

future pandemics.

The costs related to economic uncertainties associated with pandemics, especially in times of

current economic hardship, can slow down fragile economic recovery. For developing

countries, the WHO has stressed that all means available will be used to avoid inequities and

give developing countries access to vaccines. This would make sure that developing countries

do not suffer disproportionately. A strong health system is also necessary. This is why the

WHO has called for solidarity to target such structural weaknesses too. On 20 May 2009, the

WHO issued a report which stated that 72 countries had been provided with antiviral

medicines.

The World Bank supports solidarity with countries that need help to respond efficiently to the

pandemic and its effects. Therefore, on 2 June the World Bank approved ‘fast-track’ status for

$500 million to help countries finance operations to prevent and control outbreaks of

pandemic (H1N1) 2009.

The diffusion of the pandemic (H1N1) 2009 may have important implications on global

regional and national security, stability and governance. In this respect an EU external policy

aimed at strengthening “early warning” capacity in third countries should be seen as a major

component of the overall EU Security Strategy and a major EU contribution to better world

stability and governance.

During the informal Health Council on 6 July and based on a broad consensus on pursuing

joint procurement of vaccine against the pandemic (H1N1) 2009 influenza virus, in particular

for Member States which had not yet placed orders, the Swedish Presidency asked the

Commission to set up a mechanism to help with joint procurement of vaccines for interested

Member States.

Given the stage of development of the pandemic, and the advance purchase orders already

concluded by several member states, it is not considered reasonable or efficient at this stage to

launch a joint procurement procedure at EU level between interested Member States for

vaccine procurement.

The aim should rather be to launch a bundle of national calls for tender by the interested

Member States to be carried out simultaneously or as a whole. At first sight, taking into

account the time pressure (vaccines to be bought in October) this option seems to be the most

workable (all contractual documents in place, no issue of conflict of laws) and it could have

the most significant impact in ensuring availability of supply of vaccines for target and

priority groups in the timeframe available.

The Commission will support the Member States in their joint procurement efforts and will

organise necessary coordination meetings. The Commission is ready to act as facilitator in

order to provide advice on the EU legal basis where necessary and support mutual

information exchange between Member States having already advance purchase agreements

and those having not yet concluded such agreements. For the mid and long term the

Commission will continue exploring alternative procedures.

The Commission also encourages, in parallel to the joint procurement initiative, a common

approach to cross-border sharing and voluntary sale within the EU. A mechanism to envisage

cooperation between Member States in order to address shortages of vaccine in one Member

State and high supplies in another country could be envisaged and might be coordinated at EU

level. On the basis of the replies received so far by the Commission, some Member States

have already included in the contracts that vaccines, which are not used, can be sold to other

countries.

The key specific objective of the staff working document on support to third countries is to

identify areas and existing EU mechanisms by which the needs of third countries could be

supported with the aim of steadily increasing their level of protection in the face of the

pandemic (H1N1) 2009, while respecting the principles of country ownership and aid

effectiveness. All donor support to the health sector in developing countries has to respect

country leadership in strategy design and ownership of the implementation process, as

internationally agreed in 2008 in the Accra Agenda for Action, in order to make the

international aid effort more effective. It is important to ensure that initiation and concrete

help for third countries is carried out in close cooperation with the WHO and, where relevant,

with Non-Governmental Organisations (NGOs). A gradual increase of cooperation between

ECDC and certain third countries, in particular those falling under the European

Neighbourhood Policy, would also help in fighting the pandemic.

The Commission has strongly contributed to global influenza preparedness through its leading

role in the global response against Avian Influenza going largely beyond the sole challenge of

Avian Influenza, focusing on the sustainable reinforcement of health systems and including

general pandemic preparedness. Furthermore, the European Commission is providing funding

to a number of low income countries through a range of bilateral measures (projects, health

sector budget support, general budget support and regional programmes), so that their national

health systems can respond more adequately to the challenge of Pandemic (H1N1) 2009.

The Commission will address the following specific objectives: to closely monitor the

situation in third countries, through regular relations with UNSIC, WHO, EU Member states

and with other stakeholders, so as to be in a position to confirm in time a potential threat from

the pandemic (H1N1) 2009; to identify the actual needs of the countries, for strengthening

their preparedness and prevention capacities, but also for coping with acute outbreaks if and

when they occur; to conduct EU vaccine procurement in a way so as not to impede access by

developing countries to vaccine and other medical goods and to promote increased access

taking into account limited resources. In line with the WHO Director-General's call for

international solidarity to provide fair and equitable access for all countries to pandemic

vaccine when it becomes available, the possibility to reserve for developing countries a share

of vaccines ordered by Member States should be seriously considered.

Recognising that the responsibility for developing a vaccination strategy against pandemic

(H1N1) 2009 lies with the Member States, the Commission Staff Working Document on

vaccination strategies based on the current scientific evidence and epidemiological trends sets

out possible options that Member States might take into account when determining strategies

fitting the specific conditions prevailing on their territories Indeed, based on the broad

orientations provided for by the Commission Staff Working Document Member States can

develop different vaccination schemes, taking into account epidemiological trends, health

service structures and available resources. The statement on target and priority groups for

vaccination against pandemic (H1N1) 2009 influenza, agreed by the European Union Health

Security Committee on 26 August 2009, provided basis for this document13.

The initial limited availability of vaccines, together with the potential need for a large-scale

vaccination campaign, poses challenges to healthcare systems and highlights the need for a

carefully planned vaccination strategy, taking into account the need to protect vulnerable

people, to limit the spread of infection and to maintain essential services in the society. Public

confidence, and therefore the success of any vaccination campaign against pandemic (H1N1)

2009, will depend on active and transparent communication on the benefits and the risks of

vaccination against pandemic (H1N1) 2009.

Indeed it is important to consider that there is a common interest for each national vaccination

scheme to be efficient in order to curb the spread of the virus and to eliminate any "virus

reservoir" to prevent further successive reactivations of the pandemic.

The EU has prepared itself early for a pandemic through establishing provisions for an

accelerated assessment, such as the assessment of new applications for marketing

authorisations of pandemic Influenza A (H1N1) vaccines and variations thereof.

The Commission Staff working document provides a comprehensive overview on the key

steps and aspects related to the authorisation of anti-viral medicines and vaccines. Specific

consideration is given to a description of tailor-made provisions for a fast-track authorisation

in a pandemic situation and subsequent pharmacovigilance obligations.

To achieve an adequate uptake of vaccines among risk groups and to deal efficiently with

other prevention and vaccination-related problems, public health authorities across Europe

will face challenges necessitating a carefully planned communication strategy.

The Staff Working Document on Information to the Public outlines the main issues relating to

coordinated communication with the public on pandemic (H1N1) 2009 with a view to

delivering targeted and scientifically validated messages for the general public and for

specific risk groups. The document identifies possible joint action between the EU Member

States and the Commission to develop a coherent European strategy on information and

communication.

Pandemic (H1N1) 2009 is a global challenge. In the Commission’s view, the EU coordination

has worked well so far. This crisis has shown that efficient channels for exchanging

information are in place to support good cooperation and coordination of efforts at European

level. The international work and collaboration can also be built on to tackle health threats

effectively. The benefits are that they ensure coherence and maximise the effectiveness of the

national public health response. The Commission will continue to work toward supporting

national health authorities to review their preparedness regimes and their response to the

pandemic as appropriate.

Inter-sectoral action will remain a key component in tackling pandemic (H1N1) 2009. An

important dimension of responses to a pandemic at any level is that they must be multisectoral,

encompassing services outside the health sector. More needs to be done and the

Commission will consider with Member States the need for measures to strengthen inter and

multi-sectoral collaboration to ensure business continuity and minimise the disruption of the

negative impact of the pandemic.

Depending on the scale and severity of the public health situation, business continuity plans

could also identify measures and arrangements to keep critical services working. Establishing

continuity plans in relevant areas will be useful to prevent any avoidable, negative economic

impact of the influenza pandemic.