16 July 2010

Global Health Europe has prepared the below response to the EU Stakeholder Consultation on Strengthening European Union Preparedness on Pandemic Influenza. Responses must be submited to the European Commission by 23 July 2010. We are making our response available here first where registered viewers can send us their comments. Alternatively email your comments and suggestions on the Global Health Europe response to This e-mail address is being protected from spambots. You need JavaScript enabled to view it before Thursday 22 July.

Background

The aim of this consultation is to seek the views of key stakeholders on what action the European Commission should take to strengthen European Union Pandemic Preparedness. The Commission is seeking the views of stakeholders in two main areas. These are:

1. How useful was the 2005 plan both during the pandemic preparedness phase and during the response to pandemic (H1N1) 2009 and how should it be improved?
2. What should be done at EU level to improve EU pandemic preparedness? The questionnaire is divided into sections covering, preparedness and co-ordination, surveillance, containment and mitigation (including vaccines and antivirals), health system response, international communication and communication with citizens.

The final section is about multi-sectoral preparedness, which has been highlighted as an area for development.

Consultation Questionnaire

Pandemic Influenza Preparedness and Co-ordination

1. It is important that individual country's plans work well with other countries in the EU.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

2. Co-operation between Member States on pandemic influenza preparedness would help enhance preparedness at a national and European level.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

3. There is a need for the European Commission to assist Member States in coordinating in areas of pandemic influenza preparedness and response where there is a cross border aspect involved.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

4. (if strongly agree or agree ) Please describe the role you believe the Commission should take and how this would aid preparedness.
The main role of the EU is to work with WHO Euro, through ECDC to ensure that all countries in the EU and the wider region have adequate pandemic preparedness plans and are able to share experience and learn from best practice. Beyond this we suggest that the nature of disease surveillance and pandemic preparedness as regional and global public goods means that there is an important role for the Commission to play in supporting global health diplomacy to ensure that all countries raise the level of their efforts to improve our collective security. This may also mean providing support to countries unable to achieve adequate standards without assistance.

Global Health Europe believes that the objective of the Commission in pandemic preparedness should be defined in terms of the provision of a public good at regional level, and the roles of the Commission should be defined accordingly. In this regard, Global Health Europe urges the Commission to consider the 2009 analysis of the European system for public health crisis management by Mark Rhinard. A common system of communicable disease surveillance and control can be understood as a transnational public good. Once in place it is ideally nonrivalrous and non excludable, i.e. it cannot be depleted by overuse, and non-contributing members cannot be excluded from benefits. More distinctively, a system of communicable disease surveillance and control displays characteristics of a "weakest-link"-type transnational public good. This is because whether a robust system is achieved depends on the country that contributes the least, in other words, when stemming the dispersion of a disease the least active efforts determine outcomes. Everyone must pitch in at an adequate level for the good to be produced.

There is a specific set of incentives and disincentives associated with weakest link-type transnational public goods. While collectively states have ample incentive to prevent pandemics each individual state has an incentive to "under-supply" or "free-ride" on the efforts of other states. This is due to the transboundary nature of pandemics. National governments only reap a fraction of the benefits of their investments which are shared by other states from the supply of this good. The costs of cooperating to supply this good therefore will most likely equal or exceed benefits. Once one country decides to contribute less the whole effort may fail. A more likely scenario is referred to as "matching behaviour", which describes the incentive countries will have to match the smallest level of the provision of this good because doing more will achieve nothing. This outcome assumes that participating countries are fully aware of one another's provision levels-when there is incomplete information it may be that countries "hedge their bets" to make sure they are not making to great an effort for no purpose. Contributions can therefore sink even lower.

A public goods analysis shows that having an active system for disease surveillance and control in place is not enough as it may be poorly provided or "undersupplied". Rhinard's analysis suggests that this is indeed the case for the EU's current institutional framework for cooperation in public health.
Better pandemic preparedness and response means a coordinated raising of the minimum standards and capacity of all EU Member States. The ECDC already issues guidelines; adequate provision of this good requires rules with binding authority. The provision of and oversight of such rules should an additional coordination role of the Commission.

5. It is important that there is a plan in place at European level to support interoperability of Member States plans.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

6. The interoperability of Member States plans should be facilitated at European level.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

7. (if strongly agree or agree) Please describe how you think this should be done.
The approach taken by ECDC in supporting the development of shared goals and standards, through shared learning, developing expertise and providing support and monitoring within the EU and beyond by agreement worked well in this case. It balanced collective aims with national responsibilities, the role of WHO in providing normative leadership provided an important context.

Effectively mitigating and controlling the risks of pandemic influence, understood as the provision of a regional public good, presents an example of a challenge rooted in the interdependence of nation states. The Commission is already involved in reviewing national plans. Such efforts are inadequate unless plans are interoperable across national borders. Analysis of the interoperability of national plans will further illuminate areas of weakness in the provision of this regional public good. The Commission should bring relevant authorities together from different countries to discuss how pandemic response would function at border zones. Furthermore, just as viruses do not respect national borders within the EU, they will not respect the border of the EU. The Commission should work with the World Health Organization Regional Office for Europe, Regional Office for the Eastern Mediterranean and Regional Office for Africa, to address similar issues of interoperability.

8. Cross border issues within the EU complicated the response to pandemic (H1N1)?
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦

9. (If strongly agree or agree) Please describe the cross border issues that arose. Please give as much detail as possible.
The development of broadly similar pandemic preparedness plans went well and the fact that Poland took a different approach to its neighbours in responding to the H1N1 -not centrally purchasing anti virals and taking a wait and see approach to shape their response - should not have created major problems. But it now appears that the aftermath may lead to some undermining of public confidence in the planning system. We need to find ways of learning lessons from this (because Poland's approach proved right in this case) while building public confidence in future plans and responses.

We also note the issue that arose with regard to sharing resources with Indonesia. While this was amicably resolved it points to the need for clarification of how IHR are applied in practice.

10. Stronger co-ordination of pandemic preparedness and response at European level would have reduced the impact of cross border issues that arose.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

11. Please describe possible European level actions you believe would have prevented or lessened the impact of cross border issues you have identified.
Greater engagement and a more open debate with civil society, academic and businesses on the plans and responses at EU and National levels would be helpful. However, it leadership from an authoritative and impartial source - the WHO is also essential. While this has been posed as an issue of "transparency" we see little evidence of secrecy but more need for engagement.

[Q's 12 - 15 public authorities only]

16. The EU plan should be updated in the light of recent developments and lessons learnt from pandemic (H1N1) 2009.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

17. Please identify any areas of the plan you think should be reviewed in particular or that are missing altogether from the 2005 plan
We suggest that it is important to see pandemic preparedness as a societal issue rather than solely in terms of medical and emergency service response. This requires an understanding on how international, national and local social networks prepare, respond and gain resilience in the face of perceived and actual threats to health. Clearly this will differ across EU Member States and amongst different communities within states. More research and sharing of lessons in this field would provide the basis for a broader range of strategies to respond to such threats. It also underlines the importance of developing public understanding of the nature of health (and other) risks and the role of communities in responding to such risks.
The nature of the threat posed by the recent H1N1 pandemic was significantly different from the potential threat foreseen from H1N5, which dominated thinking at the time most national plans were prepared. H1N1 required a community based response to deliver advice, medication, vaccination and care to a large number of people with relatively mild cases and emergency response to relatively few. This would have been helped by greater engagement of civil society organisations in preparedness planning.

For these reasons Global Health Europe agrees with the Council of Europe Parliamentary Assembly Report on the handling of H1N1 that updates are necessary to increase the openness of public health decision making processes and to engage civil society organisations. We suggest that WHO should continue to provide impartial technical advice and value based leadership in a transparent manner. Greater engagement and debate with academic civil society and business interests is appropriate at EU, national and local levels.
The lesson from this is that while openness and transparency is required in preparing for pandemics there is also a need for flexible rapid response. Preparedness plans must be interpreted flexibly as evidence emerges and the leadership of European, national and local response teams should engage civil society actors and be more visible and also more adaptable.

18. The following are reasons the 2005 plan should be reviewed
Review of the IHR: Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion
Review of WHO guidance: Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion
Need for better Intersectoral preparedness: Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion
Other - please specify

19. Better co-ordination of national pandemic plans could be helped by a revision of the EU preparedness plan.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

20. Please give reasons for your answer to 19
The current EU plans adequately outlines the EU role in providing risk assessment but more detail is needed in the plan to set out the EU roles in risk management. This refers to the translation of the evidence generated through risk assessment processes into actionable policy guidelines and directives. A clearer understanding of these roles, which include the Commissions roles in achieving coordination and coherence between national plans, would contribute to improving national plans.

21. Member States should ensure their national pandemic plans are coherent with the EU plan.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

22. if strongly agree or agree to 21 How would this best be achieved?
The new public health article 168 of the new Treaty of the Functioning of the European Union strengthens EU mandate in public health. The previous article 152 gave the EU mandate to promote research into the causes, transmission and prevention of major health threats as well as providing information and education. Article 168 expand this mandate to include "monitoring, early warning of and combating serious cross-border threats to health." The use of the term combating should not be taken for granted; it is a strong term and thus should be reflected in strong EU action.

Furthermore the new paragraph 6 of Article 168 which states that "The Council, on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article." This can be interpreted as significantly strengthening the EU's ability to take action on pandemic preparedness and response by removing the burden of qualified majority from the process of adopting council recommendations.

Based the new treaty, the EU should establish a diplomatic process to ensure Member State coherence with EU pandemic preparedness plans. This could be accompanied by other tools such as a regulatory committee established under an EU directive on pandemic preparedness and response, as for example, that which has been established under article 10 of the EU Directive on the regulation of Tobacco products.

23. It is important to maintain the link between WHO pandemic alert phases and EU preparedness planning.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

24. Please explain your answer to 23
As stated in the 2005 Communication (607), the recognition of the pandemic (Phase 6 of the WHO recommendations) will almost certainly be first issued by the WHO. However, recognition of a state of a public health emergency linked to the emergence of a pandemic strain may come earlier. Once the EU becomes affected, different Member States may move through the phases at different times and rates. Therefore it is necessary that the EU maintain its own systems for surveillance and alert. However this needs to function within the framework of the WHO which is globally the lead agency for pandemic preparedness and response.

Furthermore, the EU could create systems to compliment the WHO phased system which does not indicate the level of threat posed to individuals but its human to human transmission within communities across countries in different WHO regions. Assessing and communicating a realistic level of threat could have avoided the controversies now arising in the evaluation of responses to H1N1. However, the key word is complementary. EU preparedness planning should remain linked to WHO pandemic phases, but can also incorporate region specific systems which would in turn produce benefits beyond the EU.

25. The pandemic plan should be modified to take disease severity into account.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

26. The EU should maintain the ability to declare a pandemic independent of WHO.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

27. Please explain your answer to 26
The EU's performance in pandemic preparedness and response should not undermine the authority of the World Health Organization. The EU should maintain its ability, in fact it's obligation, to announce public health emergencies, and work closely with the WHO Regional Office for Europe to define region appropriate phases and terminology if it is the case that EU interventions for serious cross-border health threats are at all impeded by WHO phases.

[Q's 28 - 33 on Monitoring and assessment  are for public authorities and organisations only]

Prevention and containment (including contact tracing, antivirals and vaccination)

34. There should be action at a European level to better facilitate the sharing of information on current containment and mitigation strategies across the EU.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

35. if strongly agree or agree to 31 Please describe how this could happen
The current approach through ECDC works reasonably well and it is too soon to consider fundamental changes, however there is room for the Commission to engage and inform civil academic and business organisations without impinging on the expert role of ECDC or WHO Euro.

36. It would be useful to share the rationale and evidence behind Member State's strategies across the EU.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

37. The EU should provide all Member States with up to date advice on public health strategies and the evidence behind these to aid their decision making in a pandemic.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

38. Joint procurement or sharing mechanisms for pandemic vaccines at EU level would help ensure all MS have timely access to vaccines.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

39. Joint procurement or sharing mechanisms for pandemic vaccines at EU level is desirable.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

40. The European Commission should issue guidance on priority groups for vaccination to assist Member States implement pandemic vaccination programmes. (optional)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

41. The EU should consider the development of a virtual stockpile of pandemic vaccine to facilitate sharing of vaccines among Member States in case of outbreaks. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

42. The EU should consider working with Member States to develop virtual stockpiles of other medical countermeasures to facilitate sharing among Member States in case of outbreaks. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

43. If SA or A Please tick which of the following you think should be considered for a virtual EU stockpile(ie; a sharing mechanism between member states not based on sharing of supplies in an outbreak)? (optional)
Antivirals - Yes but further research is needed on their effectiveness
Antibiotics - Shared preparation for anti biotic resistance should include some strategic reserve
Medical devices -
Other - please specify Simple emergency supplies of protective measures for medical staff (gloves masks suits) are still required in some EU member states and certainly for neighbouring states in the Euro region.

44. The European Commission should take the lead role in managing any virtual stockpiles created. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion
ECDC could play an important role in managing virtual stockpiles (which would probably be physically maintained by manufacturers and Member States) however, supplies for neighbouring states in the WHO Euro region or for international emergencies should be established and deployed in cooperation with WHO Euro.

45. If you have any other comments on virtual stockpiles or other alternative approaches please outline here.

46. The EU should consider working with Member States to develop a physical stockpile of medical countermeasures. (optional)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

47. if strongly agree or agree which of the following do you think should be considered for a physical EU stockpile. (optional)
Antivirals
Vaccines
Antibiotics
Medical devices
Other please specify

48. The Commission should provide guidance on travel restrictions to Member States. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

49. A more co-ordinated EU approach to port/land border health measures (such as entry / exit screening and advice for travellers) is needed. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

Health systems response

50. The potential for co-operation and sharing of health services resources between Member States at times of pandemic should be explored at EU level. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

51. Member States should consider how spare capacity within their health services (for example Intensive Care Units) could be used to assist other Member States who are affected by a pandemic. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

Communication

52. Communication of public health information to citizens could be better coordinated at EU level. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

53. if strongly agree or agree please describe how you think this could be improved.
Perhaps the most harmful outcome of the H1N1 pandemic is the risk that the general public and health professionals may now feel that public health experts have "cried wolf" too often and thus there may be less willingness to respond to their next call. In future pandemics media relations must be carefully managed to prevent sensationalism. Better coordination of communication at EU level may help to ensure that balanced and coherent over the messages that are being communicated.

54. Communication of information to health professionals could be better coordinated at European level. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

55. If SA or A please describe how you think this could be improved.
See answer to 53

International Co-operation

56. Do you have any views or ideas on how co-operation between the EU and non EU countries should be improved? (optional)
The position of the EU on support for partner countries that may have been impacted by the influenza pandemic is not clear. It does not seem that a common approach has been agreed on the sharing of expertise or indeed sharing of resources such as anti- virals and vaccines. The reaction of Indonesia, which threatened to withhold flu virus samples unless agreement could be reached through discussions at WHO on sharing vaccines, shows the importance of clarity on such issues. In practice this has now been resolved and EU countries find they have a surplus of both anti virals and vaccines (because it was found that 1 inoculation rather than 2 was sufficient and because demand has been low). However, this is an outstanding issue on which clear principles are required.

Furthermore the role of the EU (and in particular the European Commission) can be crucial in health diplomacy related to pandemic preparedness and response. A case in point is the negotiation on sharing of influenza viruses and access to vaccines and other benefits held at the 63rd World Health Assembly in May 2010. The result were draft proposals for a text for a Standard Material Transfer Agreement (SMTA) put forward by a WHO open-ended working group and referring to the sharing of viruses. Proposed changes to the text were put forward jointly by Brazil, India and Indonesia with additional proposed changes put forward by the European Region. External representation with third countries is a competence of the European Union, and one greatly strengthened under the new treaty. The EU should facilitate negotiations between EU member states and Brazil, India and Indonesia so that an agreement can be reached. The European Region proposal has not determined whether the Region wants to support a text that says that Members "shall" or members are "urged to" comply. If the EU wants this text to be at all meaningful it should work to facilitate consensus within the European Region that the text should read "shall".

The European Union also has a critical role to play in negotiations with the pharmaceutical industry. During the H1N1 pandemic European countries negotiated prices for vaccine purchases separately, and in many cases had to sign agreements that the contents of the contracts for purchase orders could not be shared. This put individual states into a weak position visa vie the pharmaceutical companies when negotiating prices. This situation could be turned around if the European Commission would negotiate one price on behalf of all the member states. This would be a pooled purchase and not a joint purchase. Global Health Europe does not mean to recommend the Commission should purchase vaccines and then distribute to member states, but rather that it should collect the desired prices and quantity orders from the various member states, and then pool these orders together into one lump call.

57. What kind of (multi- or bilateral) relations to non-EU countries have been important for your country during the response to the Pandemic (H1N1) 2009?

Multi sectoral preparedness

58. It is important that sectors other than health have business continuity plans in place to ensure they can continue to operate during a pandemic. (compulsory)
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

59. The following sectors are critical and should have business continuity plans in place to ensure they can continue to function during a pandemic.
Energy
Water
ICT
Transport
Food
Chemical industry
Education
Civil Protection
Funeral providers
Strongly Agree¦ Agree¦ Disagree¦ Strongly Disagree (optional)

60. If there is another sector that you think is essential please identify it below and outline why it is so important.
Foreign Affairs/Diplomatic service. As answer 56 shows, there are many essential issues dealt with in this sector that have impacts on the ability of the EU to adequately and appropriately respond to pandemics; however, not all EU Member states have health attachés in key locations to negotiate on technical issues such as vaccine and virus sharing. This should be a capability of the EU External Affairs Service.

61. Member States should ensure that critical sectors have business continuity plans in place.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

62. The European Commission should take a co-ordinating role in multi-sectoral preparedness planning involving trans-national companies at EU level.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

63. There are cross border implications for organisations / companies in the event of a pandemic.
Strongly Agree ¦ Agree ¦ Disagree Strongly ¦ Disagree ¦ No Opinion

64. Please highlight any specific cross border implications you have identified below.

65. Would your administration / organisation / company be willing to share your business continuity plan and best practice with other countries / competitors? (optional)
Yes/No

66. Has your administration / organisation / company participated in any cross sectoral planning simulations? (optional)
Yes/No

67. Would your administration / organisation / company be willing to participate in pandemic simulations to test planning in the future? (optional)
Yes/No