1. Hepatitis B Vaccination: Safety Issues Communication: The Industry Perspective Luc Hessel Hugues Bogaerts Aventis Pasteur MSD GlaxoSmithKline Biologicals Viral Hepatitis Prevention Board Meeting Geneva, Switzerland, 13-14 March 2003

2. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.2Introduction The Hepatitis B vaccine crisis has been the most important crisis for vaccine manufacturers in Europe It illustrates major changes in risk environment in vaccinology It had a profound impact on the way vaccine industry is managing risk assessment and communication

3. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.3 Presentation Outline Vaccine Manufacturers communication strategy during the Hepatitis B crisis Main pitfalls in communication Lessons learnt Consequences –Understanding the environment –Dealing with uncertainty –Risk-assessment / crisis management / communication –Vaccine advocacy and role of vaccine industry –Impact on clinical development and PMS Conclusion

4. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.4 Communication strategy during the hepatitis B crisis Essentially reactive, « No Comment » despite willingness to communicate Internal considerations –Lack of preparation (data, messages, communication skills and pathways) External constraints –DoH –AFSSAPS Legal issues –No comment on legal decisions

5. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.5 Pitfalls in Communication during the hepatitis B crisis Slow reactivity Management of scientific communication to media and lay public (specificity of vaccines) Difficult relationship with HA Lack of consistency in messages Lack of trust, confidence and credibility of the industry (e.g. safety databases, epidemiological studies) Lack of « third parties » Lack of defined communication strategy

6. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.6 Lessons learnt 1996-1999 Industry (and other internal and external stakeholders !) poorly prepared for c risis management “Fire fighting”, reactive strategies, “running behind the facts” An important learning period on what to do, how to manage / anticipate crises, with whom …

7. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.7 Lessons learnt From 1999 Vaccine issues (not only safety) are here to stay and are part of our environment: dealing with uncertainty Support vaccination rather than vaccines Industry & others partners are better prepared, stronger, know more Greater awareness = better anticipation Audiences / partners better identified Crisis management = team work !

8. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.8 Consequences Understanding the environment Risk assessment - Crisis management & Communication strategy “Vaccine advocacy” Impact on clinical development and post-marketing activities Role of the vaccine industry (EVM)

9. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.9 Understanding the Environment Concern over vaccine safety is a major determinant of immunisation policy New technologies have revolutionized information & communication on health prevention Political environment: precautionary principle / zero-risk society / somebody should pay... Increasing level of scepticism by public & media about understanding of science Gap between public opinion and public policy « traditional » vs « new players »

10. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.10 Traditional players Health Authorities Patients Industry Health professionals Scientific Media

11. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.11 New Players Health Authorities Patients Industry Health professionals Scientific Media Lay Media Patient Action Groups Lawyers Internet

12. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.12 How does this affect vaccine manufacturers ? Low credibility in risk communication: –«Conspiracy theory» –Conflicts of interest between public health impact of vaccination and company’s profit External communication limited by regulatory and health authorities Liability / legal actions Need to permanently anticipate / manage critical situations

13. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.13 Dealing with uncertainty (internally and externally) Do not wait to be confronted Listen to concerned people Put bounds on uncertainty Not all data are equally uncertain Say what is done to reduce uncertainty Do not hide behind uncertainty Explain your cautiousness Acknowledge if you have dragged you feet

14. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.14 Risk Assessment Common features of vaccines scares Causal link usually claimed with a disease or condition of unknown or unclear etiology Association claimed by one investigator or a small group of investigators Association not confirmed by peers or subsequent research Claims made with no apparent concern for potential harm from public loss of confidence and refusal to vaccinate children

15. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.15 Crisis Management and Communication Preparing for a crisis Impossible to prepare for every crisis Each crisis is unique But some crisis preparation is essential More about attitudes (ethics, public health) than procedures Communication  marketing Flexibility essential

16. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.16 Crisis Management and Communication Tools  Key messages  Position papers  Q&A’s  Intranet-vaccine Issues  Scientific articles and presentations  Alert / monitoring Organisation  Multi disciplinary company team  One communication contact - clear process  Develop strategy & stick to it  Media-trained spokespersons  Permanent / pro-active

17. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.17 Crisis Management and Communication Monitoring Local company network monitors local media (not specifically on issues) and alerts ad hoc –Lay press as crucial as specialised media New issues are picked up in scientific press and via relations with opinion leaders –potential issues may be “known” before media attention

18. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.18 Crisis Management and Communication Internal communication Intranet based one stop-shop for: –company position papers –links to third party organisations –press release –briefing documents –Q&A …

19. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.19 Crisis Management and Communication External communication Mostly reactive versus media (depends on and if litigation has started) No press releases on legal actions against industry reliance on authorities CDC, WHO, VHPB, immunisation advisory groups because poor credibility of industry Understanding does not necessarily bring support, whereas trust is associated with support

20. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.20 Vaccine Advocacy Role of the vaccine industry At the company level: importance of internal stakeholders Through vaccine industry associations Partnership with HA and expert groups (CDC, WHO, VHPB …) Not limited to safety issues (supply)

21. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.21 Impact on vaccine development Prelicensure: – Extensive safety studies Post-licensure – Pharmacoepidemiology Development of epidemiological surveillance – Vaccine and disease registries Overall increase in development costs and cost of compliance

22. L Hessel, H. Bogaerts, VHPB meeting, Geneva, 13-14 March 2003.22 Conclusion The Way Forward Industry and 3rd parties in the vaccine community need to build partnership Retrospective databases (sometimes difficult to access) need to be identified and queried Prospective: post-marketing surveillance systems need to be set up: epidemiology, disease burden, side effects Adapt information pathways and messages to different audiences