1. Commission strategy to
European Commission
Peter Arlett: June 2007
Commission strategy to
Strengthen and Rationalise the EU Pharmacovigilance System

2. Strengthening and Rationalising EU Pharmacovigilance
In this talk:
Drivers for the project
Commission strategy

3. Strengthening and Rationalising EU Pharmacovigilance
Why conduct a strategic assessment of EU PhV?
ADRs – significant morbidity and mortality
Major product withdrawals: harm to patients and innovation
Robust PhV supports earlier product authorisation
“2001 Review” - modest changes to the law
EU enlargement – 15 becomes 25 becomes 27 becomes………
Society changing
complex system (30+ agencies, 2 MA routes, responsibilities differ)
resource (money, people, technology)
Duty to ensure our system is fit for the future

4. Strengthening and Rationalising EU Pharmacovigilance
The assessment 2004 to 2007 – key steps
2004 – Commission launches call for proposals for independent study
2005 – independent study conducted for Commission
2006 – based on independent study, Commission launches public consultation
2007 – Commission announces its strategy

5. Strengthening and Rationalising EU Pharmacovigilance
2006 Commission consultation - method
March to May (July) 2006:
Web based public consultation
Commission / Industry workshop – April 06
Commission / Patient / HCP / academia workshop – April 06
Commission / regulators dialogue

6. Strengthening and Rationalising EU Pharmacovigilance
Consultation results – 48 responses – all stakeholder groups
Patients, consumers – 7
HCP – 10
Industry – 16
Regulators – 10
Other 5
See:

7. Assessment of the Community System of Pharmacovigilance
Response announced by Commission Vice-President Verheugen on 26 February 2007
Commission response includes both:
better implementation of the current system and
proposals to change the legal framework for pharmacovigilance in the EU.

8. Assessment of the Community System of Pharmacovigilance
Response Improving implementation of the current framework will include but not be limited to:
·  Working with the Commission’s Directorate General for Research on funding of studies into the safety of medicines as well as studies into the methodologies used to conduct pharmacovigilance.
· Working with the Member States to resolve implementation issues, including administrative practices that complicate reporting rules for industry.
· Working with the EMEA to strengthen its coordinating role including supporting full compliance and maximum utilisation of the EU pharmacovigilance database ‘Eudravigilance’.

9. Assessment of the Community System of Pharmacovigilance
Response Proposals for change to the legal framework will focus on but not be limited to:
· Strengthen the rules on transparency relating to pharmacovigilance data, assessment and decision-making and involve stakeholders (e.g. patient and healthcare professional groups) in the processes including reporting (including patient reporting).

10. Assessment of the Community System of Pharmacovigilance
Response proposals for change to the legal framework will focus on but not be limited to:
Establish clear standards (‘Good Vigilance Practices - GVP’) for the conduct of pharmacovigilance by both the industry and regulators.

11. Assessment of the Community System of Pharmacovigilance
Response proposals for change to the legal framework will focus on but not be limited to:
Free up resource by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), both expedited and periodic reporting, making best use of current information technology (including Eudravigilance) and matching the reporting requirements with the level of knowledge about the safety of a specific product.

12. Assessment of the Community System of Pharmacovigilance
Response proposals for change to the legal framework will focus on but not be limited to:
Make clear the respective roles and responsibilities and minimise duplication of effort, while maintaining the current split of competences between the Member States and the EMEA.

13. Assessment of the Community System of Pharmacovigilance
Response proposals for change to the legal framework will focus on but not be limited to:
Establishing a clear legal requirement to conduct post-authorisation safety studies including those in risk management systems.

14. Assessment of the Community System of Pharmacovigilance
Response proposals for change to the legal framework will focus on but not be limited to:
Rationalise EU decision-making on drug safety issues to deliver fast, robust decisions that are equally and fully implemented for all relevant products and across all markets.

15. Assessment of the Community System of Pharmacovigilance
The Commission services will be working on an impact assessment during the course of 2007 with a view to a legal proposal in 2008.