European Commission Peter Arlett June 2007 Commission strategy

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

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

Strengthening and Rationalising EU Pharmacovigilance Why conduct a strategic assessment of EU Ph. V? • • ADRs – significant morbidity and mortality Major product withdrawals: harm to patients and innovation Robust Ph. V supports earlier product authorisation “ 2001 Review” - modest changes to the law EU enlargement – 15 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

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

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

Strengthening and Rationalising EU Pharmacovigilance Consultation results – 48 responses – all stakeholder groups • Patients, consumers – 7 • HCP – 10 • Industry – 16 • Regulators – 10 • Other 5 See: http: //ec. europa. eu/enterprise/pharmaceutica ls/pharmacovigilance_acs/index. htm

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.

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’.

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).

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.

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.

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.

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.

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.

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.