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Peter Arlett June 2007
Commission strategy to Strengthen and Rationalise
the EU Pharmacovigilance System
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Strengthening and Rationalising EU
Pharmacovigilance

• In this talk
• Drivers for the project
• Commission strategy

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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

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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

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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

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Strengthening and Rationalising EU
Pharmacovigilance

• Consultation results 48 responses all
  stakeholder groups
• Patients, consumers 7
• HCP 10
• Industry 16
• Regulators 10
• Other 5
• Seehttp//ec.europa.eu/enterprise/pharmaceuticals
  /pharmacovigilance_acs/index.htm

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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.

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Assessment of the Community System of
Pharmacovigilance

• Response Improving implementation of the current
  framework will include but not be limited to
•   Working with the Commissions 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.

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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).

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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.

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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.

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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.

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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.

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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.

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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.

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