slide 1 november 2008 name sarah morgan © crown copyright 2005 pharmacovigilance working party -...

November 2008Name Sarah Morgan

© Crown copyright 2005

Pharmacovigilance Working Party - Role and future perspective

Sarah MorganMedicines and Healthcare products Regulatory Agency

UK Delegate - PhVWP

November 2008



Roles of key players

National Competent Authorities (NCAs)

operate national systems in member states

European Medicines Agency (EMEA) co-ordinates pharmacovigilance for

centralised products (and non-centralised products)

Committee for Medicinal Products for Human Use (CHMP) provides opinions on safety issues with centrally authorised products and other issues as referred



Pharmacovigilance Working Party

‘The mission of the PhVWP is to provide advice on the safety of medicinal products authorised in the EU and …recommendations for regulatory action to its stakeholders, i.e. the CHMP/EMEA and NCAs.’



EfficacyEfficacy SafetySafety PhVWPPhVWP QualityQuality BiotechBiotech

European CommissionEuropean Commission

CHMPCHMP CMD(h)CMD(h)

NCAsNCAs



PhVWP

Chairperson – Dr June Raine, MHRA

1 representative per Member State appointed by NCAs

7 Co-opted members with expertise in pharmacoepidemiology, risk management, biological products/advance therapies, paediatrics, communications

http://www.emea.europa.eu/htms/general/contacts/CHMP/CHMP_PhVWP.html



PhVWP's responsibilities

evaluation of potential signals arising from spontaneous reporting provision of advice on confirmation and quantification of risk and on regulatory optionsrisk managementmonitoring regulatory actionsetting standards for procedures and methodologies to promote good vigilance practicepromotion of communication and exchange of information between the EMEA and national competent authoritiesinternational cooperation



PhVWP

Meets monthly (for ~ 3 days) in parallel with CHMP

Agenda

Drug Safety IssuesTour de table (emerging issues) ~6 per month*Issues at request of CHMP ~14 per month*Issues at request of NCAs ~9 per month*

Guidelines (Volume 9A)

Procedural/methodological issues (PSUR worksharing)

*average from March-May 2008



Principles of EU pharmacovigilance

All MS run national pharmacovigilance systems (areas of expertise, levels of ADR reporting and resource vary)

Any safety concern identified within a MS should be shared with other MS

Worksharing – one MS will take the lead on assessment (rapporteur, RMS or appointed lead)

Work to achieve informal consensus for national products



PhVWP - challenges

Has to meet needs of multiple stakeholders – CHMP, CMD(h), member states

Heavy workload

Ensuring implementation of conclusions (decisions have no legal weight)



PhVWP recommendations



Communication to health professionals/patients

EMEA - centrally authorised products and issues under referral - website/press releases

Communication with health professionals and patients at national level

Direct Health Professional Communications from MAH – agreed at EU level

Different MS have different abilities to communicate at national level (e.g. bulletins)



Communications - national



EU system - challenges

Achieving consensus and timely action - key challenge for protection of public health and credibility of system

Ensuring effective work sharing and minimising duplication

Dealing with differences (clinical/political) between MS - impact on risk assessment, regulatory action and communication

Ensuring compliance (pharmacovigilance requirements, delivery of risk management plans)

Effective communication



EC Consultation on EU Pharmacovigilance System (2006)

Majority of response call for a change to the legal framework

Rationalisation needed (current system contradictory, complex, confusing, unclear)

Resources focussed on meeting administrative requirements – could be focussed on public health protection

Need clear roles and responsibilities and accountability Increased and better use of resource Better use of Eudravigilance and modern IT Strengthen the system



Future challenges



EC initial proposals (published Dec 07)

Rationalise decision making (Pharmacovigilance Committee)

Clarify roles and responsibilities (Good Vigilance Practice)

Risk-based approach to PSURs

Simplified ADR reporting

Clear legal base for Risk Management Plans (penalties for non-fulfilment)

Transparency



PhVWP response..

“The Pharmacovigilance Working Party broadly welcomes the European Commission’s legislative proposals ….. The Working Party supports the strategic aims of the Commission, not only to address weaknesses in the current system, but to introduce a new approach where requirements are proportionate to risk, the current complexity and duplication is simplified, and best use is made of resources in the EU network.”



What next?

New legislation not before 2010

Future of PhVWP not certain, however:

Important challenges - work needs to start now!



EudraVigilance – opportunity for signal detection

Member States have access – need to incorporate into national procedures and co-ordinate at EU level..



Signal management

Explicit roles and responsibilities of Member States and industry in signal detection and analysis

Need for carefully co-ordinated work sharing

Use of best available tools



Advanced therapies

Long term follow up of efficacy and safety – recipients and donors

Need for registries

Risk management plans key



Changing global regulatory environment

FDA

Early Communication About an Ongoing Safety ReviewOmeprazole (Prilosec)

Esomeprazole (Nexium) August 2007

… Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. …………… FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action.

FDA has received and is reviewing new safety data about Prilosec (omeprazole) and Nexium (esomeprazole). …. The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery.



Transparency

Increasing public expectations

Global initiatives (FDA publication of signals)

Increasing demand for PhVWP papers (mainly from law firms and MAH)

Development of public PhVWP report to communicate agreed recommendations (including summary of assessment)

Patient representation on PhVWP



Conclusions

PhVWP central to pharmacovigilance network in EU

Complex system requires close integration and work-sharing

EC proposals for legislative change should bring many benefits

Need to continue to adapt to changing regulatory environment



Thank you for your attention.

Any questions?

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Documents

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referred slide

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national products

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safety of medicinal

phvwp recommendations

chmp agenda drug safety