Transcript WHAT HEALTHCARE FROM THE

TAIEX Workshop on the
Implementation of EU
Pharmacovigilance Legislation
- BELGRADE 2015 CLAUDIA PANAIT
TAIEX Expert – European Commission
Legal Adviser
Ministry of Health,
ROMANIA
WHAT HEALTHCARE
PROFESSIONALS AND
PATIENTS CAN EXPECT
FROM THE IMPLEMENTATION
OF THE NEW EU
PHARMACOVIGILANCE
LEGISLATION ?
Key provisions for patients in the
new EU legislation
Directive (Directive 2010/84/EU)
and
Regulation (Regulation No. 1235/2010)
amend the existing EU legislative framework
Directive 2001/83/EC and Regulation 726/2004,
only as regards pharmacovigilance
 adopted by the Council of the European Union
on 29 November 2010 without debate, having
reached agreement with the European
Parliament on first reading
 published in the EU Official Journal on 31
December 2010.

Transposing EU Regulation and
Directives into national legislation
EU Regulation is directly applicable
and binding to every Member State
 Directives require a formal legislative
act in order to be to transposed them
into national law
The New Pharmacovigilance Legislation is
an important step for medicines safety but
also for patient involvement !
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The main pillars of the new
EU legislation
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Risk management
Rafety data
Stronger link between safety assessments and
regulatory action
Transparency, communication and patient
involvement
Clear tasks and responsibilities for all parties
Improved EU decision-making procedures
New scientific committee at the European
Medicines Agency: The Pharmacovigilance
Risk Assessment Committee
Adoption of revised
pharmacovigilance legislation

Definition:
Pharmacovigilance is the process and
science of monitoring the safety of
medicines and taking action to reduce the
risks.
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It is essential for protection of public
health !
New amendments to the EU
legislation
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Now the use of medicines in the EU is
even safer !
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Patients and healthcare professionals
will be specifically informed and asked
to notify adverse reactions to the
medicine!
Institutions involved in the field
of pharmacovigilance
COMPETENT AUTHORITY (CA)
=government of a member state to act in
order to ensure that the requirements of
directive (directives) in this field are met
 POLITICAL ORGANIZATION
= responsible for policy
is the body authorized by the
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In Romania:
National Agency for Medicines and
Medical devices (NAMMD)
Competent Authority (CA) :
NATIONAL AGENCY FOR MEDICINES
AND MEDICAL DEVICES (NAMMD) responsible for pharmacovigilance activity
 The NAMMD has implemented an
electronic data exchange system
regarding suspected adverse reactions
using the webtrader component of
EudraVigilance Web Application (EVWEB)
In Romania:
MINISTRY OF HEALTH
Political Organization :
MINISTRY OF HEALTH - responsible for
policy
NEW EU PHARMACOVIGILANCE
LEGISLATION
 Healthcare professionals and patients
are also involved
Those directly involved in
pharmacovigilance
Patients
 Doctors, pharmacists, nurses
 Regulatory authorities
 Pharmaceutical companies and
companies importing or distributing
medicines
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How will the new Pharmacovigilance
legislation ensure greater patient safety?
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Clear tasks and responsibilities for all
parties involved (MS, marketing authorisation
holders and the European Medicines Agency)
Improving decision-making procedures
Using resources more efficiently
Managing risk proportionately
Involving stakeholders in pharmacovigilance
including through direct patient
Reporting
Communication and transparency on
medicine safety
Companies’ pharmacovigilance systems
How will this legislation ensure greater
transparency and patient
involvement?
Patients + healthcare providers :
to reports ADRs directly to the competent
authorities.
 National authorities : web-portals
 MS: regular reports to "Eudravigilance“
 Public hearings on medicines:announced
on the European web portal.
 Patients :
to express themselves
to be more active participants in their health
identifying patterns of ADRs.
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What is the Committee on Pharmacovigilance
that will be set up under
this legislation?
The Pharmacovigilance legislation: a new
scientific committee at the European
Medicines Agency:
 ”Pharmacovigilance Risk Assessment
Committee (PRAC)” :
access to the best scientific and medicinal
expertise for the evaluation of the safety
of medicines and risk minimisation measures
with the ultimate goal of reducing ADRs.
Appointments
Are based on relevant experience in
pharmacovigilance and risk assessment.
The committee is composed of:
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- 1 member and 1 alternate appointed by each Member
State
- 6 members appointed by the Commission to ensure
availability of relevant expertise in the committee, on the
basis of a public call for expression of interest
- 1 member and 1 alternate appointed by the Commission on
the basis of a public call for expression of interest in order to
represent healthcare professionals
-1 member and 1 alternate in order to represent patients.
Impact on patient organisations
at national and EU level
At European level, EPF working with
the Commission, other stakeholder
groups (doctors and pharmacists) and
monitoring the implementation of the
new legislation.
 At national level, the legislation does
not directly oblige MS to involve patient
organisations, but it does encourage
this.
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In Romania: periodic meetings between
patient associations and NAMMD
Participants representing patient associations
promote the patient reporting form as well as their
availability for posting it on their respective
websites.
 The NAMMD encourages both patients and
healthcare professionals to report suspected
adverse reactions to all medicines, vaccines
included.
 By reporting adverse reactions, patients can help
improvement of the drug safety profile, protecting
public health.
 The patient reporting form: on the NAMMD website
http://www.anm.ro/anmdm/med_reactie_adversa.html.
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Guidance for Patient
Organisations
The new EU pharmacovigilance
legislation:
Directive 2010/84/EU
and
Regulation No. 1235/2010
Purpose
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information and guidance for patient
organisations on the EU
pharmacovigilance legislation
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aspects of the legislation that have
particular implications for patients
Why is pharmacovigilance
important for patients?
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Adverse drug reactions : the fifth
largest cause of deaths in hospitals
(only around 10% to 25% of all adverse
reactions are reported)
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Patients and healthcare professionals
are currently underreporting
Improve the safety and quality of
care
clear EU-wide rules on
pharmacovigilance
and
 ensuring effective cooperation between
Member States for all medicines sold in
more than one Member State
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IS FUNDAMENTAL !
The new EU rules
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improve the collection of information on
adverse reactions
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bring new ways to encourage reporting
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more options for patients
The competence of the EU to legislate in
the field of pharmacovigilance
Limited competence
 Generally only adopts non-binding
legislative instrument (recommendations
and communications)
 Specific areas: binding legislation to
harmonise national laws (to set high
standards of quality and safety for
medicines and medical devices)
Responsibility for organisation of
health systems: Member States
National Competent Authorities (NCA)
Their task:
 to evaluate all information scientifically
risk minimisation
 prevention and take action regarding
the marketing authorization (revoke it, or
not renew it).
 ask for more information from the
company that holds the authorization.
The role of patients and health
professionals
= the key to building a better system of
pharmacovigilance
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Patients are best placed to assess
the impact of a medicine on their
bodies and their quality of life
High quality of information to
patients is crucial
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good information on medicines and
adverse drug reactions can empower
patients to participate more actively
in healthcare decisions, together with
health professionals.
A good patient-health
professional relationship
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Trust and mutual respect = crucial to
ensure that patients are comfortable
discussing the effects of medicines with
their doctor or other health professional.
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Systems for direct reporting of
suspected adverse reactions by
patients (or consumers) already operate
in some EU Member States, notably the
Romania, UK, Denmark and Netherlands.
The new EU rules
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Will allow direct patient reporting in all
EU Member States
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Giving patients this possibility will be
empowering
Reporting the adverse reactions
=an important way to collect more information
The regulatory authorities :
 analise the adverse reactions reports
 together with all the information they
already have,
The patients and the medical staff are
encouraged to report the suspected
adverse reactions related to any medicinal
product.
In compliance with the new
legislation
The patients :
 report the adverse reactions directly to
the national authorities in the medicinal
products field of their countries
The modality of transfering such
notifications :
the leaflet of each medicinal products
and
in the Summary of product characteristics.
Quick identification
=
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The black triangle
The patients and medical staff are
encouraged to report any suspected
adverse reaction related to the medicinal
products bearing the black triangle
Patient reports are as valuable as
reports by healthcare professionals
Special added value:
patients are able to specify the
circumstances in which the reaction
occurred
 they often give much more detailed and
nuanced descriptions
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Different types of reactions
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Patients also report different types of
reactions than health professionals
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they perceive the impact and severity of
reactions differently
Better information on
pharmacovigilance to the public
greater transparency of the
pharmacovigilance system
 better access to information
 the confidence and trust of patients and
the general public.
 national medicines web-portals linked
to a European medicines portal
(developed by the EMA)
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National medicines web-portals
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Publicly available versions of the
assessment reports with their summaries
Summaries of product characteristics
Package leaflets
Summaries of the risk management plans
for authorised medicinal products
The list of medicinal products that are
subject to additional monitoring
Information on the different ways of
reporting suspected adverse reactions to
the national competent authorities by
healthcare professionals and patients
European medicines portal, developed
by the EMA
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information
about
the
EMA
Pharmacovigilance
Risk
Assessment
Committee and its meetings;
post-authorisation studies;
summaries of risk management plans;
information about Union reference dates and
frequency of submission of periodic safety
update reports;
protocols and public abstracts of results of
the post-authorisation safety studies;
information on the initiation of urgent union
procedures
Eudravigilance database
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Partially accessible to the public,
health professionals and research
organisations.
EPF has been actively contributing to an
EMA working group to advise on the
implementation of the Eudravigilance
access policy to ensure the clarity and
user !
Encouraging reports by adverse
drug reactions
MS :
 “may” involve patient organisations to
encourage reporting by patients
 have to provide at least one other way for
patients to report directly to the national
competent authorities
Patient organisations :
 can offer help in preparing guidelines for
implementation of direct patient reporting
Transparency on pharmacovigilance
- public awareness
Patient organizations
 can give advice concerning the set-up
of national medicines web-portals to
ensure the information is clear, meets
patients’ needs and is user-friendly
 can suggest other information that
would be useful to include although not
strictly required by the rules.
Patient organisations play a key
role
In addition to public information
campaigns, patient organisations play a
key role supporting long-term patient
awareness about pharmacovigilance, as
they are in regular and close contact
with grass-roots patient communities.
! Make sure the national authorities are
aware of Patient organizations activities
and their added value.
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Conclusions
What healthcare
professionals and patients
can expect from the
implementation of the new
eu pharmacovigilance
legislation?
Expectations
Reducing medication errors from
pharmacovigilance perspective
 Minimising risk
 Minimising risk for a new presentation of
a existing medicine
 Involvement of authorities for reducing
medication errors
 Reducing the incidence of medication
errors
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THANK YOU FOR ATTENTION !