PURPOSE: to
improve the functioning of Community rules on the pharmacovigilance of
medicinal products for human use, with the overall objectives of better
protecting public health, ensuring proper functioning of the internal market
and simplifying the current rules and procedures.
PROPOSED ACT:
Directive of the European Parliament and of the Council.
CONTENT: it is
estimated that 5% of all hospital admissions are due to an adverse drug
reaction, that 5% of all hospital patients suffer an adverse drug reaction
and adverse drug reactions are the fifth most common cause of hospital death.
Some adverse reactions will only be detected after a medicine has been
authorised and the full safety profile of medicinal products can only be
known once they have entered the market.
Community
rules so far adopted have made a major contribution to the achievement of the
objective that medicinal products authorised to be placed on the Community
market are continuously monitored as regards their safety. However, in the
light of the experience acquired and following an assessment by the
Commission of the Community system of pharmacovigilance, it has become clear
that new measures are necessary to improve the operation of the Community
rules on the pharmacovigilance of medicinal products for human use.
Therefore, the
proposals aim at the strengthening and rationalizing the Community
pharmacovigilance system of medicinal products for human use through the
amendment of the two legal acts governing this field, i.e.
Directive 2001/83/EC (see COD/2008/0260)
and Regulation (EC) No 726/2004. The specific objectives are:
- providing
for clear roles and responsibilities for the key responsible parties and
clear obligations against which they perform their roles;
- rationalising
EU decision-making on drug safety issues;
- strengthening
medicines safety transparency and communication;
- strengthening
companies' pharmacovigilance systems;
- ensuring the
proactive and proportionate collection of high quality data relevant to
the safety of medicines through risk management and structured data
collection;
- involving
stakeholders in pharmacovigilance;
- simplification
of the current Community pharmacovigilance procedures.
The key
elements of the proposals can be summarised as follows:
Clear roles
and responsibilities:
- the key
tasks of the Agency in the area of pharmacovigilance are overall
maintained, but the Agency's coordinating role at the centre of the
Community pharmacovigilance system is reinforced;
- the Member
States should remain core to the operation of pharmacovigilance in the
Community, with increased cooperation and work-sharing mechanisms;
- the
pharmacovigilance responsibilities of marketing authorisation holders
are also clarified, in particular as regards the scope of the obligation
of marketing authorisation holders to continuously monitor the safety of
products to ensure that all information available is brought to the
attention of the authorities;
- a new
scientific committee responsible for pharmacovigilance is created within
the Agency: the Pharmacovigilance Risk Assessment Advisory Committee. This
Committee is intended to play a key role in the pharmacovigilance
assessments in the Community;
- the mandate
of the coordination group composed of Member States representatives is
enhanced;
- the
Community procedure for the assessment of serious safety issues for
nationally authorised products is stream-lined through clear and binding
initiation criteria for the Member States.
Transparency
and communication in terms of drug safety issues:
- strengthening
of the Eudravigilance database, which should become the single point of
receipt of pharmacovigilance information for medicinal products for human
use authorised in the Community;
- Community
coordination of communication about safety issues and establishment of a
European medicines safety web-portal;
- introduction
of a new ‘key information' section in the summary of the product
characteristics and the package leaflet which accompany every medicinal
product placed on the Community market.
Pharmacovigilance
obligations of the marketing authorisation holder:
the proposals simplify the requirement that a ‘detailed description of the
pharmacovigilance system’ be submitted in marketing authorisation
applications. In the marketing authorisation application, only key elements
of the pharmacovigilance system should be submitted, but this is balanced
with a requirement for companies to maintain a detailed pharmacovigilance
system master file on site.
Risk
management planning and non-interventional safety studies:
- the
establishment of a risk management system for each medicinal product to
be newly authorised in the Community (or for existing products on the basis
of safety concerns), which should be proportionate to the identified
risks, potential risks, and the need for additional information on the
medicinal product;
- the
establishment of harmonised guiding principles and a procedure for the
supervision of non-interventional post-authorisation safety studies
(i.e. safety studies of authorised products that are not clinical
trials), in particular to ensure that they are non promotional, and the
follow-up of any safety data generated in such studies.
Adverse drug
reaction case reports: the proposals are intended
to make reporting proportionate to risks, to empower patients to report their
side effects, and to ensure that overdoses and medication errors are reported.
The following has therefore been proposed:
- simplification
of adverse reaction reporting by providing that all adverse reaction
data are reported directly to the Eudravigilance database;
- requiring
the Agency to assume the role of monitoring scientific literature by the
Agency and to enter case reports of adverse effects into the
Eudravigilance database;
- clarification
of the definition of adverse drug reaction to make clear that companies
report medication errors that result in an adverse reaction to the
competent authorities for medicines and ensure that all the relevant Member State authorities share data;
- clarification
of the legal basis for patients to report suspected adverse drug
reactions.
Periodic
safety update reports and other safety related assessments: the proposals simplify periodic safety update report submission
by industry and make it proportional to the knowledge about the safety/risk
of the product. They introduce work-sharing mechanisms for the assessments,
with a prominent role in all cases by the Pharmacovigilance Risk Assessment
Advisory Committee, and faster updating of product information through the
establishment of clear procedures.