PURPOSE: to
amend, as regards pharmacovigilance, Directive 2001/83/EC on the Community
code relating to medicinal products for human use.
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 (ADR), and that ADR is 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.
Pharmacovigilance rules are therefore necessary for the protection of public
health in order to prevent, detect and assess adverse effects of medicinal
products.
The proposals
aim at the strengthening and rationalising the Community pharmacovigilance
system of medicinal products for human use The specific objectives are:
- providing
clear roles and responsibilities for the key responsible parties and
clear obligations;
- strengthening
transparency and communication on medicine’s safety issues to increase
the understanding and trust of patients and health professionals and
improve the penetration of key warnings;
- strengthening
companies' pharmacovigilance systems, allowing companies to improve
their systems regularly whilst reducing administrative burden;
- introducing
a risk management planning for each new medicinal product
- strengthening
the reporting system for adverse reactions by rationalising current
system and involving all stakeholders in pharmacovigilance
- ensuring the
proactive and proportionate collection of high quality data relevant to
the safety of medicines through risk management and structured data
collection.
In addition to
achieving better protection of public health the proposals will also simplify
the current EU procedures with consequent efficiency gains for both the pharmaceutical
industry and medicines’ regulators.
Clear roles
and responsibilities:
- Member
States should remain central to the operation of pharmacovigilance, with
increased cooperation and work-sharing mechanisms (Member States not the
Commission).
- companies’
responsibilities are clarified, in particular as regards the scope of
their obligation to continuously monitor the safety of products thereby
ensuring that all information available is brought to the attention of
the authorities.
- a new
scientific committee, the Pharmacovigilance Risk Assessment Advisory
Committee, is created within the EMEA and it will play a key role in the
pharmacovigilance assessments in the EU.
- the mandate
of the coordination group composed of Member States representatives is
enhanced for the sake of closer cooperation between the Member States
and in order to increase work-sharing.
- the EU
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: clear, EU coordinated messages
about specific safety risk issues:
- the
Eudravigilance database should become the single point of receipt of
pharmacovigilance information for medicinal products authorised in the
EU.
- EU
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.
Pharmacovigilance
obligations by industry: currently legislation
requires a ‘detailed description of the pharmacovigilance system’ to be
submitted in marketing authorisation applications. These proposals simplify
the existing requirement by introducing the "Pharmacovigilance system
master file". In the applications only key elements of the
pharmacovigilance system should be submitted, but this is balanced with a
requirement for companies to maintain a detailed file on site.
Risk
management planning and non-interventional safety studies: in the existing provisions, companies may provide a risk
management system for specific medicinal products if considered appropriate,
and there is no explicit legal basis for competent authorities to request it.
These proposals require:
- a risk
management system for each new medicinal product (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.
- 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 date generated in such studies.
Adverse
drug reaction case reports: current reports are
submitted to several authorities if a product is authorised in more than one Member State , and lead to duplicative assessments as there is no provision to group
assessments by products or substances. The proposals are intended:
- to make
reporting proportionate to risks;
- to empower
patients to report their side effects;
- to ensure
that overdoses and medication errors are reported;
- to simplify
adverse reaction reporting. It is proposed to report all adverse
reaction data directly to the Eudravigilance database.
- for the
Agency to take on a new task for the monitoring of selected scientific
literature and for entering case reports of adverse effects onto the
Eudravigilance database.
- for
medication errors that result in an ADR to be reported to the competent
authorities for medicines. Member State authorities should ensure that
data is shared (including between the authorities for medicines and any
authorities for patient safety) and make clear the legal basis for
patients to report suspected adverse drug reactions.
Periodic
safety update reports and other safety related assessments: as there is currently no provision for group submissions and
assessments on products or substances, this leads to duplicative submissions
and assessments. The update of product information as a result of these
assessments is not governed in detail by the actual legislation. The
proposals:
- simplify
periodic safety update report submission by industry and make it
proportional to the knowledge about the safety/risk of the product;
- would
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;
- amend the
scope of periodic safety update reports to become an analysis of the
risk-benefit balance of a medicinal product rather than a detailed
presentation of individual case reports as a result of the submission of
all ADR data directly to the Eudravigilance database,;
- make the
requirements for periodic safety update reports proportional to the
risks posed by medicinal products, and routine reporting is no longer
necessary for products considered low risk or where reporting would be
duplicative (with the possibility for ad-hoc requests for such
products).
- make
explicit provision for the regulatory follow-up of assessments of
periodic safety update reports, to ensure a clear link between
pharmacovigilance evaluations and the review and updating of marketing
authorisations authorised in the EU.
- create the
framework for the shared use of resources between competent authorities
for the assessment and follow-up of periodic safety update reports, with
a strong involvement of the Agency's Pharmacovigilance Risk Assessment
Advisory Committee.
- introduce a
single assessment of periodic safety update reports for medicinal
products authorised in more than one Member State,(including all products
containing the same active substance),. This will also be the case for
products authorised by the Member States and/or by the Commission.
Lastly, the
proposal also contains two provisions to improve the availability of medicine
in Member States, in particular the smaller ones.