8 Pharmacovigilance of medicinal products
for human use
| (a)
(30309)
17502/08
COM(08) 665
(b)
(30291)
17501/08
COM(08) 664
+ ADDs 1-3
|
Draft Directive amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal product for human use
Draft Regulation amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing the European Medicines Agency
Commission staff working documents: impact assessment and summary of assessment
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| Legal base | (Both) Article 95 EC; co-decision; QMV
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| Documents originated | (Both) 10 December 2008
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| Deposited in Parliament | (a) 12 January 2009
(b) 22 December 2008
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| Department | Health |
| Basis of consideration | (Both) EM of 14 January 2009
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| Previous Committee Report | (Both) None
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| To be discussed in Council | (Both) No date set
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| Committee's assessment | (Both) Politically important
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| Committee's decision | (Both) Not cleared; further information requested
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Background
8.1 Pharmacovigilance is the process for monitoring the use of
medicines to identify previously unrecognised adverse effects;
assessing the risks and benefits of medicines so as to decide
what action, if any, is needed to improve the safe use of them;
and providing information to healthcare staff and patients on
the safe and effective use of medicines.
8.2 In 2001, the Council adopted a Directive laying
down the procedure for Member States to authorise and supervise
the marketing, manufacture, importation and wholesale distribution
of medicinal products for human use.[30]
Articles 101 to 108 set out the responsibilities of Member States,
the holders of marketing authorisations and others for pharmacovigilance.
8.3 In 2004, the Council adopted a Regulation on
the authorisation and supervision of medicinal products for human
and veterinary use.[31]
Article 21 to 29 set out the responsibilities of the Commission,
the European Medicines Agency and the holders of marketing authorisations
for the pharmacovigilance of medicinal products for human use.
8.4 Whereas the 2001 Directive is concerned only
with medicines for human use, the Regulation of 2004 is concerned
with products for both human and veterinary use. Moreover, whereas
the Directive is about the authorisation and supervision of most
products by Member States, the Regulation concerns the authorisation
and supervision of certain products by the Commission. An authorisation
given by a Member State or States in accordance with the Directive
is valid only in that State or States, whereas authorisations
given by the Commission in accordance with the Regulation are
valid throughout the EC.
8.5 The legal base for both the Directive and the
Regulation is Article 95 of the EC Treaty. It authorises the Council
to adopt measures for the approximation of the laws of Member
States on the establishment and functioning of the EC's internal
market.
Documents (a) and (b)
8.6 Document (a) amends the pharmacovilance provisions
of the 2001 Directive and document (b) the corresponding provisions
of the 2004 Regulation.
8.7 In its explanatory memorandum on the documents,
the Commission notes that it has been estimated that 5% of all
hospital admissions are due to an adverse drug reaction; 5% of
all hospital patients suffer an adverse drug reaction; and adverse
drug reactions are the fifth most common cause of hospital death.
In the light of experience and its assessment of the EC's present
rules on pharmacovigilance, the Commission considers that improvements
are necessary.
8.8 The Commission's aims in proposing documents
(a) and (b) are:
- to strengthen the protection
of public health;
- assist the functioning of the internal market
for medicines for human use; and
- simplify the current rules on pharmacovigilance
so as to obtain the benefits of better regulation.
8.9 The main provisions of documents (a) and (b)
are to:
- repeal the pharmacovigilance
chapters of the present Directive and Regulation and replace them
with new chapters;
- clarify the responsibilities of Member States,
the European Medicines Agency and the holders of marketing authorisations;
- create a new Pharmacovigilance Risk Assessment
Advisory Committee to provide support to both the Committee for
Medical Products for Human Use (which assists the European Medical
Agency by giving opinions on the safety, quality and efficacy
of medicinal products) and Member States;
- strengthen the EU's Adverse Drug Reaction Database
(the EudraVigilance database), which would become the single point
of receipt for all pharmacovigilance information about medicinal
products for human use authorised in the Community;
- give the European Medicines Agency responsibility
for coordinating communication between Member States about major
new concerns about the safety of active substances authorised
by one or more Member States;
- introduce a new "key information" section
into the summary of the product's characteristics which appears
in the leaflet which accompanies every medicinal product;
- simplify the present requirements for a detailed
description of the pharmacovigilance system to accompany applications
for marketing authorisation;
- require applicants for authorisation to provide
a risk management system for their products;
- simplify the obligations of holders of marketing
authorisations to report adverse reactions to medicines ("adverse
drug reactions") and require Member States to submit to the
EudraVigilance database adverse reports by patients and healthcare
staff;
- simplify the requirements for holders of marketing
authorisations to produce periodic reports to update the information
about the safety of products ("periodic safety update reports");
and
- strengthen the arrangements for Member States
and the European Medicines Agency to assess and follow-up periodic
safety update reports.
8.10 The Commission estimates that the total net
saving to companies and regulators if the proposals were adopted
would be about €140 million a year and that between 591 and
5910 deaths would be avoided each year.
The Government's view
8.11 In her Explanatory Memorandum of 14 January
2009, the Minister of State for Public Health at the Department
of Health (Dawn Primarolo) tells us that the Government recognises
the need to simplify, rationalise and strengthen the European
system of pharmacovigilance. It believes that the Commission's
proposals to amend the existing Directive and Regulation have
the potential to enable the achievement of both a high level of
public health protection and the benefits of better regulation.
8.12 The Minister tells us that the Government broadly
supports the proposed structure of the board of the new Pharmacovigilance
Risk Assessment Advisory Committee, including the proposals for
its membership. She adds that clarity will be required about the
precise responsibilities of the new body within the existing structure
of the European Medicines Agency and its Committee on Medicinal
Products for Human Use.
8.13 The Government supports the proposals to rationalise
the requirements for the reporting of adverse drug reactions but
will want to ensure that Member States continue to receive prompt
reports from holders of marketing authorisations. The Government
also supports the proposals for the rationalisation of periodic
safety update reports.
8.14 Commenting on the Commission's proposals for
pharmacovigilance information to be reported to and held on the
EudraVigilance database, the Minister says that the UK's Medicines
and Healthcare Products Regulatory Agency has a comprehensive
database on adverse drug reactions ("ADR") which is
one of the best in the EU. The Minister tells us that:
"A key issue for the UK would be to ensure that
our national database remained complete. Therefore, the EudraVigilance
database would need to be compatible [with] and linked to national
databases, so that ADR reports submitted by [holders of marketing
authorisations] into EudraVigilance would be automatically copied
into Member State databases."[32]
8.15 The Minister says that the Government is initiating
public consultations on documents (a) and (b) and will have meetings
with interested organisations and experts throughout the negotiations
so as to keep them informed and seek their views on the proposals
as they develop. The Government is also inviting written comments
on a draft of an assessment of the impact of the proposals on
the UK. The Minister will send us the final Impact Assessment
when it has been completed.
Conclusion
8.16 We welcome the aims of the Commission's proposals,
which are to strengthen the protection of public health; improve
the functioning of the internal market for medicines; and reap
the benefits of better regulation. Because of the complexity of
documents (a) and (b) and the importance of the proposals, it
is essential that the Council's examination of the documents is
rigorous. It has only just begun. We should be grateful, therefore,
if the Minister would send us progress reports on the negotiations.
We also ask her for a note on the responses to the Government's
consultations. Meanwhile we shall keep both documents under scrutiny.
30 Directive 2001/83/EC: OJ No. L 311, 28.11.01, p.67. Back
31
Regulation (EC) No. 726/2004: OJ No. L 136, 30.4.04, p.1. The
products for which authorisation is required from the Commission,
with the assistance of the European Medicines Agency, are described
in the Annex to the Regulation and include, for example, products
developed by means of one of certain biotechnology processes,
such as recombinant DNA technology. Back
32
Paragraph 13 of the Minister's Explanatory Memorandum. Back
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