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 products 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 a 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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| Document 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 and Ministerial letters of 20 May 2009, 19 November 2009, 18 March 2010 and 25 October 2010
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| Previous Committee Report | HC 19-v (2008-09), chapter 8 (28 January 2009)
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| To be discussed in Council | Possible adoption in November
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| Committee's assessment | Politically important
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| Committee's decision | Cleared
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Background
8.1 In order to ensure the quality, safety and efficacy of
medicines, medicinal products require a marketing authorisation
before they may be placed on the market. In 2001, the Council
adopted a Directive laying down procedures for Member States to
authorise and supervise the marketing, manufacture, importation
and wholesale distribution of medicinal products for human use.
An authorisation given by a Member State or States in accordance
with the Directive is valid only in that State or States.
8.2 In 2004, the Council adopted a Regulation
establishing procedures for the authorisation and supervision
of certain medicinal products intended for human and veterinary
use by the Commission. An authorisation made in accordance with
the Regulation is valid throughout the EU.
8.3 Pharmacovigilance — the process for
monitoring and assessing the risks and benefits of medicines and
for taking remedial action if needed (such as suspension of a
marketing authorisation) — is a central element of both
measures. In December 2008, the Commission proposed amendments
to the 2001 Directive and 2004 Regulation which were intended
to strengthen the protection of public health and patient safety,
cut red tape, and improve the operation of the internal market
for medicines. Document (a) amends the pharmacovigilance provisions
of the 2001 Directive and document (b) the corresponding provisions
of the 2004 Regulation.
Previous scrutiny
8.4 Our predecessors considered the amendments
proposed in documents (a) and (b) on 28 January 2009. The Committee's
Report[17] set out the
main provisions, which were to:
- repeal the pharmacovigilance
chapters of the 2001 Directive and 2004 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 ("PRAC") to provide support to both
the Committee for Medical Products for Human Use (which assists
the European Medicines 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.
8.5 The Commission estimated 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
5,910 deaths would be avoided each year.
8.6 The previous Government indicated broad support
for the Commission's proposals but highlighted two issues: further
information would be needed on the precise role and responsibilities
of the new advisory Pharmacovigilance Risk Assessment Committee
(PRAC); and the EudraVigilance database would have to be compatible
with and linked in to national databases on adverse drugs reactions.
Our predecessors also welcomed the aims of the Commission's proposals
but, as they were complex and detailed, asked the then Minister
for progress reports on the negotiations and kept both documents
under scrutiny.
8.7 Progress reports since then have continued
to focus on PRAC, with the Government seeking to ensure equal
representation of Member States on the Advisory Committee, and
on the need to ensure that the development of EudraVigilance as
a single point of receipt for adverse drug reactions does not
undermine the UK's own comprehensive database.
The Minister's letter of 25 October
8.8 The Parliamentary Under Secretary of State
(Anne Milton) explains that significant progress was made under
the Spanish Presidency, culminating in political agreement on
compromise Presidency texts at COREPER (the Committee of Permanent
Representatives to the EU) in June. As both documents were under
scrutiny at the time, the Minister says that the Government abstained
on the vote in COREPER. She expects that the texts agreed in June
will be proposed for formal adoption by the Council in November.
8.9 The Minister sets out the main features of
the agreed texts as follows:
- equal representation of Member
States (supplemented by additional experts) on the Pharmacovigilance
Risk Assessment Committee and clarification of its relationship
with other EU Committees;
- streamlining of reporting of adverse drug reactions,
so that drug companies need only submit reports to EudraVigilance,
but with guarantees to ensure that the relevant Member States
will have immediate access to these reports to enable them to
continue to monitor medicines used in their domestic markets;
- introducing a risk-based approach (reducing administrative
burdens) for the production of Periodic Safety Update Reports
by drug companies;
- greater opportunities for national regulatory
authorities to work together to reduce the cost of regulation;
- greater use of risk management plans, especially
for new medicines, to assess and monitor risks arising from the
use of medicines;
- greater legal clarity about the obligations on
drugs companies to report adverse reactions arising from the use
of medicine, whether use is in accordance with the relevant licence
or not;
- new regulatory procedures, for example, to ensure
that patients taking new medicines know that they are under additional
monitoring, or to restrict the use of a medicine if risks are
identified that require further investigation.
8.10 The Minister explains that the agreed texts
also reflect changes resulting from the entry into force of the
Lisbon Treaty last December. First, the legal base has been amended
to cite Treaty Articles in the Treaty on the Functioning of the
European Union (TFEU) and now includes Article 168(4)(c) —
which provides for measures setting high standards of quality
and safety for medicinal products — as well as Article 114
on the approximation of national laws for the purpose of the establishment
and functioning of the EU's internal market. The Minister says
that, previously, medicines legislation only cited an internal
market legal base but the addition of Article 168(4)(c) has no
implications for EU competence.
8.11 Second, Article 290 TFEU provides for EU
legislative acts to delegate power to the Commission "to
supplement or amend certain non-essential elements of the legislative
act". Document (a) — the draft Directive — now
includes provision for the Commission to adopt delegated acts
setting out detailed rules for pharmaceutical companies on the
minimum requirements needed to ensure compliance with the pharmacovigilance
provisions of the draft Directive and clarifying the situations
in which they are required to undertake efficacy studies after
a medicine has been authorised. The Minister believes that the
powers delegated to the Commission are "appropriately framed"
and says that the Government is "content that Member State
experts will be consulted when the guidance is drawn up".
8.12 The Minister asks us to clear the draft
Directive and draft Regulation from scrutiny to enable the Government
to lift it parliamentary scrutiny reserve on both proposals and
support the adoption of the Presidency compromise texts at a forthcoming
Council in November.
Conclusion
8.13 We note that the Presidency compromise
texts address the principal concerns raised by the Government
in the course of negotiations. In particular, the texts secure
equal representation of Member States on the new advisory Pharmacovigilance
Risk Assessment Committee and ensure that the reporting of adverse
drugs reactions via a centralised EU database — EudraVigilance
— will not undermine the efficacy of the UK's own database.
We agree with the Government that the addition of Article 168(4)(c)
TFEU to the legal bases cited for the proposals does not represent
an extension of EU competence.
8.14 The changes contained in the amending
Directive and Regulation will not fundamentally affect existing
procedures for authorising or suspending the marketing of drugs.
While we are content to clear both documents from scrutiny, we
do so subject to the following observation. We anticipate that
pharmaceutical companies will increasingly use EU procedures to
obtain EU-wide authorisation to market their drugs in all Member
States. While this may reduce the regulatory burden on companies,
this should not be at the expense of public health protection.
We note that the 2004 Regulation provides, in recital 13, that
where a drug has been authorised at EU level, Member States should
be able "exceptionally to prohibit the use in their territory
of medicinal products for human use which infringe objectively
defined concepts of public policy and public morality." We
wish, therefore, to emphasise the need for national regulators
to exercise vigilance and to act quickly and decisively if safety
concerns about the use of a drug authorised at EU level emerge
within their own territories, including by invoking, where necessary,
the public policy safeguards contained in Article 114(4) TFEU.
17 See HC 19-v (2008-09), chapter 8 (28 January 2009).
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