5 Prevention of the counterfeiting of
medicinal products
| (30293)
17504/08
COM(08) 668
+ ADDs 1-2
| Draft Directive amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Commission staff working documents: impact assessment and summary of assessment
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| Legal base | Article 95 EC; co-decision; QMV
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| Document originated | 10 December 2008
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| Deposited in Parliament | 22 December 2008
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| Department | Health |
| Basis of consideration | EM of 14 January 2009
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| Previous Committee Report | None
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| To be discussed in Council | No date set
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| Committee's assessment | Politically important
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| Committee's decision | Not cleared; further information requested
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The document
5.1 There has been a substantial increase in the number of counterfeit
medicines in circulation in the EC. They contain, for example,
sub-standard or falsified ingredients or ingredients in the wrong
dosage. They pose a serious threat not only to public health but
also to trust in the pharmaceutical industry. Some of the counterfeit
products are being marketed illicitly but some are infiltrating
Member States' legal supply chains.
5.2 A Council Directive of 2001 sets out the rules
for Member States to authorise and supervise the marketing, manufacture,
importation and wholesale distribution of medicinal products for
human use.[21] In the
Commission's view, the provisions of the Directive are insufficient
to deal with counterfeiting. So it proposes this amending Directive.
5.3 The Commission proposes, for example, that the
Directive of 2001 should be amended to:
- require all the parties involved
in the distribution of medicines (including importers and middle-men)
to comply with the wholesale distribution requirements of the
2001 Directive;
- authorise the Commission, through the comitology
procedure, to introduce a requirement for manufacturers to place
a safety feature on the outer packaging of prescription-only-medicines
to enable the authenticity and identity of the product to be confirmed
and to prohibit tampering with the safety features of packaging;
- require wholesalers who buy medicines from other
wholesalers to verify that the supplying dealer complies with
the EC's good distribution practices;
- require wholesalers who buy medicinal products
from manufacturers or importers to verify that they hold manufacturing
authorisations;
- strengthen the requirements for the verification
of the validity of imported active pharmaceutical ingredients;
and
- strengthen the rules for inspections to check
compliance with the EC's standards of practice for good manufacturing
and good distribution.
The Government's view
5.4 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, in the past four years, there
have been nine recalls of batches of counterfeit medicines which
had reached the legitimate supply chain in the UK. The Government
agrees with the Commission's assessment of the problem facing
the EC. It also agrees that the regulatory framework needs strengthening
and broadly supports the proposals in the draft Directive.
5.5 The Government is currently holding public consultations
on the proposals and will keep in touch with interested organisations
and experts during the negotiations.
Conclusion
5.6 We welcome the Commission's initiative in
bringing forward proposals to prevent counterfeit medicinal products
getting into the legal supply chain.
5.7 The legal base for the draft Directive appears
to be appropriate and, in our view, the document is consistent
with the principle of subsidiarity.
5.8 The proposed amendments to the Directive of
2001 are complicated and the negotiations on them are only just
beginning. We can understand, therefore, why the Government offers
only broad support for the proposals at this stage. We should
be grateful if the Minister would send us progress reports on
the negotiations. We should also be grateful if she would send
us a note on the responses to the Government's consultations.
Meanwhile, we shall keep the document under scrutiny.
21 Directive 2001/83/EC: OJ No. L 311, 28.11.01, p.67. Back
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