7 Information about prescription-only
+ ADDs 1-2
Draft Directive amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Draft Regulation amending, as regards information for the general public on medical products for human use subject to medical prescription, Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation and supervision of medical products for human and veterinary use and establishing a European Medicines Agency
Commission staff working documents: impact assessment and summary of assessment
|Legal base||(Both) Article 95 EC; co-decision; QMV
|Document originated||(Both) 10 December 2008
|Deposited in Parliament||(a) 12 January 2009|
(b) 22 December 2008
|Basis of consideration||(Both) EM of 14 January 2009
|Previous Committee Report||(Both) None
|To be discussed in Council||(Both) None
|Committee's assessment||(Both) Politically important
|Committee's decision||Both) Not cleared; further information requested
7.1 In 2001, the Council adopted a Directive setting out the rules
for the authorisation and supervision by Member States of medicinal
products for human use.
Title VIII (Articles 86 to 100) of the Directive are concerned
with the advertising of medicines. Article 88(1) prohibits the
advertising to the general public of products which are available
only on medical prescription. Title VIII does not, however, contain
rules about the provision of information on prescription-only
medicines. So Member States are free to make their own rules on
7.2 A Regulation of 2004 lays down the procedure
for the Commission and European Medicines Agency to authorise
and supervise certain medicinal products for human and veterinary
use. The Regulation contains no provisions on the provision of
information to the general public about products authorised in
accordance with the Regulation.
7.3 In 2007, the Commission published its Report
on current practices with regard to the provision of information
to patients on medicinal products.
It found that some Member States apply strict rules, while others
allow several types of non-promotional information to be made
available to the public. Some Member States give public authorities
(such as regulatory agencies) a prominent part in the dissemination
of information, while others allow partnerships between public
and private organisations. The differences between Member States'
rules create difficulties for manufacturers who wish to market
a product in several Member States or throughout the EC.
Documents (a) and (b)
7.4 So the Commission proposes a draft Directive
and a draft Regulation (documents (a) and (b)) with the aim of
providing a clear framework for the provision of information about
prescription-only medicines and encouraging the rational use of
them. The Commission's explanatory memoranda on the two measures
say that this aim would be achieved by;
- ensuring that information of
a high quality is provided by the application throughout the EC
of defined standards;
- allowing the information to be provided through
channels which suit the needs and capabilities of different types
- allowing the holders of marketing authorisations
to provide objective and non-promotional information about the
benefits and risks of their medicines; and
- ensuring that monitoring and enforcement arrangements
exist to check, without unnecessary bureaucracy, that the providers
comply with the quality criteria.
7.5 The proposals take account of the extensive consultations
the Commission held in 2006 and 2007 with pharmaceutical companies,
Member States, regulators, patients' organisations and others.
In the 2007 consultations:
- 47% of respondents said that
the pharmaceutical industry is not an appropriate source of information
about prescription-only medicines;
- but most respondents considered that the industry
should be allowed to provide information to patients who seek
- there was a consensus that pharmaceutical companies
should be allowed to publish summaries of product characteristics
and patient information leaflets on their websites; and
- 6% of respondents explicitly supported the use
of television and radio to disseminate information about prescription-only
medicines, whereas 35% did not.
7.6 The main amendments proposed to the 2001 Directive
are set out in a new Title VIIIa, headed Information for the
general public on medicinal products subject to medical prescription.
The new Title includes
- a definition of the information
that holders of marketing authorisations may disseminate (such
as the summary of product characteristics and the packaging leaflet,
as approved by the national authority responsible for granting
marketing authorisations; and information about the environmental
impact of the product);
- a prohibition on the dissemination of the information
by radio or television;
- a provision restricting the means of publication
to the internet, written answers to requests for information from
a member of the public or health-related publications;
- the conditions with which the information should
comply (for example, the information should be objective, based
on evidence, up-to-date, and verifiable);
- a requirement that the information should contain
specified statements that, for example, the information is disseminated
by the holder of the marketing authorisation and that the product
is available only on prescription;
- a requirement for Member States to ensure that
there are monitoring arrangements to ensure that the information
complies with the provisions of Title VIIIa; and
- a duty for Member States to ensure that there
are appropriate measures to ensure the application of Title VIIIa
and penalties for non-compliance with it.
The advertising of prescription-only drugs would
continue to be banned.
7.7 Document (d) contains the Commission's proposals
for amendments to the Regulation of 2004. It applies Title VIIIa
of document (a) to the medicinal products for human use authorised
under the 2004 Regulation subject to the vetting of product-related
information by the European Medicines Agency (rather than the
national regulatory authorities) before the information is disseminated.
The Government's view
7.8 In her Explanatory Memorandum of 14 January,
the Minister of State for Public Health at the Department of Health
(Dawn Primarolo) tells us that the Government supports the provision
to patients of non-promotional information of high quality. It
also supports a ban on the advertising of prescription-only medicines.
7.9 The Minister says that the UK has adopted a less
restrictive approach than many other Member States to the information
which pharmaceutical companies may disseminate to the public.
The Government will want to ensure during the negotiation of documents
(a) and (b) that the UK's current practices are not affected adversely.
7.10 The Minister draws our attention to a discrepancy
between the two documents. Document (a) makes Member States responsible
for ensuring that there are adequate arrangements to monitor the
compliance of information with the requirements of the proposed
Title VIIIa. But document (b) requires the vetting to be done
before the information is disseminated and gives the responsibility
to the European Medicines Agency. The Government considers that
the vetting arrangements proposed by the Commission are disproportionate
and that they run the risk of creating conflict between the European
Medicines Agency and the national courts about, for example, what
is advertising and what is information.
7.11 The Government will hold public consultations
on documents (a) and (b) and on a draft Impact Assessment of the
effect of the proposals on the UK.
7.12 We recognise that differences in Member States
rules about the provision of information on prescription-only
medicines might lead to the distortion of the single market for
medicinal products. We also recognise that patients may want objective
and factual information and that it could properly be provided
by the manufacturers so long as they comply with conditions such
as those proposed in document (a).
7.13 The Government has some concerns about these
documents and it would be surprising if other Member States did
not have their own reservations. The negotiations on the proposals
are only just beginning. It would be premature, therefore, for
us to reach a view on the documents at this stage. We should be
grateful, if the Minister would provide us with progress reports
on the negotiations and a note on the responses to the Government's
consultations. Meanwhile, we shall keep both documents under scrutiny.
27 Directive 2001/83/EC: OJ No. L 311, 28.11.01, p.67. Back
(29830) 5242/08. Back
See page 4 of ADD 1. Back