Policy responses and statements
- Name of organisation:
- Medicines and Healthcare
Products Regulatory Agency (MHRA
- Name of policy document:
- MLX 358: European Commission proposals on
information to patients for prescription medicines
- Deadline for response:
- 14 August 2009
Background: This consultation sought views on a
European Commission proposal that would allow the pharmaceutical industry
to provide information to the public on prescription only medicines
(advertising of these to the public is not allowed). The MHRA wished
to know whether or not respondents agreed with the UK government position
on the proposals and what impact they think they might have in the
UK.
This legislative proposal is part of the European Commission pharmaceutical
package announced in December 2008. MLX 357 sought views on measures
to strengthen the medicines’ supply chain and reduce the risk
from counterfeit medicines.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY
AGENCY (MHRA)
MLX 358: EUROPEAN COMMISSION PROPOSALS ON INFORMATION
TO PATIENTS FOR PRESCRIPTION MEDICINES
The Royal College of Physicians of Edinburgh is pleased to respond
to the MHRA on consultation MLX 358: European Commission proposals
on information to patients for prescription medicines. Our
responses to the questions are as follows:
Q1. Do you agree with the key elements of the European
Commission proposal outlined in paragraph 13?
Yes, we agree with
the key elements outlined in paragraph 13 and would support these proposals.
Q2. Do you agree with the UK government position at
paragraph 16-18? Do you have any alternative proposals?
We would favour more
regulation, as we are slightly sceptical about the ability of industry
to self-regulate on this issue. The main risk is that “information” could
transmute into advertising. It is important that a body with “teeth” can
review and call to account anyone seeking to provide biased information.
Q3. It would be very helpful if you could quantify any
assessment of the impact of these proposals and the Commission options
2-4, as well as providing information about the type, and size of
organisation that will be affected most. It would be helpful
if your assessment were to include, but not be restricted to, the
financial impact of these proposals.
We are unable to comment on
this question.
Q4. Do you think there are any additional measures that
the UK should lobby to be included in the proposals?
The factual information
provided should be limited in some way, and the definition of what
may be considered information should be made clear at the outset. In
general, it should not go further than the SPC. Legislation should
attempt to prevent broadcasters being seeded with stories that are
intended to provide an imbalanced perspective on new technologies and
treatments.
Q5. Do you have any concerns that any of these measures
could adversely impact on public health? Please explain your
concerns.
We are concerned
that information provided could have at least two negative impacts.
Firstly, patients may want to take medication that they otherwise would
not, with the associated increased cost and risk of adverse effects. Secondly,
they may seek clarification of the information from their GP whose
workload would be impacted adversely. Company help-lines may
be a solution, but they would need to be closely monitored.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[14 August 2009]
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