Medicines Legislation Review: responses trigger a re-think
In the face of proposals from policy makers,
the 'man in the street' often feels powerless, with no real avenue
open to disagree or effect a change. When we heard
about the Medicine and Healthcare Products Regulatory Agency's
(MHRA) informal consultation on 'Issues relating to the
Product Licences of Right (PLR) regime and homeopathy' early
this year that could easily have been our position. However,
given that the MHRA's initial proposals threatened the availability
of the majority of anthroposophic medicines, which are currently
licensed under the PLR scheme, this was not an option. The
MHRA proposals formed part of a wider review to consolidate the
Medicine Act 1968 and associated legislation through updating and
simplifying regulations while providing an appropriate level of
public health protection.
So we asked patients and supporters of
anthroposophic medicine to express their concerns to their MPs and
to seek their help in bringing this issue to the attention of the
responsible Minister, Earl Howe. We at AHaSC did likewise
through Dame Anne Begg, MP Aberdeen South.
We also coordinated the formal responses
submitted by stakeholders interested in promoting and safeguarding
the availability of Anthroposophic Medicine (PAFAM, Weleda, AHaSC, CAHSC, AMA,
BAAP)
The overall outcome of this activity has been a
spark of hope to all who participated. It appears that the
MHRA has listened and has taken our responses into account in
formulating its formal consultation on the proposals for changes to
the Medicine Legislation. This consultation was launched on 25
October 2011 as Public consultation MLX 375 and is open until
Tuesday 17 January 2012.
Of particular significance for anthroposophic
medicines are the following two paragraphs from the consultation
document:
____________________________________________________________________________________
Issues relating to the product licence
of right (PLR) regime, homeopathy and non-orthodox practitioners
(NOPs)
4.25 In January this year we published an
informal consultation on proposals to amend (a) the PLR regime; (b)
information requirements for marketing authorisation of homeopathic
medicinal products under national rules, implementing Article 16(2)
of Directive 2001/83; and (c) the NOP scheme. We are still
developing proposals in this area.
4.26 As they are still being considered, the
provisions for the PLR regime and NOP scheme are not included in
the draft regulations accompanying this consultation. The lack of
provisions for PLRs and NOPs in the draft accompanying this
consultation is not an indication of our policy in these areas and
does not affect their current status.
____________________________________________________________________________________
These indicate that:
• PLRs will not be part of
the current consultation
• Proposals on any
modification or change to the PLRs is still under
consideration.
We interpret this as positive news and have
assurances from Lord Howe that any proposed changes to the PLR
scheme will be subject to public consultation, including assessment
of the impacts on manufacturers of anthroposophic medicines,
practitioners and patients. What is clear from this
experience is that policy makers can be influenced but that
engaging in the debate and mobilising the strong support of
patients and other stakeholders is required to achieve an
encouraging outcome. The AHaSC will continue to be involved
in this issue and you can follow developments too by visiting our
website www.ahasc.org.uk