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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