We received a fantastic response given the tight timeline – 34 practitioners, 13 consumers and 4 manufacturers, to be precise – to our recent call for input to the UK government’s Red Tape Challenge. We’ve collated your comments and sent them, along with our own, to the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). So, now that the results are in, let’s see what happens!
What we said: herbal medicines
Since the major regulatory problem currently facing the UK comes in the form of the European Union’s (EU’s) Traditional Herbal Medicinal Products Directive (THMPD), we submitted our comments to two of the Red Tape Challenge’s themed areas, Traditional Herbal Medicines and Medicines.
In terms of herbal medicines, prime concerns included the THMPD’s so-called ’15-year rule’ – which were described as, “Arbitrary and inappropriate...and could be regarded as a protectionist measure” – exclusion from the THMPD scheme of products containing non-herbal ingredients and the high costs of data compilation. We also called for food supplements to remain on the UK market if they contain the same herbal ingredients as THMPD-registered products. Respondents were worried that, if consumers are unable to buy the herbal products they need in the UK because of the THMPD, “[It] may encourage the black market sale of sub-standard contaminated herbs from elsewhere”.
There were some concerns over the UK government’s proposed statutory regulation (SR) of herbalists, particularly that SR is, “Unlikely to adequately safeguard the practice of herbal medicine”.
What we said: medicines
EU medicines law does not sufficiently define the borderline between foods and medicines, and that the scope of medicines law is so broad that anything – even a glass of water – may be caught under its definition of a medicine. Food supplements should be able to make medicinal claims, in line with the available scientific evidence, and medicines law does not guarantee the safety of pharmaceutical medicines – one comment was, “Regulators should look at the figures for deaths and injuries caused by prescription medication...[and] compare...to the number of deaths/injuries from herbs and food supplements”. “Based on the above,” conclude our comments, “It is evident that UK laws affecting medicinal products should be urgently reformed.”
Wait and see!
It will be wonderful if the MHRA takes our concerns on board and positively reforms the regulations in question. If the Red Tape Challenge is to be taken at face value, we should have high hopes: “The default presumption will be that burdensome regulations will go,” apparently. Out here in the real world, however, we know that the MHRA is a notorious ‘gold plater’ of EU regulation and will be keen to hang on to every bit of power that it can.