The British government is about to give the Medicines Control Agency powers that are more sweeping than any other authority in the land, and we are all just sitting back and letting it happen.
Two months ago, I wrote in this space about consultation letter MLX 249, a proposed amendment to give the MCA new powers to regulate herbs and vitamins.
Astonishing as it may seem, under this new regulation, which the MCA is seeking to put into effect this summer, the agency would have the right to decide itself, with no consultation or right of appeal, whether a vitamin, a herbal product or an oil is medicinal in nature and so in need of a very costly licence.
If a product is deemed to be medicinal, the manufacturer has one month to produce evidence that his product works. If he can’t, it gets taken off the shelves while he applies for a licence, which would currently cost somewhere in the region of £20,000 to £100,000 to obtain.
The net effect of this new ruling would be to wipe most products off the shelves of health stores, save those few whose companies have already sought licences.
Aside from eroding your personal power to control your own health, some critics point out that MLX 249 is against the laws of natural justice, which holds that a party is innocent unless proven guilty. According to the International Journal of Alternative and Complementary Medicine (April 1999), it may also contravene the Human Rights Act, due to become law in 2000, which gives all a right to a fair trial and presumes innocence unless proven otherwise.
Under the new proposal, only the MCA can decide if a product is medicinal. The product must meet the demands of what some have termed a ‘Nuremberg Trial’ commission consisting of one chairman and two ad hoc members, which presumes guilt unless the manufacturer can prove ‘innocence’ in this case, effectiveness.
The most astonishing aspect of this saga has been the general ennui of the press and public. The government has come along and said that it is going to establish an independent body answerable to no one with powers unprecedented in British law, and only one national newspaper has said boo about it. With very poor publicity about this, the letter writing campaign has been decidedly light, particularly in comparison to the avalanche produced in support of vitamin B6.
In late March, a meeting was held with the Department of Health and various interested parties, where the possibility of a ‘third way’ was put forward. This is the path adopted by the Americans, Canadians and Australians with vitamins and herbal supplements.
Basically a form of ‘soft’ licensing, it requires manufacturers to demonstrate only that their product isn’t harmful. If they do produce decent research proving any benefits, they are allowed to make some claims. Such a method may cost ony £750 to apply for a licence well within the budget of what are often small companies in the health business.
The Department of Health has promised to consider this proposal. Whatever, they do, it’s clear they will have to convince Europe as well to agree to a third way approach, since the pressure to regulate comes from Europe, which is likely to withdraw the exemption the UK currently enjoys allowing unregulated sale of herbal products.
While they are considering, all of us must vociferously protest MLX 249. Write to your MP and tell him or her that you take supplements to balance your diet.
The repercussions of this draconian proposal could be felt far beyond the health food business. As we’ve said before, it’s wise to remember that freedom falls one freedom at a time.