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Majority Say Herbal Medicines Should Be Regulatedby the EditorA recent Ipsos MORI report shows that 77% of adults agree that it is important that herbal medicines are regulated. The Medicines and Healthcare products Regulatory Agency (MHRA) commissioned a programme of research by Ipsos MORI to identify the public’s view on herbal medicines. The report sought opinion on safety issues arising from usage, the regulation of herbal products and how the public obtains information about herbal medicines. The research involved both quantitative surveys and discussion group discussions. Historically, in the UK, most herbal medicines have been unlicensed. In 2005 the MHRA launched the new Traditional Herbal Registration Scheme (THR) which means herbal medicines now have to be made to assured standards of safety, quality and patient information. Companies with existing unlicensed herbal medicines on the market have until 2011 to register them with the Agency. Richard Woodfield, Group Manager for Herbal Medicines at the MHRA explained: ‘We welcome the findings of this research. The research shows that the public clearly see a need for herbal medicines to be regulated. So it is encouraging that the MHRA has already received 53 applications to register products under the THR scheme and that 25 products have so far been registered’. He added, ‘However, we are not complacent and acknowledge that the research also shows that the MHRA has challenges ahead. 58% of recent users of herbal medicines (defined as those who have used a herbal medicine within the last 2 years) agree with the statement that “herbal medicines are safe because they are natural”. This means that the public still remains vulnerable to some of the less responsible operators who peddle low grade, and sometimes, dangerous herbal products - portraying them as natural and safe whilst failing to meet any meaningful standards of safety, quality and consumer information.’ Here are some of the key findings from the Ipsos MORI survey;- General public usage of herbal medicines
Perceptions of risk
Regulation
Features of regulation that British adults feel are particularly important include:-
InformationDoctors have been used as a source of information about the risks or benefits of herbal medicines by just under 1 in 5 (17%) of British adults. Relatively informal sources of information about herbal medicines are also widely used, as are pharmacists. This includes family (15%), friends, colleagues and workmates (13%), pharmacists (9%), herbal or traditional medicine practitioners (8%), sales assistants in herbal medicine retail outlets (7%). Sources that British adults are most likely to trust for accurate information about the risks and benefits of herbal medicines are doctors (41%) and pharmacists (23%). The UK traditional herbal registration scheme was launched in 2005 which requires products to meet assured standards of safety, quality and patient information. There is a transitional period for some existing unlicensed products until 2011. Regulated products distinguished by their traditional herbal registration (THR) number on the packaging are progressively coming onto the UK market. As of December 2008 the MHRA had received 53 applications to register products under the scheme and had so far registered 25 products. There also continues to be available licensed herbal medicines, shown by the PL number, which MHRA meet assured standards. Historically, most over the counter herbal medicines in UK have been sold as unlicensed herbal remedies under s12(2) of the Medicine Act 1968. This regime provided the public with little protection against low grade products. Repeated examples were found on the UK market of dangerous products eg containing heavy metals, undeclared pharmaceutical substances or the wrong, toxic herb. Technical details of the reportThis program of research involved both qualitative and quantitative research among British adults. The details of each stage of the research project are as follows: General Public Qualitative Research: four discussion groups were conducted between 8 and 10 July 2008 at two locations; one in the North (Stockport) and one in the South (Croydon) of England. Two groups were conducted in each location, one with users, and one with non-users of herbal medicines. General Public Quantitative Research: Questions were placed on the Ipsos MORI Omnibus. A nationally representative quota sample of 2,305 adults (aged 15 and over) was interviewed in 197 sampling points throughout Great Britain. Interviews were carried out face-to-face in respondents’ homes. Fieldwork was conducted between 5 and 11 September 2008. Data are weighted to match the profile of the Great Britain adult population. |
Herbal medicines
What does MHRA do?The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all their work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. MHRA keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. They encourage everyone –the public and healthcare professionals as well as the industry – to tell them about any problems with a medicine or medical device, so that they can investigate and take any necessary action. Not included
According to the MHRA, the definition of 'herbal medicines' does not currently include;-
• Vitamins & minerals CommentNobody can deny that removing unsafe products from the marketplace is a good idea. Most people understand that just because a product is natural it does not mean it is safe. However, the danger is that perfectly safe and useful herbs may become restricted due to inaccurate 'expert' information. This has happened before, and continues to affect certain aspects of using essential oils. If we are not vigilant, regulation could become yet another way of our freedom of choice in natural products being restricted, to the benefit of the pharmaceutical manufacturers. Those of us who have been in the industry long enough have seen the effects of innocent-looking changes in regulation. Things can often have an impact in areas that were previously not forseen. Or to put it another way; how things start out, is usually not where they end up when it comes to regulation. |
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