Regulation of medicines Flashcards

Question

Herbal medicines regulation: Problems with the exemptions

Answer 1

Throughout the 1990s, it became clear that some of these products could have significant harmful effects on users’ health, due to poor quality, adulteration, cross- contamination, or ill-advised usage. Soon, safety concerns led to calls for tighter regulation of herbal products...” Urquiza-Haas N. & Cloatre E., ‘Tradition and reinvention: the making and unmaking of herbal medicines in the UK’ in Journal of Law and Society, 2022; 49: 317–338.

Answer 2

EU introduced Directive 2004/24/EC to strengthen and harmonise the regulation of medicinal herbs across Member States, keeping consumers safe by ensuring their safety and quality. - all herbal meds must either have full marketing auth or a traditional herbal medicine registration which would check for safety and quality Instead of clinical trial evidence of efficacy, proof that a herbal medicine has been used ‘traditionally’ (i.e. used for at least 30 years, of which 15 years must have been within the EU). The UK introduced the THR in 2004 and it fully came into effect in April 2011, at which point the exemption for herbal medicines in the Medicines Act 1968 (s12(2)) was repealed. Today, for a herbal medicine to be lawfully sold it is obliged to have a THR or a normal marketing authorization. [The requirements of the THR scheme can be found in Part 7 of the Human Medicines Regulation 2012 (Regulations 125 to 155)]

Answer 3

packaging must clearly state product = trad herbal med product, used for given purpose and based on traditional use only not clinical ev must contain a patient information/safety leaflet, including information on what the product is, who should take the product, when, how often, what side effects have been reported, where to report side- effects, potential drug interactions, when to go to a Dr if symptoms persist, and so on. Users of these products can report suspected ADRs to the Yellow Card Scheme.

Answer 4

still apply a normal marketing auth but no product has ever done this MARKETING AUTHORISATION - Requires evidence of safety. - Requires evidence of quality. - Requires clinical trial data of efficacy. SIMPLIFIED SCHEME (1992) - Instead of safety data, proof that the substance is sufficiently diluted is taken as an indicator of safety. - Requires evidence of quality. - No evidence of efficacy required (but cannot be sold with any indications - i.e. the product cannot claim to treat anything). - as no medicinal claims NATIONAL RULES SCHEME (2006) - Instead of safety data, proof that the substance is sufficiently diluted is taken as an indicator of safety. - Requires data on quality. - No clinical trial data on efficacy required. - Instead, historical evidence that product is used ‘within the homeopathic tradition’ for a given purpose. - can make medicinal claims similar to traditional herbal registration so far as very restrictive medicinal claims due to lack of clinical trials - Importantly, can only be sold with indication for ‘minor self-limiting conditions that do not require medical supervision’.

Answer 5

before MA 1968 - unlicensed and unregulated could be sold ‘with indications’ – i.e. specifying that the medicine could be used to treat particular illnesses without requiring any proof of efficacy. When PLRs were given to all products on the market when the Medicines Act 1968 entered into force, homeopathic medicines continued to be sold with indications without having to demonstrate efficacy, safety and quality. Unlike with herbal medicine, no exemptions in the Medicines Act were created for homeopathic medicines. - only way after 1971 that a homeopathy medicine could be sold = marketing auth so must out perform a placebo in a clinical trial - no new homeopathic medicines could be introduced to the market because they struggle to outperform a placebo so only homeopathic meds were those with automatic PLRs - not reviewed as unable to demonstrate efficacy This meant that existing homeopathic products (on sale before Sept 1971 which were granted PLRs) could continue to be sold lawfully, but no new homeopathic medicines could be introduced to market, as the only route for new products to be licensed after 1971 was a full marketing authorisation – and while homeopathy is generally safe, it is unable to outperform a placebo in a clinical trial (efficacy).

Answer 6

In 1992, the ‘Simplified Scheme’ for homeopathic medicinal products was introduced under European Directive 92/73/EC. Importantly, products registered under this scheme cannot claim to treat any illness (i.e. they are sold without indications). As they do not claim to treat any illness, they do not need to provide evidence of efficacy. MHRA launched national rules scheme for homeopathic meds in 2006 because consumers could purchase homeopathic products with PLRs (i.e. those which were on sale before Sept 1971, which could claim to treat illnesses) and homeopathic products registered under the Simplified Scheme (which were prohibited from making any medicinal claims). The National Rules Scheme allows for homeopathic products to be granted a NRS license for the treatment of “mild, self- limiting conditions (those that can ordinarily be relieved or treated without the supervision of a doctor)” (MHRA, n.d.: 82). The idea is that old products with PLRs and new products registered under the Simplified Scheme will eventually be transferred onto the NRS scheme (although this hasn’t happened yet). manufacturers must demonstrate safety (through sufficient dilution) and quality. used within the homeopathic tradition for a given purpose rather than clinical trialsThe National Rules Scheme (NRS)

Answer 7

packaging must clearly state that the product is a homeopathic medicinal product, used for a given purpose (e.g. to treat a mild cough), and that this indication is based on ‘use within the homeopathic tradition’ (rather than clinical evidence). contain a patient information/safety leaflet Both the THR (for herbals) and NRS (for homeopathy) were controversial, although the latter was significantly more controversial when it was launched and generated a lot more criticism

Answer 8

some crit from manufacturers and sellers who though reg = too strict Some criticised THR scheme for allowing products to be sold with indications that were not clinically proven (i.e. through a clinical trial). - lots of herbal medicines unable to prove efficacy and quality disappeared from shelves

Answer 9

National Rules Scheme - Prof. Michael Baum suggested the licensing of homeopathy would place medicine consumers at risk: "If someone suffers from a cough, it could be the first sign of lung cancer...However, if they use homeopathic medicine and the cough disappears it means doctors are not being given a chance to diagnose the condition in the early stages”. Some focussed on issues of regulatory fairness and questioned why it was reasonable to license some placebo products but not others: - Catherine Collins (Chief Dietician at St. George’s Hospital, London): ‘The only plausible explanation for any objectively determined benefit of homeopathy is the placebo effect. I assume that the regulations would, therefore, legitimately be extended to cover Smarties [a brand of chocolate] used for similar ‘treatment’ purposes? Some focussed on what they felt were the misleading nature of the NRS, which might trick consumers into believing these products are efficacious when, in fact, they are merely safe and of a sufficient quality: - Prof. Michael Baum: “This is like licensing a witches’ brew as a medicine so long as the bat wings are sterile.” - Catherine Collins (Chief Dietician at St. George’s Hospital, London): ‘Whilst I agree that there needs to be some control on the preparation, sale and usage of alternative health products, this regulation gives homeopathy a legitimacy it does not deserve, and infers that homeopathy works to the same degree of efficacy as conventional medicine. This is misleading and untruthful.’ Finally, others focussed on the perceived negative consequences for trust in medicines regulation, science and modern medicine. Dr Evan Harris, MP suggested that allowing these products to be sold with indication (without requiring clinical proof of efficacy) erode public trust in modern medicine and its regulation (The Guardian, 2006). He went on to describe medicines regulation as being ‘diluted and polluted by processes which allow ineffective products to be licensed as medicines without having to provide any scientific evidence of effectiveness’. Dr. Christopher Cate, senior research fellow at St. George’s Hospital: ‘if an exception is made for the normal requirements of evidence of efficacy for homeopathic treatments it will devalue the whole regulation process.” Professor Tom Addiscott (research scientist) suggested that the licensing of homeopathic medicines demonstrated that ‘we are now part of the post-scientific society and ripe for historical oblivion.’ The MHRA defended the NRS: It provides ‘a significant opportunity to improve consumer information about the use of homeopathic products on the UK market whilst maintaining rigorous control over their quality and safety...The scheme requires that products have patient information leaflets which are regulated to the same standards as conventional medicines, ensuring that they are clear and comprehensive.’ Some expressed bemusement at the strong reaction the NRS generated. Dr Peter Fisher, clinical director of the Royal London Homeopathic Hospital, said: - "The regulations just tidy up the situation by saying 'this homeopathic medicine has been traditionally used for' and it brings it into line with the regulations for herbal medicines...I think it's a bit of a storm in a teacup’ (BBC News, 2006)

Regulation of medicines Flashcards

(33 cards)