18 February 2012
ByAppeared in BioNews 693
Law and the Regulation of Medicines
Published by Routledge
ISBN-10: 1849461791, ISBN-13: 978-1849461795
Buy this book from Amazon UK
The principal purpose of Professor Emily Jackson's book, Law and the Regulation of Medicines, is to outline medicine's journey through UK regulation. Using the law and regulation as 'actors' in this 'story', Jackson seeks to show that those responsible for the content of the regulatory regime, and the way in which it is administered, play a crucial role in shaping the development, supply and marketing of medicines.
Admittedly, it is not for the faint hearted. As the title of the book suggests, it is jam-packed with legal and regulatory requirements that must be established before a medicine is licensed for use. But this illustrates Jackson's point: the systems surrounding regulation are complex. Jackson's 'story' starts by defining what a medicine is and how law defines them; why we have a special regulatory regime and how it is sometimes difficult to distinguish medical and non-medical products. Within this she also examines whether alternative and complementary medicines should fall within the regulatory scheme and discusses the deficiencies of the system for registering alternative medicines.
Next she delves deep into the realms of clinical trials, providing a detailed analysis of the phases that a trial can take in order for drug companies to establish the safety and efficacy of the medicine before it can be licensed. She also talks about the recruitment of research participants, their welfare and whether children, pregnant women and people who lack capacity should ever be recruited.
We learn that the pharmaceutical industry exercises a considerable amount of control over clinical trials and the publication of trial data, which inevitably leads to a conflict of interest and publication bias. Jackson states that a staggering 90 percent of clinical trials for medicines are funded by the pharmaceutical industry. Furthermore, Jackson outlines how drug companies can distort the evidence base of a trial (evidence which is then used to make licensing, funding and prescribing decisions) by publishing more positive results and under-reporting negative results.
Jackson considers whether pre-trial registration might make it more difficult to conceal the existence of trials with inconvenient results and suggests that equal emphasis needs to be placed on publishing all trial results as it is on obtaining informed consent from participants in the first place.
Jackson then continues the journey by examining licensing aspects of the medicines: from the granting of a marketing authorisation, through to the post-marketing surveillance and the difficulties faced by those trying to bring a successful legal claim against a drug's manufacturer. She also mentions the rise of online pharmacies which have dramatically increased the rise in inappropriate use of prescription medicines and the difficulty in regulating such services.
In this section, Jackson's main focus is on the lack of robust rules that surround the post-marketing surveillance of a drug. She believes a lack of 'pharmacovigilance' is the weak link in regulation, stating that 'the moment at which a medicine receives marketing authorisation should not be treated as the moment at which definitive and final evidence of safety and efficacy is established'. Currently, there is primarily a voluntary reporting system that patients, doctors and pharmacists can use to report any additional side-effects of a drug.
Her solution is to ensure that marketing authorisations are time-limited to five years after the drug received its initial marketing authorisation.. A medicine could therefore only continue to be licensed for use if robust evidence of its safety and efficacy in its post-licensing phase were presented to the regulator.
The book provides an intriguing insight into the fascinating world of pharmaceutical marketing and the affect that this has on the 'pharmaceuticalisation' of medicine. For example, in the UK there is a ban on direct-to-consumer advertising of prescription-only medication. But Jackson explains that the pharmaceutical companies will circumvent this either through the use of disease awareness campaigns, or by directing their marketing towards doctors. Jackson believes this should stop, and that instead the funding of drug development should be pooled across the pharmaceutical industry so that individual drug companies cannot be tied to product specific campaigns, brands or products.
Jackson explains why some prescription medicines are so expensive and examines the mechanisms used to control the costs of medicines in the UK. She provides some alarming statistics: in 2009, it was estimated that the NHS spent a total of £11.9 billion on drugs, which is more than £32.6 million every day.
The key regulatory challenge is to ensure patients benefit from access to effective medicines while containing costs within the NHS. Currently, NICE, the National Institute for Health and Clinical Excellence, performs an evidence-based cost-effectiveness appraisal of new and expensive medicines. However, from 2014 there are plans to replace this system with one of 'value-pricing', where the price of a medicine reflects its value to patients. In doing so, NICE's powers to determine the availability of medicines within the NHS will be removed. These decisions will instead be devolved to GPs and GP consortia. Jackson does not believe that moving towards this new system will improve the NHS's ability to ensure that it does not waste money on medicines that are insufficiently cost-effective.
Towards the end of the book Jackson looks into a future of pharmacogenetics, where a genetic test could reveal in advance whether a drug would be likely to work in a particular patient. She raises practical issues about what dose would be appropriate, and whether the patient would be likely to suffer an adverse reaction. Jackson is cautious of such advances fearing that confidentiality and informed consent may be compromised. Such an approach may well also categorise patients into different sub-groups, leading some patients to be classed as 'untreatable'. She also questions the use of drugs to enhance rather than treat a patient, and whether we might be entering a new era of cosmetic pharmacology where medicines are taken as a lifestyle choice, rather than a public health good.
Jackson has written a comprehensive book detailing the fascinating journey medicine takes. She has done well to highlight how the system of regulation is far from perfect, and that its biggest flaw is that too much control is placed in the hands of the pharmaceutical industry. She should be commended for tackling the tension between for-profit drug companies and our state-run healthcare provision, and she is right to question whether this pursuit of profit should ever clash with the promotion of public health.
Buy Law and the Regulation of Medicines from Amazon UK.