Law and the Regulation of Medicines
Published by Routledge
ISBN-10: 1849461791, ISBN-13: 978-1849461795
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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.
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