|
David Taylor is professor of pharmaceutical and
public health policy at the School of Pharmacy, University of London
|
Medicines counterfeiting is a global threat to public health. This is most obvious in sub-Saharan Africa and Asia; Europe, by contrast, is relatively secure. EU citizens can normally be confident that medicines supplied by pharmacists will be safe and effective. As yet there have been no recorded deaths resulting from medicines counterfeiting in the EU, albeit that if these were to occur they may be difficult to identify.
However, there is an undeniable danger from medicines counterfeiting
in Western Europe. Information from the Medicines and Healthcare products
Regulatory Agency, for example, shows that presently there are some 20
individuals being prosecuted for counterfeiting-related offences in the
UK alone. The agency is currently investigating a further 25 cases, three
of which involve counterfeits that have entered the legal supply chain.
Our relative security does not mean that current patterns of medicines
discounting, trading and supply in the EU cannot or should not be reformed.
The School of Pharmacy’s new report “Trick or treat?”,
published earlier this week, explores the extent to which medicines counterfeiting
is a threat to public interests. In the wider context of European pharmaceutical
sector policy as a whole it also outlines a range of political, economic,
regulatory and commercial responses that may be needed to promote better
health and better pharmaceutical care in the decade ahead.
Criminal sanctions
One way to contain any criminal activity is to increase the sanctions
for those who are caught. The World Health Organization (which is in
the process of establishing
the International Medicines Products Anti-Counterfeiting Taskforce) has
recommended strengthening the law, so that any person or company found
making, purchasing or supplying counterfeit medicines can be made to
pay a higher penalty.
We support such action. However, alone it is unlikely to address the
root causes of what appears to be a growing hazard in Europe. And simply
policing the situation more firmly will not enable European society to
find ways forward in relation to broader questions, eg, appropriately
supporting public engagement and choice in relation to health and medicines
use, facilitating the ongoing discovery of new medicines, and creating
a knowledge-based economy able to compete with the US, China and India
as this century progresses. We argue the medicines counterfeiting hazard
is linked to all these areas. An effective precautionary approach will
require extensive European reforms.
For example, the parallel importing of medicines across the EU’s
internal borders is not a criminal enterprise. To the extent that it
exploits patented medicine price differences imposed by different member
states to gain savings it is seen by some commentators as ethically and
economically desirable. But our analysis questions this view: it suggests
that dependence on parallel trading and related practices is creating
an undesirable culture in much of European pharmacy, while also weakening
the overall European economy.
This is partly because at the margins of the complicated medicines trading
system which has grown up in Europe in the past 40 years (and most notably
in circumstances where relatively small scale operators act as both parallel
traders and secondary wholesalers) there are opportunities for both error
and on occasions the deliberate insertion of fake products into the legitimate
supply chain. It is also because evidence available from independent
studies funded by agencies such as the UK Economic and Social Research
Council shows that the overall impact of pharmaceutical parallel trading
on the UK economy (and the UK is by far Europe’s largest user of
PI medicines) is in fact negative. The total cost of the trade outweighs
the savings it may make for the NHS and other benefits generated. This
is no foundation for pharmacy to build its future upon.
We do not in “Trick or treat?” explore the controversy that
has surrounded Pfizer’s recent attempts to increase its control
over the distribution of its medicines in the UK, through seeking to
use a wholesaler as its distribution agent and establishing more direct
relationships with its pharmacy customers. But it is relevant to note
that if the professional focus of pharmacy is to move more
towards improving clinical outcomes (in addition to supplying medicines
efficiently) such developments could in time prove beneficial for pharmacy
as well as the public.
If a culture has been created that legitimises spending excessive amounts
of professional time and effort on activities such as buying drugs as
cheaply as possible from (in effect) any supplier, then patient services
are likely to suffer. Despite recent developments in the UK in the context
of generic medicines supply, Europe as a whole should seek to increase
further the integrity and transparency of its medicines supply chain.
This ought logically to be with a view not only to further insuring against
the dangers of counterfeit medicines being given to patients, but also
to protecting public interests in maintaining a strong, research-based
industry alongside appropriately funded pharmacy services. Without a
viable knowledge-based economy, with robust intellectual property laws
and a respect for innovators’ rights to profit exclusively from
their products, neither Europe’s economy nor its health care systems
will in future be able to prosper.
Pharmacy opportunities for service improvement are also being created
and threatened by the expansion of internet use. It is, of course, desirable
that more people are seeking information about their health and health
care options, and are more prepared than in the past to question professional
judgements and seek alternative advice. But where enhanced autonomy leads
to self purchase of potentially toxic and on sometimes fake medicines,
increased risks must also recognised and managed.
One important reason for Europe’s past pharmaceutical security
has been that the citizen’s of countries such as the UK have had
comprehensive access to treatments. Unlike many relatively poor Americans
they have not had to pay for medicines out of their own pockets. But
as Europe expands eastwards and its social environment becomes in some
ways harsher this situation may be changing. For instance, Karol Sikora
has recently speculated (The Observer, November 5) that British cancer
patients, because of judgements by the National Institute for Health
and Clinical Excellence and other NHS restraints, are turning to the
internet to purchase medicines they believe may benefit them. If trends
like this are real and sustained the risks of harm from both fake and
genuine medicines will inevitably rise.
Towards solutions
Better regulation, shortened and more direct medicines supply lines
and enhanced public information about, trust in and use of pharmacists
and the research pharmaceutical companies that create new treatments
are all part of the possible solution to the problems. Europe to date
has not been a leader in seeking to adapt its regulatory environment
to meet the 21st century public’s requirements for safe, convenient
and innovative medicines and information supply. But it is to be hoped
that constructive partnerships between pharmacists, pharmaceutical
producers and other stakeholders in medicines supply and use will in
time lead to a better understanding of the relationships between problems
(such as medicines counterfeiting), challenges (such as adequate funding
for European medicines research) and fundamental goals (such as assuring
better global public health). Statement “Trick or treat?” was written by Natasha Campling
and David Taylor of the School of Pharmacy, University of London. Its
preparation was supported via a programme grant from Pfizer. Neither
Professor Taylor nor Dr Campling are in receipt of personal income via
sources other than the School of Pharmacy, University of London. Copies
of “Trick or treat?” are available by contacting david.taylor@pharmacy.ac.uk |
The
Pharmaceutical Journal