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Category M cuts, changes to medicines supply, new clinical roles and
100-hour pharmacies. With all these things to think about — and
more — it is likely that community pharmacists are not giving much
thought to what goes on at European level.
But they can rest assured
that at least one person is: “What happens in Europe is very significant
to pharmacy practice,” declares Colette McCreedy, the National
Pharmacy Association’s chief pharmacist and director of pharmacy
practice.
Mrs McCreedy has had a passion for things continental since she worked
in Switzerland “in a skiing village up in the mountains” as
a young pharmacist. She recalls customers bringing in mushrooms they
had picked for her to check which were safe to use — for culinary
purposes.
“Mushroom season — and everybody had their own secret places
where they used to get them [although] they used to tell me,” she
laughs, adding (with mock gravitas) that she did not spread the word
because
it was confidential information under the code of ethics.
Fluent in French, and with an understanding of German, Mrs McCreedy has
been keeping a close eye on decisions from Brussels affecting health
and pharmacy in her work with the Pharmaceutical Group of the European
Union — or Groupement Pharmaceutique de l’Union Européenne.
Working
alongside other members of the PGEU’s UK delegation (see
Panel), she clearly enjoys the challenge of this
additional role — “it
keeps me busy” — and, particularly, building relationships
with PGEU representatives in other member states.
UK delegation
The UK delegation to the Pharmaceutical Group
of the European Union consists of five representatives:
• National
Pharmacy Association board member
• NPA staff member
• Royal Pharmaceutical Society Council member
• Society staff member
• Pharmaceutical Society of Northern Ireland council member |
A PGEU policy statement “Targeting
adherence: improving patient outcomes in Europe through community pharmacists’ intervention” was
presented to the European Parliament earlier this month. It is designed
to inform discussions that are taking place around European health policy,
particularly within the Directorate-General for Health and Consumer Protection
(DG-SANCO), says Mrs McCreedy.
“This will feed into the need to
consider medication adherence, and issues like the costs and wastage
from non-adherence,” she explains.
Mrs McCreedy and her European colleagues have been working hard to ensure
that pharmacy’s voice is heard when decisions are being made by
the European Commission. So what have they been keeping an eye on? Control
of entry
Abdone/Dreamstime.com
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“One of the biggest issues that pharmacy needs to be aware of
is the continuing drive by the commission to deregulate pharmacy,” Mrs
McCreedy begins. She believes this is something that the EC has been
looking to do over
a number of years. “And it has attempted to do it in many different
guises,” she remarks.
One of the most recent such attempts, Mrs McCreedy suggests, was through
the EC’s services directive, which has now been passed and published.
“Initially,
when that draft directive came out,” she explains, “health
was included in the directive — and the way that it was drafted
could have called into question member states’ ability to control
geographical distribution of pharmacies and pharmacy ownership at national
level.”
Mrs McCreedy believes that the PGEU, at a European level, and its UK
delegation, at a national level, “contributed significantly to
getting health out of that directive”.
But how important is that? She suggests that the impact depends largely
on the country. “If we look at the UK, the most significant concern
about the services directive was that it could have made it difficult
for the four UK health departments to continue with control of entry — or
variations on the control-of-entry theme,” she explains.
“So now, as a result, we’ve got a services directive that is looking
at free movement of services between the countries, but without having
the difficult issues for UK pharmacy within it.”
While she flags this up as a real success, she acknowledges that the
issue of control of entry is still under the microscope in Europe “in
the form of infringement proceedings taken out by the commission against
Spain and Austria”.
“What the commission is doing,” she pauses before getting down to
the nitty-gritty, “is challenging Spain and Austria’s national
laws relating to pharmacy ownership and pharmacy establishment.
“If these
cases are taken to the European court and the court decides that the
establishment laws in those countries are against the Treaty of Rome,
that could put in question the ability of the four UK countries to have
control of entry.”
Mrs McCreedy is of the opinion that many pharmacists do not think that
the goings-on in Europe have a great impact on national bodies — “that
we just carry on doing the things we do within our own national legislation” — but,
in fact, “there’s so much that goes on in Europe that can
have a significant effect at national level — and pharmacy is not
exempt from that”, she says.
“That is not to say that individual pharmacists need to be active in this
area,” believes Mrs McCreedy. “What it does illustrate is
the importance of having a strong UK delegation to the PGEU … to
influence the process.”
She goes back to Spain and Austria: “At the moment, we are waiting
to see whether the College of Commissioners will agree to those cases
being sent to the European Court. What we are seeking to do is persuade
the College of Commissioners to take out geographical distribution from
those cases.”
She explains that in the professional services directive, which has only
recently been implemented, there is a recital saying that establishment
of geographical and demographic criteria for the opening of pharmacies
is a matter for member states.
“The case that we are making is that it would be inappropriate for the
European Court to consider an issue that the democratically appointed
bodies in Europe … have already acknowledged is a national issue,” says
Mrs McCreedy.
“Why should the commission be trying to challenge
something just because it didn’t get its own way during the democratic
process?” Counterfeit medicines
Another subject the commission has been focused on is counterfeiting,
according to Mrs McCreedy.
There have been various discussions in Europe around how best to ensure
the integrity of the supply chain, she explains, and a number of options
have been put forward by the commission in a recent EC consultation
on combating counterfeit medicines (PJ, 29 March 2008, p356).
“Should
there be a pedigree for the medicine from the time it leaves the manufacturer
to the time it gets to the patient? Should there be an authentication
system at pharmacy level, at the point of dispensing or at the point
of entry into the pharmacy? Should authentication be at wholesaler level?
All of these different initiatives are being explored.”
She points out that authentication systems have already been put in place
nationally in some EU countries — she gives the example of the
Aegate system in Belgium. Mrs McCreedy says that the commission in its
consultation document “appears to feel that authentication at pharmacy
level is disproportionate to the problem”.
She continues: “Of concern to the UK delegation is the idea of
a special seal at manufacturer level that cannot be broken until it gets
to the health professional level.” This will make parallel importing
difficult, she explains, because an element of repackaging is involved
in the licensing process — insertion of English language patient
leaflets, for example.
And she makes clear that UK pharmacists — as well as those in Germany — rely
on parallel imports as part of their business model. “We need to
consider what impact this might have,” Mrs McCreedy insists. “For
some community pharmacists it will be more important than others.”
But the issue goes further than parallel imports. “How will this
affect monitored dosage systems,” she questions. “We need
to get clarity in the consultation on what [the EC] means by repackaging.”
She describes this as “a prime example” of how, when proposed
legislation comes out at EU level, “the commission is less informed
about community practice in every single country. … The majority
of countries don’t have monitored dosage systems, so it’s
not been taken into account.” The value of pharmacy
Mrs McCreedy is proud of the background work that the PGEU does in
promoting the value of pharmacy — “making sure that pharmacy is included
in debates at an early stage”.
She describes a brochure on the pharmacist’s role in patient safety,
produced by the PGEU last year. “In that brochure there are examples
of good practice and the UK is featured in that. This is about making
the decision makers in Europe very much aware of the role and the value
of pharmacy so that when they start to produce legislation pharmacy is
in the forefront of their minds.”
She elaborates: “The PGEU helps us to focus on what developments
are occurring within the European institutions, but what it also enables
us to do is to learn about pharmacy practice in different countries and
understand pharmacy developments there.”
Mrs McCreedy believes that UK pharmacy is “leading the way in terms
of how we’re developing our services and how the Government is
focusing on making better use of pharmacy”.
Nevertheless, she does
acknowledge that there might be older models of remuneration in other
member states that are “based quite strongly around medicines supply”.
The NHS, she suggests, may have paved the way for more innovation within
pharmacy.
Mrs McCreedy seems genuinely enthusiastic about the European agenda: “It’s
wonderful to learn so much about how pharmacy is practised. To compare
notes with my equivalents in other [European] pharmacy bodies and to
get to understand their ways of working is very useful.”
But national temperaments vary and opinions are diverse. “You cannot
go into Europe thinking you are going to have your own way all the time,” Mrs
McCreedy admits. “To be effective in Europe you need to have this
amount of diplomacy and recognise that you’re not going to win
everything.”
She believes it is crucial to understand when it is
possible to win, when Europe can be worked with effectively and when
it is necessary to act at a national level.
“Fascinating” is how she describes the EU process. “Dealing
with it for the past 20 years, I have to say that it is extremely interesting.” To
not be around the table in Europe would be detrimental to community pharmacy,
she insists. |
The
Pharmaceutical Journal