A Message from Lord Pickles and Lord Blunkett, followed by PCCA Ltd's best practice article

The ability to listen and learn from one another has always been vital in parliament, in business and in most aspects of daily life. But at this particular moment in time, as national and global events continue to reiterate, it is uncommonly crucial that we forge new channels of communication and reinforce existing ones. The following article from PCCA Ltd is an attempt to do just that. We would welcome your thoughts on this or any other Parliamentary Review article.

Blunkett signature Rt Hon The Lord David Blunkett
Pickles signature Rt Hon The Lord Eric Pickles


Managing Director Sharon Clift
Bespoke medicines
Originally founded in 1999 as The Specials Laboratory,
PCCA is a manufacturer and provider of unlicensed
medicines, commonly known as specials. In an industry
where delivery time could take up to 10 days, PCCA led a
market change, aiming for delivery within 24 hours, giving
patients in need quicker access to medications. As well as
manufacturing these medicines, the company has worked
alongside the Department of Health on drug tariffs and liaised
with prescribers to best meet the needs of patients. Sharon
Clift, Managing Director at PCCA, explains more.
We operate in a highly regulated sector of the UK pharmaceutical market,
providing medicines on receipt of a prescription to either a pharmacy, hospital,
dispensing doctor or vet. Regulated by the Medicines and Healthcare Products
Regulatory Agency, we hold several licences including a licence to manufacture
medicines for patients on an individual basis. Essentially, we make one product
for one patient at a time. Our products help patients across a broad range of
spectrums but normally we focus on paediatric or geriatric patients, or those with
specific medical needs. Simply put, our medicines help a patient where no licensed
medication is available in a form that they require.
An extension of the pharmacy team
We can manufacture a whole spectrum of non-sterile products for our customers.
This means that raw material availability, flexibility and quality are at the heart of
everything we do, ensuring we can provide the right product, manufactured to the
»Managing Director: Sharon Clift
»Established in 1999
»Based in Northumberland
»Services: Creates,
manufactures, distributes
and dispenses personalised
»No. of employees: 80
Highlighting best practice
highest quality standards, at the right
time. As an agile manufacturer, we
need to be reactive to our customers’
needs, often within 24 hours. Given
that our products are used by patients
– often the most vulnerable – having a
robust quality management system is
ingrained into everything we do.
Support for our customers is an
important factor for success in the
market. We have technical experts
on hand who sit alongside the
customer services team to provide
advice and guidance about any
aspect of a specials prescription. This
resource is widely used and valued by
pharmacists across the UK. We also
advise customers on the administration
of their supply to ensure they receive
reimbursement for prescriptions
effectively. With this in mind, we
are not just a supplier, but also an
extension of their pharmacy team.
The saying “charity begins at home”
resonates with us as a business. Over
the years we have tirelessly raised money
for local charities through sponsored
activities. Each year our staff vote for a
local Charity of the Year for whom we
hold various fundraising activities. Over
20 years, this has amounted to tens of
thousands of pounds in donations.
The introduction of the
Specials Drug Tariff
PCCA is a founding member of
The Association of Pharmaceutical
Specials Manufacturers (APSM), which
represents the interests of the sector.
It is a not-for-profit trade association
established to represent those who
supply specials in the UK.
In 2011, the UK specials market
changed with the introduction of a
tariff pricing mechanism. During the
run-up to the launch of the Specials
Drug Tariff, PCCA worked very closely
with the Department of Health as
part of its APSM role of representing
members on all industry matters. It was
vital that the tariff proposed would
continue to ensure that safe and
effective specials would be available
to the NHS and, most importantly,
to patients. It was also essential that
we ensured longevity of supply. The
tariff was launched in November 2011
and continues to change every three
months, based on the pricing and
volume data submitted by specials-
manufacturing licence and WDA
holders. Prescriptions are reimbursed by
the DoH at the relevant tariff price. We
also operate in non-tariff items where
the reimbursement is at netprice.
Bespoke manufactured
We are not
just a supplier,
but also an
extension of
Pastures new
With a changing market, we were
provided with opportunities to diversify
our business when we were acquired
by PCCA in 2014.
We engage with prescribers to better
understand patients’ requirements and
challenges, leading us to diversify our
product range to better serve specific
therapy areas. PCCA Worldwide
are innovators in developing base
technologies that are changing the
industry with a focus on patient
outcomes. For instance, finding more
beneficial ways to deliver drugs to
patients than, say, the traditional
oral route, which can sometimes
be fraught with problems such as
gastrointestinal issues or compliance
when a patient has to take multiple
doses in a day.
Even though we remain very much
focused on the specials market, we
are now proactively at the forefront
of working with prescribers to create
better ways of addressing unmet
clinical needs for their patients.
Our vision is to offer personalised
medicines to patients who are
struggling with ongoing conditions,
making their conditions easier to
live with where perhaps a licensed
medicine cannot help them.
By looking at different ways to deliver
patient critical medications, for pain
relief for instance, we can make a
real difference to patients with life-
threatening or life-limiting conditions.
By working closely with prescribers,
we can offer alternative methods of
drug delivery, including combination
medicines, enabling a multimodal
approach via our innovative proprietary
delivery bases. These can include
transdermal and mucoadhesive creams
and gels to help address multiple
requirements. Our range of licences
also helps veterinarians to prescribe
specific dosage forms and alternative
ways to deliver medication for their
patients too.
Another way of achieving this is
via our Distribution Deals service to
import, export and distribute specials
medications to provide access for
patients. Currently we deal with a
number of companies in the fields
of nuclear medicine and medical
cannabis, for example. Offering the
manufacture of medicines for clinical
trials is also a part of our strategy to
enable us to achieve our vision.
Creating patient access is key to
enabling medicine to come to life;
we therefore also offer a dispensing
service via a closed-door pharmacy,
which is used by some of our private
With two decades of experience
behind us, we very much live by our
ethos of creating, manufacturing,
distributing and dispensing
personalised medicines, helping
prescribers, consultants, veterinarians
and pharmacists make a difference to
patients with unmet clinical needs.
Our vision is
to offer
medicines to
patients who
are struggling
with ongoing
Base manufacture


This article was sponsored by PCCA Ltd. The Parliamentary Review is wholly funded by the representatives who write for it. The publication in which this article originally appeared contained the following foreword from Rt Hon Michael Gove.

Rt Hon Michael Gove's Foreword For The Parliamentary Review

By Rt Hon Michael Gove

This year's Parliamentary Review comes at a momentous time for parliament, as we collectively determine the destiny of the United Kingdom. 

On October 31, the UK will leave the European Union. The successful implementation of this process is this government's number-one priority.

Three years after a historic referendum vote, we will deliver on the decisive mandate from the British people. Trust in our democracy depends on it. Until that final hour, we will work determinedly and diligently to negotiate a deal, one that abolishes the backstop and upholds the warm and close relationship we share with our friends, allies and neighbours in the EU. But in the event that the EU refuses to meet us at the table, we must be prepared to leave without a deal.

As the Chancellor of the Duchy of Lancaster, it is my job to lead on this government's approach, should that scenario happen. Preparing for Brexit is my department's driving mission. But while I am leading this turbocharged effort, the whole of government is committed to this endeavour.

Ministers across Whitehall are working together to ensure that every possibility is considered, every plan is scrutinised and every provision is made. A daily drumbeat of meetings means that we are holding departments accountable, so that preparations are completed on time.

The chancellor has confirmed that all necessary funding will be made available. And we have mobilised thecivil service, assigning 15,000 of our most talented civil servants to manage our exit from the EU.

We will make sure that on November 1, there is as little disruption to national life as possible. Our trade relationships will continue to thrive, thanks to agreements with countries around the world worth £70 billion. Our country will remain secure, thanks to nearly 1,000 new officers posted at our borders. And the 3.2 million EU nationals now living and working among us can remain confident, with absolute certainty, of their right to remain in the UK.

Above all, our goal is to be transparent. Soon, we will launch a public information campaign so that citizens, communities and businesses are ready and reassured about what will happen in the event of “no deal”.

In my first few weeks in this role, I have travelled to ports and tarmacs, borders and bridges, all across the UK –from the seaside of Dover to the rolling green hills of County Armagh. I have heard from business owners and border officials, farmers and hauliers. They are ready to put an end to uncertainty. And they are ready to embrace the opportunities ahead.

Our departure from the EU will be a once in a lifetime chance to chart a new course for the United Kingdom. Preparing for that new course will be a herculean effort. But this country has made astounding efforts before. We can do it again.
Rt Hon Michael Gove
Chancellor of the Duchy of Lancaster