Thank you for your question. It's a big question, so I've started with
an outline and then added more detail.
In the UK National Health Service (NHS) treatment is often described
as "free at the point of delivery".
This means that NHS funding comes through central government and is
"invisible" to the patient. Insurance companies are not involved.
People who pay income tax also pay "National Insurance" to the
government but this is not directly linked to availability of
NHS care is divided into "primary care" (for people at home or in care
homes) and "secondary care" (for hospital patients). Funding is
channelled through various NHS Health Authorities, Trusts and Boards.
These are organised regionally and locally. An NHS Hospital Trust may
represent several hospitals in the same area.
In secondary care, suppliers are paid by an NHS Trust. In primary
care, payment comes from a pharmacist who is then reimbursed by the
If you want your product to be prescribed by general practitioners
(GPs - also known as "family doctors") for patients in nursing homes,
and supplied by a pharmacist, you must apply to the Prescription
Pricing Authority (PPA). (See below)
If you want your product to be used in hospitals, the medical staff
play an important role, but even senior doctors' wishes can, in
theory, be blocked by the NHS Trust which pays the bill. I think this
only happens rarely, when there is a debate about a very expensive
Your sales representative would have to speak to medical staff and
administrators in hospitals and NHS Trusts about the benefits of your
product for hospital patients. Hospital consultants (senior doctors)
traditionally have the most powerful voice in decision-making.
For patients in care homes (or at home), GPs are important contacts.
The GP liaises with community nurses and/or care home staff. Your
product may be prescribed by the GP and supplied by a pharmacist.
Recently the UK has begun to introduce "nurse prescribers". Some
nurses are now allowed to prescribe products like yours and this could
mean that some nursing homes/care homes will ask a nurse to write
prescriptions for a patient. However, the device would still be
supplied by a pharmacist following the PPA's tariff.
There are several UK organisations you need to know about, though most
of them play an advisory role and there is no requirement to register
with them. (Except for the PPA)
The Medicines and Healthcare products Regulatory Agency (MHRA)
evaluates products, and collects information about problems.
Your product would be called a "medical device". If your product meets
EU standards and you are already registered elsewhere in the EU, the
MHRA does not ask for further registration.
"Does a manufacturer need to have his device licensed by a national
authority before being sold?
No. The Directives place the responsibility for meeting the rules set
out in the Directives firmly on the manufacturer . . ."
"Who should register?
The medical devices Regulations require manufacturers of generally low
risk devices to register in the country in which they have their
registered place of business."
You will probably want to click the many links on the webpages above
which lead to further information.
The MHRA plays a role in providing the medical profession and health
administrators with information about different products.
"The MHRA Device Evaluation Service assesses the safety, reliability
and performance of a wide range of medical devices and equipment."
The Prescription Pricing Authority (PPA) determines which devices will
be prescribed by GPs (or nurse prescribers). Without the PPA's
listing, pharmacists do not get paid for supplying devices to
patients. You need to fill in an application form to have your device
listed in their Tariff. The PPA will set a maximum price for
reimbursing the pharmacist; this obviously affects your selling price.
" . . . pharmacies will only be paid for supplying a medical device if
it is listed in the Drug Tariff (Part IX)."
Drug Tariff Part IX
If your product is listed by the PPA, "the GP may prescribe on the NHS
for any patient or condition for whom he considers the appliance
Nurse Prescriber's List
"Stoma Appliances and Associated Products as listed in Part IXC" of
the PPA's Tariff include tracheostomy and laryngectomy appliances.
There are various regional and local Health Authorities, Boards and
Trusts. Trusts in England purchase goods for their area hospitals, and
pay suppliers. Trusts are supposed to pay suppliers "within 30 days of
receipt of goods or a valid invoice (whichever is the later) unless
other payment terms have been agreed with the supplier."
This search leads to reports on how well Trusts meet their payment targets.
This website may also be of interest:
The Trust system varies slightly in different parts of the UK.
NHS Northern Ireland
"What are confederations?
Since the publication of Modernising Supply in the NHS there has been
a considerable amount of activity towards meeting its prime objectives
of trusts working together on a regional basis in supply management
confederations. As at November 2004, 27 supply confederations have
formed covering the majority of the English NHS. Only a handful of NHS
Trusts remain outside a confederation and the Agency remains on target
to achieve 100% inclusion by 31 March 2005."
"Group purchasing: the power shift towards purchasers
The development of purchasing groups in a number of European countries
reflects a wish to endow hospital purchasers with increased
negotiating power and to achieve economies of scale, which save
procurement costs and ensure uniformity of health care provision.
Examples include the recent development of health enterprises in
Norway, which centralise purchasing for groups of hospitals within
geographical areas, and the introduction of NHS Supply Confederations,
which will include all hospital and primary care Trusts in a certain
area, in the UK. It is planned that the Supply Confederations will
manage procurement for over 80% of NHS Trusts by March 2004.
The development of large purchasing groups may simplify negotiations
between medical device suppliers and purchasers, since companies do
not have to deal with each hospital individually. However, large
purchasing groups are able to exert considerable leverage on suppliers
and can demand lower prices and high service provision."
The next two organisations, NICE and PASA, may not concern you.
The National Institute for Health and Clinical Excellence (NICE) may
appraise medical devices. NICE are particularly associated with
controversial or expensive treatments. They aim to reduce inequalities
of treatment in different regions of the UK.
The NHS Purchasing and Supply Agency (PASA) aims to provide financial
benefits to the NHS by negotiating large scale contracts.
You can ask to be listed in their suppliers' database. This is
particularly appropriate for suppliers seeking large contracts.
When a patient moves out of hospital ('secondary care'), a GP
('primary care') will become responsible for prescribing. This is true
whether or not the patient is in a care home.
"Q. How can a person who lives in a residential care home consult a GP ?
A. All residents of care homes, both residential and nursing, should
be registered with a local GP so that they can have access to the full
range of NHS services which are, and must be free for patients."
The GP will normally follow hospital guidelines for treatment. For example:
"Planning for going home
When your child is ready to leave hospital, a letter will be sent to your GP.
[ . . .]
A list of recommended equipment and supplies will be sent to your
health visitor or community paediatric nurse. The first two weeks?
supply will be provided by [the hospital] but after that supplies will
come from your local health authority. . . . .
You will need . . . . . . . . . . heat and moisture exchanger (HME)."
HMEs and related devices are supplied free:
"The following is a list of Items which are available free of charge
from your local pharmacist with a prescription . . . . . HME System"
Although there are some private hospitals in the UK, there would not
be many patients in a vegetative state having private treatment.
Private medical insurance is not usually comprehensive and rarely
covers long-term treatment.
The private sector is much smaller than the NHS.
"Of the 6.4 million operations performed yearly, just 250,000 . . are
done privately. "
List of private hospitals
I hope these excerpts and links will illustrate medical sales in the UK.
(By the way, a GP's "surgery" means his office!)
"Secondary care representatives develop long term business
relationships through regular contact with relevant physicians, NHS
non-clinical managers and other staff to maximise business
opportunities in the secondary care sector."
"The NHS has a buying structure - in hospitals, this ranges from
individuals with almost autonomous choice if not budget (e.g. for
leading edge cardiac surgery), to those with little choice, e.g. care
assistants. Somewhere here are supplies departments and buyers gaining
a better deal for the NHS. Whilst pharmaceuticals would typically be
approved or not by a committee of interested parties, you only have to
enter a major hospital and look at the long list of departments to
have an idea of the range of products bought and sold. "
Nurse prescribers and sales
A day in the life of a medical sales representative
The next webpage includes some personal accounts from a pharmaceutical sales team:
I hope this helps you understand the (daunting?) NHS bureaucracy!
After reading all this, let me know if you need any clarification, and
I'll do my best for you.
Best wishes - Leli
Answer based on personal knowledge and searches.
Searches used names of agencies and:
heat moisture exchanger
Request for Answer Clarification by
08 Jun 2005 04:42 PDT
first of all, thanks a lot for the great job. I would like to ask some
minor questions regarding your answer:
1) The selling process for "primary care":
1.1) is it all the time the case, that products like HMEs are sold
through a pharamacist?
1.2) would it be possible to bypass the pharamacists and to sell
directly to the care homes? 1.3) If yes, is then the NHS paying
directly the supplier?
2) The selling process for "secondary care":
2.1) If I got it right, the hospitels tell their regional
NHS-Trust-office to buy for them a specific amount of our product/HME.
Then it is the NHS (or a supply confederation) who orders the product
from us and pays our bill. Now I wonder, our product is not a standard
HME (something totally new). How will the regional NHS-Trust-office
decide, if they will accept the demand from a hospital we were able to
convince about our product. You wrote, that our Sales Rep. also have
to get in touch with the NHS. Hence, is it in that way, that we
introduce at each regional NHS-Trust-office our product and hope they
will remember it, if a hospital is asking for it. Is there not a list
similar the PPA?
3) I could imagine to address this question directly to the PPA, but
perhaps you have here some experience as well: the PPA sounds very,
very similar to the German HMV (Hilfsmittelverzeichnis), which also
requests clinical studies. Have you ever heard about a product which
passed the German HMV criteria and then applied for the PPA. I could
imagine, the PPA will accept some of the tests which were already
carried out for the German HMV.
4) If you can answer our questions for other EU-member countries as
well, please let us know for which one, and we would be happy to make
a further deal.
Once again, thanks a lot and with
Clarification of Answer by
09 Jun 2005 00:29 PDT
Thank you very much for the kind words and generous tip.
1) Although I don't have conclusive evidence, I believe that:
- The reason for buying HMEs through a pharmacist is that the
official prescription is the only way to get the NHS to pay for them.
I don't think the NHS would pay the supplier otherwise, but I found no
100% definite statement on this.
- A nursing home will order products like incontinence pads directly
from suppliers because they are "basic" care home supplies and paid
for by local government social services, whereas an HME is considered
a "medical" requirement for one individual patient and must be paid
for by the NHS.
Perhaps a pharmaceutical wholesaler could help you on this point.
Three major pharmaceutical wholesalers in the UK are:
Phoenix Medical Supplies
Their addresses are here with other information:
2) Most information online is about large-scale purchasing decisions
and it is difficult to find comments on how a hospital department
places a relatively small order. However, my understanding is that
when doctors make choices which are not particularly expensive, their
opinion is respected. Hospital consultants in the UK have always been
quite powerful figures and this is borne out by an excerpt I quoted in
my original answer: "individuals with almost autonomous choice if not
budget (e.g. for leading edge cardiac surgery)".
Although sales representatives do talk to administrators, I suggest
the medical staff are the key to introducing your product.
Trusts may interfere with doctors' decisions if they want very
expensive treatments. For example:
NICE (see original answer) is the national body which gives advice
intended to resolve these kind of situations.
After searching thoroughly, I don't see any sign of a list of products
from which Trusts must choose, but
- The MHRA does evaluations and gives advice:
- There is at least one commercial database which could influence purchasing:
3) Sorry! I can't find anything about this.
4) Many thanks - I appreciate the suggestion and wish I could help.
Unfortunately, I don't have enough background knowledge of other
countries' health systems. I worked on this question because I live in
the UK, and have enough understanding of the NHS to know how to
approach the research.
There is a document in French which I found while looking for an
answer to (3) which may help you with France and Italy:
It reminded me also of this answer which may have some useful links or addresses:
Thank you once again, and I wish you good luck with your plans.
Best wishes - Leli