Selling a medical product (CE Class1 sterile, selling price approx.
12,- Euro) in The United Kingdom:

We have a medical product similar to a HME (Heat Moisture Exchanger),
which is used from patients in the vegetative state. For selling the
product, we distinguish three cases: (1) patients in hospitals, (2)
patients in care homes, (3) patients in ambulatory treatmenst. For
each case, we need to know what to consider for selling the product.

E.g. for Germany we found out:

1 - hospitals: hospitals are getting a flat rate for each patient
according to his illness. The nurses will decide together with a
doctor if they will use our product or not. Hence, we need a sales
man, who has to speak with the head of the nurses in each clinic and
to give them some product examples.

 2 and 3 - care homes and ambulatory treatment: here the situation is
totally different. Our product has to be on a list from the health
insurances (so called Hilfsmittelverzeichnis), otherwise the health
insurances will not finance our product. And if this is the case, we
will have no chance to sell the product. To get this product into this
index is quite complicated.

Now, we would like to know, how the situation is in The United Kingdom
 
It is important for us to know,
- how does the payment work? When will the health insurances pay or
when have the patients pay from their private wallet?
- what do we have to do, that the health insurances will pay for our
product (e.g. in Germany we have to prove the products quality with
clinical studies)?
- which difference does it make, if the patient is in a hospitals, a
care homes, or in ambulatory treatment. Again from the point of
absorption of costs as well as from a selling point (with whom has our
sales man do speak)?

We know, these are quite a lot of questions. Depending on the quality
of the answer we are also willing to pay 75%-100% more.

Hello fraunhofer

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
healthcare.

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
NHS.

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
treatment.

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)

MHRA 
====

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 . . ."
http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSearchResults/2fcd7a0a53e671b580256bd600311fc3?OpenDocument&ExpandSection=8#_Section8

"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."
http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSearchResults/2fcd7a0a53e671b580256bd600311fc3?OpenDocument&ExpandSection=19,8#_Section19

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."
http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwKeyTopics/2185f1438232731f80256df00038d8b0?OpenDocument&ExpandSection=1#_Section1


PPA
===

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)."
http://www.psnc.org.uk/index.php?type=more_news&id=1673

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
appropriate."
http://www.ppa.org.uk/ppa/drug_tariff_part_ix.htm

Application form
http://www.ppa.org.uk/ppa/dt1_form.pdf

Nurse Prescriber's List
"Stoma Appliances and Associated Products as listed in Part IXC" of
the PPA's Tariff include tracheostomy and laryngectomy appliances.
http://www.nurse-prescriber.co.uk/news/formulary.htm



NHS TRUSTS
==========

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.
://www.google.co.uk/search?hl=en&q=hospital+OR+nhs+trust+%22payment+code&btnG=Google+Search&meta=cr%3DcountryUK%7CcountryGB

This website may also be of interest:
http://www.abhi.org.uk/healthcareindustry/ukmarket/procurement/creditcircle.aspx

The Trust system varies slightly in different parts of the UK. 

NHS England
http://www.nhs.uk/England/AuthoritiesTrusts/Default.cmsx
NHS Scotland
http://www.show.scot.nhs.uk/organisations/orgindex.htm
NHS Wales
http://www.wales.nhs.uk/catorgs.cfm#2
NHS Northern Ireland
http://www.n-i.nhs.uk/



Supply Confederations
=====================

"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."
http://www.pasa.nhs.uk/confederations/

Confederations
http://www.pasa.nhs.uk/confederations/links/

"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."
http://www.pharmsinfo.com/archive/PIAAABDW.shtml


The next two organisations, NICE and PASA, may not concern you.

NICE
====

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.
http://www.nice.org.uk/page.aspx?o=251106

PASA
====

The NHS Purchasing and Supply Agency (PASA) aims to provide financial
benefits to the NHS by negotiating large scale contracts.
http://www.pasa.nhs.uk/suppliers/selling/

You can ask to be listed in their suppliers' database. This is
particularly appropriate for suppliers seeking large contracts.
http://www.pasa.nhs.uk/sid/



FURTHER INFORMATION
===================

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."
http://www.rnha.co.uk/csu/csu06.htm


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)."
http://www.ich.ucl.ac.uk/factsheets/families/F000305/trac4.html


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"
http://www.cancerlt.org/assets/prescriptionlistmarch04.pdf


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.
http://www.abi.org.uk/Public/Consumer/Medical/pmedins.pdf

The private sector is much smaller than the NHS.

"Of the 6.4 million operations performed yearly, just 250,000 . .  are
done privately. "
http://www.bnn-online.co.uk/news_datesearch.asp?page=3&SearchDate=25/Jun/2004&Year=2004

List of private hospitals
http://www.carehealth.co.uk/directry.htm


SALES
=====

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."
http://www.zenopa.com/hospital_sales_jobs.html

"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. "
http://www.zenopa.com/nhs.html

Nurse prescribers and sales
http://www.pharmafield.co.uk/asp/article.asp?id=255&source=1

A day in the life of a medical sales representative
http://www.futures-resourcing.com/candidate/hints_tips/Graduates/Futures_articles_graduates/typical_medreps_day.asp

The next webpage includes some personal accounts from a pharmaceutical sales team:
http://www.boehringer-ingelheim.co.uk/careers/prescription_medicine.html



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:
secondary care
primary care
HME
heat moisture exchanger
sales
procurement
purchasing
supply
medical device
NHS trusts
private hospitals
nurse prescribers

---

Request for Answer Clarification by fraunhofer-ga on 08 Jun 2005 04:42 PDT

Hi leli-ga,

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
kind regards
Alexander Grossmann

---

Clarification of Answer by leli-ga on 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:
AAH
Alliance UniChem
Phoenix Medical Supplies
Their addresses are here with other information:
http://www.bapw.net/members_directory.php?member=aah


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:
http://news.bbc.co.uk/1/hi/health/4612739.stm
http://news.bbc.co.uk/1/hi/health/3220023.stm
http://news.bbc.co.uk/1/hi/wales/973264.stm

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:
http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwSectionsMDA/About+MDA?Open
 - There is at least one commercial database which could influence purchasing:
http://www.unipart.com/press/pre_1999_0007.htm
http://www.surestock.co.uk/

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:
http://www.dmsconseil.com/lettres/lettre11.pdf

It reminded me also of this answer which may have some useful links or addresses:
http://answers.google.com/answers/threadview?id=252556


Thank you once again, and I wish you good luck with your plans.

Best wishes - Leli

This was a good answer.  I also found the following website very
useful for locating information with regards to selling devices in
Europe:

http://www.medicaldeviceschool.com/european%20medical%20device%20requirements.html

Johan S.

Hi Ya Leli

This comment actually refers to question 222827  (just to jog your
memory that's the one about all the British MP's who spent time in
Jail. Sorry for been a bit of a pest but for some bloddy reason I
cannot add comments to this question)

Anyway one important person you missed from your list is the Reverend Ian 
Paisley I understand he spent time in prison sometime in the mid sixties.

Kind Regards

Mongolia