How can I sell my Case Logic product?

Selling a medical product in the United Kingdom

• 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.

• Answer:

  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