From a media perspective, a NICE headline is generally a bad headline. Despite this, the controversial NHS regulator could have some good news for the medical device sector. On Target Editor Chris Ross interviews Professor Sir Michael Rawlins. The National Institute for health and Clinical Excellence (NICE) is well-accustomed to criticism. Whether from angry patient groups, frustrated pharmaceutical companies or just mainstream journalists hungry for controversy, the important work of the NHS regulator is forever scrutinised and quite often contested. An interview with its Chairman, published in The Times earlier this year, described NICE as the “organisation that decides whether or not you die for want of a medical treatment. And decides it not on the basis of whether your life will be saved, but whether it is cost-effective to save your life.” Finding a balance These are challenging times for an independent body charged with finding a balance between economics and human tragedy, within the context of a healthcare system that cannot withstand the escalating cost of innovation and the growing impact of an ageing population. Last month, the High Court ordered a judicial review into how NICE reached its recent conclusion on Alzheimer’s drugs. The repercussions could be huge. The medical devices industry has managed to avoid much of the media attention that accompanies NICE decisions, so much so that observers may be unaware that the organisation regulates medtech in the same way that it does pharmaceuticals. Its purpose, says Professor Sir Michael Rawlins, Chairman of NICE, talking exclusively to On Target, is to establish an affordable standard of healthcare for the NHS. “Fundamentally, the role of NICE is nothing to do with pharmaceuticals or devices, in one sense. Like all other healthcare systems, and this is nothing unique to the NHS, there is an inappropriate variation in the quality of care. We are mandated to ensure that the standard of healthcare is as high as we can afford across all sectors of healthcare.” Not just HTAs Professor Sir Michael concedes that the appraisal of pharmaceuticals has always generated “the most heat” for NICE, but that the appraisals aspect is only a small part of what the organisation does. “Technology appraisals look at either single technologies, like pharmaceuticals, devices or diagnostics, or ones within the same classification. About a third of the appraisals we have conducted so far have been devices, although people aren’t generally as aware of this. One of the first appraisals we did looked at hips, and we’ve also, for example, made some recommendations about implantable defibrillators. However, in some ways, a more important component of our work is our Guidelines programme.” NICE Guidelines The Guidelines Programme looks at the management of conditions. It does, of course, involve drugs and devices, but it also tackles other sorts of care. “We make Guidelines on procedures, referral to hospital or tertiary care, and all the other factors that are important when you are looking after patients: when should you use clinical psychologists? When should you use occupational therapists? How quickly should a patient get up out of bed after an operation? These are concerned with a pathway of care, rather than products specifically.” Cost-containment The strongest allegation against the work of NICE is that it favours cost-containment over innovation. Critics have long re-branded it as the National Institute of Cost-Effectiveness. It is a comment that Professor Sir Michael acknowledges, and one that he feels wider public opinion has begun to accept. “To some extent they are right. It is about cost-effectiveness a lot of the time. I’m unashamed about that. The more thoughtful writers now accept that we have to make the money we devote to healthcare go as far as we can. There is an increasing realisation that there is not an open chequebook for the NHS.” Disinvestment – the device is right However, the accusation that such a cost-containing philosophy stifles innovation is dismissed by Professor Sir Michael. He points to a relatively recent new programme NICE has introduced that focuses on what he terms “disinvestment” – the concept of stopping doing things that don’t work, or moving towards ways of conducting healthcare that improve health outcomes and quality of life, but are less expensive. This, he says, is a massive opportunity for the medical device sector. “The concept of disinvestment is actually very important from the point of view of devices. Some devices do stop you having to have major surgery and are some of the things we would wish to see more widely used. For example, for women with heavy periods, there are ways of destroying the lining of the womb – the endometrium – that don’t involve having a hysterectomy. The NHS does 50,000 hysterectomies a year. Women stay in hospital for a week and end up heavily scarred. There are now implantable devices that burn the endometrium and destroy it. These can be done as a day case with no surgery – although you may need to have a general anaesthetic – and women don’t end up scarred.” Commissioning guidelines This is just one example of how the medical device industry can limit the resources required of the NHS, and produce health outcomes that are an improvement on historical treatments. Clearly, this provides ample food for thought for sales and marketing professionals in the medtech industry. If your product can help save NHS money by changing a pathway of care, but can deliver an improvement in patient quality of life, it will undoubtedly lead to a competitive advantage and increased uptake. To this end, NICE has also developed a new programme that provides commissioning guides in order to give commissioners the advice they need. “NICE Commissioning Guides derive from our Guidelines, and are there to help commissioners decide what they should be purchasing and what they should stipulate in their contracts when they do. “Some devices do stop you having to have major surgery. These are some of the things NICE would wish to see more widely used...” They cover the quality of the service that should be stipulated, and the volume. For example, we have recently published a commissioning guide to upper GI endoscopy, giving advice as to what should be expected from an endoscopy and how many commissioners should be contracting each year, depending on their population size.” Supply-side reform This programme is very much aligned to new NHS supply-side reforms, which are providing true opportunities for medical device and pharmaceutical manufacturers to work in partnership with the NHS and influence service redesign. The sustained focus on the cost of healthcare, as underpinned by the work of NICE, is a necessary and accepted way of life in the modern NHS. It is also widely criticised, as healthcare reaches a crossroads where what is financially right and what is morally right appear to go in different directions. This is not, however, an argument in which innovation is slain by economics. The medical device industry has an opportunity to demonstrate its true value to healthcare in the UK by using its innovative potential to drive down costs while improving the quality of care. It has the support of the NHS’s most important regulator. You see, it’s true: NICE is not always nasty. For further information on the role of NICE and to access its guidelines, visit www.nice.org.uk. NICE to know... 1. Sales & marketing professionals should understand the role of NICE and be familiar with the devices already appraised. 2. Be aware of upcoming HTAs and how they might impact on your market. 3. The NICE ‘disinvestment’ focus offers a great opportunity for device companies to demonstrate how devices can provide value over traditional approaches and treatments. 4. Understand how your device can assist service redesign and improve health outcomes. 5. Familiarise yourself with NICE Commissioning Guidelines to understand what your customers are being encouraged to procure.

X-ray system on target for UK hospital UK MEDICAL EQUIPMENT supplier Xograph Healthcare Ltd has been awarded the contract to supply a MobileDaRt Direct Digital Mobile X-ray system to Addenbrooke’s Hospital in Cambridge. The MobileDaRt is a state-of-the-art motor-driven Direct Digital Radiography system, incorporating a CXDI-50C Portable Flat Panel Detector from Canon. The CXDI-50C features a very high Detective Quantum Efficiency and a 160μ pixel pitch for reduced patient dose with excellent image quality. It weighs just 4.8kg, an important manual handling advantage. The MobileDaRt mobile X-ray unit provides rapid high-definition digital images just 3 seconds after exposure. Images are archived automatically within the unit, and are available for instant recall and display. The compact design of the MobileDaRt also ensures safe and accurate positioning. “Addenbrooke’s Hospital is a great advocate of Direct-DR technologies,” said Neil Staff, Technical Director at Xograph Healthcare. “Once installed, MobileDaRt will complement an existing suite of Xograph Healthcare direct digital imaging systems. We are committed to delivering a first-class aftercare service.” Xograph Healthcare is the exclusive partner of Canon Medical for the UK and Ireland. It has extensive consultancy and technical experience in helping hospitals move towards a full digital strategy. For more information, visit www.xograph.com Pronostics launches improved immunoassay system A NEW ASSAY SYSTEM pioneered by UK diagnostics company Pronostics employs a long-life shutter mechanism developed by UK specialist device manufacturer Emessem Solenoid. The new shutter assembly has extended the mechanism’s life from one million to over 10 million operations. Pronostics has developed a range of diagnostic products based on its new ‘multiplexing’ technology, UltraPlex™, which enables barcoding at molecular level so that large numbers of biological assays can be undertaken concurrently in a single container. This drastically cuts the cost and time of performing diagnostics in hospital laboratories. “Emessem Solenoid have done a magnificent job in developing the new shutter systems,” said Chris Savory, European Sales Manager, Pronostics. “Previously we were using a US-manufactured shutter which was not only very expensive but also wore out very quickly. Emessem Solenoid’s new shutter is a excellent alternative, providing 10 times the longevity and costing substantially less.” Pronostics was formed by the merger of SmartBead Technologies Ltd and FingerPrint Diagnostics Ltd in June 2006. This combination of two advanced technologies made available a new class of medical diagnostics, ‘pronostics’, based on multiplexed biological profiling. For further information, visit www.pro-nostics.com. Several major companies, including GE and Becton-Dickinson, have stated an interest in biological profiling. Emessem Solenoid Company Ltd is a wholly-owned subsidiary of the Magnet-Schultz Group, a manufacturer of electromagnetic devices. New breathalyser stops pregnant smokers A new breath monitor from a UK company could transform the field of smoking cessation. The Baby CO monitor, designed and manufactured by Micro Medical, measures not only the mother’s carbon monoxide levels but also those of the foetus – giving pregnant smokers a powerful incentive to quit. The Baby CO is a hand-held device that measures the components of a single breath. The alveolar CO concentrations of the mother and the foetus appear on a large LCD, with light indicators ranging from red (danger) to green (healthy). All 6 of the UK smoking cessation clinics where the product has been trialled have since ordered it. Mary O’Connor, an Isle of Man midwife specialising in smoking cessation in pregnancy, said: “I have been using the Baby CO since November 2006, and am finding it to be a highly motivational tool in helping pregnant women give up smoking.” Micro Medical’s International Sales & Marketing Manager, Martin Marsh, said: “This new technology will have a life-changing effect on future generations. The feedback from our prototype groups has been astounding, with one midwife reporting a quit rate amongst pregnant smokers of over 60% in one month.” For further information, visit www.micromedical.co.uk. CE approval and first implants for REPLY™ pacemaker THE SORIN GROUP has announced the CE Mark approval and first implants of its next-generation REPLY pacemakers, the world’s smallest dual-chamber devices (8cc). This new pacemaker line is designed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia (slow ventricular rhythms). The REPLY pacemakers integrate the Sorin Group’s proprietary and exclusive SafeR™ pacing mode that constantly monitors the patient’s natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function. The first REPLY pacemaker implants were successfully performed by Dr. Georg Noelker in the Internal Medicine Department, Klinikum Coburg, Germany and Dr. Ezio Aime at the IRCCS Policlinico of S. Donato, Milan. Dr. Ezio Aime said: “My experience is that the Sorin Group’s technology really has an edge in terms of the clinical benefits it brings to my pacemaker patients. After implanting the REPLY pacemakers, I am amazed that such a small device contains such a broad arrray of advanced features.” The Sorin Group expects to introduce its new pacemaker platform on the European market within the next few months. For further information, visit either www.sorin.com or www.sorin-crm.com. New views of the prostate BK MEDICAL has launched a new transrectal prostate transducer, the 8818, that combines the functionalities of biplane and endfire ultrasound imaging. This device enables urologists to examine any prostate in any plane. It provides unprecedented image quality, and facilitates biopsies in all sections of the prostate. Being able to perform two techniques with one transducer will mean that urologists can use one solution to biopsy all sections of the prostate. They can carry out their biopsy scheme with optimal precision, leading to a more informed diagnosis, and can perform all their biopsies with one guide and one probe insertion. Michael Brock, President of B-K Medical, said: “The 8818 is simply the best ultrasound solution for urology. Doctors save time and effort by using this single transducer to see all sections of the prostate in all planes. The images may be converted to 3-D, archived and shared in a variety of ways. It is a solution that is cuttingedge, yet is approachable, reliable and adaptable.” B-K Medical, a whollyowned subsidiary of Analogic Corporation, specialises in the development and production of diagnostic ultrasound equipment. B-K Medical is represented in 60 countries, and has a subsidiary sales company in the UK. For further information, visit www.bkmed.com. Assay screens platelet function at PoC HORIBA ABX DIAGNOSTICS, in association with GTA (UK) Ltd, is launching a new diagnostic screening assay in the UK. Plateletworks provides a rapid, easy solution for measuring platelet function. To date, assessing platelet function at the point of care has been difficult, especially in the clinical environment. However, the Plateletworks kit has been developed specifically for point of care (POC) testing. A simple test, carried out on whole blood samples, can achieve both quantitative and qualitative platelet assessments within five minutes. The physician is then able to make an informed decision on effective and efficient administration of appropriate blood products and drugs to the patient. Horiba ABX Diagnostics is a leading developer and manufacturer of haematology diagnostic systems. Within the UK, it markets an array of haematology analysers for users in a range of environments, such as any size of laboratory or any location that needs a standalone analyser (including A&E, small clinics or at the patient’s bedside). For further information, visit www.horiba-abx.com.

The OFT has recommended significant reforms to the current Pharmaceutical Price Regulation Scheme, provoking a mixed reaction from industry representatives. Pf examines the OFT report.

THE OFFICE OF FAIR TRADING has recommended that the Pharmaceutical Price Regulation Scheme (PPRS) be replaced with a value-based approach to prices, which assesses pharmaceutical products based on their therapeutic value to patients.

However, the pharmaceutical industry has questioned the need for reform and emphasised that a new scheme must not delay patients’ access to new medicines or discourage future investment in innovative therapies.

The current scheme

The OFT’s study of the PPRS was launched in September 2005 to assess whether it is effective in meeting its objectives or if there is a case for reform. The NHS spends around £7 billion a year on branded prescription medicines. The PPRS is used by the UK Health Departments to control this expenditure, and aims to provide value for money for the NHS while giving pharmaceutical companies the incentives to invest in drugs for the future.

The scheme has two main components: profit controls set the maximum level of profits that a company can earn from the supply of branded drugs to the NHS, and price controls impose restrictions on increasing the price of a branded drug and set agreed price cuts. The OFT expresses concern that neither of these controls help secure prices that represent the therapeutic value of the drugs. The report argues that imposing restrictions on the level of profits a company can make, without reference to the value of the drugs supplied, does not encourage innovation in the industry. Furthermore, one-off price cuts mean that companies all have to reduce their prices by the same percentage regardless of the value of their products. The danger is that companies will try to anticipate price cuts when setting prices, resulting in a guessing game between DH and the industry as each tries to second-guess the other.

The current scheme means that drugs with similar clinical effects have widely different prices. The report mentions a variance of 500% or more for very close substitutes. In 2005, for one drug alone, the OFT estimates that £350 million could have been potentially saved by using more value-reflecting prices; and in the case of off-patent brands where generics are available, £65 million could have been saved. The study said that some treatments for cholesterol and blood pressure, in particular, have price tags that are “significantly out of line with patient benefits”. The effect of this is that PCTs may have to restrict access to more innovative drugs due to lack of financing, and this has been seen in NICE’s recent rejection of drugs on the basis of cost.

Inefficient pricing also means that there is no incentive for drug companies to invest in the drugs that will be most beneficial to society. The report comments: “To restrict access to new treatments while ignoring inefficiencies in current expenditure is not an efficient use of resources. Nor is it in the interests of patients.’”

The OFT’s recommendations

In the light of these shortcomings, the OFT recommends the PPRS be reformed so that pricing is based on the clinical value of drugs. This would mean that the NHS budget is spent more cost-effectively, so more money can be invested in newer, innovative drugs, and this would give the pharmaceutical industry the incentive to invest in those drugs that are most beneficial to society. This reform is felt to be of particular importance due to the influence of the UK market: the report estimates that around a quarter of the world’s pharmaceutical market is influenced by UK pricing.

The OFT favours the second option, but suggests that if there is not enough information available, some sort of risk-sharing agreement could exist between the company and payer whereby drugs would be reimbursed, but which could be changed later if the expected clinical outcomes are not met.

The report suggests that NICE and the SMC should play a central role in whichever of these schemes is chosen.

Two options are suggested for the pricing of on-patent branded drugs: Ex post value-based pricing would maintain freedom of pricing for companies for new drugs, but would replace profit controls and price cuts with ex post reviews of the cost-effectiveness of drugs or drug classes. These reviews would set a maximum price for a product based on its clinical benefits, and would coincide with major events such as new drugs entering the market or comparators going off patent. Ex ante value-based pricing would involve a fast-track ex ante assessment of a new drug’s cost-effectiveness during the licensing process, which would decide the maximum price and whether to reimburse.

Industry reactions

The ABPI has strongly refuted the claim made by the OFT that the NHS pays too much for drugs. The Association pointed out that the current PPRS has produced £1.2 billion savings to the NHS according to National Audit Office figures, that prices are 21% lower than they were 10 years ago and that new medicines often attract a lower price in the UK than in other major European markets. Dr Richard Barker, Director General of the ABPI, said, “These facts clearly demonstrate that the UK gets its life-improving and – saving medicines at a fair and reasonable price, and that the broad assertions that the OFT has made in launching its study are wrong. It is important that any new system does not delay patients’ access to new medicines and that it should not lead to major increases in costly bureaucracy.”

While the report acknowledges the concerns that the second suggested scheme could result in protracted negotiations and delays to the launch of a drug, it points out that most other countries in the world have a system where drug prices are assessed up front. It also argues that some prescribers will feel more confident in using a drug if they know it has already been judged as cost-effective.

The report agrees with the view of some companies that the assessment of a drug should take on board incremental benefits and relevant patient benefits, but disagrees with the argument made by the ABPI that comparing onpatent brands against generics in terms of costeffectiveness will reduce incentives to invest in new drugs.

The OFT argues the view that new treatments must demonstrate their benefits in relation to generics to receive higher prices, and this will encourage companies to target areas of unmet patient need. It concludes by saying: ‘Companies that are successful in producing drugs that make major improvements to patients’ lives will prosper.

In our view, that is the essence of effective competition.’

The DH has commented: ‘’We recognise the importance of the pharmaceutical industry to healthcare and the development of medical advances and it is in all of our interests to encourage research and reward innovation.”

For further information on the OFT's recommendations, and to download the market study visit: http://www.oft.gov.uk/shared_oft/ reports/comp_policy/oft885.pdf

 

Bullying

Tim, our representative speaking ‘from the field,’ gives his take on the issues facing pharma sales representatives.

IT'S DEPRESSING TO THINK that bullying occurs at all, but even more depressing that it still goes on long after we have finished our days in the school playground. I really don't understand why bullying happens at work, the bullies don't even take your lunch money.

What's in it for the bully? Fuelled by their insecurities, they go through life on a spiteful, ego-driven power trip. I feel sorry for them. I can't imagine having so little sense of self-worth that the only way I can justify my existence to the world is by putting others down.

Life can be miserable for those who are bullied. Sleepless nights, days off sick due to the stress, a lack of motivation at work. It's little wonder that employers see bullying as a major problem. But the situation is usually difficult to resolve. It should be a simple case of contacting your manager or Human Resources department and working towards a solution together. It is rarely that easy. How do you prove you are being bullied? What constitutes bullying? And if you fight back through official channels, what will your reputation in the company be like afterwards? Nobody wants to be branded a troublemaker.

Sometimes bullying can be accidental. You are probably reading this and agreeing with everything I say (well, there has to be a first time), but you may be a bully and not even realise it. Think about the joke insults we all dispense from time to time. Are you sure the recipient gets the joke? And what about the extra work pressures you have given your colleague on occasion. Does your colleague think it is occasional or are they struggling to cope with your regular demands? Confession time – I have bullied someone without realising it. I was lucky: after a while they told me, and we are now firm friends. I have also been bullied. I said nothing and eventually the problem went away – eventually. After several unhappy months. Several months! Life's too short to spend that much time feeling down because of the actions of someone else.

If you are being bullied at work then you have my sympathy. I am genuinely sorry that I don't know how to solve your problems. If I have any advice that might be useful, it is to write every bullying incident down. This will be evidence in case you need it in the future, and it might make things clearer in your mind. And try and talk to your bully about how you feel, they may not know what they are doing. If it doesn't stop you must speak to someone. A manager or someone in Human Resources is ideal but if you don't feel able to speak to them try a trusted colleague. There will be someone who will listen to you. Finally, don't be afraid to follow official procedures if things get unbearable. By this point I would suggest you are likely to leave if things don't improve, so what do you have to lose? Your employer should be grateful that you have brought the issue to their attention, and although it is too late for you it might just help stop someone else being the victim in the future. Please, please, please don't suffer in silence. The day you say to yourself 'I can handle this on my own' is the day you admit there is a problem, and is the day you should start to sort things out. Not a month later, not a week later, not a day later. Immediately.

I apologise if this month’s column isn't particularly humorous (I apologise even more if you didn't notice any difference) but bullying, like the sitcom Two Pints of Lager and a Packet of Crisps, just isn't funny.

Please email me at tim@healthpublishing.co.uk if you have any comments on a ‘From the Field’ article.

 

Madeleine’s uncle is medical rep

The sad disappearance of Madeleine McCann from a Portugese holiday resort has undoubtedly touched the hearts of the national and international communities. But the disturbing story also has a connection with the medical representative community. Madeleine’s uncle, 48-year old John McCann, is a medical representative for AstraZeneca. AZ has granted John indefinite leave as he plays a central role in the international campaign to find Madeleine. Pf wishes to take this opportunity to extend its thoughts and sympathies to the McCann family, and, as does the rest of its loyal readership, prays for the safe return of Madeleine. For further details of the McCann’s campaign, please visit www.findmadeleine.com .

When we think of bullying, we automatically think of bullying in school – yet it's responsible for 30 to 50 per cent of all stress-related illness in the workplace. Pf takes a look at an issue that is costing companies millions, and what you should do if you find yourself being bullied by your manager or another colleague.

ACCORDING TO THE HEALTH & SAFETY EXECUTIVE, bullying costs employers 80 million working days and up to £2 billion in lost revenue every year. It also results in poor morale, lower productivity and higher staff turnover. Bullying can take many different forms, from actual physical violence and threats of violence to name calling, sarcasm and teasing, but bullying that doesn't include physical abuse can be just as hard to deal with and is often more hurtful than actually being punched or kicked.

What is workplace bullying?

The results of a survey of 5,300 employees indicated that victims of workplace bullying take an average seven extra days off each year compared with those not bullied. The report also found that, in most cases, a manager was identified as the bully. Another report indicated that, in almost all cases, higher management knew what was going on but did nothing about it.

Generally, bullying at work is an abuse of power or position. It manifests itself as persistent, cruel, vindictive or humiliating attempts to undermine, criticise, condemn or hurt an individual or group – it is clearly not banter! It can make employees miserable, affect performance and damage careers. If you genuinely feel you are being singled out for unfair treatment by a boss or a colleague, you are probably being bullied. Bullying behaviour can include:

• competent staff being constantly criticised, having responsibilities removed or being given trivial tasks to do
• shouting at staff
• persistently picking on people in front of others or in private
• blocking promotion
• regularly and deliberately ignoring or excluding individuals from work activities
• setting a person up to fail by overloading them with work or setting impossible deadlines
• consistently attacking a member of staff in terms of their professional or personal standing
• regularly making the same person the butt of jokes.

However, bullying is not always an interaction between individuals. There are organisational factors at work that can facilitate it – for example, an extremely competitive environment, poor training, fear of redundancy or poor procedures for resolving grievances and problems.

Stress and ill-health can become part of the daily life of those being bullied. Symptoms can include: anxiety, headaches, nausea, ulcers, sleeplessness, skin rashes, irritable bowel syndrome, high blood pressure, tearfulness and loss of self-confidence.

Direct cost to company

Bullying is recognised as a major cause of stress in the workplace and, by law, stress must be dealt with in the same way as any other health and safety hazard. Most importantly, employers who fail to tackle bullying are breaking the law. That’s why it is in everyone’s interest to take workplace bullying seriously.

"You’re just being oversensitive to the banter, to comments from your colleagues and your boss."

Employers have a duty under the Health and Safety at Work Act 1974 to ensure the health, safety and welfare of their employees. If they do not do this, they are breaching an individual’s contract of employment. It may also be a breach of sexual harassment and racial discrimination legislation as well as the Criminal Justice and Public Order Act 1994. Employers and the bullies may find themselves facing fines, compensation and possibly a jail sentence.

"This is a tough business, if you can’t stand the heat…"

Mark Higgins, head of employment at Manchester law firm Betesh Fox, expands: "It is not at present possible to make a direct complaint to an employment tribunal about bullying in itself.

"Nobody really means what they say, it’s just our style of working here..."

Employees might be able to bring complaints under rules outlawing harassment contained within the anti-discrimination legislation, such as sex, race, religious, disability, sexuality or age discrimination legislation."

If you feel you are being singled out or bullied at work, there are steps you can take:

1. A direct approach is usually best. Tell the person that you find their behaviour unacceptable and ask them to stop. Bullies do not like being confronted, particularly by someone who is calm and civilised. This may often bring the bullying to an end, but is difficult if the bully is your boss or someone higher in the company hierarchy than you.
2. The majority of bullying goes on behind closed doors. So tell a friend or work colleague. You may well find out you are not the only one who has suffered. It is important that you do not try to cope on your own.
3. Talk to Human Resources. This will be in confidence and does not mean that a formal complaint will automatically be made. HR will only do what you want them to and will give you the advice and support you need. They will want to have the bullying stopped quietly and quickly and can go with you to speak to the bully, or see them on your behalf. HR will also help you with a formal complaint if it goes that far, giving advice and support throughout the procedure.
4. Keep a diary. This will provide a vital record of the nature of the bullying and when it occurred. It will be important evidence when the bully is confronted. Many of the incidents may appear trivial in isolation, so it is important to establish a pattern over a period of time.
5. Tell your manager or supervisor. If it is one of them who is bullying you, go and tell their manager. Take your diary with you to back up what you have to say. They may not believe you but you have at least told them there is a bullying problem. The more people who know, the more difficult it is for the bully to flourish.
6. In the end you may have to make a formal complaint and go through the grievance procedure. If you do take this route, never go to a meeting connected with the complaint without taking a friend as a witness.

What can you do yourself?

• Admit to yourself that you are being bullied and that the behaviour being aimed at you is unfair and unjustified. Try to look at your situation – and the bully – objectively. Ask yourself, "Would I accept this behaviour in someone I didn't know?"
• Believe in yourself. Don't believe what the bully says of you. You know what they say isn't true.
• If the bullying is affecting you physically, go to see your doctor. A talk with your GP or a spell of sick leave may give you the space in which to bounce back.
• Try to stand up for yourself. If you need to, take assertiveness training.
• Check out your body language. If you stoop, hang your head and hunch over, you may be giving off 'victim' signals. Practise walking with confidence, standing straight with head held high and taking deep breaths.
• Try using humour or a well-chosen word to disarm the bully – the important thing is to say something confidently back to them.
• Tell the bully how their behaviour is affecting you.
• Don't suffer in silence – talk to someone you trust.
• Tell a person in authority, giving as many details as you can. If you are too nervous to see this person on your own, take along a friend.
• Find out about your rights and, if relevant, get legal advice.
• Consider using any relevant complaints procedure, or, if this doesn't work, going to an industrial tribunal or court.

Anti-bullying policies

The Advisory, Conciliation and Arbitration Service (ACAS) has published guidance for managers and employers on bullying. This can form the minimum standard for an anti-bullying policy, which representatives can negotiate with their employer. ACAS advises that a policy should include:

• a statement of commitment against bullying
• an acknowledgement that it is a problem for the organisation
• a statement that it will not be tolerated and may be treated as a disciplinary offence
• examples of unacceptable behaviour
• steps to be taken to prevent bullying
• responsibilities of supervisors and managers
• confidentiality of complaints
• reference to investigative, grievance and disciplinary procedures with timetables for action
• protection from victimisation of complainants
• provision of counselling
• training for managers
• how the policy is to be implemented, reviewed and monitored.

The ACAS guidance will influence the outcome of Employment Tribunal cases where bullying is a factor. Employers with no or an inadequate policy will be in a weaker position than those who follow the guidance.

Further information: Andrea Adams Trust Helpline:  01273 704900  01273 704900 www.banbullying@work.com National Ban Bullying at Work Day 7th November 2007

 

This year’s Pf Awards saw one of the most exciting and challenging events ever, with over 405 candidates from 25 of the industry’s top companies competing in this prestigious event.

AS ONE OF THE LEADING PHARMACEUTICAL COMPANIES in the UK, Wyeth was delighted to have 50 entrants in the competition, with a total of 24 members of its field force progressing through to the finals. Wyeth was represented in all but two of the award categories – right through from new representatives to experienced representatives, trainers, RBMs and HDMs.

“Having 24 of our people in the final was a fantastic achievement,” says Wyeth Sales Operations Manager Jason Stone. “Everyone who gets through to the final round of the Pf Awards can be justly proud of their success. I’m personally delighted that this year Wyeth fielded its highestever number of finalists and we achieved a record result, with a total of 15 of our finalists scoring direct wins or recognition.”

Two Wyeth finalists achieved Category wins in the SALES TRAINER/COACH AWARD and INNOVATION AWARD respectively, while a further nine achieved Category ‘runner up’ status. Additionally, in the Pf Commendations – recognising individuals whose performance stood out in particular assessment areas – Wyeth representatives achieved four further successes!

So what are the reasons behind the success of so many Wyeth team members in this year’s awards? We spoke to Wyeth’s overall category award winners, Anuj Sharma and Ravinder Dhillon, to find out more.

“I was really thrilled to win the Sales Trainer/Coach Award. It’s fantastic recognition,” says Anuj, who works as a Regional Trainer in the North West. “The assessment and judging criteria were tough and challenging, but that’s what makes winning worthwhile. I don’t think I did anything in the simulation exercises that I don’t already regularly do as part of my job – which I guess reflects very positively on the way Wyeth has helped support and train me to develop my sales career and perform my training role.

“I joined Wyeth in 2000 as a Medical Representative and each and every one of my managers have always given me 100% support and encouragement. If you’re determined to succeed and advance your career, then my experience is that Wyeth is a company that is committed to putting all the right structures and processes in place to enable this to happen. It’s all about ensuring people are allowed to reach their full potential.



“I hope that in my current role as a Trainer, which I’ve been doing since 2005, that I’m part of this culture of encouragement and support, enabling others to make the most of their capabilities, develop new skills, and ultimately build strong and successful careers.”

Wyeth’s second category award winner was Ravinder Dhillon, who against some stiff competition received the Pf Innovation Award.

“Wow – I couldn’t believe it when I heard my name being announced as the winner of the Innovation Award,” comments Ravinder Dhillon, who is a Mental Health Specialist in the West Midlands. “I was particularly pleased to be a finalist in this category, as I believe identifying new and innovative ways of working with customers is so important for the way we do business, and to actually win the category is a real career highlight.

I’d like to thank my commercial director, my manager, my regional team and Wyeth for all the support that they have given me in encouraging and supporting new business ideas and practice.

“I’ve been with Wyeth for over 7 years now and I can honestly say I’ve been given every opportunity and encouragement to advance my career. Right from my initial training course, it was made clear to me that the Wyeth culture was all about helping and enabling people to succeed. I was also impressed not just by the support given to people in developing their selling skills and product knowledge, but also by the commitment given to enabling people to fully understand the complex environment we work in, the focus on understanding our customers, and also on keeping up to date with and anticipating NHS change.

“This forward-thinking culture means that when I’ve raised ideas about new opportunities or new ways of doing things, I’ve always enjoyed positive encouragement from my manager. Wyeth is an environment where openness and the ability to voice your opinions and new ideas is actively encouraged. It’s not about just sticking to the well-trodden path. I like this openness with managers and other members of the team, and the respect we enjoy as individuals.”

A FINAL WORD

“To have so many high performers across such a wide number of categories says a lot about the quality, commitment and drive of our Wyeth sales teams,” says Primary Care Director Nick Teague. “Each of our winners has put a huge amount of effort and hard work into these awards, and I believe this reflects very positively on the type of people we attract here at Wyeth, the first-class training and support they receive, and our ongoing commitment to career development. I’m delighted by these results!”

“Well done to each of our entrants, finalists and award winners,” adds UK Training & Development Manager Demitri Gabrielides. “Each of them can be justly proud of their achievement and the inspiration they give to others. At Wyeth we believe in nurturing talent and ensuring that our high performers are given every encouragement and opportunity to advance and be the best.”

Understanding the Code of Practice

from Steven Gray Consulting

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Non-HCP meetings

Scenario: You are at an exhibition meeting and you notice that some of the material on the stand is inappropriate. You rectify the situation by removing the offending material and contact your head office to advise them. They, in turn, report the incident to the PMCPA because of the circumstances. (The Prescription Medicines Code of Practice Authority administers the Code of Practice on behalf of the ABPI.) During the ensuing investigation, the PMCPA decided that you failed to maintain the high standards expected of pharmaceutical representatives (Clause 15.2). You are confused because you acted within minutes to correct your mistake.

Question: What did you do that was so bad?

Answer: As in all cases considered by the PMCPA, the answer is in the detail. The exhibition stand was at a meeting, which was attended by a mixed audience. Some were healthcare professionals; others were representatives of a patient group – in other words, members of the general public. The promotional stand was set up in what was believed to be an area for HCPs only. Unfortunately the area was not restricted. The meeting opened at 9am and a ‘handful of delegates had passed by the stand’ in the thirty minutes before the representative in this case realised his mistake. He immediately closed the stand and rang head office to tell them what had happened.

All credit to the representative involved. He acted quickly and decisively – and honestly! In my book, he showed ‘best practice’ behaviour at that point. Unfortunately, he also failed to make certain of the arrangements for the meeting before setting up the stand and assumed the area was restricted. Hence the ruling that he ‘failed to maintain high standards’. This case shows how important it is to avoid any circumstances in which we could be accused of promoting prescription medicines to the public.

Key opinion leaders (KOLs) have for a long time played an important part in pharma marketing. But as NHS reforms change the way prescribing decisions are made, they are increasingly significant for the sales force, argues James Mundy.

IT USED TO BE SO SIMPLE: reps called on doctors, who made prescribing decisions, and so the sales force knew that as long as it achieved geographical coverage and visit frequency, sales would surely follow. Even if this simplistic model was ever true, it certainly isn’t now, nor has it been for some time. Doctors don’t have the time to see individual reps for different products, and anyway, they are only a part – and an increasingly minor part – of the prescribing process.

Much has been written about how this spells the death knell for the sales rep. If by that, commentators are saying that this model of selling is dead, then they are probably right. But, as Mark Twain might have said, reports of the death of the sales force are premature. It’s just that they need to be structured and acting differently. And near the top of the new to-do list should be the cultivation of those vital KOLs.

Improving patient care

So what exactly is the role of the KOL in the process? There are those, myself included, who have always thought that the term ‘clinical advocate’ might be a better one. Either way, their role has been under the microscope over the past couple of years, not least because of the seeming ethical contradiction surrounding senior clinicians endorsing individual – and commercial – products.

That said, if the KOL is respected and perceived as speaking from true clinical opinion, rather than the piper simply playing the payer’s tune, then their endorsement can be hugely valuable, making the representative’s ‘selling’ environment much more receptive. In an era when engaging with every single clinician – let alone all the other potential prescribers, such as nurses and pharmacists – is practically impossible, building relationships with advocates who can themselves influence those prescribing decision-makers is perfectly valid.

What’s more, done properly it should lead to improvements in patient care – and there is certainly no ethical problem with that, whichever side of the fence you are sitting on.

Solution building

The techniques used in engaging with KOLs should be very familiar to those versed in the art of the sales representative. Just as identifying customers, assessing their needs and then communicating a compelling message that meets those needs is grist to the mill of any effective salesperson, then the same process is just as valid in finding KOLs and going on to build effective relationships with them.

The fundamental difference, however, is that they are not there to be sold a product. A message, maybe, but they are not going to be swayed by a simple clinical detail. Rather, they will be looking for someone who is genuinely committed to building a real partnership to further their clinical – and just as importantly, health economics – goals.

Timing Is everything

All of this does imply a fundamental change in the way that pharma companies go about launching a product, especially the stage at which the sales force gets involved. In the traditional model, there was little sales force involvement prior to launch – the R&D specialists and marketers did their bit, and then threw the finished product to the reps for them to take out and sell.

Pour KOLs into the mix, especially if you accept that the sales force should play a big part in engaging with them, and you change that model fundamentally. It is widely accepted that KOL involvement is most effective if it happens as early in the process as possible. Generally, the earlier their involvement during clinical trials, the greater influence they have over the design of those trials, which means that the final product will better meet the needs of the market that the KOL represents. There is a neat additional benefit to doing this as well: if you give the KOL more and earlier involvement, you start to build a profile for your new product among the key audiences – your customers. You end up shaping the market so that the launch and subsequent sales activity become easier and more effective.

Real partnerships

The success of such an approach depends on a shift in mindset from everyone involved in the commercial side of pharmaceuticals, none more so than sales representatives. If you accept that the traditional model has been about ‘smash and grab’ short-term sales target-meeting, then you must also accept that developing effective relationships which will create an environment in which you can persuade those with their hands on the purse-strings and their signatures on the formularies is a longerterm prospect.

Using KOLs to help get across the health economics benefits of therapies is key, and this suggests a more planned approach in which the sales force shows a better understanding of the long-term health goals of customers.

This is the basis of the account management model, and it is one that fits well with slotting KOLs into the equation. If the presence of clinical advocates can demonstrate that a representative is more interested in helping a PCT achieve its own goals than in achieving his or her own sales target, then ironically those sales targets are more likely to be achieved.

Transforming yourself into an account manager is undoubtedly the key to survival and prosperity for many representatives, and the evidence suggests that there are too many sales professionals out there who think that that transformation is simply a change in job title. The harsh reality is that it isn’t – there are lots of new skills to be learned, and perhaps the key one is the ability to build long-term, mutually beneficial relationships, recognising that adding real value is the key to that.

Convincing customers of that value becomes more difficult as the number of prescribers, and prescribing influencers, mushrooms in the new NHS. Communicating with all of them directly will be nigh on impossible, which is where having a network of influential, credible and trusted advocates – the KOLs – becomes vital. The true account manager will know how to shape this resource and tap into it effectively.

A new challenge

The sales force will survive this current round of massive changes to our industry. But the reality is that not all the current individual members of sales forces will. Those who are willing to adapt to the new NHS, and who recognise that forming genuine long-term partnerships to help meet the NHS’s goals – something that hasn’t happened in any depth up until now – is the way to achieve that, are the ones who will survive and thrive.

But you can’t achieve that alone. You have to work more closely with your non-sales colleagues in a restructured and more open industry. And you have to realise that there are hugely effective advocates out there who can create an environment in which trust is built up to enable such partnerships to exist.

KOLs are no longer the exclusive property of the marketing team: they are also there to help representatives – assuming that the representatives themselves can understand the benefit, and choose to engage with the KOLs.

James Mundy is a freelance writer.