The patents for branded pharmaceutical products were designed to safeguard the interests of the branded pharmaceutical manufacturers and offer them adequate market exclusivity time to recuperate their costs and make sufficient profits. The patents were also intended to uphold the attractiveness of the branded pharmaceutical business and sustain the pursuit of innovation for newer and better therapies. The introduction of Hatch-Waxman Act in 1984 tried to strike a balance between the research-oriented branded pharmaceutical companies and the generic pharmaceutical companies. However, the delicate balance between the two arms of the pharmaceutical industry eventually got skewed and has continued to deteriorate.

What Went Wrong?
The branded pharmaceutical companies, after having worked diligently in researching and building a brand for a large number of years, found it extremely difficult to digest the erosion of revenues and loss of profits soon after the expiry of patents. This led the branded pharmaceutical companies to examine the Hatch-Waxman Act and other legislations more closely. Branded pharmaceutical manufacturers worked overtime to find loopholes in the Hatch-Waxman Act that would enable them to extend market exclusivity of their products.

Branded pharmaceuticals adopted numerous approaches to restrict the entry of generic competition and enjoy extended market exclusivity. Since, extension of few months can also mean millions of dollars for the blockbuster products, brand name companies have tried to exploit each and every avenue. The most popular loopholes used by the branded pharmaceutical companies are:

• Filing of additional patents, by which the Hatch-Waxman Act prohibits the FDA to approve the generic version for the next 30 months unless and until a final verdict goes in favour of the generic manufacturer

• Keeping the first approved generic product out of the market through negotiations and payoffs. The first generic approved product has an exclusivity period of 180 days and by keeping it out of the market until the disputed patents expire, the branded pharmaceutical companies restricts the entry of generic competition

• Introduction of new dosage forms or slightly modified versions of the original product, extending its exclusivity regime

• Directing patients and physicians to its successor product, thereby minimising the loss inflicted by the product going off patent

Further, branded pharmaceutical companies are shielded by the Hatch-Waxman Act, which prevents the use of their clinical research data by competing generic companies for the purpose of reference, until after 5 years of the branded product being granted approval. This is known as “data exclusivity.” Since generic companies are only supposed to establish the generic drug’s bioequivalence and not conduct expensive, time-consuming clinical trials, the absence of data on the branded product creates a roadblock.

In addition, the FDA approval time for generic drugs is over 20 months, which has worked against the generic players. The multi-cycle review has added to the cost of bringing the generic drug to market as well as delayed introduction.

This deliberate delay has stripped the patients and healthcare providers of hundreds and millions of dollars over the past several years. The escalating drug prices have severely affected the healthcare budgets. All these factors have culminated into a public outcry and an infuriated generic industry.

Changing Rules of the Game: Advantage Generics
There is growing awareness and realisation of the fact that the branded pharmaceutical manufacturers have bent the rules and repressed the generic industry for a very long time. Amendment to the Hatch-Waxman Act has caught up and become an immediate priority. The changes announced earlier this year are directed towards tying loose ends and reflect a conscious attempt to facilitate the introduction of generics much faster than before. Following are some of the major changes:

• Abolish the automatic 30-month stay privilege of branded pharmaceutical companies • Amend the 180-day exclusivity rule so that it is applicable to the generic company that secures product approval and finally markets the product

• Tighten patent submission by branded pharmaceutical companies to reduce the delay in generic approvals and launch

• Reduce generic drug approval times

• Propagate the availability and use of generic medications

In addition to this, the FDA is gearing up to work more closely with generic manufacturers and enhance communication, so that the filing documents are prepared appropriately and get approved during first review. All these reforms and the announcement of the final rule are estimated to remove several roadblocks for generic manufacturers, leading to faster product approval and a promising future. These initiatives are expected to propel the generic industry on to a much stronger and surer footing and also save Americans over $35 billion in drug costs over a span of ten years.

Future Outlook
With branded products worth billions of dollars coming off patent in the next five years, the generic industry could not have asked for more. The tremendous opportunity with favourable legislation and softening FDA stance is a perfect time for generic manufacturers to retaliate with a vengeance.

Background
Frost & Sullivan, an international consultancy firm, has been supporting clients’ growth for over four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies include strategic consultancy, market intelligence and management training. Our mission is to work with our clients’ management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan’s network of more than 500 consultants, industry experts, corporate trainers and support staff, spans the globe with 19 offices worldwide.

In the second of these articles we examine specific examples of actual prescribing incentives that have been used around the country and ask why this was done, and what is the impact to the pharmaceutical industry? Importantly, how does the pharmaceutical representative work within this climate?

Percentage drugs prescribed generically: Targets 70%-75%
Don’t think that there is not a region in the country that does not have this as the first and foremost incentive. This nation does indeed seem hell bent on generics despite the fact that we now know there has been significant delays in dropping of prices of generics and indeed maybe even some level of price control of generics. The generics situation has not been ideal for quite some time and the government has just announced a completely shocking statement regarding the prices of 4 named generic drugs. Remember that branded generics do not count as generic prescribing. Hence some PCTs have been recommending branded simvastatin – whilst this will drop the percentage generic prescribing rate, the perception is that it will reduce the cost of statin prescribing.

Percentage variation in statins: Target increase from baseline
Interesting twist on the above in that we are rewarding practices for increasing their statin use! But this will increase prescribing costs! So how will this work? Well there are incentives that are quality based. In fact, we need to put in some quality-based incentives for two reasons. Firstly to improve quality of prescribing. Secondly to ensure that our prescribing incentives are not thrown out for being purely cost motivated! In truth, increasing statin prescribing from baseline ensures us that certain NSF and NICE prescribing is being undertaken.

Selling statins in this market
The statin market has become very unstable. A banned statin, a newly launched statin, a generic statin and the presence of a well-placed market leader statin has created unprecedented turbulence within the market. Being a pharma company selling within this arena is going to be fraught with significant local and regional political drivers. Certainly pharma companies are doing the following: working with NSF steering groups (diabetes and CHD), coordinating post-graduate education and local KOL meetings. But also, service delivery, practice nurses and audits and the striving to ‘aid’ in achieving ‘targets’ are also offered. Interestingly, whilst the industry pushes in one direction, you will see (or maybe hear on the grapevine) the PCT and NHS Trusts pushing in other directions. In fact PCTs have taken to ‘writing letters’ whereby ‘strong advice’ to use/not use/recommend/not recommend certain prescribed agents is widespread. It seems that both pharma companies and prescribing advisers are resorting to major ‘leaflet campaigns’ to get there agenda out en masse. Certainly if you have good relations with the PCT you may do the following: try and ascertain what are recommended agents, is there a ‘blacklist letter’ and what does it look like, what are the plans for short and medium term future. Looking at the effect of the combined generic incentive and increase statin incentive, GPs will probably be getting the message to increase statin prescribing of generic agents.

Percentage advised (named) antibiotics: Target 75%
It has already been mentioned that antibiotic prescribing is key on the government agenda. Hence I have seen significant numbers of PCTs link with the antibiotic policy of the Trust (working with the microbiologist) and then naming certain antibacterials with a view to encouraging GPs to use these products. Interestingly once an ‘antibiotic formulary or guidance’ is in place, we will pick probably 4-7 agents for the incentive scheme (usually generic alternatives to branded agents and usually agents that are being actively marketed). It seems that whilst we would want to encourage all GPs to roughly agree with our antibiotic formulary, we will name drugs that are in danger of being replaced by expensive brands of the same class, especially if there is active promotion during the particular quarter/half year.

Branded calcium channel blockers: Target 80% Branded Isosorbide Mononitrates: Target 80%
Whilst we want to increase generic prescribing, one area where we want branded generic prescribing is with calcium channel blockers of the dihydropyridine and benzthiazepine class (nifedipine and diltiazem). Hence there is prolific marketing of branded generics here and due to difference is bioavailability, the RPSGB and BMA recommend branded prescribing. Many deals are being struck for mass purchases.

Fluticasone actual cost / STARPU percentage total inhaled steroids
There are many inhaled steroids on the market. But this is the most ‘picked on’ from the point of view of prescribing incentives. Practices are penalised for spending too much on NIC fluticasone as a percentage of total spend on inhaled steroids. One could ask – what about outcomes? What about quality of life from using this agent. These are all relevant questions. The point is this. The presence of this agent on a number of prescribing incentives means those looking at budgets are wary. They don’t necessarily feel the drug is too expensive. It may come from the presumption it is being overused.

Working Reality of Prescribing Incentives
They are here and here to stay. What is interesting is that they are changing with the times. I have attested in the previous article as to ‘why’ they are created and ‘how’ they are created. But I am finding that with so many pressures these incentives are complicated and not always reflective of the overall picture. They are often created to ‘tackle’ an issue for a set time. It is a photo-picture problem of a dynamic situation. There are two points that must be made due to importance and urgency.

The most striking prescribing incentives seem to be created in response to very active marketing or a surged increase in the prescribing of a new/branded product. Essentially, a response to the marketing of the pharmaceutical industry.

If you have some form of relationship with your PA – why not ask them what is on their black list! Believe it or not – you may be able to help them. If they are trying to get rid of PPI 1 and you sell PPI 2 they may be supportive to you helping them with their messages. Kill two birds…

I am also seeing less complicated incentives developing. There are some areas that are moving away from set hurdles of restrictive prescribing and issuing the following edict: save what ever money you can from the prescribing budget and you can keep half that cash sum (the other half goes to the PCT)! Note this is JUST DRUG BUDGET MONEY. Not total expenditure.

Given that many pharma companies justify increased prescribing costs by offsetting costs in other areas of care, it is prudent to note that most prescribing incentives look purely at drug costs and drug costs in isolation.

How many times in your career have you felt low? How often have you noticed it in your peers, the people you manage, or the people that have managed you?

THIS LACK OF MOTIVATION will in almost every case have a negative effect on the person’s ability to perform to their full potential with the result that performance is not what it should be and results will suffer. As results suffer then the ill-informed and un-skilled manager will potentially increase the pressure and the level of motivation will continue in a downwards spiral. This could potentially be disastrous for both the individual concerned but also for the manager and for the organisation. Serious health issues could occur and occasionally these can result in the individual not only being ill but citing the company and the manager as the cause of their ill health.

There are numerous reasons as to why a person may not be performing to their potential but what does not help is the inability of management to properly identify what the “root cause” of the lack of performance is. Too many managers make quick and ill-informed judgements; in other words they “jump to conclusions” and as a result make hasty decisions about what the corrective course of action is.

Judgements such as “just lazy”, “not got it”, “troublemaker”, “not up to the job”, “can’t take the pressure” and “can’t cope with the new environment” are just a few comments that I heard over the years. I have heard some others as well that have absolutely appalled me, given the management positions these people were in!

Why do managers make such hasty judgements?
One reason is that they do not know their people well enough. They do not spend enough time with them to fully understand their personality style, their motivators and de-motivators, their strengths and weaknesses and how they are actually progressing with their work objectives. Their judgements are based on a lack of knowledge, understanding and skill.

One area of skill that lacks in a lot of managers is the ability to actually identify what is the real cause of the lack of performance. Simply asking the question “What do you think is causing your lack of performance?” is better than immediately jumping to an ill-informed conclusion but this may only illicit a superficial response in the form of an “excuse”. Examples of these are; “marketplace is bad just now”, “I don’t have the right materials”, “The customers cannot be seen anymore”, “Our prices are too high” or the classic “It’s only a phase, I will get through it”. Some of the “excuses” may have some validity but more often than not there is a different, more valid, reason as to their lack of motivation and performance.

Managers need to probe further and they must take time to do this if they are to get their employee back on track. I have developed a framework that managers can use to structure their time with the employee. The framework is called CARERS™, and all a manager needs to do is to outline to the employee that he or she will take them through a series of questions covering certain areas of their work with a view to supporting them to identify what areas they can work on together in order to get the individual re-motivated and performing to the level that they have worked to or aspire to.

There are some pre-requisites to CARERS™ being effective, though. Firstly, if the manager is the actual “root cause” in that their behaviours are causing the issues, then there will be little trustbetween the two and as such there will be little honesty in the answers given by the employee. Secondly, if the manager is not a listener and is prone to do a lot of “advice giving” then again the chances of getting a good result will be low. Thirdly, the manager must go in with an open mind and not have any judgements about what may or may not be the problem. Finally, the manager must know when to “refer” onwards. E.g. If in the identification process it transpires that the “root cause” is a personal family problem or a psychological problem then it is not coaching that is needed, but it may be counselling or even therapy. The manager must know when to refer to the appropriate professional.

Most situations will be as a result of the organisation, the manager or the individual’s skill and I think in my experience of dealing with people in these performance situations I have only come across two situations in twenty years where the person needed referring on to another professional.

How does a manager use the CARERS™ model?
Firstly if there is a performance issue then time must be put aside to sit down with the person concerned. At least 1-2 hours. This person must be made to feel that the manager is there to support them and not to discipline them. The process is about reversing the lack of performance by mutual discussion and positive action. Discipline procedures only come after agreed objectives have not been met within an agreed time frame and performance has stayed low or even declined.

The manager simply explains that, informally, they are going to explore some key organisational areas that are vital in motivation and productivity with a view to seeing what may be causing the lack of performance and then agreeing a plan of action that will help the person to improve their performance. It should be stated that this plan will be supported and also be monitored to help them along.

Then it is simply a case of taking the person through the various steps in an informal and supportive way, suspending judgements and attempting to understand fully what is happening with the individual. The manager should take a coaching approach, always ensuring that the person answers questions and formulates their own way forward. The manager may in some cases have their own actions as a result because it may be that some of the factors that cause demotivation lie with them and the organisation. You will also find that in some cases the cause may be a “given” (e.g. organisational policy – car policy!) and that the employee will just have to live with it. The manager needs to understand the issue here but not agree with the employee. If it is a “given”, then a way forward should be worked out that works around this “given”. You will find some useful questions below that you can ask when using the CARERS™ model. Give the model a try.

Dementia is a broad term for the deterioration of brain function which results in loss of memory, reduced language skills and behavioural and emotional problems. Alzheimer’s disease is the most common type of dementia – it accounts for more than half the estimated 500,000 to 700,000 cases in the UK.

Alzheimer’s disease is rare before the age of 60 but the risk of developing it increases with age. Around a quarter of people over 80 have the disease.

Brain function
When the brain is functioning normally, it exchanges signals from other parts of the body, and other parts of the brain, across the gaps (synapses) between nerve cells. These signals – in the form of countless electrical impulses – are essential for brain activity such as language and problem solving. They are also involved in controlling motor functions, such as instructing muscles when and how to work.

Alzheimer’s disease is the result of the destruction of nerve cells (neurons) in the brain. These nerve cells cannot be replaced, so a person with Alzheimer’s disease gets progressively worse as more cells are destroyed.

Symptoms
The onset of Alzheimer’s disease is often difficult to pinpoint, as it starts with forgetfulness and difficulty in finding the right word, which are, of course, common problems associated with ageing. In these early stages, the people closest to the person with Alzheimer’s disease may notice personality changes. For example, a previously cheerful person may become irritable and even aggressive. He or she may no longer be able to cope with the demands of a busy life.

As the disease progresses, memory loss, difficulty in completing simple tasks, and more overt personality changes, often combined with depression, become more evident. Mathematical and verbal skills decline, which mean that a person may no longer be able to read instructions or to count their change. Conversation can become empty and meaningless.

Sometimes people with Alzheimer’s may become paranoid believing, for example, that their carers are trying to harm or kill them or that their partner is being unfaithful. People with Alzheimer’s can also lose their sense of time and place – they may, for example, get dressed in the middle of night or wander off and get lost, even in once-familiar territory.

This can cause a great deal of stress and upset for the person’s carers and family who have, in effect, lost the person they once knew.

During the late stages of the disease, people with Alzheimer’s may become totally dependent on others for their care. Walking can become difficult, and he or she may be confined to bed. They may become incontinent, experience hallucina-tions and become increasingly unaware of their surroundings. It is at this stage that residential care, with round-the-clock nursing, is often considered.

The disease lasts on average about ten years, though the period of time between diagnosis and the person dying varies from three to 20 years. Often the cause of death in a person with Alzheimer’s is another illness, such as pneumonia, which becomes more common in people who are bedbound and therefore less resistant to infection.

What causes Alzheimer’s
Nerve signals travel across the synapses with the help of chemicals known as “neurotransmitters”, including one called acetylcholine. Doctors believe that nerve cell destruction causes a reduction in acetylcholine, leading to impaired transmission of nerve signals.

Other explanations of Alzheimer’s disease focus on areas of abnormal protein in the brain called “plaques” and “tangles”, the names reflecting what these abnormalities in the brain look like under the microscope.

The underlying cause of Alzheimer’s – what actually triggers the changes in the brain – is still not known. It is likely that no single factor is responsible, but rather that it is due to a variety of factors, which may differ from person to person. People whose parents or brothers and sisters develop the disease appear to be at greater risk of developing it themselves, so there may be a genetic component. However, no straightforward pattern of inheritance has been found.

It is known that head injury is a risk factor, and also that Alzheimer’s disease often affects people with Down’s syndrome.

Some researchers have suggested that people who exercise their brains (for example, doing crosswords and other mental agility exercises) are less likely to develop the disease. And Omega 3 fatty acids, contained in oily fish such as mackerel and salmon may, also help to prevent dementia. But there is no completely solid evidence to show how environmental factors influencethe chance of getting Alzheimer’s.

Diagnosis
There is no single test for Alzheimer’s disease, and diagnosis depends in part on excluding other potential causes of dementia. These include vascular dementia (often known as multi-infarct dementia, or MID), dementia with Lewy bodies (DLB), frontotemporal dementia (including Pick’s disease), Parkinson’s disease, and alcohol-related dementia (Korsakoff’s syndrome).

If a GP suspects someone may have Alzheimer’s, he or she will try to confirm some of the symptoms, such as memory loss and verbal (speech) impairment. Physical examination and blood and urine tests may be carried out to help exclude other causes of confusion.

he or she may make a referral to a specialist (a neurologist, a care of the elderly physician or a psychiatrist) for more specialist tests. These may include the mini-mental state examination (MMSE), which is a series of questions and tests which investigate memory, language and mathematical skills.

Other investigations may include a brain scan, typically magnetic resonance imaging (MRI).

Some people may also be referred to a “memory clinic” specialising in mental state assessments.

Treatment
Unfortunately, so far there is no cure for Alzheimer’s disease. However, the disease can be managed with drugs, other treatments and support from a range of services.

Drug treatment
Recently-available drugs called cholinesterase inhibitors are the first effective drug treatment for Alzheimer’s. In someone with Alzheimer’s, cholinesterase breaks down and destroys acetylcholine, the neurotransmitter chemical. Cholinesterase inhibitors help to prevent this breakdown and so promote a more plentiful supply of acetylcholine. There are three such drugs available: donepezil hydrohydrocholoride (Aricept), rivastigmine (Exelon) and galantamine (Reminyl). In people in the early to middle stages of the disease, these drugs may slow down the progression of symptoms.

A newer treatment called memantine (Ebixa) has recently been launched for people in the middle to late stages of Alzheimer’s. It is not fully understood how well this drug works in practice, and it may not work for everyone. As a new drug that has not been reviewed by the National Institute of Clinical Excellence, memantine may not be readily available on NHS prescription.

Sometimes anti-depressants are prescribed to help treat the depression that can be associated with Alzheimer’s disease.

Other treatments
There are psychological techniques for helping to cope with Alzheimer’s disease. These include techniques known as reality orientation, reminiscence therapy and validation therapy. Art and music therapies are also used, but their effectiveness is not proven.

Help and support
Help and support in terms of respite care (giving carers a break), social services and residential care is an important part of the overall care of someone with Alzheimer’s disease. Further help Alzheimer’s Society 0845 300 0336 http://www.alzheimers.org.uk Alzheimer’s Research Trust 01223 843899 http://www.alzheimers-research.co.uk proven.

Dr Jones, you have given us examples of the use of biotechnology in specialist areas such as breast cancer; are there any areas where you predict short-term widespread use of these technologies?
There will certainly be a great market for biotechnology in treating common and minor ailments in the future. One example is that it may be possible for instance for patients in a nursing home to cough on to a diagnostic chip that can recognise if they are suffering from a bacterial or viral infection. The chip can then also decide what treatment is right for that person according to the genetic make up of the infection and the patient, and can therefore then avoid the need to consult doctors and pharmacists for common ailments.

This method of diagnosis is ‘high tech’ but not ‘high touch’ – in other words it is very fast and efficient, it delivers a simple diagnosis, but it is at the expense of the human touch. It goes without saying that if you are being diagnosed with something serious, like cancer, you need a face to face consultation with a doctor.

Where this technology can be really useful though, is for patients who need long term therapy like HRT, contraceptives, diabetes therapy etc. In these situations, after the doctor has made the diagnosis and chosen the treatment, it will be possible for the routine monitoring to be done at home, electronically – this already happens in the case of diabetes, with blood glucose monitoring. The idea is that a robotic electronic doctor monitors the patient’s progress and contacts the patient if something starts to go out of synch. This could be an opportunity for drug companies to liaise more directly with patients, the drug could be delivered every month to the patient’s home, and an electronic copy of the treatment record kept by the pharmaceutical company. This could lead to disintermediation of some of the traditional players involved eg. pharmacists – the relationship could begin to be a three way one, between the patient and the drug company and the prescriber. As long as this is handled ethically, the drug company could take certain actions, such as they could inform the patient that their therapy is coming to an end, and either instruct the patient to visit their doctor, or inform them that their next supply is on its way. The drug company could also help monitor compliance, by getting the patient to check how many tablets they have actually taken against how many were prescribed.

This will cause a lot of competition for the selection of the therapy, as the first prescription will be the vital one for the pharmaceutical company to obtain. Representatives will therefore need greater understanding of disease management programmes, and the technology involved which links patient to company to prescriber.

If this is the way it goes, will it change the skills set required of those on the road to promote products?
In life generally, change is not a choice, and that is very true of the pharma industry. The kind of products I learned about in college hardly exist these days. There are some drugs that are now over 20 years old now, some of the generics are still valuable, but all the money and time we’ve spent on medical research means that new drugs are very different, and the changes and progression is bound to continue. For instance the treatment of chronic myeloid leukaemia, was extremely crude, until about 10 years ago, and despite clever drugs, death was inevitable. Suddenly, along comes a product that actually starts to switch off the accelerated phase of cell growth, and it actually reverses it and provides a cure. That’s the first in a whole new series of drugs, but it requires the medical representative to have a sophisticated understanding of genomics, of physiology, and to understand the context of the patient which means a very different working relationship for the representative.

Will we see more of a peer to peer type consultation, with doctors being sold to by other medics?
Certainly, pharmaceutical physicians have a very important educational role in informing prescribers – but if their reputation is to survive, they have to remain very objective. That means that more than ever, they must make truly informed choices. This is a different skill to the various questions that representatives have to deal with about managing disease; I actually don’t think there will be much change in the basic skills set of the representative in terms of his knowledge of physiology and pharmacology, drug activity etc, that’s still fundamental.

However a more continuing and updating educational profile will be needed as the new technology and new distribution systems and structures come in. What I am saying is that there will be big changes to the way that healthcare has been delivered in the past, where the doctor is god and the nurse is the assistant, and where the pharmacist is possibly motivated by cash. This doesn’t have to be the way forward. Patients have the right to be included in decisions about their lives. More and more, the informed patient will become the empowered patient. The patient therefore becomes a partner in decisions about their future care, so they need to be able to ask questions of the doctor, such as ‘Why are you giving me that particular medicine? Is it right for my genetic profile? Or are you trying to save money because you need to give someone else a hip replacement?’ That dialogue can’t take place in the classic seven minute interview with a doctor, and it can’t easily take place in pharmacies, because you can’t have an intimate conversation across a counter. Doctors and pharmacists are not in the home environment, and are not able to get a feel of how well the patient is coping. Such interaction can however take place with a nurse because she’s often in the home environment, and so nurses are going to be extremely important to this industry and representatives have to develop a very strong focus on that role. The critical point is that nurses have more time with the patient. For example if you’re diagnosed with Parkinson’s disease, the physician will usually get the diagnosis over fairly quickly, but the patient will spend much longer worrying what this is going to do to their life. It will be the nurse who will spend much longer with them, and will know their home circumstances more intimately. They are likely to have a degree of influence in the choice of treatment, which makes the nurse a very key player for the pharmaceutical representative.

The role of the pharmacist will certainly change. Pharmacists have a role to play in their high street environment, but increasingly they want to be prescribers. My concern about that is that they will not have easy access to the full medical record of the patient, so how can you make a decision about switching a therapy unless you have all the information?

The other problem is that if they are going to get paid more for prescribing a more expensive product, isn’t that a perverse incentive? What I think will happen is that pharmacists will become very specialised, and they will go through more training courses beyond university and specialise in an area, for example diabetes, schizophrenia and individual patients will be linked to them. Whether they will do that in the health clinic rather than the high street remains to be seen. This all means that representatives will have to cultivate relationships with these rather more specialised pharmacists as a totally new element of healthcare prescribing.

Innovation is the key to the pharmaceutical industry’s success and benefits both the health and wealth of the country, says the Association of the British Pharmaceutical Industry in its submission to the Department of Health’s consultation on the future of the Pharmaceutical Price Regulation Scheme.

“But the challenge of tackling many life-threatening and debilitating illnesses continues to grow as the cost of research increases to £500million per new medicine,” says the ABPI report. “Only a small proportion of new medicines – three in 10 – go on to return more than their costs of development. It remains vital to ensure that the UK continues to foster an environment that encourages such investment and results in major benefits for patients, the NHS and the economy.”

In real terms the price of medicines are now 12 per cent lower than 10 years ago. The PPRS caps the profits that pharmaceutical companies can make on sales of branded prescription medicines to the NHS but offers no guaranteed profit level. The current PPRS runs until at least September 2004, and the DoH is undertaking a public consultation exercise on its future format.

The ABPI’s submission illustrates how pharmaceutical costs remain a smaller proportion of health costs in the UK than in most other European countries and predicts that over the next three years patent expiries on 20 per cent of brand medicines worth over £1.5 billion a year will lead to significant savings in NHS medicine costs as generic copies enter the market. “As a result the rate of growth in the medicines bill for the NHS is falling and will continue to fall over the next six years,” say the ABPI response.

It also identifies how greater prescribing of modern medicines has shown to be beneficial in helping Government to meet its key targets for improving health care in areas such as coronary heart disease, where mortality rates over the past 10 years have fallen by more than 40 per cent.

“In recent years we have entered into a period of unprecedented partnership working between industry and Government. Any future PPRS should balance the need for NHS prudence with the industry’s future success in developing new medicines and the UK’s science base, and encouraging local and inward investment to the UK by pharmaceutical companies,” said Dr John Patterson, President of the ABPI.

ABPI welcomes Government plans to end postcode in cancer, but warns problem is wide

The Government’s announcement of plans to review the availability of cancer treatments across the NHS has been welcomed by the Association of the British Pharmaceutical Industry (ABPI). But the ABPI also warned that this problem is not confined to the treatment of cancer.

The ABPI said the Government also needs to review other areas where postcode prescribing continues to be an issue. In fact, the problem still affects many areas reviewed by the National Institute for Clinical Excellence (NICE) - including Alzheimer’s, schizophrenia and diabetes - where modern treatments are not being made universally available as recommended.

In spite of the Government’s introduction of directions to require mandatory funding of positive guidance, NHS organisations are not adopting NICE recommendations, and patients are being denied access to medicines that have been found to be clinically and cost effective.

“It is clear that a review is needed to look at where and why this is happening,” said Dr Trevor Jones, ABPI Director General. “We will probably find there are a number of reasons, including pressure on GP and hospital budgets, a traditional conservatism of doctors to take up new treatments, and a lack of knowledge in parts of the NHS about the benefits of some of these advances. It is clear that these modern treatments do have major advantages for patients and they are entitled to benefit from them.”

The House of Commons Health Select Committee review of NICE last year called for the systematic monitoring of the implementation of NICE guidance at a local level. The pharmaceutical industry believes that this is essential if patients are to benefit from NICE recommendations.

ABPI welcomes new report on Clinical Research

A new report that calls for more to be done to encourage advances in clinical research in the UK has been welcomed by the ABPI.

The report, Strengthening Clinical Research, published by the Academy of Medical Sciences, highlights key issues that the ABPI has raised about the value of research for the UK.

“This report adds weight to the pharmaceutical industry’s position on clinical research in the UK,” said ABPI Director General Dr Trevor Jones. “We have a proud record of research here, but importantly, the report draws attention to the fact that we need even better infrastructure to ensure that the UK can continue to be a preferred location for clinical studies.”

The report specifically cites increasingly complex and bureaucratic ethical and legal requirements in the UK and EU for a serious lack of activity in UK clinical trials.

“In recent years, through the PICTF initiative, we have made significant progress to reduce bureaucracy, but clearly there is considerable room for even more. The practical consequences are that, at present, patients have to wait longer for new medicines, and in some cases they may be deprived of them altogether. We believe that a co-ordinated network for clinical trials within the NHS would be a major step forward,” said Dr Jones.

The report also recognises the importance of encouraging the presence of research conducted by the pharmaceutical industry in the UK - which conducts both experimental medicine and clinical trials.

The pharmaceutical industry invested £3.2 billion pounds in R&D in the UK in 2002 - nearly £9 million every day. In addition, nearly a quarter of the world’s top 100 medicines were discovered and developed in Britain, more than any country except the US.

Of the total amount spent on healthcare-related R&D in the UK, the pharmaceutical industry contributes significantly more than all other sectors combined. The industry spent 65 per cent of the total investment in 2002, compared to eight per cent by the Medical Research Council (MRC), 11 per cent by the Department of Health, three per cent by higher education sources and 13 per cent by medical charities.

“Huge as the industry’s investment is, there is still room to improve the R&D environment in the UK,” said Dr Jones. “When companies put their money into researching new medicines, it is a major commitment - and the more that can be done to provide the infrastructure, investment incentives and an overall priority for research, the more the pharmaceutical industry will be encouraged to invest here in the UK.”

Pharmaceutical Industry continues to lead UK R&D Investment

A new study published recently reveals the significant investment made by the pharmaceutical industry into re-search and development (R&D) in the UK, said the Association of the British Pharmaceutical Industry (ABPI).

The annual publication of the Department for Trade and Industry’s (DTI) Research and Development Scoreboard shows that the pharmaceutical industry continues to be the largest investor by far in R&D in the UK. With total pharmaceutical investment amounting to 40 per cent, this notably outweighs other sectors - including the second largest, aerospace and defence, which invested nine per cent of the UK total.

“These results clearly illustrate the enormous investment made by the pharmaceutical industry in this country,” said Dr Trevor Jones. “The money spent on R&D in the UK has a real impact on patients - who receive the benefits of the latest medicines - as well as on the economy.”

The report shows that the pharmaceutical and biotechnology industry is only one of three sectors where investment in R&D occurs above an international level. The UK is second only to the US in terms of attracting R&D.

“But this level of investment will only be sustainable if the overall environment continues to be favourable - not just with regard to R&D. For the pharmaceutical industry to remain strong, all factors - from the UK’s ability to be competitive in manufacturing, to the industry’s relationship with the NHS - must be vigilantly maintained so that investment will continue to be attracted as well as held in the UK,” said Dr Jones.

Introduction
The new UK-wide General Medical Services (nGMS) contract begins in April 2004. This contract affects all practices – whether they are currently working under a GMS contract (about 62% of UKGPs) or a Personal Medical Services (PMS) contract. The goal is to broaden the range and accessibility of patient services in primary care. The implications of nGMS will be far reaching for all parties involved in health care, and will allow practices and PCTs to re-shape the way services and care are delivered.

This article focuses on how a number of services, some of which are currently delivered in secondary care will move into primary care and become the direct responsibility of PCTs. These are known, for NHS commissioning purposes, as ‘Enhanced Services’.

Enhanced Services
The definition of an enhanced service is

• Essential or additional service delivered to a higher specified standard, for example extended minor surgery (each enhanced service is commissioned according to nationally prescribed standards – see footnote)

• Services not provided through essential or additional services. These include more specialised services provided by GPs/nurses with a Special Interest (Practitioners with a Special Interest - PwSI) and other allied health professionals and other services at the primary-secondary care interface. They may also include services addressing specific local health needs and innovative services at pilot or evaluation stage

Enhanced Services comprise of 3 types:

• ‘Directed’ Enhanced Services

• ‘National’ Enhanced Services

• ‘Local’ Enhanced Services

Directed Enhanced Services (DESs)
DESs are currently being delivered largely by practices, and will continue to be unless practices ‘opt out’ (for example due to workload pressures). Responsibility for DESs lies with PCTs from 1st April 2004 so they must provide the service elsewhere if practices decide to opt out. This means some patents will have to go elsewhere to access certain services described below. The likelihood is that other practices will expand their DES to take in patients from outside their practice, in some cases providing this service for the entire PCT. DESs attract nationally-agreed rates of funding.

The range of DESs covers these areas:

• Access to a GP or healthcare professional within 48/24 hours

• Quality Information preparation – encouraging summarising of patients’ notes onto the practice computer system from the Lloyd George paper system. This is vital for practices wishing to participate in the Quality & Outcomes framework, which will use the practice computer software to audit achievement against the prescribed standards in the incentive scheme.

• Flu vaccinations for all over 65s and under 65s at high risk.

• Services for violent patients (most PCTs already have arrangements in place)

• Minor surgery involving cutting and injections. Smaller procedures such as scraping and freezing minor lesions remain an essential service. Most practices provide the latter services, which will continue. Commissioning of the former will be subject to the standards outlined in the Minor Surgery DES. Many PCTs will want to use this DES to move more minor surgery out of hospitals thereby reducing waiting times. GPwSIs will expand their caseload and become local centres for referral from other GPs.

• Childhood immunisations and vaccinations which are likely to remain services provided by practices as they already have the infrastructure to provide this service.

National Enhanced Services (NESs)
PCTs, in consultation with the BMA’s Local Medical Committees (LMCs), will decide their own service needs and priorities within this category. As a result, levels and range of NESs will vary between PCTs. Once again, rates of pay have been nationally agreed for these services. Existing providers will have to bid to the PCT to continue to provide the service. In some cases NESs are already provided by Practices but outside the existing GMS arrangements. PwSIs will want to bid for these services so work with target customers you know are planning to expand to help them successfully bid for the relevant NESs. You will need to know the standards set out in the contract documentation so you can work out where you can help.

NESs comprise the following:

• Alcohol misuse

• Substance abusers maintenance care

• Shared-care drug monitoring including rheumatoid drugs

• Specialised care of patients with depression including use of rating scales

• Multiple Sclerosis ‘rounded care’

• Sexual Health akin to a locality-based GU medicine service

• IUCDs specialised coil-fitting service

• Minor injuries service largely in areas distant from hospital A+E services

• First response service for life-threatening or trauma incidents particularly in areas where ambulance response times are inadequate

• Services to homeless patients

•Intrapartum care for mothers wishing to give birth at home

• Anticoagulant monitoring e.g. INRs for patients on Warfarin

Local Enhanced Services (LESs)
These services are based on the same principles as the DESs and NESs but tailored to meet specific needs. Payment levels for LESs are agreed locally. The BMA is drafting guidance for GPs who wish to bid for LESs based around the following service areas:

• Asylum seekers

• Non-English speakers

• Patients with learning disabilities

Other areas likely to be commissioned under the LESs could include:

• Neonatal examinations within 24 hours of birth

• Nursing Home patients care

• Area-wide in-hours home visiting schemes

Funding of Enhanced Services There has been considerable unease amongst GPs that these services will not be adequately funded after reports that PCTs have already spent money allocated for Enhanced Services during 2003/4 on other things. The DoH have sought assurances from PCTs, via the SHAs, that the Enhanced Services money allocated will be ring-fenced for enhanced services for the commencement of the new GMS contract in April 2004. The impact of short term budgetary constraints are most likely to be felt in the NESs and LESs as some of these services are not currently provided in Primary Care, so lobbying by the LMC and practices will be less intense on PCTs who will be able to continue with existing suppliers or continue not to provide the service. However, as the majority of a PCT’s annual budget is currently spent on buying secondary care services, in the longer term, PCTs will be keen to move NESs and LESs into the community as this will bring down the cost of providing the same service in a secondary care setting.

Summary
The last five issues of PF have examined how the new GMS contract will expand the range, quality and number of services and healthcare professionals working within primary care to provide better patient care closer to home.

The implications for the Pharmaceutical Industry are clear- local knowledge is required to identify how specific services are to be delivered in each PCT under nGMS, and who the key influencers/prescribers are in each area of service.

accessing an ‘Enhanced Service’ then you need to be fact-finding now to understand how that service will be delivered from April 2004, and who will be writing scripts and where they are based. If you are a medical representative, it is no longer appropriate for you to assume that the GP is your key target – GPs may have opted out of providing the service, delegated that role to someone else who now has the power of the pen, or the PCT may have commissioned delivery of some Enhanced Services from providers outside of General Practices (for example nurse-led clinics). From a secondary care perspective, enhanced services commissioning means some specialist representatives will spend more time with customers in community bases, as we have seen over recent years in Mental Health.

The major changes customers face to redesign services in their new community setting will provide a range of opportunities for medical and specialist representatives to work in partnership on projects around patient pathways, team development and sharing best practise. Look at your PCTs’ Local Development Plans to find out what they are doing.

The rapidly changing Primary Care environment created by new GMS is a critical issue to consider when writing your Business Plan for 2004. Make sure you do your research for each PCT and target practice, stay close to your customers and help them develop their services to your mutual benefit. A good business plan will highlight to your manager who you should be calling on to get maximum business, what your key customers’ needs are and what resources you need to support these, and finally what support you need from colleagues – territory partners, your local hospital specialist and healthcare development manager and marketeers. Happy joined-up Business Planning!