DTCA provides a favourable environment for shared decision-making wherein the patient is aware of the risks and benefits of new drugs. It also addresses the issues surrounding under-treatment and under-diagnosis of diseases by encouraging patient compliance with physician-directed treatment regimens

Restrictions on DTCA in Europe
The growing emphasis on DTCA is most evident in the recent publication of the draft guidance from the European Commission (EC), which raised the prospect of allowing pharma companies to communicate information about their medicines for asthma, diabetes and AIDS directly to the general public. Although this pilot scheme was eventually cancelled, Article 88a of Directive 2004/27/EC allows the EU Commission to provide a proposal report on the benefits and risks of disseminating information through the Internet to the general public. This report is likely to take three years from the implementation date of Directive 2004/27/EC for completion.
Even with these recent changes, the UK is a long way behind the situation in the USA, where branded DTCA is allowed. In Europe, there are strict regulatory restrictions on using prescription-only product names directly or indirectly during any kind of patient awareness effort. DTCA has therefore been relegated to disease awareness campaigns, which are educational and non-promotional in nature.
At the same time, however, these regulations are prompting more responsible DTCA on the industry’s part. The recent controversies in the USA have led to the development of the PhRMA Guidelines for pharmaceutical advertising, which are set to further rationalise DTCA approaches worldwide.
The trends in the global pharmaceutical space and the recent developments with respect to DTCA in the USA (the world’s largest drug market) will be the key factors that determine the course of evolution of DTCA in Europe. However, European-style DTCA will never adopt the US-style branded approach.

Understanding the regulatory framework
While advertising non-prescription medicines to the public is permitted in the UK (some limitations are provided in the Advertising Regulations to regulate the same), DTC advertising of prescription-only medicines is strictly prohibited as per the Advertising Regulations 1994 (as amended), which implement EU Directive 92/28/EC.
There are exceptions that allow information on prescription-only medicines to be provided to the public. For instance, answering a specific question about a particular medicine, factual informative announcements, reference materials (without product claims), and human health- and disease-related statements with no direct or indirect reference to the product are all allowed.
In Europe’s largest drug market, Germany, the rules against DTCA of prescription pharma products are as stringent as those in other EU countries. In Germany, the Heilmittelwerbegesetz or HWG (‘The Law on Advertising in the Field of Healthcare’) governs pharma advertising. The regulations ban the promotion of product brands where the disease has only one treatment option available in the market. It has also become mandatory for advertisements to advise the public to consult a doctor or pharmacist. Expert opinions, product recommendations, healthcare professional advice and certain graphic representations are not permitted.
In other countries, regulations also allow the advertising of non-prescription medicines – with certain limitations. For example, in France, DTCA of non-prescription medicines is permissible only if purchasers are not reimbursed by the social security system. Moreover, disease awareness campaigns are considered legal only if such campaigns do not refer directly or indirectly to the product or therapeutic class. In Spain, DTCA is allowed only for medicines that treat minor symptoms.

Key factors to consider
Although regulatory factors play an essential role in designing a DTCA campaign, it is equally important to assess the profitability of each consumer segment based on the DTCA costs. Age, location (urban or rural), frequency of requesting specific medication and consumer compliance are all important factors that need to be considered before undertaking any drug promotion. Understanding the consumer life cycle and the impact of various stages of DTCA on purchasing patterns will lead to more efficient campaigns with higher rates of success and better consumer responses.
The choice of media is another crucial factor in reaching out efficiently to the public with appropriate messages. Because of their ability to reach more consumers in a more targeted manner, print media have constituted 60% of total DTCA outlays. Expenditure on broadcast media has been 30% of the total DTCA media expenditure in Europe, with online media at a relatively low 10% of the total expenditure. The use of the Internet for pharma advertising is increasing with the growing Internet-savvy population sector in Europe.

A new approach to DTCA
With an increasing number of pharma companies realising the benefits of promoting their drugs, DTCA has taken on a more targeted and personalised approach. The emphasis is on integrated information flow and content management, with many companies looking to integrate CRM into their DTC advertising campaigns.
The first step for any successful DTCA campaign must involve a thorough feasibility analysis wherein companies identify the campaign goals, the critical success parameters and the target audience. Understanding the disease and its social sensitiveness, along with the commercial viability of the DTCA campaign over the drug life cycle, is also very important for developing an effective campaign.
Given the complexities of designing a European-style DTCA, a careful assessment of the return on investment must also take priority. ROI can be ascertained using soft metrics such as disease awareness, benefits from collaboration with physicians and pharmacies, and benefits from patient empowerment. Consumer profiling and focus on small target groups are likely to prove beneficial in optimising ROI.

The way forward
The total European non-branding DTCA expenditure by pharmaceutical companies in 2004 was estimated to be $85 million, and is expected to grow at a compound annual growth rate of 42% to reach $345.5 million by 2008. DTCA expenditure on newer drug candidates for under-diagnosed conditions is increasing, while drugs for high cholesterol, diabetes and depression are among the most-advertised products. A relatively high level of European-style pharma advertising has been seen in the UK and Germany, two major global pharmaceutical centres. In 2004, about 35% of the total European pharma DTCA expenditure was in the UK, with 25% in Germany and about 20% in France. Spain and Italy witnessed much lower levels of pharma DTCA expenditure, accounting for 6% and 4% respectively of the European total in 2004.
In the coming years, successful DTCA campaigns are expected to adopt a more tailored approach in order to meet the needs of all the interest groups involved, balancing commercial interests and social responsibilities. Pharma companies in Europe are gradually realising that DTCA, in addition to increasing awareness among patients, is a way to greater credibility and brand loyalty and will lead to increased market share and penetration.
Increasingly, DTCA in Europe is moving away from a limited and short-term focus on advertising and media to a bigger marketing space centred on enhanced patient outcomes, sustained value creation and relationship building.

Market insights
Frost & Sullivan, an international growth consultancy, has been supporting clients’ expansion for more than four decades. Our market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies includes custom strategic consulting, market intelligence and management training. Our mission is to forge partnerships with our clients’ management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost & Sullivan’s network of consultants, industry experts, corporate trainers and support staff spans the globe, with offices in every major country.

1. When and how often do you see medical representatives?
It’s variable. These days on average I see one rep a week, whereas it used to be more like one a day! The new contract has had an enormous impact on how busy we are. To use the stereotypical idea of doctors, the days of going on the golf-course are long gone! If I take the time to see a rep I have to use the only free time I will have in the week.

We used to have an appointments system, but now reps just have to call in and see what sort of day we’re having, in a way it’s gone back to the old-fashioned system. Of course this isn’t very good for the reps, but it really is the only practical way of doing it. Sometimes the Nurse Manager will see a rep, and if what they have to say is of interest the Nurse Manager will then arrange a meeting with the doctors.

2. What do you find useful about meeting with reps?
Essentially they are a source of medical information. Sometimes it’s necessary to be a little analytical of what they say and put it in perspective. They are also one of the few ways doctors network. If it weren’t for meetings organised by reps, doctors would probably never meet together outside of the Practice!

3. In your view, what could the sales-force be doing to improve their effectiveness?
My general experience of reps is that they are highly professional and patient; generally really good. However, I do think the pharma sales force waste a lot of time. What with different sales forces within the company, contract sales people and other companies co-promoting a product, there can be many people trying to sell the same product. The most I ever had was four different sales forces trying to sell me one product in one week! A lot of doctors now are beginning to ask the rep for specific information, rather than waste time going through information that just isn’t relevant to their role. Doctor-friendly reps will target their information to the doctor’s needs.

The pharma industry could also improve by not sending so much rubbish through the post! I feel sorry for the postman, who struggles to bring us a pile of letters, packages, posters etc that we will just throw in the bin. This is a waste of money and doesn’t do the industry any favours. It would also be useful if reps’ business cards indicated their speciality areas, as there is no way of knowing what they have called about if the card only has a name and contact details.

4. Do you feel the medical sales professional still has a valuable role to play?
The short answer is, definitely yes. The days of the vast sales force are certainly numbered, but they are starting to do things differently. The practicebased style meeting is now very popular and very effective. If a rep is selling products within the QOF framework they are more likely to have a good reception. The medical sales industry just has to change with the times.

Personally I have tried to break down barriers, particularly through my work with the ABPI and in commercial rep training. The pharmaceutical sales industry has more regulatory control than its customers these days. At the end of the day, it is a business, but it’s a business that is run in an ethical and controlled fashion.

5. What do you think are the major ‘don’ts’ for reps? What really winds you up?
My biggest hate is when a rep comes in with the opening statement, “What do you prescribe for X, doctor?” Where do you start? There is no easy answer to that question. From my experience that is a doctor’s number 1 pet hate, especially in more complex areas such as hypertension. Another one is the rep that tries to sell you a product you are already a high prescriber of, or one that you are opposed to for one reason or another. Or the rep that, with five minutes to go, will try and get in all their three products, whereas if they were sensible they would focus on one and leave information about the others.

A huge irritation, as mentioned earlier, is the rep that will go through their whole script without regarding what is actually relevant to general practice, and sometimes this information just seems to have been hacked together. The ideal rep will start with, “My products are A, B and C. What would you like to talk about?”

I will naturally have more time for reps if they come to talk to me about my areas of interest.

There have been a couple of cases where I’ve had to threaten to report people to the ABPI. For example, there was one rep that was telling patients in the waiting room to ask for a certain drug, and another who said he would give me something if I prescribed X amount of a product. Obviously these people are under the pressure of sales targets and these cases are a very small minority, 99% of medical sales reps are fantastic.

6. How often have you changed your prescribing habits based on information provided by a medical rep?
The best thing a rep can do is to leave detailed information with me that I can then take to a practice meeting for discussion. If we are all in agreement then we will add the product to the formulary. It is a more structural approach. My specialist areas are pain and respiratory medicine, so I will have more influence in these areas. Very few of our decisions are based in terms of finance, we will decide to change to a product if we genuinely feel it is better, regardless of cost, especially if the product fits in with the particular guidelines.

Despite some recent suspicion of reps, it is important that doctors stay balanced and try to avoid polarised opinions. To the majority of the sales force I would like to say, “Keep up the good work!”

January
Health Secretary John Reid announced a major overhaul of the way that health and social care services deliver care to the millions of people in England with long-term conditions. At the heart of the new system is the ‘community matron’, a new type of healthcare professional whose role will be to monitor patients’ health and co-ordinate their care and support. The NHS is committed to having 3,000 community matrons in place by March 2007.

February
The Department of Health announced a £135 billion investment for English Primary Care Trusts (PCTs) over the next two years. The allocation is based on four principles:

• Increases for all – PCTs will receive a minimum increase of 8.1% per year over the two years.
• Improved access – waiting times are expected to be reduced from 18 months to a maximum of 18 weeks by 2008.
• Prevention is as important as cure – cash allocations will help to fund initiatives such as school nurses, community matrons and health trainers.
• Fairness – those with greatest need have been allocated the most money. The new allocations bring the average spend per patient up to £1,388 across the UK, and around £1,710 in the areas with greatest need.

This month also saw the publication of the second part of the National Service Framework (NSF) for renal services.

March
The NSF for long-term conditions was announced. This is the first NSF to focus specifically on neurology, and thus should provide new opportunities for pharma sales professionals to access customers as there is a clear need for education in this area. The aim is to transform health and social care services for people with conditions such as Parkinson’s disease, motor neurone disease, epilepsy, multiple sclerosis and acquired brain and spinal cord injuries. Services described in the NSF include:

• comprehensive assessment and regular review of patients’ needs;
• joint health and social care plans;
• a single point of access to services via a named contact;
• self-referral as an individual’s care needs change;
• access to services such as rehabilitation, accommodation and personal care to help patients live as independently as possible;
• support to help patients work or take up other vocational opportunities.

The delivery plan for the public health paper Choosing Health was also published in March. The document focuses on promoting healthy lifestyles in children, and contains a wide range of recommendations to be implemented.
It was also confirmed in March that the Healthcare Commission and the Commission for Social Care Inspection will merge to form a single organisation by 2008.
April
The new contract for community pharmacists in England and Wales went live on April 1st, heralding a major change in the way that pharmacists are paid by creating different levels of services: essential services, advanced services and enhanced services.

• Essential services include: dispensing; repeat dispensing; disposal of unwanted medication; promotion of healthy lifestyles; signposting; support for self-care; support for people with disabilities; clinical governance.
• Advanced services require accreditation of both pharmacist and premises, and include the conducting of medicines use reviews (MURs) and the prescription intervention service.
• Enhanced services, which can be commissioned by PCTs on the basis of local needs, include: supervised administration; needle and syringe exchange; on-demand availability of specialist drugs; stop-smoking services; home care services; medicines assessment and compliance support; medication reviews; minor ailments service; out-of-hours services; supplementary prescribing by pharmacists.

The other major policy that went live in April was practice-based commissioning, something that is likely to impact on medical representatives more in 2006 than it has in 2005.

May
NHS chief executive Sir Nigel Crisp published his annual report, which marked the halfway point in the implementation of the NHS Plan. Highlights include:

• Progress towards meeting the December 2005 target of no-one waiting longer than six months for surgery is on track.
• Targets for support of mental health patients in the community have been exceeded, with 255 assertive outreach teams and 82 early intervention teams now operating.
• Walk-in health centres now see an average of 108 patients a day.
• The number of people quitting smoking increased by 63% in 2004.
• the number of NHS doctors rose by 8,000 and the number of NHS nurses rose by 11,000 in the 12 months up to September 2004.

June
Research carried out by the University of Southampton was published that evaluated the first two years of extended formulary nurse prescribing.
The majority of nurse prescribers reported that they were either confident or very confident in their prescribing practice, and the patients surveyed were generally positive about their experiences of nurse prescribing.

July
Commissioning a Patient-led NHS was published at the end of July, and is likely to be the most important document published in 2005 in terms of its impact on medical representatives. The document described the changes to be made to the structure and function of Strategic Health Authorities (SHAs) and PCTs in England. In future, both will concentrate on three main areas:

• promoting health improvement and reducing inequalities;
• securing safe and quality services for their populations;
• emergency planning.

The other main statements were:

• PCTs need to make arrangements for universal coverage of practice-based commissioning by December 2006.
• PCT reorganisation will be in place by October 2006, and a clear relationship with local authorities’ social services boundaries is expected.
• SHA reorganisation will be in place by April 2007.
• Changes in PCT service provision will be in place by December 2008. Based on the submissions published in October 2005, the number of PCTs

Based on the submissions published in October 2005, the number of PCTs is likely to fall to 100–150, with the SHAs being replaced by 9–14 regional organisations aligned to Government regional offices.

September
A major public consultation on the future of NHS services outside of hospitals was launched in September, entitled ‘Your health, your care, your say’. The findings will inform a new White Paper on care outside of hospitals, due to be published in late 2005 or early 2006.

The questions put forward to be addressed were:
1. How can people look after themselves? How can we help you take care of yourself and support you and your family in your daily lives?
2. When you and your family need help and support, how, when, where and from whom do you want to get it?
3. How can we help you get the right services when you need them, and ensure your care and support are properly co-ordinated?

October
The Government published a consultation document on the future supply of dressings and stoma products, proposing a two-stage approach to implementing new arrangements. If your company supplies dressings and appliances to the NHS, this heralds a new era in terms of how your products will be supplied and reimbursed by the NHS.

Andrew Platten, MSc, MRPharmS, DipM, MCIM is Associate Director of Consultancy at HealthGain Solutions, a contract services organisation supplying specialist sales, nurse and pharmacist and PCT teams to the pharmaceutical industry and the NHS.

Being world-class – that is our challenge

Pf caught up with Sales Director, Drew Owenson: “As one of the fastest growing pharmaceutical companies in the UK it would be easy to sit backan d enjoy our success. It was four years ago that we set out on our journey to become an unstoppable sales force. This has been a vision that inspired us all to improve the quality of what we do, to challenge the conventions we had built up and most importantly to start to put the customer at the centre of everything we do.

“We are proud of our results in recent years. Growth in the marketplace of just under 20% MAT, a record five years in a row where we have exceeded our challenging sales budgets, and a year which has seen us voted by industry sales representatives in the Pharmaceutical Field survey as the second most desirable sales force to workin. This is in addition to us being the highest placed pharmaceutical company in the Sunday Times Best Companies to Workf or survey.

“These results convince us that we are good but, as we all know, good is the enemy of great! And therefore we have set a new challenge for ourselves. We want to become a great sales force – a sales force that is truly WORLD-CLASS.

“We are convinced that by focusing on what our customers need, want and desire we will develop a sales force which continues to add value in a changing environment.”

Organising a world-class sales force

“Being world-class means many things to us but at its core is our commitment to exceeding our customer’s expectations. We are convinced that by focusing on what our customers need, want and desire we will develop a sales force which continues to add value in a changing environment. This premise is at the core of our future success.

“This is why we have just announced the largest reorganisation of our sales force in recent times. Following the success of our TEAMatrix concept, which we have been implementing for two years, we have now aligned our sales teams differently. We are now organised into fully integrated locally focused business units. These units are close to the customers and can flex resources depending on the customer’s priorities and the business opportunities that are developing.

“We are convinced that local decision-making at a business unit level will improve our customer interactions by making them even more relevant and attractive. It will increase still further the empowerment of our sales teams, leading to even more job enrichment, something which we know will appeal to sales people and managers. We have excellent people, we want to provide an environment where they will flourish.”

So what is the TEAMatrix concept?

MarkHog an, a Healthcare Development Manager with Boehringer Ingelheim explained: “The idea behind TEAMatrix is not only selling in a flexible way, but in a relevant way, selling the right products to the right customer. So our sales people are able to take real accountability for seeking out opportunities within their patch. It’s about seeing the bigger picture and what is best for the overall business.”

Another employee, Laura Garden, expanded on how the concept affects her role as a Territory Sales Manager: “By really listening to my customers I can be more flexible in the products I sell according to their needs. Different customers are interested by different topics depending on their interests, the interests of their PCO and depending on the patients they see. TEAMatrix allows me the flexibility to make those business judgements and be more customerfocused than the traditional model does. It really works for me.”

Exceeding the customer’s expectations

MarkHog an has worked with Boehringer Ingelheim for four years in COPD and cardiovascular. As a Healthcare Development Manager he works with Primary Care Trusts to set up services or projects that will benefit patients. Mark told Pf what he finds rewarding about working in these areas: “I enjoy helping the customer to develop services that will improve provision of healthcare in my PCTs and that will ultimately help the patient receive improved care. Boehringer Ingelheim is really good at customer-focused training, at developing sales calls based on the customers’ needs and talking to them about what they want to talk about.”

He emphasised that it is through the support of the company that he is able to achieve and develop in his position: “What I find rewarding is working and liaising with different people within the company. Boehringer Ingelheim is a small enough company for you to know everyone by their first name. You don’t just feel like a number, they really do lookaft er you.”

“The idea behind TEAMatrix is not only selling in a flexible way, but in a relevant way. It’s about seeing the bigger picture and what is best for the overall business.”

Laura Garden went on to explain how Boehringer Ingelheim’s locally focused structure empowers her and gives her greater autonomy in her region: “I am trusted to deliver results and responsible for delivering messages to customers in Primary Care. I am always looking to discover effective ways of working and know that I have the support of my region and my manager. I am able to suggest ideas for my own development and I am encouraged to be innovative in everything I do.” Laura Garden went on to explain how Boehringer Ingelheim’s locally focused structure empowers her and gives her greater autonomy in her region: “I am trusted to deliver results and responsible for delivering messages to customers in Primary Care. I am always looking to discover effective ways of working and know that I have the support of my region and my manager. I am able to suggest ideas for my own development and I am encouraged to be innovative in everything I do.”

From Good to Great

Drew concluded by emphasising Boehringer Ingelheim’s determination never to be complacent:

“We are proud of our results but we are looking forward to the next five years and are convinced that our reorganisation and our new vision, to be world-class, will give us the impetus to build on our good results and become the great sales force we know we can be!”