Select Committee on Science and Technology Sixth Report


Members visiting Denmark were: Lord Colwyn, Baroness Finlay of Llandaff (Chairman), Lord Haskel, Baroness Perry of Southwark. In attendance: Miss Sarah Jones (Clerk), Professor A. B. Kay (Specialist Adviser), Dr Cathleen Schulte (Committee Specialist).

Thursday 22 March

Odense University Hospital (OUH)

Presentation by Mr Peter Frandsen, Medical Director

The Committee was welcomed by Mr Frandsen, who explained that the hospital was organised into four centres containing 31 clinical departments, with around 85 wards, 1,150 beds and an additional 120 rooms in a "patient hotel." The hotel was a useful facility with a more relaxed atmosphere than the main hospital. It could be used for women expecting a normal birth, all cases of breast surgery, all patients with eye disease and also for some patients undergoing hip and knee replacements. There were also rooms available for parents of children who were admitted as inpatients, and for relatives of patients who had travelled a long distance to the hospital.

Presentation by Mr Poul-Erik Svendsen, First Deputy President, Southern Denmark Regional Council

Mr Svendsen outlined how health services were co-ordinated at a national and local level within Denmark. From 1 January 2007, the country's 13 traditional counties had been replaced by five new administrative regions, and the 270 municipalities had merged to create 98. The aim of this huge reform had been to create a new Denmark where citizens received better services, and the most important area of responsibility for the new regions was the organisation of the national health service.

National health targets were set by the Ministry of Interior and Health Affairs, whilst preventative strategies, treatments and health personnel were managed by the National Board of Health. However, responsibility for the treatment sector and allocation of the health budget had been devolved down to the municipalities and regions. The municipalities and regions ran the hospitals and entered into agreements with GPs, specialists and dentists about payments. OUH was one of three university hospitals in Denmark. The hospital was the natural choice for the inhabitants of Region Southern Denmark, but also received patients from other regions of Denmark who chose to be treated there. Patient satisfaction was high and over 80 per cent of medical research in the region was being carried out at the hospital.

Presentation by Dr Arne Høst, Head of Department of Paediatrics, OUH

Dr Høst described allergy, atopy and the different types of hypersensitivity reactions that could be either allergic or non-allergic. Epidemiological studies had shown that some allergic reactions peaked in prevalence during childhood and then became less common. For example, atopic dermatitis peaked around age one, and food allergies peaked around one to three years of age. Asthma tended to increase in prevalence until around age 15, and the prevalence of allergic rhinitis rose dramatically between the ages of three to 10 years.

A number of long-term birth cohort studies had been carried out in Denmark where follow-up assessments were needed many years later. Funding for this had come from the National Board of Health, the Danish Medical Research Council and local funding boards. There had also been good co-operation with local GPs who often referred patients to researchers for these studies. The 1985 Odense birth cohort study monitored 1,749 infants born at OUH during the first year of life, and showed that of the children who displayed cow's milk allergy as infants, 88 per cent of them had recovered by three years of age, and 97 per cent of them had recovered by 10 years of age. The children who suffered from non-IgE-mediated allergic reactions tended to have a good prognosis, whereas the children with IgE-mediated cow's milk allergy had a higher risk of the allergy persisting, and a higher risk of developing other food allergies, inhalant allergies, asthma or rhinoconjunctivitis.

Research facilities at university hospitals, and sustained levels of funding, were vital for important interventional studies. The current evidence base led clinicians to recommend that all infants should be exclusively breastfed until at least four months old, but otherwise no special diet was recommended for pregnant or lactating women. For high-risk infants (who had a family history of allergy), if a milk supplement was needed during the first four months then a documented hypoallergenic formula was recommended.

Presentation by Dr Tine Hansen, Consultant, Allergy Centre, OUH

Dr Hansen explained that hypersensitivity reactions, which included allergies, placed a huge burden on the patient as well as the economy and social services. Asthma cases in the year 2000 cost Denmark approximately DKK1,100 million in medical treatment, and DKK800 million due to work absences or early retirement. It was therefore extremely important to prevent hypersensitivity disorders.

Allergology required the treatment of many different conditions, often involving multiple organ systems, both in children and in adults. Different kinds of specialists were therefore needed and patients were often sent between several different departments. From 1982 until 2004, Denmark had offered a three-year sub-specialty training in allergology under the internal medicine specialism. However, in 2004 this sub-specialty was stopped, and since then allergology had functioned as a sub-specialty within other specialties such as dermatology, internal medicine, pulmunology or paediatrics. There was no official training programme or certificate in allergology, although the scientific societies made guidelines and education programmes. GPs received no structured education about allergology.

In 2005, the "Allergy Network" was established on a voluntary basis. The Network included representatives from different organ specialty groups, and worked towards developing common clinical guidelines and investigation programmes. It had developed a training course for specialists which awaited funding, to standardise allergology training, allow collaboration between specialties and provide evidence-based, updated education. A training course for GPs had also been developed to provide a common national programme for GPs, and had been funded by the Ministry of Interior and Health Affairs. A standard presentation was used at each course presented by a standard group of specialists, to provide high quality education that was identical in each region, although the GPs could participate to apply the information in a more local context.

Following the recent reorganisation of the Danish regions, the Allergy Network saw an opportunity to optimize collaboration and set out its vision of how allergy services could be improved in terms of education, use of resources and treatments. The network aimed to train all medical practitioners in allergology so that most patients could be dealt with by GPs. It was thought that GPs should be able to refer patients to specialists in practices or hospital departments, and close collaboration between these sectors could form a regional allergy team. The network claimed that three specialist allergy centres were needed in the country to treat complicated or rare allergic diseases and carry out research and education. So far, only one of these specialist services had been created, at Odense University Hospital. There were plans to develop a second centre in Copenhagen soon, but the creation of a third allergy centre at Aarhus awaited the construction of a new hospital.

Tour of the Department of Dermatology and Allergy Centre

Professor Carsten Bindslev-Jensen, Head of the Department, led the Committee on a tour of the facilities at the Allergy Centre. The importance of challenge tests was noted, as patients who had not received an appropriate diagnosis often avoided substances unnecessarily. Confirmation that the patient was not truly allergic to a substance, or that an allergy had been outgrown, allowed a significant social burden to be lifted from them. This was also of economic value. Doctors reported that a high proportion of patients believed they were allergic to penicillin, but only around one in six actually were. Alternative antibiotics were a lot more expensive than penicillin, so investigation of these patients was therefore extremely worthwhile.

When an allergy was confirmed, it was also important to establish the severity of the reaction, which could often only be found using challenge tests. For example, the Committee met one girl who suffered from peanut allergy, who had a positive skin prick test and high levels of IgE, so avoided all peanut products. However, the challenge test had shown that she could tolerate low levels of peanut, and could therefore consume foods with peanut traces and peanut oils. There was a danger that other food products, such as sprouts or hazelnuts, could cross-react with peanut proteins to produce an allergic reaction, so it was also important to test the girl for sensitivity to these substances. These types of detailed studies allowed specific advice to be issued to different patients and enabled them to live a more normal life.

The result of every challenge, cross-reaction, skin test and treatment was recorded within the hospital database and a blood sample of the patient was kept. This was immensely useful for further research. It was noted that there was a difference in attitude regarding research in England and Denmark; in Denmark it was largely accepted that every patient who presented for treatment would enter into the clinical trial.

Presentation by Professor Carsten Bindslev-Jensen, Head, Department of Dermatology and Allergy Centre

Professor Bindslev-Jensen noted that the prevalence of allergic diseases was still increasing in Denmark, with 40 per cent of the population being skin prick test positive to an allergen. With increased awareness of allergic diseases, more people were also reporting to doctors with symptoms of allergic conditions. Professor Bindslev-Jensen felt that attention should be focussed on the severe and most complicated cases, such as peanut, tree nut and occupational allergy and anaphylaxis. Complex allergies involved a number of organs, so no single specialist could deliver top class diagnosis and treatment in all of those fields.

The Allergy Centre had therefore been created in 2001 to deal with multi-organ, complex conditions, whether occupational or private, in both adults and children. The Centre was formed in collaboration with the Departments of Dermatology, Paediatrics, Internal Medicine, Occupational Medicine, Clinical Chemistry and Clinical Immunology. The number of staff employed by the Centre included four specialists, two or three registrars, seven nurses and lab technicians. This allowed specialised treatment of even the most complex cases, and placed the needs of the patients centrally, ensuring the best possible utilisation of resources.

The organisation of allergy services in the Southern Denmark Region resembled a pyramid-like model involving three different levels. At level one, the GP saw 80 to 90 per cent of allergy patients in primary care. Level two consisted of specialist practices or county hospital departments which dealt with around 5 to 15 per cent of patients. Then at level three, around 1 to 5 per cent of patients, who had complex or severe allergies, were referred to the Allergy Centre and other departments in the university hospital. The aim of the allergy centre was to diagnose and treat patients, and then refer them back to their GPs or district hospitals with appropriate advice for both the patient and GP.

Collaboration between the different levels was therefore essential, and the knowledge passed down from the Allergy Centre helped to educate the local GP and specialist workforce. The Allergy Centre made its standard operation procedures available to GPs which contained basic information about allergic diseases, outlined the type of samples that should be taken for each condition, and offered guidance about where to refer cases of allergy. An example of when inter-level collaboration had been important was in 2004, when it was discovered that many patients had suffered severe reactions following grass immunotherapy treatments. The Allergy Centre alerted all the GPs, specialists and hospital departments in the Region, established a hotline, and allowed GPs to refer any cases to the centre which they were uncomfortable treating themselves.

The work of the allergy centre was varied, and involved challenges to foods, drugs, and occupational substances, allergy testing in vivo such as skin prick tests or patch tests, and in vitro allergy tests such as the measurement of IgE levels. The treatments offered included allergen avoidance advice, immunotherapy and pharmacological treatments. In addition the clinic was involved in several research projects such as the Danish Allergy Research Cohort and GA2LEN research programmes.

The Allergy Centre also worked with patient organisations to organise holidays for families in locations completely free of allergens. Schools in asthma, eczema and food allergy had been organised in collaboration with other departments and the Asthma and Allergy Association (a patient organisation), to educate patients about how to cope with allergy in everyday life.

In discussion, it was debated whether allergy should be treated by separate specialists in a co-ordinated centre, such as in Denmark, or by allergy mono-specialists. It was felt that the appropriate model of service delivery in each country depended on the individual history of its health system. It was noted that allergists in Italy received training in many different fields, including paediatrics, dermatology and respiratory medicine, so the allergology specialty was justified and allergologists worked with paediatricians to provide most of the care.

However, it was suggested that in countries where allergologists did not receive this range of training, allergy should be treated by organ specialists with an interest in allergy. In Germany, most allergy expertise was provided by dermatologists and paediatricians. The system employed by the Allergy Centre at OUH, where many organ specialists cooperated in allergy treatment, was a similar model of service delivery to that used in France and Germany.

It was noted that the Allergy Centre did not detract from routine allergology performed by organ specialists. Instead, the role of the Centre was to investigate more complex cases and avoid multiple referrals between specialists. The staff at the Allergy Centre often investigated patients' histories and decided whether immunotherapy should be used, but then referred the patients back to organ specialists or GPs to administer the treatments.

Friday 23 March


Presentation by Dr Peder Anderson, UK Director

Dr Anderson briefly introduced ALK-Abelló, a small- to medium- sized pharmaceutical company. It claimed to be the world leader in specific allergen immunotherapy, holding around 32 per cent of the market share. Around 50 per cent of the products it produced were subcutaneous immunotherapy treatments, 25 per cent were sublingual immunotherapy and another 25 per cent were adrenaline autoinjectors.

Dr Anderson estimated that around five million people in the United Kingdom were allergic to grass pollen to some extent, but that due to a lack of service provision many people relied upon suboptimal treatments over the counter at pharmacies. It was thought unlikely that allergy services in the United Kingdom would be improved soon due to the shortage of allergy specialists, and Dr Anderson thought that subcutaneous immunotherapy would never be used in primary care due to the need for administration by specialists. The company had therefore developed sublingual immunotherapy tablets in the hope that these may eventually enable GPs in the United Kingdom to treat allergy using immunotherapy.

Presentation by Dr Jørgen Nedergaard Larsen, Senior Scientist

Dr Larsen outlined the scale of the allergy problem in Europe. Every allergy patient was different and could potentially suffer from several allergic diseases at once. Common comorbid conditions included hayfever, asthma, eczema, food allergy and urticaria. The mucosa in the airway functioned as one organ, so similar allergic symptoms often presented in the eyes, lungs and nose. Although the common view was that allergy presented as several diseases with overlapping symptoms, Dr Larsen therefore felt it was more useful to view allergy as one disease, with several different manifestations.

Immunotherapy was the only treatment which stopped the symptoms of allergy on a long-term basis. It could not be viewed as a "cure" because allergy symptoms could still be provoked following immunotherapy if high doses of allergen were applied. However, it rendered the patient tolerant enough of the allergen for everyday life. The efficacy of subcutaneous immunotherapy was good. There was a clear dose-response efficacy relationship, but the allergen dose that could be administered during immunotherapy was limited, due to the increasing risk of adverse reaction with increased doses.

The company had gained product licenses for subcutaneous immunotherapy products within several European countries but had virtually given up seeking product licences in the United Kingdom because it felt that the MHRA was resisting the approval of this treatment. However, its products could still be used within the NHS if they were imported on a named-patient only basis. The company's focus in the United Kingdom had turned to sublingual immunotherapy as the safety profile of this treatment was good and it allowed patients to treat themselves at home. Grazax, a tablet form of immunotherapy for the treatment of grass pollen allergy, had been granted a product license in the United Kingdom in 2007.

Tour of the Research Department

The Committee was given a tour of the research facilities by Dr Michael Spangfort, Director of Research.

Preclinical research data was needed to receive a product license in the United States and also contributed to applications for product registrations in Europe. Compared to human studies, the use of the mouse as a clinical model allowed more parameters to be investigated, so a rhinitis mouse model had been developed. Research was being carried out into the mechanisms involved in sublingual immunotherapy, and adjuvants were being tested for the next generation of sublingual products.

Presentation by Dr Rowena Holland, Marketing Manager

Dr Holland began by outlining how respiratory allergic disorders impaired patients' quality of life. Within the United Kingdom, the shortage of specialist allergy centres meant that the use of subcutaneous immunotherapy was minimal, and patient surveys had shown that many patients felt that the treatments they received had only a partial or poor effect on their symptoms. Trials of Grazax had shown that the sublingual immunotherapy product was effective at reducing symptoms and improved sufferers' quality of life. Dr Holland claimed that when quality adjusted life years were taken into consideration, the product had been shown to be cost-effective compared to other treatments and was not associated with risks of anaphylaxis. After being granted a product license by the MHRA, it was hoped that this product would be used within the NHS, but the long-term effects of the product were still under investigation.

National Board of Health

Presentation by Dr Else Smith, Acting Medical Director, National Board of Health

Dr Smith welcomed the Committee to the National Board of Health and outlined the healthcare problems the country faced. The National Board of Health was a semi-independent agency within the Ministry of Interior and Health Affairs. It acted as an advisory body to ministers, parliament and public authorities, but the Ministry had no instructive authority over the Board, so the political functions of the Ministry were separated from the health strategies.

Healthcare in Denmark was financed through general taxes. The National Board of Health co-ordinated national health policies and regulated personnel in the health services. However, the allocation of funding towards local prevention work and the provision of healthcare services was decentralised, managed locally by the five regions and 98 municipalities. The former Ministry of Health Affairs, now the Ministry of Interior and Health Affairs, had recently produced a national strategy, Healthy throughout Life which set out targets and strategies for improving public health from 2002-2010. The overall aim of the project was to increase life expectancy free of illness for everyone at all ages. Included in this strategy were eight major groups of non-communicable diseases which the Ministry felt needed to be targeted, and one of these was hypersensitivity, including asthma and allergy. Although the Ministry had set strategies, it was the National Board of Health which would have to issue guidelines in order to tackle the rise in allergic conditions.

Presentation by Dr Jette Blands, Senior Medical Officer, National Board of Health

Dr Blands outlined the ways in which the National Board of Health tried to monitor the prevalence of allergy. The National Health Interview Surveys from the National Institute of Public Health showed that there had been a large increase in the number of self-reported and parent-reported cases of asthma, wheeze, hayfever and allergic rhinitis over the last decade in Denmark. It was not clear whether the number of cases was still on the increase, but it did not look like it was on the decline. The Danish National Patient Registry contained information about all patient contact with clinical hospital departments, but GPs did not register their cases so there was still a great need to improve data collection on a national level.

As many factors contributed to allergy development it was difficult to decide how to distribute resources. Possible targets for prevention strategies included working conditions, diet, smoking and the indoor and outdoor environment. The Board provided information and guidance for families, day-care centres and schools, in addition to producing guidelines for healthcare professionals. Information was often displayed on the National Board of Health website[156] to enable easy access.

The Board also engaged in partnerships, such as the Food Allergy Project in 2003. This project was a collaboration between the Danish Veterinary and Food Adminstration, the National Food Institute, the Asthma and Allergy Association and the National Board of Health. The outcome of the project was the production of eight booklets regarding food allergies and hypersensitivities, and a conference for primary care nurses and doctors about food hypersensitivity in children. The project had also established a dedicated website[157] regarding food allergy which was aimed at the public, but which was also useful for healthcare personnel. The website contained information about food allergy, shopping, the pollen season and possible allergen cross-reactivities.

The reform of the Danish regions and municipalities had provided the Board with an opportunity to develop guidelines for allergy care and prevention. The pyramid model of service provision for patients with chronic diseases stratified them according to their individual needs. This meant that most allergy patients should be managed in primary care. For this management to be successful it was important for healthcare personnel of different disciplines and levels to work co-operatively.

Presentation by Professor Jeanne Duus Johansen, Director, National Allergy Research Centre for chemical substances in consumer products

Professor Johansen described the work of the National Allergy Research Centre for chemical substances in consumer products. The Centre had been developed in 2001 by a steering group consisting of the National Board of Health and the Environmental Protection Agency, and carried out research purely into contact allergies. Contact allergens were low-molecular weight chemicals, organic substances or metals, and were frequently found in consumer products such as fragrances, preservatives, hair dyes or jewellery, as well as at work. It was estimated that around 20 per cent of the population suffered from contact allergy, that the majority of sufferers were women, and that contact dermatitis was especially common in younger people.

The staff at the Centre consisted of the Director, 10 researchers and an IT specialist. It was important to maintain contact with clinicians who dealt with contact allergy on a regular basis, so the Centre was supported by the Department of Dermatology and Department of Respiratory Medicine at the Gentofte University Hospital, and the Department of Dermatology at OUH. The Centre carried out research into allergens contained within consumer products, and studied the details of clinical cases in order to develop prevention strategies. The National Board of Health supported a clinical database of dermatitis cases. The details of around 4,000 cases were received each year from 10 centres across the country, including university hospitals and private clinics. This assisted the surveillance of national targets, monitoring of interventional strategies, and the development of clinical guidelines and standards of care.

The Centre was also involved with consumer protection work and clinical experiments carried out at the Centre had led to allergenic products being removed from the market.

Research areas at the Centre included:

  • work on hair dyes and semi-permanent tattoos to identify the allergens contained within them, and the threshold levels at which these substances were safe
  • investigation into chromium allergy, as chromium on the leather of shoes and gloves had been shown to act as a potent allergen for a small group of individuals. The unit had measured the gene expression patterns of patients to aid diagnosis in the future, and also carried out preventative work
  • examination of perfumes and fragranced products. It was noted that perfumes were applied to the skin but were also inhaled, so for this research it was important to work with both respiratory and dermatological clinicians.

Presentation by Dr Janne Sommer, Asthma and Allergy Association Denmark

The Asthma and Allergy Association Denmark was a patient organisation established in 1971 which aimed to improve the lives of people affected by asthma and allergies, and helped them to make informed judgements about treatments. It had 14,000 members and ran activities through 22 local branches, but from 1990 a central office had been established to co-ordinate its work and initiate major national initiatives. The Association was funded partly by private organisations and partly by grants from the National Board of Health which supported activities such as the patient counselling service.

The Association offered a range of services which included a free telephone hotline offering professional counselling, a free weekly newsletter, a members' magazine and a large website with detailed information for patients, relatives and healthcare workers. The Association organised patient schools, family days and seminars which educated children and adults about how to manage allergic conditions on a day-to-day basis, and also ran a product evaluation service which worked with industry to improve the quality of products sold to the public.

The Association was also the only non-governmental, not-for-profit organisation in the EU which ran a large pollen monitoring program. The Association worked in collaboration with the Institute of Environmental Health and aerobiological groups to trap, identify and count pollen across the country. Daily counts of the six greatest allergological pollens were communicated to the public via free emails and the website. Pollen forecasts for birch, grasses and mugwort were also distributed on the internet or in leaflets, and enabled allergic patients to plan events avoiding the peak pollen seasons. As pollen levels in the air were affected by meteorological conditions on a global level, international co-operation between governments and meteorological groups would be needed to improve services in the future.

156  See Back

157  See Back

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