Organizations representing patients, healthcare workers, academics, health experts and the medical technology industry have reported the creation of a new alliance, Health First Europe (Brussels, Belgium). Health First Europe said it would launch an awareness campaign this year to "encourage reflection and dialogue on the future of healthcare in Europe at a time of demographic and technological revolution."
It said it plans to host a number of high-profile events this year, such as a "medical devices of the future" exhibition at the European Parliament in Brussels, with the aim of "further advancing the European healthcare debate." Efforts also will be focused on a number of international awareness days, such as World Parkinson's Day, through partnerships with related organizations to "draw attention to patients' needs and to the technologies and solutions available."
The primary aim of the new alliance, according to its organizers, is "to ensure that equitable access to modern, innovative and reliable medical technology and healthcare is regarded as a vital investment in the future of Europe." Health First Europe said it is pushing for "a truly patient-centered healthcare where every European citizen is able to benefit from the best medical treatments available." Alliance members added that they believe health should be seen as "a productive economic factor in terms of employment, innovation and economic growth."
Barry Wilson, chairman of the board of the European Medical Technology Industry Association (Eucomed; Brussels, Belgium), said, "New life-saving breakthrough therapies in medical technology are delayed in their availability to patients across Europe due to inadequate funding and reimbursement." He said the fundamental issues remain the low percentage of gross domestic product spent on healthcare and the way that healthcare resources are allocated. "In defining their economic priorities, the EU member states should focus more on the needs of their aging populations," Wilson said. "European citizens want and need better access to life saving and life-enhancing medical technology."
John Bowis, a member of the European Parliament and a former UK Minister for Health, said the establishment of Health First Europe "comes at a time when patients, the medical profession and industry, as well as relevant authorities, must look at how Europe will maintain the healthcare provisions that citizens have come to expect." For example, he added, "the greying of the European population and the rapid progression of medical innovation pose a number of important challenges and opportunities today. In order to meet these challenges, a rethink[ing] of European healthcare systems is required."
Saying that patient and clinical access to "modern, innovative and reliable medical technology and healthcare" should be regarded as a vital investment in the future of Europe, Albert van der Zeijden, chairman of the International Alliance of Patients' Organizations (London), added: "We must ensure that access to, and availability of, the most effective treatments and medical devices are made available to all patients."
Noting that healthcare often is seen as a burden on public finances, Health First Europe said it believes that the opposite is true. In fact, the organization said in a statement that "one can argue that 'Health=Wealth.'"
Felix Unger, MD, president of the European Institute of Medicine (Vienna, Austria), said healthcare "is still all too often considered as a drain on public finances, as a 'bottomless pit.' Yet healthcare is a key economic factor in terms of employment, innovation and economic growth." He said a healthy society "is an indispensable prerequisite of a flourishing and wealthy society," adding that "sustainable improvement to healthcare leads to an increase of human capital as a source of wealth. Effective healthcare is therefore essential to maintaining and improving the quality of life and economic growth."
European Medical Association (Brussels, Belgium) President Vincenzo Costigliola, MD, said the approach to healthcare in Europe "must change from one of reactive response to one of active promotion of good health. This implies a break with the traditional structures of healthcare provision to allow the design of new systems, individually tailored to the needs of each patient."
Health First Europe said that as Europeans live longer, "the burden of chronic disease is constantly increasing. Homecare and self-care, for example, can help to reduce the need for hospitalization and can contribute to building new and more flexible modes of healthcare delivery."
Eucomed urges approval of e-labeling option
Urging that electronic labeling of medical products be allowed as an alternative to printed leaflets, Eucomed last month submitted a proposal to the Medical Device Expert Group that the European Commission's Medical Devices Directive 93/42/EC be adopted to allow such labeling. The trade association said e-labeling should be permitted only for medical devices intended to be used or handled by professional users in healthcare facilities. "The information should be easy to read, using commonly available software formats on a standard PC and also available in paper form upon request," it added. "Moreover, the manufacturer should take the appropriate measures to protect the integrity of the data available on its web site, and the web site address must be placed on the product label."
The Medical Devices Directive refers to the use of a "leaflet" and states that medical devices must be "accompanied" by the information for use, the trade association said. But, "with the enlargement of the European Union, which is set to bring the total number of EU languages to 20," Eucomed said the size and volume of the paper instructions for use "could practically double."
The association said, "This will almost double the size and volume of the existing instructions for use." It noted that some packaging designs would need to be revised in order to accommodate the increased volume of instructions. "This translates immediately into an increased transport and storage cost, as well as increased environmental burden in the form of paper waste," it said in a statement.
Eucomed said the provision of data in an e-format would give "more flexibility to both the user and the manufacturer." It said the ease of storage, retrieval and filing are "important advantages of an e-format, as is the ability to search for keywords in the instructions for use." In addition, the association said a manufacturer can provide "higher-quality information and new tools for better understanding and illustration of the correct use of the device," such as 3-D, animation, live-case video, more attractive design, online training and certification.
It defined electronic labeling as "the information necessary for the safe and correct use of the medical device provided by the manufacturer to professional end users on an electronic support" such as Internet, CD ROM, or pacemaker programmer that displays the instructions for use in the operator's language on the built-in-screen, which is accessible while the device operates.
The association said the commission plans to issue its proposal on the review of the directive sometime this year.
Improved chronic disease management eyed
Specialist teams across the UK will provide advice, care and treatment for those suffering from chronic diseases as part of a new plan outlined by Health Secretary John Reid. A program to establish case-management demonstration sites within each of the 28 Strategic Health Authorities in the UK will be launched in 2004-2005. The improved management of patients with diseases such as asthma and diabetes will help reduce the need for visits to general practitioners (GPs) and hospitals, Reid said.
The UK Department of Health said people with chronic diseases account for up to 80% of GP consultations, or about 180 million visits a year. Existing chronic disease management programs in the United States have cut hospital admissions among the target group of patients by up to 50%, he said, adding that such programs are being tested by the National Health Service.
"Chronic disease has a huge impact on people's quality of life and on their families, and it consumes a large proportion of health and social care resources," Reid said during a "Managing New Realities Integrating the Care Landscape" conference in Birmingham. It is estimated that there are some 17.5 million people in the UK living with chronic conditions, while the World Health Organization (Geneva, Switzerland) says that the worldwide incidence of chronic disease in persons over the age of 65 will double by 2030. "The whole point of an effective health system must be to reduce the numbers of people who have to go to [the] hospital," Reid said. "Acute care will not solve the pain and distress of those 17.5 million people. Older people and those with long-term chronic disease suffer particularly where services are fragmented."
While noting that there is "a lot happening already on both the national and local levels to introduce better chronic disease management," he said such efforts need to spread. "That is why we are launching a program to establish case management demonstrator sites within each Strategic Health Authority, building on [the] existing experience of developing and implementing these approaches."
Reid said the demonstration sites planned under the new program will introduce "active management" of high-risk patients. "They will provide coordinated, patient-centered care within a systems approach to keep patients with the greatest burden of illness healthy for longer." The sites, which are in the process of being selected, will maintain health and promote well-being; detect early changes in condition and prevent unnecessary admissions; and, when admissions do occur, facilitate safe, early discharge.
Reid said the results of a pilot project involving active management of conditions at Castlefields Health Center showed a 15% reduction in admissions for older people, while the average length of stay fell by 31% from 6.2 days to 4.3 days.
Extra 100M for study of three diseases
Using the model provided by the success of the National Cancer Research Networks, the UK will use an extra 100 million to be set aside in the national health budget by 2008 to fund studies into the treatment of Alzheimer's, stroke, diabetes and mental health. It also will go toward developing new therapies for children.
Health Secretary John Reid said the creation of the UK Clinical Research Collaboration (UKCRC) will bring together the National Health Service (NHS), Medical Research Council, medical charities and industry "to speed up the development of new medicines and treatments from the laboratory to the patient's bedside." The National Cancer Research Network has led to 34 cancer networks being established in England. Each network brings together clinical teams, primary care trusts, voluntary sector and patients for larger, multicenter clinical trials.
In order to allow more patients to benefit from the latest scientific advances, the UK Clinical Research Collaboration will give more patients the chance to take part in clinical trials.
The combined government budget for medical research is currently 1 billion and will rise to 1.2 billion by 2008. The NHS will receive an additional 25 million each year for the next four years, and it is anticipated that additional resources will be made available to the Medical Research Council.
Pharmacia Diagnostics sale gets EU nod
The proposed $575 million sale of Pharmacia Diagnostics (Uppsala, Sweden) to two firms by Pfizer (New York) has gotten the go-ahead from European Union regulatory officials. An agreement by Pfizer to sell the 30-year-old operation to European private equity firm Triton and PPM Ventures, the private equity arm of Prudential, was approved by EU competition officials last month.
Pharmacia Diagnostics was acquired by Pfizer in its buyout of Pharmacia (Peapack, New Jersey) a year ago. Hank McKinnell, Pfizer chairman and chief executive officer, said last year that the Pharmacia Diagnostics business "is a successful and growing business, with an outstanding reputation and strong position in its industry. However, this business is not aligned with Pfizer's strategic focus on our three core businesses of human pharmaceuticals, consumer healthcare and animal health." Pharmacia Diagnostics makes equipment used in in vitro allergy and autoimmune diagnostic testing. Its blood-test systems are used by hospitals and laboratories in the diagnosis and monitoring of patients for upper-respiratory diseases such as allergies and asthma. The company has about 1,100 employees in 60 countries.
NICE backs EVLT procedure
Diomed Holdings (Andover, Massachusetts) reported that the UK's National Institute for Clinical Excellence (NICE; London) has issued guidance documents for users and patients indicating that its EndoVenous Laser Treatment (EVLT) procedure "is safe enough and works well enough for use in the National Health Service." The company said the document provides it with a solid platform from which to accelerate the use of EVLT for treatment of the long saphenous vein, the most common form of varicose veins, in public and private hospitals throughout England and Wales.
Kevin Stearn, director of Diomed Ltd. (Cambridge, UK), a subsidiary of Diomed Holdings, said the NICE guidance "provides [the company] with a solid platform from which to accelerate the use of EVLT for treatment of the long saphenous vein, the most common form of venous insufficiency or varicose veins, in public and private hospitals throughout England and Wales." He noted that the issuance of the guidance document was based on "a long and thorough evaluation of the safety and efficacy of EVLT clinical data spanning more than three years of patient evaluation."
Breast implant gets CE mark
Mentor (Santa Barbara, California) said its low-height, Contour Profile Moderate Plus Memory Gel breast implant has received Class III CE mark approval. The approval extends the company's Elite silicone gel product offering in Europe, where it offers both round and shaped breast implants filled with Memory Gel as well as saline-filled breast implants, Becker implants for single-stage breast reconstruction and a range of tissue expander products.
Joshua Levine, president and chief operating officer, said surgeons and patients had requested that Mentor introduce the new anatomically shaped, low-height breast implant with higher projection. Memory Gel is a cohesive silicone gel formulation used to fill all of Mentor's Elite silicone gel-filled breast implants around the world. By varying the components of the gel, the company said it is able to produce a wide selection of products ranging from a very soft to a very firm consistency.
Pulsion expands product line
Pulsion Medical Systems AG (Munich, Germany) said it has expanded its product line with a system for the early and less-invasive diagnosis and therapy of sepsis. The CeVOX system with a disposable optical probe continuously measures oxygen saturation of the blood directly before the heart and gives information about the oxygen balance of the organism and the imminent severity of sepsis.
Hartmanis to head Gambro research
Maris Hartmanis has been appointed head of corporate research at Gambro AB (Stockholm, Sweden), effective Sept. 1, and will be based at the company's corporate headquarters. He will succeed Leif Smeby, who will become senior vice president and chief science officer. Most recently, Hartmanis was president and chief executive officer of Swedish-based Gyros AB and has held positions at KabiGen AB, Pharmacia and Amersham Biosciences. Gambro is a global med-tech company with leading positions in renal care services and products, and in blood component technology.
EUR 200M for nanotechnology
The German Ministry for Education and Research is providing financial support for research into nanotechnology. During the next four years, the ministry will commit EUR 200 million to projects in the nanotech field, with particular emphasis on applications in the pharmaceutical and medical, automotive, optic and electronics sectors.