EUROPEAN IVD MARKET
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Christine Tarrajat is director general of the European Diagnostic Manufacturers Association (Brussels). She can be reached at c.tarrajat@edma-ivd.be
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To find out whether Europe's IVD industry has made good progress toward the continent's larger goal of a European union, IVD Technology editor Richard Park spoke with Christine Tarrajat, director general of EDMA. In this interview, Tarrajat talks about the unique challenges facing IVD companies in Europe. She also discusses regulatory trends, the ongoing problem of late payments, and the steps EDMA is taking to raise awareness of the value of diagnostics.
More information about EDMA and its activities can be found on the organization's Web site at www.edma-ivd.be.
IVD Technology : What unique challenges do European IVD companies encounter?
Christine Tarrajat : Europe has different countries, different national health systems, and different languages. It's not just one big continent; it's several countries, and we have to deal with that. For example, in the IVD Directive, it is stated that the decision to translate test instructions into a country's national language is left to the member states of the European Union. As a result, we must provide big booklets that contain the different instruction translations, sometimes larger than the test kit itself.
This is why EDMA is working very closely on the possibility of supplying instructions by other means—via the Internet for instance. The European Commission (EC), in collaboration with several competent authorities and EDMA, is currently developing a guidance document. This guidance would allow IVD manufacturers to provide instructions through means other than paper copy. However, in its final stage, the paper must still be endorsed by the European Medical Device Expert Group, which is the formal commission group that endorses this type of guidance.
There is also a problem with late payments to manufacturers by health institutions and hospitals in countries like Spain, Portugal, Italy, and Greece. EDMA has set up a task force to work on this and is participating in a study with the EC to evaluate the impact of the Late Payments Directive, which allows interest to be levied on overdue commercial payments.
The problem is not with the Late Payments Directive itself. The legislation has been correctly transposed by all the EU member states, with some acceptable delays. But the national laws transposing this directive are not respected. In some countries, there are payments that have been delayed for more than 600 days. For a small company, this can cause big problems.
We are also acting with the EC to respond to countries that infringe the directive. For example, Greece published a law last year that called for the discount and renouncement of interest to be paid. These provisions represent an infringement to the Late Payments Directive. We have to work with our national authorities, which monitor payments, to find an adequate response.
We also have problems with tenders in some countries, which is mainly a problem with general contractors. In some countries, hospitals will hire a general contractor not only to provide IVDs but also other things.
In 2004, the EC passed the Public Procurement Directive, which coordinates procedures for the award of public works, supply, and service contracts. Member states had until January 2006 to transpose this. So now EDMA is working to check which countries have in fact transposed it, how it has been transposed, and if it has been correctly transposed.
You mentioned initiatives that would shift lengthy test instructions to the Internet. Is there a general trend in Europe of moving records and documents to an electronic format?
We are definitely pushing for this, but of course for IVDs used by laboratory professionals. For self-testing, the necessity to provide instructions for use together with the device and in a paper format is clearly recognized and not challenged. But all labs have computers and access to the Internet.
The IVD Directive clearly separates IVDs into two categories: self-tests and professional use tests. The problem becomes more complex for medical devices because there is such a wide variety. As a result, the EC has decided to start with IVDs. Diagnostics are well characterized, well defined, and commonly used by professionals. Of course, the EC has agreed to look at medical devices next.
What type of IVD regulation does Europe plan to enact, and what role can EDMA play in the process?
One regulation that we have had trouble with is the EC's restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). The directive restricts the use of certain substances like mercury, lead, and cadmium. Many IVD manufacturers say that this can create huge costs for the industry.
Before the directive was published in 2002, medical devices were excluded from these regulations. However, a proposed revision would end this exemption. This would mean that all medical devices, including IVDs, would fall under the scope of the RoHS Directive.
The mood of recent meetings at which member states were present has been that the current carte blanche exemption for medical devices must not continue. The IVD industry through EDMA has provided detailed input into the review process. Thus, the unique nature of IVDs has been recognized and noted, including the long and complex design cycles and the use of tried-and-tested designs and components. Justification has been provided—and seems to have been accepted—for specific exemptions, including the use of lead or cadmium in electrodes and leaded solder for specific heat-sensitive components.
More importantly, there is an understanding of the need for a long transition period. The IVD industry needs to organize itself for RoHS compliance and to test the viability of lead-free solders and other technologies prior to their use in actual devices.
Another important issue involves the EU's metrication directive, which states that only measurements expressed in the international system of units (SI) are allowed. The commission and its directorate general of enterprise will hold a consultation on this issue which is expected to launch in September 2006, and EDMA will be an activeparticipant. The directive prohibits dual labeling—for instance, the inclusion of American and metric units. This provision can cause problems because some labs are used to dealing with non-SI units. EDMA will provide examples and rationale to the commission in support of continuing to provide dual labeling. We believe that if dual labeling and non-SI units are prohibited, there will probably be product safety consequences. The people who are used to the other units will not understand the new units, and errors will be caused.
This directive was originally published in 1980, but has been postponed twice with transition periods of 10 years. The compliance date has been extended to the end of 2009. But if it's not postponed one more time, the European IVD industry could face significant problems.
Doing Business in Europe
What advice would you give to a small IVD company outside Europe on the best way to approach the European market?
My first suggestion would be to join an organization like EDMA. If a company becomes a member of EDMA, it will have access to information at a very early stage. It will have the opportunity to discuss problems with other people and work to try to find a common solution.
Of course, in the case of the RoHS Directive, EDMA is working actively for the benefit of everybody in the industry, not only its members. But members do become aware of this kind of information at a very early stage, which gives them a competitive advantage over other companies. EDMA members can make faster decisions and save staff time. Acting alone, it's very difficult for a company to be aware of all the ongoing European regulations. At EDMA, companies share resources and can become informed through working groups and documents. EDMA also analyzes situations through its research project funding and can provide guidance and solutions.
What role does EDMA play in shaping European reimbursement policies?
This is a difficult question to answer because health policies are national. EDMA has affiliated national associations in 20 countries. Each of these deals with its own national health policies.
What I can say is that through EDMA and these 20 national associations, more than 25 employees are specifically working for the European IVD industry, representing over 550 companies and more than 1000 legal entities. These affiliates collaborate on issues, but also work on their own specific issues like reimbursement. The reimbursement system is not transparent at all in Europe.
A Focus on Health
Which are the health priorities for European institutions?
Many of the priorities today deal with women's health, which was a focus of the recent Austrian presidency of the EU. And it's true that Europe has been talking a lot about this.
Health First Europe—an association of patients, healthcare professionals, and industry—presented a paper at a European Parliament lunch debate on June 27. It was called “Women's Health Equals Wealth” and was contributed to by EDMA. The paper points out the need for prevention and the importance of screening women for diseases.
Another priority is cardiovascular disease, which has been linked to obesity and diabetes. On June 28, at a conference of the Global Harmonization Task Force in Lübeck, Germany, I gave a presentation on emerging technology combination products. One issue I discussed is the promise of insulin micropumps and the parallel development of self-monitoring systems with continuous measurement in the control of diabetes. Such developments will make an artificial pancreas available that could self-regulate insulin infusion, taking into account the glycemia concentration that is continuously measured. The EC has invited member states to formulate framework plans that address diabetes.
The EC has also held public consultations on nosocomial infection. EDMA sent comments on this issue in January. As nosocomial infections will likely become an increasing burden in Europe, the EC believes it may be appropriate to make suggestions in the area of infection control. Comments made on a draft document during the course of this public consultation will be incorporated with those from international experts and communicable disease surveillance authorities to form the basis for final recommendations.
Osteoporosis has also been an important topic for European institutions. In June, in Vienna, the Austrian Federal Ministry of Health and Women organized a European summit conference on the prevention and therapy of osteoporosis. The Austrian ministry will prepare a report on expert recommendations by the end of the summer.
Other important issues include tuberculosis, which is linked to HIV, cancer, chlamydia and other sexually transmitted infections, and avian flu.
With the identification of these priority issues, how do IVD manufacturers and EDMA plan to work with the EU Ministries of Health to address them?
For women's health, EDMA has collaborated with Health First Europe and the European Parliament. With nosocomial infection, we're consulting with the European Commission. We will continue to follow the issue and the draft recommendation to make sure that our comments are taken into account. Regarding the issue of osteoporosis, EDMA had a representative at the European summit and was involved in the discussion.
We always take the opportunity presented by European institutions to provide comments on and participate in the push for prevention and screening. Early screening and diagnosis is important because most of the time these infections are silent. It also saves money in the end, because treating diseases at a late stage can be both damaging and expensive. For example, with diabetes, early diagnosis can help avoid complications such as leg amputation and blindness.
Promoting the Value of IVDs
What efforts are being made in Europe by EDMA to increase awareness of the value of IVDs?
EDMA has begun a campaign to present laboratory testing as the valuable asset that it is, highlighting its cost-effective component of health maintenance and disease management. The overall aim is to ensure that healthcare resources are properly allocated and appropriately used.
To this end, EDMA has undergone an extensive priority-setting exercise over the last few months to reinforce its role as the representative voice of the IVD industry in Europe and to better serve its members' interests and need for information.
The group's efforts are focused on restructuring how it works and creating new task forces. A new communication and policies committee is helping define activities and actions to respond to these new challenges. In particular, efforts are being devoted to the collection, evaluation, and monitoring of peer-reviewed publications that demonstrate the health and cost benefits of IVD testing.
We have also redesigned our Web site to reflect a new EDMA image—to promote our increased focus on communication. As an example, we have signed an agreement with the American Association for Clinical Chemistry to translate and adapt the content of its Lab Tests Online Web site into different languages—currently German, Spanish, Italian, Hungarian, and Polish. Lab Tests Online has been developed by clinical laboratory professionals to help patients and caregivers better understand the many clinical lab tests that are a routine part of the diagnosis and treatment of diseases. A version of the site was launched in the UK in 2004. It now attracts more than 140,000 visitors each month.
Although patients and their families are the primary audience for the site, about 25% of users are physicians, nurses, or other medical professionals. We have the support of several competent authorities, as well as of clinicians, in this effort and anticipate that these sites will all be online by early 2007.
Another, complementary Web site that we are translating into different languages is MedicalLab. This site explains the differences between tests and how they are processed in laboratories. Today, for many patients, when they provide a test sample to their doctor, what happens to it is a black box. MedicalLab has been a collaborative project between our association in the Netherlands and EDMA. Dutch and English versions are already available, and French and Portuguese ones will appear online soon.
EDMA has also been happy to see that MedicalLab has international appeal. The Japanese Association of Clinical Reagents Industry has expressed interest in translating the site into Japanese.
Do EDMA's education initiatives extend to the IVD industry as well?
Absolutely. A similar exercise is being developed for trade matters that affect diagnostics manufacturers in Europe. Some of the areas of focus include the late-payments problem and public procurement systems. EDMA's aim is to encourage and help with the sharing of information between European countries.
It's important to point out that these exercises run in parallel to the reinforced information and communication activities addressed both to policymakers and the public in general. The recently redesigned EDMA Web site is at the heart of this strategy.
Similar concerns about adequately expressing the value of diagnostics have been raised in the United States, notably in a July 2005 report by The Lewin Group that was commissioned by AdvaMed. In your experience, what have been some of the primary obstacles to spreading information about IVDs?
It's true that as stated in the Lewin Report, IVD results are at the beginning of as much as 70% of healthcare decisions. It's also true that IVDs probably don't receive the attention that they should. Diagnostic testing has real consequences on medical treatments. However, it's clear that these tests are sometimes not perceived as important by politicians.
We have conducted studies in Europe and found that the cost of IVD products represents less than €20 per capita per year in most European countries. This is less than 2% of total healthcare expenditure. And sometimes it's even less—as little as €10 per person.
As a result, when the health systems want to save money, they have a tendency to cut IVD expenses. However, savings of 2% of total healthcare expenditure will not have a great effect. Instead, greater investment in IVDs could effect real long-term benefits by avoiding a lot of expensive treatments and long hospital stays.
EDMA has renewed its efforts to reach IVD players that have not been involved to date in the association's work and invite them to join. Informing patients about the valuable contribution of IVDs to healthcare is a common and passionate task for all IVD companies, and EDMA and its members are committed to working to spread the message around Europe and beyond.
What future technology prospects do you see for the European IVD market?
In the past, diagnostic technologies have changed rapidly. There have also been a lot of recent developments.
Many people have been talking about nanodiagnostics, in which new techniques have enabled the miniaturization of biosensors in IVD testing. The goal is that ultra-sensitive biochips will be able to provide a full medical diagnosis from one sample.
Personalized medicine also holds great promise. The close cooperation between diagnosis and intervention will help tailor individual therapies to unique metabolic fingerprints. The goal is not only to match the proper diagnosis to treatment, but to predict which drug and dosage will work best for each patient. With these outcomes in mind, it seems likely that cancer therapy will be based on individual molecular fingerprints. In addition, the increased understanding of genomic and proteomic information will diminish the impact of cardiovascular and other multimorbid metabolic diseases, as well as mental illnesses.
The prospects of building combination products—such as the efforts to create an artificial pancreas—are encouraging. For example, combined in vitro and in vivo techniques could lead to minimally invasive implantable devices. Theranostics—the merging of diagnostics and therapy—could become a major healthcare tool in the future. One scenario would involve nanoparticles that carry therapeutic agents into diseased cells to check for overdosage, thus preventing drug-related poisoning. However, it is important to note that and such new technologies would also produce regulatory challenges.
Similarly, although many people are talking about genomics, the real revolution is probably in proteomics—the study of the complete set of proteins and how it is expressed in a single cell. This is leading to a better understanding of disease and improved drugs and diagnostics.
The EC has created a group specifically to discuss new and emerging technologies in medical devices. EDMA has been involved in this conversation and is very much dedicated to the future developments of innovative technologies.
Christine Tarrajat is director general of the European Diagnostic Manufacturers Association (Brussels). She can be reached at c.tarrajat@edma-ivd.be.
