Medical Device Link.

Originally Published IVD Technology September 2001

View from the continent

In the EU, popular and political sentiment can make some IVDs a tough sell

John F. Place is director general of the European Diagnostic Manufacturers Association (Brussels) and a member of the IVD Technology editorial advisory board. He can be reached via edma@edma-ivd.be. EDMA's Web site is http://www.edma-ivd.be.

To find out how popular and political sentiment is affecting the current climate for diagnostic sales in Europe, IVD Technology editor Steve Halasey spoke with John F. Place, director general of the European Diagnostic Manufacturers Association (Brussels) and a member of the IVD Technology editorial advisory board. In excerpts from the interview, published here, Place describes current progress toward implementation of the EU's IVD Directive and explains some of the trends that are influencing the sales of IVD products in Europe.

IVD Technology: Have all of the member states now transposed the IVD Directive into national legislation?

John F. Place: The answer, of course, is no. However, it doesn't really make any difference, because companies can proceed as though the directive has been transposed. For example, if a company is selling an IVD in Belgium and wants to follow the directive and CE mark the product, it can go ahead and do that even though Belgium is one of the countries that haven't yet transposed the directive.

In the past, Belgium has often been one of the last to transpose EU directives into national legislation. That was true for the Medical Devices Directive, and it's true for the IVD Directive now.

Member states are obligated to transpose directives into national law, and if they don't do so they may be fined at some point. The European Commission often brings cases against countries for not transposing laws, and the courts may eventually fine them for late transposition.

How many nations have transposed the directive?

Ten of the 15 EU countries have completed transposition. In addition, non-EU nations of the European Economic Area, such as Norway, will also be transposing the directive into nationally equivalent legislation.

The IVD Directive includes by reference a set of separately written common technical specifications (CTS) for Annex II products. Those specifications were completed last year; what is their current status?

As far as I know, they have not yet been published in the Official Journal of the European Communities. How-ever, there is a readily available draft version in circulation. So again, this is a document that companies can use even though it has not been officially published. It's very unlikely that there will be any major differences between the current draft and the official version that will be published.

So the draft CTS is a de facto requirement connected with the directive even though it's still not official?

Right. And notified bodies that undertake to certify compliance with the CTS, since they lack any other information, must use the draft version that's available.

Since the CTS was compiled, have there been any objections raised against the current draft?

Not really. The draft CTS applies only to products identified by the directive in Annex II, List A. The specifications take the common denominator of approval factors that were already being required for such products in several countries, in particular Germany and France.

It's quite an extensive list.

It is, yes. But previously there had been differing national requirements, in Germany and France for example, that specified how many positive and negative patient samples manufacturers had to include in their product testing. The CTS reduces all of those varied national requirements to a single set of standards and creates a level playing field so that all countries now have to apply the same standards.

Some countries have not previously had requirements for Annex II products, and therefore this will be new to them. But, in fact, most countries were waiting for the CTS to be completed before putting out national regulations on Annex II products.

Have you heard any complaints that there are not enough notified bodies to cover all of the areas required by the directive?

No, I haven't heard any complaints about that, and in fact there are quite a number of notified bodies. The last time I looked, there were about 10, most of them in Germany, but I think there have been some more bodies notified since then. The only products where notified bodies have to be brought in are the Annex II and self-testing products. For other, ordinary products not in those lists, companies don't actually have to use a notified body.

Do you think many manufacturers will take the quality systems approach and use a notified body that way?

They may well do so, yes. If they do, it would be natural to use a notified body where needed.

Diabetes Monitoring

In the United States, one of the largest growth markets for IVDs is that of self-monitoring for diabetes. Is the growth potential in Europe as large as it is perceived to be in the United States?

It sure is. EDMA coordinates a European market estimate based on an audit of invoiced sales conducted by an independent auditor. In this year's estimate, all indications are that the fastest growing area is still self-testing for diabetes, which is growing 18% per year.

That level of growth suggests that the national authorities—the agencies in charge of administrating reimbursement and payment—are fully supportive of that kind of testing. Is that true?

Yes, I think the message has come through loud and clear on diabetes and certain other diseases, especially in certain countries. About two years ago, the British government gave more money to diabetes testing, for example, and that's certainly been the case in Sweden.

So, yes, I think the message is getting through that in order to have good treatment, you have to have a good diagnosis—or at least the right information on which to base the treatment. And that message is also coming through for certain other types of tests, such as chlamydia testing.

Has it been hard to make and win this argument with the national authorities?

Well, I think so, because IVDs have always had the problem of having no image.

Very few people outside the narrow circle of those concerned with in vitro testing understand what it is, what it does, or what it's used for. In Europe, patients give a blood sample and later come back to the doctor to get the results. But they don't really know what in vitro testing is. They have no feel for it, no conception of it.

That's one of the industry's problems. Once people begin to wake up and use the Internet to get information about the uses of in vitro testing, it will become something they'll ask for. Then it will become more important, and the industry and the profession will have an image.

Are the national authorities persuaded by the economic argument, for instance in the case of diabetes monitoring, that increased testing and monitoring decreases overall healthcare system costs?

Yes, that's the argument that's really taken hold, I think. Politicians generally have a shorter horizon than the long-term effects of healthcare. A politician who's looking at his mandate over the next couple of years is probably not going to be interested in something that is going to save money in five years' time.

But increased testing seems to be winning by means of the economic argument. That's the one they really listen to, and that's one of the reasons why the diabetic testing market is increasing. In Europe, other sorts of arguments by themselves aren't likely to win though. You have to come with an economic argument as well.

Is the receptivity of the national authorities very different country by country?

Not so far as I'm aware, but some have more money than others. There are still quite large differences between the countries of the European Union and those of Eastern Europe, which just don't have money available.

The situation is quite different in Eastern Europe and, as a European association, EDMA is interested in what's happening there. That region offers medium- and long-term growth opportunities for European industry.

Molecular Testing

Is the growth of molecular technologies in Europe as strong as it is in the United States?

Yes, I think so. But genetic testing is a special case. There's a certain amount of genetic testing going on in the United Kingdom, but otherwise there's not a lot going on in Europe. In fact, genetic testing is yet another political hot potato. It's something that people don't really understand and haven't made up their minds about.

The general tenor of European sentiment is one of gentle dissuasion. People are likely to ask why anyone would do genetic testing, or to question whether it is ethically or morally correct, rather than to look at the exciting possibilities that genetic testing has to offer.

There are also differences between clinical applications and testing for the benefit of the individual without a clinical application. For example, what if parents wanted information about whether their child had a propensity to a family disease and intended to use that as the basis for making lifestyle decisions? Wouldn't that be different?

Because the IVD industry is really globalized, there's not a lot of difference between what the industry is doing or discussing in the United States or in Europe. The big differences are in how the different governments regulate molecular technologies and how the populations view them.

Is the resistance in Europe amongst the general population likely to slow down the development of molecular products?

I think it already has to some extent. We have a big resistance in Europe to genetically modified organisms, and I think there's a general mistrust towards biotechnology in general, but especially toward genetic engineering.

Although there is general resistance to biotechnology, people probably have a more favorable view when it's applied to medicine. But then the media has a propensity to run horror stories about genetic testing.

So anytime you attach the word genetic to something in Europe...

There's a negative connotation.

...you need to be prepared to duck.

That's right. In general, that has probably held back European development in the area. On the other hand, governments are interested in pushing biotechnology and they're trying not to introduce restrictive legislation. So research is going ahead, but the actual application of any of it in the form of products is probably being held back.

Will Europe follow the way the United States handles various genetic-testing issues—such as the ethical issues—or will the EU define its own path?

Europe is watching, but it is also trying to find its own solutions. Europe may be thinking that whatever is happening in the United States is going to happen here in a few years' time. There's certainly a lot of discussion here in intellectual circles about the ethics of testing.

Europe has not had such violent discussions about abortion issues as have taken place in the United States, and one of the reasons is that Europe is not a single culture. Topics such as abortion are very much nationally dependent: some countries argue that it should be available freely, while others argue that it is illegal or immoral and shouldn't be available. We haven't had a Europewide discussion about that issue, because it's more a national discussion.

The same is happening with genetic testing. The discussions are going on at the national level, where ethical and moral attitudes are somewhat bound up with religion. Where the religions are different, the attitudes will be different.

How do Europeans view the issue of confidentiality with regard to genetic testing?

Having worked in a hospital, I don't really believe there is such a thing as confidentiality in that setting. Once test results are available in a provider's system, they are very easily accessible throughout that system where potentially hundreds or thousands of employees have more or less access to them. I really feel rather dubious that you can keep information confidential in a centrally run healthcare system.

It is essential that genetic testing results are kept confidential, and I think the only way to do that is to keep them to yourself. One way to accomplish this would be for the subject to send a coded sample to a lab, so that the lab wouldn't know the identity of the subject. The lab could then release the results over the Internet, and the individuals could access them using their unique code. Then the subjects have complete control over the results and can choose to discuss them with their doctor, family members, or whomever.

Short of setting up a system like that, all we can do is make it illegal for insurance companies and employers to test people without their knowledge. Otherwise, it would be quite easy for people to pick up a sample of hair or something and have it genetically tested.

What would be the reasons that someone would want to undergo genetic testing?

There may be certain situations where it's to the advantage of the individual concerned to be genetically tested. If you're working with animals, for example, and you have an allergy to them, it would be useful to be tested for that. It could be useful for individuals to know beforehand whether they're particularly unsuited to a certain job. For instance, there are many industries where allergies or susceptibility to certain chemical compounds could be detrimental; individuals might want to know if they're susceptible —but everybody else shouldn't have access to that information.

In the United States, compliance with the Health Insurance Portability and Accountability Act is the current focus of a great deal of activity by healthcare providers. What is the European Union's equivalent?

There is a Data Protection Directive, which is being transposed into national law at the moment. Pharmaceutical companies have been especially concerned about the terms of this directive, because it severely limits the way they can send clinical trial information across borders—including across the Atlantic to the United States. And this has led to a big discussion about data protection between the United States and Europe.

IVDs and Drugs

How do Europe's national health authorities view the relationship between IVDs and pharmaceuticals? Is there any effort to monitor the effects of therapeutic agents using IVD testing?

Most drugs undergo clinical trials where it's decided that such-and-such is a good dose for adult patients with a certain disease. But we don't do an awful lot of testing to discover the effects of various levels of medication in individual patients. Maybe we should be doing more of that.

That area of research, pharmacogenomics, is certainly one that's been highlighted as a potential high-growth spin-off of the Human Genome Project. Will it be difficult to convince European national authorities to pay for such research?

I think so, because the resulting drugs are going to be very expensive. There are two sides to pharmacogenomics. One side is devoted to developing particular drugs to suit the patient. That's the expensive route.

The other side is devoted to picking out patients to suit the drug. In the past, many pharmaceuticals have become unpopular or even failed to gain market approval because of their side effects in some patients. But if we can use testing to predict which patients will get these side effects, we might be able to bring back some of those older drugs for use on patients who would not get the side effects. That would be a big step forward, because there would be no need to conduct clinical trials for those drugs; all that work has already been done.

I think that sort of thing will happen a lot more, because the other route—developing new drugs for particular groups of patients—will be much more expensive. And healthcare systems, whether they are publicly or privately funded, are generally resistant to spending more.

The overall costs of healthcare are increasing, and in Europe, they're going up faster than growth in the GDP. Current healthcare costs in Europe average about 9% of GDP, which is quite modest by American standards. So Europe could certainly afford to pay more for healthcare.

Copyright ©2001 IVD Technology