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Innovations | Feb 2015

Confronting the Changing Landscape of EU Health Care Regulations

Although change can be daunting, it can also be opportunity-filled.

Things are busy changing. In the blink of an eye, we may realize that we no longer understand the rules of our trade. What can we do to ensure that we are we ready to work and flourish in ophthalmology despite new EU regulations?

Having attended a number of ophthalmic conferences on both sides of the Atlantic over the past decade and more, I should have had adequate forewarning that the landscape in Europe was going to change. In the back of my mind, however, I always thought that it could never get any worse than the FDA process, and that European physicians would always be assured access to cutting-edge technology.

The truth is, I am no longer sure of the validity of those thoughts at this moment.

CE MARK VS FDA APPROVAL

I assume we would all agree with the following:

• We want access to good treatment options and diagnostic devices for our patients.
• We want them as soon as they are proved to be safe and effective.
•Europe does not currently have an FDA equivalent.
•We have the CE Mark, but this validates only the manufacturing process.
• Clinical safety and efficacy currently follows through clinician use, often in informal study settings.
• FDA studies add value to the information available to clinicians.
• FDA studies are expensive, the parameters cannot be changed once started, and they often come late in terms of European ophthalmologists' experiences.

As an example, topography-guided LASIK received the CE Mark, and therefore was able to be used clinically in Europe, in 2004; yet it received FDA approval only recently—after Europeans had been using the technology for almost 10 years. If an FDA-type regulatory body had been present in Europe at that time, this technology might have been introduced to us only in the past year or so. Another example is that of CXL for treatment of keratoconus and corneal ectatic disease, which is still not FDA-approved but received the CE Mark in December 2006.

HOW TO NAVIGATE THE CHANGES

I hope you have read some of the excellent contributions in this issue of CRST Europe by experts in the field describing various issues surrounding the new European regulatory environment. I would like to share some thoughts on how I propose to navigate my way around these changes. There are other solutions too, and hopefully this series of articles will motivate like-minded clinicians to discuss this issue and to help us all find the best routes to ultimately provide our patients with the greatest technologies and treatments in the safest and most expedient manner possible.

DO YOUR PART

  • Keep excellent clinical notes and do frequent clinical audits so that, when it becomes mandatory, it is already a way of life for physician and staff.
  • Become more vigilant and observant, especially when working with new technologies that do not have an abundance of clinical information in the literature.
  • Do not believe everything that companies relay about a new product, unless they have clinical data to back up their claims from reputable, properly conducted clinical studies.
  • Work more closely with companies that conduct postmarket surveillance studies and that provide tried and tested methodologies to do these kinds of studies. Data must be easily but safely managed, and trends must be identified early so that studies can be amended or stopped early if required. The data must be processed in such a way that clinically significant findings surface early during the study.
  • When participating in investigator-initiated studies, have the study protocols approved by an ethics committee that can give guidance in the ethics of the study and in the interpretation of the data: That is, can the study findings be regarded as ethical and valid?

It has been noted that the proposed changes have positive aspects, such as increased safety for patients and protection for clinicians and investors. It has also been suggested that if a balanced approach is not employed, innovation may leave Europe's shores for pastures greener and friendlier in terms of the regulatory process. Finally, adding time to the device development process adds greatly to overall costs of development and therefore may ultimately affect a new technology's viability. It is in everyone's interest, especially the patient's, that we get this balance right.

AT A GLANCE

• In the past, EU regulators have allowed products to hit the market sooner in Europe than the FDA has in the United States.
• The new regulations may affect the timeliness with which innovations are rolled out in Europe, and a balance must be achieved between keeping innovation in Europe and increasing patient safety and protection for clinicians and investors.

HOW TO APPLY THE CHANGES TO CLINICAL PRACTICE

What can we do to help balance the scale between increasing patient safety and protection for clinicians and investors and ensuring that innovations stay in Europe? I do not have all the answers, but I know that doing some or all of the items listed above in Do Your Part may help.

Most industry-sponsored studies in phases 1 through 4 already meet the requirements of the last point in my list, but the new regulations will require ongoing clinical surveillance to be performed with the same rigor and attention to detail. This may be challenging for many individual clinicians and clinics, and I believe that a new market will evolve consisting of groups of experts who conduct such postmarket studies. My aim will be to identify the companies that are best placed in this space to provide well-run, well-documented, valid studies in the most cost-efficient and timely manner. I think such companies already exist, possibly in the early stages of development, but they will soon appear on the horizon and, within a short period, become household names in ophthalmology.

CONCLUSION

As with any new development, change can be seen as daunting and negative or as filled with opportunity and positivity. If the new regulations lead to safer and more efficacious treatments for our patients and we can collectively make the regulatory environment more user-friendly but still affordable, efficient, and timely, then everybody wins. That is always the best outcome in my experience. n

Arthur B. Cummings, MB ChB, FCS(SA), MMed(Ophth), FRCS(Edin)
- Consultant Ophthalmologist at the Wellington Eye Clinic and Beacon Hospital, Dublin, Ireland
- Associate Chief Medical Editor of CRST Europe
- abc@wellingtoneyeclinic.com
- Financial disclosure: None

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