Asking a butcher to bake bread makes no sense – so why ask EMA to approve medical devices?

Posted by MedTech Europe on 25/02/13
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The upcoming MDD revision can learn a lot from a 2007 mistake in woundcare regulation

Prof. MarazziBurn wounds result in some of the most horrific pictures one can come across as a surgeon. Burn victims not only have to suffer the immediate pain associated with burn wounds, but also have to deal with often permanent scar tissue, a lifelong reminder of that terrible moment.

However, innovations in woundcare in the last decade have allowed for health outcomes for patients to improve greatly. Only a few decades ago, certain burn wound patients would not have been treatable. Yet today we can, and in such a way that the formation of scar tissue is limited as much as possible.

One of the woundcare therapies that I am a strong advocate of is a technique whereby autologus skin, that means skin cells which are collected from the patient’s own body, are grown in the lab until they are ready to be placed onto the wound. This life-saving technique – taking a sample of unaffected skin, placing it on a mesh, and allowing the cells to reproduce and expand – has been in use for more than 10 years now with extremely good safety and efficacy records. In other words, this product is not only safe, but also very efficient for the treatment of burn wounds.

Where it gets complicated

For us surgeons the use of human tissue engineered products has allowed us to give so many patents, over 8,000 in the last 15 years, renewed hope for a better quality of life. For regulators, however, the question was whether these products were medical devices or medicinal products… I followed these discussions with increasing level of interest. After all, the classification of these ATMPs, as they are called, would impact my professional life to a great extent.

And then it was decided to classify them under gene and cell therapy which essentially meant that the European Medicines Agency (EMA) would now be responsible for approving these products. The result: since that day in 2007 EMA gave more than 100 scientific advices, of which only 9 (!) resulted into a submission. Of these 9 submissions, only 2 (!) have been approved. And when it comes to my own practice, not a single one of the products that I have been using for decades with full satisfaction has been given approval. And moreover, since the 1st of January of this year, these products can no longer be made available to patients because they have not been granted approval. Why? Because the body responsible for granting these approvals simply does not have the appropriate skills to understand the difference between these products and the classical medicinal products.

And what’s even more surprising to me is that there are voices in Brussels asking for Class III medical devices, the most sophisticated type of devices, to take a similar route? I do not see how this would benefit Europeans. I am grateful that I can work in Europe, where I can offer my patients the latest, safest technologies immediately. If I were working in the US, where FDA grants approval, I would have to wait between 3 and 5 years more before I can treat my patients with the best therapies possible. And it makes no sense because numerous studies have shown that a system whereby 1 body approves new devices is not necessarily safer than the system we are currently enjoying in Europe. I am not saying the European system is perfect, far from, but at least it has shown to work well in most cases and to the benefit of patients. I can only imagine what this would mean for fellow healthcare professionals all over Europe if Class III medical devices approval became the responsibility of the EMA.

So there you have it… I urge policymakers and politicians looking to fix what is broken to look in the right places. We all have the interest of our patients at heart, we all want what’s best for them. But what seems like an obvious solution at first may end up costing us Europeans dearly in the long run. Let’s learn from the past, let’s not make the same mistake that deprives patients from the most advanced tissue engineered products. Let’s make sure that, in our attempt to do what’s right, we are not left with a scar that won’t heal.

Prof. Mario Marazzi
Responsabile S.S. Terapia Tissutale, Centro di Riferimento Regionale per la coltura di epidermide umana in vitro e banca per la crioconservazione dei tessuti

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