Regulation

In Europe, health data are considered so sensitive that processing them is generally prohibited in the EU, unless that processing follows specific guidelines. For example, the prohibition does not apply when sharing data is essential to providing healthcare, where those data are handled by a Healthcare Professional (HCP) subject under national law and subject to professional secrecy laws. With the rapid growth in diversity of medical technologies though, more and more medtech companies are processing health data on behalf of HCPs. 

Despite the overwhelming impact that wounds have on healthcare systems, many people are still unaware of the risks for developing wounds when entering a healthcare setting.  In fact, 27-50 percent of acute hospital beds are likely to be occupied on any day by patients with a wound. Many of these patients will be at high risk of infection, which can result in extended hospital stays and for some, amputation.  Yet, patients can be better protected against such risks by instituting evidenced based guidelines in healthcare settings that include multidisciplinary approaches to wound care treatment.

The revision of the IVD and MDD Directives has ensured that the last quarter has been a really colourful, hectic and interesting one. The revision process has now entered a new phase where Council will need to agree on a position, after which it will have to negotiate this position with Parliament. That negotiation should then lead to the final texts for IVDs and devices. In terms of timelines, the Parliament is set on finalising both processes before the European elections of May 2014. Until then, I’m sure the evolutions will provide me with plenty to blog about.

Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on the reprocessing of single-use medical devices, has unwittingly slipped something similar back in again. Given the complex and highly technical nature of the Medical Devices Directives, I can see where busy MEPs would struggle to understand the details and consequences of this amendment, so I think it is essential that we take a moment to read the fine print.

Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue to have timely access to the latest life-saving and life-enhancing medical technologies.

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for IVDs rather than a bureaucratic quagmire.  The sweeping changes being made to risk classification will be complex and time-consuming.  The lessons learned from similar overhauls in other markets show us that a period of transition is essential to optimise the implementation of changes for the new European IVD legal framework.

In June, the US Supreme Court issued its opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc.).  The Supreme Court had been asked a seemingly simple question: “Are human genes patentable?”, and concluded that naturally occurring gene sequences are no longer patentable in the US.  In Europe, isolated gene sequences are still patentable, under certain conditions.  However, the differences between the two legal regimes are not as stark as might initially appear, and the practical effect for the diagnostics industry is complex.

My first blog provided the necessary insight into in vitro diagnostics and their distinguishing characteristic of never directly coming in contact with the human body. So how do they work? What differentiates them from other medical devices you hear about? The answer is that vast majority of in vitro diagnostics (IVDs) rely on biological properties and materials in order to perform as intended.

Until recently economic and regional integration in the post-Soviet countries to a large extent was only declarative. However, the initiative of going beyond the Customs Union (CU) to create Common Economic Space (CES) between Russia, Belarus and Kazakhstan draws attention to potential market opportunities and at the same time regulatory challenges for the MedTech industry.