eu policy

State of play The aim of Europe’s policies and actions in public health is to improve and protect human health, and to support the modernisation of Europe's health systems - which the EU sees both as improving the quality of its citizens' lives, and as a contribution to goals involving growth and jobs. While the responsibility for health lies principally at the level of individual Member States, EU institutions have an important role in promoting, coordinating and complementing national actions and in driving collaboration and cooperation. The Commission's key role is to support Member States' efforts to protect and improve the health of their citizens and to ensure the accessibility, effectiveness and resilience of their health systems. Work by proponents of personalised medicine has, in recent years, laid the foundation for bringing an advanced personalised healthcare approach into effect in a realistic timeframe. Leverage among the many distinct stakeholders across the complex context of personalised healthcare has opened up new possibilities for sophisticated engagement and imminent tangible change. Such activity undertaken by the European Alliance for Personalised Medicine has complemented, reinforced and influenced European thinking and the need for reinforcement is evident. A future in view A new approach towards personalised medicine can bring major benefits by the end of the next legislature, by fully exploiting the potential of personalised health with a new vision of coherent strategies based around prevention, early detection, and treatment. This will mean making optimal use of Big Data's ability to modify what is possible in medical research and patient care. It will depend on more effective leverage of new technologies, to sharpen the impact of R&D on early diagnostics. It will mobilise diagnostics to guarantee patient access to personalised healthcare. And closer collaboration between authorities involved will ease the demonstration of the value of...
One year has now passed since the ‘new’ EU IVD and medical devices regulations entered into force. Since Day 1, the medical technology industry has been working at full capacity to achieve and maintain maximum possible readiness. While I’d love to claim the same for all other essential elements of the new regulatory system, progress has so far been too slow and piecemeal. Let me repeat that: To the fullest extent possible, industry is ready, but the system is not. Time is running, and it’s running fast. Unless all essential elements of the new system are in place soon, time could very well run out. It could run out for our industry, for sure, but also for the hospitals, laboratories, patients and physicians who rely, every day, on life-saving and life-transforming medical technology products. Why, you ask? Surely the new EU regulations were designed to increase patient safety, better protect public health, and ensure both legal certainty and an innovation-friendly environment, right? Yes, those are the goals, but as we have been saying from the very beginning , these benefits can only be achieved if the necessary building blocks of the new regulatory system are in place early-on . Well, one-third of the transition period is now gone for medical devices. There is a little more time for IVDs, but on that front the work is even more daunting. Time running out to put the system in place Our regulators have been working as fast as they can, despite systemic resource constraints , it’s true that a few pieces of the system have started to emerge in the past 12 months. However, a huge amount is still outstanding, and is needed for manufacturers to fully comply by the dates of application. For instance, to date, we still have none of...
As CzechMed celebrates its 20 th anniversary on 22 March 2018, Miroslav Palát , President of the association discusses the past, present and future Czechia was a different place in 1998 when CzechMed was established to represent the medical devices sector. Since then, the economy has grown by an average of 2.5% per year – with the healthcare sector growing at twice that rate – and the country has joined the European Union. As an industry veteran and President of CzechMed, Miroslav Palát has witnessed a period of great change. What difference has EU accession made for the industry? It has enabled free movement of goods which has been of particular benefit to the exporting industry. We have a number of significant medical devices producers for whom the Czech market alone would have been too small to justify establishing a strong presence. Access to the European market is essential. Joining the Single Market also brought us EU rules which, looking back at the Medical Devices Directive, created an easier environment for import and export of products. In the 20-year history of CzechMed, what have been the biggest trends influencing your work? The biggest trends include ease of market entry but, on the other hand, an increasingly difficult environment in terms of obtaining reimbursement. Regulators have become more sophisticated over the course of the past 20 years: one needs to provide a growing volume of documentation in order to secure reimbursement, even for relatively well-established products. Another major trend is the influx of non-European imports which have, one way or another, obtained a CE mark. There are growing volumes of super-cheap products from the far East on the market. Finally, in negotiating and obtaining funding and reimbursement for new technologies, we consistently see very little room to argue on the basis...
For the first time in history, a major industrial change is taking place in parallel with a global push towards a shared vision of the future. The 4th industrial revolution can be harnessed to address global development goals How can Europe make the most of the technology changes that are afoot? I would share some of the views of Professor Klaus Schwab of the World Economic Forum: these are, potentially, the best and worst of times. We have lots of technology but we are not having the conversations with the public about how innovations might affect our lives. There is not enough attention to the potential risks nor to the many positives that technologies can bring. Past industrial revolutions spurred growth but had environmental and other downsides. How can this revolution be better managed? One of the reasons we are lucky to be embarking on this work now is that we know what we want the 4 th industrial revolution to be for . Last year, 17 Sustainable Development Goals (SDGs) were agreed. The SDGs ask every country in the world to play their part to reduce poverty, protect the planet and ensure prosperity for all. This is an unprecedented global consensus for what we want our future to look like. The first thing to do when someone says they have a new industrial or technological revolution for you is to ask them to explain how it will help the SDGs. Does this require a new way for countries and companies to think about their own priorities? Yes, responsible research is a requirement now and we’re seeing it from top companies like Dow, which has mapped their innovative activities against the SDGs. Not everyone is at the same level but growing numbers of corporate actors are producing very clear maps...
What is your day-to-day work like? How do you help improve or save people's lives through your work? I work in Ljubljana University Medical Centre, Ljubljana, Slovenia and I’m head of the Paediatric Trauma Unit. I studied and received my medicine degree in the same city, in Ljubljana University. I’ve specialised in orthopaedic trauma for 16 years. Caring for an injured child requires special knowledge, precise management and great attention-to-detail. An injured child has unique needs and a multidisciplinary approach is needed to deal with the emotional as well as the medical needs of the child. But the majority of my work involves adult trauma patients and my focus in particular is on elbow, hand and wrist trauma and reconstructions. It’s a busy, challenging role with complicated procedures, especially when it’s a poly-trauma patient with severe and multiple injuries. Every injury creates a different amount of stress: physical and psychological. If there is a severe injury to a part of the body or to multiple parts, the patient’s health status is not the same as it was before. My job as a trauma surgeon is to improve and to regenerate the function of the injured part of the body as close as possible to what it was previously. So with different treatment modalities I strive to improve the patients live. This can be done diversely : with non-operative or a surgical treatment, depending on the type of injury. What do you think are the challenges facing the healthcare system and your profession in particular? The line of work we carry out is very complex and demanding. Having a team that can take into account the specificities of the injured patient is key, as well as supporting the family who are facing considerable emotional turmoil and worry. A high-level of education...
What is your day-to-day work like? I’m the head of a busy Department in a University Hospital in Bratislava and I’m also the Secretary General of IFOS - the International Federation of Otorhinolaryngological Societies. My department is dealing with both inpatient and outpatient care. We are also a teaching hospital so aside from dealing with patients with ear, nose and throat disorders, I’m kept busy upskilling students and providing young doctors with specialised training in Otorhinolaryngology –head and neck practice (ORL). I’m also involved in different research initiatives so when there’s a deadline for a research grant in my field of business this can be quite demanding on my time, finalising research submission with my team. How do you help improve or save people's lives through your work? Rhinology conditions - nose and sinus diseases, infections, inflammatory conditions and tumours - affect a huge segment of the population, particularly if you consider the amount of people affected by allergies. We carry out a number of surgical procedures relieving patients of their sinus problems. One of the most challenging areas of our work is treating those patients with head and neck tumours. We work with a multidisciplinary team to carry out sophisticated and highly complex surgeries. Another area is helping patients with congenital hearing loss. This is another very complicated area, particularly for children with hearing impairments. To be able to carry out life-changing surgery and provide patients with an implant and thus the opportunity to hear again: it’s hugely rewarding. Indeed, by implanting a cochlear implant in the ear of a child, you are forever connected to that child and their family, right through to their adult lives. You can see them grow and develop and enjoy a happy and successful life as they return for check-ups, not impaired or...