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Author Bio: MedTech Europe is an Alliance of European medical technology industry associations. The Alliance was founded by EDMA, representing the European in vitro diagnostic industry, and Eucomed, representing the European medical devices industry.

Articles by MedTech Europe

New rules, new markets – medical devices and diagnostics’ place in a changing Europe

Posted by MedTech Europe on 23/05/13

Belgian weather in May Judging by the weather in Belgium (currently 10° and raining) you wouldn’t say it, but it’s almost summer. Well, at least according to the calendar. And apart from the supposed good weather, summer also brings with it a host of new information on the MedTech Forum. Speakers are being confirmed, registrations coming in and preparations being made. Less than 5 months from now, we will all be seeing each other again at the event no one in our industry can afford to miss. So what does the MedTech Forum hold in store this year.

The 2013 theme of the MedTech Forum is “New rules. New Markets. Medical Devices and Diagnostics’ place in a changing Europe.” For anyone “au courant” (pardon my French)of what’s happening around Rond Point Schuman, this theme does not come as a surprise as it basically encapsulates what we at EDMA, Eucomed and MedTech Europe have been focussed on ever since both revisions were still called recasts.

Under this umbrella theme, we decided to focus on three topics which you not only told us are of high interest to you, but will impact our industry vastly in the coming years. Speaking of topics which are of interest to you… when my communications team tells me which news items in our newsletter are most read, which blogposts are most visited or which videos most watched, it is clear that the revision of the IVDD (In Vitro Diagnostics Directives) and MDD (Medical Devices Directives) are what is crucial for many of you. Recognising this, we have dedicated a substantial part of the event to both legislative frameworks. Expect a plenary session focussed on clinical evidence, expect an MDD and IVDD workshop on the impact of the revision on business, and of course much more.

Regulation is a hugely important factor in determining whether or not our industry can maintain its leading role in innovation in Europe or not. This is not only important for us, but also for Europe and its citizens. Because innovation will be crucial to ensure the sustainability of Europe’s healthcare systems in the future. And we as manufacturers or medical technology have an important role to play in that. How we contribute and what we will do concretely to play our part is laid out in our 5-Year Strategy “Contract for a Healthy Future”, and it is this strategy which will be at the centre of many a session at the MedTech Forum. In fact, the CEO roundtable will be all about the Industry Strategy, and will outline the achievements of the past 2 years and what we can look forward to in the next few years. Regulators and purchasers will discuss the relation between innovation and healthcare sustainability and how the Contract can help in building more sustainable healthcare systems.

The third topic of the event will revolve around Emerging Markets. And we’ve got some excellent speakers from PwC lined up to tell you all about successful emerging markets entry strategies in Europe. Chris Wasden gave an eye opening presentation 2 years ago at the Forum where he introduced the Global Innovation Scorecard, which assesses countries’ capacity and capability for medical technology innovation. PWC updated its research and will present the new results, including the difference between technology needed in mature and emerging markets, in a plenary session and a workshop session.

If you are planning on attending the MedTech Forum, you really shouldn’t wait too long to register. Not only does the early bird discount expire on 1 July, but seats for the various workshops are filling up fast, and there are only limited seats available. Some workshops are already sold out! So head over to www.medtechforum.eu to get the latest programme, see who else is attending and save your spot.

From an event that still has to take place over to one which just took place last week – the MedTech Compliance Conference. Hosted in beautiful Warsaw this year, the joint AdvaMed-Eucomed organised event saw a record number of 227 participants. Clearly, the new concept of “Coffee Tables” whereby several topics are discussed in small groups of people proves to be very successful. Also a first this year was the much broader geographical nature of the event with speakers from Russia, China, the Middle East and Australia to name a few.

One of the topics discussed at the conference was financial disclosure requirements (aka “Sunshine”). The timing could not have been better as the French Sunshine Law decree was published earlier this morning. More information this Friday in our newsletter.

If you were not able to make it this year, make sure you do not miss next year’s event from 20 to 22 May in Barcelona, Spain. There simply is no other compliance event of its kind which offers these opportunities for networking and leaves participants with usable takeaways they can immediately apply in their professional activities.

Screenshot smartphone app Another thing I wanted to bring to your tech-savvy attention is the launch of LabTest Online(LTO) UK’s smartphone app. My tech people told me it is available for free for both iPhone and Android devices and allows you to look up all LTO UK information, even while you’re on the go and without an internet connection.

And as this blog draws to a close, so does our time at Place des Maïeurs. To be able to speak with a strong voice and deliver our message effectively, it is critical that we are among our stakeholders each and every day. In that respect, moving offices closer to our stakeholders is the right “move” , for instance to keep a close eye on the 1307 amendments that were proposed by MEPs to both the MDD and IVDD texts. And I am very excited to announce that starting Monday 17 June, you can find us on the 1^st floor of Rue Joseph II, 40 in 1000 Brussels. To celebrate our new offices we will put together a housewarming reception in September. The exact date will be announced shortly so keep an eye on your mailbox for more information.

Talk to you soon,

Serge
CEO EDMA, Eucomed & MedTech Europe

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The importance of diagnostics in steering Europe’s healthcare future

Posted by MedTech Europe on 15/05/13

With its Contract for a Healthy Future, the medical technology industry acknowledges its role and responsibility in maintaining high-quality, affordable healthcare in Europe despite an ageing population and constrained budgets. This industry commitment offers the much needed solutions to prove that innovation is not a cost driver but a facilitator for driving healthcare quality and efficiency in the future. From personalized medicine to disease monitoring, the role of the diagnostics industry will be crucial in managing healthcare spending.

A companion diagnostic test that provides vital information necessary for personalised medicine to occur is no longer a new concept. HER2/Herceptin for treating breast cancer is no longer the only successful example of personalised medicine. More and more companion diagnostic tests are being launched and the R&D pipelines of drug and diagnostics manufacturers are well filled.

Two more recent examples are KRAS/Erbitux/Vectibix for treating metastatic colorectal cancer and BRAF/Zelboraf for treating multiple melanomas.

Diagnostic innovation takes place not only in companion diagnostics but also in other areas, including disease monitoring. Asthma monitoring based on exhaled nitric oxide is expected to improve steroid therapy, resulting in fewer exacerbations and fewer ER visits and hospitalizations.

Glaucoma monitoring based on continuous IOP measurements can potentially improve therapy choice and management to the extent that expensive surgical interventions can be significantly reduced or avoided altogether.

Oncotype DX is a diagnostic test that quantifies the likelihood of disease recurrence in women with early-stage breast cancer and assesses the likely benefit of costly and burdensome chemotherapy.

Triple-rule-out computed tomographic angiography can provide a cost-effective evaluation of the coronary arteries, aorta, pulmonary arteries, and adjacent intrathoracic structures for patients with acute chest pain, helping to optimize therapy choice and preventing unnecessary cardiac interventions.

Examples are plentiful of the diagnostics industry meeting its obligations under the Contract for a Healthy Future in terms of driving value-based innovation to better serve stakeholders’ clinical and economic needs. Diagnostic R&D particularly focuses on improving the quality and cost of treating chronic diseases. As such, it plays an important role in dealing with the healthcare challenges of an ageing population in Europe. In this sense, the diagnostics sector may even be ahead of the therapeutic device industry despite its underexposure.

And yet, from my point of view, it seems that policymakers and payers do not yet fully acknowledge the positive impact that effective diagnostics can have. Companion diagnostics are in some cases not reimbursed at all, with the argument that the manufacturers of the related drug therapies already earn enough money – although the test may be marketed by a different manufacturer. The reimbursement of other advanced diagnostics, such as continuous glucose monitoring in diabetes management, is heavily restricted to small subpopulations despite their potential to reduce hypoglycemic events and/or improve HbA1c levels in larger patient groups. An insufficient clinical evidence base is very often the key reason for policymakers’ and payers’ limited support of new diagnostics. At the same time their expectations of clinical data are unrealistic to the extent that they are unfeasible or too costly for manufacturers in view of expected reimbursement restrictions. I would compare it to a chicken-and-egg situation where budget holders have to effectively balance and assess short-term costs against sustainable long-term healthcare cost savings.

It cannot be disputed that diagnostics for preventing diseases and managing therapy quality and cost play an essential role in European healthcare systems, and will continue to do so. The diagnostics industry is certainly committed to playing its part in shaping a better future. But in order to meet this obligation and to bear the necessary R&D investments and risks, I believe policymakers and payers in Europe will need to increase their involvement in transparent and constructive market access and funding decision-making for diagnostic innovations.

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HTA collaboration in Europe: Getting it right

Posted by MedTech Europe on 08/05/13

Being a patient myself, I am keenly aware of the importance of having access to innovative technologies to support my lifestyle and foster improved health and well-being. And, as a former policymaker in both the UK and the EU, I also understand the enormous responsibility of the healthcare system in determining which of the newest medical technologies are the safest and most effective for patients in each health constituency.

It is difficult to remedy these demands – those of patients, health systems and policymakers. Yet, this is why health technology assessment (HTA) is increasingly being used throughout Member States to inform decisions about the safety, quality and effectiveness of medical technologies in healthcare systems. HTA, which is a scientific evaluation of a new technology for introduction into a health system, is often times a complex process which may or may not take account of all impacts a new technology may pose for patients, professionals and systems. For example, some HTAs may focus on the economic and medical impacts only, foregoing issues such as quality of life for the patient and/or social and ethical factors. This is an important distinction because if quality of life issues are not taken into account in an evaluation, this can severely limit the access a patient like myself has to an important and potentially life-changing treatment.

The experience of HTA authorities across Europe differs immensely from Member State to Member State. However, authorities with extensive experience in conducting comprehensive evaluations of a technology have best practices to share with others. To what extent these best practices and evaluations can be shared is being tested in a European Commission project known as EUnetHTA. EUnetHTA is a Joint Action funded by the Commission which is currently in its second three-year term and looks to provide added value to Member States through efficient use of resources available for HTA, the creation of a sustainable system for HTA knowledge sharing and for promotion of good practice of HTA methods and processes. EUnetHTA outcomes will likely feed into a permanent network for HTA which must be established at EU level as part of the implementation of the Patients’ Rights in Cross-border Healthcare Directive.

I believe that the EU does have a role to play in fostering the appropriate use of HTA in Member States regarding decision-making in healthcare in order to meet the often contradictory demands of patients, professionals, providers and industry within health systems. But in order to do so, the EU must encourage broader, more meaningful involvement of all stakeholders (particularly patients) in the HTA network and processes shared by the permanent network. No comprehensive evaluation can be concluded without factoring in the opinion of the user(s). Likewise, the EU must facilitate greater transparency about the methodologies undertaken in HTA evaluations and the network that will share these evaluations. Otherwise, decisions will always be questioned by stakeholders about the comprehensiveness and/or involvement of stakeholders in HTA outcomes.

The permanent network for HTA collaboration could play a significant role in supporting Member States to make innovative, effective and complimentary medical technologies available to patients, but I believe that it can only do so through more stakeholder involvement and transparency. Encouraging Member States to make appropriate, comprehensive assessments of technologies, the EU can foster greater patient confidence in the safety and value of medical technologies for prevention, early diagnosis, disease monitoring and treatment. However, stakeholders, and particularly patients like myself, must insist that we are part of HTA decisions to ensure that the patient is always the main point of consideration throughout the entire healthcare decision making process.

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Eurasian Economic Integration – market opportunity or regulatory challenge for the MedTech industry?

Posted by MedTech Europe on 02/05/13

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.

The economic integration of such a large trading block creates plenty of opportunities. Russia is the European Union’s third largest trade partner after the US and China. While it remains the most attractive economy out of all members of the Eurasian CES, closer cooperation and regulatory convergence within the territory of the entire Customs Union should make this enlarged market even more attractive. But why is that? Well, let’s just say that figures speak for themselves: The Eurasian CES forms the largest customs union in the world (in geographical terms), its population counts over 167 million, its total GDP amounts to USD 2 trillion and its goods turnover is worth USD 900 billion. In addition, the intention is to expand the territory of the Eurasian undertaking and potentially integrate not only Kyrgyzstan, which is already an official candidate country, but also Tajikistan, Uzbekistan and Armenia. The ultimate ambition of the Eurasian CES is to create the Eurasian Economic Union by 2015 with free movement of goods, services, capital and persons.

Certain elements of a single market are progressively being realised. The Eurasian CU now encompasses single customs entity with a common external tariff and legislation including non-tariff measures as well as shared procedures for customs control and clearance.

With Russia’s accession to the WTO, its tariff obligations towards the WTO became binding for the external border of the entire territory of the CU between Russia, Belarus and Kazakhstan. For a number of industrial goods, this has almost doubled the external tariff of Kazakhstan while at the same time, benefited Russian producers whose exports to Kazakhstan increased significantly because of higher external tariff. However, even though Kazakhstan might suffer from lower quality imports from Russia and the pain of settling tariff differences with its external trade partners, in a long run the tariffs will fall due to Russia’s commitments to the WTO. For MedTech, this means huge opportunities as import tariffs for healthcare equipment are expected to fall on average from 15% to 5% – Such decrease in the level of external tariffs is binding and it is being implemented in accordance with Russia’s WTO schedule of concessions and commitments on goods that have been negotiated during the accession talks with all of the Members of the WTO. However, while the business outlook is promising, overcoming the regulatory barriers and capturing the Eurasian market is a major hurdle to say the least.

The Eurasian CU is engaged in a dialogue with the European Union regarding cooperation concerning alignment of technical regulations. Regulatory convergence would clarify and simplify market access procedures for the manufacturers and would provide access to better quality and variety of products for patients in a timely manner. Therefore, both sides can only benefit from removal of trade barriers and adoption of shared rules and standards.

However, the actual outcome of this mutual dialogue in eliminating barriers to trade is yet to be determined and the success is somehow doubtful considering the current state of play. Only recently, the industry has been alerted about plans to restrict the supply of medical devices in the future by banning access to state procurement for companies that manufacture their products outside of the territory of Russia or Belarus – if this is the way Eurasian CES is trying to attract investment and persuade foreign manufacturers to move their plants to the territory of the CU, it seems hardly encouraging.

When Russia officially joined the WTO in August 2012 after 19 years of negotiation, it was assumed that Russia is finally open for business. The creation of CES between the post-Soviet countries in principle should also create new market opportunities. However, the continuing uncertainty concerning regulatory developments is simply bad not only for business but also for the consumers.

The Eurasian Economic Commission is in the process of drafting three regulations for medical devices, which can be expected to be published later on in 2013. However, very little indication has been given as to what the manufacturers should prepare for. One thing is certain, future developments in the regulatory environment are going to be very important.

Diana Kanecka
EDMA Regulatory Affairs Intern

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The reasoning behind the “Don’t lose the 3” campaign

Posted by MedTech Europe on 29/04/13

My journey at the European industry association Eucomed started two and a half years ago. During my interviews for the communications role I was made aware that the medtech industry was facing new European legislation and that the process was underway. Never did I expect the need for a forceful modern communications campaign.

I’ve been trained professionally by a global communications consultancy firm which teaches you to be an honest devil’s advocate when advising clients. So during the last couple of years at Eucomed I’ve been able to ask many critical questions about industry’s suggestions for the new regulatory framework. I truly believe it is fair to say that industry has never opposed change and is willing to make the adjustments and investments that are necessary to improve the current approval system, which is decentralised. In essence, the industry asks for a system that improves patient safety and doesn’t unnecessarily tamper with the flourishing innovative ecosystem in Europe that is dominated by small and medium-sized enterprises. Many of these companies are developing innovative medical technologies that not only improve the lives of patients but also contribute to making healthcare systems more efficient, which is desperately needed in these times of economic hardship.

The European medical device manufacturers believe that the current decentralised approval system needs to be significantly improved but not radically transformed for the sake of change. Research reports show time over time that a centralised approval system for medical devices, as seen in the United States (FDA), does not improve safety and significantly delays life-saving medical technologies in reaching patients.

It was no surprise that there were calls for a better approval system after the PIP breast implant tragedy. It was however surprising that these calls were for a centralised approval system. The PIP incident was terrible but it was a case of fraud and a centralised approval system would not have prevented it either.

The public debates and media coverage that followed the PIP incident focused on improving safety for patients, which is without a doubt the paramount objective. But the discussions did lack another important element: the impact of delaying medical devices in reaching patients. There are medical devices that save lives and are available to Europeans three to five years earlier than Americans who have a centralised approval system. So besides achieving the most important objective of improving safety one should also take the impact of delayed treatment to patients into consideration.

When the calls for a centralised approval system in Europe became louder without taking the patient access element into consideration, industry decided to become more vocal about what really is at stake. Subsequently the “Don’t lose the 3”-campaign was launched in February this year.

The “Don’t lose the 3”-campaign is based on facts, consists of emotional ingredients and informs Europeans what could happen to them if a centralised system as seen in the US is copied into Europe. The campaign aims to grab attention by using thought-provoking videos and drive the viewers to a website that explains what is at stake in an easy-to-understand language. The medical technology examples and delay times used in the campaign are real and based on facts; the actors used in the short videos are a true reflection of real patients; the real patients tell their story in separate videos that are available and the opinions voiced in the campaign are based on research reports and real-life stories. The campaign does not exaggerate nor understate the merits of the current European decentralised approval system and clearly indicates which improvements need to be made.

When speaking to American journalists who cover the global medical device industry, I usually get the same response: they are astonished by the direction in which Europe is going. They do not understand why Europe wants to move towards a US-system of approving medical devices that has resulted in Americans waiting several years longer than Europeans for innovative medical technologies without any safety benefits. In addition they note that the American regulator (FDA) has some challenges of its own and has recently requested an 11% budget increase to speed up the approval times in its centralised pre-marketing authorisation process.

So when asked what I think is best for European patients and industry: keep the decentralised approval system and fix what needs to be improved instead of radically changing what we have today into something that won’t guarantee more safety. I believe that Europeans, including myself, want a safer system that doesn’t cause unnecessary delays in innovative medical technologies reaching us because they improve and save our lives. And when you take the time to look at how we can reach the desired outcome of improved safety and timely access, you realise that it can be achieved together through significantly improving what we have today. Europe doesn’t have to lose the 3.

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A blog on trends, issues, opinions and views about the medical technology industry. It is a collection of former Eucomed blogposts and brand new MedTech Europe ones. more.

About MedTech Europe

Articles by MedTech Europe

New rules, new markets – medical devices and diagnostics’ place in a changing Europe

The importance of diagnostics in steering Europe’s healthcare future

HTA collaboration in Europe: Getting it right

Eurasian Economic Integration – market opportunity or regulatory challenge for the MedTech industry?

The reasoning behind the “Don’t lose the 3” campaign