eu policy

Rhinological disorders: a health priority for the future

Value
17 Aug 2016
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...

Can the EU directive on public procurement encourage value-based procurement in healthcare?

Access
27 Apr 2016
This blog is part 6 of a series on the MEAT value-based procurement project, an initiative that advocates towards a shift from price-based procurement towards value-based procurement. It does so by defining a Most Economically Advantageous Tendering (MEAT) framework that includes the value of medical technologies, services and solutions in procurement processes across Europe. Read part 1 , part 2 , part 3 , part 4 and part 5 . When the new EU Directive on public procurement was finalised in 2014, replacing the previous framework, it was hailed by the European Parliament as a tool for ensuring better quality of supplies and services and value for money. The European Parliament was also keen to emphasise how the Directive was designed to encourage innovation, improve SMEs’ access to public sector markets and to integrate environmental and social considerations into procurement policy. One of the tools within the Directive to achieve these aims was the requirement for contracting authorities to base the award of contracts on the most economically advantageous tender (MEAT). Contracting authorities were also permitted to use lifecycle costing in their award criteria in order to assess total costs. Previously, tenders could be awarded either on the basis of lowest price, or on MEAT criteria which typically included a balance of price and quality criteria. All of this seemed to be good news for those of us with an interest in value-based healthcare. Defining what MEAT really means However, whilst the terminology was promising, it was misleading. Indeed the Directive provided that MEAT could be based either on price only, cost only, or best price quality ratio. Although Member States have been given a choice when implementing the Directive into national law whether they wanted to exclude or restrict the use of price or cost only as the sole...

Finding solutions to notified bodies challenge is crucial

Regulation
13 Apr 2016
It is important that the medical technology sector functions within a healthy ecosystem. Our sector needs an environment that is open, supportive and free from unnecessary bureaucracy in order to innovate and provide patients safe and effective solutions to their condition. Within the product lifecycle of a medical technology product, we work with patients, doctors, authorities and notified bodies to ensure that the product meets all the essential safety and performance requirements. Each group has a critical role to play, which in turn enables manufacturers to deliver to patients the medical technology products they need. What’s up? Notified bodies are the authority-controlled third-party, independent entities responsible for assessing whether a medical technology (device or a medical test) conforms to the relevant legislation in force. Over the last three years, however, we’ve noticed a significant decrease in the number of notified bodies. Some have been de-designated, had their scope restricted or voluntarily stepped down as a notified body in the field of medical technology. This decrease has meant fewer notified bodies are available to assess new products and renew certificates needed by companies to operate. At the same time, existing bodies are finding it difficult to find qualified personnel to help with the extra workload. The current situation with respect to notified bodies threatens the stability of the medical technology ecosystem. Without fully functioning notified bodies, our industry’s capacity to innovate is stifled. More importantly, it risks delaying or blocking patients’ access to needed medical technology. Because of these limitations, the approval process can take longer, subjecting products to considerable delays. In a time where product innovation is growing at a fast rate, we need a stable ecosystem of notified bodies that’s able to fulfil their roles and guarantee an efficient and timely service. And without this stable ecosystem, how can...

My 5 predictions for the medical technology industry in 2016

Value
26 Nov 2015
The year 2016 is just around the corner. While there are still weeks before we say goodbye to 2015, I’m going to write a few thoughts on what I think will be the key themes for the medical technology industry next year. I did a similar blogpost last year and I’ve done another round for you today. Below are my five thoughts on trends for the industry in the coming year: 1. New regulations means new ways of working As we know, the trilogue for the MDD and IVD revisions are coming to an end. While we still don’t know yet the final texts of the regulations, it is certain that these regulations will have a tremendous impact on the medical technology industry. The regulation will change how we operate, do research and distribute our products. While the regulation won’t be implemented next year – businesses will need to start adapting to the new regulation. This will have an impact not only in the European sphere but also in how companies collaborate at a global level. 2. Technology will play an even more active role to healthcare I think this comes as no surprise to a lot of people. Every year, we see new ways of working, travelling and interacting with other people. We’ve seen a rapid change in our society today thanks to technology. In the area of healthcare, this is no different. The medical technology industry is at the forefront of driving this innovation for the sector. How will technology play a role this time? In the industry, the trend will continue towards developing new devices like wearables and sensors. Technology will allow us to deliver and connect more devices, obtain better and more information using big data and be able to define new ways to diagnose, treat...

During Trilogue, IVD and MD files should be treated on their own merits

Regulation
10 Nov 2015
A month ago, the trilogue on the medical devices (MD) and in-vitro diagnostics (IVDs) regulation proposals have started.This discussion between the Council of the European Union, European Parliament and European Commission is one of the last steps of the process to land a consolidated text for the regulation. It’s almost the end of the road yet I can’t help but feel the underlying need to improve how the trilogue process is being organised so far. In the current three-way trilogue, I am concerned that the discussions on the IVD proposal are being overshadowed by topics on the medical device proposal. This concern is shared not only by the industry alone but also by several member states and officials from both the European Parliament and Commission. I’ve written in my last two blogposts the actions and consequences we needed to understand about the in-vitro diagnostics and medical devices proposals. While it may seem that these two medical technology sectors have a lot of similarities, it’s also important to note their striking differences. This is simply because, by nature and function, IVDs and medical devices are two different sectors with each having a distinct use, issues and applications. In reality, unlike other forms of medical technology, IVDs never interact directly with the human body. Their purpose is not to have a direct therapeutic effect, but rather to provide valuable information on a patient's health status. The value of IVDs comes from the information they provide. This means that the expertise of the healthcare professional in using an IVD is crucial to ensure the correct decision making for patient treatment and care. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique amongst health technologies. Given this reality, the requirements that will be put in place...

What’s with all the unnecessary complexity on the medical device revision?

Regulation
22 Oct 2015
In my view, a good legislation needs to be clear and feasible. A regulation that breeds complexity doesn’t help anyone. The medical device discussions are coming to an end with the current trilogue discussion between the European Council, Parliament and Commission. While we welcome the general direction of this regulation, I worry about the unnecessary complexity that remains in some areas. As I said in my IVD regulation blogpost , we want this regulation to happen. However, it is key for all stakeholders to understand that the new regulation must be clear, feasible and applicable. The medical device industry is the backbone of our healthcare systems. Patients are the ones who benefit from these technologies. I want that this new regulation guarantee a combined vision that advocates for people’s rights to live a healthy life. And with the trilogue just starting, I invite our policymakers to be vigilant and attentive in evaluating the impact of the regulation. There are points in the medical device file that need to be reviewed, and we have highlighted them all in our medical device regulation position paper . And for my blogpost this month, I have decided to summarize a few key points to make my case: If scrutiny is added, then it needs to be workable The medical device industry undergoes a strict control process to ensure that the products we release are of high quality and are safe for patients. These quality controls are very important for all stakeholders, particularly for patients and also for us within the industry. Within the existing rules, there are officially approved entities called notified bodies that review and implement this process. We support strengthening the capacity of these notified bodies across Europe to provide an improved standard of checks. However, placing a duplicative system to further...