Regulation

Regulation

Views on the rules and regulations that govern MedTech.

Shouldn’t we be rewarded for healthy behaviour rather than repeatedly punished for being ‘bad’? Fat tax and sugar tax, duty on cigarettes and vodka – everyone can think of a ‘sin tax’ they pay from time to time. These are the penalties we pay for making unhealthy choices. The idea of sin taxes has been gaining ground in recent years. The success of price rises on cigarettes and alcohol in curbing consumption is leading governments to consider what other disease-causing products could be taxed out of existence . In Europe, Denmark were the early movers: they introduced a tax on fatty foods in 2011. It applied to meat, dairy products, oils and certain other foods which contained more than 2.3% of saturated fat. The tax ‘worked’ in that it raised revenue and cut consumption of fatty foods by 4% . However, the policy didn’t last long. It was scrapped within 18 months because the government said the tax was too difficult and expensive to collect. Japan is taking a different route . Instead of hitting shoppers in the pocket to reduce the size of their gut, authorities impose fines on employers and local governments who fail to keep waistlines in check. Other countries, including the UK and Ireland have targeted sugary drinks by proposing a ‘soda tax’ to nudge consumers into making healthier choices. Celebrity chef Jamie Oliver – a campaigner for healthy eating – hailed the move as a victory for children’s health. He was so happy about the new tax that he did a little dance at the end of a TV interview which was captured by BBC! There’s no doubt that taxes can be used to push people into making ‘better’ choices. But what ever happened to incentives for positive change? GPs in the UK get bonuses...
Last week, the European Parliament and the Council of the EU led by the Dutch Presidency came to an agreement on the medical devices and in vitro diagnostics regulations. To say the least, it has been a long process, and for the medical technology industry, we expect these regulations will have a significant impact on our products and services. Our industry needs this modern legislation. And I welcome the fact that the specific nature of medical technologies was considered during the legislative process. With over 500,000 medical technologies registered, it is important that these regulations take into account the diversity of our products and services while acknowledging our sector’s significant role and relevance in the healthcare continuum of patients. Importance of these new regulations to patients Medical technologies save lives, improve health and contribute to sustainable healthcare. These technologies are developed and produced for the welfare of patients. Despite the sweeping overhaul, many of the proposed updates in the regulations are welcomed by our industry as they will enhance patient safety and facilitate access to new technology for patients. I believe that the new regulations are critical in filling in the gaps of the existing laws and in bringing more harmonised set of guidelines across the region. Implementation will be key Now watch out, there’s still a lot to be done. Now, we are entering an even a more critical phase for the industry. After the lengthy legislative and political discussions, our regulatory focus will now shift towards the implementation process. And this is going to be more complicated. Once this agreement has been formalised, a set of legal process will take place including translation. From our side, we at MedTech Europe, Eucomed, and EDMA expect to work on a deeper analysis once we get a sight of the consolidated...
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...
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...
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...
Summer has ended and while most are just coming back from their holidays, I’ve been busy with the team in finalising our comments on the in-vitro diagnostic regulation proposal, which is finally moving towards the last phase in the legislative process. Council is close to landing their final positioning, enabling the trilogue discussions to begin between the Council, Commission and Parliament. Let me be clear - the industry wants this regulation to happen. But the uncertainty and lack of clarity from the recent council position will yield difficulties for everyone in the future. More attention to the IVD file is needed – and the lack of thorough considerations on the technical specifications applied will have a huge impact on the industry and in the end on patients. Details matter: the quality management system clause example Quality management systems are in place to ensure that products undergo a thorough check so the quality of the devices is maintained. However, the council position on the regulation did not take into consideration the specific needs of certain products like self-tests or near-patient tests. Most have been given more requirements that require additional yet unnecessary checks that do not go with the nature of the products themselves. The requirements should be feasible and applicable towards the nature of IVD tests and should be treated in detail separately. A requirement that might sound right for one device doesn’t mean that it makes sense to the other. Do we need more regulation? Don’t get me wrong, I welcome the fact that regulation is important. But adding too much can render more issues than benefits, for regulators, the industry and patients alike. A balance has to be made right between regulation and innovation. The discussions on clinical evidence and companion diagnostics are primary examples that make this...