As CzechMed celebrates its 20th 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 of value. I have worked in this sector since 1999 and our industry has put a lot of emphasis on selling value to customers, regulators and governments – but I have not witnessed an increase in interest from the other side of the table. They are looking at the item price or the budget impact of technologies.
What product areas have seen the most growth?
We have observed a trend of technologies becoming less invasive. To reach the ‘wound point’ not by opening the patient but via tubes, catheters, probes and the like. We have also seen many things getting more digital, now we are witnessing these devices communicating with the world outside of the patient.
At the same time, we can witness an ever-increasing pressure on price.
How does CzechMed engage with policymakers and legislators?
We have consistently spoken up for the interests of our members throughout our history, making us a reputable partner for governments at regional and national levels. CzechMed is a formal member of the legislative process when new legislation or policy changes are debated. We contribute to internal consultations as well as wider, external stakeholder dialogues at various stages of the parliamentary process.
What are the major areas of interest in terms of shaping policy?
There are two main branches: one is policy creation – the drafting and passing of new bills; the other is putting policy into practice. For example, Czechia has transposed EU public procurement directives into national law, allowing us to argue on the basis of value or quality. However, the practice of public procurement lags behind what is set out in legislation. We are trying to ensure that what is written into our laws becomes common practice in the real world.
What are your current priorities?
Right now, there is a bill drafted by the Ministry of Health on reimbursement of prescription products. We are getting into the nitty gritty of this process.
At the same time, we are working on the adoption of the MEAT principles (Most Economically Advantageous Tender). We are probably a little ahead of some other MedTech Europe members as we’ve moved passed discussing the principles of MEAT and are now engaging with procurement officers. We are confident that our products are of very high value-added – which offers some protection against low-quality, low-cost competitors.
What are the trends that will influence CzechMed’s future?
Like other EU countries, we are expecting the development of increasingly sophisticated new technologies, driven by artificial intelligence and connected devices. However, there are tensions within the system between the rapid pace of new technologies arriving in hospitals and the slower pace at which obsolete technologies are abandoned. Reconciling that tension is a major challenge for the future.