The European Life Sciences industry is rapidly changing. New developments and legislation are forcing established players to pay close attention to decide whether their current strategy is still the right one for tomorrow. Companies looking at entering the European market may find that new opportunities open up while other routes may become more complicated in the future. And then there is of course Brexit, which has the potential to have a tremendous impact on the Life Sciences industry, but which is still, only months from the deadline, still largely shrouded in mystery. So what are the major developments happening right now?
Across the globe, the digitization of healthcare is spreading like wildfire. Europe is no exception to this trend, but with its unique blend of national and harmonized rules, it may be one of the most complex territories for those in the sector. The GDPR was intended to introduce uniform rules on the treatment of personal data across the continent, but various optional clauses in the regulation allow the member states to impress their own regulatory ideals on certain aspects of privacy handling, such as with regard to the access to health data.
Nevertheless, digital health applications are entering the market with force and becoming more and more a part of the daily healthcare routine. In particular, the market for telemedicine solutions is becoming more attractive after France recently passed a law generally allowing telemedic treatments and Germany has also taken the first crucial steps towards a general legal acceptance of telematics healthcare services.
The EU is also aiming to establish itself at the forefront of AI-driven solutions and we are seeing a great deal of discussion and revision around some of the older legislation (most notably regarding product liability) that can no longer keep up with the technological developments. The European Commission has already announced the publication of various guidelines in the upcoming months to tackle this phenomenon.
Medical device companies are faced with the precursors of the new Medical Device Regulation that was passed in 2017, but will not come into full force until May 2020. Drafted as a reaction to past scandals, the new rules have a definite emphasis on increasing the safety of products for the user. This means that a lot more products will be forced to undergo clinical investigation to provide sufficiently reliable data to receive a CE-mark. For example, standalone software solutions, until now usually classified in the lowest risk class (class I) will henceforth routinely be classified in risk classes IIa or higher, increasing the requirements for conformity.
The role of notified bodies will also become more complex, requiring all notified bodies to re-qualify. It is already looking likely that this will lead to a bottleneck situation and those companies planning to launch their product after May 2020 would be well advised to start organizing their assessment process now. There is a longer transition period for all those that will have their devices on the market before May 2020, but all of these devices will also need to be re-evaluated under the new regime within four years of it coming into force.
The latest Clinical Trials Regulation was passed in 2014. Its application, however, was put on hold until the technical infrastructure (EU-wide databases and portals) required therein had been set up by the respective authorities. Now it seems that all of the necessary pieces are finally coming together and the new rules are expected to come into full force in 2019.
The new regulation will facilitate the process of conducting multi-centre trials in various member states, but will also increase the requirements for the approval of clinical trials and introduce additional measures to strengthen the protection of participants’ safety. In preparation for the upcoming changes, many Member States have initiated pilot projects allowing market players and authorities alike to adjust to the new rules.
Finally, a notable surge in activity is being seen around the increasing acceptance for cannabis for medicinal use. Recent changes in the legislation of a number of countries (e.g. Germany and Italy) has paved the way for new players to enter the European market. The demand is sky-rocketing and it can already be seen that the legal restrictions governing the use of cannabis in most countries is likely to become more flexible over the course of the next few years.
These and other current developments in the European Life Sciences and Health Care market will lead to big changes in the industry, established players may be forced to adjust their procedures while the changes also open up opportunities to expand their business or for new players to enter the stage.