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In two weeks, on March 19th, the environmental, public health and food safety (ENVI) committee of the European Parliament will vote on the reform of the pharmaceutical legislation. This proposal put forward by the European Commission in April 2023 has been the centre-stage of a deeply rooted divide in the European Parliament. It opposes Members of the European Parliament wanting to find a short term solution at EU level for the accessibility of medicines – even if such an issue is done to the detriment of the actual future development of medicines – and those not willing to sacrifice Europe’s ability to innovate for the benefits of patients.
At Servier, we are committed to therapeutic progress to serve patient needs, therefore it is obvious that we are strongly involved in finding solutions to the access challenge in Europe. However, we are convinced the proposal put on the table will not reach the objective set, and on the contrary will undermine companies’ ability to follow the science and innovate.
The outcome of the vote happening in two weeks and the impact it will have on the pharmaceutical industry cannot be understated. It will have a durable impact on the way research and development is conducted in Europe, shaping the environment for the future.
In more details, the proposed text will review research incentives lowering them down and modulating them based on various criteria, some falling outside of the company’s responsibility, thus introducing a major element of unpredictability to the system. In particular, incentives would be modulated based on whether the product is launched in the 27 Member States of the EU. While industry can decide when to file for pricing and reimbursement, therefore starting the process in a given country, it does not control the length of those processes. Therefore, modulating the incentives based on an aspect that the industry does not control is not efficient, and it will not accelerate access to the medicines for the patients. It will only accentuate the lower attractiveness of the continent and jeopardize the competitiveness of the European market.
The research journey is already risky, lengthy and costly. There are many trials and errors before finding a medicine that will bring benefits to patients. Such a difficult journey requires long-term investment that will be deterred by an increasing level of unpredictability. This long-term investment is essential to all developments, but especially to the development of medicines for small populations (such as rare and paediatric diseases) where there are additional barriers to research, from sparse scientific knowledge to difficulties in recruiting for clinical trials. Medicines developed for rare diseases often stem from decades of research in other disease areas, providing valuable insights in how specific diseases come to be. Destabilizing one of the building blocks of the carefully crafted R&D process could therefore have devastating consequences.
In an increasingly polarized world, where geopolitical considerations cannot be overlooked, and questions are raised on health sovereignty, interdependencies and open strategic autonomy, it is essential to take a holistic approach. It is not possible from a political perspective to call on a resilient European Union, while from a working level, increase the burden and jeopardize the ability to operate on the continent.
While discussions on the general pharmaceutical legislation often focus on the incentives’ framework, the regulatory process or its supply chain, this file doesn’t exist in a vacuum. References are spread out within its pages to other legislations, such as environmental files that have been put forward at EU-level. Those texts are being discussed in parallel, with many of them containing provisions that could hinder access to medicines in the EU by banning substances in medicines that do not yet have alternatives or by further increasing the cost of European manufacturing. Discussions on the competitiveness of the industry cannot focus on one aspect of our industry without considering the entire lifecycle of a medicine.
As the Parliament gears up towards voting on the pharmaceutical legislation, a choice will need to be made – does the EU truly wants to be a world innovator? If that is the case, it will have to face one of its main contradictions. Policies cannot be siloed, without taking into consideration the impact on other areas which might contradict the very same objectives the Commission wants to achieve. If the EU does not adopt a holistic approach, bearing in mind the possible repercussions on competitiveness of its legislation, we risk Europe becoming a second-tier region, with not only R&D but also production being moved outside of our borders.
There is still time to rectify the course and work with all stakeholders to find a balanced approach that won’t undermine the well-being of EU citizens. The time to act is now!