Europe Life Sciences Outlook

The Life Sciences landscape is a dynamic environment. With the recent elections and appointment of new European Union Commissioners, the European Commission (EC) President’s office, has published Ursula von der Leyen’s Political Guidelines for the period 2024-2029. These Guidelines identify priorities and include a number of statements relevant to the Life Sciences industry. The new Commissioners also received Mission Letters from the President. These documents provide insights into upcoming initiatives.

Below we provide an overview of some of the focus areas including ongoing and upcoming initiatives.

Political Guidelines: Focus on supply chain security and cybersecurity

In large, the main priorities relate to supply chain security. Supply chain security may be interpreted in a broad manner, including cybersecurity and addressing any potential shortages, of raw materials and active substances. This focus is a direct consequence of the challenges identified during the COVID-19 pandemic.

To address potential supply shortages, the EC will propose a new Critical Medicines Act. This Act will be intended as a toolbox to address potential shortages. The Act will build on the Critical Raw Materials Regulation adopted last April, and, complement other initiatives such as the SSGM solidarity mechanism and the EU list of critical medicinal products.

The EC will also focus on joint procurement and stock piling of health products to be able to address public health emergencies.

Mission Letter to the Commissioner for Health: Focus on Better Regulation

The 4 expands on the priorities identified in the Political Guidelines. It sets out the focus that the respective Commissioner will have for the next (five) 5 years. Most interestingly, there appears to be a focus on eliminating overlaps and contradictions. This may be related to the recent Report on the report on the future of EU competitiveness (Draghi Report), which emphasized the need to reduce (unnecessary) regulatory burdens or red tape and to focus on Better Regulation.

The focus is to be on diversifying supply chains, improving access to the most advanced treatments, boosting competitiveness, resilience and security of health systems and working on strategic inventories (European Health Union).

In particular, what is among others new, regarding the areas of focus is to:

• propose a new European Biotech Act. This Act, once drafted, is among others to streamline to streamline the regulatory process(es) by reducing legislative and cross border fragmentation and by simplifying processes. It will not be an law exclusive to medicinal products and medical devices.
• implement a European Beating Cancer Plan and use that plan as a blueprint for work in other areas, including mental health; cardiovascular diseases; degenerative illnesses; and autism;
• investigate the impact of social media and excessive screen time on the wellbeing.

This would be on top of initiatives previously identified and/or ongoing which include to:

• propose a Critical Medicines Act to reduce shortages of medicines and medical devices and reduce dependencies from non-EU sources;
• conclude work on the pharmaceutical package by supporting the Institutions to agree on the draft proposals;
• conclude work on anti-microbial resistance as one of the major health threats;
• focus on the implementation of the European Health Data Space, promote the uptake if AI in the Medicinal Products lifecycle and scale up genome sequencing capacities;
• prepare a plan to ensure the cybersecurity of hospitals and healthcare providers in the next 3 to 4 months.

Cybersecurity will impact Life Sciences companies more and more. With increasing digitalisation, cybersecurity, is a crucial aspect of ensuring supply chain security.

Life Sciences companies will face new obligations on an organizational level in the short term, and, on a product specific level in the long term.

Organizational Cybersecurity: The NIS-2 Directive will impact (most) actors in the Life Sciences supply chain

In the short term, the NIS-2 Directive will catch most Life Sciences companies one way or the other, from 18 October 2024 and onwards. The NIS-2 Directive will impose organizational cybersecurity risk management measures and reporting requirements for sectors deemed critical.

The scope of this Directive has been formulated in such a way that many actors involved in the supply chain of medical devices and medicinal products will be covered. Companies within scope have little time left to achieve compliance with the requirements of the NIS-2 Directive.

Further, Life Sciences companies not covered by the NIS-2 Directive may still be affected through their business relationships. This is because they are part of the supply chain for entities that are covered by the NIS-2 Directive. These covered entities are required to address potential vulnerabilities involving their suppliers, service providers, and clients. Therefore, they may request companies outside the NIS-2 Directive to provide proof of adequate cybersecurity measures.

Life Sciences companies operating in the EU may, therefore, wish to prepare an approach to managing related contractual, due diligence and audit requests.

Product Cybersecurity: The Cyber Resilience Act will introduce cyber security requirements to most products with digital elements, except for, (in vitro) medical devices

Over time, product safety will more and more concentrate on cybersecurity needs. For instance, although the proposal for Cyber Resilience Act (CRA) does not apply to (in vitro) medical devices, it will include most products that have digital elements. This means that hardware and software products like real-time data collection or data management systems and lifestyle apps, which are not subject to specific cybersecurity legislation, will be covered by the CRA.

Life Sciences companies acting as manufacturers, importers or distributors may be impacted by the CRA in the future.

The CRA still requires formal adoption before being published in the Official Journal of the EU and entering into force. This would appear to be a matter of time. The publication is expected for Q4 2024.

(in vitro) Medical Devices: Focus on initiatives to improve the functioning of the MDR & IVDR

Further, the national competent authorities had, as a priority, flagged the need for continuous improvement of the regulatory (in vitro) medical devices framework in July 2024. This is to ensure supply chain security and to avoid shortages of (in vitro diagnostic) medical devices. The aforementioned Mission Letter echoes this sentiment. It reiterates the need to ensure the availability and competitiveness of medical devices, and, the need to focus on Better Regulation.

As a first step, the European Parliament and the Council of the EU have already adopted a Regulation amending the Medical Devices Regulation (Regulation (EU) 2017/745) and the In Vitro Diagnostics Regulation (Regulation (EU) 2017/746).

This amendment of the MDR and the IVDR, is intended to safeguard patient care by ensuring the continued availability of certain essential (in vitro) medical devices.
In large, the amendment introduces three main measures:

1. A further extension of the transition period for in vitro diagnostic medical devices (IVDs)
2. An expedited and gradual roll-out of EUDAMED
3. An obligation for manufacturers to notify supply disruptions of medical devices and IVDs

The amendment, also deferred the obligation for in-house device (“Homebrews”) manufacturers to justify the manufacture when CE-marked IVDs are available, to 31 December 2030.

Further, there is a focus on supporting medical devices for rare diseases.

The European Medicines Agency (EMA) has initiated a pilot programme regarding Orphan Designation (OD) medical devices. This is complemented by new OD guidance from the European Commission’s Medical Device Coordination Group (MDCG).

The OD initiatives are intended to support manufacturers of medical devices for indications that have a limited patient population. Limited patient populations pose a challenge to generating clinical data. These initiatives promise to provide guidance and reduce these hurdles in the pre-market phase.

The European Commission has, further, launched public consultations on adopting Common Specifications for certain IVDs (closed 16 September), and, on expanding the options to supply electronic Instructions for Use instead of paper Instructions for Use (closing 11 October). More initiatives are likely to follow in the course of the year.

In our next newsletters, we will delve into specific initiatives in more detail. This will among others include the pharmaceutical package, the Regulation on Substances of Human Origin and the Health Technology Assessment Regulation.