What’s next on the EU health agenda?

From trending debates to industry impact

Incoming European Commission President Ursula von der Leyen, a former doctor, has made legislation on Artificial Intelligence (AI) and a ‘European plan to fight cancer’ two of her immediate political priorities, signalling a renewed focus on the healthcare industry in the coming term. Against a backdrop of constrained healthcare budgets, with countries increasingly working together to find new ways to bring down costs, expect the EU to become increasingly active in health-related policies to help address some of the challenges facing European healthcare systems. The last Commission laid the groundwork for continued progress on the EU’s digital health agenda, while sticky debates on IP and access to medicines underscored an increasingly fragmented and politicised EU health policy landscape, which looks set to continue under the next mandate. Prepare your calendars for the opportunities and challenges this 5 year mandate could throw your way, as we outline the top 5 issues likely to dominate the EU’s healthcare agenda.

1. HEALTHCARE’S DIGITAL TRANSFORMATION

The healthcare industry has begun to see the fruits of the EU’s digital agenda, with recent steps to improve sharing of healthcare information across borders, and pilot initiatives to improve the use of healthcare data for research, which it is hoped will serve as a basis for the wider digital transformation of European healthcare systems.  While patients, industry and policymakers alike are generally supportive of this goal, the slow and fragmented uptake at national level and challenges around the legal and regulatory framework are hindering progress towards the ambition of an integrated European health data ecosystem.

Potential impact? While work so far has focused more on the ‘building blocks’ of digital health such as interoperability and data exchange, expect to see a greater focus on advanced digital tools to empower patients and improve healthcare systems under the next phase of the EU’s digital health strategy. Hard legislation on Artificial Intelligence expected in the first 100 days of the new Commission, as well as anticipated sector-specific ethical guidelines for healthcare, will be a first test for the industry, which must also work to build greater understanding and trust regarding the use of personal data.

2. OVERHAULING THE IP FRAMEWORK AND PHARMACEUTICAL LEGISLATION

The recently introduced ‘SPC waiver’ – which allows generic medicines to be manufactured for export while the originator drug is still protected by IP – has paved the way to further reforms of the EU pharmaceutical IP framework post-2019. The EU’s Paediatric and Orphan Medicinal Products Regulations, which have been criticised by health NGOs for encouraging high prices, are currently under review. A new European Parliament with a high proportion of fresh faces is unlikely to be more friendly to the pharma industry, and reforms to the IP incentives framework are widely expected.

Potential impact? The real question is whether the Commission will revisit the broader IP framework, with the potential impact on innovative industry being far greater than the SPC manufacturing waiver. Speculation is also ripe that the overall pharmaceutical legislative framework covering the requirements and procedures for marketing authorisation will be revisited.

3. AN AMBITIOUS RESEARCH AND INNOVATION AGENDA

The EU has proposed a significant boost to its R&I agenda, with Horizon Europe, its €100 billion funding programme, currently under negotiation. A new ‘mission-oriented’ approach, which includes a specific focus on cancer, could amplify its impact, but it will need to prove its worth over the coming years. The ‘ Innovative Health Initiative’, the successor to the IMI as the world’s largest life sciences Public-Private Partnership, will have a broader outlook that includes players from the medical technologies and digital industries, recognising the need for cross-sectoral collaboration to drive European healthcare innovation.      

Potential impact? Will the European Parliament agree to fund the partnership again without guarantees from the industry that this will positively impact the price of medicines? And will the medical industry be ready to pay into the partnership? As the next health PPP extends its focus towards diagnostics, digital and medical technologies, expect engagement across the broader healthcare and life sciences business community.

4. AN UNCERTAIN FUTURE FOR HEALTH TECHNOLOGY ASSESSMENT

Under the last mandate, the European Commission adopted a hotly discussed legislative proposal to perform joint HTA at EU level, hoping to provide a legislative basis for Member States to work together to assess the added value of new healthcare technologies. Industry was divided on the issue: with pharma companies generally supporting the initiative and medical devices pushing hard to remain out of scope, while the patient community voiced concerns its voice was not being heard. Most controversial was the proposed mandatory uptake of joint clinical assessments, opposed in particular by larger countries (particularly Germany and France) that are protective of their own methods of assessment.

Potential impact? The lack of an EU level HTA is widely seen as leading to duplication and inefficiencies that impede pharmaceutical market access, which the EU is trying to address through joint action. The file is unlikely to make significant progress in 2020, particularly in view of the upcoming German Presidency of the Council, but there are concerns that a softened (e.g. voluntary) approach for pharmaceuticals could end up being even more duplicative than the current situation. 

5. COUNTRIES GROUPING TOGETHER ON PRICING

European governments are looking at every possible option to bring down the price of medicines, including through multi-country cooperation to jointly negotiate prices. A number of such cross-country initiatives like the ‘Valletta Group’ and ‘BeneLuxA’ have emerged in recent years, and most recently a group of at least 12 countries has come together to develop an international horizon scanning database to inform pricing decisions. While there is no formal role for the EU in these discussions, the Commission is increasingly getting involved in a matter that for the time being is a Member State exclusive competence.

Potential impact? These initiatives highlight a clear willingness from EU countries to pool resources and present a united front in pricing negotiations. Translating political commitments into concrete outcome has proved challenging and will require countries to amend national legislation and procedures in the future.

Seize the opportunity, manage the risk

Digitisation, decarbonisation and an ever changing competitive and geopolitical global stage are going to be key themes for the upcoming mandate. This new European mandate will see the EU work fast towards meeting these challenges. The energy, transport and industrials space will look very different in 5, 10 years’ time – is your business ready?

Want to know more? Contact Antoine Mialhe, or go to getready4.eu

FTI_Logo_white

*This factsheet only addresses a selection of the key files impacting healthcare companies The views expressed are those of the author and not necessarily the views of FTI Consulting, Inc., its management, its subsidiaries, its affiliates or its other professionals

© 2019 FTI Consulting, Inc., including its subsidiaries and affiliates, is a consulting firm and is not a certified public accounting firm or a law firm. All Rights Reserved

About FTI Consulting: FTI Consulting is an independent global business advisory firm dedicated to helping organisations manage change, mitigate risk and resolve disputes: financial, legal, operational, political & regulatory, reputational and transactional. FTI Consulting professionals, located in all major business centres throughout the world, work closely with clients to anticipate, illuminate and overcome complex business challenges and opportunities. Connect with us at www.fticonsulting.com or on Twitter (@FTIConsulting), Facebook and LinkedIn. The views expressed herein are those of the author(s) and not necessarily the views of FTI Consulting, Inc. its management, its subsidiaries, its affiliates, or its other professionals, members of employees.

www.fticonsulting.com