Political change should renew focus on healthcare innovation as an EU policy priority

Political change, at the European Parliament and in Member States through upcoming national elections, brings an opportunity for sharper focus on healthcare innovation as a policy imperative.

The EU’s governments have committed to "long-term competitiveness" and a "more innovation-friendly environment"ⁱ. Europeans are ageing fast, with more exposure to chronic and non-communicable diseasesⁱⁱ. Predictions for European economic growth are modestⁱⁱⁱ. This means that the health of the EU’s citizens, and the type of economy the region wants over the next five years, should matter to all parties in the European Parliament, to Member States and to the new European Commission.

Here are priorities BMS believes European policymakers, nationally and supranationally, should focus on as political cycles renew themselves.

1. Advancing healthcare through joint working

European policymakers are concerned about protecting health, preventing and tackling pandemics, and making health systems more resilient. Europe’s Beating Cancer Plan, the ongoing revision of the EU General Pharmaceutical Legislation, as well as work to improve crisis preparedness and prioritize mental health and non-communicable diseases^iv, are all worthwhile policy initiatives pursued in the last legislative term.

1) Under Europe’s Beating Cancer Plan, the European Commission’s target is to improve the lives of more than three million people by 2030^v. The plan, adopted three years ago, still has work to do to deliver on the 10 flagship initiatives, especially on early detection, diagnosis and treatment for patients and survivors. Faster progress demands investment and Member States’ political commitment, with coordination and support from the European Commission.

2) The EU needs a plan for cardiovascular health, modelled on Europe’s Beating Cancer Plan. As well as prompting behavioral changes and increasing detection, more support for innovation in cardiovascular diseases is needed. Policymakers should better recognize the burden of less well-known inherited cardiac diseases, including cardiomyopathies, to improve early diagnosis. BMS has urged annual heart health checks in Member States to screen for metabolic and inherited risk factors, and harmonized data registries for disease prevention, diagnosis and treatment. This is consistent with the European Alliance for Cardiovascular Health whose membership includes biopharmaceutical industry trade association EFPIA.

The Regulation on the European Health Data Space (EHDS), agreed in March 2024, pledges to improve Europe’s digital health ecosystem for patients, healthcare professionals, health systems and researchers. One aim of the EHDS is to provide a consistent, trustworthy and efficient system for reusing health data for research, innovation, policymaking and regulatory activities. This aim concerns the secondary use of data. It will be critical for our industry to be involved in the implementation of the new regulation, especially since some of the definitions and types of data in scope for secondary use remain unclear.

2. Catalyzing European life sciences leadership

As well as helping with Member State funding for building critical healthcare infrastructure like hospitals, workforces and IT systems, the EU’s institutions should ensure that operating conditions support the competitiveness of the European life sciences sector. Discovery, development and manufacturing are fundamental parts of the innovation lifecycle. They should be given every chance to thrive.

Here are some ideas.

1. Retain a strong intellectual property framework.
That includes maintaining baseline Regulatory Data Protection (RDP) at eight years, ensuring efficiency and predictability in the Supplementary Protection Certificate granting procedures, and providing for adequate patent enforcement. These are all important signals of confidence in the EU as a region that values innovation. The European Commission has proposed reducing baseline RDP to six years and link ‘earning it back’ to access and supply conditions. The conditionality, proposed under the review of the EU General Pharmaceutical Legislation, is unworkable because it cannot be achieved by innovators alone. It creates uncertainty for the industry which would undermine investment. It will not deliver access to more new medicines.

2. Future-proof the European regulatory framework.
It should be faster and more agile, and tailored to the needs of science.

a. A regulatory sandbox, proposed by the European Commission and supported by the European Parliament, could provide a clear path for innovation to emerge. Legislation cannot move as fast as science so allowing space for exploratory thinking would help to overcome regulatory hurdles.

b. Expedited regulatory pathways (ERPs) consist of several regulatory tools, including PRIME, Conditional Marketing Authorization and Accelerated Assessment. Their use has so far been limited to a small number of products, in contrast with other regions. Globally competitive ERPs would accelerate the development and delivery of medicines to patients and help to close Europe’s competitiveness gap.

c. With enhanced evidentiary requirements for innovators’ products, the regulatory network, centrally and across Member States, needs investment for capacity-building. The EU should pursue regulatory convergence and harmonization among major regulators, including the US. Moving towards mutual recognition of good manufacturing practice inspections, batch release and post-approval changes can support patients’ access to new medicines and supply chain resilience.

3. Foster more clinical trials in the EU.
They offer an early access pathway for new medicines for patients who may not have an alternative treatment available. Clinical trials draw funding and talent, and generate revenue for hospitals. With the EU’s global share of clinical trials declining^vi, we support continued investment in the European Clinical Research Network, as well as taking steps to facilitate multinational clinical trials. In particular, the implementation of the Clinical Trials Regulation should be closely monitored so that it delivers on its goal to streamline how clinical trials are approved and regulated. We support moves towards more harmonization in clinical trial application reviews between the European Medicines Agency and national ethics committees.

4. Remain an attractive location for manufacturing medicines.
That includes taking a balanced and science-based approach to the implementation of environmental legislation under the European Green Deal. Environmental obligations should not turn into competitive disadvantages for the EU. They should not undermine the EU’s ambition for strategic autonomy and supply chain resilience.

3. Delivering access to new medicines

Wide disparities persist in the time it takes European patients to access new medicines, as well as the number of medicines available in Member States. The average time is 531 days, with Germany faring best at 126 days and Poland performing worst at 804 daysvii. Access to new medicines is a responsibility shared by governments, industry and prescribers. The root causes of delays and unavailability for new medicines are diverse. Healthcare systems should invest in Health Technology Assessment (HTA) capabilities to reduce wait times. Adequate multi-annual funding is needed for innovation.

More can be done to accelerate patients’ access to new medicines.

1) A European joint clinical assessment process for medicines, which comes into effect from January 2025, aims to generate efficiency gains and strengthen the quality of HTA in the EU. It is vital that implementation of the EU HTA Regulation guarantees an inclusive system yielding high-quality clinical assessments without incurring extra delays in access nationally. Member States should invest in, and adapt, their healthcare systems to make the most of the new process.

2) Cost off-sets for healthcare systems – like faster discharges, reduced hospital readmissions and return to work - should be considered in the design of HTAs.

3) The European Commission should support continued investment in national healthcare systems. This could be done through the European Semester by helping Member States to protect healthcare budgets or by considering certain healthcare spending as investment in applying fiscal rules under the Stability and Growth Pact. European policymakers should recognize the role of national commercial conditions in attracting biopharmaceutical industry investments.

Collaboration

In a surveyviii by Eurobarometer before the recent European Parliament elections, public healthcare was the second most important issue for voters. Almost one-third of respondents said supporting public health should be a priority for policymakers. With MEPs taking their seats, a new European Commission about to form and national elections happening in about one-third of Member States over the next year, it is clear that at all levels of policymaking there is work to do to ensure the EU is set up for competitiveness, growth and healthcare innovation.

Given its impact in society and the economy, the biopharmaceutical industry is uniquely positioned to be an innovation partner for policymakers. While science is a powerful tailwind, structural demand-side changes are needed to ensure that all European citizens, including patients, can fully benefit from progress.

References:

ⁱ    European Council
ⁱⁱ    European Commission
ⁱⁱⁱ   OECD
^iv   ENVI report on NCDs
^v    European Commission
^vi   Charles River Associates
^vii  EFPIA
^viii Eurobarometer